Kornimate/medical-research-clean huggingface dataset:
effect of peritoneal fixation on lymphocele formation

Conditions: Prostate Cancer; Lymphocele After Surgical Procedure

Summary: the perfix trial aims to compare the use of peritoneal fixation technique to standard of care (no fixation) during robot-assisted radical prostatectomy with extended pelvic lymph node dissection (rarp + elnd) for the prevention of symptomatic and radiologic lymphocele formation.

extended pelvic lymph node dissection (eplnd) is the most accurate staging tool to determine lymph node involvement in prostate cancer. as urologist perform this procedure more often now, thanks to the shift to more advanced and aggressive stages, the role of eplnd is expanding. the main complication of plnd is development of a collection of lymphatic fluid called a lymphocele. lymphoceles can be associated with abdominal pain, lower urinary tract symptoms, bladder outlet obstruction, penile or scrotal edema, infection/sepsis, lower extremity swelling and deep vein thrombosis. they necessitate intervention in up to 10% of patients treated with rarp + eplnd which includes drainage or surgery. radiologic incidence can be as high as around 50% of operated patients with unknown clinical relevance. many interventions aimed at reducing the rate of lymphocele formation with limited success so far. several retrospective studies suggested using peritoneal flap fixation technique which could direct the lymphatic fluid to the peritoneal cavity out of the pelvis and its ensure its reabsorption there. we hypothesize that peritoneal fixation can potentially lower the incidence of symptomatic and radiologic lymphocele formation. by preventing this potentially very dangerous complication, it could be very beneficial for a large group of patients suffering from aggressive localized prostate cancer who are scheduled for rarp + eplnd. our goal is to is to test this hypothesis in a randomized trial comparing the fixation technique to standard of care, i.e. no fixation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * able to give informed consent * histologically proven high risk prostate cancer or intermediate risk cancer (≥5% risk of nodal involvement on briganti 2012 nomogram) according to european association od urology (eau) risk groups * suitable for minimally-invasive surgery exclusion criteria: * previous pelvic surgery or irradiation. * any type of clotting disorder. * patients unwilling to undergo ct scan * kidney failure, hemodialysis * american society of anesthesiology classification\> 3 * existing contraindications for performing a lymph node dissection

Keywords: prostate cancer robot-assisted radical prostatectomy extended pelvic lymph node dissection lymphocele peritoneal fixation lymphatic disease
incremental cost-utility study on prehabilitation among older patients with colorectal cancer undergoing surgery

Conditions: Colorectal Cancer; Surgery

Summary: a prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.

this study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an american society of anesthesiologists (asa) score of iii. we also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.

Eligibility criteria:
inclusion criteria: * age ≥ 70 years or american society of anesthesiologists (asa) score of iii * scheduled for colorectal cancer surgery exclusion criteria: * metastatic disease known preoperatively * asa iv score or higher * paralytic or immobilized patients (not capable to perform exercise) * prior use of neoadjuvant therapy for the same indication * not able or willing to provide written informed consent
cardiovascular mortality associated with abnormal calcium metabolism

Conditions: Cardiovascular Disease; Kidney Disease

Summary: the purpose of this cohort study is to estimate the risk of cardiovascular mortality associated with abnormal calcium metabolism


Eligibility criteria:
all esrd patients who indicated dialysis in 1990-1993

Keywords: calcium metabolism
perioperative atelectasis in orthopaedic surgery: a prospective study

Conditions: Atelectasis

Summary: this study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. the association between the atelectasis score and previously identified risk factors will be studied.

atelectasis is one of the most common pulmonary complications in the perioperative period, occurring in 85% to 90% of patients under general anesthesia. it can be responsible for hypoxemia and be associated with postoperative pulmonary complications such as pneumonia. the consequences are a prolongation of the hospital stay and an increase in mortality. the appearance of perioperative atelectasis is mainly secondary to the induction of general anesthesia with an incidence up to 90%. the different causes are, for example, the administration of muscle relaxants, mechanical ventilation and the position of the patient. in orthopedic surgery, many procedures are performed under spinal anesthesia or under peripheral nerve block. at present, there are no studies measuring the incidence of atelectasis in patients operated under these two techniques of locoregional anesthesia, with the exception of parturients undergoing cesarean section. this study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. the association between the atelectasis score and previously identified risk factors will be studied.

