Kornimate/medical-research-clean huggingface dataset:
severe obesity: bariatric surgery vs. life-style-intervention

Conditions: Obesity; Cardiac Function; Quality of Life

Summary: the purpose of this study is to investigate the effects of weight loss induced by gastric bypass surgery in comparison to a psychotherapy-enhanced lifestyle intervention on cardiopulmonary performance and quality of life in patients with morbid obesity.

obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. especially randomized trials comparing the effects of bariatric surgery to conservative treatment in concerns of cardiac function are still lacking. the randomized was trial compares the effects of roux-en-y gastric bypass (rygb) versus psychotherapy-supported lifestyle modification in morbidly obese patients. the co-primary endpoint addresses 1-year changes in cardiovascular function (peak vo2 during cardiopulmonary exercise testing) and quality of life (short-form-36 physical functioning scale). prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. thereafter, patients were randomized and followed through month 12 to collect primary endpoints. afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization. the study was initially designed in 2008 as part of several interdisciplinary studies for a targeted grant and received a positive vote from the responsible ethics committee. prior the actual start of the study in july 2011, the initial study protocol and the patient informed consent were updated and further specified. this amendment was submitted to the ethics committee on june 9, 2011, with a positive vote on june 30, 2011 (amendment 1). an amendment 2 was submitted to ethics committee on 08.10.2014 (positive vote 16.12.2014) to adjust randomization (previously 1:1 to the two study arms) for an unequal drop-out rate in the two study arms with higher rate in the intensified lifestyle modification. in addition, few secondary endpoints were adapted and the role of the principal investigator changed from prof. stefan frantz to prof. martin fassnacht.

Eligibility criteria:
inclusion criteria: * age ≥18 years * bmi \>40 kg/m2 or bmi \>35 kg/m2 with severe comorbidities * indication for roux-en-y gastric bypass surgery * ability to perform cardiopulmonary exercise testing (cpet) * written informed consent exclusion criteria: * pregnancy or breast feeding * unstable angina pectoris * life expectancy \<12 months * endocrine or psychiatric disorder as cause of obesity * systemic glucocorticoid treatment (with exception of glucocorticoid replacement therapy) * abuse of drugs or alcohol within the last 5 years * inability to attend regular study visits for logistic reasons * participation in competing trials

Keywords: obesity bariatric surgery gastric bypass life style intervention cardiac function
real-world effects of using intermittently scanned continuous glucose monitoring and pharmacist-led coaching on the management of type 2 diabetes among adults not using insulin (real iscgm t2d)

Conditions: Type 2 Diabetes

Summary: the goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (iscgm) plus one pharmacist consultation session compared with capillary blood glucose (cbg) monitoring among insulin-naïve adults with type 2 diabetes (t2d) in a specialist endocrinology clinical setting in canada. primary outcome - to evaluate change in hba1c at 3-6 months follow-up after initiating iscgm plus one pharmacist consultation (iscgm cohort) compared with cbg monitoring (cbg cohort) among insulin-naïve adults with t2d. secondary outcomes - to determine the change in metabolic outcomes and patient reported outcomes (pros) and number of non-insulin antihyperglycemic agents (ahas) prescribed from baseline to 3-6 months (± 6 weeks) in the iscgm cohort compared to the cbg cohort. another secondary outcome is to assess iscgm metrics and number of iscgm discontinuations in the iscgm cohort at 3-6 months (± 6 weeks) compared to baseline. additionally the study will describe and/or evaluate glycemic and metabolic outcomes, and pros in participants who initiate an iscgm device and opt to enroll in a diabetes coaching program (iscgm+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks). exploratory outcomes - to compare change in hba1c between the matched iscgm cohort and cbg cohort by subgroups: age (\< 65 years old vs ≥ 65 years old) and baseline hba1c (\< 8.5% vs ≥ 8.5%).


