Kornimate/medical-research-clean huggingface dataset:
prognosis following esophageal fistula formation in pts undergoing catheter ablation for af study

Conditions: Atrial Fibrillation; Atrio-Oesophageal Fistula; PVI; Catheter Ablation

Summary: pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. atrio-oesophageal fistula (aof) represents a rare but devastating complication of af ablation procedure. this complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. a worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.

data about the incidence, optimal management and outcome of aof is sparse. the largest national and international surveys report on less than 50 aof. the latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed aof after atrial fibrillation ablation procedure. in the meanwhile, the total number of af ablation procedures increased significantly. additionally, af ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation. the study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this aof. more than 50 patients with aof following percutaneous catheter ablation will be included in the register.

Eligibility criteria:
inclusion criteria: * atrio-oesophageal fistula after ablation * indication for af ablation as per current guidelines * performing the ablation at an ablation centre exclusion criteria: * no atrio-oesophageal fistula after ablation
the effect of weight loss on bone in men

Conditions: Weight Loss; BMD

Summary: the purpose of this study is to determine the effect of weight loss on bone health in men.

this pilot study of the effect of weight loss on bone health in men is being undertaken in conjunction with studies of the effect of weight loss on bone health in women for comparison purposes. see nct00473031, nct00472680, and nct00472654. this information is important for determining optimal nutrient requirements during weight loss. participants will be recruited for both weight loss and weight maintenance. all participants will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. weight loss participants will attend regular counseling sessions (about 45 minutes each) with a dietitian for approximately 6 months; they will be asked to attend 6 sessions but will be given the opportunity to attend 13 sessions. body composition will be measured by a dual-energy x-ray absorptiometry (dxa) machine, ultrasound, and peripheral quantitative computer tomography (pqct) before and after 6 months of weight loss. bone, mineral, protein and lipid markers, and hormones that influence bones will also be measured.

Eligibility criteria:
inclusion criteria: * obese or overweight * must live in the geographic vicinity of rutgers university exclusion criteria: * currently on any medication known to influence calcium or bone metabolism, including hrt, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal ekg\], active malignancy or cancer therapy within the past year) * history of kidney stones * weight gain or weight loss (5% of body wt) within 3 months prior to recruitment * participation in other investigational studies during the 12-month study period * usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)

Keywords: bone mass calcium absorption bone quality fracture risk arthritis osteoporosis
evaluation of the efficacy and safety of vx-814 in subjects with the pizz genotype

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: this study will evaluate the efficacy, safety and pharmacokinetics (pk) of vx-814 in pizz subjects.


Eligibility criteria:
key inclusion criteria: * subjects must have a pizz genotype confirmed at screening * plasma aat levels indicating severe deficiency at screening key exclusion criteria: * history of a medical condition that could negatively impact the ability to complete the study * solid organ, or hematological transplantation or is currently on a transplant list * history of use of gene therapy or rnai therapy at any time previously other protocol defined inclusion/exclusion criteria may apply
sildenafil in hemodialysis patients with pulmonary hypertension

Conditions: Pulmonary Hypertension; Hemodialysis Complication

Summary: sildenafil is a phosphodiesterase inhibitor that can exert a nitric oxide-mediated vasodilation effect, so it's considered one of the preferred agents especially in hypoxia induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained levels of cyclic guanosine monophosphate (cgmp) and nitric oxide. despite the potential burden of pulmonary hypertension in hemodialysis patients, such agent like sildenafil has limited studies about optimum dose, safety and long term efficacy in end stage renal disease patients on hemodialysis with pulmonary hypertension

1- to evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension. 1. primary outcome: ● reduction in estimated pulmonary artery pressure value (epap) in mmhg via transthoracic doppler echocardiography. 2. secondary outcomes: * detection of safety of sildenafil in hemodialysis patients. * finding out sildenafil's optimum dose for hemodialysis patients with pulmonary hypertension.