Eligibility criteria:
inclusion criteria: * patients over the age of 18; * patients scheduled for an elective operation at the orthopedic hospital of chuv; * signature of the study consent exclusion criteria: * thoracic deformities preventing the performance of pulmonary ultrasound (dressings, drains, fractures, etc.); * refusal to participate; * patient does not speak french. * inability to discern
s9719 gene damage following chemotherapy in women with stage ii or stage iii breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy for breast cancer may damage the genes of cells. this may lead to the development of secondary cancers. purpose: pilot study to evaluate the degree of gene damage following chemotherapy in women with stage ii or stage iii breast cancer involving four to nine axillary lymph nodes.

objectives: i. estimate the incidence of early genetic damage, defined by the presence of clonal hematopoiesis using the human androgen receptor assay (humara), in pretreatment blood and bone marrow, apheresis, and two sequential post-treatment specimens from women with stage ii/iii breast cancer enrolled in swog-s9623. ii. detect genetic damage following dose-intensive adjuvant regimens for breast cancer by screening for the presence of defective dna mismatch repair mechanisms and loss of heterozygosity using microsatellite instability assays. iii. estimate the incidence of myeloid lymphoid leukemia gene fusion transcripts in cases where either the humara or microsatellite repeat assays are positive for clonal hematopoiesis. iv. determine the frequency of ras gene mutations (h-, k-, and n-ras) following dose-intensive adjuvant regimens for breast cancer. outline: prior to beginning treatment on swog-9623, blood samples and bone marrow aspirates (when available) are collected from each patient. patients randomized to autologous peripheral stem cell transplant have specimens collected again at 3 months (apheresis aliquot and blood). at 3 and 12 months after completing chemotherapy, blood samples are collected from all patients. samples are collected again from any patient presenting with a second malignancy in the future. dna is collected from blood or bone marrow samples. clonality at the humara locus is examined. microsatellite instability is assessed at multiple chromosomal loci: 7q31, 5q31, 17p12, 8p22, 11q23, and the bat loci. if the humara or microsatellite repeat assays are positive for clonal hematopoiesis, then specimens are examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid leukemia with 11q23 abnormalities. specimens are also examined for ras mutations (h-, k-, n-ras). patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. projected accrual: this study will accrue 100 patients for each arm of swog-9623, for a total of 200 patients.

Eligibility criteria:
disease characteristics: must be enrolled in swog-9623 at time of registration to this study, but must not have started treatment hormone receptor status: not specified patient characteristics: age: adult sex: female menopausal status: not specified performance status: see disease characteristics life expectancy: swog 0 or 1 hematopoietic: see disease characteristics hepatic: see disease characteristics renal: see disease characteristics prior concurrent therapy: see disease characteristics

Keywords: stage ii breast cancer stage iii breast cancer
a nutrigenetic intervention in masld

Conditions: NAFLD; Fatty Liver

Summary: the study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with nafld in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. the study sample is determined as 150 subjects and randomization will be done by stratification according to pnpla3 genotype. at baseline, hepatic steatosis and fibrosis will be measured with fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. the study will be conducted in parallel groups, with each group receiving equal amounts and intensity of mediterranean diet or low-fat diet therapy. at the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the mediterranean diet and low-fat diet therapies will be compared, as well as the effect of pnpla3 mutation on intrahepatic response will be analyzed.


