bioihbjkbjnl/mcl2 huggingface dataset:
AI-assisted Detection of Missed Colonic Polyps
Condition: Colon Adenoma; Colonic Polyp; Colon Cancer
MeSH terms: Adenoma; Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      A prospective validation of real time deep learning artificial intelligence model for
      detection of missed colonic polyps
    

Detailed description: 
      Consecutive adult patients, age 40 or above, who were scheduled to have outpatient
      colonoscopy in the Queen Mary Hospital were invited to participate. Patients were excluded if
      they were unable to provide informed consent, considered to be unsafe for taking biopsy or
      polypectomy including patients with bleeding tendency and those with severe comorbid
      illnesses. Also, patients with history of inflammatory bowel disease, familial adenomatous
      polyposis, Peutz-Jeghers syndrome or other polyposis syndromes were excluded.

      The primary endoscopist conducted the colonoscopic examination in the usual manner. All
      colonoscopy procedures were performed with high-definition colonoscopes (EVIS-EXERA 290 video
      system, Olympus Optical, Tokyo, Japan). The colonoscopy was first advanced to the cecum in
      all patients as confirmed by identification of the appendiceal orifice and ileocecal valve or
      by intubation of the ileum. After cecal intubation, the colonoscopy was slowly withdrawn to
      the rectum by the primary endoscopist. The AI real time detection was then activated with the
      output displayed in a different monitor and was only viewed by an independent investigator,
      who was an experienced endoscopist. The primary endoscopist was blinded to the AI real time
      detection result al.

      The colon was divided into three segments during the examination: right side, transverse and
      left side colon, using hepatic flexure and splenic flexure as dividing landmark. All polyps
      were marked for size (measured with biopsy forceps), location and morphology according to the
      Paris classification, and then removed or biopsied for histological examination. After
      examination of each segment, segmental unblinding of the AI results were provided by the
      independent viewer. If additional polyps were detected by AI but not by the endoscopist, that
      segment were reexamined to look for the missed polyp. If no additional polyp was detected by
      the AI, the next colonic segment was examined. Missed lesions were defined as lesions
      identified by AI and then confirmed on reexamination by the endoscopist.

      The first withdrawal time (minus the polypectomy site) was measured. The Boston Bowel
      Preparation Scale score (BPPS) was used for evaluation of bowel cleanliness.
    

Intervention name(s): Artificial intelligence-Assisted real time colonoscopy
Intervention type(s): Device
Intervention description(s): The colonoscopy was performed under artificial intelligence assistance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Artificial intelligence; Colonoscopy; Deep learning; Detection; Computer-aided
Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of smartphone application for
      management of type 2 diabetes mellitus (DM).

      Type 2 DM is an almost incurable chronic disease and continuous management is important for
      long-term prognosis. However, patient's compliance to conventional medical intervention is
      generally unsatisfactory and many patients feel difficult to access to the detail medical
      advice for type 2 DM.

      Thus, the investigators developed a smartphone application for giving programed medical
      intervention to patients according to patients data; blood pressure, fasting blood sugar,
      body weight, calorie intake,exercise amount, etc.
    


Intervention name(s): Self-Management Using Smartphone Application for Type2 DM; self-management using booklet for management type 2 DM
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T2DM; smartphone application; serum fasting glucose; HbA1c
Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
Condition: Effects of 2 Mu-opiates on Gastrointestinal Transit
Study type: Interventional
Phase: Phase 4

Summary: 
      Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the
      dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is
      potential for off label use in chronic pain.

      Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is
      a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid
      receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in
      pain relief. While its action reflects aspects of tramadol and morphine, its ability to
      control pain is more on the order of hydrocodone and oxycodone.

      Its dual mode of action provides analgesia at similar levels of more potent narcotic
      analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect
      profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain
      in various pain care settings. In addition, it was reported to be associated with
      significantly fewer treatment discontinuations due to a significantly lower incidence of
      gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The
      combination of these reduced treatment discontinuation rates and tapentadol efficacy for the
      relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in
      pain therapy by increasing patient compliance with their treatment regimen.
    

