bioihbjkbjnl/mcl2 huggingface dataset:
Perennial Allergic Rhinitis In Pediatric Subjects
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety of long-term use of cetirizine dry syrup in children with perennial
      allergic rhinitis.
    


Intervention name(s): Cetirizine Dry Syrup
Intervention type(s): Drug
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Perennial Allergic Rhinitis pediatric
The Research of AI Assistant Gastroscope Training
Condition: Gastroscopy; Training; Artificial Intelligence
Study type: Interventional

Summary: 
      In this study, we proposed a prospective study about the effectiveness of artificial
      intelligence system for gastroscope training in novice endoscopists. The subjects would be
      divided into two groups. The experimental group would be trained in painless gastroscopy with
      the assistance of the artificial intelligence assistant system. The artificial intelligence
      assistant system can prompt abnormal lesions and the parts covered by the examination (the
      stomach is divided into 26 parts). The control group would receive routine painless
      gastroscopy training without special prompts. Then we compare the gastroscopy operation
      score, coverage rate of blind spots in gastroscopy,check the average test score before and
      after training, training satisfaction, detection rate of lesions and so on between the two
      group.
    

Detailed description: 
      In this study, we proposed a prospective study about the effectiveness of artificial
      intelligence system for gastroscope training in novice endoscopists. The subjects would be
      divided into two groups. The experimental group would be trained in painless gastroscopy with
      the assistance of the artificial intelligence assistant system. The artificial intelligence
      assistant system can prompt abnormal lesions and the parts covered by the examination (the
      stomach is divided into 26 parts). The control group would receive routine painless
      gastroscopy training without special prompts. Then we compare the gastroscopy operation
      score, coverage rate of blind spots in gastroscopy,check the average test score before and
      after training, training satisfaction, detection rate of lesions and so on between the two
      group.
    

Intervention name(s): Artificial intelligence assistant system
Intervention type(s): Other
Intervention description(s): The intervention is the use of the artificial intelligence assistant system in addition to the common training. The system is an non-invasive AI system which could help the endoscopists to diagnosis and monitor the blind spot during the gastroscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy
Condition: Rectum Cancer, Recurrent; Brachytherapy, Radioisotope
MeSH terms: Rectal Neoplasms; Recurrence
Study type: Observational

Summary: 
      This study observes the efficacy and side effects of 3D-printing non co-planar
      template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS)
      brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the
      influence of clinical and dosimetric factors on the outcomes.
    

Detailed description: 
      3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a
      conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed
      brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125
      seed can release low dose of irradiation persistently which kills tumors cell and causes less
      damage to normal tissue at the same time. 3D-printing non co-planar template is made
      individually which guides the implantation of Iodine-125 seed into the tumor and ensures the
      accuracy of the position.This study collects the data of patients with pelvic recurrent
      rectal carcinoma who underwent 3D-PNCT assisted with CT-guidance for radioactive Iodine-125
      seed implantation from 2015 to 2018. We evaluate the dose that covers 90% target
      volume(D90),the volume that 100% prescription dose covers(V100) and other dosimetric
      parameters after the implantation. The efficacy and adverse effects were observed. Local
      control(LC) time and overall survival(OS) time are evaluated.
    

Intervention name(s): radioactive Iodine-125 seed implantation under the guidance of 3D template
Intervention type(s): Radiation
Intervention description(s): 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment for patients with local recurrent rectal carcinoma. Retrospective data on the effectiveness and adverse effects of the past radioactive Iodine-125 seed implantation is collected.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with local recurrent rectal carcinoma who were treated with 3D-printing non
        co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy as a
        conventional treatment in Peking University Third Hospital during December 2015 to December
        2018
      
Keywords: Three-Dimensional Printing; Rectum Cancer, Recurrent; Radioactive Iodine-125 seed implantation
Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus®
      (DACP) compared to MyDay® after 12 hours of lens wear.
    


Intervention name(s): Nelfilcon A contact lenses; Stenfilcon A contact lenses
Intervention type(s): Device; Device
Other intervention name(s): DAILIES® AquaComfort Plus®; DACP; MyDay®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: DACP; DAILIES® AquaComfort Plus; Tear film stability; NIK-BUT
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Impairment Renal Functions
Condition: Chronic Renal Impairment
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety
      of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal
      Impairment and Subjects with Normal Renal Functions
    

Detailed description: 
      This is a single-center, open-label, non-randomized, parallel-controlled Phase I clinical
      study carried out in subjects with varying degrees (mild or moderate) of renal impairment,
      and age-, weight-, and gender-matched subjects with normal renal functions.
    

