bioihbjkbjnl/mcl2 huggingface dataset:
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Topiramate; Erenumab matching placebo; Topiramate matching placebo
Intervention description: 70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks; Film-coated tablet taken orally:
25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase.; Erenumab matching placebo pre-filled syringue administered every 4 weeks; Topiramate matching placebo administered daily
Intervention MeSH terms: Topiramate; Erenumab; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 777.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Episodic migraine; Chronic migraine; Headache; erenumab; topiramate; CAMG 334; Calcitonin Gene-related Peptide; CGRP; CGRP receptor agonist; monoclonal antibody; treatment failure

Summary:

      This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind,
      double-dummy design in adult patients with episodic migraine and chronic migraine, who had to
      be either naïve or not suitable for or could have failed up to three prophylactic treatments
      out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into
      groups according to their number of migraine days during the baseline period.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Documented history of migraine in the 12 months prior to screen

          2. at least 4 days per month of migraine symptoms

          3. >=80% diary compliance during the Baseline period

          4. Patients must be either naïve or not suitable or have failed previous migraine
             prophylactic treatments

        Key Exclusion Criteria:

          1. Older than 50 years of age at migraine onset

          2. Pregnant or nursing

          3. History of cluster or hemiplegic headache

          4. History or evidence of major psychiatric disorder

          5. Score of 19 or higher on Beck Depression Inventory (BDI)
Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination
Condition: Hepatitis A; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Twinrix; Engerix-B; Havrix; HBVAXPRO; Vaqta
Intervention description: Intramuscular injection, single dose in left deltoid.; Intramuscular injection, single dose in left deltoid.; Intramuscular injection, single dose in right deltoid.; Intramuscular injection, single dose in the left deltoid.; Intramuscular injection, single dose in right deltoid.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune memory; Combined hepatitis A and B vaccine; > 41 years old

Summary:

      Only subjects who participated in the primary study will be invited to participate in the
      extension phase and the challenge dose phase of this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female who completed the primary vaccination phase of the HAB-160 study (NCT
             00603252).

          -  Written informed consent obtained from the subject.

          -  If the subject is female, she must be of non-childbearing potential; or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two months after the vaccination.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If any apply, the
        subject must not be included in the study:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the challenge dose, or planned use during the
             study period.

          -  History of any hepatitis A or hepatitis B vaccination or infection since the primary
             vaccination study.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment.

          -  Pregnant or lactating female.
Liposomal Bupivacaine vs Peripheral Nerve Block
Condition: Pain, Acute; Surgery; Anesthesia; Opioid Use
MeSH terms: Acute Pain
Intervention: Liposomal bupivacaine; Peripheral Nerve Block
Intervention description: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area; Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Liposomal bupivacaine has gained interest in recent literature for its potential to be an
      effective adjunct to other pain control modalities in a multi-modal approach to
      post-operative pain control. The goal of this investigation is to compare the efficacy of
      local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block
      in terms of post-operative pain scores after elective ankle and hindfoot surgery. The
      investigators hypothesize that there will not be a significant difference in the pain scores
      of these two groups in opioid naïve patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 18 years of age or older

          2. Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis,
             subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon
             debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy,
             Dwyer Osteotomy)

        Exclusion Criteria:

          1. Patients who are undergoing revision surgical procedure

          2. Patients who have taken opioid pain medications in the past 3 months prior to surgical
             procedure

          3. Patients who have allergies to any of the medications or components of medications
             investigated in the study

          4. Patients currently incarcerated

          5. Patients who cannot read and speak English
The Effects of Montelukast on Smokers With Asthma
Condition: Asthmatic Smokers; Non-asthmatic Smokers
MeSH terms: Asthma
Intervention: Fluticasone Propionate; Montelukast; Salmeterol
Intervention description: DPI 250 mcg BID for 3 weeks; PO 10 mg QHS for 3 weeks; DPI 50mg BID for 3 weeks
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Montelukast; Leukotriene Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: asthmatics; smokers; inhaled corticosteroids; leukotriene receptor antagonists

Summary:

      The purpose of this study is:

        1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices
           between smokers and non-smokers.

        2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

        Asthmatics:

          -  clinical history of asthma for at least 1 year

          -  with evidence of reversible airway obstruction,

          -  two documented FEV1 between 60-85%,

          -  PC20 < 4mg/ml by methacholine challenge test

          -  and average baseline β-agonist use of 2 puffs/day

        Smokers:

          -  smoke 1/2 to 2 packs a day

          -  with a smoking history of 5-30 pack years

        Non-smokers:

          -  Non-smokers will have either never smoked or have stopped smoking cigarettes over 5
             years ago

        Exclusion Criteria:

          -  positive HCG (for females)

          -  have a respiratory tract infection or need oral corticosteroids within the preceding 6
             weeks

          -  history of COPD or respiratory disorder other than asthma

          -  history of psychiatric illness

          -  allergy to fluticasone propionate, salmeterol, montelukast or any of their components

          -  significant, unstable medical condition other than asthma

          -  history of life-threatening asthma exacerbation requiring intubation and mechanical
             ventilation in the last ten years
Nebulized Sub-dissociative Dose Ketamine for Treating Pain
Condition: Pain
Intervention: Ketamine 0.75 mg/kg; Ketamine 1.0 mg/kg; Ketamine 1.5 mg/kg
Intervention description: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg; Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg; Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      The investigators previous research study comparing the efficacy of intravenous ketamine to
      morphine showed ketamine to provide equivalent relief of moderate to severe acute pain in
      emergency department patients. A second study by the investigators showed that increasing the
      time of administration of the ketamine, from a push injection to a drip infusion, will
      minimize the adverse effects experienced by recipients of ketamine.

