bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated
      for active immunization for the prevention of influenza disease. Total of 675 subjects or
      above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months
      of age are enrolled, and each subject is administered with single or two doses of vaccines
      depending on previous vaccination history.
    

Detailed description: 
      This is a multi-national, multi-center, randomized, double blinded, parallel-group study to
      assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated
      for active immunization for the the prevention of influenza disease. Total of 675 subjects or
      above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months
      of age are enrolled. Each subject is administered with single or two doses of vaccines
      depending on previous vaccination history, and randomly assigned in 2:1 ratio.

      Stratified randomization for trial site and age strata is used to achieve the balance of
      treatment assignment.

      Total of three or five visits are scheduled depeding on dosing schedule. For subjects
      assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity
      assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety
      is monitored 3 days, 4 weeks after vaccination through Visit 2* and 3 (* telephone contact).
      For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before
      first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively.
      Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2*, 3, 4*, and 5 (*
      telephone contact)
    

Intervention name(s): NBP607-QIV; Agrippal
Intervention type(s): Biological; Biological
Intervention description(s): Purified inactivated influenza virus surface antigens of four strains (quadrivalent); Influenza virus surface antigens of three strains (trivalent)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
Condition: Autism Spectrum Disorder; Developmental Delay
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      In this study, the investigators are trying to find new ways to screen for autism spectrum
      disorder (ASD) in young children. The investigators want to see if people like pediatricians
      can screen children for ASD while a psychologist watches on a monitor. The investigators are
      testing two screening tools. The investigators want to see if they are good at identifying
      children with ASD and children without ASD. The investigators hope this research will make it
      easier for families to get answers when there are concerns for ASD.
    

Detailed description: 
      The investigators will evaluate and compare two telemedicine assessment tools (TELE-STAT and
      TELE-ASD-PEDS) that could allow parents or naive providers in remote locations to complete an
      Autism Spectrum Disorder (ASD) risk assessment via telemedicine consultation via an expert
      psychologist. These tools will be low cost, compliant with privacy rules, easily deployed in
      community practice settings, and explicitly designed to work within paradigms that may be
      pragmatically and financially viable for systems of care housing remote clinicians. These
      telemedicine tools could provide methodologies wherein children could be rapidly linked to
      and appropriately assessed by ASD experts within practice locations where the children are
      currently receiving care. In turn, these children, who without such assessment may wait
      months or over a year in many circumstances to access assessments and interventions, may be
      able to receive appropriate ASD assessments within days or weeks of screening/surveillance
      concerns within practice settings where the children are already accessing and familiar with
      (i.e., minimizing loss to referral and follow-up)
    

Intervention name(s): Telehealth-Screening Tool for Autism in Toddlers (STAT); Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Intervention type(s): Other; Other
Intervention description(s): Structured autism screening tool; Semi-structured autism screening tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: telemedicine
10% Lidocaine Spray for Intrauterine Device Insertion
Condition: Contraception; Intrauterine Device
Study type: Interventional
Phase: Phase 4

Summary: 
      Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during
      IUD insertion is a barrier to use of this method. Currently, there is no recommended standard
      method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine
      formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection,
      could reduce pain during IUD insertion, but there is limited data on effect of lidocaine
      spray on reducing pain during insertion of IUD.
    

Detailed description: 
      Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method.
      However, IUD insertion is a procedure that require well-trained medical personnel and can
      cause pain in several steps during insertion such as applying tenaculum, applying uterine
      sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this
      contraceptive method. Previous researches reported mean pain score with using visual analog
      scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is
      used before IUD insertion procedure. Currently, there is no recommended standard method for
      reducing pain during this procedure. From Cochrane Database 2015, some lidocaine
      formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection,
      could reduce pain during IUD insertion, but there is limited data on effect of lidocaine
      spray on reducing pain during insertion of IUD.

