bioihbjkbjnl/mcl2 huggingface dataset:
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Condition: Arrhythmia, Cardiac; Kidney Cancer; Surgery; Anesthesia, Local
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell; Arrhythmias, Cardiac
Intervention: Bupivacaine-fentanyl; Holter ECG monitor; Open kidney cancer surgery; General anesthesia; Epidural Anaesthesia
Intervention description: Local anesthetic; 3-chanel, CM5 leads; Lateral position
Intervention MeSH terms: Epinephrine; Fentanyl; Bupivacaine; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac arrhythmia; epidural anesthesia; combined anesthesia; general anesthesia; NSS; radical nephrectomy; extraperitoneal

Summary:

      This study evaluates the incidence of cardiac arrhythmias during the perioperative period in
      patients undergoing open kidney cancer surgery in the lateral position. All the participants
      will be randomly allocated to receive general (Group G) or combined epidural/general
      anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will
      be applied at the evening before the surgery, tracing continuously for a period of 24 hours
      (7PM-7PM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open renal cell carcinoma surgery, lateral position

          -  American Society of Anesthesiologists (ASA) physical grade I-III

          -  No history of cardiac arrhythmias

          -  Informed consent

        Exclusion Criteria:

          -  Pregnancy and breast feeding

          -  Contraindications for epidural anesthesia

          -  Laparoscopic or robotic surgery

          -  Suspected difficult intubation (ex. fibroscopic)

          -  Chest deformations

          -  Prior cardiac/thoracic surgery

          -  Cardiac insufficiency

          -  abnormal ECG before the surgery
Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Resin Lacquer; Amorolfine; Terbinafine
Intervention description: 30% Resin Lacquer is applied once daily for 9 months (Abicin®) in toenail onychomycosis.; 5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.; 250 mg of Terbinafine is taken orally once daily for 3 months (Generics) in toenail onychomycosis.
Intervention MeSH terms: Terbinafine; Amorolfine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dermatophyte onychomycosis; Fungal nail infection; Resin Lacquer; Amorolfine; Terbinafine

Summary:

      The current study is conducted to corroborate the previous observational clinical trial with
      more valid methods and a more clinically relevant experimental design. This study aims to
      compare efficacy, safety, and cost between topically administered 30% resin lacquer for the
      treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5%
      amorolfine and systemic terbinafine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive dermatophyte culture in the beginning of the study obtained from the toenail
             sample.

          -  Positive KOH stain in the beginning of the study obtained from the toenail sample.

        Exclusion Criteria:

          -  Any other nail disease than dermatophyte culture or KOH stain verified onychomycosis

          -  Onychomycosis caused by yeasts or nondermatophyte molds

          -  Kidney failure determined by plasma creatinine level (P-Krea > 100 μmol/l)

          -  Liver failure determined by plasma γ-glutamyltransferase level (P-GT > 120 U/I)

          -  Sensitivity or allergy to Resin, Amorolfine or Terbinafine

          -  Potential adverse cross-reaction of Terbinafine, Amorolfine or Resin with the
             patient's permanent medication

          -  Presence of total dystrophic onychomycosis (TDO)

          -  Any topical or oral antifungal treatment within the 6 months before the beginning of
             the study (washout period > 6 months).
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Condition: Postoperative Nausea
MeSH terms: Postoperative Nausea and Vomiting
Intervention: Fosaprepitant 150 mg
Intervention description: Antiemetic used to prevent nausea and vomiting after general anesthesia.
Intervention MeSH terms: Fosaprepitant; Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A single group of up to 50 patients will be administered a standard dose of fosaprepitant 150 mg IV after induction of anesthesia. A standard neuromonitoring setup utilizing motor evoked potentials, and somatosensory evoked potentials will be used as indicated for the type of surgery. After baseline neuromonitoring measurements have been made, but prior to surgery starting, we will administer the fosaprepitant to determine if there are any effects on the motor evoked potentials or somatosensory evoked potentials measurements.
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if intravenous fosaprepitant can interfere with
      nervous system monitoring signals in patients having surgery under general anesthesia. This
      medication has numerous effects on the sensory nerve transmission which can theoretically
      have effects on the ability to accurately measure somatosensory evoked potentials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having a surgical procedure requiring general anesthesia, having a surgical procedure
             where neuromonitoing with somatosensory evoked potentials and motor evoked potentials
             neuromonitoring is requested by the surgical team

