Kornimate/medical-research-clean huggingface dataset:
a post-marketing, observational, retrospective study to assess the safety of refortrixtm (tdap) when administered during pregnancy in a maternal immunization program in brazil.

Conditions: Diphtheria

Summary: the purpose of this study is to assess the safety of refortrixtm (tdap) when administered during pregnancy in a maternal immunization program in brazil.

in this retrospective cohort study the safety of refortrixtm (tdap) administered during pregnancy as part of the national immunization program in brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the refortrixtm (tdap) maternal immunization program.

Eligibility criteria:
inclusion criteria: * subjects between 18 and 45 years of age at the time of pregnancy under consideration for the study, who deliver in the study centre. * residents of the study area * subjects who were compliant with the routine antenatal care including at least one ultrasound assessment report early in the pregnancy. * subjects with the complete and relevant medical records available. inclusion criteria for the exposed cohort: * subjects who received one dose of refortrix vaccine in the recommended time period between 27 and 36 completed weeks of pregnancy (or as late as 20 days before delivery due date) as part of the maternal immunization program in brazil, and according to the program recommendations from may 2015 onwards. * subjects with appropriate vaccination records. inclusion criteria for the unexposed cohort: * subjects who had delivered in the same hospital (study centre) before 01 september 2014 (september 2012-august 2014) and who did not receive tdap vaccination during pregnancy to the best knowledge of the investigator. exclusion criteria: * subjects who have been transferred to other specialised centres, where their medical records would be inaccessible for the study (private clinics, psychiatric or prison hospitals, other state hospitals, etc).

Keywords: exposed and unexposed cohorts post-marketing, maternal immunization neonate related adverse events congenital anomaly refortrixtm pregnancy related adverse events
peripapillary and macular vascular changes of unilateral anterior ischemic optic neuropathy: an optical coherence tomography angiography study

Conditions: Non-arteritic Ischemic Optic Neuropathy

Summary: this series aims at studying the peripapillary and macular vascular changes in subjects with unilateral anterior ischemic optic neuropathy via optical coherence tomography angiography (octa).

after approval of the local institutional ethics committee and local institutional review board, this study was conducted upon 30 patients diagnosed with acute naion attending at ophthalmology outpatient clinic in fayoum university hospitals. the participants were informed about the objectives of the study, the examination, investigations and the confidentiality of their information and their right not to participate in the study. oct and octa was done for all subjects and control group with optovue, inc., fremont, ca, usa. patients were examined on presentation, after 6 weeks and lastly after 3 months. oct was used for evaluation of central macular thickness (cmt), nerve fiber layer thickness (nflt) and ganglion cell complex (gcc). octa was done for quantitative evaluation of vessel density in the following: optic nerve head and peripapillary area, macular superficial vessel density, macular deep vessel density and foveal avascular zone. vessel density was reported as the percentage of the total area that was occupied by blood vessels. all parameters were calculated automatically by the machine software. poor quality scans and those with motion artifacts were excluded. statistical analysis was performed using spss software (version 22; spss, chicago, il, usa). the data were presented as the mean ± sd values. p-value \<0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * patients diagnosed with unilateral naion and acute or sudden painless drop of vision. * a normal fellow eye. * age ≥ 40 years old. exclusion criteria: * arteritic type of aion. * naion patients in chronic phase. * acute phase naion patients with any other optic neuropathy in the other eye. * eyes with opaque media. * elevated intraocular pressure (\>22 mmhg). * refractive errors greater than 6 diopters of spherical equivalent. * poor cooperation with fixation or the octa examination.

Keywords: octa aion naion
the effect of closed suction system on the incidence of ventilator-associated pneumonia.

Conditions: Severe Traumatic Brain Injury; Pancreatic Diseases; Trauma Injury; Seizures; Encephalitis; Abdominal Sepsis

Summary: the investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (vap) and the contamination of the closest unanimated surfaces. in 2011 david et al. have shown that closed suction systems might reduce the incidence of the late vap. research team is thinking that preventive bundle with closed suction systems can prevent to onset of the vap. all enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation beyond 48 hours exclusion criteria: * hospital - acquired pneumonia * community - acquired pneumoniae * bmi \> 35 kg/cm2 * pregnancy * tracheostomy
repeated injection of i prf and autogenous bone graft for alveolar ridge augmentation

