Kornimate/medical-research-clean huggingface dataset:
the value of multispectral 3 tesla mri in active surveillance of prostate cancer

Conditions: Prostate Cancer

Summary: multispectral 3 tesla mri (ms3tmri) can increase the yield of trans rectal ultrasound biopsy (trusbx) to improve identification of patients on active surveillance requiring treatment.

this is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo ms3tmri followed by a standard trusbx and additional biopsies guided by the ms3tmri results. the positive predictive value (ppv) of ms3tmri-trusbx for cancer requiring consideration of therapy will be compared to the ppv of trusbx alone. ms3tmri consists of t2, diffusion-weighted imaging (dwi), dynamic contrast enhanced mri (dcemri), proton mr spectroscopy (mrs) interpreted by a radiologist and by cad methods validated on whole mount prostate specimens.

Eligibility criteria:
inclusion criteria: * enrolled in active surveillance at sunnybrook health sciences centre, requiring biopsy as part of surveillance protocol. * clinically eligible for radical prostatectomy and willing to undergo surgery * clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of mri exclusion criteria: * claustrophobia * contraindication to mri * contraindication to receiving low molecular weight mri contrast agent * prior hormone therapy except 5-alpha reductase inhibitors such as avodart. flomax etc * clinically suspected or known compromised renal function or calculated estimated glomerular filtration rate (egfr) \<30ml/min

Keywords: prostate cancer mri trusbx
oxygen insufflation to reduce postoperative abscess in laparoscopic appendectomy

Conditions: Postoperative Abscess

Summary: oxygen has inherent bactericidal properties. the investigators are testing to see if they can reduce the incidence of postoperative abscesses following laparoscopic appendectomy by insufflating with oxygen at the end of the case.

intra-abdominal abscess a well-known complication of both open and laparoscopic appendectomy, especially in the setting of perforated and gangrenous appendicitis. the reviewed literature cites an incidence of about 10%. besides peri-operative antibiotic administration there have been few developments to reduce this inherent risk. oxygen rich environments are potently bactericidal, and thus it is our hypothesis that establishing an oxygen rich ambience within the abdomen at the conclusion of laparoscopy could curtail bacterial growth and subsequent abscess formation. in the experimental arm, at the conclusion of all surgical dissection and manipulation, the carbon dioxide insufflate will be exchanged with oxygen to generate a high intra-abdominal concentration. oxygen will be infused for 15 seconds as co2 is allowed to escape through the open trocars. in the control arm co2 will be allowed to escape through the open trocar ports without any oxygen flush. patients will receive a standardized operation as well as standard post-operative care and follow up.

Eligibility criteria:
inclusion criteria: * nonpregnant adults 18 or older * clinical or image proven appendicitis * undergoing laparoscopic appendectomy exclusion criteria: * any pregnant females * anyone under the age of 18
osteoporosis prevention in preadolescent girls

Conditions: Osteoporosis

Summary: this study will test an osteoporosis prevention program aimed at preadolescent girls between the ages of 10 and 12 who have not yet started their menstrual periods. girls in this age group are adding large amounts of new bone to their skeletons. adding more bone at this time of life can reduce a person's chances of developing osteoporosis (thinning bones) in later years. we will look at how this osteoporosis prevention program affects the amount of calcium in the girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured using ultrasound testing of the heel.

the study's objective is to demonstrate the efficacy of a behavioral/educational intervention in increasing levels of dietary calcium intake and weight-bearing exercise within an at-risk population in a stage of rapid accrual of bone mass-specifically, premenarchal girls between the ages of 10 and 12. we will use cluster randomization to randomize girls to either the intervention or a program of education only. we will randomize eighteen groups of girls into each arm of the study. the intervention consists of six interactive sessions using various media (i.e., overhead transparencies, graphics, and three-dimensional demonstrations) to present instructional material. topics include an explanation of osteoporosis and its modifiable and nonmodifiable risk factors, prevention of osteoporosis via healthy food choices (i.e., high calcium, low fat foods), and prevention of osteoporosis via weight-bearing exercise. each girl monitors her own progress toward the goal of 1350 to 1500 milligrams of calcium per day. a similar method allows simple self-monitoring of weight-bearing activity. the intervention program is reinforced via monthly self-monitoring for 18 months. the education-only program consists of six generic sessions on healthy eating, physical fitness, and healthy lifestyle choices. the primary outcomes of interest are higher calcium intake and higher levels of weight-bearing exercise. a secondary outcome of interest is increased broadband ultrasound attenuation of the os calcis, assessed using quantitative ultrasound. in summary, the group of girls targeted is ideal for this intervention because they are at a stage of rapid accrual of bone mass.

