Kornimate/medical-research-clean huggingface dataset:
telemonitoring to improve outcomes of patients with chronic kidney disease (ckd)

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.

chronic kidney disease (ckd) is a major public health issue. approximately, 11% of the us population has ckd with an increased prevalence among individuals great than 65years. many individuals with ckd go unrecognized because they are typically asymptomatic. individuals with ckd have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. also, individuals with ckd consume a significantly greater proportion of health care expenditures compared to other patients. this study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, er visits or admission to a skilled nursing facility in patients with ckd compared to usual care. this study will use a randomized controlled trial. few interventions have been demonstrated to improve clinical outcomes in patients with ckd. if successful, this study will enable the va to provide high quality care to patients with ckd while potentially reducing the cost of providing care.

Eligibility criteria:
inclusion criteria: enrolled at minneapolis or st. cloud veterans affairs health care system (vahcs) or affiliated community based outcomes clinic(cboc); late egfr within the va system \<60 ml/min/1.73m2 - exclusion criteria: primary care provider unwilling to have participant included in study; unable to give consent; severe mental health condition; living in a nursing home -

Keywords: telemonitoring chronic kidney disease
impact of breast cancer gene status on survival in adjuvant breast cancer (imbassa)

Conditions: Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Summary: relationship between the presence of the brca mutation (breast cancer) and outcomes is unclear in high-risk early breast cancers (bc). this study is a multi-center retrospective cohort of patients treated in region franche-comté for an early bc by neoadjuvant and/or adjuvant chemotherapy. the primary aim was to describe clinical and pathological characteristics considering brca mutated (brcam) patients versus brca wild type (brcawt) patients or untested patients. the second objective was to assess the prognostic impact of germinal brcam in this high-risk population.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old, * histologically confirmed invasive early breast cancer * neo-adjuvant and/or adjuvant chemotherapy with the first cure of chemotherapy received between january 1st, 2003 and december 31th, 2013 exclusion criteria: * clinical, radiological or histological confirmed metastatic disease * non-invasive breast cancer, * patients who received incomplete treatment * patients who did not speak french

Keywords: breast cancer brca1 brca2 chemotherapy
objective testing of tear film stability

Conditions: Contact Lens Solutions

Summary: the purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.


Eligibility criteria:
inclusion criteria: 1. the subject must be at least 18 years of age and no more than 80 years of age. 2. the subject must have a best corrected visual acuity of 20/30 or better for each eye. 3. the subject must habitually wear contact lenses. 4. the subject must have had an eye exam within the last 12 months. the exam data must be available to the investigators prior to the first visit. 5. the subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation. 6. the subject must read understand and sign the statement of informed consent. 7. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: 1. ocular or systemic allergies or disease that might interfere with contact lens wear. 2. systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear. 3. clinically significant (fda scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. clinically significant (fda scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. any ocular infection. 6. pregnancy or lactation. 7. diabetes 8. infectious diseases (e.g. hepatitis, tuberculosis) 9. contagious immunosuppressive diseases (e.g. hiv)

Keywords: contact lenses, wettability, contact lens disinfectant solutions, pre-lens tear film
gene expression analysis of patients with metastatic colorectal cancer receiving oxaliplatin based chemotherapy regimen

Conditions: Colonic Diseases; Cancer

Summary: 1.1 to collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen. 1.2 to determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients.

this is a single-arm, non-randomized trial of oxaliplatin and capecitabine. patients that are placed on other studies that utilize the same chemotherapy regimen can enter this study. those patients will be treated according to the clinical study on which they have been entered. for patients not on another clinical trial, the treatment outlined below should be followed.

Eligibility criteria:
inclusion criteria: * all patients, \>18 years of age, with metastatic/recurrent colorectal cancer are eligible. * patients must have a life expectancy of at least 12 weeks. * patients must have a zubrod performance status of 0-2. * patients must sign an informed consent. * patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \> 100,000/mm3 and absence of a regular red blood cell transfusion requirement. * patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and sgot or sgpt \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. * the patient must agree to a biopsy of a sample of tumor for correlative studies. * the patient is an appropriate candidate for oxaliplatin/capecitabine based chemotherapy. * the patient must have measurable disease. exclusion criteria: * patients with symptomatic brain metastases are excluded from this study. * pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception. * patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * patients may not have received oxaliplatin previously. * patients with a prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (dpd) deficiency, or known hypersensitivity to platinum compounds or any of the components of the study medications.

Keywords: colorectal cancer pilot study oxaliplatin
evaluation of thermal outcome and safety of nuera tight rf system

Conditions: To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face

Summary: the purpose of the study is to verify tissue heating, temperature stability and safety of the nuera tight rf device during and after treatment session applied on the face.


