bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ
Condition: Suppurative Osteomyelitis of Jaw; Potential Abnormality of Glucose Tolerance
MeSH terms: Osteomyelitis; Suppuration; Recurrence
Study type: Observational

Summary: 
      Clinically, recurrence and life-threatening complications are challenging problems for
      chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report
      about the causes of or risk factors for the two problems. Doctors identify the causes or risk
      factors only through clinical experience. The investigators performed a retrospective study
      of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors for the
      above mentioned two problems were analyzed by logistic regression analysis. The investigators
      found that some of the patients' general conditions, including age, admission temperature,
      admission white blood cell count, pre-admission antibiotic administration without
      consultation, location of the lesion, and general patient condition, were the risk factors.
      The results indicate that doctors should be mindful of those risk factors and that the
      management should be more aggressive when the above risk factors are present.
    

Detailed description: 
      This is a retrospective study of 322 patients hospitalized with CSOJ. The socio-demographic
      and clinical characteristics were recorded. The risk factors for the above two problems were
      analyzed by logistic regression analysis. Frequency and percentage were used to indicate
      descriptive research factors. A univariate logistic regression analysis was performed to
      calculate the odds ratio (OR) and to identify preliminary risk factors. The preliminary risk
      factors were further identified by multivariate logistic regression analysis.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosis of CSOJ who were admitted to our hospital from 1980 to 2009 were
        investigated. Ultimately, 322 patients were enrolled in the study of life-threatening
        complications.Patients were divided into four classes according to their age (years): <6,
        6-18, 19-65, >65.
      
Keywords: CSOJ; recurrence; life-threatening complications; risk factors
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
Condition: Cervical Cancer; Cervical Dysplasia; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical
      swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women
      screening population.
    

Detailed description: 
      The cervical screening program in the Czech Republic is based on cytology with HPV triage.
      Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in
      future. The implementation of primary HPV screening and insuficiency cervical screening
      attendance are a major challenge. The offering of self-sampling to the cervical screening
      non-attenders could increase women's participation as was shown in several European
      countries. The objective of the HPVPro study was to find out the HPV prevalence in the
      screening population of Czech women since there are no data for the Czech Republic. The
      second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal
      swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling
      HPV DNA test by Czech women. This information is important for optimisation of cervical
      cancer screening program in the Czech Republic.
    

Intervention name(s): Self-sampling using digene HC2 DNA Collection Device; Self-sampling using Evalyn Brush
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.; All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: human papillomavirus; HPV; self-sampling; cervical swab; cervicovaginal swab; cervical cancer screening
KP415 Classroom Study in Children (6-12 Years of Age) With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled,
      parallel efficacy laboratory classroom study with KP415 in children with
      Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Detailed description: 
      The study will consist of a Screening Period, an Open-Label Dose Optimization Phase, a
      Double-Blind Treatment Phase and a Follow-Up Visit, as follows:

        -  Screening Period: Subjects will undergo a screening period up to 49 days prior to
           entering into the Open-Label Dose Optimization Phase.

        -  Open-Label Dose Optimization Phase: During the Dose Optimization Phase, subjects will be
           titrated to doses of 20, 30 or 40 mg KP415 based on tolerability and best individual
           dose-response in the opinion of the Investigator.

        -  Double-Blind Treatment Phase: Eligible subjects will be randomized to receive single
           daily doses of KP415 or Placebo for 7 days according to a randomization schedule. The
           dose of KP415 given in the Treatment Phase will be the same as the optimized dose of
           KP415 at the end of the Dose Optimization Phase. All subjects will receive their
           assigned treatment daily for 7 days. The dose will be the same at each day of the
           Treatment Period. Efficacy and safety assessments will be performed after the last dose
           of the Treatment Period.

        -  Follow-Up Visit: 3 ±2 days after administration of the last dose of the Treatment Phase,
           subjects will enter a Follow-Up Visit to evaluate safety parameters.
    

Intervention name(s): KP415 oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose; Daily dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-week, open-label dose-optimization phase followed by a 1-week randomized, double-blind treatment phase
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sonographic Measurement of Intraneural Blood Flow in the Median Nerve
Condition: Carpal Tunnel Syndrome; Median Nerve Injury
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common nerve compression disease and the most
      expensive upper-extremity work-related musculoskeletal disorder, affecting approximately 10
      million people in the US. To understand the clear etiology and mechanism of carpal tunnel
      syndrome, the measurement of median nerve intraneural blood flow needs to be further
      scrutinized as the common fluctuating physiological conditions and functional hand activities
      might contribute to the fluctuation of the measurement and serve as measurement error. This
      study aims to examine how intraneural blood flow within the median nerve is affected by
      physiological factors (i.e., body temperature and blood pressure) and functional hand
      activities (i.e., typing, using a mouse, and cooking).
    


