bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation
Condition: Pancreatic Cancer
Study type: Observational

Summary: 
      <Background/aims> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle
      aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been
      demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies
      across EUS programs in Unites States, Europe and other areas of world. The investigators have
      a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in
      which the adequacy of specimens will be assessed by a single endosonographer.

      <Methods> All EUS-FNAB procedures will be performed by an experienced endosonographer and the
      adequacy of specimens obtained during EUS-FNAB will be also assessed by a same
      endosonographer. A specimen will be considered adequate if there is an adequate number of
      representative cells from the lesion. Samples considered to be adequate will be then
      interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive
      change, or negative for malignancy. Performance characteristics of EUS-FNAB including
      sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with
      the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up
      of more than 6 months with repeat imagings.
    


Intervention name(s): EUS-FNA
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion
A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of
      single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in
      adults with Systemic Lupus Erythematosus.
    


Intervention name(s): rhuMAb IFNalpha
Intervention type(s): Drug
Intervention description(s): Intravenous repeating dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SLE
Reliability and Validity of 10 Meters Walk Test Among Children
Condition: The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going Children
Study type: Observational

Summary: 
      Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During
      Covid-19 pandemic direct observation may not be feasible to record Timed motor function in
      children. Hence, the reliability and validity of video based observation and online based
      observation (VBO and OBO) methods to be explored. Middle school going children age group
      between 8 and 12 years was recruited for the study on the basis of convenience sampling.
      Sample size selected for each age group was according to sample size criteria of Interclass
      coefficient analysis. After anthropometrics, 10 meters walk test was recorded using three
      methods; VBO, OBO and direct observation for three times to estimate intrarater reliability
      and three days within a week to estimate test-retest reliability. The mean of three readings
      was used to find the estimated value. Direct observation method was used as a criterion
      measure method to report concurrent validity. After concurrent validity, Test-retest
      Reliability and Intrarater Reliability of VBO and OBO was reported. Reliability and validity
      of VBO and OBO with direct observation was reported by recording 10 meters walk test in
      children.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Middle school going children from tertiary school of Mullana-Ambala region
      
Keywords: Child; Communication media; Health services; Reproducibility of results; Research design
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate
      Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
    


Intervention name(s): SHR0302
Intervention type(s): Drug
Intervention description(s): SHR0302
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Effect of VIA-2291 on Vascular Inflammation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various
      inflammatory biomarkers in patients with recent acute coronary events
    

Detailed description: 
      This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of
      VIA-2291 on atherosclerotic vascular inflammation
    

Intervention name(s): VIA-2291; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral dosing, 1 time daily for 12 or 24 weeks; oral dosing, 1 time daily for 12 or 24 weeks
Other intervention name(s): atreleuton
Intervention MeSH terms: Atreleuton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the LMA Position Using Ultrasound in Pediatric Patients
Condition: Infraumbilical Surgeries
Study type: Observational

Summary: 
      Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA
      fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA
      malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of
      esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then
      reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA
      position, but the rotated degree of LMA was not considered in that grading. We hypothesized
      that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be
      detected on ultrasound. This study was designed to assess the predictability of the rotated
      LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.

      Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to
      this study. Ultrasound was performed on supraglottic and vocal cords area before and after
      LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was
      evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was
      showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to
      one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre-
      and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of
      rotation were measured.
    


Intervention name(s): Ultrasound exam of upper airway
Intervention type(s): Procedure
Intervention description(s): LMA-position was evaluated with fiberoptic laryngoscopy. The ultrasound findings of pre- and post-LMA were compared.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Following Internal Review Board approval(4-2011-0800) and written informed consent, total
        100 patients(ASA I and II children aged 1 month to 6years) undergoing infra-umblicular
        urologic surgeries were included in the study. Children with upper respiratory tract
        infection, restricted mouth opening, congenital heart disease and those at risk for
        aspiration were excluded.
      
Keywords: ultrasound, LMA, fiberoptic bronchoscopy
Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Patients with suspected or known coronary artery disease who are scheduled for clinically
      indicated SPECT myocardial perfusion imaging (MPI) and will receive invasive coronary
      angiogram are recruited to receive SPECT MBF study.
    

