bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures
Condition: Anxiety and Fear
Study type: Interventional

Summary: 
      Background: Different intravenous sedative drugs have been utilized for colonoscopy, with
      many anesthetists for painless sedation or monitored anesthesia care. The aim of this study
      was the quality of colonoscopy and the incidence of adverse events such as respiratory
      depression, hemodynamic instability, and failure to provide adequate sedation.
    

Detailed description: 
      Background: Different intravenous sedative drugs have been utilized for colonoscopy, with
      many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was
      the quality of colonoscopy and the incidence of adverse events such as respiratory
      depression, hemodynamic instability, and failure to provide adequate sedation.

      Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical
      status I-II, were randomly assigned to receive either dexmedetomidine (D group) or
      propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of
      dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF
      group were continued during colonoscopy, which lasted approximately 30 minutes.
    

Intervention name(s): Patients who received Dexmedetomodine; patients who received propofol-fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h).; Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.
Other intervention name(s): D group; PF group
Intervention MeSH terms: Fentanyl; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2
      mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and
      activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are
      required periodically through day 43. Subjects with sustained reductions in HbsAg will be
      requested to return for additional follow-up follow-up visits at 3 and 6 months post last
      dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic,
      and safety assessments
    


Intervention name(s): Single Ascending Dose (SAD) Cohorts GS-9620; Multiple Ascending Dose (MAD) Cohorts GS-9620
Intervention type(s): Drug; Drug
Intervention description(s): This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.; This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Intervention MeSH terms: Vesatolimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis; Hepatitis B; Hepatitis B Virus; HBV; GS-9620; Toll-like receptor (TLR)-7 Agonist
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INCB054707
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded,
      Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses
      of INCB054707 in healthy male Japanese participants. Participants in each cohort will be
      divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.
    


Intervention name(s): INCB054707; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered Orally; Administered Orally
Other intervention name(s): Povorcitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: INCB054707
CBT for Anxiety in Children With Autism
Condition: Autism Spectrum Disorder; Anxiety
MeSH terms: Anxiety Disorders; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus
      Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and
      moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in
      levels of activity/functional connectivity within the neural circuits involved in emotion
      regulation and social perception. Matched typically developing children without autism and/or
      anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked
      change relative to normative development.
    

Detailed description: 
      Anxiety is among the most common concerns in children with autism spectrum disorder (ASD) who
      seek mental health services, causing suffering and family stress and exacerbating social
      disability. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in
      children with high-functioning ASD, but the neural mechanisms supporting response to this
      treatment have not been studied. The neural-systems-level targets of CBT for anxiety in
      children with ASD will be investigated by evaluating brain indices of socio-emotional
      functioning with functional magnetic resonance imaging (fMRI) before and after treatment. CBT
      teaches emotion regulation skills, such as cognitive reappraisal, followed by behavioral
      exposure to anxiety-provoking situations. It is hypothesized that CBT aimed at the reduction
      of anxiety will enhance the neural circuitry that subserves the experience and regulation of
      emotions. This is a randomized controlled trial of CBT vs. Psychoeducation and Supportive
      Therapy (PST) in 100 school-age children with high-functioning ASD and moderate to severe
      anxiety. In addition, 50 matched typically-developing (TD) children will be scanned twice
      with a 16-week interval to enable interpretation of change in brain function in children with
      ASD after CBT vs. PST relative to TD children. CBT for anxiety will be provided using a
      structured manual that has been modified for children with ASD by increasing parental
      participation and addressing the role of core ASD symptoms in the experience and expression
      of anxiety. Subjects will be comprehensively characterized with regard to ASD diagnosis, IQ,
      adaptive behavior, and comorbid psychopathology. Functional MRI will be collected as the
      subjects perform tasks involving emotion regulation, emotional face perception, biological
      motion perception, and resting state.
    

Intervention name(s): CBT; PST
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Behavior therapy; Supportive psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Condition: Fasting
Study type: Observational

Summary: 
      In the past, some guidelines advised no oral intake for at least 8 hours before any surgery.
      However, research has shown risks associated with excessive fasting, such as postoperative
      insulin resistance, and advantages in shorter fasting protocols, such as reduced
      postoperative nausea and vomiting.

      The perioperative fasting guidelines of the European Society of Anaesthesiology focus on
      preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich
      fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids
      improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin
      resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids
      before surgery in elderly patients are limited.

