Kornimate/medical-research-clean huggingface dataset:
evaluation of a specialized therapeutic care of patients presenting an intolerance attributed to electromagnetic fields

Conditions: Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

Summary: the purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

110 patients suffering from idiopathic environmental intolerance attributed to electromagnetic fields (iei-emf) are expected in this trial. type of trial: interventional multicenter study, non-randomized, with measurement before and after intervention. each patient is his own control. primary outcome: efficacy of an individual medical care on electro sensitive (iei cem) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (emf) exposure, and quality of life. scheme: visit 1(t0): patients undergo a specialized medical examination: a standardized medical record is filled in. physicians evaluate the psychological impact of iei-emf and a psychotherapeutic care is proposed if necessary. patients fill in 2 self-questionaries: quality of life (sf-36) and emf exposure sensitivity. after the visit 1, a symptoms self-administrated questionary n°1 is completed during 7 days. 1 month after inclusions (t1), radiofrequencies (rf) are recorded by a dosimeter worn by patients for 7 days; patient fill-in the symptoms self-administrated questionary n° 2 during the same time. visit 2: 6 months after inclusion, analysis of symptoms and rf exposure is restituted at patient. an adapted care is proposed. 12 months after inclusion (t12), patients complete the symptoms self-administrated questionary n°3. visit 3: 14 months after inclusion (t14), patients have medical examination and complete the quality of life and emf exposure sensitivity self-questionaries. standardized medical record is filled in by physicians. patient and physician discuss the global and comparative analysis of individual results. inclusion duration: 24 month; follow-up: 14 months; study duration: 38 months.

Eligibility criteria:
inclusion criteria: * subjects who declare themselves to be intolerant to electromagnetic fields * subjects over 18 years old * subjects affiliated to a social security scheme * subjects who signed the consent form exclusion criteria: * subject with a disorder of the understanding of the french language at the discretion of the investigator * pregnant women, * persons deprived of their liberty, persons under guardianship, and persons in emergency situations.

Keywords: iei-emf wi-fi dect electro-sensitivity radiofrequency ehs idiopathic environmental intolerance fields mobile phone
wireless assessment of respiratory and circulatory distress in chronic obstructive pulmonary disease - an observational study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: for patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to icu admission, or unanticipated cardiac arrest. such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. new continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. the ward-copd project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission with acute exacerbation of chronic obstructive pulmonary disease (aecopd).


Eligibility criteria:
inclusion criteria: * adult patients admitted with aecopd * recruitment and monitoring start is possible within 24 hours after admission exclusion criteria: * patient expected not to cooperate * patient allergic to plaster, plastic or silicone * active therapy withdrawn * patients with dementia or not able to give informed consent * patients with pacemaker or implantable cardioverter-defibrillator (icd) unit * expected discharge within less than 24 hours from possible inclusion

Keywords: continuous monitoring
pulmonary hypertension observational study

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to establish the large ph cohort and biological database in china, aiming for precision medicine to optimize diagnosis and treatment choices.


Eligibility criteria:
inclusion criteria: * ph group: when the mean pulmonary artery pressure is greater than 25mmhg at rest or greater than 30mmhg during exercise. * signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years. exclusion criteria: * acute exacerbation in the past 3 months having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc. * serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months. * eye surgery in the last three months. * retinal detachment myocardial infarction in the last 3 months. * admission to hospital for any cardiac condition in the last month. * heart rate over 120 beats per minute. * antibacterial chemotherapy for tuberculosis pregnant or breast feeding.
impact of cardiopulmonary bypass flow on renal oxygenation, blood flow and tubular injury

Conditions: Extracorporeal Circulation; Complications; Renal Failure; Circulation Disorder; Renal Plasma Flow, Effective; Cardiopulmonary Bypass; Hemolysis; Inflammatory Response

Summary: during open cardiac surgery, cardiopulmonary bypass (cpb) is used to temporarily replace the function of the heart and lungs. renal ischemia resulting in acute kidney injury is common after cardiac surgery. the renal oxygenation is impaired during cpb, but the oxygenation may be improved by increasing the cpb blood flow. in this randomized study, two cpb flow rates will be compared regarding renal outcome (biomarkers and renal oxygenation/renal blood flow), as well as markers of inflammation and hemolysis. additionally, urine oxygen tension will be measured during cpb and the early intensive care phase and compared to renal oxygenation. regional oxygen saturation assessed with near infrared spectroscopy from the brain and kidneys will be monitored during and after surgery.


