bioihbjkbjnl/mcl2 huggingface dataset:
Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
Condition: Postoperative Pain; Carpal Tunnel Release; Distal Radius Fracture
MeSH terms: Carpal Tunnel Syndrome; Pain, Postoperative; Fractures, Bone; Radius Fractures; Wrist Fractures
Intervention: Acetaminophen; Ketorolac Tromethamine; Saline
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: carpal tunnel syndrome; opioid analgesics; postoperative pain; IV tylenol; IV toradol

Summary:

      The purpose of this study is to determine the efficacy of intra-operative administration of
      IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and
      distal radius fracture patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  carpal tunnel release surgery candidates,

          -  distal radius fracture surgery candidates

        Exclusion Criteria:

          -  under 18 years of age,

          -  pregnant women,

          -  prisoners
DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Contrast-enhanced MRA - Imaging examination
Intervention description: Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dotarem; Gadovist; Peripheral arterial disease; MRA

Summary:

      This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced
      MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male, aged ≥ 18 years

          -  Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.

        Exclusion Criteria:

          -  Patients with severely impaired renal function with an eGFR (MDRD) < 50ml/min (eGFR
             based on recent serum creatinine and MDRD formula - younger than 21 days).

          -  Patient planned to undergo therapeutic intervention in the vessels of interest between
             the two MRA procedures.

          -  Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; metformin
Intervention description: Subcutaneous (under the skin) injection, twice daily; Tablets, 1000 - 2000 mg daily
Intervention MeSH terms: Metformin; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose
      control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese
      subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Currently treated with basal insulin once or twice daily with or without oral
             anti-diabetic drugs (OADs) for at least 3 months

          -  HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both
             inclusive)

          -  BMI (Body Mass Index) maximum 40 kg/m2

        Exclusion Criteria:

          -  Metformin contraindications according to local practice

          -  Systemically treated with TZDs (thiazolidinediones) for more than one month within 6
             months prior to this trial
Effectiveness of Sugammadex in LMS Surgery
Condition: Muscle Relaxation
Intervention: Sugammadex; Neostigmine
Intervention description: Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.; Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.
Intervention MeSH terms: Neostigmine; Pyridostigmine Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rocuronium; Sugammadex; Succinylcholine; Cisatracurium; Neostigmine; acceleromyography (TOF-Watch®)

Summary:

      This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that
      is characterized by short operation time, required intense paralysis and ambulatory setting,
      has not been investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologist[ASA] class 1-3

          -  scheduled Laser microlaryngeal surgery under general anesthesia

          -  written informed consent

        Exclusion Criteria:

          -  suspected difficult tracheal intubation

          -  disorder affecting neuromuscular blockade

          -  known or suspected significant renal dysfunction

          -  known or suspected severe hepatic dysfunction

          -  history of malignant hyperthermia

          -  allergy of opioids, neuromuscular blocking drugs or other medications used during
             general anesthesia

          -  contraindication to pyridostigmine and/or atropine

          -  pregnancy

          -  breast feeding

          -  body mass index > 27kg/m2
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
Condition: Uterine Atony; Hypotension
MeSH terms: Uterine Inertia; Hypotension
Intervention: Oxytocin Infusion; Oxytocin Bolus
Intervention description: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.; 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
Intervention MeSH terms: Misoprostol; Oxytocin; Methylergonovine; Carboprost; Carboprost tromethamine; Maleic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine Atony; Hypotension; Cesarean Delivery; Hemorrhage; Phenylephrine; Ephedrine

Summary:

      The central objective of this study will be to evaluate a standardized, evidence-based
      regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean
      delivery

      The investigators primary hypothesis is that the proposed uterotonic drug regimen, when
      compared to conventional dosing regimen, during elective cesarean delivery will:

      1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain
      satisfactory uterine tone.

      Secondary outcomes to be evaluated will be:

        1. Reduce the side effects associated with uterotonic drug use

        2. Reduce the time to establishment and maintenance of adequate uterine tone
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) I or II health status

          -  Age between 18 and 50 yrs

          -  Singleton pregnancies in vertex position

          -  Elective (without prior labor) cesarean delivery with a planned lower uterine
             (pfannenstiel) incision

        Exclusion Criteria:

          -  Conditions that predispose to uterine atony and postpartum hemorrhage
A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery
Condition: Cataracts
MeSH terms: Cataract
Intervention: Moxifloxacin Ophthalmic; Besifloxacin Ophthalmic
Intervention MeSH terms: Moxifloxacin; Besifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the
      conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3
      days of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman 18 years of age or older.

          -  Physically capable of instilling eye drop or have an appropriate person available to
             assist in administration of eye drops 4 times a day.

          -  Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the
             treatment of cataract.

          -  Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be
             medically cleared for surgery.

          -  Willing to adhere to the prohibitions and restrictions specified in this protocol.

          -  Subjects must have signed an informed consent document indicating that they understand
             the purpose of and procedures required for the study and are willing to participate in
             the study.

        Exclusion Criteria:

          -  Known allergy or contraindication to the test article(s) or their components.

          -  Presence of any abnormality or significant illness in the eye that in the
             investigator's opinion could affect the subject's health or the study parameters.

          -  Presence of an active ocular infection (bacterial, viral or fungal), or positive
             history of ocular herpetic infection.

          -  History of any significant illness that could be expected to interfere with the study
             parameters. Any condition that, in the opinion of the investigator, would compromise
             the well-being of the subject or the study.

