bioihbjkbjnl/mcl2 huggingface dataset:
The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation
Condition: Child Development Checklist
Study type: Observational

Summary: 
      【Background& Purpose】In order to early detect the problems a child might have during his/her
      development, an effective screening tool is of great needs. The [Taipei City Child
      Development Screening checklist] is often used to serve this process. This text version is
      mainly distributed to the parents to fill out during their child regular check-ups to the
      hospitals and clinics. The drawbacks of this checklist is that it lacks of active
      participation of the target population, and the text version limits its usage to people who
      are not familiar with Chinese characteristics, such as those new inhabitant. These lead to
      low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of
      this study was to design and develop the multi-media graphic version of the [Taipei City
      Child Development Screening checklist] based on its original text version.【Method】The
      developed muti-media system will be checked for is validity. Thirty parents/legal guardians
      of children in each target age groups will be recruited randomly for the clinical reliability
      evaluation.
    


Intervention name(s): text-based or multimedia
Intervention type(s): Other
Intervention description(s): subjects fills in a questionnaire regarding whether the child meets the developmental milestones for his/her developmental age.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        guardians whose child is between 3 months and 7 years old
The KING'S WHOLE Feasibility Study
Condition: Overweight or Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Office working life has changed dramatically over the last 50 years with digitalization; this
      is estimated to have decreased the amount of energy (calories) used during work. Employees
      who work long or irregular working hours or experience job strain are more likely to make
      less healthy food choices. The combination of these factors may contribute to increased body
      weight during a persons working life. The aim is to investigate the feasibility of an online
      lifestyle behaviour change intervention in office workers.
    

Detailed description: 
      Office working life has changed dramatically over the last 50 years with digitalization; this
      is estimated to have decreased the amount of energy (calories) used during work. Employees
      who work long or irregular working hours or experience job strain are more likely to make
      less healthy food choices. The combination of these factors may contribute to increased body
      weight during a persons working life. The aim is to investigate the feasibility of an online
      lifestyle behaviour change intervention in office workers.

      This feasibility randomized control trial is a remote study and will be conducted online.
      Participants will be randomized to one of two health and well being interventions.

      The study will last 14 weeks. Participants need to attend two on-line study appointments (at
      the start of week 1 and end of week 14) lasting approximately 30-45 minutes.

      In weeks 2, 6 and 10 participants will be asked to participate in a personalised one-to-one
      behaviour change on-line advice session with a research nutritionist/dietitian. Each session
      will last approximately 45 minutes.

      In weeks 1, 5, 9 and 14 participants will be asked to wear a wrist-worn activity monitor and
      report what you eat and drink for 3 days.
    

Intervention name(s): Diet + Activity + Sleep; Diet + Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Personalized lifestyle behavior change counselling; Personalized lifestyle behavior change counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Employee; Lifestyle intervention; Online health and wellbeing
4 Pillars Toolkit for Adolescent Vaccination
Condition: Adolescent HPV Vaccine; Adolescent Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit
      increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV)
      but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV)
      vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to
      national guidelines. The investigators will conduct a randomized cluster trial of this
      toolkit in diverse primary care practices with electronic medical records (EMRs).
    

Detailed description: 
      This intervention is a stratified randomized cluster trial in about 22 diverse primary care
      practices. These practices will be randomly assigned to be intervention or control sites to
      test this 4 Pillars Immunization Toolkit intervention package of evidence-based techniques
      tailored to their practice structure and culture; the specialties are split between pediatric
      and family medicine practices.

      .
    

Intervention name(s): 4 Pillars Toolkit
Intervention type(s): Behavioral
Intervention description(s): Behavioral: Pillar 1: Convenient Vaccination Services (e.g. use every visit [chronic and acute] as an opportunity to vaccinate; use express vaccination clinics and dedicated vaccination stations; use influenza vaccination as an opportunity to vaccinate for other vaccines).
Behavioral: Pillar 2: Patient Notification (e.g. use electronic reminders and social media for vaccination reminders; use physician recommendations).
Behavioral: Pillar 3: Enhanced Office Systems (e.g. implement Standing Order Programs; use EMR prompts; add vaccination status as a vital sign when rooming).
Behavioral: Pillar 4: Motivation (e.g. establish an office Immunization Champion to track goal progress, aided by research team feedback).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; HPV; Tdap; MCV; vaccination; adolescents
Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy
Condition: Pelvic Endometriosis; Endometriosis Outside Pelvis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to establish a new and more accurate method to visualize the
      peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence
      imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide
      applications throughout medicine in identifying vascularity of tissues and
      neovascularization, could facilitate the localization and excision of endometriotic lesions
      exploiting the hypervascularization due to the chronic inflammation
    

Detailed description: 
      Patients were recruited within the clinical routine after indication for laparoscopy under
      consideration of the inclusion and exclusion criteria.

