bioihbjkbjnl/mcl2 huggingface dataset:
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Condition: Pain; Pain, Acute; Anesthesia
MeSH terms: Acute Pain
Intervention: Sublingual Sufentanil
Intervention description: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
Intervention MeSH terms: Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a single dose of sublingual sufentanil given
      15-30 minutes prior to wake up is efficacious at reducing recovery room time.
    

Eligibility criteria:

        Inclusion Criteria:

        - Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for
        orthopedic surgery

        Exclusion Criteria:

          -  non-english speaking patients

          -  patients who have allergy or intolerance to the study drugs or derivatives
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
Condition: Pain
MeSH terms: Headache
Intervention: aspirin and ketamine; Nurtec (Rimegepant)
Intervention description: Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin; Drug: 75 mg of ODT
Intervention MeSH terms: Aspirin; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Emergency Medicine; Pain; Pain Management; Acute Headache

Summary:

      Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache.
      Most headaches managed in the ED are benign, with 90% of these headaches classified as
      tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is
      low, and despite the multitude of available medications, the evidence- based treatment
      options are often quite limited. There are over twenty different types of medications
      available to the ED clinicians for managing headache, many with different routes of
      administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications
      are provided in so-called "headache cocktail", which varies based on the physician,
      institution, and patient preferences.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older

          -  Acute Headache

          -  Initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating
             scale.

          -  Awake, alert, and oriented to person, place, and time

        Exclusion Criteria:

          -  altered mental status,

          -  allergy to aspirin, ketamine and rimegepant,

          -  pregnancy and breastfeeding

          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150
             beats/ min, and respiration rate <10 or >30 breaths/min)

          -  inability to provide consent

          -  consumption of Aspirin or NSAID's within 6 hours of arrival to the ED or acetaminophen
             within 4 hours of arrival

          -  active PUD

          -  history of GI Hemorrhage

          -  history of renal and hepatic insufficiency

          -  past medical history of alcohol or drug abuse

          -  schizophrenia

          -  clinical findings concerning for acute intracranial process, acute infections process
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Condition: Growth Hormone Deficiency; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Pituitary Diseases; Wounds and Injuries
Intervention: Recombinant human growth hormone
Intervention description: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: TBI; Traumatic Brain injury; Growth hormone deficiency; Anterior pituitary hormone; Recombinant human growth Hormone; Genotropin

Summary:

      Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires
      hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by
      GH stimulation testing. Moreover, abnormalities have also been established for the cortisol
      and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients
      with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle
      function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH,
      thyroid, cortisol).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 21 and older.

          -  Documented moderate to severe traumatic brain injury at least one year post injury.

        Exclusion Criteria:

          -  The only absolute exclusionary medication will be an anticoagulant (Coumadin) because
             of the risk of bleeding during the possible muscle biopsy procedure and daily
             injections of rhGH in the GH arm of the study.

          -  Any subject with a history of hepatitis or a 3-fold elevation of liver function tests
             (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are
             uncertain of the effects of hormone replacement such as rhGH on the liver, so we will
             exclude any subjects with hepatitis. This exclusion applies only to subjects who would
             be enrolled in the GH arm of the study.

          -  Subjects who are deficient in cortisol or thyroid at screening will be excluded until
             hormone abnormalities have been corrected.

          -  Subjects with chronic pain who are being managed with narcotics will be excluded as
             the effects of central nervous system depressants may interfere with study test
             results.
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
Condition: Dexamethasone; Glucocorticoids; Mastectomy; Breast Cancer; Pain, Postoperative; Nausea and Vomiting, Postoperative; Steroid; Systemic Inflammatory Response Syndrome; Postoperative Complications
MeSH terms: Vomiting; Pain, Postoperative; Postoperative Complications; Systemic Inflammatory Response Syndrome; Postoperative Nausea and Vomiting
Intervention: Dexamethasone
Intervention description: pre-operative intravenous administration
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the effect of a single preoperative high-dose steroid
      injection on complications in the immediate postoperative phase after breast cancer surgery,
      with removal of the breast (mastectomy). Primary outcome is the proportion patients who
      require transfer to the post anaesthesia care unit (PACU) and the proportion that can be
      transferred directly to the ward. Secondary outcomes are organospecific complications in the
      postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first
      14 days and readmissions the first 30 days after surgery.

