Kornimate/medical-research-clean huggingface dataset:
evaluation of contrast medium enhanced post-mortem ct in virtual autopsy

Conditions: Thromboembolism; Vascular Conditions

Summary: the study aims to compare the value of contrast medium enhanced post mortem ct to classic autopsy.


Eligibility criteria:
inclusion criteria: * patients dying in the icu * age \>18y exclusion criteria: * relatives refusing to participation in the study

Keywords: contrast medium enhanced post mortem ct virtual autopsy to evaluate the value of contrast medium enhanced post-mortem ct in virtual autopsy focussing on thromboembolic and vascular conditions
local application of combined optical and magnetic stimulation (coms) for treatment of chronic wounds: safety evaluation

Conditions: Leg Ulcers Venous; Leg Ulcer Arterial; Leg Ulcer Mixed

Summary: the demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. patients suffer from pain and immobility, which dramatically reduces their quality of life. complications such as infections or tissue necrosis can lead to a bad outcome and amputation of extremities. the pio device offers a non-invasive and non-toxic therapeutic approach. the system combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. the investigational medical device represents a promising combinational therapeutic approach to synergistically increase the tissues regenerative potential. by stimulating electrophysiological processes at the site of injury, the cells regain its capacity to efficiently regenerate the injured or diseased tissue. it is expected that the patient benefits from a faster healing process, reduced inflammation as well as an improved overall treatment outcome.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * male and female patients * age: 18 - 90 * chronic wound (venous ulcer, arterial ulcer, mixed ulcer) since at least 4 weeks * wound area minimal 1 cm2, maximal 50 cm2 * no adaptions for treatment of causal therapy of disease exclusion criteria: * women who are pregnant * known or suspected non-compliance, drug or alcohol abuse, * participation in another study with investigational drug within the 30 days preceding and during the present study, * enrolment of the investigator, his/her family members, employees and other dependent persons, * patients with active devices (e.g. pacemakers and defibrillators, infusion devices, insulin pumps) * metallic implants and endoprosthesis at extremities lower than hip * life threatening condition * immunosuppressive after foreign organ transplant or chemotherapeutic treatment within 30 days before study begin
effectiveness of nursing intervention on caregivers

Conditions: Quality of Life

Summary: the purpose of this study is to evaluate the effectiveness of a structured nursing intervention (pce), including two types of intervention defined in the literature (coping strategies promoting social support and empowerment through health education), which has an effect on the perceived quality of life for the caregiver, when compared with conventional intervention or non-support.

aim: to compare the effectiveness of a standardized care plan (scp) compared to the usual nursing intervention to improve the quality of life for primary caregivers over 65 years old measured through points change with the euroqol-5d (eq-5d) scale. secondary objectives: evaluate the influence of prognostic variables on quality of life of caregiver. describe the level of caregiver burden. describe the socio-demographic profile of the dependent person and caregiver. method: design: cluster randomized trial. setting: study in health centers primary care of area of madrid health service. subjects: unit of randomization: primary healthcare centres. analysis unit: caregivers over 65 years old. intervention: the scp in the treatment group and the usual intervention in the control group. sample size adjusted for design effect= 218 (109 in each arm). main response variable: perceived quality of life (eq-5d). secondary response variables: nursing diagnosis, zarit caregiver burden interview, objective overload level. prognostic variables:dependent person-related: dependence level (barthel, lawton-brody), cognitive dysfunction (pfeiffer). caregiver-related: depression scale (yesavage), anxiety level (goldberg), family function (family apgar). sociodemographic variables. data analysis: analysis of main effectiveness by intention to treat, comparing the difference in units on the eq-5d scale before and post- intervention in both groups at 0, 6, 12 and 18 months. the estimation adjusted, using logistic regression with aleatory effects, those data that can act as confounding factors or change the effect.

Eligibility criteria:
inclusion criteria: * not psychological treatment or social support during the study period. * be able to follow the trial's demands. * experience of caring for at least 6 months in a year. * caregivers who consent to take part. exclusion criteria: * caregivers of patients hospitalized during the initial data collection. * caregivers of institutionalized patients. * severe psychiatric conditions including depression and major affective pictures. * paid caregivers. * experience as a caregiver for less than a month.

