Kornimate/medical-research-clean huggingface dataset:
stereotactic mri-guided radiation therapy for localized prostate cancer

Conditions: Prostate Cancer

Summary: as the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. in addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. however, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. for this reason and for radiobiological considerations the total treatment time is increasingly shortened. it has been shown in several randomized phase iii studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). the current, prospective, non-randomized, multicentric, phase ii smile study is now testing whether the mri-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate carcinoma with tissue classification according to gleason score and psa * low- or intermediate-risk carcinoma according to d'amico criteria or early high-risk carcinoma (ct3a and / or gs ≤ 8 and / or psa ≤ 20ng / ml) * ipss (international prostate symptom score) max. 12 * prostate volume \<80cm³ * karnofsky index ≥ 70% * age ≥ 18 years * patient information provided and written consent * ability of the patient to give consent exclusion criteria: * previous radiotherapy in the pelvis * previous local therapy of the prostate * lymphogenic metastasis * stage iv (distant metastases) * contraindication to mri * simultaneous participation in another clinical study which could influence results of either of the respective study
intracranial pressure monitoring in sever traumatic brain injury single center experience

Conditions: Head Injury Trauma

Summary: intracranial pressure (icp) is defined as the pressure inside the skull, and therefore, the pressure inside the brain tissue and the cerebrospinal fluid (csf). the relationship between csf and intracranial blood volumes is described by the monroe kellie doctrine; because the brain is incompressible, when the skull is intact, the sum of the volumes of brain, csf, and intracranial blood is constant.

icp \>15 mmhg is considered to be elevated, and this is considered an important cause of secondary injury leading to irreversible brain injury and death. icp monitoring is used in a number of conditions; traumatic brain injury, intracerebral haemorrhage, subarachnoid haemorrhage, hydrocephalus, malignant infarction, cerebral oedema, cns infections, hepatic encephalopathy, to name a few, and in all of these conditions icp monitoring in the light of other parameters can influence management for better outcomes. there are 4 ways to monitor intracranial pressure: 1. an intra-parenchymal method, the catheter is placed into the brain parenchyma through a burr hole; it has a lower complication rate, lower infection rate, and no chance of catheter occlusion or leakage. neurological injury is minimized because of the small diameter of the probe. in addition, malposition of the transducer has less impact on errors of measurement. 2. an intra-ventricular method, the catheter is placed into one of the ventricles (lat. ventricle). the catheter can also be used for therapeutic csf drainage and for administration of drugs. 3. subdural method, this method is used if monitoring needs to be done right away. a hollow screw is inserted through a burr hole and placed through the dura mater. 4. an epidural sensor is inserted between the skull and dural tissue. this procedure is less invasive than other methods. icp monitoring methods is associated with a number of complications. these include risk of infection, haemorrhage, obstruction, difficulty in placement, malposition, etc. the use of an icp monitor is associated with significantly lower mortality when compared with patients treated without an icp monitor

Eligibility criteria:
inclusion criteria: 1. age \>18 2. gcs \< 8 3. patient with severe brain insult ( marshall class ii to iv) 4. patients admitted within 24 hours from the trauma time exclusion criteria: 1. patients admitted for surgery (ex; surgical edh) . 2. patient diagnosed as brain death
systemic lupus and adverse pregnancy outcome

Conditions: Systemic Lupus Erythematosus; Pregnancy Complications

Summary: prospective analytical study of all pregnant ladies with systemic lupus in beni-suef localities


Eligibility criteria:
inclusion criteria: * all pregnant ladies with settled diagnosis of systemic lupus * all pregnant ladies who first diagnosed as systemic lupus during current pregnancy exclusion criteria: -
hematological infection score compared to the hospital standard for diagnosis of sirs or sepsis on icu

Conditions: SIRS; Sepsis

Summary: crp and pct are not valid parameters of early infection in particularly postoperative patients. (sanders et al., a\&a, june 2006, vol.102; katja et al., shock, february 2001, vol 15.2) better detection systems for sirs and sepsis are urgently required. icis® (sysmex intensive care infection score) and icps® (sysmex intensive care prognostic score) are two new score-systems depending on detectable cellular response of the innate immune system in human peripheral blood. the purpose of this observational study is to determine if these scores are superior in early differentiation between non-infectious sirs and infectious sirs (sepsis) in postoperative patients. furthermore, the applicability of the scores for triggering start and ending of anti-infective therapy will be examined.