Eligibility criteria:
inclusion criteria: 1. age from 18-80 years old. 2. patients on maintenance hemodialysis for more than six months receiving 3 sessions / week using bicarbonate dialysate with a low flux filter and heparin as anticoagulant. 3. estimated pulmonary artery pressure (epap) ≥35 mmhg via doppler echocardiography 4. urea reduction ratio (urr) will be ≥ 60% for all patients. 5. dry weight will be targeted in each case to achieve edema-free state. 6. informed consent in accordance with the declaration of helsinki. exclusion criteria: * 1. current treatment of pulmonary hypertension (prostacyclin analogues, endothelin receptor antagonists or phosphodiesterase inhibitors). 2-heart diseases (congestive heart failure, ischemic heart disease, congenital heart disease). 3- lung diseases (chronic obstructive pulmonary disease, pulmonary thromboemboli or tumor, interstitial lung diseases, sleep apnea, pulmonary fibrosis, sarcoidosis). 4-systemic diseases (scleroderma, systemic lupus erythematosus, portal hypertension). 5-human immunodeficiency virus (hiv) infection. 6-history of hypersensitivity to sildenafil. 7-treatment with any drugs that may interact with sildenafil (erythromycin , azoles, saquinavir-cyp3a4 inhibitors- , bosentan - cyp3a4 inducer-nitrates ) 8- uncontrolled hypertension 9- anemia with hemoglobin level \<10 g/dl
normal breathing and swallowing in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. this will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

the prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. there are few therapeutic options and minimal management strategies offered to treat these individuals and improve sequelae of dysphagia. dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and increased mortality in neurodegenerative disease such as als. one reason for this is the lack of normative data across various measures of swallowing and respiratory function. as a result, detecting early impairments in swallowing physiology is difficult, given the variability of swallowing and unknown normative value range of swallowing physiology. therefore, the goal of this study is to complete clinical tests of swallowing and cough function in healthy volunteers to establish normative data. this will contribute to future study in disordered populations, to determine degree and severity of impairment and efficacious treatment and management strategies based on impairment. the purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. this will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

Eligibility criteria:
inclusion criteria: * up to 120 individuals will be included in this study. * subjects will include both male and females who are aged between 18-100 * healthy and with no major medical conditions. * no specific gender or race will be excluded or targeted for participation in this study. exclusion criteria: * adults who are pregnant * those with major medical conditions (i.e., swallowing impairment, brain injury) will be excluded from this study. * anyone with allergy to barium will be excluded from this study.

Keywords: healthy volunteer
tracking physical activity throughout chemotherapy for breast cancer

Conditions: Breast Cancer; Physical Activity

Summary: physical activity during chemotherapy has been shown to increase patient health and wellbeing as well as improve outcomes in breast cancer patients. the primary aim of this project is to determine the feasibility of incorporating wearable sensors into clinical care by having breast cancer patients, undergoing chemotherapy, wear a commercially available monitor (fitbit) that tracks physical activity, sleep, and heart rate monitor.

although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. existing research has primarily relied on self-reported activity levels and only captured periodic snap shots or retrospective reports of activity levels, which are subject to recall bias. exactly how activity levels change throughout chemotherapy is not known. this study will provide minute-by-minute level objective physical activity data across the entirety of the patient's chemotherapy treatments. this in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent declines in physical activity. the investigators will assess the feasibility of the pre-treatment recruitment by documenting recruitment rates and participant acceptance of wearing the accelerometer.

Eligibility criteria:
inclusion criteria: * female * diagnosed with breast cancer * scheduled to receive chemotherapy, but has not yet started chemotherapy * receiving chemotherapy at a university of california, san diego clinic * willingness to wear the fitbit throughout the course of chemotherapy * access to a computer or bluetooth enabled phone to sync fitbit data * able to read and communicate in english exclusion criteria: • serious physical limitation that greatly limits mobility
ghrelin levels in pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: the primary outcome measure for this study is plasma ghrelin level.

the primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are: * patients with cachexia versus patients without cachexia * patients with cachexia versus healthy controls

Eligibility criteria:
inclusion criteria: * histological or cytological proof of pancreatic adenocarcinoma * the control are will include healthy age-matched patients without cancer * the test arm will include patients with pancreatic cancer and they will divided into two groups: those with and without weight loss * patients must have recovered from any major infections and/or surgical procedures exclusion criteria: * patients with other serious medical illness like congestive heart failure, thyroid disease,liver disease or renal failure - conditions that will alter their nutritional state * patients on appetite stimulant and those receiving total parenteral nutrition * patients who have undergone gastrectomy or those who have gastric ulcers * patients receiving active chemotherapy * no prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or for which patient has been disease free for at least five years.

