Kornimate/medical-research-clean huggingface dataset:
comparison of pre-procedural pcr and culture-based uti assessment prior to intravesical botox injection

Conditions: Urinary Tract Infections

Summary: this study is a retrospective record review to determine whether a novel multiplex pcr assay can be utilized as a screening method for uti in patients receiving botox injection to treat overactive bladder (oab).

the novel multiplex real-time pcr assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of uti pathogens as determined by a previous prospective comparison study. this is a retrospective record review comparing pcr and culture-based assessments for uti in patients receiving botox injection to treat overactive bladder (oab). investigators aim to determine whether m-pcr/p-ast can be utilized as a screening method for uti in these patients and whether whether antibiotic prophylaxis, peri-procedural antibiotics, and post-injection antibiotic therapy based on patients' pre-procedural m-pcr/p-ast results in improved response to botox injection compared to standard of care. the attributes and advantages of pcr testing over the use of traditional urine cultures, and the potential identification of polymicrobial infections with complicated resistance sharing mechanisms, may significantly improve patient care.

Eligibility criteria:
inclusion/exclusion criteria: * subject is male or female * \>18 years of age at date of injection * subject receiving bont injection for symptoms of oab (including urgency, urinary incontinence, and detrusor overactivity) refractory to first-line therapies

Keywords: overactive bladder pcr urine culture botox injection
silver diamine fluoride gel: case series

Conditions: Dental Caries in Children

Summary: a clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

a clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. the primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. the secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Eligibility criteria:
inclusion criteria: * at least one active caries lesion good general health by parent report exclusion criteria: * unable to cooperate with exam or procedure

Keywords: silver diamine fluoride sodium fluoride varnish dental caries primary dentition peru
blood glucose homeostasis in type 2 diabetes: the effects of saccharose

Conditions: Type 2 Diabetes; Glycemic Control

Summary: hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes. the objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.


Eligibility criteria:
inclusion criteria: lean ngt group * normoglycemic (according to 2006 ada guidelines) * bmi \< 27 kg/m2 obese ngt group * normoglycemic * bmi 30- 35 kg/m2 obese type 2 diabetes group * bmi 30- 35 kg/m2 * oral blood glucose lowering medication exclusion criteria: * exogenous insulin use * cardiac disease (any cardiac event in the last 5 years) * hba1c \>10% * microalbuminuria: albumin:creatinine ratio \>2,5

Keywords: type 2 diabetes glycemic control (postprandial) hyperglycemia sucrose
genistein in treating patients with pancreatic cancer that can be removed by surgery

Conditions: Pancreatic Cancer

Summary: rationale: genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. giving genistein before surgery may be an effective treatment for pancreatic cancer. purpose: this randomized phase ii trial is studying genistein to see how well it works in treating patients with pancreatic cancer that can be removed by surgery.

objectives: primary * to determine changes in microvessel density of the tumor specimen after 2 weeks of treatment with genistein in patients with resectable pancreatic adenocarcinoma. secondary * to evaluate the safety and tolerability of genistein in these patients by looking at the impact of genistein on pancreatic cancer angiogenesis and on the angiogenic factors vegf, cxcl1, cxcl5, and cxcl8. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity. * arm ii: patients receive no specific neoadjuvant therapy. in both arms, patients undergo surgical resection in week 3. blood, urine, and tissue samples are collected at baseline and at the time of surgery for laboratory biomarker studies. samples are analyzed for vegf, cxcl1, cxcl5, and cxcl8 by elisa and for genistein by mass spectrometry.

Eligibility criteria:
inclusion criteria: * adults over the age of 18 capable of giving informed consent * resectable pancreatic mass, known or presumed to be primary pancreatic adenocarcinoma. patients whose initial biopsy do not show adenocarcinoma will not receive the study drug. * ecog preformance status 0-2. * negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment. exclusion criteria: * comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol * hypersensitivity to genistein or to any of the excipients of genistein * prior chemotherapy or radiotherapy for pancreatic adenocarcinoma * concomitant use of warfarin, tamoxifen, or raloxifene. * pregnancy or inadequate contraception. * lactating females

Keywords: adenocarcinoma of the pancreas stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer
a study to evaluate the efficacy and safety of brivaracetam in study participants (>=16 to 80 years of age) with epilepsy

Conditions: Partial Seizures With or Without Secondary Generalization; Epilepsy

Summary: the purpose of the study is to evaluate the efficacy of brivaracetam (brv) compared to placebo (pbo) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (aeds) and to assess the safety and tolerability of brv in subjects \>= 16 years to 80 years of age.


