bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Acetaminophen in Craniotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen; Placebo
Intervention description: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.; 100 mL 0.9% Sodium Chloride
Intervention MeSH terms: Acetaminophen
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: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Acetaminophen; Intravenous Acetaminophen; Opioid Requirement; Pain; Post-Operative Pain; Craniotomy; Post-Craniotomy Pain

Summary:

      The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an
      effective adjunct therapeutic agent in patients undergoing craniotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults

          -  Undergoing Craniotomy for Supratentorial Tumor Resection

          -  Weight between 50 and 120 kilograms

          -  ASA Physical Status I-III

          -  Be able to communicate verbally

          -  Be able to use Visual Analog Score

        Exclusion Criteria:

          -  Allergies to acetaminophen, morphine or any of the anesthetic agents required by the
             protocol.

          -  Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for > 7 days
             prior to the day of surgery.

          -  Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours
             immediately prior to study enrollment.

          -  Hepatic insufficiency (elevated transaminases > 1.5 times the upper limit of normal)
             or renal insufficiency (plasma creatinine > 2mg/dl).

          -  Known or suspected history of alcohol or illicit drug abuse.

          -  Pregnant or breast-feeding.

          -  Surgical plan for infratentorial (suboccipital) craniotomy.

          -  Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.

          -  Inability to communicate due to a language barrier, impaired consciousness, cognitive
             defect or intellectual disability.

          -  Uncontrolled Hypertension
Study of Exparel Versus Epidural for Pain Control After Thoracotomy
Condition: Pain Following Thoracotomy Surgery
Intervention: Epidural; Intercostal Bupivicaine (Exparel)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Thoracotomy; Pain

Summary:

      Unilateral intercostal nerve blocks provide pain control as effectively as a continuous
      thoracic epidural, and will a lower incidence of side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older

          -  Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).

        Exclusion Criteria:

          -  Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;

          -  Current enrollment in another post-thoracotomy analgesic research protocol;
             pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or
             postherpetic neuralgia in a thoracic distribution);

          -  Daily opioid therapy;

          -  Current gabapentin or pregabalin therapy;

          -  Allergy to any study medication; coagulation or infectious issues that would preclude
             epidural catheter placement;

          -  Severe psychological disorders or inability to understand the study protocol;
             -Prisoners or other institutionalized individuals;

          -  Severe hepatic, renal or cardiovascular disorders.

          -  Women who are pregnant will not be included in this study.
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Insulin Resistance; Inflammation
Intervention: ramelteon; placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Insomnia

Summary:

      The purpose of this study is to help scientist better understand the effect of a 12-week
      single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U.
      S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep
      or staying asleep). The study will measure levels of inflammation, fasting insulin and
      fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        At screening visit:

          -  aged 18-65

          -  nonsmokers

          -  for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers

        To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion
        criteria:

          -  ages 18-65 inclusive;

          -  PSQI-Component 2 (sleep latency) score of greater than 1;

          -  non-smoker (e.g., less than 20 cigarettes in the past 5 years);

          -  habitual bedtime between 8:30 pm and midnight

          -  For premenopausal women:

               -  regular menstrual cycles determined by Framingham Study criteria;

               -  not pregnant and no history of oral contraceptive (OC) usage in last 6-months.

          -  For postmenopausal women:

               -  no recent (< 6 months) use of Hormone Replacement Therapy (HRT)

               -  no surgical menopause

        Exclusion Criteria:

          -  positive urine drug screen

          -  Potential subjects with hypersensitivity to ramelteon or any components of the
             formulation will be excluded from participation.

          -  Given that ramelteon should not be used by individuals with severe hepatic impairment,
             or in patients in combination with fluvoxamine, individuals who report liver problem
             or use of fluvox will be excluded.

          -  use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).

          -  Ramelteon has not been studied in children or adolescents, and the effects in these
             populations are unknown, thus only individuals above 18 years will participate.
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Eszopiclone; Placebo
Intervention description: 2 mg tablet once per day in the evening; Tablet one per day in the evening.
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 388.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: insomnia; chronic; primary

Summary:

      To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in
      elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at
      bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be
      safe and well tolerated, improve subjective sleep measures, improve measures of Quality of
      Life and next day insomnia symptoms, and have no significant withdrawal central nervous
      system adverse events or rebound insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with primary chronic insomnia. Subject is otherwise in good
             general health, based on screening physical examination and medical history.

