bioihbjkbjnl/mcl2 huggingface dataset:
24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle
Study type: Observational

Summary: 
      A study in which intraocular pressure (IOP) will be monitored over 24 hours using the
      SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle
      glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP
      patterns emerging from SENSIMED Triggerfish and GAT.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention description(s): Contact lens-based device for continuous intraocular pressure monitoring
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.
Socio-ecological Intervention to Promote Active Commuting to Work
Condition: Active Travel
Study type: Interventional

Summary: 
      Background Cycling and walking to work is a natural way of increasing physical activity in a
      working population. However, the evidence on the effectiveness and cost savings of promoting
      active work commuting (ACW) is thin. This cluster-randomized, controlled study aims to
      promote ACW with environmental, social and behavioral strategies in two large workplace areas
      in Tampere, Finland. The paper de-scribes the protocol, evaluation and baseline findings of
      the study.

      Methods The enrollment of the workplaces took place in 2014-15. In Phase 1, the impacts of
      environmental strategies (improvements to the walking and cycling trails) were evaluated in
      Area1 including 11 workplaces. In Phase 2, five more workplaces were recruited from Area2 to
      evaluate the impacts of social and behavioral strategies accustomed for each workplace. The
      workplaces in both areas were then randomized into experimental (EXP, n=6+2) and comparison
      group (COM, n=5+3). EXP promoted ACW with social and behavioral strategies; COM participated
      in data collection only but will have the same support post-intervention. The primary outcome
      is the change in employees' self-reported and accelerometer-based ACW. The secondary outcomes
      include e.g. the changes in employees' self-rated health and subjective wellbeing at work,
      the change in the number of walkers and cyclists based on the traffic calculations and the
      change in the quality of walking and cycling trails based on camera auditing (Area1 only).
      External validity of the intervention is as-sessed with the compliance rates of the
      workplaces and employees as well as with the fidelity of the environmental, social and
      behavioral strategies. Health Economic Assessment Tool for Cycling and Walking (HEAT) is used
      to assess the cost savings of the multilevel intervention. In addition, environmental
      variables and types that promote ACW and mediate and moderate the effects of environmental
      strategies are examined.

      Results and discussion This study is one of the first in Finland to combine interdisciplinary
      collaboration between practi-tioners and researchers working in the fields of transportation,
      urban design, physical activity and sustainable development to promote ACW. The findings
      benefit all stakeholders interested in pro-moting ACW in urban context. The study will also
      produce supportive material for promoting ACW at the workplaces.
    


Intervention name(s): KÄPY
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: walking; cycling; intervention; physical activity; environment; promotion
Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether two tooth-colored glass ionomer materials
      are effective for load-bearing dental fillings.
    

Detailed description: 
      In this post-market longitudinal prospective randomized control clinical trial, posterior
      class II restorations will be evaluated for their clinical performance. The study will
      investigate the efficacy of two high-strength glass ionomer restorative materials for a
      period of up to 3 years.
    

Intervention name(s): Ketac Universal; Ketac Molar Quick
Intervention type(s): Device; Device
Intervention description(s): High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.; High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.
Other intervention name(s): Ketac Universal Aplicap Glass Ionomer Restorative; Ketac Molar Quick Aplicap Glass Ionomer Restorative
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental caries; proximal surfaces; posterior teeth; carious lesions; tooth diseases; dental restorations; glass-ionomer
Body-oriented Interventions on Preschoolers' Social-emotional Competence
Condition: Social-emotional Competence
Study type: Interventional

Summary: 
      Experimental study with 4 groups (3 experimental and 1 control). Examine the effects of 3
      body-oriented intervention programs on preschoolers' social-emotional competence.

      Intervention programs focused on relaxation, loose parts play and combined loose parts play
      and relaxation, for 12 weeks with 2 30-min sessions per week.
    

Detailed description: 
      To examine the chronic effects of the intervention programs, instruments were collected at
      baseline (pretest) and at the end of the 12-week period (post-test). To measure the acute
      effects, salivary cortisol was measured at the beginning and end of the 1st and the 24th
      sessions.
    

Intervention name(s): Relaxation; Loose parts play; Combined
Intervention type(s): Other; Other; Other
Intervention description(s): Sessions focused on relaxations activities (Jacques Choque Method).; Loose parts play-based sessions, with open-ended materials.; Sessions focused on loose parts play and relaxation activities.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma
Condition: Dry Eye After LASIK-Laser in Situ Keratomileusis
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the
      treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis
      (LASIK).
    

