bioihbjkbjnl/mcl2 huggingface dataset:
Relationship of Deep Cervical Flexor Muscle Endurance With Neck Position Sense and Body Balance
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      The aims of this research are to investigate relationship of deep cervical flexor muscle
      endurance with neck position sense and body balance in non-specific chronic neck pain, and to
      compare the results with healthy individuals.
    

Detailed description: 
      The investigation will be included 2 groups which include 30 individuals with non-specific
      chronic neck pain and 30 healthy individuals. In evaluation of participants, endurance of
      deep cervical flexor muscles will be measured using Stabilizer Pressure Biofeedback Unit with
      cranio-cervical flexion test. Pressure rise which increases from 20 mmHg to 30 mmHg with 2
      mmHg increments will be performed in 5 stages. There are 10 seconds contractions at every
      stage and these contractions will be made 10 times. Endurance will be calculated by the
      cumulative performance index with the information obtained from this test. Neck position
      sense of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation)
      will be measured by CROM device (cervical range of motion device). Joint position error will
      be calculated by taking the average of the absolute angular difference by 3 trial for each
      direction. Body balace will be measured by Balance Master System. Modified clinical test of
      sensory interaction balance (mCTSIB), limits of stability (LOS), rhythmic weight shift (RWS),
      unilateral stance (US), walk across (WA) and step/quick turn (SQT) will be performed.
    

Intervention name(s): Evaluation
Intervention type(s): Other
Intervention description(s): Deep cervical flexor muscle endurance, neck position sense and body balance will be measured.
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals in Dokuz Eylul University Health Campus
      
Keywords: Chronic Neck Pain; Balance Master; Joint Position Error; Endurance
12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Study type: Interventional

Summary: 
      Non-carious cervical lesions are defined as loss of pathological material not associated with
      caries in the enamel-cement junction of the tooth. The etiology of these lesions has been
      defined as brush abrasion, acid-induced erosion and abstraction due to microstructure losses
      due to stress concentration in a particular region of the tooth. These lesions should be
      restored using minimally invasive techniques. The necessity of restorative treatment is
      directly related to the size of the lesion, sensitivity and aesthetic requirements. However,
      restorative procedures are often challenging because the cavity preparation does not provide
      adequate retention, and often the cervical end margin is positioned under the gingiva. This
      leads to contamination of the operation site with blood, saliva and gingival fluid.

      Several restorative options have been proposed for the treatment of cervical caries-free
      lesions. However, due to their high aesthetic properties, improved adhesive capacity and
      mechanical properties, composites have been accepted as the most suitable choice. Clinical
      studies have demonstrated that marginal adaptation, marginal discoloration, and roughening
      methods for retention are the most important factors in the clinical performances of
      composite restorations in cervical lesions. Therefore, injectable composites with wettability
      and better adaptability to cavity margins have been introduced. However, the low filler
      contents of fluid composites and their weak mechanical properties compared to conventional
      composites have led researchers to doubt their use in caries-free cervical lesions. As a
      result of the developed material technology, injectable composites with high filler which
      have reduced polymerization shrinkage have been developed with simplified filler procedure.
      However, investigators have not encountered any studies investigating which etching technique
      this material will exhibit better clinical performance and comparing it with traditional
      pasty composites. The aim of this study is to evaluate the clinical performance of
      traditional paste type and injectable composites which will be made by using two different
      etching techniques.
    


Intervention name(s): Laser Etching; Phosphoric acid etching
Intervention type(s): Procedure; Procedure
Intervention description(s): Before the restorations, cavities will be etched Er:Cr YSGG laser with 4W output power, water pressure 95% and air pressure 60% with MGG6 tip with the spot size of 600 µm will be used.; Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
XmAb5871 Bioavailability Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label comparison of concentration of the study medication administered intravenously
      (IV) versus subcutaneously (SC) in healthy volunteers.
    

Detailed description: 
      The study will enroll approximately 50 eligible healthy male and female subjects between the
      ages of 18 to 55 inclusive. There will be 5 parallel dose cohorts (Cohorts 1-5) consisting of
      10 subjects in each cohort. No subject will be a member of more than 1 cohort. Subjects will
      receive 3 administrations of study medication.
    

Intervention name(s): XmAb5871
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy; volunteer
Video Diversion Improves Success Rate of Fundoscopic Examination in Children
Condition: Fundoscopy
Study type: Interventional

Summary: 
      Fundoscopy is an important component of the neurological examination as it can detect
      pathologies such as high intracranial pressure. However, the exam can be challenging in
      uncooperative children. This study looked at whether playing a video during eye examination,
      improves the success, duration and ease of pediatric fundoscopy.
    

Detailed description: 
      Fundoscopy is an important component of the neurological examination as it can detect
      pathologies such as high intracranial pressure. However, the exam can be challenging in
      uncooperative children. This study looked at whether playing a video during eye examination,
      improves the success, duration and ease of pediatric fundoscopy. The authors plan to recruit
      from 4 different clinical care settings for a total of 101 subjects. Success rate is defined
      as visualizing the optic disc within 60 seconds from commencement of fundoscopy. The ease of
      examination is determined by using a 10 point likert scale.
    

