Kornimate/medical-research-clean huggingface dataset:
epidemiology, treatment and prognosis of neonatal meningitis in turkey: a multicenter study

Conditions: Neonatal Meningitis

Summary: meningitis, defined as inflammation of the meninges caused by different pathogens, is a serious infection associated with high morbidity and mortality. it occurs more commonly in the neonatal period than in any other age group. neonatal meningitis is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality. in this study, we aimed to evaluate epidemiology, treatment and prognosis of neonatal meningitis in a large-scale retrospective multicenter cohort study. the main objectives of this study were to assess the incidence, temporal trend, risk factors, causative organisms, and short term outcomes of neonatal meningitis in a large national cohort of newborn infants admitted to turkey nicus.


Eligibility criteria:
inclusion criteria: * subject has a positive cerebrospinal fluid culture/pcr of bacterial pathogen. * subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥20 /mm3. exclusion criteria: * major congenital anomalies * cultures positive for coagulase-negative staphylococci (cons) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.

Keywords: meningitis epidemiology neonate newborn
postoperative results of early versus on-demand maternal feeding after cesarean delivery

Conditions: Cesarean Delivery; Feeding Patterns; Patient Satisfaction; Postoperative Nausea and Vomiting

Summary: to compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.

two hundred uncomplicated singleton term pregnancies who had caesarean section under regional anaesthesia will be included in our trial. patients will be randomized to a soft food diet (honey, skimmed cheese, soup, mashed potatoe, pudding, grissini) served on postoperative 2nd hour or whenever they wanted to eat on return to the ward. thirty minutes after they eat their meal, nausea, vomiting, ileus and distention will be questioned. participants will be provided with the visual analogue scale (vas), which will be presented with a statement explaining what was intended to measure. patient satisfaction before discharge from hospital will be recorded by the patient by using a 100-mm vas (0= minimum satisfaction, 100= maximum satisfaction). time to first flatus passage and defecation will be recorded after the caesarean section.

Eligibility criteria:
inclusion criteria: * uncomplicated singleton term pregnancy * planned or intrapartum uncomplicated cesarean section * cesarean section under regional anesthesia exclusion criteria: * general anesthesia * history of bowel surgery * prenatal diagnosis of fetal anomaly * maternal disease * intraoperative or immediate postoperative major complications

Keywords: postoperative maternal feeding, cesarean section
a study of the efficacy and safety of aricept in patients with severe alzheimer's disease who are living in skilled nursing homes

Conditions: Alzheimer Disease

Summary: the purpose of the study is to evaluate the efficacy and safety of aricept in nursing home patients with severe alzheimer's disease.


Eligibility criteria:
inclusion criteria: * probable or possible alzheimer's disease * living in skilled nursing home exclusion criteria: * other types of dementia or psychiatric or neurologic disorders * musculoskeletal disease
sh l 562bb phase ii/iii dose justification and gadoteridol-controlled comparative study

Conditions: Brain Metastases

Summary: this study is conducted to compare the contrast effect and safety of sh l562bb with prohance, which has already been approved as a pharmaceutical product of similar indication.


Eligibility criteria:
inclusion criteria: * japanese patients at least 20 years of age * patients with diagnosed primary cancer * patients with metastatic lesions by ct/mri exclusion criteria: * patients who have contraindication to the mri examinations * patients who have severe renal disorder * patients in extremely serious general condition

Keywords: mri brain metastasis gadolinium imaging diagnostic agent
blood titanium analysis of patients with magec spine rods in the covid-19 environment

Conditions: MAGEC Rod

Summary: magnetic expansion control (magec) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium. since june 2019, the manufacturer has released two urgent field safety notices (fsn) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. the uk mhra has issued two similar medical device alerts (mda) with the most recent mda issued on 1st april 2020, stating that (1) magec rods must not be implanted in the uk until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible. at the time of writing, hospitals across the world are facing incredible challenges in dealing with the covid-19 pandemic. due to this, virtually all planned clinic visits for magec rod patients and x-ray appointments have been postponed to help reduce the risk of the virus spreading. recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. this wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of fsns and mdas. whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. additionally, a better understanding of blood titanium levels in patients with magec rods may enable this to become a biomarker of wear and corrosion of the rods. this may help surgeons identify earlier those patients who may develop implant related problems. furthermore, in the current covid-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits. previous work from the rnoh involved a similar study investigating patients with titanium hip implants.