Keywords: nursing intervention primary health care caregiver strain
randomized clinical trial on preoperative radiotherapy 25 gy in rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (r0) in patients with locally advanced rectal cancer operated on according to tme technique. in particular 3d endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

the treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st department of general surgery, jagiellonian university, cracow. the data on survival has been systematically collected using national census registry. patients are qualified to preoperative radiotherapy 5x5 gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3d endorectal ultrasound and endorectal ultrasound with sonovue are performed to assess the tumor before and after preoperative radiotherapy.

Eligibility criteria:
inclusion criteria: * histologically confirmed rectal cancer * tumor localised in middle or lower rectum * age \> 18 years * locally advanced cancer exclusion criteria: * previous pelvis radiotherapy * lack of patient's consent * lack of possibility to begin radiotherapy during 14 days after inclusion to the study

Keywords: rectal cancer radiotherapy overall survival recurrence rate downstaging
effectiveness of a ready-to-use-food (ruf) supplement to prevent acute child malnutrition

Conditions: Child; Malnutrition

Summary: the overall objective of this project is to assess the effectiveness and cost-effectiveness of ruf (ready-to-use food, plumpy doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.


Eligibility criteria:
inclusion criteria: * wh≥80% of median of nchs reference without bilateral pitting oedema; * age ≥ 6 months and ≤36 months; * member of a household with a dependency ratio \>4; * not planning to leave the study zone for the coming 5 months; exclusion criteria: * not showing appetite; * age \ 36 months * weight-for-height z-score \<-2 and/or the presence of bilateral pitting oedema in children 6-36 months; * member of a household with a dependency ration ≤ 4; * clinical complications * presence of chronic illness, cardiac disease, congenital abnormalities, cancer; * being allergic to one of the ingredients of the ruf.

Keywords: moderate acute malnutrition, prevention, lipid-based supplement
influence of preop fibrinogen on blood in pediatric cardiac surgery

Conditions: Cardiac Surgery; Congenital Heart Disease; Cardiopulmonary Bypass; Fibrinogenemia

Summary: fibrinogen plays an important role in the coagulation cascade. low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. guidelines from the european society of anesthesiology and intensive care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. this is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels. the aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018 * age \< 16 year exclusion criteria: * preoperative coagulopathy * jehovah's witnesses * patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit
study of tissue samples from patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies tissue samples from patients with non-small cell lung cancer.

objectives: * to identify and characterize single nucleotide variations (snvs) in non-small cell lung cancer (nsclc) specimens. * to identify and characterize structural variations in the genomes of nsclc specimens. * to identify and characterize other genomic alterations including, but not limited to, expression profiling and methylation. outline: dna and rna extracted from archived specimens are analyzed for single nucleotide variations, structural variations in the genomes, and other genomic alterations including, but not limited to, gene expression profiling and methylation. clinical data related to disease, treatment, and recurrence from each patient sample is also collected.

Eligibility criteria:
* patient must have been registered to calgb 140202. * tumor histology should be either primary adenocarcinoma or squamous cell carcinoma of the lung. * patients are eligible for this study if their samples from calgb 140202 are available. * all living patients must sign the calgb 151107 consent form to be eligible for this trial.

Keywords: adenocarcinoma of the lung adenosquamous cell lung cancer non-small cell lung cancer squamous cell lung cancer
study of bosentan in the treatment of stable severe chronic obstructive pulmonary disease patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: present treatment for chronic obstructive pulmonary disease (copd) has a certain role in reducing copd exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. but for some patients with severe copd, current treatment only partially alleviates the symptoms and has little role in the lung function decline. in this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade ⅲ or ⅳ copd patients with pulmonary hypertension detected by echocardiography. the primary endpoint is the frequency of copd exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-mwd), sgrq score and mmrc/cat score.


Eligibility criteria:
inclusion criteria: * aged 18 to 75 * gold ⅲ or ⅳ stable copd * pulmonary hypertension detected by echocardiography exclusion criteria: * acute exacerbation of chronic obstructive pulmonary disease * untreated obstructive sleep apnea * restrictive (total lung capacity\<60% predicted) lung disease * portal hypertension * chronic liver disease * transaminase increased to normal line more than 3 times; total bilirubin increased 2 times more than the upper limit of the normal value * left-sided or unrepaired congenital heart disease * patients with other serious heart diseases * patients with 1, 2, 4 and 5 categories of pulmonary hypertension * unable to complete the 6 minutes walk test * patients receiving other endothelin receptor antagonists * no cooperation to complete