        Exclusion Criteria:

          -  Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or
             sensory deficit
A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone Gel
Intervention description: Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Intervention MeSH terms: Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of dapsone gel in female subjects with skin of color
      (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acne vulgaris

          -  Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)

          -  Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg,
             sunlight, tanning beds) throughout the study

        Exclusion Criteria:

          -  Received treatment with botulinum toxin of any serotype in the face within 6 months
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin; Pramlintide + Insulin
Intervention description: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.; 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pramlintide; Islet Amyloid Polypeptide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: pediatric; juvenile; diabetes mellitus; Pediatric type 1 diabetes mellitus

Summary:

      The primary objective of this study is to examine the effect of pramlintide given pre-meal
      and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial
      glucose excursions.

      The secondary objective is to examine the effect of pramlintide and insulin on glucagon
      suppression in type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes only

          -  Diagnosed with T1DM for at least 1 year

          -  HbA1C less than or equal to 8.5%

          -  Currently treated using insulin glargine with or without Humalog/ Novolog or on the
             insulin pump

          -  Hemoglobin equal to or greater than 12mg/dL

          -  Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism

          -  Negative pregnancy test, in the case of females

        Exclusion Criteria:

          -  Lack of supportive family

          -  Evidence or history of chemical abuse

          -  BMI (body mass index) greater than the 90th percentile OR less than the 10th
             percentile for age

          -  Patient who is poorly compliant with current insulin management and/or Prescribed self
             blood glucose monitoring

          -  Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/
             hospitalizations) in the past 6 months

          -  Have hypoglycemia unawareness

          -  Have a confirmed diagnosis of gastroparesis, and/ or require medications that
             stimulate gastrointestinal motility

          -  Pregnant or lactating patients, or patients planning on becoming pregnant
Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose
Condition: Encephalitis, Japanese
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine
Intervention description: 0.5 mL subcutaneous injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 561.0
Sex: All
Minimum age: 43 Months
Maximum age: 51 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis Vaccines; Flavivirus Infections

Summary:

      This study aims to understand the persistence of the Japanese encephalitis (JE) antibody
      response in previously vaccinated children. The proposed study will enrol Bangladeshi
      children who had previously participated in a lot to lot consistency study (JEV05;
      NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV.

          -  Resides in the Matlab or Mirpur study area.

          -  At least one parent or guardian willing to provide written informed consent.

        Exclusion Criteria:

          -  Received a second dose of Japanese encephalitis vaccine within the past three years.

          -  Received immunoglobulins and/or any blood products within 90 days prior to enrollment.

          -  Been diagnosed with a primary or acquired immunodeficiency, including human
             immunodeficiency virus (HIV) infection within the past three years.
Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis
Condition: Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Intervention: Acthar
Intervention description: Acthar 80 IU SC twice a week
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveitis

Summary:

      Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis
      often responds adequately to topical corticosteroids, there are many patients for which this
      treatment is either inadequate or not tolerated. A patient with inadequate response to
      treatment would manifest uveitis activity by slit lamp examination determination of anterior
      chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension
      (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid
      administration, leading to glaucoma and permanent visual loss. Moreover, systemic
      corticosteroids may be required at a dose unsafe for chronic administration. In these
      situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If
      and when there is clinical response to the added immunosuppressive, the oral and/or topical
      corticosteroid dose can be reduced or eliminated to avoid toxicity.

      There are several reasons for believing that Acthar might be beneficial in the treatment of
      uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has
      another important mechanisms of action mediated by its binding of melanocortin receptors.
      Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In
      animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory
      cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there
      is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules.
      In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of
      VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal
      tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin
      receptor binding by Acthar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active anterior uveitis requiring oral and/or topical corticosteroid therapy

        Exclusion Criteria:

          -  Uncontrolled diabetes

          -  Uncontrolled glaucoma

          -  HIV infection or other infection for which corticosteroid therapy contraindicated

          -  Contraindication to ACTHAR

          -  Scleroderma

          -  Osteoporosis

          -  Ocular herpes simplex

          -  Systemic fungal infection

          -  Recent surgery

          -  Uncontrolled hypertension
Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour
Condition: Labour Pain; Satisfaction; Adverse Effects
MeSH terms: Labor Pain
Intervention: Remifentanil
Intervention description: Intravenous patient controlled analgesia (ivpca) during labour
Intervention MeSH terms: Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Remifentanil, parenteral opioids, obstetric analgesia, IVPCA

Summary:

      Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by
      non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of
      remifentanil used as analgesia during labour. Intravenous patient controlled analgesia
      (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a
      lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate,
      SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was
      recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were
      assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives
      also recorded their impression of the parturients pain. The parturients level of sedation
      were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered
      at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and
      concentration of remifentanil were performed. After delivery, both mother and midwife
      evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were
      sufficient, nausea, vomiting, level of sedation and dizziness.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology,
        expecting normal childbirth, informed consent.