Eligibility criteria:
inclusion criteria: * 9- and 10-year-old premenarchal girls (girls who have not started their periods). exclusion criteria: * comorbid conditions or medications that are associated with decreased bone density such as the following: corticosteroids; anticonvulsants; thiazide diuretics; history of cancer; type i diabetes; thyrotoxicosis; hyperparathyroidism; cushing's syndrome; juvenile rheumatoid arthritis; connective tissue disease or hemolytic anemia; asthma which may limit ability to participate in the exercise intervention; known history of dietary disorder, including anorexia, bulimia or lactose intolerance; postmenarchal.

Keywords: osteoporosis prevention behavioral/educational intervention preadolescent calcium exercise peak bone mass bone density
towards early detection of breast cancer in high risk population

Conditions: Breast Cancer

Summary: breast cancer is a major and growing health challenge, and the leading cause of cancer in women. as population obesity rates increase, the number of new breast cancer diagnosis continues to rise. despite treatment advances, breast cancer remains an important cause of premature mortality, taking women in the prime of life. although underlying susceptibility caused by mutation in the genes including brca1/2 is increasingly identified, current pre-symptomatic screening for the general population and those at high genetic risk remains sub-optimal, with high false negative and positive rates. alteration of breast lipid composition has been observed by us and others in patients with breast cancer and is thought to precede onset. we have developed and tested a novel method to allow a standard 3t mri scanner to perform quantitative 3d mapping of specific lipid molecules in the breast. we will investigate if this method can detect very early breast cancers, and compare the amount and spread of lipid composition in breast tissue of premenopausal women with very high genetic risk of breast cancer, women with breast cancer and women with obesity.


Eligibility criteria:
inclusion criteria: - women with brca1/2 genes: * female 18-55 years old, premenopausal * brca 1/2 gene carriers * not having any metabolic disorders (e.g., diabetes) * not on any long term medications that may affect lipid metabolism (e.g., statins) * bmi \< 30 women with breast cancer (no obesity): * females 18-55 years old, premenopausal * confirmed diagnosis of invasive ductal carcinoma of the breast * not having any metabolic disorders (e.g., diabetes) * not on any long term medications that may affect lipid metabolism (e.g., statins) * bmi \< 30 women with breast cancer (obesity): * bmi \> 30 * otherwise as women with breast cancer women with obesity: * females 18-55 years old, premenopausal * not having any metabolic disorders (e.g., diabetes) * not on any long term medications that may affect lipid metabolism (e.g., statins) * bmi \> 30 exclusion criteria: * females under 18 or over 55 years old, postmenopausal * males * have metabolic disorders (e.g., diabetes) * on long term medications that may affect lipid metabolism (e.g., statins) * contraindicated for mr investigation (poor renal function and metal implants) * (for patients) concurrent cancer in other sites * (for patients) started hormone treatment, chemotherapy or breast surgery * non-english speakers
biolux p-iii all-comers passeo-18 lux registry

Conditions: Atherosclerosis; Peripheral Artery Disease

Summary: biolux p-iii is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the passeo-18 lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

the passeo-18 lux paclitaxel releasing ballooncatheter is a novel drug-releasing balloon that received ce-mark in january 2014. its safety and efficacy has been investigated in two randomized first-in-man trials in patients with stenosis or occlusion of the femoropopliteal (biolux p-i) and infrapopliteal (biolux p-ii) arteries when compared to an uncoated device. the purpose of the biolux p-iii all-comers registry is to collect short and long-term clinical performance data on the passeo-18 lux drb in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations * subject must be willing to sign a patient data release form or patient informed consent where applicable * lesion(s) in the infrainguinal arteries suitable for endovascular treatment treated with or scheduled to be treated with the passeo-18 lux drug releasing balloon exclusion criteria: * life expectancy ≤ 1 year * subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet * subject is pregnant or planning to become pregnant during the course of the study * failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Keywords: peripheral infrainguinal drug releasing balloon drug eluting balloon
utility of pcd diagnostics to improve clinical care

Conditions: Primary Ciliary Dyskinesia

Summary: this cross-sectional and longitudinal observational study is to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (pcd). there is new testing available, called nasal nitric oxide testing, that non-invasively measures nitric oxide levels in the sinus cavity. individuals with pcd characteristically have low levels, but this testing does not have extensive data from everyday clinical practice. the objective of this proposal is to improve the diagnostic approach to children and adults with clinical concerns for primary ciliary dyskinesia (pcd).

