Kornimate/medical-research-clean huggingface dataset:
trial for the early identification of acute kidney injury

Conditions: Acute Kidney Injury

Summary: previse is a novel, software-based clinical decision support (cds) system that predicts acute kidney injury (aki). previse uses machine learning methods and information drawn from the electronic health record (ehr) to identify the early signs of acute kidney injury; by doing so before the clinical syndrome of aki is fully developed, previse can give clinicians the time to intervene with the goals of preventing further kidney damage, and decreasing the sequelae of aki. it has been demonstrated in retrospective work that previse can predict aki with high accuracy at long prediction horizons, but the tool has yet to be validated in prospective settings; therefore, in this project, the clinical utility of previse will be assessed through an individually randomized controlled multicenter trial.

the trial is designed as an individually randomized, controlled, and non-blinded multicenter prevention trial with a baseline period and a primary endpoint of proportion of patients meeting one or more criteria for the major adverse kidney events within 30 days (make30) composite of death, new renal replacement therapy, or persistent creatinine elevation ≥ 200% of baseline, all censored at the first of hospital discharge or 30 days. the trial will evaluate the efficacy of a machine learning algorithm for aki prediction, in approximately 8,574 patients aged ≥ 18 years admitted to one of three participating study hospitals. individual patient randomization will be performed at the time of the alert with a 1:1 allocation ratio. patients will be evaluated for inclusion in the trial upon admission, and will be automatically enrolled upon meeting inclusion criteria. because data collection will be conducted through noninvasive procedures that are routinely employed in clinical practice, it will require a waiver of informed consent. trial efficacy will be assessed at regularly scheduled study visits, and safety will be monitored on an ongoing basis for all patients. safety will be assessed through the collection of adverse events, laboratory tests, vital signs, and physical examinations throughout the study. an independent data monitoring committee (dmc) will be formed to assist in the periodic monitoring of safety, data quality, and integrity of study conduct. in addition, the dmc will review the interim efficacy analysis performed to determine whether the primary endpoint has been met. total trial duration is expected to be approximately 12 months.

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years admitted to a participating study hospital exclusion criteria: * ﹤18 years of age * esrd diagnosis code * stage 4 or stage 5 ckd diagnosis code * initial creatinine ≥4.0mg/dl * nephrectomy during admission * admission to hospice service * admission to observation status * any organ transplant (including kidney transplant) within 6 months * dialysis order prior to aki onset * dialysis order within 24 hours of admission * prior admission in which patient was randomized
a case-control study on risk factors, timing, and pcr use, for pneumocystis pneumonia (pcp) after allogeneic hsct

Conditions: Pneumocystis Pneumonia

Summary: the fungus pneumocystis jirovecii is responsible for pneumocystosis (pcp), a life threatening pneumonia in patients undergoing hsct. the spontaneous attack rate of 16% within the first 6 months following allogeneic hsct reported in the 1980's has considerably decreased with prophylaxis. however, pcp still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous hsct but up to 7.2% on low dose of dapsone. the mortality of pcp is especially high in hsct recipients. one of the main factors of pcp after hsct seems to be either the lack of tmp-smx prophylaxis (all the other prophylactic drugs being inferior to tmp-smx), or poor compliance to prophylaxis. due to the rarity of the disease after hsct, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome. moreover, some european laboratories involved in the diagnosis of pcp have already given up to classical diagnostic methods and switched to qpcr. this implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.

due to the lack of standardization, qpcr on sputum only will not be taken in account for the diagnosis of pcp. knowing this is a non-interventional study, no additional visits or laboratory tests will be performed for the study. only the available data will be collected.

Eligibility criteria:
inclusion criteria pcp cases: * allogeneic hsct within the previous 24 months * new case (first onset) of pcp documented in a bal fluid, whatever the positive diagnostic test (cytology or if or pcr) and whatever the presentation and treatment * any age * pre or post-transplant signed informed consent to enter the data in the ebmt registry exclusion criteria pcp cases: * autologous hsct * allogeneic hsct recipient transplanted more than 24 months at time of the onset of pcp * second episode of pcp since allogeneic hsct (patients who had experienced pcp before the allogeneic hsct are not excluded).