Intervention name(s): HSK3486
Intervention type(s): Drug
Intervention description(s): HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mild renal impairment; Moderate renal impairment
Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The main objective of this trial is to evaluate endoscopic visualization during a
      laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally
      through a new device called a Steerable Flex Trocar (SFT).
    


Intervention name(s): NOTES toolbox
Intervention type(s): Device
Intervention description(s): Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss
Effect of the Level of Dietary Protein on Body Composition
Condition: Growth Acceleration
Study type: Observational

Summary: 
      The purpose of this study is to determine if toddlers and children who were fed breast milk
      or infant formulas at different levels of protein between 3 and 12 months of age have
      differences in growth and body composition at 3 and 5 years of age.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Toddlers and Children who have previously participated in an infant formula trial where
        various levels of protein were provided and who are now at the age of 3 and 5 years.
      
Keywords: Body composition; Protein Metabolism
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1
      diabetes mellitus (T1DM).

      Secondary Objectives:

        -  To assess the ability to titrate the prandial and supplemental doses of Afrezza at each
           meal.

        -  To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4
           to 17 years with T1DM.
    

Detailed description: 
      The patients are expected to participate in the study for approximately 6 to 8 weeks from
      Screening to final follow-up visit.
    

Intervention name(s): Afrezza
Intervention type(s): Biological
Intervention description(s): Pharmaceutical form: powder
Route of administration: inhalation
Other intervention name(s): Technosphere Insulin
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label study is being conducted to confirm the safety, pharmacokinetic profile and
      efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema
      attacks in patients, from 2 up to and including 13 years of age.
    

Detailed description: 
      This study was an open-label, Phase 2, non-comparative, multinational, multicenter clinical
      study in pediatric patients from 2 up to and including 13 years of age, with a confirmed
      diagnosis of HAE. Patients were eligible for treatment with rhC1INH if they presented to the
      clinic within 5 hours of onset with an acute attack of at least moderate severity without
      signs of spontaneous regression. Patients received rhC1INH at a dose of 50 U/kg body weight
      up to a maximum of 4200 U. The reconstituted solution was administered as a slow intravenous
      (iv) injection over approximately 5 minutes. The patients remained in hospital and were
      closely monitored in the study center for at least 4 hours after study medication
      administration.
    

Intervention name(s): rhC1INH
Intervention type(s): Drug
Intervention description(s): Patients up to 84 kg will receive one i.v. injection of Ruconest at a dose of 50 U/kg. The reconstituted solution should be administered as a slow i.v. injection over approximately 5 minutes. Patients of 84 kg body weight or greater will receive one i.v. injection of Ruconest at the dose of 4200 U (2 vials).
Other intervention name(s): Ruconest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hereditary Angioedema; HAE; Angioedema; Recombinant C1 Inhibitor; rhC1INH; Pediatrics
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study
      period.

      Period: 24 hours post dose in each period. Each subject will complete two study periods.

      Washout Period: At least one week after dosing of the previous period.

      Confinement: From at least 10 hours prior to dosing until at least 12 hours post-dose, for a
      total of at least 22 hours for each study period.
    

Detailed description: 
      This study is a single center and open-label design to evaluate tolerability, safety and
      pharmacokinetic properties of HUYPS-1 after single oral administration in healthy subjects
      under fasting conditions. A total of 14 eligible subjects are expected to be enrolled to
      ensure 12 evaluable subjects. The study will be completed when there are at least 12
      evaluable subjects. The evaluable subjects are those who have completed both periods.
      Eligible subjects will be randomly assigned to either of the two treatment sequences.

      The study design in a 2-sequence, 2-period crossover design. There is at least 7-day washout
      time between periods. The formulation of HUYPS-1 for oral administration contains 100 mg
      mannitol and 100 mg sucralose per tablet will be given by one or nine tablets per person of
      each period. Mannitol and sucralose are both commonly used excipients approved by WHO. These
      excipients are included in the FDA Inactive Ingredients Guide, GRAS (generally recognized as
      safe) and commonly used pharmaceutical excipients, therefore the oral doses of these
      excipients can be regarded as extremely safe in this study.
    

Intervention name(s): HUYPS-1 one tablet; HUYPS-1 nine tablets
Intervention type(s): Drug; Drug
Intervention description(s): After 7-day washout time, subjects will receive HUYPS-1 1 tablet.; After 7-day washout time, subjects will receive HUYPS-1 9 tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section
Condition: Intracranial Pressure Increase
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal
      intubation and mechanical ventilation are components of general anesthesia. Endotracheal
      intubation has been shown to cause increased intracranial pressure. There is not enough
      information about the effect of spinal anesthesia on intracranial pressure during cesarean
      operations. Increased intracranial pressure can cause neurological complications by
      disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia
      method should be determined especially in pregnant patients who are at risk of increased
      intracranial pressure.
    