Keywords: ghrelin
d-dimer levels during and after anticoagulation in patients with a previous venous thromboembolism: effects on the risk of recurrence

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the results of the prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered d-dimer levels, measured one month after anticoagulation with vitamin k antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing significantly this rate. those patients with normal d-dimer (about 60% of all patients examined) have a low rate of recurrences (about 5%) and likely a prolongation of anticoagulation in all these patients cannot be recommended. in line with these results, the prolong-two study aims at assessing the predictive role for recurrence of d-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up. patients with a first unprovoked venous thromboembolism (including proximal deep vein thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin k antagonists for not less than 6 months are considered for the study. d-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months. those with normal d-dimer stop the anticoagulant treatment and are again examined one month later. anticoagulation is resumed for 6 more months in those patients with abnormal d-dimer results but is permanently stopped in those with a normal assay. the latter patients are examined and d-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results.


Eligibility criteria:
inclusion criteria * age \> 18 years * after a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism * after at least 6 months of oral anticoagulation * after written informed consent exclusion criteria: * age \> 82 y * recurrent venous thromboembolism * if the venous thromboembolism occurred: * during pregnancy or puerperium * after recent (i.e. within three months) fracture or plaster casting of a leg, * after immobilization with confinement to bed for three consecutive days after surgery with general anesthesia lasting longer than 30 minutes * patients with: * active cancer * antiphospholipid antibody syndrome * antithrombin deficiency * serious liver disease or renal insufficiency (creatininemia \> 2 mg/dl), * other indications for anticoagulation or contraindications for this treatment * limited life expectation * patients who live too far from the clinical center

Keywords: deep vein thrombosis pulmonary embolism d-dimer recurrence duration of anticoagulation vitamin k antagonists
hutt to assess cardiac autonomic nervous function

Conditions: Autonomic Nervous System Diseases

Summary: autonomic nervous system diseases can cause abnormalities in the circulatory system, leading to malignant arrhythmia and sudden cardiac death. standardized, operable, and simplified diagnostic indicators are urgently needed to evaluate autonomic nervous function, particularly cardiac autonomic nervous function. the investigators use hutt in order to provide data support for cardiac autonomic nervous system evaluation.

in this study, 169 samples with vertical tilt test and 24-h holter ecg data from february 13, 2023 to october 31, 2023 were selected. the ac, dc, and 24-h hrv were compared with the cass to identify the indicators with the strongest correlation with the cass sympathetic and vagus nerve scores. the best index was selected, and the score intervals were delimited. the sensitivity and specificity of the defined vagal and sympathetic intervals were analyzed.

Eligibility criteria:
inclusion criteria: * vertical tilt test and 24-hour holter electrocardiogram were performed at the same time * receive treatment in our hospital. exclusion criteria: * taking benzodiazepines or hypotensive drugs within 24 hours * combined with mental illness, severe dementia, serious organ disease * severe arrhythmia, deep breathing and poor coordination of valsaval movements affected the interpretation of results.
a study of the efficacy and safety of mk-0653h in japanese participants with hypercholesterolemia (mk-0653h-832)

