Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of outcome after catheter ablation in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation ablation is the most common intervention performed worldwide. up to 20 to 45% of patients show recurrence of af within 12 month after catheter ablation, however its determinant are incompletely understood. the aim of the prospect-af study is to assess the predictors of af recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation. the secondary aims are to assess the incidence of major adverse cardiovascular outcomes (mace) and the incidence of major bleeding within the 3 years wolfing catheter ablation.


Eligibility criteria:
inclusion criteria: * patient undergoing atrial fibrillation catheter ablation * able to give their consent exclusion criteria: * childs * patient under guardianship * patients unable to give their consent * pregnancy

Keywords: atrial fibrillation catheter ablation arrhythmia biomarkers
effects of on-line hemodiafiltration(hdf) on vascular health in chronic hemodialysis patients

Conditions: End Stage Renal Disease; Hemodialysis

Summary: the purpose of this study is to determine whether on-line hemodiafiltration ameliorate the endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease patients on maintenance hemodialysis.

1. on-line hemodiafiltration(ol-hdf) is a technique that combines diffusion with convection in which the large substitution fluid is produced directly from the dialysate. it offers many advantages aside from its safe inflammatory profile, which is attributable to the use of ultrapure dialysate and highly biocompatible dialysis membranes. due to an improved convective clearance, significantly increased removal of large or protein-bound uremic retention solutes can be achieved, with a potential benefit on cardiovascular morbidity and mortality. 2. endothelial dysfunction, almost universal in end stage renal disease, is important risk factor for cardiovascular events, and can be evaluated by brachial artery endothelium-dependent vasodilation (flow-mediated dilation) to reactive hyperemia following 5 min of forearm ischemia. 3. the stable hd patients will receive 8-week treatment on ol-hdf or conventional low flux hd and then crossed over to opposite treatment arm. the fmd will be measured by one sonographer, and at the same time whole blood and serum will be sampled and stored for further analysis. the timepoint for measurement is 4-week interval after baseline evaluation.

Eligibility criteria:
inclusion criteria: * end stage renal disease on maintenance hemodialysis for more than 3 months exclusion criteria: * diagnosis of active cardiovascular diseases in 6 months * elevation of liver enzymes over two fold of upper normal limit in 3 months * admission for acute infection in 3 months * untreatable stenosis of vascular access

Keywords: vascular endothelium-dependent relaxation hemodialysis hemodiafiltration
vascular events in patients undergoing same-day noncardiac surgery (valiance) study

Conditions: Preoperative Care; Surgery--Complications; Myocardial Infarction

Summary: the proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. the main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

the valiance study is a 15,000 patient, multicentre, prospective observational cohort of adults undergoing elective same-day noncardiac surgery and who will be followed for 90 days after surgery. the primary objective of the study is to determine the incidence of major cardiovascular complications after same-day surgery. patients will also be followed for the occurence of other adverse postoperative complications and determine their change in quality of life at 90 days after surgery. valiance will inform on the risk factors for postoperative complications and allow to develop risk prediction tools to guide patient selection and risk stratification of patients undergoing same-day surgery. the study will also look at validating the use of the duke activity status index questionnaire, clinical frailty scale, and the revised cardiac risk index. postoperative pain will be evaluated using the brief pain inventory score and quality of life using the eq-5d-5l questionnaire.

Eligibility criteria:
inclusion criteria: * 45-64 years of age with at least one risk factor, or ≥65 years of age; * undergoing elective noncardiac same-day surgery; * planned duration in the operating room 60 minutes or more; * provided written consent. exclusion criteria: * intervention does not require the presence of an anesthesiologist; * procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology); * intervention is an ophthalmologic procedure; * previously enrolled in the valiance study.