Detailed description: 
      Patients with suspected or known coronary artery disease who are scheduled for clinically
      indicated SPECT myocardial perfusion imaging (MPI) and likely will further receive invasive
      coronary angiogram will be recruited for a SPECT MBF study. The MBF study will be performed
      as an adjunct to MPI utilizing the same rest and stress injections of 99mTc-Sestamibi (MIBI)
      tracer, and the same infusion of dipyridamole, adenosine or adenosine triphosphate for
      stressing. The MBF study will be completed in single or two days depending on the imaging
      protocol of MPI for a site. This is an observational study with no interventions to the
      clinical routine whatsoever. Three models of SPECT (GE NM530c) and SPECT/CT (Siemens
      Symbia-T16 and -T2) cameras are included to acquire rest/stress dynamic SPECT and MPI data. A
      CT scan will be acquired for the purpose of attenuation correction. All dynamic images will
      be reconstructed with physical corrections, including attenuation, scatter, resolution
      recovery and noise reduction, and processed to quantify MBF with the same kinetic modeling.
      The imaging processing of MBF study will be conducted with a SPECT MBF dedicated software
      (MyoFlowQ) in a central lab. MPI images will be collected and independently read by three
      consensus readers. The angiographic result will be independently reviewed by an
      interventional cardiologist. Diagnostic performance of SPECT MBF and perfusion will be
      compared utilizing angiographic result as the reference standard.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be adult male and female patients who have suspected or known CAD
        are agreed to receive MBF measurements when their MPI scan will be performed clinically.
A Study to Evaluate the Effect of Bexarotene on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this proof of mechanism pilot clinical trial is to determine if the
      RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the clearance
      of Amyloid-Beta
    

Detailed description: 
      This is a double blinded, investigational drug study designed to measure the effect of
      bexarotene on the clearance of Aβ total and production of apoE in the human brain of young,
      healthy individuals with the APOE3/3 genotype. From the date of initial subject recruitment
      to the issuance of a final study report and closeout activities, the expected total study
      duration is 6 to 10 months.

      Each participant will be screened for eligibility and randomized to receive either oral
      bexarotene or placebo control ("Test Article").The study has the potential to demonstrate the
      pharmacodynamic properties of a novel treatment approach to Alzheimer's disease. The primary
      biomarker measurements obtained from this study are believed to be highly dynamic and able to
      provide a rapid read-out of the biologic activity of the candidate therapeutic under study.
      In addition, exploratory analysis will involve a proteomics-based screen to identify proteins
      within both blood and CSF that are induced by the Test Article, thereby potentially
      identifying new biomarkers that can be used in future clinical trials to demonstrate
      bexarotene action and target engagement.
    

Intervention name(s): Bexarotene; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Marketed product Targretin® soft gelatin capsule (75mg/capsule) is over-encapsulated in a size AA-el Swedish orange capsule. The subjects will be administered three (3) capsules of Targretin™ (75 mg/capsule) on a twice daily basis (450 mg/day) for five days.; The subjects will be administered three (3) capsules of Avicel PH on a twice daily basis (450 mg/day) for five days.
Other intervention name(s): Targretin®; Avicel PH
Intervention MeSH terms: Bexarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: ApoE; beta-amyloid
Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
Condition: Infant
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to assess the comparative calcium absorption and gastrointestinal (GI)
      tolerance in healthy normal term infants fed two commercially available powdered milk-based
      formulas which contain different fat blends.
    


Intervention name(s): Infant Formula milk based; Infant formula milk based
Intervention type(s): Other; Other
Intervention description(s): Consume ad lib; consume ad lib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Preoperative Counseling on Patient Fear From Visual Experience During Vitrectomy Surgery Under Regional Anesthesia
Condition: Any Patients Undergoing Vitrectomy Under Local Anaesthesia
Study type: Interventional

Summary: 
      This RCT aims to study the effect of preoperative counselling in reducing patients fear and
      visual perception during vitrectomy under local anaesthesia.
    

Detailed description: 
      This was a single-blinded, randomised clinical trial conducted at University of Malaya
      Medical Centre, Kuala Lumpur, Malaysia, and approved by the Institutional Review Board of the
      hospital. Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were
      included. Patients who could not understand English, who had psychiatric illness or mental
      retardation, or who refused to give consent were excluded.

      After obtaining informed consent, patients were randomised to two groups: Group A received
      additional preoperative counseling while Group B did not receive any additional counseling.
      Both groups received routine preoperative counseling regarding potential risks and benefits
      of vitrectomy by an ophthalmologist one day prior to the operation.