Detailed description: 
      Single center, parallel group, randomized controlled trial of tapentadol, oxycodone and
      placebo effects on gastrointestinal and colonic transit in healthy human volunteers
    

Intervention name(s): Tapentadol; Oxycodone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours.; Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours.; Subjects received placebo three times per day (tid) for 48 hours.
Other intervention name(s): Tapentadol brand name: Nucynta; Dazidox; ETH-Oxydose; Endocodone; Oxecta; Oxy IR; Oxycontin; Oxyfast; Percolone; Roxicodone
Intervention MeSH terms: Oxycodone; Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: tapentadol; oxycodone; mu-opiate; stomach; small intestine; colon; motility; nausea; constipation
The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Most of the available studies that are relevant to motor rehabilitation for children with
      dyskinetic type of cerebral palsy are few and are comprised of small numbers of children.
      Further researches are necessary to explore new conservative therapeutic protocols and
      techniques that should contribute to control disorganized movement, handle postural
      asymmetry, maintain postural stability, and improve gait performance. Therefore, the
      objective of this study was to examine the effectiveness of soft orthosis and strapping
      system on balance, and gait performance in children with dyskinetic cerebral palsy.
    

Detailed description: 
      Dyskinetic type of cerebral palsy typically results from extrapyramidal and basal ganglia
      damage. The most common dyskinetic movement disorders are choreoathetosis and dystonia. Their
      clinical features include fluctuation of muscle tone, involuntary and in-coordinated
      movement, and posture instability. These features have significant negative impacts on the
      children's quality of life and performance of daily activities. Management strategy for
      children with dyskinesia requires both medical and rehabilitative treatment. Most of the
      available studies that are relevant to their motor rehabilitation are few and comprised of
      small numbers of children. The therapeutic modalities currently used for their rehabilitation
      require more evidence to certain their efficacy. Moreover, further researches are necessary
      to explore new conservative therapeutic protocols and techniques that should correct postural
      instability and improve the poor mobility of these children The objective of this study was
      to examine the effectiveness of an orthotic undergarment which is (TheraTog orthosis), and
      its strapping system on balance and gait performance in children with dyskinetic cerebral
      palsy.
    

Intervention name(s): Conventional Physical Therapy Protocol; TheraTog orthotic undergarment with its strapping system
Intervention type(s): Other; Other
Intervention description(s): The conventional physical therapy protocol was designed to improve axial stability and trunk steadiness during standing and walking. The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. Every treatment session was conducted for 2 hours with a 15-minutes rest between the two training hours.; TheraTog orthotic undergarment with its strapping system was applied for eight hours every day for twelve consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Balance; Gait; Strapping; Orthoses
Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
Condition: Bowel Preparation for Colonoscopy
Study type: Interventional

Summary: 
      This trial will evaluate the efficacy in colon cleansing of a nurse-led educational telephone
      intervention 24-48 hours before a colonoscopy, in selected participants with a previous
      inadequate bowel preparation.
    


Intervention name(s): Educational telephone intervention; Standard education for colonoscopy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy; Standard education for bowel preparation at the time of colonoscopy scheduling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Colonoscopy; Educational intervention
Dailies Total 1 Sphere Contact Lenses
Condition: Dry Eye; Contact Lens Complication
MeSH terms: Dry Eye Syndromes
Study type: Interventional

Summary: 
      CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular
      Surface Society in their seminal report on contact lens (CL) discomfort as a condition that
      results in "episodic or persistent adverse ocular sensation related to lens wear, either with
      or without visual disturbance resulting from reduced compatibility between the CL and the
      environment, which can lead to decreased wearing time and discontinuation of CL wear." A
      recent review by Pucker and Tichenor found that CL discomfort was the top reason for
      established CL wears to cease wearing CLs. This same review alarmingly found that the
      frequency of CL dropout was about 20% across the many studies aimed at evaluating this
      condition, which is surprising given the introduction of better soft CL materials and daily
      disposable CLs over the past 20 plus years.

      Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used
      trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced
      material technology that is specifically aimed at improving CL comfort. While DT1 is commonly
      used in these struggling patients, the literature currently lacks a targeted study aimed at
      understanding the frequency of successfully refitting CL dropouts into this advanced CL.
      Thus, the purpose of this study is to determine the frequency that past CL wearers who failed
      because of dryness or CL discomfort who can comfortable wear DT1.
    


Intervention name(s): DT1 Sphere Contact Lenses
Intervention type(s): Device
Intervention description(s): Devices: Dailies Total 1 Sphere Contact Lenses
Intervention model: Single Group Assignment
Intervention model description: All participants will be assigned to wear Dailies Total 1 Sphere contact lenses. They will report to 3 in person visits over the course of one month.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Contact Lens; Dailies Total1; Dry Eye; Comfort
Vitamin D Supplementation in Conscripts
Condition: Vitamin D Deficiency; Military Activity
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      A longitudinal, triple-blinded, randomized, placebo-controlled trial, with a 7-month
      follow-up period is conducted between October 2016 to April 2017.
    

Detailed description: 
      Body mass (kg) and height (cm) is measured by the same person at the medical center using
      standardized equipment and the body mass index (BMI) is calculated in kg/m2.

      Computed randomization is used to divide conscripts into two groups; either the intervention
      group or the control group. Both types of capsules are administered once per day in the
      morning before breakfast for 7 months. Standardized coded packages (3 per conscript) and
      capsules (100 per package) are manufactured on a special order by Innopharma A/S (Denmark).
      No commercial sponsoring is involved.

      The key of the package code is stored in the computer database until unblinding of the
      results.

      Laboratory measurements Serum samples for clinical chemistry analysis are collected into
      serum clot activator tubes. Calcium measurements are performed using spectrophotometry
      method. Ionized calcium measurements are performed using ion selective electrodes. The direct
      chemiluminescent immunoassay method is used for measurement of PTH. 25(OH)D is measured using
      direct chemiluminescent immunoassay method.

      Power calculation The primary variable of the study is the level of 25 (OH)D in the serum. In
      the power analysis a difference of 20 nmol/L between the intervention and the control group
      is considered to be meaningful to detect. If the SD would be 25 nmol/L, then 26 participants
      would be needed in each group to reach a power of 80%.

      Statistical analysis The distribution of blood serum values in the study groups is described
      by means and standard deviations (SD). Differences in mean values of the variables of
      interest between the groups are evaluated using Welch t-test. The within group comparisons
      over time are performed using paired t-test with Bonferroni correction. Distributions of
      categorical variables are described by absolute numbers and percentages and compared between
      groups using the Fisher exact test. Statistical significance is set at the 0.05 probability
      level.
    

Intervention name(s): Vitamin D3 (1200 IU/30µg); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo oil capsule
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Triple blinded randomized placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      The treatment of systemic lupus erythematosus (SLE) may change in the future due to the
      availability of new biological treatments, especially monoclonal antibodies in patients with
      active disease. However, one of the main causes of treatment failure in SLE is the lack of
      treatment adherence since "drugs don't work in patients who don't take them."
      Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and
      investigators have demonstrated that patients who do not take HCQ for a long time have
      undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe
      non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active
      disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients
      with a SLEDAI ≥12.

      Investigators will evaluate the importance of non-adherence to the treatment in a large
      population of SLE patients with active disease. This will be done with blood HCQ monitoring
      in a translational multicentric prospective study.
    

Detailed description: 
      This international multicentric prospective study is an observational study that will include
      consecutive SLE patients treated with HCQ and with SLE flare (defined by the SELENA-SLEDAI
      flare composite). The study will only require the sampling of 1 vial of whole blood for the
      dosage of HCQ (that would be centralized and performed in PITIE-SALPETRIERE Hospital at the
      completion of the study). The patients and the physicians will also have adherence
      self-questionnaires to complete, and the physicians will complete a patient data sheet.

