Kornimate/medical-research-clean huggingface dataset:
incretin-mimetic hypoglycemic drugs and severe retinopathy

Conditions: Type 2 Diabetes

Summary: experimental data suggest that glp-1 promote endothelial cell growth and angiogenesis which may have beneficial effects on the cardiovascular system but harmful effects on the retina . this project investigate the possible link between incretin therapy and severe diabetic retinopathy. the prevalence of severe dr in patients exposed to incretin therapy (glp-1 analogs or dpp4 inhibitors) is compared to that in non-exposed patients to these antidiabetic classes.

this study is dedicated to investigate the impact of routinely prescribed hypoglycaemic treatments on the prevalence of severe retinopathy and to seek possible biomarkers of severe retinopathy. hypoglycemic treatments taken by the patients are those prescribe by the usuel diabetogist in the context of routine care. the study includes t2d patients according to ada criteria treated with any kind of hypoglycemic treatment and attending a diabetes center (three in marseille: department of endocrinology, hôpital nord, assistance publique des hôpitaux de marseille and service d'ophtalmologie, hôpital saint-joseph and service de diabétologie, hôpital saint-joseph, and two in paris : centre universitaire du diabète et de ses complications hôpital lariboisière, université paris 7, assistance publique des hôpitaux de paris and service d'endocrinologie, diabétologie et nutrition, hôpital bichat). it consists of two visits: visits1 "inclusion" and visits 2 "three years after the inclusion". in each visit, the investigators will collect results of eye examination (fundus) and annual diabetes check up including anthropometric data, routine biology, diabetes complication status as well as medications taken by the patients (past and current). a bio-banking (blood, urine and hairs) will be also collected. primary objective : to compare the prevalence of severe dr in patients exposed to incretin therapy (glp-1 analogs or dpp4 inhibitors) to that in non-exposed patients at baseline. secondary objective: to compare the proportion of patients who worsen dr between v1 (inclusion) and v2 (after 3-yr of treatment) in patients exposed to incretin-based therapy from baseline vs non-exposed patients: patients with no dr or mild to moderate non proliferative dr at v1 who progress to severe dr at v2. to evaluate whether the concentrations of angiogenic/inflammatory molecules and circulating endothelial and inflammatory cells are associated with severe dr in relation with the use of glp-1 based therapy at v1 and v2.

Eligibility criteria:
inclusion criteria: * t2d patients according to ada criteria treated with any kind of hypoglycaemic treatment * age above 18 years exclusion criteria: * type 1 diabetes * patients with cataract preventing dr grading * patients who had panretinal photocoagulation more than 10 years ago * documented pregnancy or lactation

Keywords: incretin-based therapy glp1 angiogenesis inflammation hypoglycaemic treatment
factors related to geographical variation in the incidence of end-stage renal failure: an analysis in 5 french regions

Conditions: Renal Insufficiency

Summary: the rein registry highlights significant disparities in the incidence of end-stage renal disease (esrd) between regions, especially in the north east of france. according to the literature, the incidence of esrd in an area could be related to contextual factors influencing the needs for dialysis or transplantation (age structure, prevalence of risk factors, socioeconomic and morbidity levels), as well as to primary and secondary care provision (general practitioners and nephrologists) and to practice patterns in nephrology. the aims of this project are the following: 1. to compare the incidence of renal replacement therapy (dialysis or preemptive transplantation) for esrd between the "départements" and the "cantons" belonging to the 5 regions of eastern france (alsace, lorraine, champagne-ardenne, bourgogne and franche-comté), while taking into account differences in population sizes and spatial patterns of the data, 2. to analyse the relations between incidence disparities and socioeconomic environment, geographic accessibility to primary and secondary care and medical practice patterns, after adjusting for morbidity and mortality rates (incidence of diabetes, cardiovascular mortality). this project will enable a better understanding of the mechanisms involved in the spatial variations of esrd incidence, while disentangling effects related to the need from effects related to service supply in different socio-economic contexts. it will be possible to identify a lack of equity in access to renal replacement therapy if, after adjusting for need indicators, there were variations of incidence of esrd related to availability of service or to socioeconomic context. highlighting such effects would lead to search for corrective measures in collaboration with the different stakeholders.


