Kornimate/medical-research-clean huggingface dataset:
spanish urological association registry of patients on active surveillance

Conditions: Prostate Cancer

Summary: description: multicentre observational study, not randomized. ambispective character (retro and prospective). opened to any member of the asociación española de urología (aeu), public and private medicine. justification: active surveillance is a strategy proposed to control the overtreatment derived from the opportunist screening in prostate cancer (pca). its development in our country is erratic and different in every center. this database tries to include most of patients included in active surveillance in spain with a few minimal inclusion criteria. multicentre registry and follow up of the active surveillance in spain. hypothesis: mortality cancer specific for pca includible in active surveillance to 15 years is lower than 5 %.


Eligibility criteria:
inclusion criteria: 1. psa ≤ 10 ng / ml; if prostate volume\> 60 cc in transrectal, ultrasound includable with psa\>10 ng / ml if psad \<0.20 2. local stadium dre; ct1c -ct2a 3. diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders 4. adenocarcinoma prostate gleason ≤ 6 (3 + 3) with local and central pathology review 5. maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment 6. \<80 years and greater expectancy to 10 years life (charlson score) 7. patients able to understand active surveillance and sign the informed consent exclusion criteria: 1. patient not be able to accept up with repeat biopsies 2. patient who does not want to sign the informed consent 3. hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria 4. patients with a history of asap (atypical small acinar proliferation or atypical microglands) 5. patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (avidart®) and finasteride (proscar®) during the previous six months 6. patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. it can be associated with an increase of psa prior to phlebotomy. these therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy.

Keywords: intermediate risk prostate cancer low risk prostate cancer active surveillance
antimicrobial susceptibility testing guided therapy versus empirical therapy for the first-line helicobacter pylori eradication.

Conditions: Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing

Summary: the purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

helicobacter pylori(h.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. strongly evidence supports that h.pylori eradication is an effective approach to reduce the incidence of those pathologies. antimicrobial susceptibility test can pick out sensitive drugs to kill helicobacter pylori, and reduce secondary drug resistance. but, there is a lack of high quality rct to compare its efficacy with empirical regimen in the first-line treatment. our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of helicobacter pylori infection. comparing this regimen with 14-day empirical tailored therapy to tell which one is better in clinic practice. we also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with h. pylori infection. exclusion criteria: * patients with previous h. pylori eradication therapy; * patients unable or unwilling to receive gastroscopy; * patients treated with h2-receptor antagonist, ppi, bismuth and antibiotics in the previous 4 weeks; * patients with gastrectomy, acute gi bleeding and advanced gastric cancer; * patients with known or suspected allergy to study medications; * currently pregnant or lactating; * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Keywords: helicobacter pylori infection antimicrobial susceptibility testing(ast)
sucralfate to improve oral intake in children with infectious oral ulcers: a randomized, double-blind, placebo-controlled trial

Conditions: Herpangina; Gingivostomatitis; Hand, Foot and Mouth Disease

Summary: the purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink.


Eligibility criteria:
inclusion criteria: * age ≥6 months and ≤5 years old * present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand, foot and mouth disease * history of decreased oral fluid intake by parent or guardian * english or spanish speaking parents or guardians exclusion criteria: * severely dehydrated or toxic, requiring immediate resuscitation * exclusively breastfed * severe dental disease * significant mouth trauma * active malignancy * preexisting upper airway obstruction or swallowing difficulties * received intravenous fluids within 24 hours * administration of both acetaminophen and ibuprofen prior to triage and within 4 hours of enrollment
study of glycemic control on liver transplantation outcomes

Conditions: Evidence of Liver Transplantation; Hyperglycemia; Rejection

Summary: many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. in this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dl.

many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. however, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. preliminary data suggest that this may improved by better glycemic control using the glucose management service here at northwestern. in this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dl. postoperative glucose management with insulin will be supervised by the glucose management service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.

Eligibility criteria:
inclusion criteria: 1. require liver transplantation 2. age 18 - 80 3. able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious. 4. expected survival following transplantation for \> 1 year. 5. glucose level over 180 mg/dl postoperatively exclusion criteria: 1. inability of patient or family member to give informed consent 2. not expected to survive for \> 1 year following liver transplantation. 3. previous liver transplantation 4. acute liver failure 5. living related donor

Keywords: liver transplantation glucose hyperglycemia insulin rejection hypoglycemia
early recurrence of renal colic: predictive factors

Conditions: Renal Colic; Emergency Department Patient

Summary: renal colic (rc) is a common pathology in emergency medicine, with a high risk of recurrence. early recurrence remains a major concern, affecting up to 30% of patients, with around 84% of these recurrences occurring within two days of the initial episode , despite preventive measures, both pharmacological and non-pharmacological . the recurrence of rc varies significantly between individuals, and systematic evaluation may facilitate personalized treatment . recurrence is likely influenced by multiple factors, and identifying these could help clinicians develop better preventive strategies.the main aim of our study was to identify factors predictive of early recurrence of rc pain after emergency department (ed) management.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age who were admitted to the ed for acute abdominopelvic pain and whose final diagnosis was rc exclusion criteria: * patients with documented or suspected pregnancy, and patients without a phone number

Keywords: early recurrence, rc pain, emergency department
multiple ascending dose study of amg 598 in adults with obesity

Conditions: Obesity

Summary: the main objective of this study is to assess the safety and tolerability of multiple doses of amg 598 administered alone or in combination with liraglutide in adults with obesity.