Keywords: treatment, copd, bosentan
ultrasound parameters for the outcome prediction of external cephalic version for fetuses with breech presentation

Conditions: Breech Fetal Presentation; Breech Presentation of Fetus with Successful Version; Vaginal Delivery; Cesarean Section

Summary: this study aims to evaluate possible predictors for the successful od external cephalic version (ecv), a procedure that is indicated in your case due to breech presentation of your baby and your desire to avoid cesarean section. before the procedure, a detailed ultrasound scan will be performed to measure several parameters. after the procedure we will collect data about the duration, outcome and eventual complications of ecv.

pregnant women with a diagnosis of fetal breech presentation, desirous of an attempt of ecv after counseling and written consent and hospitalized for the procedure will be consecutively enrolled. the following anonymous data will be recorded: * demographic and anthropometric data (i.e., age (y), ethnicity, height (m), weight (kg), bmi); * parity * gestational age (weeks + days) before ecv attempt, the following evaluations will be performed: * vaginal examination to evaluate the cervical dilatation and the level of presenting part (floating or not floating) * fetal transvaginal ultrasound reporting: * biometry (bpd, hc, ac, fl, efw); * occiput position (right, left); * back position (anterior, posterior, right, left); * breech variant (footling, frank, complete); * fetal leg posture (extended, flexed) * placental localization; * amniotic fluid index (afi); * fore-bag of amniotic fluid; * eventual presence of nuchal cords; * fetal head ballottement (yes, no); * occiput-spine angle (see figure 1) then, all the participants will undergo a transabdominal ultrasound-guided ecv in a semi-sitting position by the same expert operator (b.c.). after the procedure, the following data will be collected: * success (yes, no) * duration of the procedure (min); * direction of fetal flip in case of success (frontside flip, backside flip) * pain perception in numerical rating scale (nrs) (1-10); * reason for terminating the procedure (success, failure, pain, uterine contractions, non-reassuring fetal conditions)

Eligibility criteria:
inclusion criteria: * age ≥18 y.o.; * pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ecv; * singleton; * at term (≥ 37 weeks); * breech presentation; * no previous uterine scars or other indications for elective c-section; * signed written informed consent to study participation. exclusion criteria: * age \&lt;18 y.o.; * preterm gestational age; * multiple pregnancies; * indications for elective cesarean section; * incomplete obstetrical data; * refusal to provide informed consent. * desire to an elective c-section * controindications for ecv or vaginal delivery (placental abruption, placenta previa, uterine malformations) * reduction of amniotic fluid (afi \&lt;4 cm) * uterine contractions * vaginal bleeding * premature rupture of membranes * nonreassuring fetal heart rate patterns before the procedure.

Keywords: breech external cephalic version ultrasound c-section
delayed cni-based immunosuppression with advagraf after meld-based liver transplantation

Conditions: Liver Graft Dysfunction

Summary: prolonged-release low-dose advagraf should better protect from cni-side effects compared to standard immunosuppressive regiments while the rate of rejection is not increased and thus graft function is well maintained. we hypothesize that especially in high-meld (meld-score \>20) recipients who have a decreased immune competence the prolonged-release low-dose advagraf concept would better protect from side effects of immunosuppression (i.e. infection). nevertheless, we assume that also patients with a meld-score ≤20 will benefit from this concept in regard to lower infection rates and less side effects of immunosuppression.

the meld-score (model of end stage liver disease) was designed to estimate the prognosis after tips (transjugular intrahepatic porto-systemic shunt). nowadays it is the key-score for patients awaiting a liver graft and consists of serum-creatinine, serum-bilirubine and the inr-ratio with values between 6-40. the meld-based liver allocation follows the sickest patient first strategy which significantly decreased outcome after liver transplantation (ltx) in germany. there is evidence that the immune competence of very sick patients is decreased. monocytic hla-dr status is a marker for the function of the immune system. a reduced monocytic hla-dr expression is indicative for a suppressed immune system. blood levels of advagraf are slowly increased during the first week until the aimed tacrolimus trough levels are reached. since therapeutic tacrolimus trough levels are reached not before the end of the first week after transplantation this is a concept for prolonged-release immunosuppression. we assume, that high-meld patients (meld \>20) undergoing ltx are immunosuppressed per se. thus prolonged-release low-dose immunosuppression with advagraf would decrease both- infection rate (cmv-reactivation, wound infection urinary tract infections, pneumonia, etc.) and side effects of immunosuppression. the immune capacity of patients will be determined by the measurement of monocytic hla-dr status. to ensure that graft function is not impaired due to rejection episodes, liver function will be determined with the limax-test, a routine procedure in our institution. after 13-c-methacetin is given to the patient, it is metabolized to paracetamol and 13co2 by the enzyme cyp1a2 which is localized in hepatocytes. the 13co2/12co2 ratio in the exhaled air correlates with liver function.