      In our institution, there are two clinical pathways for total knee arthroplasty according to
      the surgeons. One difference is whether carbohydrate fluids drink or not before surgery. The
      purpose of this study, therefore, is to assess gastric volume in fasted elderly patients
      using ultrasound after they drank carbohydrate fluids 2 hours before surgery and to compare
      with matched patients using age, body mass index, and comorbidity, who did not drink
      carbohydrate fluids before surgery.
    


Intervention name(s): Carbohydrate fluid; Non-carbohydrate fluid
Intervention type(s): Other; Other
Intervention description(s): 400 mL carbohydrate fluid; 0 mL carbohydrate fluid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing total knee arthroplasty
You Are What You Eat: A Randomised Controlled Trial of an Appearance-based Dietary Intervention
Condition: Fruit and Vegetable Consumption
Study type: Interventional

Summary: 
      This study investigated whether illustration of the facial appearance benefits of fruit and
      vegetable consumption is able to motivate increased intake of this food group. The
      investigators hypothesize that individuals witnessing illustrations of the impact of a
      healthy diet will exhibit improvements in diet relative to a control group receiving only
      information on the health-benefits of this food group.
    


Intervention name(s): Information-only; Generic appearance intervention; Personalised appearance intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Selected pages from the British National Health Service (NHS) information booklets ["5 A Day, Just Eat More (fruit & veg)"; pages i, ii, 12-15, 20 & 21] and ["5 A Day, Just Eat More (fruit & veg): What's it all about?"; pages i-ii)] were provided to all participants on completion of baseline questionnaires. The pages provided information on recommended portion sizes, meal planning, health benefits and answered frequently asked diet-related questions; Participants in the generic appearance intervention group received images to illustrate the impact of fruit and vegetable consumption on skin appearance. Participants in this group were presented with gender congruent stimuli, constructed by averaging the facial shape and colour of four male/female faces.
Participants viewed the gender-congruent set of the resulting stimuli in two forms. Firstly, after completion of baseline questionnaires, images were displayed on a computer monitor. Participants were instructed to select what they perceived as the healthiest face colour, which was recorded by the computer program over two trials.
Participants in this group also received a take-home photo quality leaflet to further illustrate the effect of fruit and vegetable consumption on skin colour.; Participants in this group received stimuli manipulated in identical ways to that received by the generic appearance-intervention group, except the illustrations were performed upon images of the participant's own face.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fruit; vegetables; appearance; skin color; carotenoids; diet
Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch
      in children with eczema.
    

Detailed description: 
      Eczema is characterized by chronic itch. Many children develop a chronic focus (rumination)
      on their itch. Rumination is a maladaptive method of responding to distress, in which the
      individual thinks obsessively about the source of distress. The rumination on chronic itch in
      eczema can have detrimental effects on one's quality of life, as well as induce significant
      anxiety about when itch will return, how long it will last, and how it will affect physical
      and social functioning.

      Cognitive behavior therapy (CBT) is a frontline treatment for rumination, as it focuses on
      teaching strategies so that the individual can examine distressing thoughts objectively and
      determine their validity, replace negative thinking patterns with more adaptive thought
      patterns, and increase the individual's awareness to their problematic thought patterns.
      Additionally, CBT helps the individual to implement behavioral strategies to cope with
      possibly anxiety-inducing situations, such as scratching while trying to go to sleep.

      The investigators hypothesize that an Itch CBT intervention is an effective,
      non-medication-based, easy to implement strategy to improve itch in children with eczema.
    

Intervention name(s): Itch CBT
Intervention type(s): Behavioral
Intervention description(s): Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric
Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      Olanzapine is licensed for use in adults in Canada and in teens in the US with mental
      illness. It is also often used for the management of mental illness in children. This study
      will describe the feasibility of giving olanzapine plus other usual medications to prevent
      chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.

      What has been done already? - In adult cancer patients, olanzapine improved the control of
      CINV. None of the adults studied experienced any serious side effects from olanzapine.

      What is being studied and how will the study be conducted? - On each day that chemotherapy is
      given, olanzapine will be given to 15 children along with their regular medications to
      prevent CINV. Investigators will study each child only during one chemotherapy cycle.
      Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride
      levels, blood pressure, weight, mood and behavior during the time they receive olanzapine
      will be evaluated to see if they change. Investigators will record anything serious that
      happens while children receive olanzapine. If any child stops olanzapine early or decides to
      decrease the dose, the reason will be recorded. Each child and their guardian will record
      their nausea severity and the times they vomit or retch on each day they receive chemotherapy
      and for 8 days afterwards.