Eligibility criteria:
inclusion criteria: * written, signed informed consent * male and female subjects ≥18 years * left ventricular ejection fraction ≥30 % * estimated gfr ≥30 ml/min using the ckd-epi equation (levey 2009) * scheduled open cardiac surgery with cpb * planned normothermia during cpb * expected cpb time \> 60 minutes exclusion criteria: * emergency surgery * cardiac transplantation * advanced grown-up congenital heart disease corrections * previous cerebral infarction, verified with computed tomography or magnetic resonance imaging * body mass index \> 32 kg/m2 * use of hypothermia \< 32 °c during cpb * inability of the patient to give based opinion * in the investigator´s opinion, the patient has a condition that could be adversely affected by study participation

Keywords: renal oxygenation renal blood flow cardiopulmonary bypass tubular cell injury n-acetyl-beta-d-glucosaminidase nephrocheck inflammation hemolysis
dragon iii-phase 3: neoadjuvant chemotherapy (flot versus sox) for gastric cancer

Conditions: Gastric Cancer; Neoadjuvant Chemotherapy

Summary: dragon iii research, neoadjuvant chemotherapy (flot versus sox) for gastric cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.

non inferiority of sox will be tested against flot. this study will be conducted at multiple center of china and will invite international centers to join it.the sponsor of this study is ruijin hospital and the project is supported by the shanghai key laboratory of gastric neoplasms and institute of digestive surgery, shanghai.

Eligibility criteria:
inclusion criteria: * histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction. * clinical stage: clinical tumor-node-metastasis (ctnm:) stage iii * performance status: eastern cooperative oncology group (ecog) ≤ 2 (normal to symptomatic but in bed less than half the day) * clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function. * written informed consent exclusion criteria: * clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia * distant metastases (including retroperitoneal lymph node) * locally advanced inoperable disease (clinical assessment) * relapse of gastric cancer * malignant secondary disease * prior chemo or radio therapy * inclusion in another clinical trial * known contraindications or hypersensitivity for planned chemotherapy

Keywords: gastric cancer gastric adenocarcinoma stomach cancer, adenocarcinoma chemotherapy effect neoadjuvant chemotherapy
national survey of the impact of covid-19 pandemics

Conditions: COVID-19 Pandemics; Obstetrics and Gynecology; Workload; Questionnaire; National Survey; China

Summary: covid-19 pandemics have changed extensively the lives around the world. although most physicians of obstetrics and gynecology have no critical role in the frontline against covid-19 pandemics, their work, research and education activities still underwent great changes. the primary aim of this study is to analyze change of workload during the covid-19 pandemics in physicians of obstetrics and gynecology in china. a customized questionnaire will be delivered by the social software wechat to the specific hospital which has been randomly sampled, and all physicians of obstetrics and gynecology in this hospital will fill the questionnaire anonymously. a random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of china. it is assumed that acceptable 95% confidence interval is p±4%, and the sample size under the condition of simple random sampling is 600 persons. if the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. if we choose the design effect of 3, the sample size of every level needs is 1800. considering 10% population refusing to be surveyed, in all mainland of china, three levels of hospitals will include at least 6000 physicians who accept survey.


Eligibility criteria:
inclusion criteria: * aged 18 years old * belonging to and registered at specific hospital * active employment in obstetrics, reproduction, or gynecology * signed an approved informed consents exclusion criteria: * not meeting all the inclusion criteria * not completing the whole questionnaire
prognostic risk of patients with essential hypertension for cardiovascular events (prospect)

Conditions: Essential Hypertension

Summary: the registry study aims to determine serial biomarkers to prognosis of essential hypertension

the study aims to investigate the role of candidate biomarkers in the prognosis of essential hypertension. in the prognosis part of the study, patients with confirmed hypertension are enrolled. the outcome is unstable angina, coronary revascularization, acute myocardial infarction, heart failure, atrial fibrillation, ischemic cerebral infarction, hemorrhagic cerebral infarction, transient ischemic attack, doubling of serum creatinine or end-stage renal disease (defi ned as egfr less than 15 ml/min/1·73 m² or need for chronic dialysis) and all-cause mortality.

Eligibility criteria:
inclusion criteria: the inclusion criteria for the study program were as follows: men or women of any racial background, 18 years of age and older, with systolic bp greater than or equal to160 mm hg, and presence of three or more cardiovascular risk factors or disease. the qualifying risk factors were male sex, age older than 50 years, verified diabetes mellitus, current smoking, high total cholesterol, left ventricular hypertrophy by electrocardiogram, proteinuria on dipstick and raised serum creatinine between 150 and 265 umol/l. the qualifying diseases were verified coronary disease, cerebrovascular disease or peripheral arterial occlusive disease, or left ventricular hypertrophy with strain pattern. exclusion criteria: the exclusion criteria for the study program were as follows: secondary hypertension, pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (egfr less than 30 ml/min/1.73 m2) in the past three months.
efficacy of the pari lc sprint sp nebulizer for acute asthma attack in hospitalized children less than 36 months of age

Conditions: Asthma

Summary: the main objective of this study is to determine whether the use of the pari lc sprint sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.

the secondary objectives of this study are to evaluate whether the use of the lc sprint sp nebulizer results in: a-shortened duration of oxygen-dependence. b-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation \<90% during the nebulisation sessions. c-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents). d-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (clinical asthma score (cas)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (spo2)\> 94% when awake or \> 91% during sleep.