Eligibility criteria:
inclusion criteria: * healthy subjects of either gender, 18 years of age or older * subject is able to read, understand and sign an informed consent form * subject is willing to comply with all study procedures exclusion criteria: * subjects taking medicines that increase skin sensitivity to heat * subjects taking medicines that change skin metabolism * cancer or any pigmentary or vascular lesions in the planned treatment area * subjects with herpes simplex in the area to be treated * pregnant women * subjects wearing pacemakers and/or any other type of implanted electronics * subjects with any inflammatory skin conditions * subjects with active cold sores, open lacerations, abrasions * chronic or acute skin infections * subjects with active local or systemic infections * subjects with any disease in which an increase of skin temperature is contraindicated * subjects wearing piercing in the area to be treated * subjects have nerve insensitivity to heat in the area to be treated * subjects have metal implants in the area to be treated, excluding dental implants * subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile * any condition where the study investigator determined that the subject is not adequate for this study * subjects participating in other studies
efficacy assessment of methylprednisolone and heparin in patients with covid-19 pneumonia

Conditions: COVID-19

Summary: the covid-19 pandemic has been spreading continuously, and in brazil, until july 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. the present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with covid-19 pneumonia in a randomized, controlled, 2x2 factorial study.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of covid-19 by rt-pcr or serology with presence of igm positive antibodies; * lung image (x-ray or chest ct) with involvement of at least 25% of the parenchyma; * o2 saturation in ambient air less than or equal to 93% * alteration of inflammatory tests * d-dimer above the reference value and * elevation of c-reactive protein, ferritin or lactic dehydrogenase * sign the consent form. exclusion criteria: * qt interval prolongation * imminence of orotracheal intubation (intubation prediction in the first 4 hours after randomization) * women who are pregnant or breastfeeding * corticosteroid allergy or intolerance * chronic corticosteroid users (prednisone equivalent \> 10 mg daily) * patients diagnosed with cancer with increased bleeding potential * patients in hemodialysis * history of peptic ulcer * herpes zoster infection * history or active treatment of tuberculosis * systemic fungal infection * use of anticoagulation due to previous pathology * glaucoma * live virus vaccine up to 90 days before randomization * known coagulopathy or thrombocytopenia (\<40,000/mm3) or hypofibrinogenemia (\< 50 mg/dl) * recent bleeding * another limiting comorbidity for administering the therapies provided for in this protocol in in researcher's opinion

Keywords: sars-cov-2 heparin methylprednisolone anticoagulation coagulopathy respiratory failure
effect of morning snack on cognitive performance in adults

Conditions: Nutrition; Cognitive Change; Food Intake Control; Satiety

Summary: to characterize the effects of three chocolate snacks on cognitive performance, subjective appetite, food intake control, and glycemic response in normal weight adults.

on 4 separate mornings, 7 days apart, 12 hours after an overnight fast, and 3 hours after a standardized breakfast of a cereal bar, orange juice and fruit cup, participants will consume isocaloric snacks of white chocolate, 2 types of dark chocolate or control (water), followed by an ad libitum pizza lunch 90 minutes later. upon arrival, at baseline (0 minutes), participants will be asked to complete the motivation-to-eat, global vigor and subjective emotion visual analogue scales (vas), a battery of cognitive performance tasks and have blood samples taken, as reported and validated in our previous studies. over the 90 minute testing period, blood samples will be taken,the vas questions will be completed and cognitive tasks will be completed. cognitive performance assessments will include learning and memory, spatial memory, attention and processing speed, and executive functions. vas measuring physical comfort is completed pre- and post-meal. ad libitum food intake from a test meal will be measured.

Eligibility criteria:
inclusion criteria: * be between 18 and 35 years of age * be healthy and have a have body mass index (bmi) between 18.5 and 24.9 * not be taking any medications, not smoking, and * not have allergies to chocolate, dairy or gluten * be tested during the early follicular phase of their menstrual cycle for women exclusion criteria: * anyone with food sensitivities or allergies to chocolate, dairy or gluten, * smokers * diabetic or overweight/obese individuals. * restrained eating habits, defined as scoring greater than 11 points on the eating habits questionnaire

Keywords: healthy adults cognitive performance chocolate food intake glycemic response
personalized dietary advice 3 months after discharge from hospitalization in geriatrics: effect on nutritional status according to coronavirus disease 2019 (covid-19) status (positive or negative) during hospitalization

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Summary: the principal aim of this interventional, multicentre study is to compare the impact of a follow-up by monthly telephone dietetic consultations, started 3 months after discharge from hospital, for a period of 3 months, on the energy intake in patients elderly people recently hospitalized for coronavirus disease 2019 (covid-19), coronavirus disease positive group "covid (+)", or not, coronavirus disease negative group"covid (-)". the main outcome measure is to compare the total energy intake at 6 months, after 3 months of dietary consultations, between coronavirus disease positive group "covid (+)" and coronavirus disease negative group "covid (-)".

this study consists of nutritional monitoring after hospitalization, carried out by dieticians. consultations are done remotely, by phone only. eligible subjects are included, either upon discharge from hospital or within 3 months (at the latest) following their hospitalization. 135 subjects will be included, 50% will be included in coronavirus disease positive group "covid (+)" and 50% in the coronavirus desease negative group "covid (-)" . the following data will be collected * at inclusion (d0): average length of hospital stay, medical diagnoses, severity of hospital stay, autonomy and dependency scores, albumin and body mass index (bmi). * at m3, m4, m5 and m6: dietary monitoring data, patient's vital status and dependency scores.

