bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Pain Control in Septum and Sinus Surgery
Condition: Post-operative Pain; Sinus Surgery
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen 325 mg Oral Tablet; Acetaminophen 650 mg Oral Tablet; OxyCODONE 5 mg Oral Tablet; Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Intervention description: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain; Acetaminophen 650 mg scheduled every 6 hours round the clock for pain; Oxycodone 5 mg every 4 hours as needed for breakthrough pain; Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-operative pain; Sinus pain; Sinus surgery; Septum Pain; deviated septum

Summary:

      This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will
      lead to less opiate use in the first week post-operative (after surgery) in sinus/septum
      surgery patients. Participants will be randomized like a flip of a coin to either the
      standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates
      (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of
      acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum
             surgery

          -  18 years of age or older

          -  Male or female

          -  No known allergies to or contraindications to the use of acetaminophen, hydrocodone,
             or oxycodone

          -  Patients discharged to home after surgery

        Exclusion Criteria:

          -  Undergoing revision sinus, septum, or sinus/septum surgery

          -  Younger than 18 years old

          -  Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone

          -  Patients admitted to the hospital postoperatively for airway monitoring
Vaginal Preparation Prior to Hysterectomy
Condition: Hysterectomy
Intervention: Chlorhexidine; Iodine
Intervention description: Chlorhexidine preparation solutions; Iodine-based preparation solutions
Intervention MeSH terms: Chlorhexidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled trial to determine the influence of chlorhexidine gluconate
      surgical/topical antiseptic solutions on the bacterial environment of the vagina during
      hysterectomy and compare that to the effect of standard iodine-based preparations on the
      same.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or
             robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology
             Associates or Tri-State Gynecology Oncology TriHealth Inc.

          -  Concomitant procedures such as vaginal vault suspension, suburethral sling,
             cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral
             salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and
             other indicated procedures will be included

          -  English speaking

          -  Ability to provide consent

        Exclusion Criteria:

          -  Unwillingness to participate in the study

          -  Non English speaking

          -  Patients that do not undergo a hysterectomy

          -  Reported allergy to iodine or chlorhexidine preparation solutions

          -  Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary
             peritoneal cancers

          -  Current infection necessitating hysterectomy

          -  Active sepsis, pelvic abscess or pelvic inflammatory disease
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Bilateral erector spinae blocks using ropivacaine
Intervention description: Bilateral chest wall nerve blocks using ropivacaine.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Prospective single-arm intervention trial
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: regional anesthesia; cardiac surgery; erector spinae

Summary:

      To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for
      postoperative analgesia in children and adolescents undergoing cardiac surgical procedures
      via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open
      label, interventional study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for
             elective surgeries for the following congenital anomalies, or similar: atrial septal
             defects (all types), partial anomalous pulmonary venous connection (non-obstructed),
             cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous
             aortic origin of the coronary arteries, and pulmonary valve/conduit implantation

          2. Scheduled for a primary sternotomy.

          3. Ages 2 years through 17 years.

        Exclusion Criteria:

          1. Single ventricle physiology.

          2. Significant scoliosis or other anatomic contraindications to ESB.

          3. Significant intraoperative hemodynamic instability or bleeding, as ascertained by
             clinicians taking care of the patient.

          4. Patients with severe neurodevelopmental delays.

          5. Patients with previous chronic pain syndromes.

          6. Patients with a history of greater than 24 hours of postoperative or post-procedural
             opioid treatment at any point in the 2 months prior to surgery.

          7. Lack of parental consent and/or child assent.
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib
Intervention description: Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CML; Leukemia; Tasigna; nilotinib; AMN107; CML-CP; Chronic Phase

Summary:

      The purpose of this exploratory study will be to examine changes in chronic low grade chronic
      adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading,
      when patients are switched from imatinib to nilotinib therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients ≥ 18 years of age

          2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2

          3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)

          4. Patients must be an imatinib responder and achieved the following efficacy milestones
             as appropriate for the length of time on imatinib therapy as per protocol

          5. CML-CP patients initiated on any dose of imatinib

          6. Ability to provide written informed consent prior to any study related screening
             procedures being done

        Exclusion Criteria:

          1. Loss of CHR or cytogenetic response

          2. Prior accelerated phase or blast phase CML

          3. Previously documented T315I mutation

          4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than
             Ph+.