      The investigators hypothesize that the frequency of transfer to the PACU and organospecific
      complications will be lower among patients receiving high dose dexamethasone. The
      investigators hypothesize, that there will be no difference in wound infections, seroma or
      readmissions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned unilateral mastectomy with or without axillary dissection or sentinel node in
             the study period

          -  informed signed consent

        Exclusion Criteria:

          -  Chronic/ongoing use of glucocorticoids (except inhalation therapy)

          -  ongoing use of immunosuppressive therapy

          -  insulin dependent diabetes

          -  pregnancy/breastfeeding

          -  allergies toward study medication, or medication in a standard treatment

          -  contralateral surgery (lumpectomy/mastectomy) at time of mastectomy

          -  surgery cannot be performed
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Scopolamine and naltrexone; placebo arm
Intervention description: participants will receive scopolamine and naltrexone in buccal drops; participants will receive placebo medications
Intervention MeSH terms: Scopolamine; Naltrexone; Butylscopolammonium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized, controlled parallel design
Masking: Double (Participant, Care Provider)
Masking description: The participants and physician are both blinded to medication vs. control medication
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this clinical trial is to determine the safety and efficacy of scopolamine
      utilized in conjunction with naltrexone for the treatment of major depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, aged 18-65

          -  in good health other than major depression for 8 weeks or more

          -  negative pregnancy test

          -  able to comply with instructions

          -  able to provide informed consent

        Exclusion Criteria:

          -  pregnant or lactating

          -  danger to self or others

          -  severe kidney or liver disease

          -  schizophrenia

          -  allergy to scopolamine or naltrexone

          -  glaucoma

          -  Monoamine oxidase (MAO) inhibitor use
The Invia Motion at Cesarean Study
Condition: Negative Pressure Wound Therapy; Cesarean Section; Infection
Intervention: Invia Motion
Intervention description: Invia Motion NPWT system at cesarean delivery
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Medela Invia pump
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Healthy volunteers: No

Summary:

      To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at
      cesarean delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled/non-labor or unscheduled/labor cesarean delivery

          2. Gestational age greater than or equal to 23 weeks

        Exclusion Criteria:

          1. Unwilling or unable to provide consent

          2. Non-availability for postoperative follow-up

          3. Contraindication to NPWT
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
Condition: Brain Neoplasms; Brain Cancer; Brain Tumors; Cancer of the Brain; Cancer of Brain; Seizure
MeSH terms: Brain Neoplasms; Seizures
Intervention: Levetiracetam
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if there are any differences in patient reported
      neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery
      to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after
      surgery. Specifically, we will see if one group has less side effects than the other, and
      whether or not one group has more seizures than the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (>18 years of age and older) patients who have or will have undergone surgical
             resection or biopsy of a supratentorial brain tumor and are able to consent for
             themselves.

          -  Able to be randomized prior to or up to 48 hours after surgery.

        Exclusion Criteria:

          -  No known history of seizure activity.

          -  Pregnant or breastfeeding.

          -  Renal dysfunction (CrCl < 30ml/min).

          -  Beck's Depression Inventory (BDI) ≥14

          -  Allergy to levetiracetam.
Acetaminophen and Post Circumcision Pain Control
Condition: Pain; Circumcision
Intervention: Acetaminophen
Intervention description: Infants will receive 15 mg/kg of acetaminophen.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 11.0
Sex: Male
Minimum age: 10 Hours
Maximum age: 36 Hours
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infant pain; Acetaminophen; Circumcision

Summary:

      Infants do not routinely receive acetaminophen for pain control after circumcision. This
      study will determine if acetaminophen is effective at controlling infant pain after
      circumcision using nerve block and oral dextrose. Infants will undergo the routine
      circumcision procedure, and half will be randomly selected to receive half acetaminophen
      immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,
      respiratory rate, oxygen saturation), the neonatal infant pain scale (NIPS), and salivary
      cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated
      pain scoring system based on the appearance of the infant. A reduction in NIPS for those
      infants who receive acetaminophen versus nothing will be the primary outcome to determine if
      the study is significant.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery
        who's parents are requesting circumcision. Eligibility includes

          1. Apgar score at 5 minutes >7

          2. birthweight greater than 2.4 kg

          3. Age of at least 10 hours

          4. At least one void.

        Exclusion Criteria:

          1. Newborns of substance abusing mothers.

          2. Newborns with any contraindications to routine circumcision, anatomical or
             hematologic.
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
Condition: Psychomotor Agitation
MeSH terms: Psychomotor Agitation
Intervention: Clonidine; Placebo
Intervention description: Injection - during surgery; Injection - during surgery
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 379.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Anaesthesia; Children; Clonidine; Sevoflurane; Postoperative agitation; Prevention; Pharmacokinetics; Safety

Summary:

      Clonidine is widely used off-label in children for several indications. Clonidine is used for
      treatment and/or prevention of postoperative agitation in children anaesthetised with
      Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators
      don´t have data for characterization of the pharmacokinetic profile among age-groups for
      children 1-6 years.

