bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of the Echoendoscope for Clinical Performance
Condition: Endosonography
Study type: Observational

Summary: 
      The primary objective for this study is to compare the safety and validity of two endoscopic
      ultrasonography (EUS) systems (GF-UE260-ME2 and EG-UR5-S50) used for clinical performance and
      establish a relative EUS performance assessment system and clinical case data to provide
      support for the product performance improvement.
    

Detailed description: 
      This research is a random, opening and parallel-controlled clinical test. Tested device
      model: The EG-UR5 ultrasonic endoscope manufactured by SonoSscope Medical Crop. That used
      with the HD-500 image processor, HDL-500X light source and S50Exp ultrasonic color doppler
      instrument .

      Compared device model: The GF-UE260-ME2 ultrasonic endoscope manufactured by Olympus and its
      compatible light source, image processor and ultrasonic instrument.

      To scientifically compare the clinical performances of the test model and the compared model,
      the enrolled objects would be randomly distributed to the tested group and the compared group
      to conducted the examination with the tested model and the compared model respectively.

      EUS will be performed in the standard fashion by one of the experienced endosonographers in
      the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope
      withdrawn from the patient.

        1. Check Points Providing optical images of the human upper gestrointesinal tract
           (including esophagus, stomach and duodenum) for observing, diagnosis and treatment, and
           for the ultrasonic check and diagnosis for the upper gastrointestinal tract and
           surrounding organs.

        2. Test Items 1. Ultrasonic and endoscopic image quality assessment 2. Device
           controllability assessment 3. System safety assessment 4. System stability assessment

      The data are recorded in the CRF, including patient information, clinical assessment for the
      usage of the endoscope and device operation, thus to perform a comprehensive assessment
      whether the safety and validity of this product can meet the clinical requirements.
    

Intervention name(s): Assessment of the safety and validity of echoendoscope
Intervention type(s): Other
Intervention description(s): Ultrasonic and endoscopic image quality assessment
Device controllability assessment
System safety assessment
System stability assessment
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients referred to PUMCH Endoscopy Unit for EUS assessment will be included.
      
Keywords: echoendoscope; endoscopic ultrasonography
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine if single doses of BMS-986166 are safe and
      well tolerated in healthy male subjects and female subjects of non-childbearing potential.
    


Intervention name(s): BMS-986166; Placebo matching BMS-986166
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Reliability of KHQ and ICIQ-SF in Assessing Urinary Incontinence Effects in Polish Women
Condition: Urinary Incontinence; Overactive Bladder; Stress Urinary Incontinence; Urge Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Stress; Urinary Incontinence, Urge
Study type: Observational

Summary: 
      The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish
      women.
    

Detailed description: 
      Purpose The King's Health Questionnaire (KHQ) and the International Consultation on
      Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice.
      The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish
      women.

      Methods One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years
      underwent urodynamic investigation and completed both KHQ and ICIQ-SF. To evaluate the factor
      structure and construct the validity of the KHQ and ICIQ, Principal Component Analysis (PCA)
      using VARIMAX rotation was conducted for all questionnaire items. PCA results were also
      confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, the internal
      consistency of the KHQ and ICIQ was estimated by way of Cronbach's alpha coefficient (α).
      Statistical analysis was performed using STATISTICA version 13.1 software (StatSoft, Poland),
      as well as open source R software (version 3.4.4).
    

Intervention name(s): King's Health Questionnaire; the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): patients fulfilled questionnaire; patients fulfilled ICIQ-SF questionnaire
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women age 18-82 years who declared symptoms of urinary incontinence
      
Keywords: king's health questionnaire; the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone
Condition: Spondyloarthrosis, Spondylosis
MeSH terms: Spondylosis; Spondylarthropathies
Study type: Interventional

Summary: 
      The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with
      allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing.
      Allograft by itself is not an effective material as a posterior onlay graft for the PLF in
      adult surgery.
    

