Kornimate/medical-research-clean huggingface dataset:
safety and performance of a global mapping and ablation device for the treatment of atrial fibrillation (global-af)

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to provide clinical data pertaining to the safety and performance of the globe® mapping and ablation system for treating patients with atrial fibrillation.

upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (rf) ablation. cardiac ct imaging, echocardiography and baseline 12-lead ecg will be performed pre-procedure for screening and health assessment. during the procedure the globe catheter will be delivered via standard femoral vein access and transseptal puncture. anatomical and electrophysiological mapping of the left atrium (la) will be followed by rf ablation to achieve pulmonary vein isolation (pvi). additional lesions will be created as deemed appropriate by the investigator. intracardiac electrogram mapping will be used to confirm pvi during the procedure. echocardiography will be performed at discharge to assess cardiac function. electrocardiograms by 12-lead ecg and 7-day holter monitoring will be recorded at discharge, and 3, 6 and 12 months after treatment. follow-up assessments will be performed at discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from documented af and adverse events. subject-reported af symptomology and quality of life will also be assessed during follow-up.

Eligibility criteria:
inclusion criteria: * patients indicated for ablation, with a documented history of symptomatic paroxysmal atrial fibrillation * between 18 and 80 years of age, inclusive exclusion criteria: * patients who have contraindications to open heart surgery * patients from an intensive care unit * patients requiring concurrent right atrial ablation or who have had previous left atrial ablation * previous cardiac procedure or known abnormalities that would interfere with device delivery, position, or treatment efficacy * history of a documented thromboembolic event or bleeding abnormalities * contraindication to anticoagulation therapy * mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study * anatomy that would prevent safe and appropriate introduction or delivery of the globe device into the patient

Keywords: atrial fibrillation global radiofrequency rf ablation left atrium anatomical and electrophysiological mapping
radiofrequency identification technology in locating non-palpable breast lesions in patients undergoing surgery

Conditions: Breast Neoplasm; Lesion

Summary: this pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

primary objectives: i. evaluate the feasibility of utilizing a new federal drug administration (fda)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study. outline: patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. after completion of study, patients are followed up within 2 weeks.

Eligibility criteria:
inclusion criteria: * able to give written informed consent to participate in the study * able to read and write english * patients with breast lesions that are non-palpable that require surgical removal * lesions and/or clip targetable with image guidance exclusion criteria: * multicentric breast cancer * stage iv breast cancer * pregnant or lactating females
dash cloud: using digital health to improve adherence to the dash diet among women

Conditions: Diet Modification; Hypertension; Women's Health; Cardiovascular Diseases; Digital Health

Summary: this study will test whether a digital health intervention (dash cloud) using smartphones can improve diet quality among women at risk for cardiovascular disease. the dash (dietary approaches to stop hypertension) diet has been proven to lower blood pressure, yet dissemination efforts remain poor. this study aims to use technology to improve adherence to dash.

specifically, this study aims to 1. to test the feasibility of the dash cloud intervention compared to education control among women with prehypertension and hypertension via a 3-month randomized controlled trial. 2. to evaluate the preliminary efficacy of the dash cloud intervention relative to education control on blood pressure, weight and medication adherence at 3 months. this study will enroll 50 adult women aged 21-70 with pre-hypertension or hypertension in a 3-month randomized controlled trial to test the initial feasibility of dash cloud. women will be randomized to either the dash cloud intervention or dash light and followed up 3 months post randomization. the investigators will recruit participants from the durham, nc area. women randomized to the dash cloud intervention will be asked to track their diet daily using a smartphone diet tracking app. based on the foods/beverages entered, the intervention will send daily or weekly text messages with feedback about dash adherence and information videos about how to follow dash. women randomized to dash light will also be asked to track their diet using the smartphone diet tracking app and will receive basic informational materials about dash.