Keywords: preoperative care surgery postoperative complications same-day surgery ambulatory surgery outpatient surgery
a study on the correlation between endometriosis and intra-tissue microbiota

Conditions: Endometriosis

Summary: endometriosis (em) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. the investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments.

endometriosis (em) is a common gynecological condition that occurs in women of reproductive age and is characterized by pain, masses, and infertility. em is a tumor-like disease that is invasive, metastatic, recurrent, but the pathogenesis of em has not yet been clarified. advances in the study of intratumoral microbiota provided increasing evidence confirming the presence and mechanism of bacteria in tumor tissues. therefore, the investigators wanted to investigate the correlation between endometriosis and its microbiota in the endometrial tissue. participants in this study will be recruited in the obstetrics and obstetrics and gynecology medical center of zhujiang hospital. with reference to the inclusion and exclusion criteria, patients admitted for surgery were under screening. participants were assigned to endometriosis group after confirmation by laparoscopy together with biopsy analysis, while the control group was identified as non-em patients, usually with benign gynecologic conditions such as uterine fibroids or teratomas. the investigators will obtain serum, vaginal swabs, cervical mucus, and feces from the participant before surgery. the peritoneal fluid, eutopic endometrium, and ectopic endometrium lesion will also be collected if the surgical approach allows. the specimens will be sent for microbiota sequencing, transcriptome sequencing, metabolome sequencing, single cell sequencing, and laboratory experiments.

Eligibility criteria:
inclusion criteria: 1. women aged 18-52 years old. 2. regular menstruation with a cycle of 28-35 days. 3. no sexual intercourse 1 week before the operation. 4. no systemic or local use of antibiotics and probiotics for 6 months prior to surgery. 5. no history of acute or chronic pelvic inflammatory disease. 6. subjects fully understand the significance of the study and sign the informed consent form. exclusion criteria: 1. in pregnancy. 2. intraoperative conditions or pathological examination suggest a malignant or junctional disease. 3. severe anatomical abnormalities of the pelvis. 4. pelvic contamination with large amounts of blood during laparoscopic operation. 5. history of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation 6. psychiatric, personality disorders, or abuse of psychoactive substances. 7. immunodeficiencies, allergies, or autoimmune diseases. 8. contraindications to endotracheal intubation anesthesia. 9. absolute or relative contraindications to laparoscopic or hysteroscopic surgery.

Keywords: microbiota microbiome endometriosis
the ocular microbiome in patients with dry eye disease

Conditions: Dry Eye Disease

Summary: the primary objective of this study is the characterization of the ocular microbiome in a healthy cohort and in patients with dry eye disease using whole-metagenome shotgun sequencing. secondary objectives are the identification of differences between the ocular microbiome of healthy controls and patients with dry eye disease as well as between the ocular and the gut microbiome.

dry eye disease is considered to be the most common ocular surface disease worldwide. recent studies revealed that the ocular microbiome plays an important role in maintaining ocular surface homeostasis and health. commensals colonizing the ocular surface seem to support the local innate immune system. as the ocular microbiome coordinates several functions together with ocular mucosal and immune epithelial cells, alteration of the microbiome can lead to changes in the integrity of the ocular surface. this can lead to the development of ocular surface related diseases such as dry eye. inflammation seems to be a key component of dry eye disease in terms of being a propagator as well as a consequence. in contrast to earlier approaches of identifying the microbiome by cultivating with only limited results, it is now possible to provide more details regarding all microbiota residing on the ocular surface due to modern sequencing techniques. thus, the overall aim of this study is the identification of the role of the ocular microbiome in dry eye disease.

Eligibility criteria:
inclusion criteria: * patients willing to sign informed consent * patients 60 years of age or older exclusion criteria: * patients not willing or able to sign informed consent * patients younger than 60 years * smoking * wearing contact lenses * recent (3 month) history of use of systemic and/or topical antibiotics * usage of medical eye drops (lacrycon and other moisturizing eye drops are allowed) * recent (3 month) history of ocular surgery

Keywords: ocular metagenome
prevalence of refractive errors in primary school children

Conditions: Refractive Errors

Summary: the study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in the new valley , egypt .

the refractive state of the eye changes as the eye's axial length increases and the cornea and lens flattens. in general, eyes are hyperopic at birth, and become slightly more hyperopic until the age of 7, at this point we see a myopic shift toward plano until the eyes reach their adult dimensions, usually by about the age of 16.

