Kornimate/medical-research-clean huggingface dataset:
stereotaxis study to obliterate persistent ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: this is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (vt) cases. subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.

catheter ablation of ventricular tachycardia (vt) is greatly facilitated by using a substrate mapping approach - that is, mapping of the left ventricle during sinus or paced rhythm to identify diseased myocardium. using three dimensional electroanatomical mapping, it is possible to reconstruct an anatomical rendering of the left ventricle based on voltage. for hemodynamically stable or unstable vts, various electrophysiologic maneuvers can then be used to identify the critical portions of the vt circuit within the scar (entrainment mapping, identification of diastolic potentials, identification of electrically-unexcitable scar, fractionated potentials and pace mapping). these methods are limited by the resolution of the substrate map, accuracy of catheter manipulation, and operator skill. to this end, a magnetic navigation system has been developed that allows for remote cardiac mapping. when used in concert with a compatible electroanatomical mapping system, it is possible to create a high-density ventricular substrate map of healed myocardial infarction. by removing the necessity for technical skill with catheter manipulation, this system has the potential for both improving the efficacy of vt ablation and expanding the clinical use of this substrate mapping approach. recently, a higher-powered, irrigated tip catheter has become available in certain markets for use in cardiac arrhythmia ablations. this study will evaluate the outcomes of using this magnetic irrigation ablation catheter during mapping and ablation of vt while also using remote magnetic navigation.

Eligibility criteria:
inclusion criteria: * subject must be between the ages of 18 - 80 years * willing to provide prior written informed consent per local ethics committee guidelines * subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia * able to be safely exposed to static magnetic fields * no in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields exclusion criteria: * presence of a mobile ventricular thrombus * inability to access the left ventricle * subjects must not have any contraindications to short-term anticoagulation * subjects must not have a life expectancy of \<1 year due to a medical illness

Keywords: arrhythmia ventricular tachycardia ablation mapping electrophysiology
the effects of case management in a medicaid managed care plan

Conditions: Neoplasms; Heart Diseases; Adrenal Cortex Diseases

Summary: the purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a medicaid managed care plan.

this study will assign participants based on zip code to one of two conditions: control and experimental. in the control group, participants will receive telephonic assessments at baseline, three months, and six months. these assessments will be conducted by a member of the medical center's department of geriatrics under the supervision of the principal investigator. participants in the experimental group will receive medical case management provided by a nurse and social worker in the homecare setting including an in-home assessment. assessments will be conducted at baseline, three months, and six months during routine homecare visits. dependent variables being measured include: access to primary care physicians, emergent hospitalizations/admissions, articulation of advance directives, and quality of life. data will be collected through the participants' medical claims and records to analyze the number of emergent hospitalizations/admissions, documentation of advance directives, and number of visits to primary care physicians. to measure participants' quality of life, the depression self-rating scale and the clinical anxiety scale will be utilized. data will be compared between and within the groups via statistical analyses. the researcher will conduct pre-post comparisons of utilization and other database-derived outcomes for both groups, comparing the 12 months prior to and up to 20 months following enrollment.

Eligibility criteria:
inclusion criteria: * participation in a medicaid managed care plan * resident of identified zip codes in brooklyn, ny * frequent hospitalizations and low frequency of primary doctor visits exclusion criteria: * residents outside the catchment area * patients not being managed in a medicaid managed care plan
apacc study:prospective study on aspirin efficacy in reducing colorectal adenoma recurrence