      Lidocaine is introduced to use for pain relieving in medical procedures with advantages of
      rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic
      method that use in obstetrics and gynecology procedures and has favorable efficacy in
      reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD
      insertion. In this study, we investigate pain during IUD insertion using lidocaine spray
      compared with placebo.
    

Intervention name(s): lidocaine spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10% lidocaine spray 4 puffs; Sterile water 4 puffs
Other intervention name(s): Xylocaine; Sterile water
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intrauterine device; lidocaine spray
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective of this study is to investigate the efficacy, safety and pharmacokinetics of
      KDT-3594 in patients with early Parkinson's disease without a concomitant medication of
      L-dopa.
    


Intervention name(s): KDT-3594; Pramipexole
Intervention type(s): Drug; Drug
Intervention description(s): oral administration, dose titration; ER formulation, oral administration, dose titration
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
Condition: Cerebral Infarction
MeSH terms: Ischemic Stroke; Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able
      to improve the outcome of acute ischemic stroke and to observe its safety.
    

Detailed description: 
      The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able
      to improve the outcome of acute ischemic stroke and safety.
    

Intervention name(s): Erigeron breviscapus injection; hua tuo zai zao wan (a herbal medicine pill); Compound stroke herbal medicine (8 herbal)
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: acute intracerebral infarction
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
Condition: Non Neoplastic Condition; Precancerous Condition
MeSH terms: Mastocytosis; Precancerous Conditions; Mastocytosis, Systemic; Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to
      the disease.

      PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with
      relapsed or progressive systemic mastocytosis.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the objective response rate at 6 months in patients with systemic mastocytosis
           treated with thalidomide.

      Secondary

        -  Determine the tolerability of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral thalidomide once daily for 6 months in the absence of disease
      progression.
    

Intervention name(s): thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aggressive systemic mastocytosis; smoldering systemic mastocytosis
Systems Biology of Vaccination for EV71 Vaccine in Humans
Condition: Systems Biology; Early Gene; EV71 Vaccine
Study type: Interventional
Phase: Phase 2

Summary: 
      Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1
      and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good
      safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the
      candidate vaccine for the phase 3 clinical trial.

      This clinical trial is a supplementary phase 2 trial, which is designed to study the gene
      expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5
      years old use a systems biology approach combined with microarray analysis，RT-PCR and
      neutralizing antibody testing for PBMC and serum collected form the studied children
      population, to predict immunogenicity, and explore mechanistic insights about the EV71
      vaccine.
    


Intervention name(s): 320U /0.5ml; 0/0.5ml placebo
Intervention type(s): Biological; Biological
Intervention description(s): inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval; 0/0.5ml placebo, two doses, 4 weeks interval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
Condition: Immunity
Study type: Interventional

Summary: 
      The investigators performed randomized, double-blind, placebo-controlled human trial to
      evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces
      hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity
      parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP,
      antibody titer, and upper respiratory tract infection(URI)
    


Intervention name(s): Cordyceps sinensis mycelium culture extract 0.76 g; Cordyceps sinensis mycelium culture extract 1.15 g; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2); immunity
Exercise Treatment of Dental Anxiety
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      A single bout of physical activity (treadmill)immediately prior to the dental examination
      reduces anxiety in patients with dental phobia.
    

Detailed description: 
      The primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic
      treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a
      minor dental dental procedure.

      Primary efficacy endpoint:

      Change in the visual analogue scale (VAS) for anxiety before and after the intervention prior
      to the elective minor dental procedure
    

Intervention name(s): Aerobic treadmill exercise; placebo exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Experimental training: Aerobic treadmill exercise (30 minutes, 70% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).; placebo exercise: Aerobic treadmill exercise (30 minutes, 20% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
Other intervention name(s): physical activity VO2-70%; physical activity VO2-20%
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental Anxiety, Physical Activity, Dental Phobia; Cortisol, Amylase
Water and Land-based Exercise for Children With Post COVID-19 Condition
Condition: COVID-19; Children, Only; Lung Function Decreased; Quality of Life
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The latest data indicate that post COVID-19 condition is frequent in children and
      adolescents, with the most common symptoms being fatigue, shortness of breath, exercise
      intolerance and weakness. Evidence that COVID-19 can have significant long-term effects on
      children's health highlights the need for measures to reduce the impact of the pandemic on
      children, ensuring that they receive appropriate treatments. Those experiencing post COVID-19
      condition require more tailored exercise-related advice and improved support to be able to
      resume activities important to their individual well-being. To the best of our knowledge, no
      studies have yet addressed the issue of exercise programs for children with post COVID-19
      condition.