      How will the study help? - This study will help investigators decide if it is feasible to
      conduct a larger study to find out if olanzapine improves CINV control in children. If most
      children are able to take olanzapine as set out in the study without having significant side
      effects, then a larger study would be feasible.
    


Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.
Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: olanzapine; pediatrics; chemotherapy-induced nausea; chemotherapy-induced vomiting
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions
Condition: Parkinson's Disease; Restless Leg Syndrome
MeSH terms: Parkinson Disease; Restless Legs Syndrome
Study type: Interventional

Summary: 
      The objective of this study was to assess the single dose bioequivalence of Roxane's
      Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting
      conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over
      design.
    

Detailed description: 
      The objective of this study was to assess the single dose bioequivalence of Roxane's
      Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting
      conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over
      design.
    

Intervention name(s): Ropinirole Hydrochloride
Intervention type(s): Drug
Intervention description(s): Restless Leg Syndrome
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicenter Observational Study of Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy Type 1
MeSH terms: Myotonic Dystrophy
Study type: Observational

Summary: 
      The purpose of the study is to determine the best ways to assess how people are affected by
      myotonic dystrophy type 1 (DM1). The study will assess walking speed, muscle strength, muscle
      size, myotonia, heart rhythm, mental efficiency, and overall health. Participants will
      complete questionnaires to record their ideas about how they are affected by DM1. The study
      will evaluate people with DM1 over 1 year to determine how the condition changes over time.
      The study will identify biomarkers of DM1. Biomarkers are laboratory measurements that show
      the effects of DM1 on a person's muscle tissue or blood. Biomarkers are needed in future
      studies to determine how DM1 may respond to treatments.
    

Detailed description: 
      Participants in the study will come to the study site for 3 study visits. Each visit will
      take most of the day. Each visit will include a series of evaluations to determine how the
      person is affected by myotonic dystrophy. The results from the initial study visit will be
      compared to the second study visit after 3 months and the third study visit after 1 year. A
      small needle biopsy of a leg muscle will be performed at the first and second study visits
      (but not at the third visit). After the second study visit, participants will be asked to
      make a phone call every day for 30 days to report their symptoms and muscle strength (grip
      strength).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 100 adult patients (18 to 70 years old, inclusive) with DM1 will be enrolled
        at 6 centers.
      
Biospecimen description: 
      Blood samples will be used for routine laboratory testing, such as tests of blood cells,
      chemistry, and ability to form blood clots. Blood samples will be used for genetic testing
      (DNA testing) and to identify biomarkers. Needle muscle biopsies will be obtained from the
      tibialis anterior, a muscle in the front of the leg, next to the shin.
Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane
Condition: Recurrent Pterygium
MeSH terms: Pterygium; Recurrence
Study type: Interventional

Summary: 
      To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane
      graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal
      in patients with recurrent pterygium.
    

Detailed description: 
      Excision alone for treating recurrent pterygium was reported to be at risk of high recurrence
      again. As one of adjunctive methods, intraoperative application of a single dose of mitomycin
      C (MMC) seems to be the most commonly used method for preventing recurrence of pterygium.
      Additionally, closure of conjunctival defect after excision of pterygium by limbal
      conjunctival autograft or amniotic membrane have also become popular in recent years. There
      are a few reports in which MMC combined either limbal conjunctival autograft (LCAG) or
      amniotic membrane graft (AMG) for the treatment of recurrent pterygium. To assess the
      effectiveness and safety of these two combined approaches, the investigator plans to work on
      a randomized comparative and prospective trial of recurrent pterygium extensive excision with
      intraoperative 0.02% MMC application comparing LCAG to AMG.The patients enrolled in this
      study will be followed for at least 12 months after the surgery. Recurrence was defined as
      fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous
      pterygium excision.
    

Intervention name(s): MMC; LCAG; AMG
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.; Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.; Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Other intervention name(s): mitomycin C; limbal conjunctiva; limbal conjunctival autograft; limbal conjunctival autograft transplantation; amniotic membrane graft; amniotic membrane transplantation; amniotic membrane graft transplantation
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amniotic membrane; Limbal conjunctival autograft; Limbal; Conjunctival; Mitomycin C; Recurrent pterygium; Pterygium
Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances
Condition: Healthy
Study type: Interventional

Summary: 
      Interventional crossover study on healthy volunteers aimed at evaluating the effect of the
      composition and timing of ingestion of different types of water on the urinary excretion of
      lithogenic substances; the study will also analyze the effect of potassium citrate on urine
      pH and lithogenic substances
    


Intervention name(s): Water
Intervention type(s): Other
Intervention description(s): 1 liter of water in meals; 1 liter out of meals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other