Eligibility criteria:
inclusion criteria: * able to understand and sign informed consent * bmi\> 25 kg/m2 * between 18-80 years * previous clinical diagnosis of masld by abdominal usg, mri, fibroscan® or liver biopsy exclusion criteria: * excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 units alcohol/day for women and \>3 units for men) * other liver diseases: hepatitis b virus, hepatitis c virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, wilson's disease, alpha 1 antitrypsin deficiency * secondary causes for steatosis: disorders of lipid metabolism, hcv genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and haart) * celiac disease * pregnancy and breastfeeding
performance comparison of revaclear with larger dialyzer

Conditions: Renal Failure Chronic Requiring Hemodialysis

Summary: the purpose of the study is to show equivalent performance of the revaclear dialyzer when compared to a dialyzer with larger membrane surface area. study design: open, randomized, cross-over, multicentric, controlled prospective medical devices: revaclear 200 versus fx 60 or revaclear 400 versus fx 100, depending on patient needs patients/sample size: 30 adult chronic hemodialysis patients treatment: each patient will be treated by hemodialysis for one week (3 dialysis sessions) with revaclear dialyzers and one week (3 dialysis sessions) with fx dialyzers. objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss primary variable: dialysis dose kt/v urea secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin safety variable: albumin loss, blood count


Eligibility criteria:
inclusion criteria: * chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months * patients aged 18 years or more * written consent to participate in the study (informed consent) * dialysis via native fistula or gore-tex graft capable of providing a blood flow rate of at least 300 ml/min exclusion criteria: * single-needle dialysis * pregnant and lactating women * participation in other interventional studies less than 3 months prior to study start * non-compliance with the dialysis prescription * hematocrit less than 28% * hospitalization * antibiotic therapy * active infection * active cancer * known positive serology for hiv, hepatitis b or c * serious hemostasis disorders * any comorbidity possibly conflicting with the study purpose or procedures
evaluation of the brain and renal regional oxygenation using nirs in preterm infants

Conditions: Pre-Term; Persistent Ductus Arteriosus

Summary: this study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus

patent ductus arteriosus (pda) is common in preterm infants. in the presence of a large pda, significant systemic to pulmonary shunting occurs, which may result in pulmonary hyperperfusion and systemic hypoperfusion. the evidence on pda effect on brain and renal tissue oxygenation, measured by near infrared spectroscopy is still controversial. this study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy (nonin sensmart model x-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2) persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.

Eligibility criteria:
inclusion criteria: * preterm infants with gestation age of \< 32 weeks * birth weight \< 1500g * \> 72 hours of age. exclusion criteria: * cardiovascular, renal, cerebral congenital defects, * confirmed sepsis, * no parental consent

Keywords: near-infrared spectroscopy preterm infant echocardiography
a pilot trial to determine the efficacy of lactobacillus rhamnosus for reducing colonization by methicillin-resistant staphylococcus aureus (mrsa) (prose)

Conditions: Infection

Summary: the purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, lactobacillus rhamnosus versus oral placebo for reducing colonization by mrsa.

healthcare-associated infections are an important threat to patient safety. currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the united states, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as methicillin-resistant staphylococcus aureus (mrsa), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential. eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. no effective means of eradicating mrsa colonization exist. probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as mrsa.

Eligibility criteria:
inclusion criteria: * subjects will be male or female * 18 years of age or older * may or may not be hospitalized * able to take oral medications * have been found to be colonized with mrsa or at high risk of being colonized by mrsa and are not taking antibiotics exclusion criteria: * people on antibiotics will not be eligible to participate

Keywords: probiotic lactobacillus antibiotic resistance
turkish validity and reliability of baltimore orthopedic subscapularis score

Conditions: Rotator Cuff Injuries; Subscapularis Tendon Tear

Summary: the aim of this study is to adapt the baltimore orthopedic subscapularis score (boss) to turkish society and to make its validity and reliability in turkish. the boss was developed by hameker et al to differentiate subscapularis tears from other rotator cuff muscle tears in patients with rotator cuff injuries. the boss has 5 questions. this study will be conducted with patients with rotator cuff injuries. the patients will be sought to answer questionnaires during regular rehabilitation sessions. 25 participants will be included in the study. in order to evaluate the validity of the boss, the western ontario rotator cuff disability index (worc), which can evaluate the functionality of the shoulder in patients with rotator cuff injury and has been validated in turkish, and the sf-12 which can evaluate the quality of life and has been validated in turkish, will be used. scales will be repeated after 15 days to assess test-retest reliability.

