bioihbjkbjnl/mcl2 huggingface dataset:
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
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Mavenclad®
Intervention description: Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Intervention MeSH terms: Cladribine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Mavenclad ®; Cladribine

Summary:

      The main purpose of the study was to determine the onset of Mavenclad® action by frequent
      magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in
      participants with highly active relapsing multiple sclerosis (MS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Highly active RMS as defined by:

          -  One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or
             more T2 lesions, while on therapy with other disease modifying drugs (DMDs)

          -  Two or more relapses in the previous year, whether on DMD treatment or not.

          -  Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.

          -  Other protocol defined inclusion criteria could apply.

        Exclusion Criteria:

          -  Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone
             and ocrelizumab.

          -  Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core
             antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).

          -  Current or previous history of immune deficiency disorders including a positive human
             immunodeficiency virus (HIV) result.

          -  Currently receiving immunosuppressive or myelosuppressive therapy with, for example,
             monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine,
             or chronic use of corticosteroids.

          -  History of tuberculosis , presence of active tuberculosis, or latent tuberculosis

          -  Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic
             Resonance Imaging (MRI).

          -  Active malignancy or history of malignancy.

          -  Other protocol defined exclusion criteria could apply.
Polidocanol Versus Glucose Treatment of Telangiectasia Trial
Condition: Varicose Veins; Telangiectasis
MeSH terms: Telangiectasis; Varicose Veins
Intervention: Glucose; Polidocanol with Glucose
Intervention description: Sclerotherapy of telangiectasis in one lower limb.; Sclerotherapy of telangiectasis in one lower limb.
Intervention MeSH terms: Polidocanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: telangiectasis; varicose veins; veins; glucose; sclerotherapy

Summary:

      It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%
      hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only
      adult women with reticular veins on the side of the thighs and mild venous insufficiency
      (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females

          -  with telangiectasis on thigh side

          -  clinical classification of chronic venous disease C1(mild venous disease),

          -  minimum age of 18 year-old and maximum age 65 year-old

          -  agreement with the study

          -  signing the free and informed consent ( IC)

          -  not use anticoagulant drugs .

        Exclusion Criteria:

          -  male

          -  varicose disease in any quantity or location with clinical classification of chronic
             venous disease different of C1(mild venous disease)

          -  restrict mobility

          -  arterial insufficiency

          -  be allergic to any substance that may be related to the study drugs

          -  any cause of dermatitis on application site

          -  don´t be free of comorbidities clinically serious as diabetes mellitus, heart failure,
             respiratory failure, uncontrolled hypertension with medication, and uncontrolled
             hypothyroidism

          -  pregnancy

          -  previous deep vein thrombosis (DVT)

          -  family history of DVT

          -  thrombophilia

          -  do not agree with the search terms
TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Plain bupivacaine; Liposomal bupivacaine
Intervention description: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn; Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain, Liposomal bupivacaine, Wound infiltration

Summary:

      In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after
      ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound
      infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  ASA physical status 1-3

          -  Scheduled for open abdominal hysterectomy

          -  Age 18-80 years old

          -  Able to participate personally or by legal representative in informed consent in
             English or Spanish

        Exclusion Criteria:

          -  History of relevant drug allergy

          -  Age less than 18 or greater than 80 years

          -  Chronic opioid use or drug abuse

          -  Significant psychiatric disturbance

          -  Inability to understand the study protocol

          -  Refusal to provide written consent
Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.
Condition: Muscle Relaxation
MeSH terms: Pneumoperitoneum
Intervention: rocuronium; Sevoflurane; remifentanyl
Intervention description: measure effect on laparoscopic workspace; 1 MAC sevoflurane inhalation is given; remifentanyl is given in infusion
Intervention MeSH terms: Remifentanil; Sevoflurane; Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: pneumoperitoneum; laparoscopy

Summary:

      The objective of this study is to compare the value of deep neuromuscular block (NMB) (using
      rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum
      alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon.

      The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus
      opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the
      pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points
      allow to calculate the abdominal compliance and the pressure at zero volume (PV0).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous
        laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve
        gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric
        bypass

        Exclusion Criteria:

          1. Allergies or contraindications to the use of one or more of the following drugs:
             propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane

          2. History of a laparotomy

          3. Emergency laparoscopy
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Condition: Neuromuscular Blockade; Anesthesia
Intervention: Neostigmine; Glycopyrrolate; Sugammadex
Intervention description: Neostigmine injection; Glycopyrrolate injection; Sugammadex injection
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sugammadex; Neostigmine; Reversal of neuromuscular block

Summary:

      The aim of this study is to evaluate whether the use of Sugammadex for reversing the
      neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed
      recovery of neuromuscular function. Half of participates will receive Neostigmine with
      glycopyrrolate, while the other half will receive Sugammadex.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years;

          -  American Society of Anesthesiologists (ASA) physical status 1-3;

          -  Scheduled for catheter-based neurointerventional procedures including coiling and
             stent insertion;

          -  General anesthesia.