Eligibility criteria:
inclusion criteria: * all icu patients age \> 18 years * more than 36h on icu exclusion criteria: * icu patients age \< 18 years * less than 36h on icu

Keywords: sirs sepsis hematological infection score
fast assay for pathogen identification - quasi-experimental intervention study

Conditions: Sepsis; Septic Shock; Bacteremia

Summary: the performance and clinical impact of two diagnostic systems will be evaluated using whole blood samples that are collected in parallel with samples for blood culture. as the rapid diagnostic systems will have the largest impact on severely ill patients (in need of a fast diagnosis) with bacterial infection, the evaluation will be performed in patients suspected of bacteraemia. during the study the new systems will be used in parallel with routine blood cultures. in alternating periods of 1 month, the results of the diagnostic system will be communicated to treating physicians (intervention) or not revealed (control). blood culture results will be reported throughout the complete study period. patients with suspected sepsis at the emergency department (ed), the department of infectious diseases/nephrology, and the department of haemodialysis will be included. in routine care, two blood culture sets (2x2 bottles) per patient are collected. one extra blood sample (edta tube, 9 ml of blood) will be sampled for each routine set of blood cultures. in addition, the clinical data of the patients will be collected. the samples will be sent to the clinical laboratory where samples are tested with the new systems during regular working hours in batches of 8 samples per run (2-3 runs per day). on average, 10%-20% of the blood cultures drawn on the presumption of bacteraemia yield bacterial pathogens. previous data show that 13% of patients yield positive blood cultures. thus, in order to collect blood samples of 100 new episodes of bacteraemia approximately 1000 patients (2000 blood cultures + 1000 edta tubes) have to be collected for each system (2000 patients in total). the results of the systems will be used to evaluate the clinical utility of the system regarding time to antibiotic treatment change and bacteraemia management. the system will be used directly for the diagnosis of patients, resulting in a possible change of treatment strategy. however, routine blood culture practices will still be done during the whole study period.


Eligibility criteria:
inclusion criteria: * suspicion of sepsis * the drawning of blood cultures * age \>18 years exclusion criteria: * children (\<18 years) * patients who are not hospitalized and sent home after ed admission * duplicate blood cultures from the same bacteraemia episode (7days between positives with the same organism, or 24h for different organisms) * patients from who blood cultures are drawn on friday evening (17h) or saturday during intervention periods
phase i study of neoadjuvant chemotherapy for patients with borderline resectable pancreatic cancer.

Conditions: Pancreatic Cancer

Summary: gemcitabine plus nub-paclitaxel (gemabr) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the nac-gemabr regimen includes only two cycles (three times weekly and one week rest) of gemabr regimen.

gemcitabine plus nub-paclitaxel (gemabr) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. gemabr is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy . on the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the nac-gemabr regimen includes only two cycles (three times weekly and one week rest) of gemabr regimen. the investigators also evaluate the optimal treatment schedule of nac-gemabr therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, r0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Eligibility criteria:
inclusion criteria: * pathologically proven invasive pancreatic ductal carcinoma * cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) 1. definition of a borderline resectable pancreatic cancer is filledin nccn guideline version 1.2014 pancreatic adenocarcinoma 2. patients indicated distal pancreatectomy with en bloc celiac axis resection * ps (ecog) 0-1 * ≧20 years old and \< 80 years old * first line treatment * the following criteria must be satisfied in laboratory tests within 14 days of registration white blood cell count ≦12,000/mm3 neutrophil count ≧1,500/mm3 platelet count ≧100,000mm3 total bilirubin \<2.0mg/dl serum creatinine ≦upper limits of normal(uln) ast, alt≦2.5×uln albumin≧3.0g/dl hemoglobin≧9.0g/dl * written informed consent to participate in this study exclusion criteria: * severe drug hypersensitivity * multiple primary cancers within 5 years * severe infection * with grade2 or more severe peripheral neuropathy * with intestinal paralysys, ileus * interstitial pneumonia or pulmonary * with uncontrollable pleural effusion or ascites * receiving atazanavir sulfate * with uncontrollable diabetes * with uncontrollable heart failure, angina, hypertension, arrhythmia * with severe psychological symptoms * with watery diarrhea * pregnant or lactating women, or women with known or suspected pregnancy * inappropriate patients for entry on this study in the judgment of the investigator
feasibility study of a post-hospitalization self-rehabilitation program for elderly suffering of sarcopenia

