bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: secukinumab; AIN457; Moderate to severe plaque psoriasis; immune-mediated systemic disease; scaly patches; papules; plaques; itching

Summary:

      Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients
      with or without prior exposure to systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged at least 18 years at time of Screening.

          -  Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to
             Screening and candidate for systemic therapy.

          -  Other protocol defined inclusion criteria may apply. Please refer to the protocol.

        Exclusion Criteria:

          -  Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g.
             drug-induced psoriasis at Screening.

          -  Patients with previous treatment with any agent targeting interleukin (IL)-17 directly
             or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential unless they use effective contraception
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
Condition: Agitation
MeSH terms: Emergencies
Intervention: Quetiapine; Haloperidol; Lorazepam; Cogentin
Intervention description: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD; given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary; given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.; given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
Intervention MeSH terms: Lorazepam; Haloperidol; Benztropine; Quetiapine Fumarate; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M.
      Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to
      be an effective treatment. However, since it is an intramuscular injection, it is more
      complicated and perhaps less acceptable to patients as well as more likely to cause EPS
      (extrapyramidal symptoms). Of late in our emergency room, we started using high dose
      Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising
      results.
    

Eligibility criteria:

        Inclusion Criteria:

          1. English or Spanish speaking patients

          2. Provision of written informed consent-English and Spanish

          3. Males and females age 18 to 60 years. Females who are pregnant by inspection should
             not be included.

          4. Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental
             Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an
             agitated state. PANSS-EC score should be >15.

          5. Ability, in the treating physician's opinion, to co-operate with taking oral
             medication

        Exclusion Criteria:

          1. Pregnant females who will thus receive routine care in the treating physician's
             opinion

          2. Unstable medical illness

          3. Withdrawal stage from any illicit drugs

          4. Psychosis that prohibits participation in trial

          5. Females of childbearing age where pregnancy cannot be confirmed or denied by screening

          6. Patients who required continued intervention or prolonged restraint
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Morphine PCA; Hydromorphone PCA
Intervention description: Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL; hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: pain; morphine; hydromorphone; nausea; vomiting; pruritis

Summary:

      Both morphine and hydromorphone are pain medications commonly used after surgery. It is
      thought at the institution that hydromorphone causes less side effects but this has not been
      studied. The study proposes to treat the patients with either morphine or hydromorphone and
      determine how much nausea, vomiting, and itching they have with each drug
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients scheduled for abdominal surgery requiring post-operative PCA

          -  ASA = I or II

        Exclusion Criteria:

          -  preoperative pain or use of pain medication

          -  narcotic allergy

          -  morbid obesity (Body Mass Index > 30)

          -  diagnosis of sleep apnea

          -  hepatic or renal disease

          -  use of medications that would affect narcotic pharmacodynamics

          -  preoperative nausea, vomiting, or pruritis

          -  diagnosis of alcoholism
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
Condition: Smoking Cessation
Intervention: placebo; varenicline
Intervention description: placebo tablet taken orally twice daily for 12 weeks; varenicline tablets, 1 mg taken orally twice daily for 12 weeks
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 659.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: smoking cessation; smoking treatment; patient self-selected quit date

Summary:

      The hypothesis is that varenicline will be effective (compared with placebo) for smoking
      cessation when subjects are allowed to set their own quit date within the first 5 weeks of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women

          -  18 to 75 yrs old

          -  Motivated to stop smoking

          -  Smoke at least 10 cigarettes/day

        Exclusion Criteria:

          -  Active psychiatric disease

          -  Severe or unstable cardiovascular or pulmonary disease

          -  Current or recent treatment to stop smoking

          -  Previous use of varenicline
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Condition: Bleeding; Blood Loss, Surgical; Cardiovascular Surgical Procedures; Prothrombin Complex Concentrates; Fresh Frozen Plasma
MeSH terms: Hemorrhage; Blood Loss, Surgical
Intervention: Prothrombin complex concentrate (Human); Fresh frozen plasma (FFP)
Intervention description: PCC (Kcentra); FFP
Intervention MeSH terms: Thrombin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be the first prospective randomized controlled clinical trial directly comparing
      Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post
      cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a
      difference in bleeding and transfusion requirements in patients received PCC versus FFP?
    

Eligibility criteria:

        Inclusion Criteria

        All subjects accepted for this study must:

          -  Be 18 years of age

          -  Be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass

          -  Have evidence of excessive microvascular bleeding in the surgical field as determined
             by the surgical team in addition to a PT >16.6 sec or INR >1.6 sec.

        Exclusion Criteria

        Subjects who have one or more of the following will be excluded from the study:

          -  Are unable to grant informed consent or comply with study procedure

          -  History of hypercoagulable condition (e.g. Factor V Leiden, AT-3 deficiency,
             Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc) or previous
             unprovoked thromboembolic complications

          -  Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin
             induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at
             the time of cardiovascular surgery

          -  Thromboembolic event within past 3 months

          -  Received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within
             the past 5 days

          -  Patients taking chronic warfarin therapy who have not discontinued treatment and
             demonstrated an INR <1.3 prior to surgery

          -  Fibrinogen level <150 mg/dL on initial post cardiopulmonary bypass labs

          -  Antithrombin 3 level < 80% control (preoperative)

          -  Are undergoing emergency open heart-surgery

          -  Cardiopulmonary bypass time is expected to be < 30 minutes

          -  Age < 18 years of age

          -  Are pregnant
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: Sodium Ferric Gluconate Complex in Sucrose.
Intervention MeSH terms: Ferric gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Anemia

Summary:

      A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal
      guardian had provided signed informed consent, and who had satisfied the inclusion and
      exclusion criteria of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally
             authorized representative provided signed informed consent.

          -  Stabilized on chronic hemodialysis therapy with an identified need for maintenance
             iron therapy.