Eligibility criteria:
inclusion criteria: * age 18 and older * resident of the 5 french administrative regions (alsace, bourgogne, champagne-ardenne, franche-comté, and lorraine) * first renal replacement therapy by renal dialysis or preemptive kidney transplant between january 1st, 2010 and december 31, 2014 * found in the rein registry exclusion criteria: * transfer from another french administrative region * return to renal dialysis after graft rejection or a period without dialysis

Keywords: incidence renal replacement therapy socioeconomic factors clinical practice pattern
an open label, proof of concept study to evaluate the effects of dalfampridine withdrawal on gait and balance parameters in subjects with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-er 10mg in ms subjects who are receiving the medication consistently for at least two weeks prior to screening.

longitudinal study design

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * receiving ampyra® consistently for at least 2 weeks prior to the screening visit * no history of seizures except simple febrile seizures exclusion criteria: * sexually active woman of childbearing potential who is not surgically sterile, \<two years post-menopause or is not using effective birth control methods * subject who is pregnant or breastfeeding

Keywords: multiple sclerosis ms
glucobay m - evaluation of safety and effectiveness in type 2 diabetes not well controlled on monotherapy in real life practice

Conditions: Diabetes Mellitus, Type 2

Summary: the study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in india. the study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. the study will begin after the study approval by ethics committee. all patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed glucobay m will be included in study after taking the informed consent. patients will be observed for up to 24 weeks (2 weeks).the study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. the study is planned to enroll 10000 subjects from multiple study centers spread across india. the study data will be analyzed with appropriate statistical methods.


Eligibility criteria:
inclusion criteria: * patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs. * willing to give informed consent for participating in this study exclusion criteria: * patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. however, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed \& recorded in case record form. * patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment. * exclusion criteria should be read in conjunction with local product information

Keywords: diabetes mellitus type 2 diabetes acarbose (25/50mg) and metformin (500mg) in fixed dose combination
immunogenicity and safety of nbp608 compared to zostavax in healthy adult aged 50 and over

Conditions: Herpes Zoster

Summary: this study assesses non-inferiority by comparing gmr(geometric mean ratio) of nbp608 to zostavax which are evaluated by gpelisa (glycoprotein enzyme linked immunosorbent assay). total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

this is a multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of nbp608 compared to zostavax which are indicated for the prevention of herpes zoster. total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. stratified randomization for age group is used to achieve the balance of treatment assignment within age strata. total of five visits are scheduled including two visits via telephone contact. blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at visit 2 and visit 4 respectively. safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through visit 3\*, visit 4 and visit 5\* (\* telephone contact)

Eligibility criteria:
inclusion criteria: * healthy adult over aged 50 years * menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent exclusion criteria: * those with hypersensitivity to any component of ip(investigational product), such as gelatin * those with a history of hypersensitivity to vaccination, such as guillain-barre syndrome * those who have received antiviral agents witin 1 month prior to ip vaccination (topical antiviral agent is allowed) * those who have previously received herpes zoster vaccine * those who have a history of herpes zoster * those with congenital or acquired immunodeficiency * those with active untreated tuberculosis * those who have received blood products or immunoglobulin within 3 months prior to ip(investigational products) vaccination * those who have received other ips(investigational products) in another clinical study witin 4 weeks prior to ip vaccination in this study

Keywords: herpes zoster vaccine prevention of herpes zoster
atherectomy followed with a drug coated balloon in the treatment of long femoropopliteal lesions

Conditions: Peripheral Arterial Disease

Summary: the study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the ultrafreetm drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.

this is a multicenter, prospective, randomized, controlled comparison study. a total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( stenotic lesion\>15cm or chronic total occlusion between 6-15cm). angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (mld) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. the primary endpoint is primary patency at 12 months based on kaplan-meier survival analysis. follow-up visits are scheduled at 1,3,6,12,24 months.

