bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Condition: Dexmedetomidine; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the study are to determine peak plasma drug concentration levels and
      corresponding time of dexmedetomidine following intranasal administration in children age ≥1
      mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or
      interventional cardiac catheterization procedure.
    

Detailed description: 
      The high anxiety levels that children may experience during the preoperative period may be
      associated with negative medical, psychological, and social consequences. To reduce this
      stress, and to facilitate separation from parents and the induction of anesthesia, children
      are often given a sedative prior to undergoing a procedure. Dexmedetomidine is a highly
      selective a2-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties.
      While off-label in its use, the administration of dexmedetomidine by the intranasal route has
      become a popular and effective technique for sedation in children because it is non-invasive,
      easy to administer, well tolerated, and relatively fast in onset. Despite this, little
      consistent data have been published on its onset time, duration of action, or optimal dose.
      The only available pharmacokinetic (PK) data on dexmedetomidine in pediatric patients is in
      children who were administered IV dexmedetomidine. We are proposing a prospective open-label
      inter-subject cohort dose-escalation pharmacokinetic study to obtain peak dexmedetomidine
      drug concentration level in plasma and the corresponding time point following intranasal
      administration in the pediatric patient with cardiac disease.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dose-escalation of atomized intranasal dexmedetomidine
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Intranasal; Pharmacokinetic; Pediatric
Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient
Condition: General Anaesthesia
Study type: Observational

Summary: 
      the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric
      race according to weight measurement recommended by manufacturer
    

Detailed description: 
      sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using
      laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight.
      Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure
      ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and
      inspiration tidal volume less than 5%, and there is no cuff appear in mouth.
    

Intervention name(s): laryngeal mask
Intervention type(s): Device
Intervention description(s): the size of laryngeal mask given to the patient was based on patient's weight measurement
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        pediatric population aged 1 - 10 years old underwent general anesthesia procedure with
        laryngeal mask airway device
Adapting Dialectical Behavior Therapy for Children in Residential Care
Condition: Childhood Aggression
MeSH terms: Aggression
Study type: Interventional

Summary: 
      I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children
      (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60
      children in the comparison condition).

      II: Finalize therapist training manuals and educational materials to guide selection,
      training, and supervision of treatment providers.
    

Detailed description: 
      Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment
      attendance, treatment satisfaction, and any differences in these rates by groups.

      Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly
      greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.

      Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and
      externalizing symptoms.

      Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer
      internalizing and externalizing symptoms.

      Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation,
      risk taking, and social skills, and reducing depression.

      Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly
      greater improvement in adaptive coping skills, emotion regulation, risk taking and
      impulsivity and social skills, and reducing depressive symptoms.

      Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.

      Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer
      critical incidents, including psychiatric hospitalization, emergency room visits, total
      number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting
      out, running away, stealing, police involvement, etc.
    

Intervention name(s): DBT for children; Enhanced Supportive-Educational therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): intervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents; weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.
Other intervention name(s): Dialectical Behavior Therapy adapted for Children; Enhansed TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DBT, child, emotion regulation, behavior problems
Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery
Condition: Obesity; Sleep Apnea; Diabetes; Hypertension
MeSH terms: Sleep Apnea Syndromes; Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will
      reduce postoperative morphine consumption and improve postoperative quality of recovery as
      compared to morphine in patients undergoing laparoscopic bariatric surgery.
    

Detailed description: 
      effect of Dexmedetomidine bolus on postoperative morphine requirements
    

Intervention name(s): Dexmedetomidine; Morphine
Intervention type(s): Drug; Drug
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; bariatric surgery; postoperative pain; morphine consumption; Quality of recovery
Effect of Hypnosis on Motor Cortex Excitability
Condition: Healthy
Study type: Interventional

Summary: 
      This study is intended to investigate neurophysiological mechanisms of hypnosis using
      transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in
      healthy volunteers under hypnosis.
    


