bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this randomized clinical trial is to compare the antibacterial effects of sodium
      hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .
    

Detailed description: 
      This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to
      find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide
      (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is
      investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting
      cell membrane integrity.
    

Intervention name(s): Polyhexamethylene biguanide; Sodium Hypochlorite
Intervention type(s): Drug; Drug
Intervention description(s): Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant; A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter
Other intervention name(s): PHMB; Bleach
Intervention MeSH terms: Biguanides; Sodium Hypochlorite; Polihexanide; Eusol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Identification of Risk Patients in Emergency Medical Services
Condition: Malnutrition; Falling; Cognitive Impairment
MeSH terms: Malnutrition; Emergencies
Study type: Observational

Summary: 
      Background: Inadequate nutrition has been associated with growing risk of falling and
      impaired ability in elderly patients. Falling is a significant threat to the health of the
      elderly. It is estimated that one third of people over the age of 65 experience at least one
      falling each year. Over 60% of the falls cause serious injury or disability. Adequate
      nutrition increases the muscle strength of the elderly. Therefore, determining and managing
      the nutrition level is important for preventing falling. As far as we know emergency medical
      services has never before reported being a part of prevention by performing risk
      identification.
    

Detailed description: 
      Aim: The purpose of the study is to assess whether it is possible to use a simple screening
      tool to find out the risk of falling, the nutritional status and the level of cognitive
      functioning activity when the EMS faces the elderly over the age of 70 years. In addition,
      the flow of information between primary care and emergency services and nutritionists is
      examined.

      Material and method: Identification of poor nutrition is carried out in the Helsinki
      University hospital area. All people over the age of 70 requiring ambulance transport will be
      included in the study for 4 months during 2018. A structured electronic form is used to
      identify the malnutrition, the level of cognitive functioning activity and the risk of
      falling. The assessment is performed during the transport. The data is analyzed by the SPSS
      statistical program both by descriptive and statistical significance by looking at the
      methods suitable for the data.

      Conclusion: The information produced by the research aims to develop (a) Identifying in the
      ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists
      and, by means of these measures, increase the number of patients receiving effective
      nutrition therapy.
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All people over the age of 70 requiring ambulance transport will be included in the study
        for 4 months during 2018 in the Helsinki University hospital area.
      
Keywords: EMS; elderly; nutrition; falling; cognitive functioning
Safety and Feasibility of a New Neuromuscular Monitoring Device
Condition: General Anesthesia
Study type: Interventional

Summary: 
      The aim of the study is to compare, during general anesthesia using neuromuscular blocking
      agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software)
      with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during
      the first 24 hours after surgery.

      The two devices will be studied simultaneously in each patient.
    


Intervention name(s): Isometric Trumb Force handle
Intervention type(s): Device
Intervention description(s): Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Physical Activity and First Degree Female Relatives of Breast Cancer Patients
Condition: Female; First-degree Relative With Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about encouraging physical activity among first
      degree female relatives of women with breast cancer. Physical activity can decrease a woman's
      risk of developing breast cancer, on average, by 20%; however, physical activity
      interventions have not been developed specifically for first degree female relatives of
      cancer patients, so currently, it is unknown whether standard physical activity interventions
      are sufficient for these women or if first degree female relatives would benefit from an
      enhanced physical activity intervention that addresses information about breast cancer risk
      reduction. To obtain information about first degree female relatives preferences for a
      physical activity intervention, this study seeks to have first degree female relatives of
      breast cancer patients enroll in a standard physical activity intervention developed for
      healthy men and women. After completion of the three month intervention, the women will be
      asked to participate in two, one-hour long focus group with 5-7 other participants. The first
      focus group is to discuss aspects of the physical activity intervention that they liked and
      did not like, as well as things they think may have enhanced the intervention and made it
      more relevant to other first-degree relative of breast cancer patients. In the second focus
      group, participants will be shown enhancements that were developed based on information
      gathered from the first focus group. Participants will be asked for their feedback on the
      newly developed enhancements.
    


Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): 12 week print based intervention
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Relationship Between Optimal Laryngeal Mask Airway Cuff Volume and Physical Examination of Head and Neck
Condition: Anesthesia
Study type: Interventional

Summary: 
      Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord
      paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway
      cuff volume and pressure and physical examination of head and neck.
    

Detailed description: 
      Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal
      cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum
      pressure which is not increase side effect.

      The manufacturer recommends that the cuff is inflated with the minimum volume of air required
      to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).