Eligibility criteria:
inclusion criteria: 1. subject must be between 18 and 85 years old; 2. chronic, symptomatic lower limb ischemia defined as rutherford categories 3-5; 3. stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: stenotic lesion(\>70% diameter stenosis) \>15cm or chronic total occlusion between 6-15cm; target vessel is 3.0 to 7.0 mm in diameter (visual estimate); guidewire must be across the target lesion within the true lumen before study randomization; 4. patent distal popliteal artery and at least one patent distal runoff; 5. willing to comply with the follow-up evaluation; 6. written informed consent prior to any study procedures. exclusion criteria: 1. women during pregnancy and lactation, or patients with baby planning; 2. life expectancy\<2 years; 3. target lesion/vessel with in-stent restenosis 4. target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy \<12 months 5. subjects s who are currently participating in other interventional drug or device trials; 6. angiographic evidence of thrombus within the target vessel 7. subjects have a history of stroke within 3 months; 8. subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks; 9. concomitant renal failure with a serum creatinine\>2.0mg/dl; subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.

Keywords: atherectomy drug coated balloon
the challenge study: a dietary personalization protocol for patients with crohn's disease and deep remission

Conditions: Crohn's Disease

Summary: the challenge study is a prospective, open label, pilot trial in patients in deep remission on dietary maintenance therapy. the purpose of this study is to determine whether they can consume some of the products that were eliminated from their diet, named the crohn's disease exclusion diet (cded), and to evaluate if low dose exposure is harmful.

the investigators have previously hypothesized that crohn's disease may occur via a sequence of events involving dysbiosis and genetically determined or environmentally acquired defects in innate immunity, and have further hypothesized that the mechanism of een for induction of remission acts by reducing exposure to dietary components that may cause an acquired bacterial clearance defect or generate dysbiosis. based on this premise, the investigators developed a new exclusion diet. this diet, named the crohn's disease exclusion diet (cded) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. this diet was evaluated for induction of remission through week 12 and succeeded in inducing remission in 70% of 47 selected patients. the investigators have now progressed to three randomized controlled trials to evaluate the diet in different populations with different disease severity, and the results from the first rct demonstrate a high remission rate in the cded arm. however , to date the investigators have used the same diet for all patients. the investigators are now encountering patients on the diet in deep remission, but the investigators do not know if they can consume some of the products ( such as milk fat and gluten) that were eliminated. the investigators therefore are starting to challenge our patients in deep remission with low dose exposure to evaluate if low dose exposure is harmful. the investigators wish to document this and obtain stool samples for calprotetctin and microbiome to investigate these patients at a microbiological level as well.

Eligibility criteria:
inclusion criteria: 1. established diagnosis of crohn's disease. 2. patients in sustained remission with pcdai 0 \> 6 months 3. ages 8-20 4. normal crp (crp\<0.5), normal calprotectin (\<100) 5. patients with uncomplicated disease 6. signed informed consent exclusion criteria: 1. patients with active disease (pcdai \>10) 2. pregnancy 3. patients with complicated disease (b2, b3) 4. patients with recent onset use of an immunomodulator \<12 weeks, or dose change in past 12 weeks. 5. patients with current use of biologics. 6. elevated crp or calprotetcin\>100 at screening.
effect of food order on postprandial glucose excursions in pre-diabetes

Conditions: Obesity; Pre-Diabetes

Summary: the natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. approximately 38% of the us adult population is estimated to have pre-diabetes. in a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. in the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. the study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.