          -  Use of disallowed therapies (systemic or topical):

               -  Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of
                  Visit 1 or anytime after Visit 1 for the duration of the study.

          -  Use of contact lenses for one week prior to the study and for the duration of the
             study.

          -  Received an experimental drug or used an experimental medical device within 21 days
             before the planned start of treatment.
Unicirc Adolescent 12-15 Year Old Boys
Condition: Circumcision, Male
Intervention: Unicirc circumcision
Intervention description: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Male
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged
      12 to 15 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy boys desiring circumcision

        Exclusion Criteria:

          -  current illness

          -  bleeding disorder

          -  reaction to local anaesthetic

          -  infection

          -  any penile abnormality potentially complicating circumcision
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Condition: Anemia, Iron Deficiency; Delivery Complication
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferrous sulfate; Iron dextran
Intervention description: one tablet 325 milligrams three times a day; 1000 mg intravenous infusion
Intervention MeSH terms: Dextrans; Iron-Dextran Complex
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum, iron deficiency anemia, intravenous iron

Summary:

      This trial will be a comparative pragmatic open label feasibility randomized controlled trial
      of oral daily versus IV iron in anemic postpartum patients.

      Two randomly assigned groups will be compared during the postpartum period:

        1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6
           weeks TID.

           IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home
           over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.

        2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9%
           500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron
           dextran infusion in 100mL 0.9% sodium chloride.

      2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Delivery at our institution

          -  Hemoglobin below 9 g/dl in postpartum day 1

          -  Singleton gestation

        Exclusion Criteria:

          -  Diagnosis of malabsorptive disorder or history of gastric bypass procedure

          -  Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia,
             sickle cell, etc.)

          -  Significant cardiovascular disease, including but not limited to myocardial infarction
             or unstable angina within 6 months prior to study inclusion or current history of NYHA
             Class III or IV congestive heart failure

          -  Patient has received blood transfusion or there is a plan to transfuse

          -  Lactose intolerance
Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Milk; CCK
Intervention description: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low.; CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.
Intervention MeSH terms: Cholecystokinin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study aims to combine the use of IV CCK administration followed by oral milk during a
      HIDA scan to further stimulate the gallbladder contractility and decrease the number of false
      abnormal HIDA scans and unnecessary cholecystectomies in some patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients referred to a HIDA scan for evaluation of gallbladder function.

          -  No evidence of gallbladder stones on any prior anatomic imaging studies.

          -  Patients who are able to lie flat on the imaging table for an additional 30 min. of
             imaging after the standard of care 1.5 hour HIDA scan.

        Exclusion Criteria:

          -  Patients who are under 18 years of age.

          -  Patients with evidence of gallbladder stones on other imaging modalities.

          -  Patient allergic to milk or dairy products.

          -  HIDA scan ordered to evaluate for acute cholecystitis.
Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine; Placebo
Intervention description: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation); Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Rotigotine; Apathy; Nonmotor; Motor; Neupro

Summary:

      This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement
      of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic
      Parkinson´s Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with early or advanced idiopathic Parkinson's Disease

          -  Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable
             dose of at least 200 mg/day

          -  Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment

          -  Patients experiencing Apathy associated with Parkinson's Disease

          -  Hoehn and Yahr stage score of I to IV

          -  Mini-Mental State Examination score ≥ 25

          -  If an antidepressant drug is taken, the dose must be stable

        Exclusion Criteria:

          -  Therapy with a Dopamine agonist

          -  Discontinuation from pervious therapy with a dopamine agonist after an adequate length
             of treatment, at adequate dose, due to lack of efficacy

          -  Any medical or psychiatric condition that jeopardizes / compromises patient's ability
             for participation

          -  Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating
             substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone

          -  Electroconvulsive therapy

          -  Patient has a

               -  current/anticipated psychotherapy or behavior therapy

               -  history of deep brain stimulation

               -  history of suicide attempt or has suicidal ideation

               -  impulse control disorder

               -  severe Depression
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment, 2%; Hydrocortisone butyrate cream, 0.1%; Pimecrolimus cream, 1%; Crisaborole Vehicle
Intervention description: Applied twice a day (BID); Applied BID; Applied BID; Applied BID
Intervention MeSH terms: Hydrocortisone; Pimecrolimus; Hydrocortisone-17-butyrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The investigational products above are masked for appearance, and will be placed into identical cartons. Once removed from the product cartons, the investigational products could be discerned from each other based on commercial product tube shape/size and should only be handled by unblinded site personnel.
Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.
Enrollment: 237.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis, Crisaborole ointment 2%, TCS, TCI

Summary:

      This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%;
      crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice
      daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

      A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years
      old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or
      Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be
      conducted at select sites.
    

Eligibility criteria:

        Inclusion Criteria:

        Is male or female 2 years and older at the Screening visit/time of informed consent/assent
        diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at
        least 5% BSA.

        Exclusion Criteria:

        Has any clinically significant medical disorder, condition, or disease (including active or
        potentially recurrent non AD dermatological conditions and known genetic dermatological
        conditions that overlap with AD, such as Netherton syndrome.

        Subjects in Cohort 1 are excluded if they have a contraindication for treatment with
        hydrocortisone butyrate cream 0.1%

        Subjects in Cohort 2 are excluded if they have a contraindication for treatment with
        pimecrolimus cream, 1%