          5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

          6. Treatment with other investigational agents within 30 days of Day 1.

          7. History of non-compliance to medical regimens or inability to grant consent.

          8. Women who are pregnant, breast feeding, or of childbearing potential without a
             negative serum test at baseline. Male or female patients of childbearing potential
             unwilling to use contraceptive precautions throughout the trial and 3 months following
             discontinuation of study drug. Post-menopausal women must be amenorrheic for at least
             12 months to be considered of non-childbearing potential. Women of childbearing
             potential must have a negative serum pregnancy test prior to the first dose of
             nilotinib.

        Other protocol-defined inclusion/exclusion criteria may apply
RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
Condition: Acute Pain; Wound Care; Posttraumatic Stress Disorder
MeSH terms: Acute Pain; Stress Disorders, Post-Traumatic
Intervention: ketamine; Fentanyl
Intervention description: Information included in arm descriptions; Information included in arm descriptions
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, repeated exposure (twice daily, 7 days), safety and efficacy trial of Usual Care (fentanyl PLUS saline / placebo) versus Usual Care plus Study Drug Augmentation (fentanyl PLUS ketamine) in reducing acute pain severity assessed before, during and after wound care for acute burn injury in the Burn Center of an Academic Medical Center.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Pharmacy receives order from provider and then prepares the study drug in an unmarked, nondescript delivery system ("bag") and the study drug information is entered from the bag into the pump so that delivery that is timed and volume controlled per study protocol. This is hung next to patient, connected and started. Masked personnel include provider (order study drug protocol), nurse (wound care), data assessor (Research Assistant), and consenting participant (patient with acute burn).
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: opioid; ketamine

Summary:

      The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group
      trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine
      Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of
      Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual
      Care-Opiate (UC-O), dose/timing as per Burn Center protocol).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40%
             TBSA

          -  English speaking

          -  pain in emergency room during initial wound evaluation (on admission) greater than 5
             /10

          -  estimated length of stay greater than or equal to 5 days

        Exclusion Criteria:

          -  requiring endotracheal intubation and sedation,

          -  severe hearing impairment,

          -  cognitive impairment status - Mini-Mental State Examination (MMSE) </=20,

          -  diminished capacity unable to provide informed consent;

          -  Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)

          -  Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
Condition: Workplace Migraine Treatment
MeSH terms: Migraine Disorders
Intervention: Triptan; Treximet 85Mg-500Mg Tablet
Intervention description: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan; Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium
Intervention MeSH terms: Naproxen; Sumatriptan; Naratriptan; Zolmitriptan; Rizatriptan; Eletriptan; Almotriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a randomized, open-label, 6-attack (3-attacks per arm) crossover design in which subjects were randomized to threat their first 3 workplace migraines with sumatriptan/naproxen sodium or with their usual triptan monotherapy before treating their subsequent 3 workplace migraines with the opposite medication.
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Productivity; Migraine; Treximet; Triptan

Summary:

      Researchers want to learn about work productivity after treatment of a migraine headache with
      your usual migraine medication as compared to your work productivity after treatment with
      Treximet.

      During this research subjects will take Treximet to treat 3 workday migraine attacks. For a
      second part of the research subjects will take their usual prescribed medication for 3
      workday migraine attacks. The subjects will complete questionnaires after treating each
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  episodic migraine diagnosis

          -  age 18 or older

          -  currently using a triptan as primary migraine monotherapy

          -  currently employed

          -  if of childbearing potential, willing to prevent pregnancy during study participation

          -  able to understand and consent to study participation

        Exclusion Criteria:

          -  younger than age 18

          -  not having episodic migraine diagnosis

          -  not using a triptan as primary migraine monotherapy

          -  not currently employed

          -  pregnant or nursing or unwilling to prevent pregnancy during study participation

          -  unable to understand and consent to study participation
rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Thrombosis; Syndrome
Intervention: rtPA lock therapy
Intervention description: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as "lock therapy" in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The primary research question is, in patients with short bowel syndrome requiring central
      venous access device (CVAD) for long-term total parenteral nutrition, is once weekly
      recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care
      using heparin flushes in reducing the incidence of line-associated thrombosis and infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. subjects with short bowel syndrome

          2. requirement for central venous access device (CVAD) for long-term TPN administration

          3. age >/= 6 months to < 16 years

          4. ability to initiate rtPA during hospitalization for newly inserted CVAD

          5. ability to be enrolled within 48 hours of CVAD placement.