        Exclusion Criteria:

          -  Subject has recent history of known clinically significant abnormal laboratory
             findings.
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
Condition: Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Intervention: Endovascular Repair; Standard Open Repair
Intervention description: Endovascular Repair; Standard Open Repair
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 881.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Abdominal; Aortic Aneurysm; cost of AAA repair; Endovascular Repair; Grafts; Long-term survival; secondary outcomes

Summary:

      A multi-center, randomized clinical trial that will compare endovascular repair with standard
      open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results
      as well as the cost and quality of life associated with these two strategies for AAA repair
      will be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AAA with a maximum external diameter in any plane greater than or equal to 5 cm.

          -  An iliac aneurysm (associated with an AAA) with a maximum external diameter in any
             plane greater than or equal to 3 cm.

          -  AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal
             to 0.7 cm in diameter in 6 months.

          -  An AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or
             equal to 1 cm in diameter in 12 months.

          -  An AAA greater than or equal to 4.5 cm and the AAA is saccular (i.e., a portion of the
             circumference of the aorta at the level of the aneurysm is considered normal based on
             CT scan or MRI).

          -  An AAA greater than or equal to 4.5 cm and the AAA is associated with distal embolism.

               -  as measured from two imaging studies (ultrasound CT scan or MRI) within the
                  appropriate interval, the later one within 6 months of randomization.

        Exclusion Criteria:

          -  Patient has had a previous AAA repair procedure

          -  Evidence of AAA rupture by imaging test

          -  AAA is not elective (i.e., urgent or emergent operation, usually due to suspected
             rupture)

          -  Likelihood of poor compliance to the protocol

          -  Patient refused randomization

          -  Physician refused randomization
Cost- Effectiveness and Quality of Life Assessment in Mood Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Intervention: Lithium; Valproic Acid; Carbamazepine
Intervention MeSH terms: Carbamazepine; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cost effectiveness; Bipolar disorder; Mixed episodes; Quality of life

Summary:

      To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD)
      mixed episodes using medications available in the Brazilian Public Healthcare System (SUS),
      and assessment of the quality of life of these patients.

      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
      episodes of bipolar mixed episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ages between 18 and 65;

          2. BD current acute mixed episode;

          3. total capacity to understand and respond to self-applied instruments;

          4. the presence of symptoms in the last 30 days;

          5. abstinence for at least 30 days for drug addicts.

        Exclusion Criteria:

          1. presence of Organic Brain Syndrome (OBS);

          2. pregnancy or lactation;

          3. criteria for psychiatric hospitalization.
Comparison Between Two Different Dosages of Remifentanil During Colonoscopy
Condition: Colonoscopy
Intervention: Remifentanil; Remifentanil; Meperidine
Intervention description: Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button.; Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button.; Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.
Intervention MeSH terms: Meperidine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colonoscopy; Remifentanil; Sedation

Summary:

      The purpose of this randomized double-blind trial is to define the correct dosage of
      Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to
      analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and
      Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and
      side effects.

      90 patients undergoing colonoscopy will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Patients

          -  Diagnostic and Operative Colonoscopy

          -  ASA Physical Status I-II

        Exclusion Criteria:

          -  Age < 18 years
Nasal Decolonization for Orthopedic Trauma Patients
Condition: Surgical Site Infection
MeSH terms: Infections; Surgical Wound Infection
Intervention: intranasal povidone-iodine
Intervention description: povidone-iodine USP, 10% w/w antiseptic
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: 50 patients will receive PROFEND intranasal povidone-iodine prior to surgery and after surgery. The study aims to evaluate the real-world effectiveness of PROFEND® in reducing S. aureus colonization and surgical site infections (SSIs).
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nasal decolonization; Orthopedic trauma surgery

Summary:

      Many surgical site infections are caused by bacteria that is transferred from a patient's
      nose to their open surgical wound. Some small studies have shown that putting povidone-iodine
      in a patient's nose reduces this risk. This study aims to evaluate the real-world
      effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University
      of Iowa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing operative fixation of lower extremity fractures at the University
             of Iowa during the study period.