Conditions: Sarcopenia

Summary: loss of autonomy among elderly during and after hospitalisation is a well-known problem. patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not to recover their previous autonomy. studies have shown that physical exercise, especially resistance exercises, is the most efficient known treatment of sarcopenia. several institution-based rehabilitation programs had been implemented in this purpose. on the other hand, some studies have shown that home-based self-rehabilitation can be as efficient as institution-based rehabilitation, for example in stroke, cardiac failure and copd rehabilitation. the investigators propose to set up a home-based self-rehabilitation program to fight against sarcopenia and hence increasing autonomy among elderly. this study aimed to establish the feasibility of such a program.


Eligibility criteria:
inclusion criteria: * patients aged 70 or older * non-institutionnalised patients * patients suffering of sarcopenia during hospitalisation (assessed by the short physical performance battery, bio-impedance analysis and griptest) * patients hospitalised in the service of internal medicine of institut mutualiste montsouris * patients returning at home after hospitalisation * patients who gave their written consent * patients who benefits from a social security coverage exclusion criteria: * patients suffering from a severe medical condition not allowing them to follow a physical exercise program * palliative care patients * patients without the musculo-squelettic capacity to follow the program : 4/4 on seated postural stability scale ; no motor deficit on lower limb muscular testing ; quadricipital locking when standing * patients with severe cognitive disorders (according to mmse score adapted to socio-cultural level and age) * patients who live more than 150 km away * patients following specific physiotherapy
ocular pathogen and transcriptome investigation using comprehensive sequencing

Conditions: Uveitis; Infectious Disease

Summary: this is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (mds) versus standard of care testing for improvement of outcomes for intraocular infections. patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive mds testing results or not to receive mds testing results. all patients will receive standard-of-care testing to guide management. enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. the proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. patient quality of life, mds performance, and the provider certainly of belief will be collected.


Eligibility criteria:
inclusion criteria: * presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis * presumed post-operative endophthalmitis * unilateral or bilateral * 18 years and older exclusion criteria: * insufficient specimen for mds * age \< 18 years of age * pregnancy * unable to consent

Keywords: uveitis metagenomic deep sequencing intraocular infection mds
viral load analysis of the sars-cov-2 virus in nose versus mouth sites

Conditions: Sars-CoV-2 Infection

Summary: it is a single-center, non-profit experimental study, intended to evaluate the viral load of sars cov 2 in nasal and oral samples of positive subjects to evaluate any variation and understand which is the most suitable site for carrying out the swab.

experimental study on de-identified, biological samples (nasal and buccal swab). the study will be performed on patients admitted to irccs sacro cuore don calabria hospital or health care workers or their family members, who tested positive for sars-cov-2 by either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics. among the family members, also children \>4 years old will be included. the reason for including children and young subjects is based on data indicating that they seems to be highly sensitive to omicron infection and that their vaccination status could influence viral load. the nose and mouth swab are poor invasive and they could be well tolerated also by children. whinin 7 days from diagnosis, the subjects will be requested to sample another two specimens i.e. nasal swab and mouth swab, that will be tested for the presence of sars-cov-2 rna. results, expressed as cycle threshold will be then compared to analyze viral loads from the two different sites. moreover, an aliquot will be retro-transcribed into cdna and sequenced by next generation sequencing (ngs) to obtain the virus entire genome sequence or evaluated by rt-pcr for variant determination.