Detailed description: 
      The study was prospective, randomized, controlled and blinded. Eighty patients with
      degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF. In
      forty cases, the PLF was done with spongious allograft chips alone (Group I). In another
      forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal
      stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients
      were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the
      surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of
      mineralization of the fusion mass were evaluated separately by two radiologists blinded to
      patient group affiliation.
    

Intervention name(s): bone allogaft with bone marrow concentrate
Intervention type(s): Biological
Intervention description(s): In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbar spine; Posterolateral fusion; Allograft; Bone marrow concentrate; Mesenchymal stem cells; Fusion rate
PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study is to evaluate and compare the safety, reactogenicity, and
      tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel
    


Intervention name(s): PA83-FhCMB
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study
Condition: Healthy Volunteers Only
MeSH terms: Oroantral Fistula
Study type: Interventional

Summary: 
      Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral
      Communications.
    

Detailed description: 
      the current study was carried on 24 patients suffering from Oro-Antral Communications. All
      patients were divided into 4 equal groups.
    

Intervention name(s): Buccal Pad of Fat; A-PRF; fibrin glue; oxidized cellulose
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): surgical procedure; blood sample; procedure; procedure
Intervention MeSH terms: Fibrin Tissue Adhesive; Cellulose, Oxidized
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benacel;; bone regeneration;; platelet rich growth factor;; Oro-Antral Communication; buccal pad of fat; fibrin glue
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
Condition: Healthy Volunteers; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the amount of the active ingredient and helping agent
      in the blood in two different tablet versions of Semaglutide. The study will consist of 3
      groups and the treatment the participants will get is dependent on the group the participants
      will be enrolled in.

      The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and
      group 3 for 20 weeks.

      The study will last up to 29 to 31 weeks for each participant. This includes a screening
      period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20
      weeks) and a follow-up period (5 weeks after the last dose).
    


Intervention name(s): Semaglutide D Dose 1; Semaglutide D Dose 2; Semaglutide D Dose 3; Semaglutide Dose 4; Semaglutide Dose 5; Semaglutide Dose 6
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled,
      positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of
      balovaptan on the QTc interval in healthy subjects.
    


Intervention name(s): Balovaptan therapeutic dose Treatment A; Balovaptan supra-therapeutic dose Treatment B; Active control [moxifloxacin] on Day 2 Treatment C; Active control [Moxifloxacin] on Day 15 Treatment D; Placebo for Balovaptan Treatment C; Placebo for Balovaptan Treatment D; Placebo for Moxifloxacin Treatment A; Placebo for Moxifloxacin Treatment B; Moxifloxacin Treatment C; Placebo for Moxifloxacin Treatment C; Placebo for Moxifloxacin Treatment D; Moxifloxacin Treatment D
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days; Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.; Day 2: A single oral dose of 400 mg moxifloxacin capsule.; Day 15: A single oral dose of 400 mg moxifloxacin capsule.; Days 1-14: Matching placebo for balovaptan for 14 days.; Days 1-14: Matching placebo for balovaptan for 14 days.; Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.; Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.; Day 2: A single oral dose of 400 mg moxifloxacin capsule.; Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.; Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.; Day 15: A single oral dose of 400 mg moxifloxacin capsule.
Intervention MeSH terms: Moxifloxacin; Balovaptan; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related
      death can be prevented through fecal occult blood test screening. Because of economic and
      high sensitivity, fecal immunochemical test is recommended for screening population of CRC.
      The purpose of this study is to compare the accuracy of 4 different fecal occult blood
      testing in medium and high risk screening population in Chinese.
    

Detailed description: 
      Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number
      of cancer-associated mortality. CRC screening has been shown to be effective in reducing the
      incidence of, and mortality from, CRC. There are several recommended screening options for
      screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT)
      .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced
      colorectal neoplasia but also has several disadvantages, including higher cost and poorer
      compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based
      fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes
      quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of
      hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use
      FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in
      screening population of CRC in Chinese. To add to the evidence on FIT performance
      characteristics for detection of CRC, the investigators design this research to compare qFIT
      with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them
      is chemical and immunologic combined detection）in medium and high risk screening population.
    