        Exclusion Criteria:

          -  Patients unable to provide informed consent due to head trauma or dementia.
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Intralesional Triamcinolone 10 mg/mL; Intralesional Triamcinolone 20 mg/mL; Intralesional Triamcinolone 40 mg/mL; Placebo
Intervention description: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.; Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.; Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.; Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Currently, there is limited evidence showing increased resolution of HS flares with higher
      doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile
      between the doses. The goal of this study is to determine the efficacy of treating HS flares
      with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 13 years old.

          -  Subject must voluntarily sign and date an informed consent, approved by an independent
             ethics committee / institutional review board.

          -  Subject is willing to comply with the procedures in this protocol.

          -  The subject must be diagnosed with HS and receiving care at HSC

          -  Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score
             between 2 and 5

          -  The subject must have an inflamed nodule or abscess at the time of enrollment.

        Exclusion Criteria:

          -  The subject has an HS-PGA score of 0 or 1

          -  The subject has received ILTAC less than 8 days prior to the initial visit.

          -  The subject does not have capacity to consent to the study.

          -  The subject is has taken systemic steroids at least 4 weeks prior to the time of
             enrollment.

          -  The subject has a known allergy or history of adverse reaction to steroids.

          -  The subject is pregnant.

          -  Subjects who have received a biologic therapy two weeks before and during the study
             period.
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
Intervention description: Subjects may receive glaucoma medications after Ahmed valve implantation
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Glaucoma tube shunt procedure

Summary:

      The purpose of this study is to compare the occurrence rate of the high pressure phase and
      the final pressure outcomes between patients treated with glaucoma medication prior to the
      expected onset of the high pressure phase to those patients who have glaucoma medication
      started at the onset of the high pressure phase. The investigators hypothesize that if
      glaucoma medications are started prior to the expected onset of high pressure phase, the high
      pressure phase will not occur as frequently and the ultimate pressure level will be lower
      than if the glaucoma medications are started at the onset of this phase.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure
             between the ages of 18 and 85 years.

        Exclusion Criteria:

          1. Unwilling or unable to give consent or unwilling to accept randomization.

          2. Patient out of area and potentially unavailable for follow-up visits.

          3. Known allergic reaction to timolol, brimonidine, dorzolamide, brinzolamide, or sulfa
             drugs.

          4. Known medical contraindications to the use of beta-blockers, including congestive
             heart failure, heart block, asthma, and chronic obstructive pulmonary disease.

          5. Concurrent intraocular procedure with Ahmed glaucoma valve implantation

          6. Previous Ahmed glaucoma valve implantation
Sitagliptin Dose Determination Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sitagliptin; Placebo Oral Tablet
Intervention description: In each intervention arm the participant receives a different dose of sitagliptin.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 13 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 1

Summary:

      There are many recent advances in insulin treatment of type 1 diabetes, however after a meal
      sugars are always a concern. There is a drug sitagliptin (Januvia) which is FDA approved to
      treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.
      This study is going to test whether this drug can improve the after meal sugars in people
      with type 1 diabetes. To test this you will be given a test mixed meal and its effects on
      insulin, other hormones that affect blood glucose as well as your sugar will be measured by a
      series of blood tests. Insulin dose will be reduced by 20-50% to prevent low blood sugars
      which might occur because of food staying longer in the stomach than usual or due to the
      suppression of a hormone called glucagon which increases blood sugar. If you qualify you will
      be given sitagliptin (Januvia) 3 different times in 25 mg, 50 mg and 100mg dosages. You and
      the researchers will not know which dose you are taking at any single visit. A total of 30
      people in which some will be children aged 13- 17 and others will be adults aged 18-30 will
      participate. Some will have had diabetes for over a year, others will be within 3 months of
      having been found to have type 1 diabetes. Furthermore, only 18-30 year people who are
      diagnosed with type 1 diabetes for a year or more will be studied initially (4 subjects) to
      establish safety data before younger subjects are enrolled into the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 13 to 30 years

          2. Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if
             present

          3. Menstruating women must have negative pregnancy test.

          4. Hemoglobin (Hb) more than 12 g/dl

        Exclusion Criteria:

          1. Having any other chronic condition except hypothyroidism stable on medications

          2. On chronic medications that may affect glucose excursions

          3. Hemoglobin less than 12 g/dl

          4. Positive pregnancy test (based on Urine)

          5. Pregnant or lactating mothers

          6. Known allergy to Januvia