      In this study the investigators want to investigate if IV Clonidine administered at the end
      of surgery can prevent/reduce postoperative agitation. Secondary outcomes include
      measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled for surgery with Sevoflurane as the choice of anesthesia.

        Exclusion Criteria:

          -  ASA classification >2

          -  Premedication with Clonidine

          -  Ex-premature (born before week 37+0 AND <60 weeks old)

          -  Intubated before anaesthesia and/or no plans for extubation after anaesthesia.

          -  Critical illness with haemodynamic instability.

          -  Active bleeding.

          -  Cancer.

          -  Cardiac diseases including arrhythmias.

          -  Malignant hyperthermia.

          -  Mental retardation.

          -  Neurological illness with agitation-like symptoms.

          -  Weight >50 kg.

          -  Allergy to Clonidine.

          -  Patients treated with methylphenidate / Concerta.
Rifaximin Therapy in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Rifaximin; Placebo
Intervention description: 550mg pills; Placebo pill
Intervention MeSH terms: Rifaximin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Rifaximin decreases serum and urine levels of
      bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to
      evaluate changes in the bacterial content of the stool from these individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

        Exclusion Criteria:

          -  Patients with normal renal function or those with less advanced kidney disease

          -  Inability or unwillingness to provide consent

          -  Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have
             undergone organ transplant

          -  Patients who may be pregnant

          -  Hemodynamically unstable patients

          -  Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease

          -  Patients with ongoing or recent infection and those with history of C-diff infection

          -  Patients with abnormal bowel structure secondary to surgical or anatomic variations

          -  Patients on certain medications including immunosuppressants, antidiarrheal agents,
             bile acid sequestrants and current or recent (within the last 3 months) use of
             antibiotics
The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas
Condition: Tracheostomy Infection
MeSH terms: Pseudomonas Infections
Intervention: Inhaled Aztreonam
Intervention description: Inhaled antibiotic with anti-pseudomonal properties
Intervention MeSH terms: Aztreonam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: two-center, prospective, case control clinical trial
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: tracheostomy tube; Pseudomonas aeruginosa

Summary:

      This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in
      pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa. The aim of
      the study is to see if AZLI being taken in a one month on / one month off cycle over the
      course of a year can decrease the need for systemic antibiotics and/or hospitalizations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  o Age: 7 - 21 years old

               -  Currently has a tracheostomy tube

               -  One of previous 3 tracheostomy tube aspirate cultures positive for Pseudomonas
                  aeruginosa

               -  Non-smoker

               -  Ability of parent to provide informed consent, as evidenced by signing a copy of
                  the consent form approved by the Institutional Review Board of the subject's
                  respective study institution.

               -  Written assent for children 7-17 years of age.

               -  Informed consent for children ages 18-21, as evidence by signing a copy of the
                  consent form approved by the Institutional Review Board of the subject's
                  respective study institution.

        Exclusion Criteria:

          -  o History of immunodeficiency

               -  History of cystic fibrosis. Primary ciliary dyskinesia, or bronchiectasis

               -  History of tuberculosis

               -  History of positive culture for Burkholderia cepacia

               -  Use of inhaled antibiotics in the last 6 months
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
Condition: Intrauterine Device Expulsion
Intervention: Copper IUD placement at time Cesarean Delivery (Copper T 380A)
Intervention description: Placement of Paragard IUD at time of Cesarean Delivery
Intervention MeSH terms: Copper
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum IUD; Cesarean Delivery; 6 months postpartum; satisfaction

Summary:

      The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices
      (IUDs) placed at time of Cesarean Delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  singleton gestation

          -  greater than 35 weeks gestation

          -  speaks English or Spanish

          -  desires IUD for contraception

          -  undergoing a cesarean delivery

        Exclusion Criteria:

          -  evidence of chorioamnionitis

          -  history of chlamydia within this pregnancy