          -  Predetermined TSAT and serum Ferritin (at the screening visit).

          -  Receiving a stable EPO dosing regimen.

        Exclusion Criteria:

          -  Receipt of any form of iron supplementation during the 2 weeks prior to the first
             Ferrlecit dosing.

          -  Hypersensitivity to Ferrlecit or any of its inactive components.

          -  High TSAT level.

          -  High Serum Ferritin
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Condition: Clostridium Difficile Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Metronidazole; Placebo
Intervention description: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days; Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 76.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Clostridium difficile infection; Diarrhea; Flagyl; Metronidazole

Summary:

      The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing
      the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk
      for this infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inpatients >55

          -  Proton Pump inhibitor / Histamine-2 Blocker

          -  On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are
             selected based on current hospital formulary/use

          -  Anticipated hospital stay >48 hours

          -  Mental capacity (able to give informed written consent).

        Exclusion Criteria:

          -  Admission for CDI

          -  Existing diarrhea at admission

          -  Passed prophylactic window (>48 hours on broad spectrum antibiotics)

          -  Unable to take PO at the time of evaluation for study entry

          -  No more than 14 days of broad spectrum antibiotics anticipated

          -  Medications with serious interactions/contraindications to that would be taken
             together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin
             inhibitors)

          -  Inflammatory Bowel Disease

          -  Admission for colonic bowel surgery or h/o total/Subtotal colectomy)

          -  Hospice

          -  Mortality expected <7days

          -  Previous CDI in the past 6 months

          -  Intensive care admission due to the difficulty of monitoring them

          -  Allergy to Metronidazole or other Antibiotics in protocol

          -  Patients with neuropathy

          -  History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past
             24 hours,Solid organ transplant.
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Condition: Pain
Intervention: etoricoxib
Intervention description: etoricoxib 60 mg QD for 4 weeks.
Intervention MeSH terms: Etoricoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to collect disease burden of OA and the effectiveness and
      patient satisfaction of treatment by Etoricoxib in the normal practice setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must Be Over 20 Years Of Age, Regardless Of Sex

          -  Must Have A Diagnosis Of OA That Requiring Treatment

          -  Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The
             Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse
             Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From
             0-100 mm)

          -  Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health
             Based On Medical History, Physical Examination, And Routine Laboratory Tests

          -  Must Agree To Participate Voluntarily In The Study

          -  Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study

          -  Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks
             After The Initiation Of Treatment With Etoricoxib

          -  Patient Is Willing To Sign Informed Consent Form

        Exclusion Criteria:

          -  Under 20 Years Of Age

          -  Severe Hepatic Insufficiency (Child-Pugh Score > 9)

          -  Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)

          -  Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug
             Package Insert

          -  Gi Ulcer With Active Bleeding Present At Study Enrollment

          -  Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic
             Attack (Within The Previous 2 Years)
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Dysport® (abobotulinumtoxinA); Botox® (onabotulinumtoxinA)
Intervention description: Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units; Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cervical dystonia; botulinum toxin

Summary:

      1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in
           comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment
           of Cervical dystonia.

        2. double blind, randomised, multi center, crossover study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years of age of both genders,

          -  Cervical dystonia

          -  symptoms with a minimum duration of 18 months,

          -  Negative pregnancy test in sexually active women,

          -  Able to participate in the study (understand goals of botulinum toxin A treatment and
             sign Informed Consent Form).

        Exclusion Criteria:

          -  Patient with cervical contractures

          -  Known significant underlying dysphasia

          -  Patients who have received botulinum toxin treatment within the past 4 months.

          -  Contraindication to botulinum toxin treatment

          -  Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert
             syndrome, ALS …)

          -  Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or
             denervation surgery, deep brain stimulation for cervical dystonia,

          -  Patients who required more than 500 units of Dysport or 200 units of Botox.

          -  Any concomitant treatment that could interfere with the action of botulinum toxin,

          -  Subjects having participated within the last 3 months or currently participating in an
             investigational drug study,

          -  Pregnancy,

          -  Lactation.
Clinical Outcomes Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine
Condition: Anesthesia, Local
Intervention: Lidocaine
Intervention description: Efficacy for mandibular molar and canine anesthesia
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking description: double blind
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: lidocaine, mandible

Summary:

      Assess the clinical impact of Buffered 1% lidocaine with epinephrine as compared to the
      Non-buffered 1% lidocaine with epinephrine in dental and oral surgical procedures.
    

Eligibility criteria:

        Inclusion Criteria:

        Age 18-30 years American Society Anesthesiologists I,II

        Exclusion Criteria:

        Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week
        Current symptoms in teeth or oral mucosa
Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty
Condition: Arthroplasty, Replacement, Knee; Pain
Intervention: Liposomal bupivacaine
Intervention description: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liposomal Bupivacaine; Simultaneous Bilateral Total Knee Arthroplasty; Safety

Summary:

      The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine
      in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the
      use of a standardized periarticular injection containing free bupivacaine and liposomal
      bupivacaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients deemed appropriate candidates for simultaneous bilateral total knee
             arthroplasty.

          -  Patients receiving general anesthesia

          -  Understands the local language and is willing and able to follow the requirements of
             the protocol

          -  Understands the informed consent and signs the institutional review board/ independent
             ethics committee (IRB/IEC) approved informed consent form

        Exclusion Criteria:

          -  Patients less than 18 years of age

          -  Allergy to bupivacaine

          -  Allergy to epinephrine

          -  Patients who are not medically cleared to undergo bilateral total knee replacement
             surgery, or

          -  Patient-reported liver impairment (per investigator discretion)

          -  Patient-reported renal impairment (per investigator discretion)

          -  Patients receiving spinal anesthesia

          -  Females who are pregnant or lactating