Eligibility criteria:
inclusion criteria: * patient hospitalized or having been hospitalized in acute geriatrics * living at home 3 months after hospitalization in acute geriatrics * having a good understanding of the french language * being able to understand the study information and participate in telephone follow-up * having read the information notice and agreeing to participate in the study * for the covid (+) group: hospitalized for covid-19 (diagnostic confirmation by positive rt-pcr) * for the covid group (-): hospitalized for any other reason (negative rt-pcr) exclusion criteria: * patient refusing to participate in the study * subject to a legal protection measure (curatorship, guardianship or safeguard of justice) * with cognitive impairment making it impossible to understand the study protocol and express consent.

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2)-positive patients severe acute respiratory syndrome coronavirus 2 (sars-cov-2)-negative patients coronavirus disease 2019 (covid-19)
predictability of preoperative carotid artery corrected flow time for hypotension after spinal anesthesia in patients undergoing cesarean section

Conditions: Cesarean Section

Summary: the purpose of this study was to investigate the incidence of hypotension after spinal anesthesia in patients undergoing cesarean section as predicted by preoperative carotid artery corrected flow time measured by doppler ultrasound. before entering the operation room, two inspectors perform two measurements of carotid artery corrected blood flow time respectively, and an average of the four measurements is calculated and analyzed. at this time, the patient's posture is supine, and the head is turned about 30 degrees to the left. corrected blood flow time (ftc) is measured using carotid ultrasound as previously described by blehar and colleagues. corrected blood flow time is calculated by bazett's formular and wodey's formular by evaluating a single cycle after several successive cycles have reached a stable and acceptable quality level. the occurrence of hypotension is recorded from the spinal anesthetic injection until the fetus is delivered. the definition of hypotension after spinal anesthesia is that the systolic blood pressure drops to 80 mmhg, less than 75% of the baseline value, or even if it does not meet the former criteria, symptoms that are consistent with hypotension (dizziness, dizziness, dyspnea, nausea or vomiting).


Eligibility criteria:
inclusion criteria: * uncomplicated singleton full-term parturients undergoing cesarean delivery * age 20\~40 * asa class 1\~3 exclusion criteria: * emergency surgery * placenta previa * preeclampsia or preeclampsia * cardiovascular or cerebrovascular disease * morbid obesity with a body mass index (bmi) of 40 kg / m2 or higher * gestational age \<36 or ≥ 41 weeks * contraindications to spinal anesthesia * carotid stenosis\> 50% (angiography, ct angiography, mr angiography, or duplex ultrasonography) * basal systolic blood pressure\> 160 mmhg * the preoperative examination revealed that the electrocardiogram was not normal sinus rhythm * chronic kidney disease (egfr \<60 ml / min / 1.73 m2) * if the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
the first-in-man pilot study of firehawk

Conditions: Coronary Heart Disease

Summary: this is a small-scale pilot clinical study of the rapamycin-eluting coronary stent system of microport for the first time to assess the preliminary safety and feasibility used in the human body. and provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in china.


Eligibility criteria:
inclusion criteria: 1. 18-75 years of age, males or non-pregnant females; 2. with silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3. total number of target lesion is 1; 4. target lesion length ≤ 30mm (visual); target lesion diameter between 2.25mm to 4.0mm; 5. visual assessment of target lesion diameter stenosis ≥ 70%,timi blood flow≥1; 6. each target lesion may be covered by a single stent; 7. patients with indications for coronary artery bypass graft surgery; 8. to understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. exclusion criteria: 1. within 1 month of any acute myocardial infarction; 2. chronic total occlusion (timi grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge; 3. severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery; 4. in-stent restenosis lesions; 5. intracoronary implantation of any branding stents within 1 year; 6. severe congestive heart failure (nyha class iii and above) ,left ventricular ejection fraction or \<40% (ultrasound or left ventricular angiography); 7. preoperative renal function serum creatinine \>2.0mg/dl; 8. bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy; 9. aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies; 10. the patient's life expectancy is less than 12 months; 11. top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame; 12. researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements; 13. heart transplantation patients.

Keywords: sirolimus eluting stents percutaneous coronary intervention first in man
impact of home zinc treatment for acute diarrhea in children

Conditions: Diarrhea

Summary: background. zinc deficiency is common in africa. it has been shown in asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. the use of zinc at home to treat diarrhea in an african setting, where malaria, hiv and malnutrition are common, has not been well-studied. objective. to evaluate if zinc treatment for diarrhea given at home in kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic work planned. we propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ors, to treat diarrhea in children under-5 years of age living in a rural part of bondo district. the comparison group will be children who receive zinc and ors in the clinic only. the primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year. significance of results. if this study shows zinc given at home to be effective, this might be considered by the kenyan moh as an essential component of the treatment of diarrhea in children at the community level.


Eligibility criteria:
inclusion criteria: * all children 2 to 59 months of age in households within 33 selected villages exclusion criteria: * children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. children of parents who do not give written informed consent for their participation will not be enrolled.

Keywords: diarrhea zinc oral rehydration therapy