Eligibility criteria:
inclusion criteria: * age \>18, \<65 * first liver transplantation * immunosuppression with advagraf, mmf, corticosteroid * surgery and postoperative treatment at the department for general-, visceral- and transplantation surgery exclusion criteria: * missing informed consent * re-transplantation * acute infection: cmv (pp65 positive), pneumonia, urinary tract infection, wound infection, reactivation of hepatitis b/c

Keywords: advagraf meld-score na-meld-score liver function limax-test infection rate hla-dr status immunostatus
exercise recovery from persistent depression: a thematic analysis

Conditions: Major Depressive Disorder; Depression Moderate; Depression Severe

Summary: depression is a leading cause of disability worldwide and poses a large economic burden in the uk. there is evidence that exercise is beneficial in the management of depression and nice now recommends group exercise programs as a treatment for people with mild and moderate-severe depression. research shows that patients with severe depression are less likely to engage in exercise than patients with mild to moderate depression. there is little evidence, however, on the barriers and drivers to participation in such programs experienced by patients with depression; leading to uncertainty in the most effective way to implement these programs. we aim to analyse accounts of patients who have been referred to or participated in the exercise recovery group (erg), a group exercise program at the nottingham specialist depression service (nsds). the nsds is a tertiary unit where referred patients have suffered moderate-severe, persistent clinical depression. eligible participants will be patients with persistent major depression who have agreed to referral to the erg at the nsds and who are able to provide informed consent. participants will undergo a one-off 60 minute meeting via ms teams, including an in-depth semi-structured interview on their experience as well as self-completion questionnaires assessing demographics, depression, anxiety and shame. transcripts of the interviews will be subject to qualitative thematic analysis addressing questions on barriers and drivers of exercise treatment in depression; and the perceived impact of an exercise group on the individual participating. themes will be developed to give an account of these questions, supported by anonymised quotes from the transcripts. the questionnaire data (on demographics, depression, anxiety, shame) will be used to characterise the group, in order to help assess directness of the evidence provided for other clinical populations; ultimately helping clinicians to implement exercise groups for depression that are acceptable for patients.


Eligibility criteria:
inclusion criteria: * patients with persistent major depression * patients who have at least agreed to referral to the exercise recovery group within the previous 24 months * patients who are able to provide informed consent. exclusion criteria: * patients with a main diagnosis of bipolar disorder. * patients who cannot speak fluently in english. * patients without an email account or access to an electronic device that could be used for the ms teams meeting. * patients who are younger than 18-years-old. there is no upper age limit.

Keywords: exercise barriers facilitators
posterior cruciate ligament reconstruction using knot/press-fit technique

Conditions: PCL TEAR

Summary: this study presents an arthroscopic-assisted pcl reconstruction using femoral knot/press-fit technique with a periosteum-enveloping graft in tibial tunnel. the investigators evaluated the results of patients with pcl ruptures, who undergoing pcl reconstruction using this unique technique.


Eligibility criteria:
inclusion criteria: * pcl tear exclusion criteria: * pl instbility
trimodal (18)f-choline-pet/mpmri/trus targeted prostate biopsies

Conditions: Prostatic Neoplasm; Positron-Emission Tomography; Fluorocholine

Summary: prostate cancer is the first cancer in humans (25%). the most widely used tracer in oncology, the 18-fluoro deoxyglucose does not allow the study of prostatic neoplasia. on the other hand, choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. its concentration is directly proportional to cell proliferation. the analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection). the goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after imaging fusion of choline-pet/ct compared to 1.5t multiparametric magnetic resonance imaging (mpmri) with 3d-transrectal ultrasound (trus) .


Eligibility criteria:
inclusion criteria: * patients with suspicion of prostate cancer * patients who performed prostate mpmri and f-choline 18 pet scan * patient capable of receiving clear informations * patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor) * patient covered by a healthcare insurance exclusion criteria: * patients without suspect image of neoplasia after mpmri and f-choline 18 pet scan