Keywords: jirovecii pneumocystis pcp
comparison of 2 treatment regimens for eradication of p aeruginosa infection in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: treatment of new pseudomonas aeruginosa (pa) infection in cystic fibrosis (cf) can postpone chronic infection. aim of the study: compare 2 pa eradication regimens in children with new pa infection.

methods: cf children (0-18 years) with a new isolation of pa from the airway were randomized to tobramycin inhalation solution (tobi® 2x300 mg for 28 days) (tis) or inhaled colistimethate sodium (colistineb® 2x2 mill u daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (cc). the primary outcome was eradication at end of treatment. secondary outcome parameters were time to pa relapse, total and pa specific igg, fev1, bmi and pa status.

Eligibility criteria:
inclusion criteria: * diagnosis of cf (clinical signs consistent with cf and a sweat chloride \> 60 meq/l by quantitative pilocarpine iontophoresis and/or two cf causing mutations identified) * age 0 to 18 years old at time of inclusion * 'first' or 'new pa infection' defined as 'first pa isolation ever' or 'isolation of pa from the airway (sputum, throat swab or bal) after a pa free interval of at least 6 months and documented with at least 3 negative cultures'. exclusion criteria: * chronic pa infection defined according to the leeds criteria\[17\] * pulmonary exacerbation needing iv ab treatment at time of new pa isolate * pa isolation at time of cf diagnosis * patient already on an antipseudomonal antibiotic * interval between positive culture and start of treatment \> 4 weeks.

Keywords: cystic fibrosis- p aeruginosa- eradication-child
icbt for depression - a factorial investigation of kinds of therapist support and self-/expert-selected content

Conditions: Depressive Disorder, Major; Depressive Symptoms

Summary: the study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.

the study is a 2 x 2 design. the first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. the second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an it-technician and the principal investigator of the study.

Eligibility criteria:
inclusion criteria: * current depressive symptoms equivalent to a score of at least 5 on patient health questionnaire 9 and a minimum of 10 points on becks depression inventory. * 18 years or older. * adequate ability to understand and speak swedish. * access to the internet and a smartphone/computer. exclusion criteria: * other ongoing psychological treatment or counselling. * recent (within the past 3 months) changes in the dose of psychotropic medication. * prior diagnosis of psychosis, bipolar disorder, or substance dependence.
salicylic acid versus cryotherapy for the treatment of hpv1-induced plantar warts

Conditions: Warts

Summary: to evaluate whether salicylic acid was superior to cryotherapy for plantar warts

patients with plantar warts were randomized equally to receive salicylic acid or cryotherapy. cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. thirty percent of salicylic acid is applied once daily by the patient (or parent) for a maximum of 12 weeks. the primary outcomes were the cure rates at 12 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.

Eligibility criteria:
inclusion criteria: * patients with hpv1-induced plantar warts. * total number of warts is ≤5. * aged 12 years or older. exclusion criteria: * patients are currently participating in another trial for the treatment of plantar warts. * patients had received two or more consecutive sessions of cryotherapy, with an interval of no more than 4 weeks (the history of salicylic acid treatment was not considered as criteria for exclusion because high concentration salicylic acid is not commercially available in chinese mainland). * patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months. * patients have impaired healing eg due to diabetes, vitamin a deficiency, hyperthyroidism and hypothyroidism. * patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases). * patients are pregnant or ready for pregnancies or breast-feeding. * patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or raynaud's syndrome). * patients have local pain intolerance. * patients have local hypoesthesia. * patients are unable to tolerate salicylic acid or cryotherapy.
digestive tract reconstruction after gastrectomy of gastric cancer with type 2 diabetes

Conditions: Gastric Cancer

Summary: different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. subtotal gastrectomy with billroth ii reconstruction and total gastrectomy with roux-en-y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, c -peptide and body weight of gastric cancer patients with type 2 diabetes.

different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. subtotal gastrectomy with billroth ii reconstruction and total gastrectomy with roux-en-y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, c -peptide and body weight of gastric cancer patients with type 2 diabetes. the investigators will observed fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, c -peptide and body weight of the patients preoperation, 14 days postoperation 3 month and 6month postoperation. the investigators will observed the effect of blood glucose to different digestive tract reconstruction after gastrectomy of gastric cancer with type 2 diabetes