Intervention name(s): Optic Nerve Sheath Diameter Measurement
Intervention type(s): Other
Intervention description(s): The change in intracranial pressure via optic nerve sheath diameter measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: optic nerve sheath diameter; intracranial pressure; intraabdominal pressure; cerebral regional oxygen saturation; c-section
Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA
Condition: Ischemic Heart Disease; Atherosclerosis
MeSH terms: Heart Diseases; Atherosclerosis; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      The main purpose of this single-center study is to determine the spectrum and levels of
      cardiospecific circulating microRNAs in patients with different stages of atherosclerosis
      according to 640-slice multispiral computed tomography (MSCT).
    

Detailed description: 
      The study will be conducted in two phases. Phase one. After signing the informed consent,
      patients with coronary heart disease, angina pectoris II-IV functional class, who underwent
      MSCT angiography of the coronary arteries for medical reasons, regulated in the relevant ESC
      and the Russian Society of Cardiology guidelines, will be included in the study. According to
      the results of MSCT, the participants will be divided into 4 groups: those with
      atherosclerotic plaques with signs of instability; those with stable atherosclerotic plaques
      without marked calcification; those with calcined atherosclerotic plaques; those with no
      signs of atherosclerosis of the coronary arteries. Plasma samples will be analyzed by
      microarray, using a cardiospecific set.

      Phase two. Validation of the results obtained after the first phase will be performed on a
      larger sample of patients. Patients after signing an informed consent will also undergo MSCT
      angiography of coronary arteries and according to its results will be devided in 4 groups. To
      assess the level of microRNA expression in the blood of patients, real-time reverse
      transcription-polymerase chain reaction (RT-PCR) will be used.

      The expected result of the study. For the first time ever, there will be determined the
      profile of circulating regulatory RNA in patients who underwent MSCT angiography of coronary
      arteries. Features of expression of circulating microRNAs will be compared with different
      severity degrees of the atherosclerotic process based on MSCT criteria. The results will be
      compared with each other (including the "control" group), which will allow to identify common
      patterns and specific differences.
    

Intervention name(s): blood test
Intervention type(s): Diagnostic Test
Intervention description(s): Blood test for spectrum and level of cardiospecific micro-RNA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ischemic Heart Disease; Atherosclerosis; micro-RNA; multislice spiral computed tomography; coronary angiography
Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age
Condition: Aging
Study type: Interventional

Summary: 
      This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised
      exercise versus no exercise. Several end points were evaluated after 16 weeks including
      insulin sensitivity and muscle physiology.
    

Detailed description: 
      Healthy subjects performing < 30 min exercise twice per week were studied prior to
      randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of
      supervised exercise performed on a stationary bike vs. placebo exercise (a series of
      flexibility exercises performed at home). Intensity, duration and frequency of exercise were
      gradually increased to four sessions per week lasting forty minutes each and achieving 80%
      target heart rate. Participants were weighed perioidically and counseled appropriately when
      weight changed by > 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were
      studied.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Mindfulness for Burnout Prevention in Primary Care Providers
Condition: Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      Burnout Syndrome is one of the major challenges for health systems worldwide. This study
      strives to evaluate the feasibility and effectiveness of an 8- versus 2-week
      mindfulness-based self-care program on burnout symptoms and psychological and biological
      variables.
    

Detailed description: 
      The development of stepped-care interventions allows for the development of new strategies
      within mindfulness-based approaches, classically described as a weekly two-hour commitment
      which lasts eight weeks. Such approaches might reach larger and stratified groups, more
      suitable for usage in Brazilian health-system context. For such evaluations, the
      investigators will use a 3-arms randomized clinical trial design, with Sociodemographic and
      Labor variables, such as age, sex, number of offspring, adherence to the program, adherence
      to the mindfulness practices, Burnout Clinical Subtype Questionnaire -(BCSQ-36), Maslach
      Burnout Inventory (MBI-GS), Mindfulness Attention Awareness Scale (MAAS), Freiburg
      Mindfulness Inventory adapted for Brazil (FMI-Br-13), Five-Facet Mindfulness Questionnaire
      (FFMQ-Br). DNA methylation will be measured by Methylase-reaction, and BDNF (brain-derived
      neurotrophic factor) will be quantified by ELISA-sandwich. The primary outcome will be the
      effectiveness of such programs on different clinical subtypes of Burnout symptoms (frenetic,
      under challenged and worn-out). The secondary outcome will be mindfulness levels, and
      adherence to the program and to the mindfulness practice, and on inflammation and epigenetic
      variables.
    

Intervention name(s): Mindfulness 8 weeks; Mindfulness 2 weeks
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions of mindfulness; 2 sessions of mindfulness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mindfulness-based; Self-care; Health workers; Epigenetics