Kornimate/medical-research-clean huggingface dataset:
sc2i viper: envenomation investigation pilot to evaluate recovery

Conditions: Critical Illness

Summary: the purpose of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. this sub-study will analyze samples of participants enrolled under the parent study "surgical critical care initiative tissue and data acquisition protocol".

the goal of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. the investigators will characterize transcriptomic and immune biomarker response to varying clinical severities of snakebite envenomation and compare to that of sepsis and traumatic injury. this sub-study will analyze samples of participants enrolled under a previously irb-approved protocol, "surgical critical care initiative tissue and data acquisition protocol (sc2i tdap)". all participants eligible for protocol sc2i tdap (nct 02182180) are eligible to be included in the current proposal, and conversely, the investigators will not enroll any participants in the current protocol who is not enrolled in sc2i tdap. participants enrolled under that protocol who have suffered snakebite envenomation will undergo additional procedure of follow up phone call 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital to fill out the psfs via phone. all labs and other procedures will otherwise be as described in sc2i tdap.

Eligibility criteria:
inclusion criteria: * patients enrolled into the surgical critical care initiative tissue and data acquisition protocol (nct02182180) who have suffered a snakebite envenomation (enrolled under "group 5: non-traumatic conditions: individuals with non-traumatic causes of organ or system failure that mirror the phenotype of traumatic complications in group 1") are eligible to be included in this study. * adult patients (18 years of age or older) in a manner that is sensitive to the inclusion of women and members of underserved minority groups. * potential participants or legally authorized representative (lar) will be originally identified by clinical team, as described under pro00054947 (nct02182180). only participants enrolled in pro00054947 (nct02182180) will be recruited for this sub-study exclusion criteria: * pregnant women will be excluded from the study.
the effect and mechanisms of the second-meal phenomenon in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood glucose after a subsequent meal. this phenomenon occurs in normal subjects while it is not clear whether it is also observed in type 2 diabetic patients. this study aims to define whether the second-meal phenomenon occurs in type 2 diabetic patients. we will also seek for the mechanism.


Eligibility criteria:
inclusion criteria: * age 35-70 * hba1c 6-8% * dm duration less than 5 yrs exclusion criteria: * type 1 dm, secondary dm, gestational dm * patients using insulin, tzds * patients using corticosteroid, herb medication or other medications affecting glucose tolerance * renal dysfunction (cr \> 1.5mg/dl) * hepatic dysfunction (lft \> x 3unl) * anemia (hg \< 10g/dl) * ischemic heart disease, congestive heart failure * severe diabetic complication (crf, cva, pdr, gastroparesis) * infectious disease * malignancy * pregnant women
european aortic data collection project

Conditions: Complex Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Aortic Arch Aneurysm; Chronic Aortic Dissection

Summary: the purpose of this study is to evaluate the safety and performance of cook's various custom-made stent-graft devices (cmd) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. the study results will be used to support the continuation of the cmds on the market. in addition, the study will support the manufacturers obligation for post market product surveillance as well as cook's technology development.


Eligibility criteria:
inclusion criteria: 1. patients who will be treated with a cook cmd exclusion criteria: 1. patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or 2. patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the informed consent.

Keywords: complex aortic repair aortic aneurysm aortic dissection fenestrated/branched endograft custom-made endovascular graft
ascension® humeral resurfacing arthroplasty (hra) follow-up study

Conditions: Arthritis

Summary: this is a prospective study on the ascension hra device to collect data to assess the safety and effectiveness of the hra.

this study protocol will provide guidance to investigators wanting to perform a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the ascension® hra. its purpose is to measure and document the outcomes associated with implanting the ascension hra prosthesis. patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.