Eligibility criteria:
inclusion criteria: age: 6 -12-year-old myopia :- 0.5 d to -10d hypermetropia: 1 d to 8 d astigmatism: 0 to 6 d distance correction: 0.1 logs mar (20/25 ) or better exclusion criteria: retinopathy, prematurity, history of genetic disease, connective tissue diseases (e.g. stickler or marfan syndromes, any ocular diseases, glaucoma, cataract, squint.
study of vay736 as single agent and in combination with select antineoplastic agents in patients with non-hodgkin lymphoma

Conditions: Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics (pk), immunogenicity and preliminary efficacy of vay736 alone or in combination with other therapies in patients with nhl in a platform trial.

the primary objective of the study is to evaluate the safety and tolerability in patients with nhl and identify a maximum tolerated dose (mtd) and/or recommended dose (rd) of vay736 single agent and in combination with other anti-cancer therapies. this is a phase i/ib, multi-center, open-label study with multiple treatment arms in an adaptive study design. the study is comprised of a dose escalation part and dose expansion part. in dose escalation, the investigational drug vay736 was explored alone or in combination with lenalidomide. increasing doses of vay736 alone or in combination were given to small groups of patients to identify the maximum tolerated dose/recommended dose (mtd/rd) in patients with nhl. in dose expansion, some or all the treatments from dose escalation could be tested at the recommended doses in patients with nhl. the study was expected to last approximately 4 years (from the enrollment of the first patient to the discontinuation of the last patient), but it was terminated early due to a business decision, not because of any safety or tolerability concerns. consequently, the dose expansion part was not conducted.

Eligibility criteria:
inclusion criteria: * adult patients with confirmed diagnosis of relapsed/refractory b-cell nhl with all subtypes of dlbcl, follicular lymphoma (fl), marginal zone lymphoma (mzl) and mantle cell lymphoma (mcl) per who 2016 criteria. patients in subtype arm e.g. dlbcl must have confirmed diagnosis of relapsed/refractory dlbcl. * received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-cd20 therapy for nhl) * must have measurable disease and ecog of 0 to 2 exclusion criteria: * baseline laboratory results outside of protocol defined ranges * patients with primary cns lymphoma * history of hypersensitivity to vay736 or any drugs in similar chemical classes (e.g. monoclonal antibodies) * impaired cardiac function or clinically significant cardiac disease * history of or current interstitial lung disease or pneumonitis grade 2 or higher * hiv infection * active hepatitis c infection and/or hepatitis b infection * pregnant or nursing (lactating) women * women of child-bearing potential unless they are using highly effective methods of contraception other inclusion/exclusion criteria may apply

Keywords: vay736 ianalumab lenalidomide non-hodgkin lymphoma nhl diffuse large b cell lymphoma dlbcl follicular lymphoma fl mantle cell lymphoma mcl marginal zone lymphoma mzl
18348-human phototoxicity test

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a hipaa authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator; exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
l-gastrectomy with the intelligent navigation 4k uhd 3d endoscopic imaging system

Conditions: Stomach Neoplasms

Summary: this study aims to evaluate the safety, efficacy, and feasibility of the intelligent navigation 4k uhd 3d endoscopic imaging system in patients with gastric cancer.

background: lymphadenectomy in laparoscopic gastrectomy can significantly improve the long-term survival and accuracy of the tumor staging of patients with gastric cancer. the retrieval of more lymph nodes has gradually become a trend among surgeons. however, lymphadenectomy is currently performed without the aid of visual instruments which might lead to an unknown pathological outcome and influence the prognosis of gastric cancer patients. and none of the indocyanine green (icg) fluorescent imaging systems applied in clinical practice now is equipped with ultra-high definition (4k) or three-dimensional (3d) lens. to explore the advent of minimally invasive surgery with a conveniently switchable high-quality imaging system, we designed a new laparoscopic navigating technique that combined all the three characteristics. aims: this study aims to evaluate the safety, efficacy, and feasibility of the intelligent navigation 4k uhd 3d endoscopic imaging system in patients with gastric cancer. methods/design this is a prospective, one-arm, single-center, single-set target value clinical trial to investigate the clinical value of the intelligent navigation 4k uhd 3d endoscopic imaging system on laparoscopic gastric surgery. the trial will recruit a total of 67 participants.