Eligibility criteria:
inclusion criteria: 1. 18-75 years old,gastric cancer ,can be performed operation 2. with type 2 diabetes,fasting blood glucose \> 6.1mmol/l 3. without serious underlying diseases which may affect the metabolism and nutrient uptake 4. without serious underlying diseases which may affect anesthesia and operation 5. can be performed subtotal or total gastrectomy, predicted survival period \> 6months 6. no other abdominal operation 7. preoperation consultation 8. informed consent exclusion criteria: 1. recurrent,metastasis or die 2. patient requests for quit 3. pregnancy
sems placement with and without biliary sphincterectomy in patients with malignant biliary obstruction

Conditions: Malignant Bile Duct Obstruction

Summary: placement of biliary self expanding metal stent (sems) is indicated when malignant common bile duct obstruction is encountered \[1\]. currently, there is still controversy regarding the use of endoscopic sphincterotomy (est) before the placement of biliary stents \[2-5\]. the aim of this prospective randomized, multicenter study is to investigate the role of est before fully covered sems placement in patients with neoplastic biliary obstruction.


Eligibility criteria:
* inclusion criteria * patients referred for endoscopic retrograde cholangiopancreatography * malignant bile duct obstruction * signed written informed consent * age \> 18 * exclusion criteria * inability to provide inform consent * pregnancy or lactation * suspected perforation of the gi tract * anatomical alterations due to previous surgery (billroth surgery) * coagulation alterations
safety and efficacy of agn208397 in the treatment of macular edema associated with retinal vein occlusion (rvo)

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will evaluate the safety and efficacy of a single intravitreal injection of agn208397 to treat macular edema associated with retinal vein occlusion. this study is being conducted in two stages: stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of agn208397 and be followed for 12 months post treatment; based on stage 1 results, stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of agn208397 or ozurdex® and be followed for 12 months post treatment.


Eligibility criteria:
inclusion criteria: * macular edema due to retinal vein occlusion * visual acuity in the study eye between 20/320 to 20/40 exclusion criteria: * cataract surgery or lasik within 3 months prior to study day 1 or anticipated need for cataract surgery during study period (12 months) * use of injectable drugs in the study eye within 2 months prior to day 1 * active eye infection in either eye * visual acuity in the non-study eye of 20/200 or worse
a comparison of the effects of ketamine and remifentanil on serum cystatin-c levels in cabg surgery

Conditions: Coronary Artery Disease

Summary: in this prospective, randomized, clinical trial, we have investigated the effects of ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c levels, and creatinine and/or cystatin-c based egfr equations in terms of acute kidney injury in cabg surgery.this study was approved by the ethics committee of hospital and all patients were informed and gave written consent. patients scheduled for elective cabg with cardiopulmonary bypass. patients were randomly allocated to anesthesia with remifentanil-propofol-midazolam (rpm) group or ketamine-propofol-midazolam (kpm) group. blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1, 2, and 4.


Eligibility criteria:
inclusion criteria: patients undergoing elective cabg with cardiopulmonary bypass exclusion criteria: patients undergoing emergency operation, combined operation, off-pump surgery, repeat surgery or valve surgery, patients presenting with chronic kidney disease or renal impairment, patients younger than 18 years old and neurological and/or psychiatric disturbances.

Keywords: troponin t,cystatin-c,ketamine,remifentanil
the diversity of the fungal and bacterial in colon mucosa of patients with different degree of inflammation of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: we analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of ulcerative colitis.

in recent years, the relationship of intestinal fungus with inflammatory bowel disease was gradually revealed. we divided the patients with ulcerative colitis into three groups on the basis of world gastroenterology organisation (wgo) classification about inflammation degree and progress classification and established the healthy control group. analyzing the diversity of the fungal and bacterial within colon mucosa between patients with different clinical classification, for example, the proportion of bacteria and fungi, the proportion of candida albicans, the proportion of yeasts, and so on.

Eligibility criteria:
inclusion criteria: * patients at our tertiary care medical center, aged between 18 and 80 years, scheduled to undergo surveillance colonoscopy. * the patients with ulcerative colitis for ulcerative colitis group. * the patients without ulcerative colitis for control group. * 18-80 years. exclusion criteria: * using antibiotics, glucocorticoid and immunosuppressants wintin one month. * there are contraindications for enteroscopy and biopsy. * there are other intestinal diseases. * pregnancy or breast-feeding women. * patients with serious lung disease and mental illness.

