bioihbjkbjnl/mcl2 huggingface dataset:
Differential Diagnosis Between Granuloma and Radicular Cyst: Effectiveness of Magnetic Resonance Imaging.
Condition: Periapical Diseases
MeSH terms: Periapical Diseases
Study type: Observational

Summary: 
      The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were
      investigated by two radiologists using MRI, based on the same six criteria, to categorize the
      lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded
      to the radiologist's diagnoses) analyzed all specimens by referring to seven specific
      parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater
      agreements between the radiologists and pathologists in terms of MRI and histological
      diagnoses, respectively, along with the discriminant power of the adopted criteria and the
      accuracy of the MRI assessments compared with the histopathologic results, were calculated.

      A strong inter-rater reliability was observed between the two radiologists (k-statistic =
      0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was
      higher for the radiological (Guttmann's lambda lower bound > 0.6) than histopathological
      criteria. The accuracy (true positives plus true negatives) of the radiologists was higher
      than that of the pathologists based on receiver operator characteristic analysis (area under
      the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and
      comparable to histopathological reliability, highlighting the usefulness of this non-invasive
      exam as a pre-treatment diagnostic method for periapical endodontic lesions.
    


Intervention name(s): apicoectomy
Intervention type(s): Procedure
Intervention description(s): After flap elevation and osteotomy , peri-apical lesion and the root tip were located: after root-end resection using a fissure bur, the resected root tip and the pathological tissue were removed and immediately preserved in 1% formaldehyde solution.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        34 patients (17 males and 17 females; mean age 41.9 (range 21-76) years) with periapical
        endodontic lesions diagnosed by clinical and radiological examination using 2D standard
        x-rays (periapical and panoramic x-rays) or multislice CT/CBCT in the Oral and
        Maxillofacial Unit of the University of Bologna between January 2011 and December 2015, and
        treated with enucleation of the lesion and apicoectomy after a pre-operative MRI exam were
        retrospectively enrolled in this study. The chart of these patients, that underwent a
        traditional and standard therapeutic protocol, the radiological imaging and the
        histopathological data, were analysed after the treatment by a team of two radiologists and
        two pathologists.
BioimPEDance of Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      The BIPPED study seeks to determine whether wound healing, in particular diabetic foot
      ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the
      resistance of biological tissue to the passage of a very small electric current applied with
      electrodes. Different types of tissue, due to cell structure, hydration and vascularization,
      have specific electrical characteristics. The BIPPED study aims to provide experimental data
      for the development of a BIA sensor for monitoring of wound healing in chronic wounds.
    


Intervention name(s): Foot ulcer impedance
Intervention type(s): Other
Intervention description(s): lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diabetic foot ulcer
Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      Control of food intake, size and frequency of meals are critical to the development of
      obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in
      control of calorie intake. It is unclear whether the approved appetite reducing drug
      sibutramine changes the function of the stomach. Differences in the way individuals respond
      to treatment with the appetite suppressant sibutramine may also explain why some people lose
      weight while others do not.

      This single center clinical study aims to compare functions of the stomach in healthy,
      overweight and obese individuals, and to evaluate the effects of the FDA-approved appetite
      suppressing medication sibutramine on weight loss and stomach functions in patients who are
      overweight or obese. The effect of individual differences in inherited genes on weight
      reduction with sibutramine will be tested.
    

Detailed description: 
      Background: Control of food intake, size and frequency of meals are critical to the
      development of obesity. The stomach signals satiation in response to calories and volume
      ingested, playing a role in control of calorie intake. It is unclear whether the approved
      appetite reducing drug sibutramine alters gastric physiology. Genetic variations are
      potentially key to inter-individual differences in responses to treatment with the appetite
      suppressant sibutramine.

      Aims: 1. To compare gastric functions in healthy, overweight and obese individuals. 2. To
      evaluate effects of sibutramine on gastric functions and weight in patients who are
      overweight or obese. 3. To obtain preliminary data on the effect of genetic variation on
      responses to sibutramine.

      Methods: We shall measure gastric emptying, fasting and postprandial gastric volumes (using
      validated, non-invasive imaging methods), postprandial satiation and satiety, and integrated
      plasma ghrelin, leptin, insulin, GLP-1 and peptide YY levels before and after 12 weeks of
      sibutramine 15mg vs. placebo. We shall also collect DNA, to eventually study effects of
      candidate genes on response to sibutramine.

      Significance: Our study will provide the first evidence of the effects of sibutramine on
      gastric function.
    