Eligibility criteria:
inclusion criteria: * ages 21-70 years; bmi \>18.5 kg/m2 * on antihypertensive medication or systolic blood pressure 120-159 mmhg and/or diastolic blood pressure of 80-99 * current use of a smartphone and willingness to be texted daily or weekly * an email account; spoken and written english fluency. exclusion criteria: * cvd event in prior 6 months * active malignancy; active psychosis or recent psychiatric institutionalization * current pregnancy or lactation * current participation in a similar trial.
a study of oral ergocalciferol to treat pruritis in hemodialysis patients

Conditions: Pruritis

Summary: pruritis (itching) is common in many people with chronic renal failure on hemodialysis. there may be many different reasons for the pruritis. efforts to treat the problem have not been very effective. vitamin d levels have been found to be low in many hemodialysis patients. since vitamin d plays an important role in the skin and is effective in treatment of certain skin conditions that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients. the objective of the investigators study is to determine the effect of supplementation with oral vitamin d2 (ergocalciferol) on pruritis in hemodialysis patients.

vitamin d2 is a fat soluble steroid hormone precursor which must be hydroxylated in the liver and kidney respectively to make the active form 1-25-vitamin d. this active metabolite and related analogs have been synthesized and are frequently used in the treatment of hyperparathyroidism in patients with chronic kidney disease. however the active metabolite may not be back metabolized to the precursor forms which may have functions in other organs including the skin. supplementation of hemodialysis patients with oral vitamin d forms would provide a source of precursors for use throughout the body.

Eligibility criteria:
inclusion criteria: 1. hemodialysis treatment for \> 3 months 2. subjective complaint of excessive itching exclusion criteria: 1. age \< 18 years 2. failure to provide informed consent 3. intact pth \ 1,000 pg/ml 4. serum phosphorus \> 7.0 5. serum calcium (adjusted for albumin)\> 11 6. active malignancy 7. likelihood of imminent renal transplantation 8. current ergocalciferol treatment

Keywords: pruritis in hemodialysis patients 25-vitamin d in chronic kidney disease
t-cell pet imaging with [18f]f-arag in lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (nct03217071; pembrolizumab with and without radiotherapy for non-small cell lung cancer). each patient will undergo a single \[18f\]f-arag pet exam as part of this study. \[18f\]f-arag will be administered at a single time point intravenously prior to pet imaging. whole-body pet will be acquired along with a whole body low dose ct (pet/ct) used for attenuation correction and anatomic localization of \[18f\]f-arag uptake, suv calculation, and volumetric selection for radiomic analyses.

this is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (nct03217071; pembrolizumab with and without radiotherapy for non-small cell lung cancer). each patient will undergo a single \[18f\]f-arag pet exam as part of this study. \[18f\]f-arag will be administered at a single time point intravenously prior to pet imaging. whole-body pet will be acquired along with a whole body low dose ct (pet/ct) used for attenuation correction and anatomic localization of \[18f\]f-arag uptake, suv calculation, and volumetric selection for radiomic analyses. a total of 20 patients will be enrolled over an accrual period of approximately 12 months. approximately 10 patients will be enrolled in the immunotherapy alone cohort and approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation therapy cohort. patients will be evaluated one day and one week via telephone after each radiopharmaceutical injection for safety follow-up. all adverse events will be recorded. due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years 2. histologically or cytologically documented stage i-iiia non-small cell lung cancer (nsclc) 3. eligible for with plan to undergo immunotherapy alone or both immunotherapy and stereotactic radiation therapy as part of nct03217071 4. in female patients, negative pregnancy test with no plans to become pregnant during the duration of the study 5. able to provide informed consent and follow the study guidelines exclusion criteria: 1. female patients who are pregnant or breastfeeding
granulocytapheresis in psoriasis

Conditions: Psoriasis

Summary: in a prospective, randomized, controlled, double-blinded, multicenter study, granulocytapheresis using a novel cellulose-based adsorber will be compared to control sham treatment (placebo). the effects on clinical symptoms and on some inflammatory parameters of patients with moderate to severe plaque psoriasis will be evaluated over a 24-week period. the primary end-point is a ≥75 percent improvement in pasi (psoriasis area and severity index). the study purpose is to demonstrate a beneficial therapeutic effect of granulocytapheresis using the novel cellulose-based adsorber device in moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * moderate to severe plaque psoriasis with a pasi \>/=10 * age \>/= 18 years * negative pregnancy test in woman of childbearing age acceptable method of contraception for both men and women * written informed consent that can be withdrawn at any time or for any reason * discontinuation of any systemic psoriasis treatment. washout period of at least two weeks for prior systemic medications * only emollients for topical treatment * no vaccinations for at least 14 days prior to first treatment exclusion criteria: * other forms of psoriasis (e.g., guttate, pustular, erythrodermic, palmoplantar etc.) * history of ongoing uncontrolled bacterial, fungal or viral infection (including opportunistic infections); hiv positivity * pregnancy * clinically relevant thrombocytopenia or bleeding disorders * wbc \ 12.000/µl * malignancy within the last five years (exception: successfully treated basal cell carcinoma or squamous cell carcinoma of the skin) * severe cardiac disorders, stroke, pulmonary disease within the last year * any medical condition that, in the judgment of the investigators, would jeopardize the patient's safety during the study