Eligibility criteria:
inclusion criteria: any patient who is to be treated with the ascension hra is eligible for inclusion in this study. therefore, principal investigators should attempt to recruit all patients at the study site who are treated with the ascension hra the following patient will be included in the study - patient who: * is treated with the ascension hra * is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis * has mild or moderate humeral head deformity and /or limited motion * has post-traumatic arthritis * has an intact or reparable rotator cuff * has the means and ability to return for all required study visits * is willing to participate in the study * has signed an informed consent form * is at least 18 years of age and skeletally mature at the time of surgery * is less than 75 years of age at the time of surgery exclusion criteria: * infection, sepsis, and osteomyelitis * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * rapid joint destruction, marked bone loss or bone resorption apparent on x-ray * revision procedures where other devices or treatments have failed * refuses to be in the study; or does not have the means and ability to return for all required study visits * currently participating in another clinical study
continuous glucose monitoring in inpatients

Conditions: Hyperglycemia

Summary: the purpose of this study is to contribute to current research regarding the feasibility and accuracy of cgm in the hospital setting for both the medical and cardiovascular intensive care (icu) patient populations.

the use of continuous glucose monitors (cgm) in the outpatient setting has dramatically increased as these devices continue to improve in both ease of use, accessibility, and accuracy. federal drug administration (fda) clearance of certain devices has now been granted in both pregnancy and automated insulin delivery systems. as the world has embraced the safety and efficacy of continuous glucose monitors in the outpatient setting, health systems have turned attention to the potential of utilizing these devices to improve glycemic control in the hospital setting. with the announcement of the fda granting enforcement discretion regarding the use of cgm technology in the hospital setting during the covid-19 pandemic, the result was an abundance of research evaluating the potential of cgm longevity in the hospital setting. the standards of care in diabetes: 2023 reported that "preliminary data suggests that cgm can significantly improve glycemic management and other hospital outcomes." additionally, a systematic review of 32 studies evaluated the accuracy of cgm in the intensive care unit, with a consensus of moderate to good accuracy. cgm in the hospital setting could provide a valuable tool in reducing hypoglycemia, hyperglycemia, and increasing time spent in normoglycemia. other potential benefits of cgm include a broader view of glucose patterns, capture of asymptomatic hypoglycemia, reduced length of stay, and decreased cost. the diabetes technology society organized the hospital consensus guideline panel in 2020, with the final report including the recommendation for additional research on the accuracy, data management, and patient-centered outcomes of cgm use in the inpatient setting.

Eligibility criteria:
inclusion criteria: * admitted patients 18 years of age or older * glucose management per glucommander and/or receiving poc blood glucose testing * patients admitted to medical 6 or elective or urgent open-heart surgery patients admitted to the cardiovascular intensive care unit (cvicu) exclusion criteria: * patients less than 18 years of age * pregnant or currently breastfeeding * prisoners * patients unable to consent in english. * patients with a preexisting insulin pump on admission * active skin infection at the insertion site(s)

Keywords: continuous glucose monitor cgm
nusantara diet (low calorie and low sodium) for metabolic syndrome

Conditions: Metabolic Syndrome; Diabetes; Hyperlipidemias

Summary: the goal of this randomized clinical trial is to evaluate the effect of nusantara diet (low calorie and low sodium) for metabolic syndrome. the main questions it aims to answer are: * how effective the nusantara diet in reducing body mass index and body fat percentage? * how effective the nusantara diet in affecting lipid profile and insulin resistance? participants will be given this diet for a period of 56 days and undergo repeated outcome measurement. this study has a comparison group (no intervention) to see the difference of reduction or slope of changes in outcomes. we assumed that the nusantara diet will reduce the metabolic syndrome indicators (anthropometry, lipid profile, and insulin resistance profile).

design a. randomized controlled trial with pre-post design intervention : 1. balance nutrition with low calorie and low sodium. low calorie means a diet with 500 kilocalories lower than the basal energy expenditure, according to the harris-benedict formula. the daily limit of sodium is 2300 mg. 2. organoleptic test for set menu 3. given as a set for 56 days 4. dietary counseling is given before intervention, followed by a 24-hour food recall every week. outcome 1. body mass index 2. blood chemistry test: total cholesterol, low-density lipoprotein (ldl), high-density lipoprotein, triglyceride, 4. glucose profile (fasting blood glucose, and homeostatic model assessment for insulin resistance / homa-ir) 3. body fat percentage using bioelectrical impedance analyzer sample size estimation with the following assumption 1. type i error: 5% 2. power of study: 80% 3. superiority trial 4. equal allocation with two arms 5. assuming that the reduction of ldl would be 30% of the average ldl level among metabolic syndrome individuals (106.4 mg/dl), the total sample would be 48 participants protocol analysis 1. intention-to-treat analysis 2. sensitivity analysis and subgroup analysis 3. if the randomization obtains an equal baseline characteristic, an independent t-test will be applied. 4. regression model will be applied, adjusting any possible confounder.