Intervention name(s): 4 kind of FOBT and colonoscopy with pathological examination
Intervention type(s): Diagnostic Test
Intervention description(s): Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Continuous participants intending to undergo colonoscopy and meet the inclusion and
        exclusion criteria from Qilu Hospital were enrolled.
      
Biospecimen description: 
      Stool sample
    
Keywords: Colorectal cancer; fecal occult blood testing; quantitative fecal immunochemical test
The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
Condition: Anxiety; Emotional Regulation
MeSH terms: Emergencies; Anxiety Disorders
Study type: Observational

Summary: 
      The purpose of this study is to assess the impact of therapy dogs on children's anxiety and
      emotional management during a visit to the pediatric emergency department.
    


Intervention name(s): 10-minute visit with therapy dog and child life specialist handler
Intervention type(s): Behavioral
Intervention description(s): A visit from a therapy dog and child life specialist will occur which will last for approximately 10 minutes. Parents and patients will be asked to sanitize their hand prior to the visit. The child life specialist will be instructed to have ad lib conversation with the family. The dog will remain on a leash during the visit. The patient will be free to pet the therapy dog if they wish.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited at both Norton Children's Hospital Emergency Department and
        Norton Children's Medical Center Emergency department.
      
Keywords: Pediatric Emergency Medicine; Therapy Animals; Animal Assisted Therapy; Anxiety; Emotional Regulation
A Study to Assess the Safety and Tolerability of Once Daily Inhaled Doses of GSK573719 Made With Magnesium Stearate in Subjects With Chronic Obstructive Pulmonary Disease(COPD)for 7 Days
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to
      both healthy volunteers and to COPD patients before. This study will assess a new formulation
      of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less
      likely to deteriorate in its container, it is mixed with an inactive substance that helps to
      to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with
      another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at
      a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance.
      MgSt itself is not a medicine but is approved as a food ingredient and has also has been
      approved to be used in a number of marketed medical inhalers. The purpose of this study is to
      assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for
      once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given
      to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will
      receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed
      dosing in group 1 without any significant safety concerns. The following safety measures will
      be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung
      function and 24 hour monitoring of the heart. We will also take blood and urine samples to
      measure medication levels in the body.

      GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of
      their centres in the UK.
    


Intervention name(s): GSK573719
Intervention type(s): Drug
Intervention description(s): 7 day repeat dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); Magnesium stearate; GSK573719
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of
      America.
    

Detailed description: 
      -  Controlled challenge, Phase I/IIa WRAIR study.

        -  Healthy, malaria-naive adults aged 18 - 50 years.

        -  2 groups, 5 subjects in group A (10µg dose) and 13 subjects in group B(50µg dose).

        -  Control: none for immunization phase; infectivity controls for challenge and rechallenge
           phases. Six infectivity controls per day of challenge will be enrolled for the challenge
           phases, with 3 alternates available for challenge if needed.

        -  Vaccination schedule of 0, 1 months.

        -  Challenge of up to 13 subjects in Group B.

        -  Contingent upon short term efficacy, rechallenge of initially protected subjects 6
           months (+/- 2 months) after second dose of vaccine.

        -  Self-contained study.

        -  Duration of the study, per subject: approximately 15 months (screening, enrollment,
           vaccination, challenge and rechallenge).

        -  Data collection will be by done onsite.
    

Intervention name(s): Falciparum Malaria Protein 11 with AS01B adjuvant.
Intervention type(s): Biological
Intervention description(s): malaria experimental vaccine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Phase I/II; Malaria; Liver Stage Antigen -1; Falciparum Malaria Protein -11; AS01B; adjuvant
Safety and Immunogenicity of MSB11455 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and
      Neulasta in healthy adult participants.
    


Intervention name(s): MSB11455; US-Neulasta
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.; Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
Other intervention name(s): pegfilgrastim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy Participants; MSB11455