Detailed description: 
      Prospective interventional consecutive case series including 156 eyes of 80 patients affected
      by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy
      for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in
      corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival
      hyperemia.
    

Intervention name(s): PRP autologous
Intervention type(s): Biological
Intervention description(s): Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
Intervention model: Single Group Assignment
Intervention model description: Prospective interventional non-comparative consecutive case series.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dry eye; PRP; autologous; after LASIK; ocular surface
Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the safety and tolerability of BPI-15086.
    

Detailed description: 
      The main objective of this study is to evaluate the safety and tolerability of BPI-15086. In
      addition, the anti-cancer effect of BPI-15086 in EGFR T790M mutation-positive advanced NSCLC
      patients who have progressed on a previous EGFR tyrosine kinase inhibitor therapy will also
      be evaluated. Biomarkers related to the efficacy of BPI-15086 will be investigated.
    

Intervention name(s): BPI-15086
Intervention type(s): Drug
Intervention description(s): BPI-15086 is administered once daily with a starting dose of 25 mg in a 21-day cycle. When tolerated, increasing doses of BPI-15086 will be tested in subsequent cohorts, until a maximum tolerated dose is determined.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Condition: Effects of Oxytocin on Borderline Personality Disorder; Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if
      oxytocin, compared to placebo shows any additional effect on the therapy achievements
      (outcome) of patients with borderline personality disorder, who receive an in-patient
      standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).

      Secondary objectives :

      Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in
      patients with borderline personality disorder. Comparison of the effects of Oxytocin on
      patients with BPD and major depression.
    


Intervention name(s): Oxytocin; placebo
Intervention type(s): Drug; Other
Intervention description(s): Oxytocin; placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Oxytocin; BPD; Borderline
Clinical Evaluation of Two Toric Contact Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The study objective was to compare short-term clinical performance data of two toric contact
      lenses.
    

Detailed description: 
      The aim of this non-dispensing fitting study was to evaluate the short-term clinical
      performance of a monthly toric contact lens when compared to a daily disposable toric contact
      lens after 15 minutes of daily wear each.
    

Intervention name(s): Lens A; Lens B
Intervention type(s): Device; Device
Intervention description(s): Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear; Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants received Lens A and then Lens B in fixed-sequence order.
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Fuzheng Huayu Tablets on COVID-19
Condition: Novel Coronavirus Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      The 2019 novel coronavirus (2019-nCoV) infection caused clusters of severe respiratory
      illness similar to SARS and was associated with ICU admission and high mortality. There is no
      confirmed antivirus therapy for people infected 2019-nCoV, most of them should receive
      supportive care to help relieve symptoms. This clinical trial is to evaluate the effect of
      Fuzheng Huayu tablet on lung inflammation in intensive patients with novel coronavirus
      pneumonia and reduce the progressive rate to critical type.
    

Detailed description: 
      In December 2019, new coronavirus pneumonia (NCP) occurred in Wuhan, Hubei Province, which
      spread rapidly. Some of the patients developed into severe or critical illness. It became an
      international concerned public health emergencies and one of the major epidemics seriously
      endangering people's health and public safety after severe acute respiratory syndrome (SARS)
      in 2003.

      At present, we lack the specific treatment for NCP. The anti- novel coronavirus drugs are
      been conducting in clinical trials, and the other options includes the symptomatic treatment.
      The pathological mechanism of the disease is not clear, but due to the continuous development
      of inflammation, some cases can become severe or critical, which threatening the life and
      health of patients. Intensive cases with obvious inflammation, after the control of acute
      symptoms and signs, often have the performance of pulmonary fibrosis, affecting the recovery
      of lung function. Therefore, actively reducing lung inflammation, controlling and reversing
      pulmonary fibrosis is of great significance for the life and health of patients Infected
      novel coronavirus.

      Our previous study found that Fuzheng Huayu prescription can reduce the inflammation and
      fibrosis of the lung in the model rats, and improve the lung function of the patients with
      COPD. Therefore, we hope to take Fuzheng Huayu tablet to NCP patients, and observe whether it
      can reduce the lung inflammation of patients, so as to reduce the rate of progression of
      critical illness.
    

Intervention name(s): Fuzheng Huayu tablet
Intervention type(s): Drug
Intervention description(s): Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan
Condition: Pulmonary Alveolar Proteinosis, Autoimmune
MeSH terms: Pulmonary Alveolar Proteinosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.

      Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy
      study.
    