Eligibility criteria:
inclusion criteria: * 18 years or older * clinical diagnosis of t2d ≥ one year * using at least one aha * status as a sun life group benefits member, initiates iscgm device through lumino health™ pharmacy, and completes one initial pharmacist consultation (iscgm cohort) or completes 2 or more diabetes coaching program consultations (iscgm+coaching cohort); or has private health insurance and uses cbg monitoring (cbg cohort) * baseline hba1c ≥ 7.0% * ≥ 1 hba1c value up to 6 months prior to index date * exclusive use of iscgm for ≥ 3 months * informed consent exclusion criteria: * have a history of insulin use * are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study * have an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * previously used rtcgm or iscgm for \> 3 months * recent or expectant change to antihyperglycemic medications or doses within 30 days of index date

Keywords: continuous glucose monitoring type 2 diabetes time in range hba1c
comparison of repeatability between ss and sd-oct for measuring retinal thickness in various retinal diseases

Conditions: Macula Abnormality

Summary: comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using ss-oct and sd-oct

the investigators studied the intradevice repeatability of thickness measurements for total retina, retinal nerve fiber layer (rnfl) and ganglion cell-inner plexiform (gc-ipl) layers of macular area in the eyes with normal and various retinal diseases using ss-oct and sd-oct and compared the repeatability between two devices.

Eligibility criteria:
inclusion criteria: * age-matched normal group was composed of subjects with age over at least 19 years, * a best-corrected visual acuity of 20/25 or higher, * normal fundus and intraocular pressure (iop) \< 21mm hg. exclusion criteria: * an spherical equivalent (se) larger than ± 6 d, * cataract graded as more severe than grade 3 (lens opacities classification system iii), * a history of glaucoma and optic nerve diseases, or a history of vitrectomy.
skeletal muscle expression of myostatin and cancer of digestive system associated cachexia

Conditions: Cancer of Digestive System

Summary: cancer cachexia is responsible for the death of approximately 20% of patients. myostatin is a master negative regulator of skeletal muscle mass. if the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of myostatin in relation to the degree of cachexia. the hypothesize is that muscle myostatin a biological marker of cachexia in patients with cancer of digestive system. the main objective is to compare skeletal muscle myostatin messenger ribonucleic acid (mrna) level as a function of cachexia in cancer of digestive system patients. myostatin messenger ribonucleic acid (mrna) level will be determined in a muscle sample taken during the resection under general anaesthesia. skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. blood sampling will also be performed on these 4 occasions.


Eligibility criteria:
inclusion criteria: * women and men aged 40-80. * diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not. * signature of consent * affiliate or beneficiary of social security exclusion criteria: * administration of corticosteroids. * thyroid disease treated. * severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, copd under continuous oxygen therapy). * psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol. * bmi\> 30 due to the difficulty of interpretation of bmi variations in obese patients

Keywords: cachexia cancer of digestive system myostatin skeletal muscle
cutting balloon predilation prior to abluminus sirolimus-eluting stent implantation (cut-dress).

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Cutting Balloon

Summary: drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. notwithstanding, stent-related events yet occur. lesion pre-dilation prior to des implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. however, the best pre-dilation strategy has not yet been determined. therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (cb) followed by abluminus sirolimus-eluting stent (ases) implantation for de novo coronary lesions

the study will be a prospective, multicenter, randomized controlled trial in patients undergoing pci with the novo coronary disease. a total of 96 patients with de novo coronary artery stenosis will be included. after being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. random allocation in a 1:1 fashion to one of the following strategies: a) study group: pre-dilation with cutting balloon followed by ases implantation. b) control group: pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ases implantation. stent optimisation will be performed based on intracoronary imaging findings.

Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses \>50% in a native coronary artery. exclusion criteria: 1. cardiogenic shock 2. patients presenting with st-segment elevation myocardial infarction 3. patients undergoing chronic total occlusions pci 4. patients undergoing left main pci 5. patients undergoing venous bypass graft lesions pci 6. patients with in-stent restenosis 7. inability to provide informed consent 8. life expectancy \<1year due to non-cardiac disease 9. currently participating in another trial before reaching first endpoint there will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.
static implant versus dynamic implant in the surgical treatment on ankle syndesmosis rupture

Conditions: Ankle Syndesmosis Rupture

Summary: ankle fracture is frequent and its number is increasing. in canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant. the purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the olerud-molander functional score of more than 15 points at the 3 months follow-up.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years-old; * ankle fracture type 44-c (ao classification) with an ap, lateral and mortise x-ray views of the ankle and an ap and lateral x-ray views of the leg; * open fractures (gustilo i-iiib) or closed; * trauma-surgery delay of less than 7 days; * consent form signed. exclusion criteria: * ankle fractures without syndesmotic lesion; * fracture associated with neuro-vascular lesions (gustillo iiic); * pathologic fracture; * fracture in a polytraumatized patient; * fracture of a bone in the ipsilateral leg; * men or women \> 65 years-old; * chronic cardiac insufficiency (ejection fraction \< 30%); * lower leg chronic venous insufficiency; * neuro-arthropathic foot (charcot, diabetes, etc...); * body mass index ≥ 40; * past medical history of fracture of the same ankle; * medical conditions too serious for a surgery; * men or women unfit to consent; * any other conditions that make the examinator thinks that the follow up would be problematic.