the reliability and validity of the scale will begin with language equivalence and cultural adaptation. the scale will be translated from english to turkish by two people who are fluent in turkish and english. a single turkish translation will be obtained from these two turkish translations with a common opinion. the scale, which has been translated into turkish, will be translated into english by two other people who are fluent in turkish and english. the scale translated into english will be compared with the original. in the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. based on the results of the pre-test phase, the final version of boss will be able to be modified. the data of boss will be collecting through face-to-face when the patients came to the rehabilitation center. 25 participants will be included in the study. in order to evaluate the validity of the boss, the western ontario rotator cuff disability index (worc), which can evaluate the functionality of shoulder in patients with rotator cuff injury and has been validated in turkish, and the sf-12 which can evaluate the quality of life and has been validated in turkish, will be used. scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria:
inclusion criteria: * individuals over 18 years of age who have been diagnosed with a rotator cuff injury, * patients whose native language is turkish, * individuals with a mini mental state examination score of \>24, exclusion criteria: * individuals with pain and disability due to any shoulder pathology other than rotator cuff injury, * individuals who cannot read or write turkish, * individuals with shoulder fractures, surgical interventions and other accompanying shoulder pathologies,

Keywords: scale validity rotator cuff injuries subscapularis tendon tear
abtest© card clinical perfomance study

Conditions: Transfusion Reaction

Summary: the study confirms the performance equivalence of the in vitro diagnostic reagent abtest card used with the new reformulated ws solution

the study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent abtest card (ce marked reagent) followed by a another pre transfusional control with the in vitro reagent abtest card in study (new reformulated ws solution used) .

Eligibility criteria:
66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not. 10 neonatal patients, background transfusion or guthrie test.

Keywords: reagent kits, diagnostic
navigated abdominal lymph node dissections

Conditions: Image-guide Surgery; Lymph Node Metastasis

Summary: image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. in this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation

in the study patients will be randomized between the use of a surgical navigation system or not. the operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.

Eligibility criteria:
inclusion criteria: * scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan exclusion criteria: * metal implants in the pelvic area * contra-indication for contrast enhanced ct scanning
non-invasive biometric monitoring in nursing homes to fight covid-19

Conditions: Covid19; Community-Acquired Respiratory Tract Infection

Summary: solving the problem of detecting asymptomatic carriers who can transmit infection is key to protecting vulnerable residents of nursing homes and assisted living facilities, to protecting frontline workers who care for them, and to facilitating return to work (including return of nurses and medical assistants). the wearable biometric technology, if widely disseminated among vulnerable populations and the community-at-large, will help avoid the ravages of seasonal flu and other contagious illnesses, and the society will be better prepared for future waves of covid-19 or other pandemics. even if a vaccine is developed, due to immune senescence and immunocompromise, elderly people and those with chronic medical conditions may not be well protected by it. continuous biomonitoring provides another layer of protection for them.

1. building the algorithm for early, pre-symptomatic detection of respiratory viral infection and for predicting eventual deterioration. 2. create an app that automates these algorithms and clearly reports actionable results to users, i.e., to medical professionals and citizens-at-large in near-real time. if alerted to a possible - and likely still asymptomatic - covid-19 infection, they can self-isolate or be quarantined, get confirmatory covid-19 testing done promptly, limit transmission to others, and stay safe knowing that if they are likely to deteriorate, the algorithm will alert the participants and their caregivers to the need to obtain medical attention promptly.

Eligibility criteria:
inclusion criteria: * residents and staff members of u.s. ltcfs where covid-19 transmission is actively occurring. the ltcf medical director must agree to enroll the ltcf, and each participant must have the capacity to agree and sign consent. exclusion criteria: * current atrial fibrillation. * nb: paroxysmal atrial fibrillation is permitted if the participant is in atrial fibrillation less than 50% of the day on most days. * pacemaker in place. * known active infection other than covid-19. * dementia

Keywords: covid-19 wearables biometric data