Eligibility criteria:
inclusion criteria: * subjects (male or female) from 16 to 80 years of age at visit 1, both inclusive * female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method * subjects having at least 8 partial seizures (according to the 1981 ilae classification) during the 8-week baseline period with at least 2 partial seizures during each 4-week interval of the baseline period * subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding visit 1 * subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug \[aed\](s). vagal nerve stimulation (vns) is allowed and will be counted as a concomitant aed exclusion criteria: * subject has history or presence of status epilepticus during the year preceding visit 1 or during baseline * subject is currently treated with levetiracetam * subject has taken levetiracetam within 90 days prior to visit 1

Keywords: epilepsy partial seizures with or without secondary generalization brivaracetam briviact
the effectiveness of the push-pull-hold program on improving self-care in patients with heart failure

Conditions: Heart Failure

Summary: this study is a randomized controlled trial that tests the effectiveness of a novel intervention called the push-pull-hold program on improving self-care in patients with heart failure. this intervention was developed based on our previous quantitative and qualitative findings and existing psychological concepts. results would inform current understanding of the intention-behavior link in self-care and inform future policy and intervention development to improve patient and caregiver outcomes.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with chronic heart failure for at least 1 month * more than 21 years old * able to read and understand english or chinese exclusion criteria: * dependent on caregivers * awaiting implantable devices or surgery * pregnant

Keywords: heart failure self-care behavio* intervention randomized controlled trial
trial of herb yuyang ointment to diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to determine if dressing change with a kind of herb yuyang ointment is clinically more efficacious and safer than conventional treatment in the treatment of diabetic foot ulcers.

1. developing a document retrieval strategy for clinical trials of chinese medicine treatment of diabetic foot ulcer according to the research program(finished) 2. selecting and evaluating the above trials,developing a methodological quality evaluation criteria(finished) 3. extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished) 4. comprehensive evaluating the pros and cons evidences of traditional chinese medicine, acupuncture and chinese and western combined medicine with the treatment of diabetic foot of (finished) 5. we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.the following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety

Eligibility criteria:
inclusion criteria: * in-patient or out-patient patients diagnosed with diabetic foot ulcers * gangrene or ulceration occurred more than 3 weeks * over 18 years of age * gender-open * the type of diabetes (type 1 or type 2) open * patients receive a written informed consent to participate in the trial exclusion criteria: * serious complications of heart, liver, lung, kidney damage * malignant tumors * allergy for chinese medicine used * pregnant women and breast-feeding women

Keywords: evidence-based evaluation multi-center randomized controlled clinical trials traditional chinese medicine therapy diabetic foot ulcer clinical trails
igm-enriched immunoglobulin for neonatal sepsis

Conditions: Neonatal Sepsis, Early-Onset; Very Low Birth Weight Infant; Inflammation; Infant, Newborn, Disease

Summary: this study compares giving prophylactic igm enriched intravenous immunoglobulin (ivig) with placebo in 1 hour after birth, in neonates with risk factors of early-onset neonatal sepsis (eons). in addition to the intervention, standard regimen antibiotics are also given within 1 hour. the ivig is given for 3 days and primary and secondary outcomes will be collected. risk factors are both from maternal and neonate origin.