        Exclusion Criteria:

        Failure to obtain informed consent, received opioids within last 8 hours before study
        start, serious side-effects mother and abnormal fetal heart rate.
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Condition: ADHD; Stimulant-Induced Euphoria
Intervention: SODAS MPH; Naltrexone
Intervention description: Adults with ADHD will receive open-label SODAS MPH; Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: ADHD; Naltrexone; SODAS MPH; Stimulant-Induced Euphoria; Substance Abuse; Adults

Summary:

      The purpose of this study is to a) assess the efficacy of naltrexone in preventing
      stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere
      with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether
      naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We
      predict that naltrexone will successfully prevent stimulant-induced euphoria without
      interfering with the ability of stimulants to effectively treat ADHD in adults. This study
      will be an 8 -week trial with young adults (18-24) with ADHD.
    

Eligibility criteria:

        Inclusion

          1. Male and female outpatients

          2. age 18-30

          3. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured
             interview

          4. likeability response (> 5) on Question #2 of the DRQ-S after an initial test dose of
             60 mg of IR MPH.

          5. Baseline ADHD severity of > 20 on the Adult ADHD Investigator System Report Scale
             (AISRS)

          6. Able to participate in blood draws and to swallow pills.

          7. Subjects must be considered reliable reporters, must understand the nature of the
             study and must sign an informed consent document

        Exclusion

          1. Any current (last month), non-ADHD Axis I psychiatric conditions

          2. Ham-D > 16, BDI > 19, or Ham-A > 21

          3. Any clinically significant chronic medical condition

          4. any cardiovascular disease or hypertension

          5. Clinically significant abnormal baseline laboratory values

          6. I.Q. < 80)

          7. Organic brain disorders

          8. Seizures or tics

          9. Pregnant or nursing females

         10. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)

         11. Current or recent (within the past year) substance abuse/dependence

         12. patients on other psychotropics

         13. Current or prior adequate treatment with MPH

         14. known hypersensitivity to methylphenidate

         15. Current opioid use (by history and urine screen) or potential need for opioid
             analgesics during the study

         16. acute hepatitis or liver failure (baseline blood tests).
Posterior Spinal Fusion With Two Energy Dissection Techniques
Condition: Scoliosis
MeSH terms: Scoliosis
Intervention: Ultrasonic Dissection (UD); Electrocautery Dissection (ED)
Intervention description: Ultrasonic energy will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF; Electrocautery dissection will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for
      soft tissue removal from vertebral surfaces. The aim of the present study is to compare blood
      loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or
      neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative
      surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will
      assess the possible influence of the device use in secondary perioperative outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Between 10 and 21 years of age;

          2. Diagnosed with neuromuscular scoliosis associated with cerebral palsy or with
             idiopathic scoliosis between the ages of 10 and 18;

          3. Indicated for primary PSF surgery;

          4. Anticipated >= 6 vertebrae fusions;

          5. Not in need of three column osteotomy (pedicle subtraction osteotomy [PSO]);

          6. Not in need of vertebral column resection (VCR);

          7. Curve magnitude >45 degrees for scoliosis and for sagittal deformity; and

          8. An American Society of Anesthesiologists (ASA) physical status (PS) classification of
             1 to 4

        Exclusion Criteria:

          1. One or both parents or a guardian unable or unwilling to provide parental permission
             and child assent (if capable, the child must express willingness to participate);

          2. Previous failed vertebral fusion at same target levels;

          3. Syndromic scoliosis;

          4. Congenital scoliosis;

          5. Early-onset scoliosis (onset before 10 years of age);

          6. Requiring an anterior procedure;

          7. Requiring PSO;

          8. Requiring VCR;

          9. Presence of coagulation abnormalities;

         10. Planned staged procedure (exclude if second stage or beyond);

         11. Requiring emergency surgery; and/or

         12. Participation in any other clinical study (not to include registry or survey-only
             studies) for the duration of the study.