Intervention name(s): Cooling; Heating; Exercising; Typing; Using a mouse; Cooking
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants' dominant hand and wrist will be immersed in cool water (20°C) for five minutes. The cool water will be kept to around 20°C (19 - 21°C) by frequently checking the temperature and corrected when it rises to 20.5°C; A heat pack wrapped in a towel will be applied to participants' dominant hand for five minutes.; Participants will be asked to participate in moderate-intensity physical activities to induce an increase in blood pressure. The physical activity will be two sets of 30 jumping jacks, followed by 15 squats. Participants are allowed to rest for 20 seconds between the two sets.; All participants will be asked to perform a typing task with a standard wired keyboard. All subjects will be asked to type for five minutes.; Participants will be asked to draw as many lower-case alphabet characters from "a" to "z" as possible using a standardized scroll mouse for five minutes in the Windows Microsoft Paint software.; Participants will be asked to participate in a cooking trial following a prespecified cooking recipe of Rice Krispy Treat. he participant will be asked to follow the procedures as follows: (1) cut and put wax paper in the pan; (2) cut butter into 4 pieces; (3) place butter in a pot over a portable stove and stir until the butter is completely melted; (4) add four oz of marshmallows and stir until melted; (5) add cereal and the rest of marshmallows and stir until all ingredients are combined (6) transfer the ingredients to the pan and use a silicone spatula to pat the ingredients evenly into pan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intraneural blood flow
Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in
      patients with mild renal impairment compared to their sex, age and weigh based healthy
      volunteer counterparts.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Intervention description(s): 16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days.
Intervention MeSH terms: Vildagliptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type-2 diabetes, DPP-4 inhibitor, vildagliptin
Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions
Condition: Skin Lesion; Skin Abnormalities; Sebaceous Hyperplasia
MeSH terms: Skin Abnormalities; Hyperplasia
Study type: Interventional

Summary: 
      This study is designed as a multi-center, single-blinded, prospective, randomized, study to
      compare the safety and effectiveness of the CellFX System to the comparator group,
      Electrodessication for the treatment of SH lesions in healthy adult subjects.
    

Detailed description: 
      This SH comparative study will evaluate safety and efficacy in a split face design using the
      CellFX System and pre-defined energy profile for all primary and secondary treatments based
      on Fitzpatrick Skin Types and tip size. The comparator group will be treated with the same
      standardized intralesional electrodesiccation procedure conducted by all participating
      clinical sites. Subjects with 4-10 qualifying SH lesions on the face except the scalp, nose
      and within the orbital region will be enrolled. Each subject will be evaluated by the blinded
      site investigator at 7-days, 30-days, and 60-days post-initial CellFX and Electrodessication
      treatments. At the 30-day follow-up visit, lesions will be evaluate using Global Aesthetic
      Improvement Scale (GAIS), for eligibility to receive an additional treatment. In case of a
      second treatment, the subject will be evaluated by the blinded site investigator at 30-days
      and 60-days post-retreatment. Photography of the study lesions will be captured along with
      the blinded site investigator assessments at all visits.
    

Intervention name(s): CellFX System; Intralesional Electrodesiccation
Intervention type(s): Device; Device
Intervention description(s): CellFX System consists of a console combined with a handpiece and coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm); Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receiving the two treatments in a split-face design with CellFX being used on only one side of the face and Electrodessication on the other side. The randomization assignment will include the type of treatment and which side of the face.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CellFX; Nano-Pulse Stimulation; NPS; Clearance
Inhibition of Lipid Peroxidation During Cardiac Surgery
Condition: Cardiopulmonary Bypass Induced Lipid Peroxidation
Study type: Interventional

Summary: 
      Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary
      bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to an
      increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin. Free
      plasma hemoglobin and myoglobin have been shown to be independent predictors of the acute
      kidney injury that results from CPB. When these hemeproteins are released into the plasma,
      they undergo redox cycling, generating radical species that initiate lipid peroxidation and a
      cascade of oxidative damage to cellular membranes, notably in the kidney. F2-isoprostanes and
      isofurans are sensitive and specific markers of oxidative stress in vivo, and are increased
      after CPB, particularly in those patients with acute kidney injury. Acetaminophen inhibits
      the lipid peroxidation catalyzed by myoglobin and hemoglobin. Moreover, in an animal model of
      rhabdomyolysis-induced kidney injury, acetaminophen significantly attenuated the decrease in
      creatinine clearance compared to control. The current proposal tests the central hypothesis
      that acetaminophen will attenuate the lipid peroxidation associated with the hemolysis and
      rhabdomyolysis that occur in patients undergoing CPB. Demonstration that acetaminophen
      inhibits the lipid peroxidation resulting from CPB would provide a rationale for a
      prospective randomized trial to test the hypothesis that acetaminophen will reduce the acute
      kidney injury that results from CPB.
    


Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): Acetaminophen 1g every 6 hours for 4 doses over 24 hours
Other intervention name(s): Tylenol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxidative stress; cardiopulmonary bypass; acetaminophen; hemolysis
Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients
      with various degrees of renal insufficiency

      Objectives:

      Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various
      degrees of renal insufficiency?

      Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various
      degrees of renal insufficiency compared to patients with a normal renal function?

      Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various
      degrees of renal insufficiency?

      Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various
      degrees of renal insufficiency compared to patients with a normal renal function?

      Study design: Comparative study in 4 groups with various degrees of renal insufficiency,
      duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the
      hospital (on nursing ward)

      Study population: Patients with various degrees of renal insufficiency

      Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients
      with a normal renal function and in patients with variable degrees of renal insufficiency

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead
      to a more efficient administration of erythropoietin and melatonin in the future.

      Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11
      times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour
      continuous ambulant blood pressure monitoring.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with various degrees of renal insufficiency, admitted to Meander Medical Center

          -  A: Patients with renal insufficiency (clearance 10-30 ml/min)

          -  B: Patients with renal insufficiency (clearance 30-60 ml/min)

          -  C: Patients with renal insufficiency (clearance 60-80 ml/min)

          -  D: Patients with normal renal function (clearance > 80 ml/min)
      
Biospecimen description: 
      serum
    
Keywords: chronic kidney disease; melatonin; erythropoietin; circadian rhythm
Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant
      IBS patients over a 28-day period.
    

Detailed description: 
      This is a randomized, double blind, placebo controlled study of a maximum of 24 subjects with
      constipation predominant irritable bowel syndrome (IBS-C). Sixteen subjects will receive
      active treatment and 8 subjects will receive matching placebo. There will be a 21-day
      screening phase before 1st study drug administration on Day 1.
    

Intervention name(s): TC-6499; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg enteric-coated oral hard gelatin capsule, administered twice daily; placebo as enteric-coated oral hard gelatin capsule, administered twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; IBS-C
Using Real Time Biofeedback to Alter Running Mechanics
Condition: Healthy
Study type: Interventional

Summary: 
      The purposes of this study are 1) to assess foot strike patterns initially, at six months and
      at one year between two groups of runners attempting to transition to a non-rearfoot strike
      pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively
      compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.
    


Intervention name(s): Biofeedback Sensor
Intervention type(s): Device
Intervention description(s): Tibia accelerometer strapped to distal tibia to detect tibial shock
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Reverse Trendelenburg Position Versus Semi-recumbent Position in Obese Critically Ill Patients
Condition: Ventilation and Oxygenation; Obese; Positioning; Critically Ill
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The aim of this study is to assess the effect of reverse Trendelenburg position versus
      semi-recumbent position on ventilation and oxygenation parameters of obese critically ill
      patients
    

Detailed description: 
      Obese critically ill patients' position significantly impacts on their ventilation and
      oxygenation status. It is also associated with mechanical ventilation success or failure and
      may be a main determinant of the obese patients' outcome. Reverse Trendelenburg position is
      recommended for obese patients but in critical illness with mechanical ventilation little is
      known about its effect on respiratory therapeutic targets. This trial was conducted in four
      general intensive care unit of Alexandria Main University hospital in Alexandria, Egypt. One
      hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were
      randomly assigned by a computer program to either reverse Trendelenburg position group (n=55)
      which is the intervention group or semi-recumbent position group (n=55) which is the routine
      unit position. Patients were positioned in the study positions 4 times per day. Patients were
      maintained in the study positions for 2 hours each time. Baseline ventilation and oxygenation
      parameters were assessed immediately before positioning then it was reassessed every 10
      minutes after positioning for 30 minutes.
    

Intervention name(s): Reverse Trendelenburg position; Semi-recumbent position
Intervention type(s): Other; Other
Intervention description(s): The Reverse Trendelenburg position is a position in which patients' hip and knee are not flexed but the head and chest are elevated at 30° than the abdomen and legs.; The semi-recumbent position is an upright positioning of the head and torso at an angle of 45° while legs are lying on the bed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two-group pre-test and repeated post-test study
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Reverse Trendelenburg position; semi-recumbent position; ventilation; oxygenation; obese patients