      The end points are adherence of the treatment in the whole group, and subgroups, adherence
      according to the severity of SLE, and the relationship between patient's questionnaires,
      physician evaluation of adherence and blood HCQ dosage.

      If investigators confirm their previous data, this study might demonstrate that a significant
      proportion of patient candidates for treatment escalation are in fact nonadherent to the
      treatment. It might further demonstrate the interest of HCQ concentrations monitoring, both
      in "real life" and in therapeutic study in SLE as it may avoid unnecessary, expensive or even
      hazardous regimen escalation.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Active Systemic Lupus Erythematosus (see eligibility criteria)
      
Biospecimen description: 
      blood
    
Keywords: Adherence; Compliance; Systemic Lupus Erythematosus; Hydroxychloroquine; Blood monitoring; Flares
SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes
Condition: Muscle Power; Muscle Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether supplementation with SierraSil can improve
      anaerobic power and reduce muscle fatigue in a group of well-trained athletes.

      A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset
      muscle soreness.
    

Detailed description: 
      This is a double blind, crossover, pilot study that will examine the effect of SierraSil
      supplementation on the determinants of human performance. Anaerobic capacity, muscle fatigue,
      the severity of delayed onset muscle soreness (DOMS) and markers of inflammation will be
      measured before and after 3 weeks of supplementation with SierraSil or placebo. There will be
      a 3 week washout period prior to the crossover to ensure SierraSil supplementation has no
      residual effect.
    

Intervention name(s): SierraSil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): SierraSil is a natural, mineral supplement currently used to improve joint health and function.; Sugar pill manufactured to mimic SierraSil 667 mg capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: muscle power; muscle fatigue; SierraSil
The Acute Effect of Dynamic Taping on Upper Body Posture.
Condition: Dynamic Tape; Postural; Defect
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the acute effect of Dynamic tape on cervical and
      thoracic region posture in asymptomatic male individuals.
    

Detailed description: 
      Fifty-one asymptomatic individuals between the ages of 18 and 32 years were included in the
      study. The participants in this study were randomised into two groups, named "Dynamic Taping"
      (mean age± sd: 23.28±3.41 yrs, n=25) and "Sham Taping" (mean age± sd: 25.15±4.13 yrs, n=26).
      In the Dynamic taping group, tapes were applied with optimal stretching, while in the Sham
      taping group, tapes were applied without any stretch. All measurements were done before
      taping and 30 minutes after taping. Craniovertebral, cranio-horizontal and sagittal shoulder
      angles were calculated with photographic posture analysis, while thoracic kyphosis was
      evaluated with a digital inclinometer (JTech IQ Pro™, ABD).
    

Intervention name(s): Dynamic tape on experimental group; Sham tape on placebo group
Intervention type(s): Other; Other
Intervention description(s): The dynamic taping application was carried out in 2 stages. Three "I"-shaped tapes were cut. In the first stage, the person was asked to perform scapular retraction, and in this position, the tape was placed by applying medium tension to the anterior part of the other deltoid muscle, passing from the anterior part of the deltoid muscle to the upper thoracic region. In the second stage, the participant was asked to do scapular retraction and depression, and while maintaining this position, medium tension was applied to the lower thoracic vertebra starting from the anterior part of the deltoid muscle and the acromion and tape was applied. Afterward, this process was applied on the other side; Sham taping was performed in 2 stages. Three "I"-shaped tapes were cut. Participants were asked to stand in the comfortable position they used during the day. The first tape was adhered from the starting point of the spine of the scapula with the acromion to the junction of the spine of the scapula and the acromion on the other side without any tension. The other two tapes, starting from the beginning and ending points of the first tape, were adhered to the lower thoracic region without any tension
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind randomized controlled trial
Masking: Double (Participant, Investigator)
Primary purpose: Prevention