Eligibility criteria:
inclusion criteria: * patients admitted to irccs sacro cuore don calabria hospital or health care workers or their family members. among the family members, also children \>4 years old will be included. * subjects verified as positive to sars-cov-2 according to either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics. * subjects who will accept to participate to the study and will sign the informed consent. exclusion criteria: * lack of any needed data or inform consent
hpv vaccination: evaluation of reminder prompts for doses 2 & 3

Conditions: Human Papilloma Virus Infection Type 11; Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Human Papilloma Virus Infection Type 6; Cervical Cancer; Genital Warts; Oropharyngeal Cancer

Summary: randomized, 2-arm observational study. the 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of hpv vaccine for eligible male and female adolescents who have initiated vaccination.

the study team plans to conduct a randomized clinical trial with three arms: (1) usual care, (2) the simple reminder, and (3) the simple reminder plus the script. randomization will be carried out at the physician level at each clinical site, to ensure that all three treatment arms are represented in each clinic. the primary outcome, hpv vaccine acceptance, will be assessed for each study participant. this study will be implemented through the child health improvement through computer automation system (chica). chica is a computer based clinical decision support system that has been operating in the wishard/eskenazi system since 2004. chica now operates in 5 clinics in the health system and has served well over 37,000 children. chica supports primary pediatric care, supporting screening, counseling, anticipatory guidance, vaccinations, and chronic disease diagnosis and management. chica is unique in several respects. these include a unique tailored, scannable paper interface, a prioritization scheme that assures the highest priority reminders are given to physicians, and the ability to collect data directly from families in the waiting room. chica acts as a front end to the regenstrief medical record system (rmrs), the electronic medical record for the eskenazi health system. the rmrs and chica communicate using industry standard hl7 communication protocols. when a patient checks into a chica clinic, chica receives an hl7 adt (registration) message. in response chica requests a download of the patient's record from the rmrs. chica applies a set of arden syntax rules to the patient's data to select 20 yes/no questions that are printed. the family answers these questions by checking boxes. the nurse or medical assistant enters height, weight, etc. on the same form and the form is scanned. the data enter chica's database through optical mark recognition and optical character recognition. recently we have begun converting from this scannable paper format to electronic tablets.

Eligibility criteria:
inclusion criteria: provider criteria * all pediatricians and nurse practitioners who provide health care at the 5 chica clinics will be included in this study subject criteria * patients will be 11-17 year old * males and females * a visit to at least one of the five chica clinics * eligible for the 2nd or 3rd dose of hpv vaccine exclusion criteria: * patients in the eligible age range who have not started or have completed the hpv vaccine series will be excluded

Keywords: hpv vaccinations quadrivalent vaccine
genetic markers and biomarkers in patients with intellectual disabilities of genetic origin

Conditions: Down Syndrome; Intellectual Disability

Summary: analyze genetic and biological markers in patients with intellectual deficiencies (id) of genetic origin in order to better understand the mechanisms of modified genes, cellular mechanisms, pathways involved in different disorders , complications and pathologies associated with id of genetic origin.

blood and skin samples will be taken from patients coming at the outpatients clinic of the institut jérôme lejeune and who consent to participate to the study. search and identification of markers will be then done from the collected samples.

Eligibility criteria:
inclusion criteria: * patient diagnosed with an intellectual disability of genetic origin * patient of all ages coming for consultation at the institut jérôme lejeune * patient whose parents or legal representative have received and understood the information document and signed the informed consent for a sample for the research project. * patient affiliated to a social security scheme exclusion criteria: * parents unable to find out about the constraints related to the study * refusal of informed patient participation * pregnant, parturient and nursing mothers * persons deprived of their liberty by judicial or administrative decision
european prosthetic joint infection cohort study- hip, knee and shoulder prosthetic joint infection

Conditions: Prosthesis-related Infections

Summary: the purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (pji) by improving the treatment concept of pji.

the aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. the decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.the success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. all consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.the samples are obtained preoperatively and intraoperatively as part of routine care practice. the study is not randomized.

Eligibility criteria:
inclusion criteria: * subject is older than 18 years of age * written informed consent has been obtained * subject needs a revision surgery of the hip, knee or shoulder prosthesis exclusion criteria: * subject is currently enrolled in another investigational study * inability to read and understand the participant's information * subject is younger than 18 years of age

Keywords: infection prosthesis hip knee shoulder