      The first abdominal and pelvi's inspection was made using direct laparoscope visualization
      under white light conditions. All areas suspected of peritoneal endometriosis were classified
      as white, black and red lesions and recorded together with their anatomic location in the
      surgical record for the purposes of subsequent extirpation.

      After the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg BW)
      Indocyanine Green intravenously. The Indocyanine Green imaging mode of the Olympus
      Indocyanine Green Imaging System was activated and suspected areas in Indocyanine Green
      imaging mode were recorded with their corresponding appearance in white light mode.

      If suspected areas were visible either in white light or Indocyanine Green imaging mode,
      specific sample has been taken from these areas.

      In addition control biopsy specimens from inconspicuous peritoneum has been taken.
    

Intervention name(s): Indocyanine Green
Intervention type(s): Drug
Intervention description(s): 0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously
Intervention model: Single Group Assignment
Intervention model description: In the selected patients, after a first white light visual inspection, 0.25 mg/(kg BW) ICG were injected intravenously. After 5 to 30 minutes a second inspection of the abdomen and pelvis in Near Infrared vision was made. All the visualized lesions were carefully described pre and post the Indocyanine Green injection, removed and listed
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Indocyanine Green; Deep Infiltrating Endometriosis; Near-Infrared Vision; Occult endometriosis; Invisible endometriosis
Daily Sessions of rTMS to the Left DLPFC Modulate the Pain Thresholds and CPM
Condition: Pain Relief
Study type: Interventional

Summary: 
      The main purpose of the study is to assess whether repeated sessions of repetitive
      trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex main
      boost the pain thresholds.
    

Detailed description: 
      Pain is the largest health-related burden on society and, despite many decades of pain
      research, there are still few effective treatments. Since pain experience is a construct of
      the central nervous system (CNS), chronic pain has been recently thought to be a CNS
      disorder.

      Repetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive technique for
      cerebral cortex stimulation and the clinical applications of which have expanded considerably
      in recent years. Recent studies have been shown that 'classical' rTMS to different cortical
      areas temporary reduce chronic and acute pain, suggesting that rTMS may ´have some clinical
      application in future management of chronic pain. However, new rTMS paradigms involving theta
      burst stimulation (TBS) have recently been described with the major clinical advantage to be
      much shorter than 'classical' rTMS. The investigators hypothesize that cTBS would yield
      analgesic effects similar to or, possibly, even stronger than those produced by 'classical'
      rTMS. The investigators will carry out a sham-controlled, randomized, double-blind, crossover
      study in healthy volunteers, to compare the analgesic effects of two rTMS protocols over
      dorsolateral prefrontal cortex: classical high-frequency rTMS (10 Hz), and TBS. As
      rTMS-induced analgesia may be dependent on changes in pain modulatory systems, the
      investigators will analyze the effects of the stimulation on conditioned pain modulation
      (CPM). More specifically, the investigators will compare the effects of multiple sessions of
      rTMS on the inhibition of a test experimental stimulus induced by heterotopic noxious
      stimuli, to assess possible changes in diffuse noxious inhibitory controls.
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation; dorsolateral prefrontal cortex; pain thresholds
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Condition: Laparoscopic Cholecystectomy; Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the analgesic efficacy, general safety, and effects on health outcome measures
      and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients
      with moderate or severe pain following laparoscopic cholecystectomy surgery.
    


Intervention name(s): placebo; valdecoxib; valdecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5; valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.; valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Intervention MeSH terms: Valdecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of two different corticosteroid
      ointment application regimens for the treatment of eczema (atopic dermatitis).
    


Intervention name(s): Soak and smear; Dry Smear
Intervention type(s): Other; Other
Intervention description(s): Corticosteroid ointment applied to wet skin once a day and dry skin once a day.; Corticosteroid ointment applied to dry skin twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Topical corticosteroid; Pediatric; Eczema
Efficacy and Safety of Hippophae Rhamnoides L. Leaf Extract on Body Fat
Condition: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Obesity is a major health issue worldwide; there is a constant raise in obesity related death
      each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a
      novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf
      Extract supplementation on body weight regulation in humans are lacking.
    

Detailed description: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Hippophae rhamnoides L. Leaf Extract on body
      fat. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and
      body mass index.
    