Keywords: fungal mucosa diversity basidiomycete
evaluation of cdss in detection of sirs and sepsis in pediatric patients

Conditions: SIRS; Sepsis; Pediatric SIRS

Summary: this trial aims to evaluate the accuracy of a clinical decision-support system to support early recognition of sirs in paediatric intensive care patients. this assessment will be rated by the primary goals, the sensitivity and specificity of the system. two experienced paediatric intensivists, who are blinded for the cdss results, will analyse the electronic patient file (epf) for sirs criteria and thus establish our goldstandard. all sirs events recognized by the cdss during the patient's stay are taken into account and will be compared with the established goldstandard. the secondary goal of this trial is to evaluate the cdss-results with the assessment of sirs by paediatric doctors during their routine work on the picu.

clinical decision-support systems (cdss) are designed to solve knowledge-intensive tasks for supporting decision-making processes. although many approaches for designing cdss have been proposed, due to high implementation costs, as well as the lack of interoperability features, current solutions are not wellestablished across different institutions. recently, the use of standardized formalisms for knowledge representation as terminologies as well as the integration of semantically enriched clinical information models, as openehr archetypes, and their reuse within cdss are theoretically considered as key factors for reusable cdss. the investigators already successfully transferred their concept into a prototype and evaluated the practicability on clinical data sets and in close cooperation between the clinicians and the technical experts. to the author's knowledge, currently, there are no openehr based cdss approaches which have been implemented and evaluated with such complex and important clinical contexts. hence, the first clinically evaluated cdss based on openehr was successfully designed. when enhancing the described approach and implementing a live system, it might support clinicians to identify the patient's course of disease at an early stage, which can lead to better outcome for the patient. furthermore, the system can serve as a basis for integrating (cross-institutional) machine learning components that could facilitate dealing with other high-complex decision problems or revealing yet unknown disease patterns.

Eligibility criteria:
inclusion criteria: * all pediatric patients admitted to our picu exclusion criteria: * patients that are supposed to stay for less than 12 hours on our picu

Keywords: clinical decision-support system
characteristics of primary and plasmatic hemostasis in preeclampsia

Conditions: Coagulation Disorder, Blood; Platelet Function

Summary: the study aims to investigate the impact of preeclampsia on hemostasis.

in comparison to healthy pregnant women and non-pregnant woman, this study analyses parameters of primary hemostasis and plasmatic coaguation in preeclamptic pregnant woman. detailed analyses of the platelet function is performed using the multiple electrode aggregometry, detailed analyses of the plasmatic coagulation syste is performed by isolated coaguation factor analyses and conventional coagulation analyses.

Eligibility criteria:
inclusion criteria: * platelet count \> 100 / nll * in study group and control group 1: week of pregnancy: 35-40 * in control group 2: healthy, not pregnant woman exclusion criteria: * hereditary coagulopathy * missing content of the patient / proband * eclampsia * hellp syndrome * crp \> 1 mg/dl * fever (\> 38°c)

Keywords: aggregometry
endometriosis patients undergoing quinagolide treatment

Conditions: Hyperprolactinemia; Endometriosis

Summary: dopamine agonists, such as quinagolide, are able to act on the vegfr-2 blocking antibodies, diminishing vascular endothelial growth factor effect on angiogenesis in human endometriotic lesions.


Eligibility criteria:
inclusion criteria: * hyperprolactinemia * unexplained infertility * endometriosis

Keywords: hyperprolactinemia endometriosis laparoscopy angiogenesis, vegf
reduced cardiovascular morbi-mortality by sildenafil in patients with arterial claudication

Conditions: Peripheral Arterial Disease

Summary: sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the no/gmpc pain activation. the investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

eligible patients will ask to participate after oral and written information. evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (welch, sf-36, edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months. indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the rutherford classification. primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.

Eligibility criteria:
inclusion criteria: * abi\<0.90 * vascular type claudication * stable walking impairment for at least 3 months * optimal cardiovasc treatment (anti-platelet, hmgcoa-inh, ace-inh or at2 inh) * age \> 30 years exclusion criteria: * refuse to participate * administrative protection * severe renal (clearance \< 30 ml/min) or hepatic (child-pugh c) failure

Keywords: claudication maximal walking distance morbi-mortality