      The aim of this study, therefore, is to evaluate the effectiveness of different interventions
      on pulmonary function, exercise capacity, fatigue and quality of life in children with post
      COVID-19 condition.

      This will be a randomized controlled study with pre and post intervention assessment.
      Children will be recruited from primary schools and primary health care units in Warsaw.
      Participants meeting the inclusion criteria will be randomized to one of 3 groups:
      water-based exercise, land-based exercise or control (no exercise). The water-based and
      land-based exercise groups will be held twice a week, 45 min per session for 8 weeks.
      Participants will be assessed at baseline and immediately post-intervention in terms of
      changes in pulmonary function, exercise capacity, fatigue and quality of life. Research
      outcomes will build the evidence-based practice for health professionals.
    


Intervention name(s): Water-based exercise; Land-based exercise
Intervention type(s): Other; Other
Intervention description(s): 8 weeks x 2 times per week for 45 min; 8 weeks x 2 times per week for 45 min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Carotid Body Removal for the Treatment of Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is a pilot study to assess the effectiveness, safety and feasibility of carotid body
      removal in patients with high blood pressure (hypertension) resistant to medical treatment.
      Patients with high blood pressure are at significant risk of medical complications including
      stroke and heart disease. The principle research question is whether removal of the carotid
      body will lead to an improvement in the blood pressure of this patient group.
    


Intervention name(s): Carotid body excision
Intervention type(s): Procedure
Intervention description(s): This surgery does not involve any study drug or investigational device.
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with
      eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of
      four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit
      the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for
      clinical symptom assessment and safety evaluation (including adverse events and vital signs).
      All study treatments (active drug and placebo) will be administered orally twice daily during
      the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.
    


Intervention name(s): budesonide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension; oral suspension matching budesonide
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: eosinophilic esophagitis
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects
Condition: Healthy Elderly Subject; Pharmacokinetic of YM150
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and plasma concentration change of YM150
      after repeated administration to healthy elderly male and female subjects.
    


Intervention name(s): YM150; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): darexaban
Intervention MeSH terms: Darexaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: YM150; Plasma concentration; darexaban; Healthy elderly subject; Pharmacokinetics of YM150
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
Condition: Adult Rhabdomyosarcoma; Lung Metastases; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Stage IV Adult Soft Tissue Sarcoma; Stage IV Wilms Tumor; Stage V Wilms Tumor; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis; Sarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Rhabdomyosarcoma, Embryonal; Neuroectodermal Tumors, Primitive, Peripheral; Lung Neoplasms; Recurrence
Study type: Interventional

Summary: 
      This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating
      younger patients with lung metastases. Specialized radiation therapy that delivers a high
      dose of radiation directly to the tumor may kill more tumor cells and cause less damage to
      normal tissue.
    

Detailed description: 
      OBJECTIVES:

      I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional
      setting with central quality control for children and young adults with metastatic tumors in
      the lungs.

      II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over
      standard whole lung irradiation by comparing treatment plans and different organ dose-volume
      histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this
      study.

      III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance
      of whole lung IMRT at a minimum period of six months after IMRT.

      OUTLINE:

      Patients undergo cardiac-sparing whole lung IMRT.

      After completion of study treatment, patients are followed up for 1-5 years.
    

Intervention name(s): intensity-modulated radiation therapy
Intervention type(s): Radiation
Intervention description(s): Undergo cardiac-sparing whole lung IMRT
Other intervention name(s): IMRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment