bioihbjkbjnl/mcl2 huggingface dataset:
Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
Condition: Healthy; Pain; Pregnancy
Intervention: Hydromorphone 25mcg; Hydromorphone 50mcg; Hydromorphone 100mcg; spinal anesthesia
Intervention description: Intrathecal Hydromorphone 25mcg; Intrathecal Hydromorphone 50mcg; Intrathecal Hydromorphone 100mcg; bupivacaine 0.75% 1.6 mL (12mg)
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pregnancy; Healthy; Intrathecal; Opioids; Spinal; Anesthesia; Pain; Cesarean; Delivery; Human

Summary:

      Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain
      medications called opioids, such as morphine, are given through the vein or into the muscle.
      However, a more effective way to give pain relief with fewer side effects (such as nausea and
      slowing your breathing) is to give opioids in the spinal space as part of the medications
      given for a cesarean delivery.

      For many years, the opioid of choice was morphine due to its long anesthetic effect and
      acceptable side effect profile. A nation-wide disruption in the supply of preservative-free
      morphine has made it necessary to look for alternatives. Many institutions worldwide have
      used another opioid, called hydromorphone, in the spinal space for over a decade. This drug
      has a very good safety and side effect profile and has been used at the investigators'
      institution for more than a year. Of interest, while a number of different doses of
      hydromorphone have been used, there have been very few studies to evaluate the best dose for
      providing good pain relief with minimal side effects. The goal of this study is to find the
      best dose of spinal hydromorphone for women undergoing cesarean delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy at-term parturients undergoing elective cesarean delivery under spinal
             anesthesia

        Exclusion Criteria:

          -  Emergency cesarean delivery

          -  Respiratory disease

          -  significant comorbidities: preeclampsia, insulin-dependent diabetes mellitus

          -  obstructive sleep apnea

          -  body mass index > 35kg/m2

          -  <18yrs

          -  documented intolerance or allergy to systemic or neuraxial opioids

          -  patient with a history of chronic opioid or current use of opioids
Gabapentin for Alcohol Withdrawal Syndrome
Condition: Alcohol Withdrawal Syndrome
MeSH terms: Syndrome; Substance Withdrawal Syndrome
Intervention: Gabapentin; Benzodiazepines; Divalproex Sodium
Intervention description: Gabapentin administered as a taper; Benzodiazepines administered using a symptoms triggered protocol; Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
Intervention MeSH terms: Chlordiazepoxide; Gabapentin; Lorazepam; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gabapentin; Alcohol Withdrawal Syndrome; benzodiazepine; symptom-triggered

Summary:

      The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is
      symptom-triggered administration of benzodiazepines. This method of treatment has several
      drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have
      been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS
      but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings
      is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due
      to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS,
      a study to compare gabapentin to symptom-triggered lorazepam will be completed.
    

Eligibility criteria:

        Inclusion criteria

          1. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score >4.

          2. Adults age 18 or older.

          3. Sufficient understanding of English.

          4. Hospitalized on Hospital Internal Medicine or Generose.

        Exclusion criteria

          1. Severe renal impairment (estimated CrCl < 30).

          2. Intensive Care Unit (ICU) level of care.

          3. Not responsive due to alcohol intoxication or withdrawal.

          4. Already taking gabapentin more than 300 mg three times a day.

          5. Prescribed pregabalin.

          6. Primary seizure disorder.

          7. Acute benzodiazepine withdrawal.

          8. Concurrent substance use disorders (such as opioid use disorder, stimulant use
             disorder) if the disorder is assessed to be clinically significant. Cannabis use
             disorder will be allowed.

          9. Concurrent anticonvulsant medications for psychiatric indications (e.g. bipolar
             disorder) will be allowed.

         10. Pregnancy.

         11. Involuntary legal status (e.g., on court commitment).

         12. Patients admitted greater than 12 hours prior to potential enrollment.

         13. Patients receiving therapeutic dose of gabapentin (rather than continuation of home
             dose) prior to enrollment.
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Interferon beta 1a, oral doxycycline
Intervention description: Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular
      interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in
      patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease
      activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-55

          -  Relapsing-Remitting Multiple Sclerosis (RRMS)

          -  Avonex therapy for 6 months prior continuous

          -  annualized relapse rate >2 during Avonex therapy

          -  most recent relapse within 60 days of baseline

          -  entry Expanded Disability Status Scale (EDSS) 1.5-4.5

          -  one or more gadolinium (Gd+) MRI lesions on a baseline MRI

          -  no history of immune modulator or immunosuppressant therapy used in combination with
             Avonex (other then GSC administer for clinical relapses)

          -  not participating in any other study of ms therapeutics

          -  Serum neutralizing antibodies (NABs) titer to Avonex <20

        Exclusion Criteria:

          -  Medical or Psychiatric conditions that will affect patients ability to provide
             informed consent

          -  inability to undergo MRI

          -  clinically serious medical conditions or significantly abnormal labs

          -  no use of these medications or procedures within six months prior to study:

             *monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or
             immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other
             investigational drugs

          -  Interferon neutralizing antibody titers >20

          -  no breast feeding or pregnant

          -  no patients with any systemic illness,psychiatric condition or other disorder that
             would concern safety of patient to complete procedures of protocol

          -  abnormal blood test

          -  clinically significant abnormality on chest x-ray (CXR)
Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal
Condition: Difficult Airway; Anesthesia; Functional
Intervention: Laryngeal Mask Airway (LMA)
Intervention description: Comparison of airway seal pressure, airway morbidity bronchoscopic view obtained between two different laryngeal mask airways.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Introduction:

      The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved
      for use as a primary airway and as an aid for intubation in situations of anticipated or
      unanticipated difficult airways. A unique feature of this device as compared to other airways
      on the market is the size of the inner diameter (ID) and length of its airway tube. Direct
      placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.

      The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to
      airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is
      significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a
      maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.

      In this study the investigators aim to test whether the air-QⓇ creates an airway seal
      pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation
      to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the
      LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the
      LMA-ProSealTM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 18 years or greater may be included if they presenting for any
             elective surgery or procedure to take place in any anesthetic location and require
             placement of a LMA for their surgery or procedure.

        Exclusion Criteria:

          -  non-English speaking

          -  pregnant

          -  are a minor

          -  are a prisoner

          -  have impaired decision-making capacity or any condition for which the primary
             anesthesia team deems intubation with a tracheal tube to be necessary
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Condition: Childhood Obstructive Sleep Apnea Syndrome (OSAS)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Intervention: fluticasone furoate
Intervention description: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to find out how a nasal spray (fluticasone furoate),
      sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain
      cells within a child's adenoids. We hypothesize that intranasal steroids lead to an
      upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will
      result in a local reduction in inflammation and edema explaining the improvement in OSAS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: between 2 and 12 years

          -  Polysomnogram results showing AHI >5/hr irrespective of saturations

          -  No other significant medical problems except well controlled asthma

          -  No chronic medication intake except bronchodilators and leukotriene receptor
             antagonists

          -  No systemic steroids within the past month

          -  No intranasal steroids within the past 2 weeks

        Exclusion Criteria:

          -  Patients with OSAS who are overweight (BMI>95th percentile for age) or who have
             neurological or craniofacial abnormalities as these tend to have OSAS related to these
             factors per se.

          -  Females of the specified age group who have already had their first period.
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Condition: Pain
MeSH terms: Cancer Pain
Intervention: Osmotic Release Oral System (OROS) hydromorphone
Intervention description: OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pain; Cancer; Osmotic Release Oral System; OROS Hydromorphone; Jurnista

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral
      System (OROS) hydromorphone using standardized conversion from prior opioid therapy among
      participants with cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant with histological confirmed malignancy

          -  Participant on stable morphine or 25 milligram oxycodone dose equivalent per day.
             Stable dose is defined as no dose change for 3 consecutive days and does not require
             more than 3 doses of rescue medication per day

          -  Life expectancy of at least 3 months

          -  Negative urine pregnancy test

          -  Participants with signed informed consent

        Exclusion Criteria:

          -  Participant intolerant or hypersensitive to hydromorphone or other opioid agonist