Conditions: Colon Adenomas

Summary: experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. in the apacc study we randomly assigned 291 patients to daily aspirin or placebo for 4 years. however, the available data are not sufficient to serve as the basis for firm recommendations

the apacc study is a prospected, randomized, double-blind, placebo-controlled multicentre clinical trial design to test the efficacy of regular low-dose aspirin administration in reducing the recurrence rate of colorectal adenomatous polyps. the study involved 49 gastroenterology centers from various parts of france. patients were eligible if they had either at least 3 adenomas irrespective of size, or at least one measuring 6mm in diameter or more histologically confirmed colorectal adenomatous polyp by the local pathologist, and 2 independent pathologists, underwent a complete colonoscopy with polypectomy and were then confirmed free of polyps, were aged between 18 and 75 years at recruitment, and were be able to conform to the protocol during the study period. during a 4-week run-in period before enrolment, all subjects took 300 mg aspirin per day to test tolerance and compliance with the treatment. they were then randomized to either of the following three groups: placebo, aspirin as acetylsalicylate of lysine 160 mg/day or aspirin as acetylsalicylate of lysine 300 mg/day. information on compliance, tolerance of the treatment and concomitant disease is obtained at regular clinical visits every 4 months. informations on factors such as smocking habits, previous medical history was recorded at enrollment. the primary outcomes were defined as the proportion of subjects in whom at least one new adenoma was detected, and the adenomatous polyp burden calculated as the sum of the diameters of these adenomas at the follow-up colonoscopy 1 and 4 years after enrollment.

Eligibility criteria:
inclusion criteria: * patients are aged between 18 and 75 years at least 3 adenomas irrespective size or at least one measuring 6mm or more all subjects had a clean colon at the study entry exclusion criteria: * no personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin

Keywords: colon cancer aspirin adenomas prevention
feasibility and performance of virtual software for virtual bone graft planning in cleft patients

Conditions: Cleft Palate Children

Summary: objective: the investigators aim to compare the licensed brainlab iplan® software, considered the gold standard, to the 3d slicers and blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3d template for development of the bone graft. study design retrospective, pilot study patients presenting at the division of maxillofacial surgery at the az sint-jan brugge-oostende av (belgium) or the 1st department of pediatrics at the usemmelweis (hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam ct (cbct). a single surgeon will run all the virtual planning steps with both the licensed software and the freeware. timing of the four major steps will be measured with a digital chronometer (http://www.online-stopwatch.com/download-stopwatch/). ten children, 5 belgian patients and 5 hungarian patients, that already had a work-up and surgery for a unilateral cleft requiring a bone graft, will be planned. this based on the preoperative cbct that is already present, by using both the licensed software and free software. the investigator will register patients' age, gender and cleft size and register the required time to complete the different planning steps, as well as list the number of actions to complete the planning, and the occurrence of software bugs. in addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon. all patients will be planned twice with an interval of two weeks in order to measure intra-observer reliability. moreover, a second surgeon will also plan the 10 cases to measure inter-observer reliability. main study endpoints the investigators hypothesize that the licensed software is more user-friendly, ensuring a significant shorter overall treatment planning time to create a model for accurate bone transfer from the iliac crest to the jawbone.


Eligibility criteria:
inclusion criteria: * patients with a unilateral cleft * patients of all genders * patients aged 7-12 years old * patients should have presented themselves at the division of maxillofacial surgery, at the participating hospital centers, for bone graft surgery * patients should have received standardized cone-beam computed tomography (cbct) image acquisition as part of routine work-up, and all original dicom files should be present * preoperative 3d virtual planning should be performed by the same investigator per center with both the licensed software and the freeware exclusion criteria: * all patients that do not fit the abovementioned description * patients with previous bone graft surgery * patients with posttraumatic deformity * patients with preprosthetic indication

Keywords: 3d virtual software bone graft
residual pain after successful implant of metaphyseal sleeves in total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: : total knee revision arthroplasty is increasing in daily practice and will become more relevant in the years to come. bone loss is a significant challenge in total knee arthroplasty (tka) especially in revision procedures. metaphyseal sleeves are widely used to bypass bone loss and improve stability. this study aims to report the results of primary and revision tka (r-tka) using metaphyseal sleeves.