Eligibility criteria:
inclusion criteria: * men and women with ages between 18 and 65 years old, inclusive, at time of signing consent * body mass index (bmi) between greater than or equal to 30.0 kg/m\^2 and less than or equal to 40.0 kg/m\^2 at screening * except for obesity, otherwise healthy or medically stable per protocol * have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening * other inclusion criteria may apply * stable on liraglutide, depending on cohort exclusion criteria: * history or clinical evidence of diabetes * inadequate organ function at screening * currently receiving treatment in another investigational device or drug study * women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product * history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion * a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma; confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for cohorts receiving liraglutide * history of major depressive disorder * other exclusion criteria may apply
clinician-collected versus patient-collected cervical pap smears

Conditions: Cervical Cancer

Summary: the purpose of this study is to see if it is possible to conduct a full study to determine whether the solopap™ cervical cell sample collection kit is as good as a clinician performed pap test in detecting precancerous cervical lesions in females. begin to determine patient attitudes regarding ease of use and discomfort using solopap.

the solopap "kit" provides to subjects who would not otherwise have a pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. the current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether solopap is truly noninferior to clinician-collected pap smears in detecting cervical pathology. it will also determine user preference and willingness to perform a self- test.

Eligibility criteria:
inclusion criteria: * tricare insurance beneficiary (military insurance) receiving care at nellis afb * all women at least 18 yrs of presenting for pap smear who have not previously participated in this protocol. solopap can be performed any day that a woman is not having vaginal bleeding exclusion criteria: * age \<18 years (not recommended for pap smear) * known pregnancy * women who have had a total hysterectomy (cervix removed) * women with vaginal bleeding * persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands

Keywords: cervical cancer
study of risk factors for developing inhalation pneumonia after inhalation

Conditions: Inhalation Pneumonia; Risk Factor

Summary: inhalation pneumonia (pi) is common in clinical practice but is rarely studied. for example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an ip. there is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. in this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent ip.


Eligibility criteria:
inclusion criteria: * in intensive care: any intubated patient who presented: * it is a coma with gcs ≤ 12 without vas protection, whatever the duration * either a proven inhalation, defined by the presence in the vas of gastric fluid or food * either a suspected inhalation, defined by the extrahospital anamnesis * in medicine : * any wrong way (defined by a reflex cough when taking food) * coma without intubation, regardless of duration or depth exclusion criteria: * patients with vap
antibiotic outbreak, risk factors for never event, prediction of inappropriate use

Conditions: Infectious Disease

Summary: in order to decrease inappropriate antibiotic use, drivers of inappropriate use must be identified locally. this study will focus on the most inappropriate use, which are defined as 'never events'. previous work has shown that antibiotic use clusters over time. it is hypothesized that never events also cluster over time. using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

appropriateness in antimicrobial prescribing has become a focal national and international issue. it has been estimated that upwards of 50% of antibiotic use is inappropriate. with this backdrop, a national strategic goal has been set by the united states white house to decrease inappropriate antibiotic use by 20% and 50%, respectively for inpatient and outpatient settings. in order to decrease inappropriate use, drivers of incorrect use must be identified at each local setting. the actual drivers of confirmed inappropriate use have been difficult to identify except when using time and resource intense chart reviews. even the largest contemporary antibiotic consumption studies have not assessed appropriateness as it was 'outside of study scope'. further, there is no consensus or agreement on what constitutes inappropriate use. these apparent omissions underscore the difficulty and complexity in attributing appropriateness of use for antimicrobials. importantly, this study will focus on the most inappropriate use, which are defined as 'never events'. previous work has shown that antibiotic use clusters over time. it is hypothesized that never events also cluster over time. using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

Eligibility criteria:
inclusion criteria: * receipt of inpatient intravenous vancomycin during proposed study period * adults 18 years of age or older and less than 90 years of age exclusion criteria: * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: anti-bacterial agents/therapeutic use drug utilization/statistics & numerical data hospitals/statistics & numerical data data analysis, statistical interpretation, statistical data antibiotic stewardship electronic medical record
assessing neurodevelopment in congenital heart disease.