Eligibility criteria:
inclusion criteria: * fulfill the definition of metabolic syndrome 1. blood pressure\>135/85 mmhg 2. central obesity with waist circumference for males\>90 cm or \>80 cm in females 3. triglyceride level \>150 mg/dl, followed by hdl\<40 mg/dl 4. blood fasting glucose \>100 mg/dl exclusion criteria: 1. pregnant or breastfeeding women 2. suffer from chronic disease

Keywords: diet nusantara low calorie low sodium lipid profile insulin resistance
quantitative and functional study of th17 lymphocytes in horton's disease (hd)

Conditions: Horton's Disease; Infectious Disease; Neoplasia; Solid Tumor; Hemopathy

Summary: the aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with horton's disease. this would make it possible to improve the diagnosis and management of this disease. participation consists in taking one or several blood samples depending on the group patients/controls.


Eligibility criteria:
inclusion criteria: patients * patients who have provided written informed consent * patients with national health insurance cover * age: 50 to 90 years patients with horton' s disease : * at the diagnosis, before any treatment * or in remission * or in relapse patients with an infectious disease : * bacteriologically or radiologically confirmed * presenting an inflammatory syndrome defined by : * crp ≥ 10 mg / l * and fibrinogen ≥ 4 g / l or esr ≥ 30 mm at h1 patients with neoplasia ( solid tumour or hemopathy ) : * at the diagnosis, before treatment by chemotherapy * presenting an inflammatory syndrome defined by: * crp ≥ 10 mg / l * and fibrinogen ≥ 4 g / l or esr ≥ 30 mm at h1 controls : these are healthy volunteers recruited among blood donators at dijon chu, voluntary hospital personnel ( nurses, doctors and secretaries ), patients at the ephad ( champmaillot centre for geriatric patients ) and patients without infectious, inflammatory, or auto-immune disease ( crp \< 5mg / l ) or cancer recruited from the investigating departments of dijon chu. they will be matched for age and sex. * age: 18 - 90 years * patients with national health insurance cover * who have provided written informed consent * absence of an inflammatory syndrome ( crp \< 5 mg / l ) exclusion criteria : * any patient who does not meet the inclusion criteria
warfarin in preventing blood clots in cancer patients with central venous catheters

Conditions: Thromboembolism

Summary: rationale: warfarin may be effective in preventing the formation of blood clots in patients with central venous catheters. purpose: randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters.

objectives: * determine the utility of warfarin in reducing thrombosis rates in cancer patients with central venous catheters. * compare the thrombosis rates in patients treated with different warfarin dosing schedules. * compare the adverse events and survival of patients receiving or not receiving this drug. outline: this is a randomized, multicenter study. patients are stratified according to sclerosant potential of cytotoxic regimen (low vs high), site of placement of catheter (peripheral vs central), and duration of drug administration (brief infusion (under 24 hours) vs prolonged infusion (24 hours and over)). patients are randomized to 1 of 3 arms. * arm i: patients receive no warfarin. * arm ii: patients receive oral warfarin daily beginning 3 days before placement of central venous catheter (cvc) and continuing until cvc is removed or thrombosis occurs. * arm iii: patients receive oral warfarin as in arm ii, with dose adjustment after cvc placement to achieve and maintain inr level. patients are followed at 12 months. projected accrual: a total of 1,400 patients (400 in arm i, 700 in arm ii, and 300 in arm iii) will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed cancer * planned placement of central venous catheter (cvc) for administration of chemotherapy * no use of cvc for additional purposes except for antibiotic therapy or blood products patient characteristics: age: * 16 and over performance status: * not specified life expectancy: * not specified hematopoietic: * wbc at least 2,000/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 10 g/dl * no congenital bleeding disorders hepatic: * not specified renal: * not specified other: * no contraindication to warfarin * no anatomic lesions that bleed (e.g., duodenal ulcers) * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * no prior enrollment on this study * no concurrent therapy that would interfere with study drug * no concurrent warfarin