Intervention name(s): sibutramine
Intervention type(s): Drug
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education
Condition: Crisis Resource Management
Study type: Interventional

Summary: 
      Crisis management is important for operating room practice and non-technical skills are
      acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be
      difficult to find instructors with appropriate experience. A peer-led team debriefing is led
      by the team it self rather than an external expert instructor but remains a reflective
      process. Incorporating peer-led debriefing compared to expert-led debriefing may increase
      access to an interprofessional crisis resource management course using simulation.

      The goals of the study are to observe the effect of an interprofessional peer-led team
      debriefing in the change in performance of non-technical skills of team performance and to
      compare it with the "gold standard" of expert-led debriefing on the performance of
      non-technical skills during a simulated operating room crisis.

      The investigators hypothesize that interprofessional peer-led debriefing will improve the
      performance of non-technical skills of the team during simulated intraoperative crisis
      management and that this improvement will be equivalent to the "gold standard" expert-led
      debriefing.
    


Intervention name(s): Peer-led debriefing; Expert instructor debriefing
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Interdisciplinary Health Team; Training
Carvedilol Vascular Efficacy Trial
Condition: Heart Failure; Acute Myocardial Infarction
MeSH terms: Heart Failure; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Beta-blockers should be administered to all patients with heart failure stages II to IV NYHA.
      It should also be administered to patients with stage I after myocardial infarction. The low
      ejection fraction, especially after myocardial infarction is a strong indication for
      beta-blockers, as many studies indicate that administration of these drugs substantially
      reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and
      improve the operational phase for all categories of patients with heart failure. Since
      beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown
      these benefits and thus, only those have to be administered.

      The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol
      on cardiac function in patients with heart failure or reduced left ventricular ejection
      fraction after acute myocardial infarction.
    

Detailed description: 
      The relationship between stroke volume, which is extruded from the left ventricle gives a
      measure for the restrictive left ventricular function. Any patient with known cardiovascular
      disease should undergo assessment of left ventricular function by measuring the ejection
      fraction. Several studies have shown that when the ejection fraction (LVEF), which measures
      the heart's ability to eject blood to the aorta does not exceed 40% (natural price ^ 50%)
      increased dramatically in the post-infarction mortality. The ejection fraction as a reliable
      predictor, can be measured by ultrasonography. The reduced ejection fraction is associated
      with an increased risk of life-threatening arrhythmias, heart failure and death. The low
      ejection fraction, especially after myocardial infarction is a strong indication for
      beta-blockers, as many studies indicate that administration of these drugs substantially
      reduces cardiovascular mortality.
    

Intervention name(s): Carvedilol
Intervention type(s): Drug
Intervention description(s): Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
Other intervention name(s): Carvepen
Intervention MeSH terms: Carvedilol
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Heart Failure and post-MI LVEF<40%
      
Keywords: Heart Failure; Acute Myocardial Infarction; LVEF
An Evaluation of VR942 in Healthy Volunteers and Patients With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and
      pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated
      doses in mild asthmatics (part 2).
    


Intervention name(s): VR942 delivered via a Vectura Dry Powder Inhaler; Placebo delivered via a Vectura Dry Powder Inhaler
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Fasting II Study
Condition: Diabetes; Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      This study will determine whether an intensive fasting protocol alters hemoglobin A1c
      measurements or other markers of metabolic and cardiovascular risk by performing a 5-week
      clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is
      controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour
      water-only fasting, including at baseline and at the end of the week for each week of the
      study (a total of 6 24-hour fasts).
    


Intervention name(s): water-only 24-hour fasting once per week for 6 weeks
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes; Fasting; Pre-diabetes; Hemoglobin A1C
A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The purpose of this study was (i) to develop a brief counseling letter intervention aiming to
      reduce sedentary time and to increase physical activity during leisure time among adults aged
      42 to 64 years and (ii) to provide information on the feasibility.
    

Detailed description: 
      The study aimed to assess the feasibility of a brief counseling letter intervention to
      increase physical activity and to reduce sedentary time in leisure time.

      Following the Intervention Mapping Protocol we developed the counseling letter intervention.
      The intervention is based on the Health Action Process Approach, comprising 3 tailored
      letters based on separate assessments, delivered over 6 month.

      All participants consented (i) to participate in an examination at the university hospital
      including standardized measurements of blood pressure, waist and hip circumference, body
      height and weight as well as blood sample taking, (ii) to fill in a paper-pencil
      questionnaire, and (iii) to wear an accelerometer for 7 days at baseline and at 12-month
      follow-up.

      A general population sample of cardiovascular healthy adults was randomly allocated to a
      control and an intervention group. At 5 time points (baseline, 3-month, 6-month, 7-month, and
      12-month follow-up) participants of both study groups completed standardized questionnaires.
    