Eligibility criteria:
inclusion criteria: * the parent or legal representative must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria: * requires oxygen: spo2 \<92% on room air (if cas ≤ 4/10) * and / or cas\> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care). exclusion criteria: * the patient is participating in another study * the patients has already been included in this study a previous time * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the parent or legal representative refuses to sign the consent * it is impossible to correctly inform the parent or legal representative * the patient has a contra indication for a treatement used in this study * patient was born at \< 34 weeks of pregnancy or bronchdysplasic * first or second episode of bronchiolitis * asthma attack with cas score ≤ 4/10 or inpatient basis for a non-breathing related motive. * acute severe asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol iv * patient with known congenital heart disease * patient with chronic respiratory disease other than asthma * patient with encephalopathy * patient with known immune deficiency * cas ≤ 2 and transcutaneous oxygen saturation (spo2)\> 94% when awake or \> 91% when asleep for at least 12h

Keywords: nebulizer pari lc spring sp
electronic patient reporting of side effects to chemotherapy: a cluster randomized controlled trial

Conditions: Adverse Event; Cancer, Breast; Chemotherapeutic Toxicity; Patient Outcomes Assessments

Summary: the aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. we are using the patient-reported outcomes version of the common terminology criteria for adverse events (pro-ctcae) for the patients' reporting of side effects.


Eligibility criteria:
gender •female: only female participants are being studied minimum age •18 years maximum age •n/a accepts healthy volunteers •no eligibility criteria inclusion criteria * breast cancer patients starting adjuvant chemotherapy in the period november 1, 2015 - september 1, 2016 in danish oncology clinics exclusion criteria: * more than six scheduled cycles of chemotherapy * not able to read and understand danish language
comparison of the efficacy of rapid-acting aspart and faster acting aspart within the context of single-hormone closed-loop strategy at regulating postprandial glucose levels

Conditions: Type 1 Diabetes Mellitus

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. the objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. in addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect. faster insulin aspart (fiasp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting aspart in adults with type 1 diabetes using insulin pump therapy.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years of old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. the subject will have been on insulin pump therapy for at least 6 months. 4. hba1c ≤ 12%. exclusion criteria: 1. using a patch-pump (e.g. omnipod) 2. clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 3. recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 4. ongoing or planned pregnancy. 5. breastfeeding. 6. severe hypoglycemic episode within two weeks of screening. 7. current use of glucocorticoid medication (except low stable dose and inhaled stable treatment). 8. known or suspected allergy to the trial products or meal contents. 9. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 10. failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc). 11. problems with venous access.

Keywords: closed-loop control artificial pancreas postprandial glucose control insulin
an observational follow-up study for subjects receiving salvage therapy after previous treatment in a visilizumab study for intravenous steroid-refractory ulcerative colitis

Conditions: Ulcerative Colitis

Summary: to assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.


Eligibility criteria:
inclusion criteria: * previous participation in a visilizumab study of ivsr-uc. * disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy. exclusion criteria: * unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent. * for u.s. sites, unwilling or unable to provide authorization to use protected health information.

Keywords: ulcerative colitis colitis steroid-refractory visilizumab intravenous steroid-refractory ulcerative colitis (ivsr-uc)
effect of intraoperative crystalloid volume on postoperative vomiting

Conditions: Postoperative Vomiting

Summary: postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. the purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.

at the initiation of the study, 160 patients we enrolled consecutively . six of the patients were excluded according to the inclusion/exclusion criteria. remaining one hundred fifty four were american society of anesthesia (asa) i-ii classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (n(2)o). subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.

Eligibility criteria:
inclusion criteria:asa physical status i or ii * age 2-15 yr * scheduled for elective tonsillectomy and/or adenotonsillectomy exclusion criteria: * history of diabetes * history of mental retardation * obesity (bmi = \> 95th percentile for age and sex) * intake of antiemetic or psychoactive medication within 24 hours before surgery * known gastroesophageal reflux
noninvasive blood pressure monitor evaluation including performance during dysrhythmias

Conditions: Healthy

Summary: this protocol focuses on the evaluation of the ge noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. the study follows the recommendations of the ansi/aami sp10 standard.


Eligibility criteria:
inclusion criteria: * signed informed consent * a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values. * ability to monitor ecg, nibp and/or pulse oximetry * presence of atrial fibrillation, atrial flutter, or normal sinus rhythm exclusion criteria: * any subject deemed too unstable, at the clinician's discretion, to participate in the study * any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard * any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery. * presence of peripheral vascular disease in arms * inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. the volume of fluid will not exceed a total pre-specified by the principal investigator or designee. * if the baseline arm to arm mean difference is \> 10 mmhg, then the differences will be recorded and evaluated by the principal investigator for possible subject exclusion from the data analysis. * subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm

Keywords: non-invasive blood pressure sinus rhythm oscillometric invasive blood pressure aami/ansi sp10 standard compliance with ansi/aami sp10 2002 standard