      The investigators now aim to see if nebulized subdissociative-dose ketamine administered as a
      single agent in a dose of 1.5 mg/kg via Breath-Actuated Nebulizers (BAN) over 5-15 minutes
      will provide a better pain relief in comparison to 1 mg/kg and 0.75 mg/kg doses or if the
      lower doses are equally as effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older

          -  acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as
             well as cancer pain

          -  initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating
             scale.

        Exclusion Criteria:

          -  altered mental status,

          -  allergy to ketamine,

          -  weight greater than 150 kg,

          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg,

          -  pulse rate <50 or >150 beats/min,

          -  respiration rate <10 or >30 breaths/min)

          -  alcohol or drug abuse

          -  inability to provide consent

          -  psychiatric illness (schizophrenia),

          -  recent (4 hours before) opioid use.
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution; bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
Intervention description: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.; 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or
      Ocular Hypertension Subjects Treated with Xalatan®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with glaucoma or ocular hypertension.

          -  Visual Acuity 20/100 or better in both eyes

        Exclusion Criteria:

          -  Any active ocular disease

          -  History of any intraocular surgery or glaucoma laser surgery within 3 months

          -  Contraindication to pupil dilation

          -  Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Condition: Otitis Media
MeSH terms: Otitis Media
Intervention: dornase alfa (Pulmozyme®)
Intervention description: This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: clogged ear tubes

Summary:

      The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear
      drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the
      new drug for any problems related to the medication. Patients are being asked to be in this
      study because they had tubes placed for the treatment of chronic ear infection and the
      tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes.
      This problem occasionally is improved with ear drops like Floxin®. However, it is frequently
      not improved even after this standard ear drop treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects from age 1 to 18 years who have undergone tube placement in the previous 9
             months.

          -  subjects with middle-ear fluid on entry into the study will be required to have had a
             prior normal hearing test.

        Exclusion Criteria:

          -  subjects with symptoms of an acute otitis media (otalgia or otorrhea), sensorineural
             hearing loss,cranio-facial syndromes, cystic fibrosis, prior ear surgery except tube
             placement, sensitivity to fluoroquinolones and presence of granulation tissue in the
             lumen of the tympanostomy tubes will be excluded.
Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Oxcarbazepine
Intervention description: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Intervention MeSH terms: Oxcarbazepine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oxcarbazepine; Brain Derived Neurotrophic Factor; Bipolar disorder; Neuroprotection

Summary:

      The present study has been designed to evaluate the change in serum BDNF level with
      oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its
      neuroprotective effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with the diagnosis of bipolar affective disorder (by ICD-10 DCR) current
             episode mania without psychotic symptoms

          -  Patients aged 18-45 years, of either sex.

          -  Patients with baseline score > 20 on the Young Mania Rating Scale (YMRS).

          -  Patients who had not taken any treatment for at least 4 weeks before inclusion.

        Exclusion Criteria:

          -  Patients with bipolar disorder (by ICD-10 DCR) presenting during
             depressive/euthymic/mixed episode.

          -  Patients who are already under treatment for the presenting conditions.

          -  Rapid cycling in the past 12 months.

          -  Previous history of refractoriness to carbazepine or oxcarbazepine.

          -  Patients with comorbid substance abuse or history of organicity

          -  Pregnant and nursing women, patients with history of major medical or neurological
             illness.
Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Condition: Catheter-related Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Intervention: Chlorhexidine-impregnated foam dressing
Intervention description: Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.
Intervention MeSH terms: Chlorhexidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1088.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      We proposed to perform a prospective randomized controlled trial to study the effect of the
      use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of
      central venous catheter care on catheter-related bloodstream infections among patients in two
      Barnes-Jewish Hospital ICUs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen
             catheters, quadruple lumen catheters, percutaneously inserted central catheters,
             arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).

        Exclusion Criteria:

          -  patients who are not enrolled into the trial within 7 days of having the catheter
             being placed and patients who are allergic to chlorhexidine.
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Condition: MRI Sedation
Intervention: dexmedetomidine; propofol
Intervention description: dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan; propofol IV administration will be given if needed to maintain sedation
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: procedural sedation; dexmedetomidine; propofol; MRI

Summary:

      This is a randomized, double-blind, dose-ranging study of the efficacy and safety of
      dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric
      subjects ≥1 month to <17 years of age undergoing MRI scans in the US and Japan.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female subject ≥1 month and <17 years of age.

          2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.

          3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for
             a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or
             other proceduralist in attendance.

          4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3
             hours to complete

        Key Exclusion Criteria:

          1. Pregnant female subjects (including those with an indeterminate or positive pregnancy
             test); breastfeeding female subjects.

          2. Weight on Day 1 before randomization is less than the 10th percentile of weight for
             age and sex in the US and Japan or is greater than the 95th percentile of weight for
             age and sex in the US or greater than the 97th percentile of weight for age and sex in
             Japan based on sponsor-provided growth charts.

          3. Planned medical procedure during the MRI scan or post-MRI recovery period.

          4. Requires endotracheal intubation or laryngeal mask airway (LMA).

          5. Known allergy to eggs, egg products, soybeans or soybean products.

          6. SpO2 <93 % on room air -