      The information covered during counselling and the method of delivery were standardised for
      all patients. An ophthalmologist reviewed the patient one day prior to the operation and
      patients who were randomised to additional counselling were counselled regarding the possible
      visual perceptions that they might encounter during surgery. These included lights, colours,
      movements, flashes, instruments and surgeon's hands or face. Twenty four hours after the
      surgery, another ophthalmologist blinded to the patient randomisation interviewed the
      patients on their visual perceptions during surgery using a standard questionnaire. Patients
      were interviewed regarding the types of visual sensations they perceived and if they caused
      fear to them. Patients were asked to grade their fear based on a visual analogue scale. The
      fear was graded from 0 to 10, with a score of 0 meaning no fear and a score of 10 being the
      maximum or extreme fear. At the end of the questionnaire the interviewer was allowed to ask
      the patient if he or she has received preoperative counselling and if they prefer to be or
      not to be counselled. Patients were asked to describe in details the images and objects that
      they saw during the operation. The data were analyzed using SPSS version 17.0.
    

Intervention name(s): Counselling
Intervention type(s): Behavioral
Intervention description(s): Preoperative counselling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Vitrectomy; Local anaesthesia; Counselling; Fear; Visual perception
A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma
Condition: Healthy Volunteers; Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      different single and repeat doses of PIN201104 in healthy volunteers and in patients with
      asthma.
    


Intervention name(s): PIN201104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV or SC administration; IV or SC administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects
Condition: Phase 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and
      in particular the dose proportionality of setanaxib and its metabolites after a single oral
      dose (400 mg, 800 mg, 1200 mg, and 1600 mg) (Part 1) and after multiple oral doses (Part 2).
    

Detailed description: 
      The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and
      in particular the dose proportionality of setanaxib and its metabolites after a single oral
      dose (400 mg, 800 mg, 1200 mg, and 1600 mg) (Part 1) and after multiple oral doses (Part 2).
      The study will include 2 parts conducted in separate cohorts of subjects.

        -  Part 1 of the study will be an open label, single dose study evaluating the
           pharmacokinetics, and in particular the dose proportionality of setanaxib formulated as
           tablets, in 4 separate cohorts of 6 to 8 healthy adult subjects

        -  Part 2 of the study will assess the pharmacokinetics of setanaxib tablets, expand the
           evaluation of potential drug-drug interactions, and assess the safety of setanaxib
           tablets at doses up to 1600mg/day for 14 days in separate 2 cohorts. The evaluation of
           drug-drug interactions will be carried out only at the top dose. Accordingly, a larger
           cohort (i.e. 16 subjects) will be included in Cohort 7.
    

Intervention name(s): Setanaxib
Intervention type(s): Drug
Intervention description(s): Nox 1/4 inhibitor
Other intervention name(s): GKT137831
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Open-Label Phase 1 Study
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 2

Summary: 
      Lesions of the lichen planus type within the oral mucosa are now considered a potentially
      cancerous condition. One of the minimally invasive methods of treating these lesions is
      photodynamic therapy, and the gold standard in therapy is topical steroid administration
    

Detailed description: 
      Lichen planus shows an irregular shape, which is quite difficult to measure objectively,
      which is important in assessing the effectiveness of treatment.

      Patients will be treated in protocol split mouth with the treatment of lesions on one cheek
      with a steroid (on an adhesive plaster) and on the other - photodynamic therapy with a foot
      sensitizer in the form of a methylene blue also on an adhesive plaster The treatment
      evaluation procedure will consist of taking a series of intraoral photographs. These photos
      will be taken at each visit. This procedure will involve taking pictures traditionally in
      "white" light and in the spectrum of 405 nm, 460 nm and 405 + 460 nm (using the unique
      feature of the prototype laser - emission of two wavelengths simultaneously) in order to
      induce autofluorescence of the mucosa and treated lesions to better visualize them

      A prospective, randomized, single-blind 12-week clinical trial of full contralateral
      split-mouth in patients with bilateral erythematous or erosive lichen planus in the mouth.On
      one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy using
      methylene blue in four sessions every 2 days.

      olp on the other side was treated with the administration of the steroid triamcinolone for 8
      days

      The clinical evaluation of the evolution of OLP eruptions was performed within 12 weeks of
      qualifying for treatment: at baseline, at the end of both treatments (day 8) and after the
      next 11 weeks
    

Intervention name(s): PDT Therapy; Triamcinolone (Substance) therapy side
Intervention type(s): Device; Drug
Intervention description(s): the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density; th The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
Other intervention name(s): Photodynamic Therapy; Steroid therapy
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: full contralateral split-mouth
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: photodynamic therapy