Keywords: granulocytapheresis, psoriasis, pasi, apheresis
medical nutrition therapy intervention program for women with gestational diabetes--a prospective study

Conditions: Diabetes, Gestational

Summary: gestational diabetes mellitus (gdm) is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world. the overall purpose of this study is to determine the efficacy of individualized medical nutrition therapy (mnt) intervention to reduce and control the development of gdm.

the number of women with gestational diabetes mellitus had been increasing. maternal gdm has a great impact on both the health of the mothers and the offspring. antenatal lifestyle interventions, in particular dietary intervention appear to be feasible to improve maternal gdm and weight gain. to the best of our knowledge, there has been no such trial examining the feasibility of mnt intervention in pregnant women in hu'nan province. the aim of this study is to evaluate the efficacy of individualized mnt intervention to reduce and control the development of gdm. this is a prospective study, 500 patients who meet inclusion and exclusion criteria will be included. the changes of glucose and weight will be evaluated every two weeks.

Eligibility criteria:
inclusion criteria: * women with gestational diabetes exclusion criteria: * none

Keywords: diabetes, gestational nutrition therapy
gastrografin in postoperative ileus

Conditions: Prolonged Postoperative Ileus

Summary: after abdominal surgery there is a period of unavoidable dysfunction of the gut. during this time patients are often unable to eat and drink, and do not pass any flatus or stool. though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. it has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital. the aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. it is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * current inpatient following elective laparoscopic or open surgery. * classified as having prolonged postoperative ileus. * able to understand risks/benefits of the study. * able to give informed consent. exclusion criteria: * pregnancy. * asa of 4 or greater. * previous allergic reaction to gastrografin or iodinated contrast agents. * manifest hyperthyroidism.
a real-world study on the treatment of non-small cell lung cancer with leptomeningeal metastasis in china

Conditions: Meningeal Metastasis; Non-Small Cell Lung Cancer

Summary: this is a retrospective and prospective study planned to include nsclc patients with leptomeningeal metastasis (lm) and treated with antitumor therapy after 2018, from multiple centers such as the first affiliated hospital of guangzhou medical university, guangdong sanjiu brain hospital, etc., aiming to establish a database related to the treatment strategies of lm patients, and to evaluate the efficacy (eg. overall survival/time to failure) and safety of different treatment strategies of lm patients, etc., as well as the significance of concomitant testing in lm patients.

retrospective and prospective study

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer patients with leptomeningeal metastases diagnosed after january 2018; * patients who underwent antitumor therapy after diagnosis of lm. exclusion criteria: * patients with small cell lung cancer components; * complicated with tumors other than non-small cell lung cancer.

Keywords: non-small cell lung cancer meningeal metastasis real-world study database
berodual® respimat® solution for inhalation in patients with chronic obstructive airways disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: tolerability, efficacy and handling of berodual® respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice


Eligibility criteria:
inclusion criteria: * men and women presenting with symptoms of chronic obstructive pulmonary disease * both previously untreated patients and patients treated previously with berodual® or with other anti-obstructive respiratory tract agents may be included exclusion criteria: * patients presenting with the general and specific contraindications listed in the patient information leaflet and the basic product information
atorvastatin, l-carnitine and non-alcoholic steatohepatitis

Conditions: Non-alcoholic Steatohepatitis

Summary: the aim of the present study was to compare the effects of simvastatin and l-carnitine coadministration versus simvastatin, l-carnitine monotherapy on liver transaminases and liver elasticity in nash patients.