Conditions: Hypercholesterolemia

Summary: this study will evaluate the efficacy and safety and tolerability of 2 dose levels of mk-0653h in japanese participants. the primary hypotheses are that the administration of mk-0653h is safe and tolerable and that mk-0653h is superior to single entity of ezetimibe and rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (ldl-c) after 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * japanese * outpatient with hypercholesterolemia * female participant who is of reproductive potential has to agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug * will maintain a stable diet that is consistent with the japan atherosclerosis society guideline 2012 (jas 2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study exclusion criteria: * uncontrolled hypertension (treated or untreated) * uncontrolled type 1 or type 2 diabetes mellitus * history of coronary artery disease (cad), cad-equivalent disease * familial hypercholesterolemia or has undergone ldl apheresis * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * has had a gastrointestinal tract bypass, or other significant intestinal malabsorption * history of cancer within the past 5 years (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer) * human immunodeficiency virus (hiv) positive * history of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy * consumes more than 25 g of alcohol per day * currently following an excessive weight reduction diet * currently engages in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study * hypersensitivity or intolerance to ezetimibe or rosuvastatin * myopathy or rhabdomyolysis with ezetimibe or any statin * pregnant or lactating * taking any other investigational drugs and/or has taken any investigational drugs within 30 days
myhealthevet to enable shared decision making regarding menopausal in postmenopausal women veterans (means)

Conditions: Menopause

Summary: the purpose of this research study is to examine the impact of educational secure messages on menopause. in particular, the investigators will examine whether the secure messages increase menopause knowledge and communication between patients and their providers.

the overall goal of this project is to determine the effectiveness of the means (myhealthevet to enable and negotiate for shared decision making) intervention in improving women's self-reported knowledge and rates of diagnosis and appropriate management of menopause symptoms. the proposed intervention is an educational and shared decision making platform for menopause symptoms to improve communication between patients and their providers regarding menopause symptoms. means combines educational secure messages through the veterans affairs online personal health record called myhealthevet, along with face-to-face and print interventions. means will be applied in target population consisting of postmenopausal women veterans ages 45 to 60 who receive primary care at the miami veterans affairs healthcare system. this project will enroll women in myhealthevet, develop a library of menopause symptoms material for distribution, and evaluate how useful of myhealthevet use for educating and tracking women regarding menopause symptoms.

Eligibility criteria:
inclusion criteria: * women veterans, age 45-60 * receive primary care at the miami veterans affairs healthcare system * able to communicate in english * already or willing to register and become authenticated in the patient health portal, myhealthevet. * able to use read, understand, and respond to secure messages using patient health portal. exclusion criteria: * not willing to register and become authenticated for patient health portal. * not willing to receive educational secure messages from patient health portal.

Keywords: shared decision making knowledge patient portal secure messaging
fatigue and qol among gastric cancer patients undergoing abdominal surgery

Conditions: Gastric Cancer; Surgical Wound Infection; Fatigue; Quality of Life

Summary: background: cancer-related fatigue (crf), one of the indicators of qol, is one of the most common side effects of cancer and its treatment. however, the pathophysiological mechanisms involved in crf among cancer patients are not completely understood. therefore, more in-depth researches on crf of surgical patients suffering from gastric cancer are needed in taiwan. purpose: the purpose of this study is to examine the incidence rate and correlated factors (qol and immune biomarkers) of crf among gastric cancer patients undergoing major abdominal surgery. method: a longitudinal study was conducted to recruit gastric cancer patients who scheduled to operate at surgical clinics from a northern medical center in taiwan. the data will be collected with a structured questionnaire and immune markers assessments via purposive sampling of 120 subjects. before operation, on day 1 after operation, and on day 7 after operation, the biomarkers will be measured. the bfi-t questionnaire will be filled out before surgery and on day 1, 2, 7, 28 after surgery; the eortc qlq-c30 and eortc qlq-sto22 questionnaire will be filled out before surgery and on day 7, 28 after surgery; type d scale-14(taiwanese version) questionnaire will be filled out before surgery and on day 28 after surgery. data will be analyzed by using descriptive statistics, paired t-test, chi square test, pearson's correlation, and the generalized estimating equation (gee) was used to identify significant factors with qol after operation. anticipated achievement: the anticipated achievement of this study is to provide healthcare providers with more knowledge about crf, and help them to enhance the quality of life on gastric cancer patients in the future.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of gastric cancer and schedule for major abdominal surgery 2. eastern cooperative oncology group (ecog) performance status ≤2 exclusion criteria: 1. severe multiple organ impairment, comorbidities or immune disorder before surgery 2. undergoing chemotherapy or radiotherapy

Keywords: gastric cancer surgery fatigue quality of life