this randomized-controlled trial conducted in cipto mangunkusumo hospital, jakarta, indonesia aims to determine the efficacy of prophylactic igm-enriched ivig in preventing eons. a total of 70 very low birth weight (vlbw) neonates with risk factors for eons including maternal factors of premature rupture of membrane (prom), fever, urinary tract infection (uti), chorioamnionitis, and neonatal factor of prematurity and resuscitation history will be collected. these neonates within 1 hour of life will then be administered either placebo or igm-enriched ivig 0.25g/kg/day for 3 days, in addition to first-line empiric antibiotic. randomization is done using simple randomization. triple masking (participant, investigator, outcomes assessor) is conducted. these neonates will then be clinically observed and evaluated for early mortality (mortality below 7 days), hemodynamics, length of stay, blood culture results, c-reactive protein (crp), it ratio, routine hematological examination, and iggame as parameters of improvement and prevention of eons. stata version 12 (macintosh version) will be used for data management and statistical analyses. the variables will first be presented descriptively, continued with bivariate and multivariate analysis. bivariate analysis will be conducted between independent and dependent variables using chi-square/fisher's exact test, student's t-test, and kruskal-wallis. variables with p-values \<0.25 will be included in the multivariate analysis using logistic regression. the investigators will use two-sided p-values in our analysis with a p \< 0.05 level of significance.

Eligibility criteria:
inclusion criteria: * very low birth weight infants (\< 1500 g) * gestational age below 32 weeks * risk of early-onset sepsis from maternal and neonate factors * inborn neonates exclusion criteria: * birth weight \< 600 g * gestational age \< 26 weeks * multiple congenital anomaly * neonates with suspected congenital syndrome

Keywords: igm-enriched intravenous immunoglobulin
influence of preoperative nutritional status on perioperative period in cardiac surgery in patients with frailty

Conditions: Malnutrition; Protein; Frail Elderly Syndrome

Summary: the aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty. subjects: patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac surgery . research methods: edmonton crispness scale, a mini nutritional assessment (mna-sf) test will be used to select subjects. body composition will be examined by bioelectrical impedance analysis (bia) to determine the degree of phase angle. changes in laboratory blood tests will be recorded and evaluated the subjects randomly will be divided into control and study groups. the diet of the patients in the study group will be optimised by protein supplements before elective heart surgery. the benefits of optimising nutritional status will be evaluated comparing laboratory blood tests, changes in organ function, adverse outcomes, the need for vasoactive drugs, artificial lung ventilation time and length of hospitalisation between the groups.


Eligibility criteria:
inclusion criteria: * patients 65 years of age and older. * patients for whom cardiac surgery will be performed on a scheduled basis. * patients able to move without the help of others except for an aid: a stick, a walker. * patients who speak and understand lithuanian perfectly. * patients who have read the informed consent form and confirmed their consent to participate in the study in writing. exclusion criteria: * patiens younger than 65 years. * no written consent of a person to participate in a biomedical research has been obtained; * patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks. * patients with amputated lower extremities. * patients with hepatic insufficiency, one or more of viral hepatitis. * it is not possible to perform a qualitative physical examination for other reasons (hearing, vision, etc.) * allergy to b vitamins.

Keywords: preoperative malnutrition frailty cardiac surgery
sensor augmented pump (sap) therapy for inpatient cfrd management

Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis Pulmonary Exacerbation; Cystic Fibrosis in Children

Summary: this research proposes a pilot study using the combination of continuous glucose monitor (cgm) and insulin pump therapy, also known as sensor augmented pump (sap) therapy, for cystic fibrosis related diabetes (cfrd) management in the inpatient setting, with the aim of improving glycemic control.


Eligibility criteria:
inclusion criteria: 1. age ≥8 years 2. confirmed diagnosis of cf by consensus guidelines \[50\] 3. diagnosis of cfrd based on american diabetes association and cff criteria \[51\] 4. admission for pulmonary exacerbation exclusion criteria: 1. known type 1 or type 2 diabetes, monogenic diabetes (mody) 2. critical illness requiring admission to the intensive care unit 3. admission for indications other than pulmonary exacerbation (ex. distal intestinal obstructive syndrome, surgery) 4. pregnancy
combination therapy in indian visceral leishmaniasis

Conditions: Leishmaniasis, Visceral

Summary: rationale the overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of vl which could be easily deployed in a control programme. the hypothesis is that the combination treatment is as effective or better than the 5 mg/kg single dose of ambisome and will reduce the risk of parasite resistance occurring. safety and tolerability should be such that the combination can be easily deployed. objective the specific primary and secondary objectives are as follows: primary objective: to identify a short course combination treatment regimen which is at least as effective as a single dose of ambisome 5mg/kg secondary objective: to compare safety and tolerability of the various treatments measured by vital signs, blood biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse event reporting primary endpoint: the primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of vl at 6 months post treatment. parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of vl infection.