Conditions: Alveolar Bone Loss; Alveolar Ridge Abnormality

Summary: the current st udy's objective was to validate the repeated effect of i prf with autogenous bone on the of gingival thickness , width a n d volumetric bone changes durig maxillary alveolar augmentation using cone beam computer tomography (cbct). patients and methods:

the study was a randomized clinical study in which participants needed to augment defective ridge were selected from the outpatient clinic, department of oral medicine, periodontology and diagnosis , faculty of dental medicine for girls, al azhar university. the research ethics committee, faculty of dental medicine for girls, al azhar university (rec code (p. pd 24 19 ) certified this study and a signed informed consent form with approval was obtained from each. each patient who was enrolled in the study had a complete medical record and a proper clinical examination. these patients had to have a horizontal or vertical alveolar ridge deficiency and have enough bone in the mandibular donor site (external oblique ridge). however, patients showing any signs of active periodontal disease, on long term corticosteroid therapy, persons taking bone metabolism drugs as well as individuals suffering from any systemic illness that may impact bone repair were excluded from the study. patients were assigned to one of two 2 groups, group i or group ii. group i, consisted of patients grafted with autogenous bone graft alone. i n group ii, patients were grafted using autogenous bone combined with repeated injection of i prf assessment of the alveolar ridge dimension and the bone block to be harvested preoperatively using cbct. t he measurements of the alveolar ridge mesio distaly and bucco lingually in mm were determined at the recipient site . it was crucial to visualize the anatomic structures at the osteotomy site, including the alveolar canal, the mental foramina, and the teeth roots present to create ideal bone cutting planes according to the depth and extension of the graft without any injuries to the aforementioned structures.

Eligibility criteria:
inclusion criteria: * patients who have a horizontal or vertical alveolar ridge deficiency exclusion criteria: * patients showing any signs of active periodontal disease * patients on long term corticosteroid therapy, * patients taking bone metabolism drugs * patients suffering from any systemic illness that may impact bone repair

Keywords: a lveolar ridge defect , khoury technique guided bone regeneration, i prf, cbct analysis
effect of the intensity of continuous renal replacement therapy in patients with acute kidney injury

Conditions: Acute Kidney Injury

Summary: the current international continuous renal replacement therapy (crrt) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . it is whether the best amount of replacement fluid for chinese people, it is unclear. especially,there is little evidence about the optimal dose from randomized trials in cardiac surgery associated acute kidney injury (csa-aki )required crrt,according to the clinical situation, the design of replacement fluid to 25 ml/kg/h.the observation of two doses 14 days, 28 days, 90 days survival and renal function.

acute kidney injury (aki) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. however, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with cardiac surgery-associated acute kidney injury (csa-aki) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg／h),the primary study outcome was death from any cause within 14, 28 and 90 days.

Eligibility criteria:
inclusion criteria: * \> = 18 years of age, crrt indications for acute kidney injury (rifle criteria) patients with cardiac surgery exclusion criteria: * \< 18 years old, * with chronic kidney disease, * dialysis history, to leave the icu patients with acute kidney injury (aki). - chronic kidney disease, * all causes kidney damage (pathology, hematuria, and radiographic abnormalities)\> = 3 months or glomerular filtration rate \< 60ml/min for 3 months or more.

Keywords: crrt cardiac surgery associated acute kidney injury intensity
assessing the effectiveness of a stress reduction intervention in inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Diseases; Remission; Perceived Stress

Summary: the investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.

in a randomized controlled trial, the investigators assessed the impact of an online, 3-month stress reduction intervention (yoga, breathwork, and meditation). the primary outcome was the change in cohen's perceived stress scale (pss) between the control and intervention arms. the following secondary outcomes were also assessed: anxiety, depression, ibd disease activity (e.g., changes in crp, fecal calprotectin, medication, hospitalization, or surgery), serum inflammatory markers, serum and salivary markers of stress, stress-resilience, and health- related quality of life. participant satisfaction and adherence to the intervention were also evaluated.