Intervention name(s): Hypnosis
Intervention type(s): Behavioral
Intervention description(s): Hypnosis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hypnosis; TMS; Cortical excitability
Effects of Graptopetalum Paraguayense E. Walther on the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes
      of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther
      on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with
      metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the inclusion
      criteria of MS are according to the Bureau of Health Promotion, Department of Health in
      Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and Graptopetalum
      paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of this study could
      provide the information of Graptopetalum paraguayense E. Walther supplements to what has been
      know in MS subjects.
    


Intervention name(s): Graptopetalum paraguayense E. Walther; Placebo
Intervention type(s): Other; Other
Intervention description(s): Graptopetalum paraguayense E. Walther; starch
Other intervention name(s): starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain
      following bunionectomy surgery.
    


Intervention name(s): diclofenac potassium (XP21L); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg every 6 hours; Placebo every 6 hours
Other intervention name(s): Zipsor Liquid Filled Capsule; XP21L
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bunionectomy; Bunion surgery; Post-operative pain
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
Condition: Japanese Encephalitis; Japanese Encephalitis Vaccine
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more
      than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used
      since 2006. JE vaccines give protection by generating a neutralizing antibody response, but
      both naturally exposed persons and patients with JE also have T cell responses. Whether JE
      vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that T
      cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this study
      is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to
      investigate differences in T cell responses between natural exposure, vaccination and
      disease.
    


Intervention name(s): Live attenuated Japanese encephalitis vaccine SA14-14-2
Intervention type(s): Biological
Intervention description(s): Live attenuated Japanese encephalitis vaccine SA14-14-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Japanese encephalitis; Japanese encephalitis vaccine; T lymphocyte; Immune response
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Condition: Corneal Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This will be a randomized non-dispensing study comparing the overnight corneal swelling of an
      eye while wearing no contact lens to the Ultra contract lens.
    


Intervention name(s): B&L Investigational Contact Lens
Intervention type(s): Device
Intervention description(s): The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nebivolol in Patients With Systolic Stage 2 Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary object of this study is to evaluate the efficacy and safety of 6 weeks of
      nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.
    


Intervention name(s): Nebivolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg, titrated to 20 mg, once daily oral administration; 5 mg or 20 mg once daily, oral administration
Other intervention name(s): Bystolic
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nebivolol; Bystolic TM; Hypertension; Stage 2 Hypertension
The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
Condition: Surgical Procedures, Operative
Study type: Interventional
Phase: Phase 4

Summary: 
      Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these
      findings are relevant to humans but the issue has become a major concern. Recent data have
      found that monkeys exposed to anaesthesia as infants grow up to have slower learning than
      those not exposed.

      The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic
      regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.
    

Detailed description: 
      Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these
      findings are relevant to humans but the issue has become a major concern. Recent data have
      found that monkeys exposed to anaesthesia as infants grow up to have slower learning than
      those not exposed.

      The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic
      regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.

      An alternative anaesthetic regimen comprises a dexmedetomidine-based anaesthetic, augmented
      with an opioid (remifentanil) and a regional nerve block (such as a caudal).

      This open label prospective single arm pilot study will enrol 60 infants aged 1-12 months
      scheduled for lower limb, urologic, or lower abdominal surgery. After sevoflurane induction,
      the infants will have a caudal anaesthetic and intravenous dexmedetomidine and remifentanil.

      The outcome will be need for intervention for light anaesthesia, intervention for
      haemodynamic changes and rate of abandoning the protocol. Recovery times will also be
      recorded.
    

Intervention name(s): Dexmedetomidine; Remifentanil; Bupivacaine; Ropivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Loading dose:1 mcg/kg over 10 minutes. Infusion: Start 1-1.5 mcg/kg/hr. Titrate up or down within 50% of starting doses as needed.; Loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2-0.5 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed.; Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist); Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)
Other intervention name(s): Precedex; Ultiva; Marcaine; Naropin
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Bupivacaine; Ropivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: abdominal; lower extremity
Triple Therapy With Tegoprazan in H. Pylori Positive Patients
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy
      (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy
      (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori
      eradication rate and to evaluate the safety of tegoprazan after oral administration of the
      therapy for 7 days, twice daily in H. pylori positive patients.
    