Eligibility criteria:
inclusion criteria: * patients were included if they were older than 18 years and underwent a primary or revision tka using cement-less metaphyseal sleeves, performed by the same senior surgeon exclusion criteria: * patients were excluded from the final analysis if they did not have 18 months of minimum follow-up and if they were lost to the final control.
volatile organic compounds (vocs) of exhaled breath in patients with gi bleeding

Conditions: Gastrointestinal Hemorrhage; Volatile Organic Compounds

Summary: cross sectional case-control study investigating the difference of volatile organic compound in the exhaled breath of the patients with gi bleeding and normal population.

this study investigates the difference of volatile organic compound in the exhaled breath of the patients with gi bleeding and normal population. we aimed to find out the biomarkers for gi bleeding.

Eligibility criteria:
inclusion criteria: * adults aged between 20 and 80 * low possibility of gastrointestinal bleeding was proven by esophagogastroduodenoscopy and colonoscopy which were performed within 1 year. * nsaid non-user (within 1 months before the date of inclusion) exclusion criteria: * diagnosis of malignancy diagnosed within 5 years * past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma * surgical history of any kind of gastrectomy * surgical history of any kind of lung resection which could impact the patient's lung function.
prevention of mild-to-moderate hypoglycemia in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: according to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose \< 4.0 mmol/l), 15-20g of rapidly absorbed carbohydrates should be ingested. patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. these recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy. in practice, only 32-50% of patients follow the current guidelines. in addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. with the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years old 2. clinical diagnosis of type 1 diabetes for at least one year 3. treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin) 4. a glycated hemoglobin a1c ≤ 10% exclusion criteria: 1. clinically significant microvascular complications: nephropathy (egfr \< 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis) 2. recent (\< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery) 3. known significant cardiac rhythm abnormality based on investigator's judgement 4. known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement 5. ongoing pregnancy or breastfeeding 6. severe hypoglycemia episode within 1 month of screening 7. known uncorrected hypokalemia within the past 3 months (potassium \< 3.5 mmol/l)

Keywords: hypoglycemia type 1 diabetes carbohydrates
evaluation of spot urine as a biomarker of fluid intake in real life conditions

Conditions: Healthy Adults

Summary: evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors


Eligibility criteria:
inclusion criteria: * healthy female and male subjects aged 20- 30 years old (both ages included). * bmi within the range 20-25 kg/m2 (both inclusive). * height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects. * monophasic contraceptive method (female subjects only) * smoking less than 10 cigarettes/day * fluid intake habits falling within one of three designated arms exclusion criteria: * pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman. * any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. * having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.
a study to evaluate efficacy and safety of hm11260c in adult obesity patients without diabetes mellitus

Conditions: Obesity

Summary: a multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of hm11260c in adult obesity patients without diabetes mellitus


Eligibility criteria:
inclusion criteria: 1. patients with following criteria : * bmi ≥ 30 kg/m2 or * 27 kg/m2 ≤ bmi \< 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease) 2. a person who have failed at least once to weight control using diet and exercise therapy before screening visit. exclusion criteria: 1. a person whose weight change exceeds 5kg within 3 months prior to screening visit. 2. diabetes mellitus (type 1, type 2, etc.) or hba1c ≥ 6.5 %. 3. administration of hypoglycemic agents. 4. administration of medicines inducing weight gain. 5. prader-willi syndrome or mc4r deficiency. 6. cushing's syndrome. 7. administration of medicines for weight management. 8. a person who has a history of surgery(including device-based therapy) related to obesity or who has a plan during the clinical trial period. 9. administration of steroids for the systemic use. 10. clinically significant gastric emptying abnormalities. 11. history(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis. 12. history of acute or chronic pancreatitis. 13. a person who has the following clinical laboratory test results : * tsh \ 6 miu/l * calcitonin \> 100 ng/l * amylase or lipase \> 3 x unl 14. severe liver disease (ast or ast \> 3 x unl or total bilirubin \> 1.5 x unl). 15. severe renal disease ( egfr \< 30ml/min/1.73m 2 ). 16. qtc \> 450 ms. 17. answered 'yes' to question 4 or 5 of the suicidal ideation domain in c-ssrs or history of suicide attempt. 18. phq-9 ≥ 15 or history of depression, anxiety, and other severe mental illness. 19. history of alcohol addiction or drug abuse. 20. history of malignant tumors. 21. history of severe heart disease or severe neurovascular disease. 22. hypersensitivity to investigational products or multi-drug allergy. 23. positive to pregnancy test, nursing mother, intention on pregnancy. 24. considered by investigator as not appropriate to participate in the clinical study with other reason.
simplified diet approach in phenylketonuria