Keywords: thromboembolism
3d craniofacial morphologic development of healthy infants

Conditions: Development, Infant; IMAGE; Craniofacial Asymmetry; Plagiocephaly

Summary: healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month. all the image data was analyzed to reveal infants' craniofacial development.

importance the development of craniofacial morphology in the first year of life is critical, especially when analyzed with longitudinal 3-dimensional photographs. objective to evaluate the development of the craniofacial region in healthy infants in the first year of life and provide treatment guidelines for craniofacial deformities such as orofacial clefts and deformational plagiocephaly. design, setting, and participants three-dimensional (3d) photographs of included participants were captured using a 3dmd system. participants were grouped by sex and age (1, 2, 4, 6, 9, and 12 months). we placed 32 craniofacial anatomical landmarks on 3d craniofacial photos. the thin-plate spline algorithm and closest-point matching were applied to transform a symmetric 3d template into a series of scanned images to calculate 3d composite heads at different ages. main outcomes and measures average craniofacial meshes were calculated for each group. the growth patterns of the following anthropometric indices were determined: craniofacial height, depth, width, volume, body height, weight, body mass index (bmi), and head circumference.

Eligibility criteria:
inclusion criteria: * asian ethnicity * healthy infants * full-term exclusion criteria: * growth curve \<3% * premature * congenital craniofacial anomaly * hormonal anomaly. * chromsomal anomaly * thyroid anomaly * bone anomaly

Keywords: craniofacial development growth chart
evaluation perioperative nutrition on donor site healing in patients undergoing reconstructive burn surg

Conditions: Burn; Reconstructive Surgical Procedure

Summary: the investigators hope to learn if taking a nutrition drink for a short time after surgery for an elective reconstructive burn injury improves donor site healing, muscle mass and scar maturation time (the point at which the redness, height and firmness of the wound has faded, flattened and softened, and no longer changes in appearance).


Eligibility criteria:
inclusion criteria: * at least one year post-acute burn injury * admitted for surgery whereby split thickness donor site created * received initial acute treatment at shriner's hospital in cincinnati exclusion criteria: * less than 6years of age * less than one year from acute burn injury * split thickness donor site/autograft not anticipated * initial treatment not at shriners hospital in cincinnati

Keywords: pediatrics
hemodialysis health management model

Conditions: Physical Inactivity; Nutritional Wasting

Summary: aim: by application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.

background: end stage renal disease (esrd) is a global public health issue. the dialysis therapy brings huge economic burden to many countries. if patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care. aim: by application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients. material and methods: the investigators plan to recruit 30 ckd patients as trial subjects for intervention. the intervention included wearable devices and health management platform for 24 weeks. patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. then, all the collected information will be upload to health management platform. the investigators compare physical and laboratory examinations before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 20 years and older * diagnosis of esrd receiving maintenance hd for more than 3 months exclusion criteria: * inability to use a smartphone * impaired walking capacity * having a psychiatric disorder * any hospitalization during the previous 3 months. * has been changing dialysis modality or receiving renal transplantation

Keywords: hemodialysis wearable device health management platform
determination of the levels of lipocalin-2 and semaphorin3a

Conditions: Gingivitis; Periodontitis; Periodontal Diseases

Summary: the aim of this clinical trial is to investigate the concentrations of lipocalin-2 and semaphorin 3a levels in gingival crevicular fluid in subjects with different periodontal diseases. at the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.

in our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. lipocalin-2 and semaphorin 3a levels will be determined by an enzyme-linked immunosorbent assay test (elisa). subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment. possible significant differences may illuminate the future work with lipocalin-2 and semaphorin 3a. also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.

Eligibility criteria:
inclusion criteria: * being systemically healthy * having at least 20 teeth in the dentition, excluding third molars * not using alcohol nor smoking * not using medications * not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months * not being in the lactation period nor pregnancy exclusion criteria: * having any oral or systemic diseases * using alcohol or smoking * using medications * taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months * being in the lactation period or pregnancy * being treated with periodontal treatment in the last six months

Keywords: periodontal disease, non-surgical periodontal treatment, gcf