Eligibility criteria:
inclusion criteria: 1. diagnosed with gastric cancer require surgery; 2. without a history of abdominal surgery; 3. bmi ≤ 30 kg/m2; 4. preoperative ecog score is 0\~1 and asa score is i\~iii; 5. having signed the medical informed consent. exclusion criteria: 1. patients with metastasis or invasion of surrounding tissues; 2. undergoing emergency operation (perforation, hemorrhage, obstruction); 3. patients with serious medical co-morbidity (heart, lung, liver and kidney diseases) and could not tolerate laparoscopic surgery; 4. with poor incorrigible physical condition before surgery; 5. the patient who underwent gastrojejunostomy or jejunostomy; 6. the patient who refuses to accept standardized postoperative systemic therapy according to the guidelines.

Keywords: laparoscopy gastrectomy 4k 3d lymphadenectomy
tell me more ("dime mas")

Conditions: HIV; Mental Health Issue

Summary: this study will be used to develop a program to help latino men who have sex with men obtain pre-exposure prophylaxis (prep), hiv testing, and behavioral health services. the project will then involve a pilot test of this program with a community partner.


Eligibility criteria:
inclusion criteria: * identify as latino/hispanic * identify as a sexual minority man (e.g., gay, bisexual) and/or a man who has sex with men * age 18 years or older * english and/or spanish speaking * self-report an hiv-negative or unknown hiv status * currently reside in the greater miami area * prep eligible (based on centers for disease control (cdc) criteria) and not currently taking prep adherently * self-report experiencing one or more clinically significant behavioral health concerns (mental health, substance use) and/or are not currently receiving behavioral health services or self-report an unmet need for behavioral health services exclusion criteria: * unable to provide consent * opinion of the pi that the participant would be at risk for harm to self or others * have a medical or psychiatric condition that would interfere with ability to participate in study procedures in the opinion of the pi * involvement in any other hiv prevention or behavioral health study that may interfere with the ability to test major study outcomes (evaluated by the pi on a case-by-case basis)
determining the physiological mechanisms behind the obeend device on factors regulating appetite

Conditions: Healthy Obesity, Metabolically; Obesity

Summary: in canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many canadians. to overcome these barriers, the obeend device, manufactured by wat medical enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point pc6 to help control appetite. pc6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. if pc6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss. to measure the change of appetite hormones and enzymes related to appetite regulation after using the obeend device. the investigators hypothesize that, compared to placebo, electrostimulation of pc6 an acupuncture spot on the wrist over a two-week period will result in changes in enterogastic hormones in a direction that decreases appetite. the investigators also hypothesize that these changes will not affect physical activity levels but will correspond to changes in appetite and diet. this study will provide the first evidence of the effects of electrostimulation at pc6 on factors affecting body weight regulation providing insight into the utility of the obeend device for weight control.


Eligibility criteria:
inclusion criteria: * bmi \>30 kg/m2 * no history of chronic illness or disease * premenopausal exclusion criteria: * pregnant, breastfeeding * medications that may affect outcomes * chronic disease or conditions that may affect outcomes * smoking or use of nicotine containing products

Keywords: acupuncture obesity appetite weight
neural injury in adolescents with concussion

Conditions: Mild Traumatic Brain Injury; Concussion, Mild; Acute Brain Injury

Summary: this study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain injury and to improve understanding of the biological basis of brain pathology in adolescents with concussion. adolescents with a concussion will undergo neuroimaging and neuropsychology assessments acutely and four months after injury.

concussion is a highly prevalent condition in adolescence, but it remains a clinical diagnosis that largely relies on subjective patient report with no reliable objective biomarkers for diagnosis. traditional clinical brain imaging has not been found useful for concussion as the pathology is generally not visible on conventional acute mri or ct. the proposed study addresses this gap in concussion diagnosis and management by examining the sensitivity of magnetoencephalography (meg) for identifying areas of brain injury through detection of abnormal neural activity (slowing) in adolescents with concussion compared to healthy controls. adolescents with a concussion will complete neuroimaging (meg and mri) and neuropsychology assessments at two time points within ten days and then again 4 months post-injury. healthy controls will complete neuroimaging and neuropsychology assessments at a single time point.

Eligibility criteria:
inclusion criteria: * diagnosis of concussion and within 2 weeks of injury (case subjects) * no history of diagnosed concussion (control subjects) exclusion criteria: * head injury within 1 year of recent concussion (case subjects) * history of neurologic, psychiatric, developmental or learning disorders (all subjects)

Keywords: magnetoencephalography (meg) magnetic resonance imaging (mri)