        Exclusion Criteria:

          1. platelet count <50,000

          2. active bleeding

          3. age =/> 16 years at time of consent.
Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery
Condition: Knee Arthroscopy
Intervention: Sufentanil; Fentanyl
Intervention description: 30 µg tablet of sublingual sufentanil; 50 µg fentanyl
Intervention MeSH terms: Fentanyl; Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A pilot study to evaluate the effect of incorporating sublingual sufentanil into our
      perioperative opioid regimen for ambulatory orthopedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18 years or older;

          -  Scheduled for elective knee arthroscopy without anticipated ligamentous repair;

          -  Planned general anesthesia without a regional block or wound infiltration with local
             anesthesia;

          -  Planned day-of-surgery discharge.

        Exclusion Criteria:

          -  Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of
             another opioid within 30 days of surgery;

          -  Known hypersensitivity to sufentanil or components of DSUVIA;

          -  Patients with an allergy or hypersensitivity to opioids;

          -  Pregnancy or actively breastfeeding;

          -  Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
             MAOIs within 14 days of the first dose of study drug;

          -  Patients with a medical condition that, in the Investigator's opinion, could adversely
             impact the patient's participation or safety, conduct of the study, or interfere with
             the pain assessments, including chronic pain or active infection.
Subantimicrobial Doxycycline in Acne
Condition: Acne Vulgaris; Pediatrics
MeSH terms: Acne Vulgaris
Intervention: Doxycycline Hyclate
Intervention description: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acne Vulgaris; Doxycycline; Sub-Antimicrobial; Pediatrics

Summary:

      Antibiotic resistance is a public health problem that worsens the more physicians prescribe
      standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most
      common dermatologic conditions among pediatric populations. As such, clinicians can make a
      large impact by practicing good antibiotic stewardship while still addressing the impact of
      acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its
      anti-inflammatory effects while eliminating antimicrobial properties and associated risks of
      drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial
      doxycycline is efficacious in treating acne from a physician standpoint. The investigators
      aim to investigate the patient experience of acne treatment with subantimicrobial dose
      doxycycline in the pediatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented moderate to severe facial acne

        Exclusion Criteria:

          -  Other skin conditions on the face

          -  Previous antibiotic treatment for acne

          -  Use of antibiotics for any reason within the past month

          -  Use of new prescription regiment for acne within the last 3 months

          -  Positive pregnancy test in the clinic

          -  Cognitive impairments
Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone
Condition: Reproductive Techniques, Assisted
Intervention: Subcutaneous progesterone; Intramuscular progesterone
Intervention description: subcutaneous progesterone 25 mg/day; intramuscular progesterone 50 mg/day
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Masked samples for histological evaluation and assessment of gene expression
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: endometrial receptivity; endometrial predecidualization; endometrial genomics; endometrial receptivity array

Summary:

      Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus
      intramuscular progesterone 50 mg/day, to determine whether there are differences in the
      endometrial transformation and endometrial receptivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female aged between 18 and 34 years

          -  BMI between 18 and 28 kg/m2

          -  Endometrial thickness > 7 mm the day of progesterone treatment initiation (day of
             follicular puncture)

          -  Follicular maturation with a single bolus of GnRH agonist

          -  Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre

          -  Egg donors selected in accordance with the requirements of Law 14/2006 of 26 May 2006
             on Assisted Human Reproduction Techniques

          -  Informed consent has been signed and dated

        Exclusion Criteria:

          -  Known allergy to progesterone formulations or their excipients

          -  Known allergy to estrogens

          -  Known thrombophilias

          -  Alcohol, drug or psychotropic medication dependence

          -  Concurrent participation in another study

          -  Concomitant medication that may interfere with the study medication and ovarian
             stimulation

          -  Failure to comply with the requirements for egg donors in accordance with Law 14/2006
             of 26 May 2006 on Assisted Human Reproduction Techniques