Intervention name(s): Hippophae rhamnoides L. Leaf Extract (3g/day); Placebo (3g/day)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hippophae rhamnoides L. Leaf extract (3g/day), parallel design; Placebo (3g/day), parallel design
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Interferon α 2b Pharmacovigilance Study
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3
      patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks,
      and the verification of sustained virological response at week 48.

      The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic
      Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:

      http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf
    


Intervention name(s): interferon α 2b + ribavirin
Intervention type(s): Drug
Intervention description(s): interferon α 2b: 3.000.000 IU SUBQ 3 times / wk for 24 weeks
ribavirin 250 mg: 15mg/kg/day,ORALLY twice a day for 24 weeks
Intervention MeSH terms: Interferons; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Genotype 2/3; Interferon α 2b; Ribavirin; Pharmacovigilance
Caffeine Intake Inrelation to Perioperative Analgesic Consumption
Condition: Analgesia; Caffeine
Study type: Observational

Summary: 
      Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of
      caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to
      promote arousal, alertness, energy, and elevated mood.

      We designed this prospective observational study to determine if caffeine consumption would
      influence intraoperative analgesic consumption
    

Detailed description: 
      Caffeine is a well-known natural compound present in various plant products. Caffeine is an
      integral component of several daily drinks, including tea, coffee, soft drinks, and energy
      drinks [1]. (e consumption habits of these caffeinated drinks have facilitated the wide
      distribution of and dependence on caffeine. For instance, 89% of the US adult population has
      an average caffeine intake of 200 mg/day [2]. Among the multiple effects and side effects,
      caffeine also has an analgesic action and is used to reduce pain in several pharmaceutical
      forms as an adjuvant [1]. Several studies have reported a role for caffeine in controlling
      pain and suggested that caffeine may block the central processing of pain signals in the
      brain and enhance the body's natural pain resistance pathways [3]. In addition, Overstreet et
      al. found that habitual caffeine consumption diminishes pain sensitivity in a laboratory
      setting [4]
    

Intervention name(s): Caffeine intake in mg
Intervention type(s): Dietary Supplement
Intervention description(s): Preanesthetic check-up was done. Average daily caffeine consumption in mg was calculated according to "caffeine content in consumed drinks" as estimated by "Food Data Central".
Intervention MeSH terms: Caffeine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        18 - 65 years old, physical status American Society of Anesthesiology (ASA) I&II, body
        weight from 70-80 kg,
Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the
      ECG in comparison to placebo and moxifloxacin
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ritobegron Cl (KUC 7483 CL) tablets low dose
Other intervention name(s): Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose; Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose; Ritobegron Cl (KUC 7483 CL) tablets high dose
Intervention MeSH terms: Moxifloxacin; p-Hydroxyamphetamine; Ritobegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate, in 12-23 months old subjects, the
      non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™,
      compared to each vaccine administered individually and to licensed meningococcal vaccine
      Meningitec™.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered
      with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and
      Infanrix hexa™ and the final group will receive Meningitec™.

      For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination
      and 1 month after each vaccination.

      For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after
      vaccination.
    

Intervention name(s): Meningococcal vaccine GSK134612; Infanrix™ hexa; Meningitec™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose intramuscular injection; Single dose intramuscular injection; Single dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal vaccine; Immunogenicity; Routine infancy vaccination; Safety
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects
      with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis
      transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective
      potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators
      are pharmacological agents that increase the chloride ion transport properties of the channel
      in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA)
      activation.
    

Detailed description: 
      This is a Phase 3, 2-part, randomized, double-blind, placebo-controlled, parallel group
      multicenter study of orally administered ivacaftor in subjects with cystic fibrosis (CF) 6 to
      11 years of age who have the G551D-CFTR mutation and a forced expiratory volume in 1 second
      (FEV1) between 90% and 105% predicted (using Knudson standards).

      Based on in vitro studies and pharmacologic, pharmacokinetic (PK), and safety profiles,
      ivacaftor was selected for clinical development as a possible treatment for patients with CF.
      Patients with the G551D mutation were the targeted population for this study because
      ivacaftor is a potentiator of the gating effect of the CFTR protein, and the most prevalent
      mutation with a gating defect in CF is the G551D mutation.

      This study was conducted in 2 parts. Part A was conducted to analyze the PK properties of
      ivacaftor and to determine the most appropriate dose to administer to subjects in Part B of
      this study. Part B explored the safety and efficacy of ivacaftor over long-term treatment in
      subjects 6 to 11 years of age.
    

Intervention name(s): Ivacaftor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150-mg tablet given orally q12h for up to 48 weeks; Tablet given orally q12h for up to 48 weeks
Other intervention name(s): VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibrosis; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Pathologic Processes