          -  Participant with unstable medical condition

          -  Participant with renal dysfunction and liver dysfunction

          -  Participant dependence to opiates

          -  Inability to take oral medication
Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy
Condition: Femoracetabular Impingement; Pain, Postoperative
MeSH terms: Femoracetabular Impingement; Pain, Postoperative
Intervention: Morphine with clonidine; Normal saline
Intervention description: see arm description; see arm description
Intervention MeSH terms: Clonidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip arthroscopy; Intra-articular injection; Morphine; Clonidine

Summary:

      The purpose of this study is to determine whether intraoperative (during surgery) morphine
      and clonidine hip injections are effective in postoperative pain management for patients
      undergoing hip arthroscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient undergoing a hip arthroscopy procedure for femoracetabular impingement by
             the senior surgeon (M.T.)

        Exclusion Criteria:

          -  Morphine contraindication

          -  Clonidine contraindication

          -  Pregnant women

          -  Prisoners

          -  Adults unable to consent
Fucidin® Cream in the Treatment of Impetigo
Condition: Impetigo
MeSH terms: Impetigo
Intervention: Fucidin® cream
Intervention MeSH terms: Fusidic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment
      of impetigo in paediatric patients.

      To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a
      prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin®
      cream.

      To investigate the genetic relationship between S. aureus-strains isolated from impetigo
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of impetigo,

          -  Patients aged 2-11 years,

          -  Patients of either sex,

          -  Patients whose parent(s) has(ve) provided written consent, AND

          -  Patients with a severity score of 1 for at least one of the following signs:
             pustules/infected bullae, erythema and infiltration/induration.

        Exclusion Criteria:

          -  Patients with other active inflammatory dermatitis at the area of impetigo,

          -  Patients with a temperature above 38.5 C rectally (or equivalent), OR

          -  Patients who have been administered topical or systemic Fucidin® or other
             antibacterial agents within the previous 4 weeks.
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
Condition: Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost 0.004% Ophthalmic Solution (Travatan); Timolol 0.5% Ophthalmic Solution (Timoptic)
Intervention description: Travoprost at 9 AM + Placebo & 9 PM; Timolol in each eye, twice daily at 9 AM & 9 PM
Intervention MeSH terms: Timolol; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004%
      compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension
      (OH). The study structure is a parallel design. The patients will receive treatment for 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years;

          -  IOP=16-30mmHg

          -  OH or OAG with visual filed abnormality:

               1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal
                  meridian, that have p <5% on the prepapillary diameter plot, one of which must
                  have p <1%,

               2. Glaucoma Hemifield Test outside normal limits,

               3. Corrected Pattern Standard Deviation with p <5%

        Exclusion Criteria:

          -  Previous damage of anterior chamber angle;

          -  ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual
             Acuity (logMAR) <1.0;

          -  contact lens wearer;

          -  severe central field loss;

          -  uncontrolled cardiovascular, hepatic or renal disease;

          -  any medication within past 1 month.
Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen/Ibuprofen; Acetaminophen/Codeine
Intervention description: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit; After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain, Postoperative

Summary:

      The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen
      (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after
      hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger,
             under local anesthesia with or without sedation.

        Exclusion Criteria:

          -  ASA> 3;

          -  Coagulopathy;

          -  Renal disease,

          -  Liver disease,

          -  History of recent gastro-intestinal bleeding

          -  Pregnancy.

          -  Diagnosis of chronic pain currently taking opioid pain medication or with a history of
             drug abuse.

          -  Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine.

          -  All patients receiving a brachial plexus block for anesthesia and/or analgesia
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: bamlanivimab
Intervention description: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation.
Intervention MeSH terms: Bamlanivimab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID19; bamlanivimab; UnitedHealth

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  UnitedHealthcare member

          -  confirmed COVID-19 positive

          -  located in an area where Bamlanivimab (LY3819253) is available for infusion

        Exclusion Criteria:

          -  current (from first symptom report) hospitalization for COVID-19

          -  prior administration of Bamlanivimab or other COVID-19 therapies

          -  previous COVID-19 diagnosis

          -  prior receipt of a COVID-19 vaccine

          -  not authorized for patient use per the EUA