Intervention name(s): Video diversion
Intervention type(s): Other
Intervention description(s): The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Coccinia Cordifolia Extract on Blood Sugar of Newly Diagnosed Diabetics
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the effectiveness of Coccinia Cordifolia (synonym
      Coccinia indica) on the blood glucose levels of newly detected type 2 diabetic patients
      requiring only behavioral or lifestyle intervention. The hypothesis of the study is that
      there will be significant decrease in the blood glucose levels after a period of 90 days in
      the diabetic patients who consumed the coccinia extract.
    

Detailed description: 
      The prevalence of diabetes is increasing in all countries, especially India at an alarming
      rate. Appropriate interventions in the form of weight reduction, changes in dietary habits
      and increased physical activity could help in preventing or delaying the onset of diabetes
      and reducing the burden due to non communicable diseases in India.

      Plants or their extracts may also have a potential therapeutic role in the treatment for
      diabetes. Coccinia indica (synonym Coccinia cordifolia), a herb that belongs to the
      Cucurbitaceae family and that grows abundantly in India, is widely used in the traditional
      treatment of diabetes mellitus. Coccinia leaves, when administered orally twice a day for six
      weeks, to patients with untreated but uncomplicated maturity onset diabetes demonstrated
      hypoglycemic activity with significant improvement in glucose tolerance. The aim of the
      present study was to evaluate the effectiveness of Coccinia Cordifolia on the blood glucose
      levels of newly detected type 2 diabetic patients requiring only behavioral or lifestyle
      intervention.

      The study was a double blind, placebo controlled, randomized trial. The study was carried out
      at Nutrition and Lifestyle Management Clinic, St. John's Medical College Hospital. After
      recruitment , the diabetic subjects were assigned either to the experimental or placebo
      group. They were provided with the extract for a period of 90 days. Prior to the
      intervention, the subjects underwent baseline investigations which included anthropometric,
      biochemical, dietary and physical activity assessment. These investigations were repeated at
      day 45 and day 90 of the study. The compliance of the subjects to the ingestion of capsules
      was documented every week when they reported to the Nutrition Clinic. All the study subjects
      were provided with standard dietary and physical activity advice for the control of their
      blood sugars. The compliance of the subjects to the prescribed diet and physical activity was
      assessed weekly by asking the subjects to rate their compliance on a scale of 0-100%.
    

Intervention name(s): Coccinia Cordifolia (herbal extract)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: Diabetes; India; Coccinia Cordifolia; Coccinia indica; Blood glucose levels
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra
      (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy
      volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab).
      The anticipated time of study duration is 28 days.
    


Intervention name(s): tocilizumab [RoActemra/Actemra] Syringe; tocilizumab [RoActemra/Actemra] auto-injector
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administration with pre-filled syringe; Single dose administration with auto-injector
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study in healthy subjects to determine the effect of food on the pharmacokinetics of
      BGB-3111.
    

Detailed description: 
      A randomized, crossover study to evaluate the effect of food on pharmacokinetics of BGB-3111
      when administered in subjects either after a high fat/calorie meal or a low fat/calorie meal
      or after an overnight fast.
    

Intervention name(s): Zanubrutinib
Intervention type(s): Drug
Other intervention name(s): BGB-3111
Intervention MeSH terms: Zanubrutinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1, pharmacokinetics safety
Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program
Condition: Colo-rectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Background: Participants in the colon and rectal cancer (CRC) screening program that have a
      positive result in the Fecal Immunological Test (FIT) are visited by the screening nurse who
      explains the meaning of the positive test and the need to perform a colonoscopy. Having a
      positive result in the screening test can have a negative psychological impact on patients
      causing anguish.

      Objective: To evaluate whether the use of iconographies to communicate the risks of possible
      diagnoses to patients with positive FIT improves the understanding of the information and
      reduces the degree of anguish.

      Methods: Quasi-experimental pre-post intervention study with a control group. 240 individuals
      (men and women between 50-69 years of age, with a positive FIT result attending the nursing
      visit) will be included in two non-concurrent study groups (120 individuals per group). The
      control group will receive the nurse visit as usual. For the intervention group, the nurse
      will use iconographies to communicate the risk of the different possible diagnoses and the
      risk of complications of the colonoscopy. The degree of distress (Distress Thermometer and a
      scale of emotion-faces) will be measured before and after the visit and the understanding of
      the information (visual analog scale) after the visit. The degree of distress between the
      control group and intervention group will be compared.

      If the results are favorable, the systematic use of iconographies can be implemented in the
      nursing screening visit and be extended to other Screening Units.
    


Intervention name(s): Iconographies to communicate risks
Intervention type(s): Other
Intervention description(s): Use of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two consecutive study groups (no-concurrent).
Masking: None (Open Label)
Primary purpose: Other
Keywords: Colorectal cancer screening; Iconographies; Risk communication; Patient medical knowledge
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine in Population Aged 3-8 Years
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in
      healthy population aged 3-8 years following different immunization procedures.
    

Detailed description: 
      To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in
      healthy population aged 3-8 years following different immunization procedures, and the
      participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at
      day 0 and 28.
    