Eligibility criteria:
inclusion criteria (rct): * adults (≥18 years) * with ibd in remission (uc - partial mayo \<2 and fecal calprotectin \<250 μg/g; cd regular hbi \<5 or crp \<8) * on stable therapy for the past 3 months * the last flare \<24 months prior to enrollment * pss-10 score ≥ 7 at time of screening inclusion criteria (substudy): * adults (≥18 years) * ibd * on stable therapy for the past 3 months. exclusion criteria (rct or substudy): * major medical co-morbidity * steroid use in past 3 months * clostridium difficile infection in the last 3 months * unstable dose of psychiatric medications for the last 3 months * inability to provide informed written consent * severe psychiatric disorders (hads scores \>10 or suicidal ideation)

Keywords: ulcerative colitis remission perceived stress fecal calprotectin salivary stress biomarker psychological stress stress reduction crohn's disease inflammatory bowel diseases
physiotherapy in overactive bladder: electrical stimulation treatment

Conditions: Overactive Bladder Syndrome

Summary: to evaluate the efficacy of combined transvaginal electrical stimulation (es) and transcutaneous tibial nerve electrical stimulation (ttns) in the treatment of female overactive bladder syndrome (oab).

this is a clinical trial, blind and randomized study with 86 women with oab or mixed urinary incontinence with prevalence in the oab symptoms, who were randomly and allocated into 2 equal groups. group 1 underwent transcutaneous tibial nerve electrical stimulation (ttns),for 30 minutes using 10hz for frequency and 200µs for pulse. group 2 received a combined of vaginal electrical stimulation (es) using a transvaginal probe applied ,for 20 minutes using 10hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at the same parameters used in group1. both groups were treated once a week for 12 sessions. all patients were evaluated before and after treatment by a voiding diary, king´s health questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire (oabv-8).the analyzed variables included day and night time frequency, urgency and urge incontinence. the sample calculation was based on the difference waited between 2 groups regarding the frequency improvment.

Eligibility criteria:
inclusion criteria: * women diagnosed with overactive bladder syndrom no neurogenic or mixed incontinence urinary with overactive bladder´s predominance symptoms more than 6 months. * over 18 years old. * normal cognitive level to understand the orientations during the treatment. exclusion criteria: * stress urinary incontinence * drugs treatment for overactive bladder * pregnant women * neurologic diseases * urinary infecction * cystocele, rectocele and uterine prolapse * infectious contagious diseases * metal implants on the hip or lower members * cardiac pacemaker * bladder tumor * vaginal infecction

Keywords: overactive bladder electric stimulation physical therapy modalities
clinical frailty assessment and postoperative adverse outcomes and quality of life in elderly patients

Conditions: Perioperative Complications

Summary: the frailty index may represent a useful decision support tool to optimize modifiable drivers of the quality and cost of digestive surgery care. however, classical indices are cumbersome to compute and often require unavailable data. the number of operations in the elderly is gradually increasing, and the prevention and treatment of adverse postoperative outcomes has become the focus of clinical attention. more recently, clinicians have focused more on the association between frailty and adverse postoperative outcomes, but this has not been rigorously applied to long-term prospective studies in older patients.

as the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. more than 20 million elderly patients undergo surgery each year in china, accounting for a quarter of the population who undergo surgery. advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. the incidence of postoperative complications is twice as non-elderly patients, and mortality rates are five times higher than non elderly patients. thus, it is a significant challenge to safely and stably ensure the elderly in an optimal perioperative period. elderly patients continue to pose a major threat to the world's rapidly ageing population due to high rates of surgery and postoperative complications in elderly patients. therefore, optimizing perioperative management strategies for elderly patients remains one of the biggest challenges facing clinicians. frailty is a multidimensional clinical syndrome characterized by vulnerability to dependence and increased mortality when exposed to stressors. it is often clinically described as a lack of physiological reserve, manifested as a loss of physical ability, metabolic function, and cognitive abilities. a systematic review of studies of patients in general surgery reported that the prevalence of prefrailty was estimated to be between 11.3% and 45.8%, while the prevalence of frailty was estimated to be between 10.4% and 37.0%. although clinicians or relatives may be aware of frailty, there is currently no standardized clinical gold-standard assessment tool to widely use and quantify frailty.

Eligibility criteria:
inclusion criteria: * geriatric surgical patients ≥65 years old * non-selective cardiac surgery exclusion criteria: * missing or incomplete patient follow-up records * asa degree v * delirium before surgery * patient refused to enroll

Keywords: frailty assessment non-cardiac surgery elderly patients adverse outcomes after surgery frailty scale
effects of topical sesame oil in the prevention of peripheral venous catheter phlebitis: clinical trial.