nonalcoholic fatty liver disease (nafld) represents a spectrum of disease ranging from steatosis to steatohepatitis (nonalcoholic steatohepatitis, nash) to cirrhosis. statins are competitive inhibitors of hydroxymethylglutaryl-coa reductase, the rate-limiting step in cholesterol biosynthesis. they occupy a portion of the binding site of hydroxymethylglutaryl-coa, blocking access of this substrate to the active site on the enzyme. a reduction in intrahepatic cholesterol leads to an increase in ldl receptor turnover that results from an enhanced rate of hepatic ldl receptor cycling. on the other hand recent studies have implicated several important cellular processes and signaling pathways that are affected by abnormal lipid metabolism, resulting in specific biochemical, histological, and clinical changes associated with nafld. maybe statins, as lipid lowering agents, and through their effect in reduction of intrahepatic cholesterol, can affect the abnormal lipid metabolism in nash. l- carnitine, can improve the outcome of nash, because it reduces lipid levels, limits oxidative stress, and modulates inflammatory responses . it performs a number of essential intracellular and metabolic functions, such as fatty acid transport, detoxification of potentially toxic metabolites, regulation of the mitochondrial acyl-coa / coa ratio, and stabilization of cell membranes. it has a pivotal role in the transport of long chain fatty acids across the inner mitochondrial membrane.

Eligibility criteria:
inclusion criteria: * nash diagnosed on the basis of the following criteria: 1. imaging techniques showing evidence of hepatic steatosis 2. increased alanine transaminase above 1.5 times normal (normal: 20 iu/l for women, 30 for men) on two occasions three months apart. exclusion criteria: * patients with hepatitis b or c * alanine transaminase \> 300 iu/l * participants presenting one or more causes commonly associated with secondary nafld (drugs, surgical procedures, environmental toxins, or total parenteral nutrition) * alcohol ingestion greater than 40 gr per week * abnormal lipid profile (tg\>500 , ldl\>160) * patients with hypertension, diabetes mellitus, coronary heart disease * fibroscan score more than 14 kp * pregnancy, lactation * drug addiction * reynolds risk score \> 10% * not consenting to the study

Keywords: non-alcoholic steatohepatitis, atorvastatin, l-carnitine
effect of meal frequency on glycemic control of people at high risk or diagnosed with diabetes

Conditions: Impaired Glucose Tolerance; Hyperinsulinism; Poor Glycemic Control; Hyperglycemia; Insulin Sensitivity

Summary: this study investigated any potential associations between two isocaloric diets with different meal frequency (3 meals versus 6 meals) and glycemic control in people at high diabetes risk (lean and overweight/obese women with pcos, individuals with hyperinsulinemia, individuals with impaired glucose tolerance) and diagnosed with diabetes.

the effect of meal frequency on diabetes risk markers (e.g. glucose and insulin metabolism) has been studied in several studies so far, both in healthy individuals and in individuals being at risk for diabetes mellitus, with or without concurrent weight loss. in addition, few studies have investigated the effect of different meal frequency on glycemic control in patients with diabetes mellitus under conditions of weight maintenance. however, the results regarding the ideal number of meals remain controversial. to our best knowledge, there is no study available that has investigated the effect of meal frequency on glucose and insulin metabolism in lean and obese women with pcos, in lean and obese individuals with hyperinsulinemia and impaired glucose tolerance, and in obese individuals with type 2 diabetes, independently of weight loss.

Eligibility criteria:
inclusion criteria: * the presence of type 2 diabetes was defined according to the current diagnostic criteria: (a) hba1c ≥ 6.5%, (b) fasting plasma glucose ≥126 mg/dl (7.0 mmol/l). (c) 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (ogtt), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, or (d) a random plasma glucose ≥ 200 mg/dl (11.1 mmol/l) in patients with classic symptoms of hyperglycemia or hyperglycemic crisis. * pcos was defined according to the rotterdam criteria (rotterdam 2004) which include the presence of two or more of the following features: chronic oligoovulation or anovulation (fewer than six menstrual periods in the previous year), androgen excess (serum total testosterone \>70 mg/dl) and polycystic ovaries. exclusion criteria: * insulin sensitizers, i.e. metformin, contraceptives, steroids or any medications known to affect glucose, insulin or reproductive hormones for at least the last 6 months. * serious health problems like cardiovascular, liver or kidney diseases. * volunteers who were on diet, using medications affecting body mass or who had experienced a change in body weight ≥ 4.5 kg or a change in physical activity within the 6 months preceding the study onset were excluded.

Keywords: polycystic ovary syndrome type 2 diabetes hyperinsulinemia meal frequency