Conditions: Congenital Heart Disease

Summary: congenital heart disease (chd) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. children with chd are a known risk population for brain injury, with neurodevelopmental alterations shown over time in up to 50% of cases. no adequate description exists of the type of neurocognitive anomalies or risk factors associated with chd, and consequently no prognostic markers that may allow identification of high-risk cases are available.

the main objectives of this study are: 1. to describe the neurodevelopmental outcome of patients with chd at 24 months of age; 2. identify the subgroup with poorer outcome; and 3. evaluate the utility of fetal and postnatal diagnostic techniques for early detection of patients at risk for altered neurological outcomes. seven spanish referral centers for chd included in the research network on maternal and child health currently participating in this prospective multicentric case-control coordinated study. fetuses with chd (transposition of great arteries, tetralogy of fallot, hypoplastic left heart syndrome and septal defects) will be studied from 24 weeks of gestation to 2 years of age. diagnostic tests will be repeated throughout the study in all patients, from the fetal period to 24 months of age, and will include: fetal cerebral hemodynamic doppler assessment, functional echocardiography, brain mri, regional cerebral oxymetry, electroencephalography and serum neurological and cardiac biomarkers analysis. neurodevelopmental assessment will be made at 12 months of age using the ages and stages questionnaire (asq) and at 24 months of age with the bayley-iii test. from this data, statistical analysis will select the most useful as predictors of damage; to be then combined and create algorithms for predicting brain damage and poor neurodevelopment. once description has been made, we will proceed to identify amongst our results, children with the poorest neurological outcome and remark possible common prenatal and early life markers in them as well as the chd severity they present. while advances in early diagnosis and postnatal management have increased survival in chd children, worrying long-term outcomes, particularly neurodevelopmental disability, have emerged as a key prognostic factor in the counseling of these pregnancies. evidence available does not allow clinicians to assess on neurological prognosis although has opened up the possibility of finding prenatal markers of brain damage. even though, no prospective studies have been performed until now. we present a multicentric prospective study able to recruit enough fetal chd affected pregnancies to obtain neurological prognostic tools.

Eligibility criteria:
inclusion criteria: * single pregnancies * major congenital heart disease * informed consent signed exclusion criteria: * major extra-cardiac malformations * parental refusal to participate * maternal chronic disease * multiple pregnancies

Keywords: lvoto fallot great arteries transposition
mesh versus suture repair for umbilical hernias

Conditions: Umbilical Hernia

Summary: the purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. this method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). especially risk factors for hernia recurrence such as hernia size and bmi \> 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.

purpose the purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. this method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). especially risk factors for hernia recurrence such as hernia size and bmi \> 30 kg/m2 need to be evaluated and correlated to the method of hernia repair. study design randomised controlled, double blinded, multi-centre trial. 300 consecutive patients with an umbilical hernia will be included in the study. patients will be randomised in one of two groups of 150 patients each. group 1 will include patients that will undergo primary (suture) repair; group 2 umbilical hernias will be repaired using a pre-peritoneal, flat polypropylene mesh in a tension free fashion. stratification will be utilized for the size of the hernia (1-2 cm or ≥2-4 cm) and the participating centre. patients will visit the outpatient clinic after 2-3 weeks and after 3, 12 and 24 months. the cumulative hernia recurrence rate during the 2-years follow-up period will be the primary outcome of the study. complications, pain and qol are secondary endpoints. statistical analysis all analyses will be performed according to the intention to treat principle and as specified in the protocol. financial support none.

Eligibility criteria:
inclusion criteria: * primary umbilical hernia * signed informed consent exclusion criteria: * umbilical hernia ≥ 4 cm diameter * recurrence * midline laparotomy * ascites/cirrhosis * asa score iv or above * incarcerated hernia/emergency procedures

Keywords: umbilical hernia mesh
combination therapy prevents the relapse of ra

Conditions: Recurrence (Disease Attribute)

Summary: this trial aims to compare the cost effective and effect of preventing recurrence by different treatment of tfp and hcq combined ssz for remittent ra.

patients were divided into 3groups: group a:tfp+mtx (week0-week60) group b:tfp+mtx+hcq+ssz(week0-week12) and then mtx+hcq+ssz(week13-week60) group c:tfp+mtx (week0-week12) and then mtx (week13-week60)

Eligibility criteria:
inclusion criteria: * fulfill 2010 eular/acr ra dignose criteria * age18-70 years old * have been teated regularly for 3 months * disease duration \> 6months * das28\>3.2 exclusion criteria: * received surgical operation in 8 weeks * received other biological agent (eg. rituximab, anti-tnf agents, anti-il6 agents)in 6 months; * injection of steroid in 4 weeks * coexisting with other ctd except for ss * with severe and not controled cardiac vescular disease, neurological disease, pulmonary disease (including copd and ild), renal disease, liver disease, endocrine disease and gastric intestinal disease * with not controled diseases including asthma, ibd and psoriasis needing oral or injection of steroid * active infection with t\>38℃. patients need admitted into hospital or biotics injection in 4 weeks or need oral biotics in 2 weeks * malignant history. * serum creatinine \>130 µmol/l * ast/alt higher than 2 times upper level * platelet count\<100 x 109/l，or white blood count\<3 x 109/l * interstitail lung disease: chest x ray * hands x ray acr radiology staging shows iv stage ra * pregnancy or planing to pregnant in 2 years or suckling period women.