Intervention name(s): Sargramostim; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Measuring Smoking Behaviors While Using Varenicline
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will demonstrate the behavioral responses to varenicline, helping to better
      understand its mechanisms. Hypotheses for the study are to observe decreases in smoking
      topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases
      on day 21 relative to day 7 during varenicline treatment. We also propose to examine if
      extended duration of treatment has clinical significance in decreasing smoking behaviors,
      thus increasing the efficacy of varenicline.
    

Detailed description: 
      This study is designed to examine the behavioral responses a cigarette smoker may have to
      using varenicline. Behavioral responses may help to better understand its mechanisms which in
      turn could improve treatment outcomes. The primary hypothesis for the study is to observe
      decreases in smoking topography, an objective measure of smoking behavior or puffing, on
      varenicline, relative to placebo; and decreases on day 21 relative to day 7 during
      varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab
      visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of
      treatment has clinical significance in decreasing smoking behaviors, thus potentially
      increasing the efficacy of varenicline.
    

Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: smoking; nicotine; varenicline
Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study was a partly controlled laboratory-based study comparing the glycemic and
      insulinemic indices of 3 test meals containing soft drink alone or with SUGARDOWN™
      (Galactomannan) in overweight adults.
    

Detailed description: 
      STUDY SUMMARY This study was a partly controlled, laboratory-based study comparing the
      short-term postprandial glucose and insulin responses produced by three test meals containing
      soft drink consumed alone or with SUGARDOWN™, relative to the responses produced by an
      equal-carbohydrate portion of glucose solution (the reference food). The study used a
      repeated measures design, such that every subject consumed the reference food and each test
      food on two separate occasions, completing a total of eight separate test sessions. Each
      subject completed their test sessions on separate weekday mornings at a similar time each
      day, as close as possible to the time they would normally eat breakfast.

      SUBJECTS Ten healthy, non-smoking, overweight or obese subjects (6 females and 4 males)
      voluntarily participated in this study. The mean ± SD age of the subjects was 32.4 ± 10.9 yr
      (range: 18.7 - 55.6 yr), and their mean ± body mass index value was 27.4 ± 2.6 kg/m2 (range:
      25.3 - 32.3 kg/m2).

      Volunteers were given detailed written and verbal information about all of the study's
      inclusion criteria and experimental procedures. If the volunteers decided that they would
      like to participate in the study, they were asked to come to the research centre on another
      morning, where they completed a detailed screening questionnaire that assessed their current
      health status and medical history. In order to participate in the study, the volunteers had
      to meet the inclusion criteria. All suitable volunteers that were invited to participate in
      the study were required to sign a detailed subject information sheet and a consent form
      before commencing any experimental procedures.
    

Intervention name(s): Sugardown™; Soft drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test food #2: 495.0 g Sprite™ soft drink plus 2 Sugardown™ tablet consumed with 250 mL water (repeated twice) Test food #3: 495.0 g Sprite™ soft drink plus 4 Sugardown™ tablet consumed with 250 mL water (repeated twice); Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)
Other intervention name(s): BTI320; PAZ320; Sprite™
Intervention MeSH terms: PAZ320
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sugardown™; Galactomannan; Postprandial blood glucose; Insulin
Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange
Condition: COPD
Study type: Observational

Summary: 
      To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in
      stable patients with moderate-to-severe COPD who are current non-smokers and not on oral
      corticosteroids.
    

Detailed description: 
      Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single
      blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of
      fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary
      end points will include measurements of nitric oxide at varying expiratory flow rates to
      calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will
      evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous
      inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled
      nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.
    

Intervention name(s): fluticasone 100mcg/ salmeterol 50mcg; fluticasone 250/salmeterol 50; salmeterol; Salmeterol; salmeterol and fluticasone propionate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months; inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide; salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide; salmeterol 50mcg bid X 3months; salmeterol 50mcg/fluticasone 250mcg by DPI bid
Other intervention name(s): Advair 100/50; Advair 250/50; Serevent 50mcg; serevent 50 mcg disk; Advair 250/50
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD
      
Keywords: chronic airflow obstruction
To Assess Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Epiitalis is an ingredient of a currently marketed product named as Osteo-Restore, indicated
      for joint health.The present study is primarily planned to establish the role of Epiitalis as
      a single ingredient in the treatment of mild to moderate cases of knee Osteoarthritis.
    


Intervention name(s): Epiitalis; Placebo
Intervention type(s): Other; Other
Intervention description(s): Two capsules twice daily 30 mins before meals (breakfast & dinner).; Two capsules twice daily 30 mins before meals (breakfast & dinner).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other