      The investigators will measure anatomical structure (neck circumference, neck length,
      thyroid-mental distance, etc.) which can influence cuff volume and pressure and find
      correlation between cuff volume and physical figure measured.
    

Intervention name(s): Classic laryngeal mask airway
Intervention type(s): Device
Intervention description(s): measurement of head and neck
Ht,Wt,BMI, neck circumference above a thyroid cartilage, mandible circumference( from the lower part of earlobe-mandible angle-mentum-mandible angle to the lower part of earlobe), neck length (mastoid tip~sternal notch), modified mallampati classification under sitting position, thyromental distance.
laryngeal mask airway insertion and measuring cuff pressure by pressure transducer
# 4.0 for female, #5.0 for male
initial cuff volume(air) : maximum volume recommended by the manufacturer
check pressure : if it exceed 60cmH20, we will remove air until 60cmH20
remove air until gas leak occured around the cuff under airway pressure 15cmH20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Laryngeal mask airway
Nordic 8 - A Phase II Trial
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating
      FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in
      patients with potential resectable KRAS wildtype metastatic colorectal cancer.

      All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A)
      FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46
      hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6
      (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU
      infusion of 2400 mg/m2 every 2 weeks) .

      Primary objective: response rate (RECIST 1.1) in patients with with potential resectable KRAS
      wildtype metastatic colorectal cancer.

      Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker
      evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will
      be collected to search for markers that may predict efficacy including respectability and
      safety.
    


Intervention name(s): Cetuximab; Irinotecan; Oxaliplatin; Folinic Acid; Calcium Carbonate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Folic Acid; Oxaliplatin; Irinotecan; Cetuximab; Calcium Carbonate; Levoleucovorin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform
Condition: Stress; Health Behavior; Nutrition; Physical Activity
Study type: Interventional

Summary: 
      Dietary choices, quality of life and stress will be evaluated in a sample of 100
      undergraduate students who are in their first year of university. Students will be randomized
      into the following two groups; intervention arm (students who will use a preventative
      self-care program for 12 weeks) vs. control arm (students who will not use a preventative
      self-care program for 12 weeks).
    

Detailed description: 
      When individuals look after their own health using online applications they can expect
      similar or even better health outcomes compared to those obtained by using conventional
      methods. These kind of tools are popular among University students. Due to the many changes
      and challenges that students face in the first year of University, this sector of our
      population is at higher risk of presenting nutritional problems, anxiety, depression and
      suicidal thoughts.

      Recently, a Canadian online application called My Viva Plan® became available. This program
      is based on preventive self-care and it includes three key pillars of health: nutrition,
      fitness, and mindfulness. Changes in dietary choices, quality of life and stress will be
      evaluated in a sample of 100 undergraduate students who are in their first year of
      university. Students will be randomized into the following two groups; students who will use
      the program vs. students who will not use the program. Questionnaires regarding physical
      activity, mindfulness and mental well-being will be evaluated at baseline, week 6 and week
      12. Body composition characteristics using bioelectrical impedance analysis will be collected
      at the start and end of the study (baseline and week 12).

      The objective is to determine if the use of an online application based on preventive
      self-care will result in better food choices, better quality of life, and reduced stress in
      first year university students.
    

Intervention name(s): My Viva Plan
Intervention type(s): Behavioral
Intervention description(s): Use of the online platform, My Viva Plan, to support health and wellness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The primary objective is to confirm the specificity of a multi-target stool DNA test
      (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
    

Detailed description: 
      Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will
      complete the mt-sDNA screening test (Cologuard) followed by completion of a screening
      colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to
      investigators for clinical management of study subjects. Personnel performing the colonoscopy
      and producing the resulting report and personnel performing histopathological review of
      tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test
      (Cologuard) result.
    

Intervention name(s): mt-sDNA screening test; Colonoscopy
Intervention type(s): Diagnostic Test; Procedure
Intervention description(s): Stool samples will be collected by the subject for the mt-sDNA screening test.; Subjects will undergo a screening colonoscopy.
Other intervention name(s): Cologuard
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects 45-49 years of age who are at average risk for development of CRC. 942 subjects
        are targeted to enroll.
      
Biospecimen description: 
      Residual stool samples may be used to develop and evaluate the performance of biomarker
      assays to detect cancers. Sample may be stored for up to 20 years. These stool samples will
      be de-identified.
    