Eligibility criteria:
inclusion criteria: * patients that have been treated with, and still have, a magec rod. exclusion criteria: * patients that do not have a magec rod implant.
effect of liraglutide on blood glucose control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe and south america. this trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * treatment with oral anti-diabetic drugs for at least 3 months * hba1c: 7.5-10.0 % (both incl.) in subjects on oad monotherapy. 7.0-10.0 % (both incl.) in subjects on oad combination therapy. * body mass index (bmi) less than or equal to 45 kg/m2 exclusion criteria: * treatment with insulin within the last 3 months * treatment with any drug that could interfere with the glucose level * any serious medical condition * females who are pregnant, have intention of becoming pregnant or are breastfeeding
the effect of interventions for health behaviors in hypertensive patients

Conditions: Hypertension; Health Behavior; Public Health

Summary: hypertension is a major risk factor for cardiovascular disease, chronic kidney disease, and premature death worldwide. with an aging population and changes in dietary patterns and lifestyles, the prevalence of hypertension is rising globally, especially in developing countries. hypertension is the most common chronic disease and a growing public health problem in china. a recent study estimated the prevalence of hypertension to be 28.56 % ± 10.44 %, ranging from 14.28% to 44.28% among the chinese population aged over 15 years. the preceed-procede model provides a framework to help health planners and policymakers design effective health interventions based on evaluation and analysis of situations. this model has been used in different recent studies related to behavioral change. the study aims to examine the effectiveness of interventions for health behaviors in hypertensive patients based on the precede-proceed model.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with mild to moderate primary hypertension according to the diagnostic criteria of the "2018 revised edition of the chinese guidelines for the prevention and treatment of hypertension," whose blood pressure is not well controlled or who have poor treatment compliance; 2. age greater than 18 years and less than 80 years; 3. normal language communication ability and willingness to participate in the study; 4. have lived in the community for at least 12 months. exclusion criteria: 1. patients who lack basic behavioral abilities, have impaired memory function, or have limited language expression abilities; 2. patients who are simultaneously participating in other intervention studies.
multicenter neonatal eye disease screening in china

Conditions: Eye Disease

Summary: these exams are vital to protect healthy neonates from blindness. the purpose of this study is to better screen ocular disease in otherwise healthy neonates using wide-field digital imaging system (retcam iii) in a multi-center network in china leaded by xinhua hospital affiliated to shanghai jiao tong university school of medicine. the multi-center network will be built with the collaboration of eight hospitals from different parts of china.

studies reveal that ocular anomalies may also be found in healthy full-term babies. these abnormal ocular findings included subconjunctival haemorrhage, congenital microphthalmos, congenital corneal leukoma, posterior synechia, persistent pupillary membrane, congenital cataract, enlarged c/d ratio, retinal hamartoma versus retinoblastoma, optic nerve defects, macular pigment disorder and non-specific peripheral retinopathy. the highest proportion of these abnormal findings is retinal haemorrhages, accounting for 92% of abnormalities. most retinal hemorrhages are benign and will finally self-resolve. however, sometimes it takes a long time for the hemorrhage to resolve. some slow-resolving hemorrhages could obstruct the visual axis and may do great harm to visual development in critical period. some neonatal eye diseases are time sensitive, such as retinoblastoma, and if found late, the best opportunity for effective treatment is missed, leading to irreversible visual impairment. newborns are unable to express their discomforts or visual disorders as adults do and only through an examination, the neonatal eye diseases can be detected. therefore, this screening protocol is designed to screen the otherwise healthy neonates in a multi-center network on neonatal ophthalmopathy and to achieve early diagnosis and timely treatment. all the neonates will undergo eye examination by using retcam iii. the external eye, pupillary light reflex, red reflex, opacity of refractive media, anterior chamber and posterior segments will be examined. the outcomes will be analyzed by a blinded specialist in order to discover serious congenital, hereditary and acquired diseases in the neonatal period of healthy newborns and to improve epidemiological information of neonatal ophthalmopathy. neonatal ocular examination may play a positive role in promoting paediatric eye health to paediatricians and parents.