        Exclusion Criteria:

          -  Suspected difficult intubation;

          -  Neuromuscular disorder;

          -  Renal impairment creatinine ≥ 2 mg /dl;

          -  Hepatic dysfunction;

          -  History of malignant hyperthermia;

          -  Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;

          -  Perioperative respiratory infections and/or pneumonia;

          -  Intubated or unresponsive;

          -  Pregnancy or breastfeeding.
Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Intervention: IANB Articaine; SUP Articaine; SUP Lidocaine
Intervention description: IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.; After unsuccessful IANB with articaine, proceed to give 1.7cc of 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).; After unsuccessful IANB with articaine, proceed to give 1.7cc of 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).
Intervention MeSH terms: Lidocaine; Carticaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Articaine; Lidocaine; Anesthesia, Local; Endodontics; Molar; Dental Pulp Diseases

Summary:

      The purpose of this trial is to study the ability of a frequently used dental anesthetic
      (articaine) to achieve complete numbness of a diseased tooth with the most commonly used
      injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique
      fails, a commonly used supplemental (SUP) technique with one of two possible dental
      anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of
      complete numbness between the two anesthetics.

      Standardized administration of anesthesia is provided by controlled delivery using Midwest
      Comfort Control Syringe.

      The investigators hypothesize that supplemental infiltration anesthesia with articaine will
      give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular
      molars with irreversible pulpits.

      This study consisted of two periods of patient enrollment, treatment and data collection:
      Part I: 101 subjects; Part II: 100 subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients

          -  irreversible pulpitis in mandibular molar

        Exclusion Criteria:

          -  below 18 years
24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E
Condition: Abortion, Second Trimester
Intervention: Vaginal Misoprostol; Buccal Misoprostol
Intervention description: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E; Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Computer-generated randomization will be utilized to assign treatment arms and the vaginal misoprostol and buccal placebo and buccal misoprostol and vaginal placebo will be prepared according to randomization scheme by the research pharmacy in opaque-sealed envelopes as to blind participants and providers.
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: D&E; dilation and evacuation; abortion; second trimester; mifepristone; misoprostol

Summary:

      This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal
      misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The study will enroll healthy English or Spanish-speaking women, over 18 years of age,
             eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by
             sonogram, and willing/able to undergo informed consent.

        Exclusion Criteria:

          -  Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy,
             intolerance, allergy or contraindication to mifepristone or misoprostol
A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
Condition: Thoracolumbar Scoliosis
MeSH terms: Scoliosis
Intervention: Methadone; Normal Saline
Intervention description: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes; the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Intervention MeSH terms: Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can
      affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which
      is a measurement used for evaluation of curves in scoliosis on an anterior-posterior
      radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40
      degrees in the lumbar region) or when the curvature causes significant pain, or respiratory
      and cardiovascular restriction. Patient undergoing this surgical correction experience severe
      pain in the postoperative period and the management includes the use of opioid-based
      patient-controlled analgesia (PCA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient age 10 - 17 years

          2. Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and
             fusion

        Exclusion Criteria:

          1. Preoperative methadone therapy

          2. Inability to use the PCA

          3. Allergy to methadone or morphine

          4. Morbid obesity with a body mass index >36.0 kg/m2

          5. Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL

          6. Liver failure defined as a history of cirrhosis or fulminant hepatic failure

          7. Preoperative congenital heart disease or arrhythmias

          8. Patient refusal to participate in study

          9. Pregnancy (It is standard of care for all post menarche female patients to undergo a
             urine pregnancy test prior to surgery).
Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Gabapentin 250mg/5mL NDC:59762-5025-01; Simple Syrup
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: gabapentin; Analgesic Drugs; Analgesics, Nonopioid

Summary:

      The purpose of this study is to evaluate the patient experience when using gabapentin with
      other pain control medications after posterior spinal fusion surgery for scoliosis in
      adolescents. These results will be compared to patients who underwent the same procedure
      during the study period and received the same standardized pain control regimen excluding
      gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side
      effects including nausea, sedation and urinary retention (inability to empty one's bladder)
      will also be recorded.The null hypotheses are as follows:

        1. There is no significant difference in pain control when adding gabapentin to a
           multimodal pain management protocol in pediatric post-operative posterior spinal fusion
           patients.

        2. There is no significant difference in the amount of opioid medication required for pain
           control in pediatric post-operative posterior spinal fusion patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of age 10-19 with an American Society of Anesthesiologists patient
             classification of I to III undergoing surgery to correct idiopathic or neurogenic
             scoliosis.

        Exclusion Criteria:

          -  Patients who require a surgical approach or technique differing from posterior spinal
             fusion and/or have allergies to any of the standardized or experimental study
             medications: acetaminophen, gabapentin, hydromorphone, ketorolac or oxycodone.