Conditions: Phenylketonuria

Summary: this is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (pku). anybody with a positive diagnosis of pku, between the ages of 13-65 years will be invited to participate in this study. subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (phe) levels will be used for comparison. subjects will also be asked about their attitudes towards their current phe counting system.

this is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (pku). anybody with a positive diagnosis of pku, between the ages of 13-65 years will be invited to participate in this study. subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (phe) levels will be used for comparison. subjects will also be asked about their attitudes towards their current phe counting system. upon enrollment, a 3-day food record and phe levels over the past 12 months will be collected. demographic information will be asked, as well as questions regarding their current phe counting system. patients will be educated on the new counting system, stressing 3 key principles: 1) free use of fruits and vegetables, low in protein, 2) protein counting as a simpler version of phe counting, including reinforcement of label reading, and 3) daily use of pku formula for enhanced nutrient and protein intake. patients will be given written educational tools to reinforce this new method. at the end of the 12 months, subjects will be asked to provide a 3-day food record, and questions will be asked about their attitudes toward the use of the new simplified system. phenylalanine levels from the 12-month study period will be used to compare with historical data.

Eligibility criteria:
inclusion criteria: 1. positive diagnosis of pku 2. males and females \>13 year of age 3. currently on phenylalanine-restricted diet exclusion criteria: 1. any woman planning, or becoming pregnant during study duration 2. any patient who starts kuvan during the study, as kuvan lowers phenylalanine levels in some patients. 3. any patient currently enrolled in other research studies (prism 301/302 protocol; institutional review board protocol # 376-13-fb)
a study to assess the pharmacokinetics of lanthanum carbonate, investigate and compare the efficacy, safety and tolerability of lanthanum carbonate with calcium carbonate in hyperphosphataemic children and adolescents with chronic kidney disease on dialysis

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Summary: the purpose of this study is to summarize the percentage of participants achieving age-specific kidney disease outcomes quality initiative (kdoqi) targets for serum phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (ckd) who are on dialysis, following 8 weeks of treatment with lanthanum carbonate.


Eligibility criteria:
inclusion criteria: 1. aged 10 years to less than (\<) 18 years of age at the time of consent. 2. participant or parent/legally authorized representative (lar) understand and are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol. 3. male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol. 4. established chronic kidney disease (ckd), on dialysis, and requires treatment for hyperphosphatemia with a phosphate binder. 5. serum phosphorus levels after a washout period of up to 3 weeks as follows: age \ ) 6.0 mg/dl (1.94 mmol/l); age 12 years and older: serum phosphorus \>5.5mg/dl (1.78mmol/l). 6. ability to provide written, signed and dated (personally or via an lar) informed consent/and assent, as applicable, to participate in the study. exclusion criteria: 1. current or recurrent disease (example \[eg\], cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than ckd or end-stage renal disease that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments. 2. current or relevant history of physical or psychiatric illness, any medical disorder (except for ckd or end-stage renal disease and related co-morbidities) that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. 3. unable to eat semi-solid foods or on total enteral alimentation. 4. known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients. 5. history of alcohol or other substance abuse within the last year. 6. current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment. 7. weight and age of participant are outside of local applicable criteria for blood sample volume limits. 8. use of another investigational product within 30 days prior to receiving the first dose of investigational product.