Eligibility criteria:
inclusion criteria: 1. male and female subjects between 30-65 years of age 2. bmi 25-40kg/m2 3. hba1c 5.7%-6.4% 4. willing to comply with study requirements 5. provide written informed consent exclusion criteria: 1. known diagnosis of diabetes / taking any medication for treatment of diabetes 2. history of previous bariatric surgery 3. history of chronic liver or renal disease 4. current treatment with systemic corticosteroids 5. pregnant women 6. history of allergy to any component of the test meal
development of active safety surveillance system for traditional chinese medicine

Conditions: Climacteric Symptoms; Hot Flushes and/or Sweats

Summary: context:clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. this study drug- a mixture of chia-wei-hsiao-yao-san, chih-po-ti-huang-wan, hsiang-sha-liu-chun-tzu-tang (tmn1) is widely used as an alternative to hormonal therapies for hot flush in taiwan. however, there is a paucity of data supporting their efficacy and safety. objective:to evaluate the safety and efficacy of tmn1 in the treatment of hot flush. design and setting:a multi-center, prospective, observational follow-up study was conducted from july 2003 to december 2004 in 4 hospitals. participants:in total, 136 eligible subjects entered this study. they were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations. main outcome measures:during the observation period, the investigators and study nurses actively enquired subjects if there was any adverse event (aes) occurring to them by using traditional chinese medicine adverse events (tcm ae) questionnaire which includes 20 aes proposed by experienced cm doctors as most commonly seen in the use of study drug. every subject's complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team. the primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the kupperman menopause index. the secondary outcome measures included changes in quality of life measured by world health organization quality of life (whoqol) questionnaire, and adverse events monitored actively by a global assessment of tolerability. during the study period, every subject also received tests on routine hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4 weeks and 12 weeks after medication.


Eligibility criteria:
inclusion criteria: 1. women between age of 45 and 55 and suffered from hot flushes and/or sweats 2. had not participated in any trial within the previous 3 months before beginning this study 3. were willing to participate in the trial and give written informed consent exclusion criteria: 1. had received any form of hormonal therapy within 3 months prior to the study 2. had been diagnosed with any form of cancer and under treatment 3. were afflicted with abnormal uterine bleeding and unknown etiology 4. had hypertension or diabetes mellitus and were under treatment for these conditions 5. had any abnormal finding for kidney, liver, or thyroid functions 6. were currently taking antidepressants, alpha or beta-blocking agent, e.g., clomidine, ergot, ergot derivatives, or anti-estrogen medications such as tamoxifen and/or herbal hormones (isoflavon 7. were suffering from arrhythmia or any other form of heart disease.
lidocaine and dexmedetomidine infusions for intraoperative bleeding in functional endoscopic sinus surgery

Conditions: Lidocaine; Dexmedetomidine; Infusion; Intraoperative Bleeding; Functional Endoscopic Sinus Surgery

Summary: this work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.

sinus surgery is one of the most prevalent surgeries on the ear, nose, and throat (ent). it is mainly carried out through endoscopy and significantly improves the clinical symptoms of patients with rhinosinusitis. safe conditions must be maintained for this surgery, and the major problem reported during functional endoscopic sinus surgery (fess) under general anesthesia (ga) is impaired visibility due to excessive bleeding. dexmedetomidine is an α2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, analgesic-sparing effects and minimal depression of respiratory function. it is potent and highly selective for α2-receptors. lidocaine is an amino amide-type short-acting local anesthetic (la). it has a short half-life and a favorable safety profile and is,, therefore,, the la of choice for continuous iv administration.

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years old. * american society of anesthesiologists (asa) physical status i - ii. * scheduled for elective functional endoscopic sinus surgery. exclusion criteria: * diabetes mellitus. * coagulation disorders. * kidney and liver dysfunction. * cerebrovascular disease. * cardiovascular problems. * high blood pressure. * asthma. * chronic obstructive pulmonary disease (copd). * end organ damage. * psychosis. * taking antipsychotic drugs. * allergy to study drugs. * substance abuse. * taking beta blockers. * heart rate of \< 55 beat/minute.