this is an observational study to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (pcd). participant selection will be on a referral basis for the consideration of a clinical suspicion for pcd. participants will be identified by pulmonary providers that consider testing for pcd based on the clinical symptoms of the participant. these providers will then refer for enrollment in the study based on the clinical considerations for a diagnosis of pcd. participants will be consented during the time of testing at the pulmonary department. any patient referred by a clinician for concerns for pcd, including those who have had pcd genetics sent, or a ciliary biopsy performed will be enrolled in the study. in addition, any participant who is referred for nasal nitric oxide testing and meets the inclusion and exclusion criteria for this testing, will also need to provide informed consent and be enrolled in the nasal no redcap registry. this equipment is not currently fda approved or clia certified for pcd diagnostic testing and therefore referring clinicians will be informed that the results of this test should not influence clinical decision making regarding the diagnosis of pcd. however, there is growing evidence that this testing has utility as a non-invasive screening tool for pcd and continued data from the general pediatric pulmonary population is needed.

Eligibility criteria:
inclusion criteria: * age ≥ 2 years of age * must have two of the following clinical history points: * neonatal respiratory distress * chronic nasal congestion/runny nose * chronic cough * situs/laterality defects * bronchiectasis * ability to provide informed consent or consent of parent/guardian and ass exclusion criteria: * recent history of sinus surgery or bloody nose in the past week * age \< 2 years of age * inability to tolerate probe in nose * sinusitis or other respiratory exacerbation currently being treated with antibiotics * admitted to hospital for respiratory exacerbation (inpatient status) * inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by the irb) * any other reason for which the study investigators feel the patient is not a good candidate to complete the testing

Keywords: pcd nasal nitric oxide testing
repair or not repair pronator quadratus in the volar plating of distal radial fracture are functional outcomes differ ?

Conditions: Distal Radius Fracture

Summary: the theoretical benefits of the repair of the pronator quadratus include flexor tendon protection, remain of the normal pronation-supination range of motion (rom) and strength, and keeping the stable druj. repair or not repair pronator quadratus in the volar plating of distal radial fracture-are functional outcomes differ?

in the operation of distal radial fractures, the volar plating techniques become popular. during the surgical approach, the pronator quadratus (pq) muscle needs split or full-thickness strip to exposure the fracture site and facilitate the instrumentation of the plate. generally, the pq would be repaired. sometimes, the pq is damaged by the fracture fragment so severely that it is difficult to repair the pq. however, there is few reviews paper to discuss the consequence of the unrepaired or repaired pq and the aaos guideline1 of the treatment of distal radial fracture in 2009 did not even list the management of the pq. the function of the pq includes pronation and stability of the distal radial-ulnar joint (druj). according to the study, the elimination of pq function will cause a significant decrease in pronation torque, which is supposed to affect the function of the wrist in the daily life. the theoretical benefits of the repair of the pronator quadratus include flexor tendon protection3,4, remain of the normal pronation-supination range of motion (rom) and strength, and keeping the stable druj.

Eligibility criteria:
inclusion criteria: * ≧ 20 or ≦ 80-years-old adult patients * cooperative to evaluation * distal radial fracture, fresh, single fracture * volar plating exclusion criteria: * \ 80-years-old patients * uncooperative adult, such as dementia * old fracture, more than 1 week * multiple fractures * pathological fracture * surgery other then volar plating

Keywords: pronator quadratus distal radius fracture volar plating
liking of snack foods - sub-study 1

Conditions: Eating Behavior; Obesity; Satiation

Summary: specific aims: environmental factors contributing to overconsumption, such as larger food portion sizes, may be contributing to the obesity epidemic. the objective of the proposed study is to examine the independent and combined effects of portion size and quantity of food on intake in normal weight males and females. participants will be randomly assigned to one of four conditions varying in the portion size and quantity of junk food provided: small quantity of food packaged in small portions (ssp), small quantity of food packaged in large portions (slp), large quantity of food packaged in small portions (lsp), and large quantity of food packaged in large portions (llp). a box containing four different junk foods, packaged according to one of the four conditions, will be given to participants to take home for three days. the total amount of food consumed from the box over the three days will be measured. it is anticipated that portion size and quantity of food, both independently and combined, will influence intake, such that larger portion sizes and quantity of food provided to participants will produce greater intake.subject population: we propose to recruit 60 healthy men and women, aged 18-50 years, with a body mass index (bmi) of less than or equal to 28. participants will be non-smokers, unrestrained eaters, and have no known food allergies to the foods used in the investigation.methods/design: participants will be randomly assigned to one of four conditions, varying in portion size (small versus large) and quantity of food provided (small versus large). a box containing four junk foods, packaged according to one of the conditions, will be provided to participants. they will be encouraged to eat as much or as little of the food as they want, but to at least taste each of the four foods over the three-day period. during this time, they will be instructed to not eat any other junk foods. at the end of the three-day period, participants will return the box with any remaining uneaten junk food.data analyses: the dependent variables, the amount of grams and kcals consumed from the provided junk foods, will be examined between the four different conditions.significance: if portion size and quantity are related to intake, subsequent studies will develop clinical interventions related to reducing portion size and/or quantity of food available in the household.