Eligibility criteria:
inclusion criteria: * patients \> 5 years old with symptoms and signs of kala-azar (fever, weight loss, splenomegaly) and parasites demonstrated by microscopy in splenic aspirate smear exclusion criteria: * pregnant or breast-feeding women * individuals seropositive to hiv or individuals with a serious concurrent infection such as tuberculosis or bacterial pneumonia. * women of child-bearing age will be counseled about adequate birth control during and for three months after miltefosine treatment and provided with a satisfactory method of contra-ception. * granulocyte count \< 1,000/mm3, hemoglobin \< 5 g/dl or platelet count \< 40,000/mm3 * hepatic transaminases or total bilirubin greater than three times normal * serum creatinine \> 2.0 mg/dl * prothrombin time \> 5 seconds above control * inability of subject or guardian to provide written informed consent

Keywords: kala-azar miltefosine liposomal amphotericin b
oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in the reduction of the postoperative morbidity and mortality after major pulmonary resections

Conditions: Infections and Respiratory Infectious

Summary: despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. among postoperative complications, respiratory failures (nosocomial pneumonia, ards) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. these complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. current management of these complications stands on antibiotics, oxygen supply and physiotherapy. in severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases. recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. these colonizations could act as a major predisposing factor to these postoperative respiratory failures. because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. this decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. decontamination of oropharynx and nasopharynx with chlorhexidine gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. to date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.


Eligibility criteria:
inclusion criteria: * adult men and women over 18 years * submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis * anatomical resections (segmentectomy, lobectomy, pneumonectomy) * with mediastinal lymph node dissection. * patient fit for operation * after informed consent non inclusion criteria: * patients \< 18 years * pulmonary infectious lesions * recent respiratory infections * tracheostomy * swallow difficulties * need for non-invasive ventilation before surgery * documented sensibility to chlorhexidine * previous ent cancer * previous thoracic surgery * patients with an oral assessment score (oag) \>9
unexpected pharmacokinetics of vancomycin in patients with severe acute pancreatitis compared with pneumonia

Conditions: Arbitrary Restriction Polymorphism 1

Summary: the purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.

the purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent. after reviewing more than 6000 clinical charts of patients who received vancomycin therapy and whose serum vancomycin level was monitored between january 2010 and december 2013, we identified 212 patients who also had diagnosed as severe acute pancreatitis (sap group), and 98 patients who also had diagnosed as pneumonia (pneumonia group) at that time. the fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration. using these measurements, we calculated the pharmacokinetic parameters using the bayesian estimator.

Eligibility criteria:
inclusion criteria: * age 18-85years old * vancomycin use ≥ 3days exclusion criteria: * age \ 85 years old * vancomycin use \< 3days

Keywords: vancomycin severe acute pancreatitis creatinine clearance
effects of cytotoxic chemotherapy and parp inhibition on the genomic contexture of ovarian cancer

Conditions: Ovarian Cancer

Summary: effects of cytotoxic chemotherapy and parp inhibition on the genomic contexture of ovarian cancer: tr_nact_ov/17 in order to approach the above open questions, ultimately aiming in understanding the effects of cancer drugs on tumor biology and hence in selecting the proper drugs for the patients in the context of precision medicine, the objective of this study is to study the genomic characteristics of ovarian tumors before and after treatment with classic neoadjuvant chemotherapy (nact) and with the more recently approved parp inhibitor olaparib.


Eligibility criteria:
inclusion criteria: * ovarian cancer eligible for neoadjuvant chemotherapy exclusion criteria: -