Keywords: ankle fracture with syndesmotic ligament rupture ankle syndesmosis rupture
enteral glutamine in reducing bloodstream infections in short bowel syndrome infants

Conditions: Bloodstream Infections; Short Bowel Syndrome; Development; Nutrition; Biological Markers

Summary: the purpose of this research study is to evaluate the effects (good and bad) of supplementation with glutamine to that of a placebo (l-alanine), on your child and their short bowel syndrome. researchers are doing this study to see if the addition of glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. glutamine is approved by the fda for use in adults with short bowel syndrome. in this study, the investigators will be assessing how well glutamine affects short bowel syndrome in children.

this is a double-blind, randomized placebo-controlled pilot study to investigate the efficacy of enteral glutamine (gln) supplementation in 36 infants, ≤ 12 months of age with parenteral nutrition (pn)-dependent short bowel syndrome (sbs) due to massive small bowel resection for nec and/or atresia on improving weaning of pn and preventing infections. the investigators intend to evaluate the effect of enteral feeding and gln supplementation on the gut bacteria. the investigators will also recruit 12 age-matched controls to evaluate the normal gut bacteria.

Eligibility criteria:
inclusion criteria for controls: * less than or equal to 12 months of age * normal small bowel length without any intestinal resection or primary intestinal disease * not currently on total parenteral nutrition (tpn) and if ever on tpn this should have been discontinued for at least 4 weeks. exclusion criteria for controls: * major congenital or chromosomal anomalies * inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula * history of liver/intestinal transplantation inclusion criteria for glutamine and placebo group of short bowel syndrome (sbs) patients: * less than or equal to 12 months of age * patients who have undergone small bowel resection due to necrotizing enterocolitis (nec) or intestinal atresia with known small bowel length * patients who have been parenteral nutrition (pn) dependent for more than 42 consecutive days and currently on tpn at time of enrollment * patients who have the ability to take partial enteral nutrition or breast milk or elemental formula to allow the appropriate dose of glutamine or placebo * signed informed consent for the use of glutamine or placebo exclusion criteria for glutamine and placebo group of sbs patients: * major congenital or chromosomal anomalies * inability to tolerate enteral nutrition that will preclude treatment with enteral glutamine or l-alanine placebo for \> 2 weeks * liver/intestinal transplantation

Keywords: short bowel syndrome necrotizing entercolitis (nec) atresia parenteral nutrition biological markers growth
interest of whole-body mri correlated to spreading sequences for staging neuroendocrine tumors

Conditions: Neuroendocrine Tumors With Metastasis

Summary: the diagnosis and the follow-up of neuroendocrine tumors can be difficult to assess, especially in the detection of metastasis as they can grow in different organs such as liver, lungs, bones or lymph nodes. nowadays, the diagnosis is made with two main imaging techniques which are the thoraco-abdomino-pelvic ct-scan and a scintigraphic method (octreoscan and sometimes a tep-scan). the use of a whole-body mri is more and more often used for the detection and evaluation of tumors and metastases; therefore, it could be used for neuroendocrine tumors. the mri would allow to replace the two imaging techniques and to avoid the use of irradiation but also to have a better detection of metastases. this purpose of the study was to evaluate this statement by assessing the consistency between the routine techniques and the mri and finally to update the recommendation if the study is positive.

the main metastatic sites of neuroendocrine tumors can be the liver, the bones, the lungs and lymph nodes. according to the french recommendations (" thesaurus national de cancérologie digestive "), the initial assessment includes a thoraco-abdomino-pelvic ct-scan and a scintigraphic method (octreoscan and tep-scan if octreoscan negative). the aim is to detect metastases and tumoral progression to offer the appropriate treatment, such as surgery. due to its high contrast resolution, its absence of irradiation, and diffusion sequences, the mri is more and more used to detect tumor progression. the recent literature shows better results with the diffusion sequences than the t2-weighted sequences and, potentially, than the contrast-enhanced sequences to detect liver metastasis. the whole-body diffusion-weighted mri seems promising for the staging and the following of some cancers. only two publications have evaluated the diagnostic value of diffusion sequences to detect pancreatic neuroendocrine tumors and liver metastasis. yet, no publication has assessed the diagnostic value of whole-body diffusion-weighted mri in the patients with neuroendocrine tumors.