Conditions: Phlebitis

Summary: cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses. for the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. these peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis. phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward. phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism. the existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling. with the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis.


Eligibility criteria:
inclusion criteria: * be over 18 years of age. * to be conscious and have a cognitive state that allows him/her to give consent to participate in the study. * be diagnosed with a neoplasm that requires chemotherapy treatment. * to be a carrier of a cvp in the upper extremity as vascular access for chemotherapy administration. exclusion criteria: * being allergic to sesame oil. * be allergic to nuts. * not being able to speak, read and write in spanish. * last days or palliative situation.

Keywords: neoplasms antineoplastic agents phlebitis sesame oil catheterization peripheral
tailorx tissue bank

Conditions: Breast Cancer

Summary: this is an exploratory, translational, non-interventional and multi-centre biobank. the aim of the development of such a biobank is to identify potential biomarkers that are indicative of disease relapse.

the primary objective is to develop a biobank, tissue microarrays (tmas) and full face sections, which will be used to identify candidate/ novel biomarkers prognostic for disease relapse and predictive for endocrine and/or chemotherapy resistance. the secondary objectives are: * to validate emerging signatures/biomarkers identified. * to develop new assays for the breast cancer clinic.

Eligibility criteria:
inclusion criteria: * patients that were registered with the icorg 06-31 tailorx trial and participated in trial arms * patients with adequate tumor tissue available

Keywords: must have registered with the icorg 06-31 tailorx trial
assessment of the impact of body position on diaphragmatic excursion in obese patients to improve proactice in respiratory kinesitherapy

Conditions: Obesity

Summary: the exdecho study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound. the investigators suppose that the course of the right diaphragmatic hemicupola would be increased by an increasingly horizontal position (gradual increase in the diaphragmatic excursion from standing to lying down). if this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.


Eligibility criteria:
inclusion criteria: * to have a bmi greater than or equal to 30; * to have not had intense physical activity during the hour preceding the measurements; * to be enrolled in a social security plan; * to give a written consent; * to have underwent a pre-inclusion medicalexamination. exclusion criteria: * to have a respiratory pathology unrelated to obesity (sleep apnea syndrome, obesity-hypoventilation syndrome, restrictive ventilatory syndrome with no other known cause); * to have a cardiac pathology not stabilized by drug treatment and/or resulting in heart failure and/or requiring the fitting of a pacemaker or defibrillator; * to have a chronic inflammatory disease (rheumatoid arthritis, crohn's disease, cirrhosis, etc.); * to have a chest deformity (kyphoscoliosis, funnel chest, etc.); * to be anactive smoking or former smoker (stopped for less than 3 months and total consumption \> 10 pack-years); * to have an history of major surgery, surgery under general anesthesia for less than 3 months, or minimally invasive surgery for less than 1 year of the thoraco-abdomino-pelvic compartments; * to have a known sensitivity to monopropylene glycol (substance present in the sterile ultrasound gel); * temperature of the room in which the ultrasound measurements are carried out below 20°c or above 25°c; * subject under a measure of legal protection.
early detection of lung cancer in czech high-risk asymptomatic individuals

Conditions: Lung Cancer

Summary: the aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the czech republic. an estimated 3200 high-risk (age 55-74 years, \>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest ct (ldct) and a follow-up ldct at 1 year. patients with poor performance status (ps) 2-4, history of malignancy in the past 10 years, chest ct in the past 1 year, bodyweight \>140kg will not be included. the patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, ct imaging of the thorax, and will undergo spirometry. outcomes of the study include: * optimization of entry criteria, optimization of timing of a follow-up ldct and management of the patients, proposal of quality assurance indicators * influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost * cost-effectiveness of the screening program * evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)


Eligibility criteria:
inclusion criteria: * age 55-74 years * smoking: \>= 30 pack-years, smoker or ex-smoker \<15 years * performance status (0-1) - can climb at least one floor without any difficulty or pause exclusion criteria: * body weight above 140 kg * malignant disease within the last 10 years (except non-melanoma skin cancer). * chest ct less than one year ago * clinical signs suspicious of lung cancer (weight loss, new cough, hemoptysis)

Keywords: lung cancer low dose ct