Keywords: Sample Collection; Stool DNA; Colonoscopy
Correlation of Albuminuria With Arterial Stiffness
Condition: Diabetes Mellitus; Hypertension; Albuminuria; Vascular Stiffness
MeSH terms: Albuminuria; Hypertension; Diabetes Mellitus
Study type: Observational

Summary: 
      The investigators aim to investigate the relationship between albuminuria and arterial
      stiffness in diabetic patients, hypertensive patients and healthy subjects.
    

Detailed description: 
      CONTEXT: Albuminuria is an important cardiovascular risk factor. Arterial stiffness also
      gives important information about atherosclerosis. Oscillometric methods may be useful in
      assessing arterial stiffness in a mainly operator independent way.

      OBJECTIVE: We aim to investigate the relationship between albuminuria and arterial stiffness
      measured with an oscillometric device in diabetic patients, hypertensive patients and healthy
      subjects.

      METHODS: 152 diabetic patients, 152 hypertensive patients and 152 healthy subjects are
      planned to be enrolled in this study. The measurements will be done between 9:00 and 13:00.
      After the measurements, blood and urine samples will be obtained, centrifugated and kept in
      -80°C until assayed. Afterwards, echocardiographic left ventricle mass index will be
      calculated. The correlation between albuminuria and arterial stiffness will be assessed as
      the primary outcome measure.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with diabetes, patients with hypertension and healthy subjects
      
Biospecimen description: 
      Serum and urine samples.
    
Keywords: Diabetes Mellitus; Hypertension; Albuminuria; vascular stiffness
The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Ongoing fear and catastrophization in people with chronic low back pain (CLBP) causes
      increased pain, disability and kinesiophobia, and decreased endurance of trunk muscles.
      Nowadays, recurrent low back pain complaints are increasing day by day. Besides the use of
      electrophysical agents and exercise in the treatment of chronic low back pain, education
      methods used to reduce the negative effects of psychosocial factors are important for
      healing.

      Although there were studies about the combination of Therapeutic Neuroscience Education (TNE)
      with exercise in CLBP, there are no studies that combine electrophysical agents, exercise and
      TNE methods in the literature. Therefore, in this study, we aimed to investigate whether TNE
      combined with physiotherapy consisting of electrophysical modalities and home program
      exercise is superior to only physiotherapy in patients with CLBP.
    


Intervention name(s): physiotherapy and education; Physiotherapy alone
Intervention type(s): Other; Other
Intervention description(s): Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program. In addition to physiotherapy, therapeutic neuroscience education were applied to experimental group. One-to-one speech sessions focusing on pain neurophysiology were organized twice a week for three weeks. Each session lasted 40 minutes. The Therapeutic neuroscience education program included nociception, ion channel neurophysiology, central and peripheral sensitization, methods to help reduce sensitization, neuroplasticity, psychosocial factors involved in the transition from acute pain to chronic pain and behavioral, cognitive responses to pain.; Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: therapeutic neuroscience education; chronic low back pain; kinesiophobia; pain
Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Condition: Bronchoscopy; Anesthesia
Study type: Observational

Summary: 
      This study is designed as a prospective observational, non-controlled, non-interventional
      study.

      The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho,
      focusing on the device functionalities within regular clinical practice and therapeutic use
      of flexible bronchoscopes in the OR and ICU.

      The study will include a minimum of 100 adult patients admitted to the operating room (OR) or
      Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will
      stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.

      The involved sites will include patients during a five months' period, from September 2017 to
      January 2018.
    

Detailed description: 
      Refer to brief description
    

Intervention name(s): aScope 4 Broncho
Intervention type(s): Device
Intervention description(s): Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient's ≥18 years, Clinical indication and eligible for an airway procedure involving a
        bronchoscopy procedure, as judged by the Investigator, Patients being admitted in the OR or
        ICU at the investigational site
VLDL-triglyceride Kinetics in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for
      coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of
      lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence
      suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG)
      is a central pathophysiological feature of the lipid and lipoprotein abnormalities in
      diabetic dyslipidemia.

      The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral
      VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or
      deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls
      in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG
      tracers.
    


Intervention name(s): Hyperinsulinemic euglycemic glucose clamp
Intervention type(s): Other
Intervention description(s): Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        11 men with type diabetes and 11 healthy men, matched for age and BMI.
      
Biospecimen description: 
      Blood samples Subcutaneous adipose tissue biopsies Muscle biopsies
    
Keywords: Type 2 diabetes; Diabetic dyslipidemia; VLDL-TG kinetics; VLDL-TG metabolism