Detailed description: 
      This is a randomized, double blind, active controlled, multicenter, Phase 3 study to
      demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple
      therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan
      in H. pylori positive patients after oral administration of therapy for 7 days, twice daily.
      After the treatment, UBT test will be conducted to confirm the Helicobacter pylori
      eradication.
    

Intervention name(s): Tegoprazan/Amoxicillin/Clarithromycin; Lansoprazole/Amoxicillin/Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.; Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Other intervention name(s): Tegoprazan triple therapy (TAC); Lansoprazole triple therapy (LAC)
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preparation Protocol for the First Pediatric Dental Visit
Condition: Behavior, Child; Dentist-Patient Relations
Study type: Interventional

Summary: 
      To date, not enough attention has been paid to the role of communication before the first
      dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The
      dentist can provide parents with the information they need to adequately prepare the child
      for treatment. The present study aims to investigate the effectiveness of an infor-mation
      booklet to promote pediatric patients' cooperation during the first dental visit
    

Detailed description: 
      The aim of the study was to test an Information Booklet preparing the child to the first
      dental vis-it. Forty-five children and one parent per included child took part in the trial.
      Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents
      of the study group. At the end of the visit, the dentist and the parent evaluated the child's
      behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet
      through a Likert scale. The children evaluated the pleasantness of the visit and the
      perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).
    

Intervention name(s): Information Booklet
Intervention type(s): Behavioral
Intervention description(s): Information Booklet prior to the dental visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: behavior management; first dental visit
Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of two approved drugs
      in lowering high cholesterol when taken together, compared to taking only one of the drugs.
    

Detailed description: 
      The duration of treatment is 12 weeks.
    

Intervention name(s): MK0733, simvastatin; Comparator: simvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: High cholesterol
Persistent Pain After Laparoscopic Inguinal Hernia Repair
Condition: Pain, Postoperative; Neuropathic Pain; Postherniotomy Pain
MeSH terms: Neuralgia; Hernia; Pain, Postoperative; Hernia, Inguinal
Study type: Observational

Summary: 
      Describe and characterizes laparoscopic postherniotomy patients with persistent
      moderate/severe pain affecting every day activities - including detailed quantitative sensory
      assessment
    


Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Patients with persistent pain after laparoscpic inguinal hernia repair
      
Keywords: Groin hernia; Chronic pain; QST; Quantitative sensory testing; Persistent postoperative pain; Laparoscopic inguinal herniotomy; Postherniotomy Pain after laparoscopic inguinal herniotomy; laparoscopic inguinal hernia repair
A Study in Healthy Volunteers to Evaluate the Application of Stable Isotope Approach to Reduce Number of Subjects Needed for PK Studies
Condition: Metabolic, Cardiovascular
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label, single dose, 4-period, period balanced, crossover
      study. There will be at least 5 days between dosing in each session. The study consists of
      Screening period (30 days prior to Day 1), Treatment period consisting of 4 dosing periods
      (Day 1 is the dosing day and Day 2) and Follow-up period (7-14 days post-last dose).

      The detailed treatment regimen will be A and B (27.5 mg total maximum dose): Single oral dose
      of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol powder
      under fasted conditions; C (33.75 mg total maximum dose): Single oral dose of carvedilol
      31.25 mg as 25 mg immediate release tablet, a 6.25 mg immediate release tablet and up to 2.5
      mg of enriched carvedilol powder under fasted conditions; D (27.5 mg total maximum dose):
      Single oral dose of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched
      carvedilol powder under fed conditions. Approximately 15 subjects will be randomized to
      receive one of four treatment sequences (ADBC, BACD, CBDA, or DCAB).

      The pharmacokinetic sampling and safety data will be collected in the Treatment period (Day 1
      and 2).
    


Intervention name(s): Tab carvedilol 25 mg; Tab carvedilol 6.25 mg; Powder carvedilol up to 2.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carvedilol 25 mg immediate release tablet; Carvedilol 6.25 mg immediate release tablet; Carvedilol up to 2.5 mg isotopically enriched drug substance powder
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetic; carvedilol; Stable isotope technique