Intervention name(s): Quadrivalent Influenza Virus Split Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5ml Quadrivalent influenza vaccine The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/ H3N2, B/Victoria and B/Yamagata strains
Intervention model: Single Group Assignment
Intervention model description: Subjects in one group received a first and a second dose of the vaccine at different time points.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: QIV, safety, immunogenicity
Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults
Condition: Depression; Depression in Old Age; Elder Abuse; Anxiety
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly
      mistreatment) victims, to work in synergy with EM mistreatment resolution services that
      provide safety planning, support services, and links to legal services. PROTECT is built on a
      model which postulates that chronic stress promotes dysfunction of the cognitive control
      (CCN) and reward networks, impairing the victims' ability to flexibly respond to the
      environment and limits their reward activities. PROTECT therapists work with victims to
      develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has
      been designed in an iterative process with community EM providers of the New York City (NYC)
      Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and
      referral for service. In the current study, the investigators will compare the effectiveness
      of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental
      health services (EM/MH). The investigators intend to enroll 50 subjects that will participate
      in the study for approximately 12 weeks.
    


Intervention name(s): PROTECT with Technology Augmentation
Intervention type(s): Behavioral
Intervention description(s): PROTECT is a therapeutic intervention focused on treating victims of elder abuse who are experiencing depression. PROTECT therapy will be delivered through video. Participants will be provided with a mobile device (iPhone), and a wearable device (smart watch) that will track sleep, mood, steps, and heart rate.
Intervention model: Single Group Assignment
Intervention model description: The investigators will be comparing data collected from this project to previously collected data from the first phase of this project, in which PROTECT was delivered only in-person.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mental Health
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether treatment with an investigational drug as
      compared to placebo will reduce the risk of major cardiovascular events in patients with
      aortic stenosis.
    


Intervention name(s): ezetimibe (+) simvastatin; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment: 4 years; matching Placebo
Other intervention name(s): MK0653A
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Snuff Use, Smoking, Periodontal Health and Premature Death: 30-year Study
Condition: Tobacco Use; Periodontitis
MeSH terms: Periodontitis
Study type: Observational

Summary: 
      Snuff use and smoking associated with poor periodontal health, especially if used together.
    

Detailed description: 
      Aim: The investigators investigated how snuff use and smoking affect periodontal health
      parameters and mortality in a Swedish cohort, hypothesizing that snuff use increases the
      risks.

      Material and methods: Study cohort of 1 532 subjects aged 30 to 40 (758 men and 774 women)
      from Stockholm area was clinically examined and followed up from 1985 to 2015. Associations
      were analysed between periodontal health parameters, snuff use, smoking and age of death. For
      analyses, all subjects were classified into four groups: "dual-users" (current and
      ex-snuffers, current and ex-smokers); "pure snuffers" (current and ex-snuffers); "pure
      smokers" (non-snuffers, current and ex-smokers) and "non-users" (non-snuffers and
      non-smokers). Cross-tabulation, chi-square and Fisher's exact tests were used.
    

Intervention name(s): Epidemiological study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Swedish national database sample
      
Keywords: Tobacco; Calculus; Gingiva; Oral hygiene; Periodontitis; Biofilm
Total Body Vitamin A Before and After Vitamin A Supplementation in a Community Where Liver is Frequently Eaten
Condition: Hypervitaminosis A
MeSH terms: Hypervitaminosis A
Study type: Observational

Summary: 
      This study will assess total body vitamin A pool size, as well as liver vitamin A stores, by
      means of stable isotope dilution in preschool children from a South African community where
      liver, an exceptionally rich source of vitamin A, is frequently eaten, and the children
      exposed to vitamin A fortified staple foods, as well as a vitamin A supplementation
      programme.
    

Detailed description: 
      Serum retinol, the most commonly used indicator to assess vitamin A status, is
      homeostatically controlled and, although it is able to detect deficiency, it does not
      necessarily reflect liver stores or measure excessive vitamin A intake. The stable isotope
      dilution method is able to measure total vitamin A body pool size over the vitamin A status
      continuum, including the sub-toxic range,and would add valuable information about the vitamin
      A status in a community where liver (an exceptionally rich source of vitamin A) is frequently
      eaten, and children also exposed to other vitamin A interventions. Total body vitamin A will
      be assessed before and 4 weeks after a high dose vitamin A supplement given to the children
      as part of the national vitamin A supplementation program. The confounding effect of
      infection/inflammation on the biomarkers of vitamin A status will also be examined, as well
      as how serum retinol and retinol binding protein relate to each other, and to vitamin A pool
      size.
    

Intervention name(s): Vitamin A supplement
Intervention type(s): Dietary Supplement
Intervention description(s): 200 000 IU vitamin A (once-off dose), given to participants as part of the national vitamin A supplementation program
Intervention MeSH terms: Vitamin A
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        3-5 year-old children from a low socio-economic South African community where liver is
        frequently eaten
      
Biospecimen description: 
      Serum
    
Keywords: Vitamin A stores; Stable isotope dilution; Multiple vitamin A interventions