Intervention name(s): Counseling letter
Intervention type(s): Behavioral
Intervention description(s): The intervention is based on the Health Action Process Approach. The first letter provides information on knowledge regarding sedentary time and physical activity as well as intervenes on self-efficacy depending on the mindset of participants (non-intender, intender, actor). The second letter focuses on benefits and barriers of physical activity as well as the role of social support for physical activity. In case of actional stage, the third letter intervenes on self-efficacy again and suggests action and coping planning. Otherwise, the letter includes ipsative feedback according to the second letter.
Other intervention name(s): Feasibility of brief counseling letter intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: physical activity; sedentary time; feasibility study; accelerometer
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy
Condition: Type 2 Diabetes; Cardiac Autonomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in
      people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the
      nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may
      cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.
    

Detailed description: 
      Study type : Interventional Study Design : Allocation: Randomized Control: no treatment
      Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment
      Masking: Open Label Primary Purpose: Treatment Primary Outcome Measures : Heart rate
      variability(HRV) Index

      Secondary Outcome Measures : Autonomic Nerve System(ANS) function 5 test, EuroQoL 5-Dimension
      Questionnaire(EQ-5D)
    

Intervention name(s): α-lipoic acid
Intervention type(s): Drug
Intervention description(s): α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
Other intervention name(s): Neuropaid OD Tablet
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac Autonomic Neuropathy
Evaluation of Cognitive Performance in 4 Dairy Beverages
Condition: Cognitive Performance
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the cognitive performance of 4 chocolate milk
      drinks.
    

Detailed description: 
      Subjects will make a total of 4 visits. Four visits in which they will drink a chocolate
      milkshake at each visit.

      At each visit the subjects will have to come fasting, and they will have to perform the
      cognitive test at the time when they have their peak glycemic level.
    

Intervention name(s): Chocolate milk shakes - Product 1; Chocolate milk shakes - Product 2; Chocolate milk shakes - Product 3; Chocolate milk shakes - Product 4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 11.3 glucose; 8.84 glucose; 4.24 glucose; 4.36 glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
Condition: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
MeSH terms: Otitis; Ear Diseases; Otitis Externa; Otorhinolaryngologic Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel
      medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.

      The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
    

Detailed description: 
      Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal,
      which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common
      infections encountered by otolaryngologists, pediatricians and family physicians. The
      reported annual incidence of AOE is between 1:100 and 1:250 in the general population with
      large seasonal and regional variations. Diagnosis of AOE requires rapid onset (generally
      within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia
      (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B)
      tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without
      erythema, sometimes accompanied by ear discharge.
    

Intervention name(s): 0.3% Ciprofloxacin Ear Drops; 0.3% Ciprofloxacin Foam Otic Cipro
Intervention type(s): Drug; Drug
Intervention description(s): 4 gtt BID for 7 days.; 1 application, BID for 7 days
Other intervention name(s): Ciloxan; Ciprofloxacin; Cipro; Ciloxan; Ciprofloxacin; Cipro
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: swimmer's ear; ear drops; ear foam; otic foam; ear infection; ear pain; ear inflammation
Short-term Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Subjective Appetite
Condition: Subjective Appetite
Study type: Interventional

Summary: 
      This study investigated the short-term effects of fruit juice enriched with vitamin D3, n-3
      fatty acids, and probiotics on subjective appetite, energy intake, and glycemic responses, in
      both normal-weight and overweight, healthy adults.
    

Detailed description: 
      This study aimed to 1. Assess the subjective appetite of participants after the consumption
      of fruit juice (100% orange) enriched with vitamin D3, n-3 fatty acids, and probiotics
      compared to regular fruit juice (without any fortification), and 2. Examine the short-term
      effects of enriched fruit juice compared to regular fruit juice on glycemic responses and
      blood pressure, in both normal-weight and overweight healthy adults
    

Intervention name(s): Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload
Intervention type(s): Behavioral
Intervention description(s): Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast consisting of 2 slices of white bread and honey (350 kcal in total) after a 12-hour fast. Two hours later they were offered 347 mL of the enriched orange juice (containing 50 g available carbohydrates), and 3 hours after the preload they were offered an ad libitum lunch (chicken breast with white rice). Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. Fingertip capillary blood glucose samples and visual analog scales (VAS) of 100 mm were collected at baseline and at 60, 120, 135, 150, 180, 210, 240, 270, 300, 330, 360, 390, and 420 minutes after breakfast consumption. Blood pressure was measured at baseline, 120, 300, and 420 minutes.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: subjective appetite; feeding behavior; glycemic responses; enriched juice; probiotics; vitamin D3; n-3 fatty acids