Eligibility criteria:
inclusion criteria: healthy, non-smoking, normal- and over-weight (body mass index \[bmi\] \ 3 times per week). exclusion criteria: participants will be excluded if they are not between the ages of 18 and 50, smoke, following a weight loss diet, an athlete in training, pregnant or breastfeeding, or have a health condition or use medication that affects eating or requires specialized diet therapy (e.g., diabetes). additionally, if participants rarely consume junk foods (\ 12 on the three factor eating questionnaire \[tfeq\] \[stunkard \& messick, 1985\]) or report being a binge eater.-
one and two-visit root canal retreatment

Conditions: Root Canal Infection

Summary: a hundred previously root canal treated asymptomatic single-rooted teeth with periapical lesions were treated in single versus multiple visit root canal retreatment. half of the teeth were randomly assigned to the one-visit (ov) group. the other teeth were treated in two visits (tv). all patients were recalled and investigated clinically and radiographically for 24 months.

the aim of the study was to evaluate the radiographic evidence of periapical healing in previously root canal treated teeth with apical periodontitis treated in a single visit and to compare the results with conventional two-visit root canal treatment .100 asymptomatic single rooted teeth with periapical lesions were included. the root canal filling material was removed and reinstrumentation was performed using hand files with 2.5% sodium hypochlorite (naocl) and 5% ethylenediaminetetraacetic acid (edta) as irrigants. half of the teeth were randomly assigned to the one-visit (ov) group. the other teeth were treated in two visits (tv), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. all patients were recalled and investigated clinically and radiographically for 24 months. changes in apical bone density indicating radiographic healing were evaluated.

Eligibility criteria:
inclusion criteria: * with a non-contributory medical history, * single-rooted teeth with periapical lesions, * previously root canal treated but no reduction in the lesion after the treatment * diagnosed as asymptomatic apical periodontitis exclusion criteria: * clinical symptoms, drainage, * more than 5 mm loss of periodontal attachment, * non-restorable tooth
bioavailability of glimepiride/extended release metformin (gli/metxr): high fat diet study

Conditions: Healthy

Summary: objective: the purpose of this study is to evaluate the effect of food intake in bioavailability (ba) of the combination glimepiride/ extended release metformin gli/metxr (4/850mg) in healthy mexican volunteers. methods: a prospective, longitudinal, open label, non randomized study, was performed. a single oral dose of gli/metxr (4/850 mg) was administered to 24 health mexican volunteers 30 min after a high fat meal.

blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. plasma concentration of the drug was measured by using hplc. plasma concentration of both drugs were measured using high-performance liquid chromatography (hplc). plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (pk) were calculated. the pharmacokinetic parameters to be determined are: cmax, tmax, auc0-t, auc0-inf, tmr, ke, t1 / 2 of glimepiride and metformin. the statistical analysis will be descriptive for plasma concentrations with respect to time and the pharmacokinetic parameters of cmax, tmax, auc0-t, auc0-inf, tmr, ke, t1/2 of glimepiride and metformin. adverse events were determined using clinical and laboratory test results throughout the study.

Eligibility criteria:
inclusion criteria: * healthy mexican volunteers, considered healthy according to standard screening assessments * aged between 18 and 50 years old * body mass index (bmi) was 18 to 27.5 exclusion criteria: * those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality * any acute or chronic disease * any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding

Keywords: dm2 glimepiride metformin extended release
feasibility, safety, and outcomes of intensive enteral nutrition in patients with mechanical ventilation

Conditions: Critical Illness

Summary: patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. according to guidelines released from authority organizations, enteral nutrition (en) should be prior approach for critically ill patients. however, initiation and delivery of en during the early period of icu admission are frequently hampered, which results in underfeeding. the investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of en thereby improving outcomes. in this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.


Eligibility criteria:
inclusion criteria: * predicted time of mechanical ventilation more than 48 hours exclusion criteria: * no enteral nutrition pathway * refuse to informal consent * surgeon refuse the protocol * palliative care

Keywords: mechanical ventilation enteral nutrition feeding intolerance