Eligibility criteria:
inclusion criteria: * patients with moderately to well-differentiated neuroendocrine tumors with stage ≥ 3 according to the classification enets, regardless the tumor site and the oms * patients who signed the informed consent * patients followed in one of the participating center exclusion criteria: -
investigation of the absorption, metabolism, and excretion and the absolute bioavailability of yh12852

Conditions: Constipation

Summary: this study investigates the absorption, metabolism, and excretion and the absolute bioavailability of yh12852 in healthy male subjects

part 1 : investigate the absorption metabolism, and excretion of yh12852 after single oral administration of yh12852 and 14c-labeled yh12852. part 2 : investigate the absolute bioavailability of yh12852 after single oral administration of yh12852 followed by a single i.v. administration of 14c-labeled yh12852.

Eligibility criteria:
inclusion criteria: * subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study * healthy adult, 19 - 55 of age (inclusive) * subjects weighing over 55 kg (inclusive) with bmi between 18 and 25 (inclusive) at screening visit * subjects with no clinically significant abnormal findings as determined by physical examination, ecg, medical history, or clinical laboratory test results exclusion criteria: * history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder * surgery of the gastrointestinal tract that could interfere with kinetics of the study drug * history of (or suspected at screening visit) disease listed below myocardial infarction cerebral infarction/stroke arrythmia that need medical treatment unstable angina pulmonary hypertension * subjects who are positive for hepatitis b, hepatitis c, and hiv * history of relevant allergy/hypersensitivity * subjects who took prescribed medications within 14 days or over-the-counter (otc) medications within 7 days prior to the first dose of the study drug * subjects who have been consuming over 21 unit(1 unit = 10 g of alcohol) per week of alcohol prior to the study initiation or who is not able to stop consuming alcohol throughout the hospitalization period * subjects who consumed products listed below within 2 days prior to the first dose of the study drug or who is not able to stop consuming products listed below until the last site visit foods and/or beverages containing grapefruit products containing caffeine (coffee, tea, chocolate, caffeine-containing soft drinks) * subject who is not willing to use contraception throughout the study * subjects who have smoked over 10 cigarettes until 3 months prior to the study initiation or who is not able to stop smoking throughout the hospitalization period * subjects who have donated whole blood within 2 months or blood component within 1 month or received blood transfusion within 1 month of participating in this study * administration of any investigational products within 3 months from the first dose of the study drug * subject who's serum prolactin is over 3-fold higher than the upper limit of normal range * subject who judged not eligible for study participation by investigator

Keywords: accelerated mass spectrometry microtracer microdose hame absolute bioavailability
research for pathophysiology of cancer related fatigue (crf) and chronic fatigue (cfs/me)

Conditions: Cancer Related Fatigue; Fatigue Syndrome, Chronic

Summary: research for pathophysiology of cancer related fatigue (crf) and chronic fatigue syndrome (cfs/me) by lipidomics, metabolomics, intestinal and peritoneal microbiome analysis and exome analysis and investigation of a possible benefit of probiotics.

this study aims to identify the underlying pathophysiology of cancer related fatigue (crf) by screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease with and without fatigue. these results will be compared to an age- and gender matched control group with a comparable tumor disease and to another age- and gender matched control group without tumor disease. the investigators are following the same strategy for investigating an underlying pathophysiology of chronic fatigue syndrome (cfs/me) in another group of patients. the age- and gender matched control group will be established from the beforementioned control group. the investigators will also be screening for a peritoneal microbiome (possible correlate for leaky gut) in study patients undergoing abdominal surgery. we will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome by double-blinded, placebo-controlled administration of probiotics to the study population.

Eligibility criteria:
inclusion criteria: * histologically, cytologically or radiologically confirmed tumor disease * indication for chemotherapy * written consent to participation exclusion criteria: * chronic-inflammatory bowel disease * pregnancy

Keywords: cancer fatigue, chronic fatigue