Eligibility criteria:
inclusion criteria: * otherwise healthy neonates ( ≥37weeks' gestational age, weighing ≥2500 g, no evidence of systemic disease and an apgar score of 7 or more.) exclusion criteria: * preterm /neonates with systemic diseases * neonates unable to undergo the examination

Keywords: eye disease neonatal eye disease newborn screening multicenter
breath-hold cardiac hybrid spect/ccta

Conditions: Coronary Artery Disease

Summary: this study aims at combining inspiration breath-hold myocardial perfusion spect with coronary ct angiography.


Eligibility criteria:
inclusion criteria: * referral for cardiac hybrid spect/ccta * male and female subjects 18 years of age or older * written informed consent by the participant after information about the project exclusion criteria: * contraindications for coronary ct angiography (including renal failure with a gfr \<30ml/min/1.73m2, allergies to iodinated contrast agents) * pregnancy or breast-feeding * previous coronary revascularisation * inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc
a study to evaluate the pharmacokinetics, safety and tolerability of amg 592 in healthy japanese participants

Conditions: Chronic Graft-versus-Host Disease (cGVHD)

Summary: the primary objective of this study is to characterize the pharmacokinetics (pk) profile of a single dose of amg 592 administered subcutaneously in healthy japanese participants.


Eligibility criteria:
inclusion criteria: * participant must be first generation japanese (4 grandparents, biologic parents, and subject born in japan and of japanese heritage) * male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (bmi) of ≥ 18.5 and ≤ 25.0 kg/m\^2 at the time of screening exclusion criteria: * participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ * participants with a known history of autoimmune disease * participants who have donated or lost ≥ 500 ml of blood or plasma within 8 weeks of administration of the first dose of ip * participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to day 1 * positive for hepatitis b surface antigen (hbsag) (indicative of chronic hepatitis b or recent acute hepatitis b) * participant has positive test results for human immunodeficiency virus (hiv) * participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (ppd) (\>= 5 mm of induration at 48 to 72 hours after test is placed) or a positive quantiferon test

Keywords: chronic graft-versus-host disease amg 592 inflammatory conditions
search for predictors of therapeutic response in ovarian carcinoma

Conditions: Carcinoma of the Ovary; Fallopian Tube Cancer; Peritoneal Serous-type Advanced Stage

Summary: in order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of mirna expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the mirna profile of serum before treatment and (ii) identification of polymorphisms or snp (single nucleotide polymorphism) in particular genes involved in the metabolism of chemotherapy agents in the case of mirna, expression profiles will also be studied during the first course in response to chemotherapy. indeed, the mirna profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).


Eligibility criteria:
inclusion criteria: * patients with cancer of the ovary, peritoneum or of the fallopian tube * stage iii or iv * cancer of serous histology * patients of any chemotherapy naive * patients should receive treatment with chemotherapy for first line by taxol- carboplatin. avastin is authorized in concomitant. * an initial surgery or through authorized * patients who signed informed consent * patients over the age of 18 years exclusion criteria: * patients being treated for another cancer chemotherapy and / or hormone therapy * patients receiving other chemotherapy taxol-carboplatin associated or not to avastin * patients under guardianship * previous history of pelvic radiotherapy * history of malignancy blood

Keywords: carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage chemotherapy with taxol and carboplatin predictors of therapeutic response serum mirna identification of polymorphisms or snps (single nucleotide polymorphism)
ldn and tdcs in fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. in this context, low-dose naltrexone (ldn) was able to increase nociceptive threshold in patients with fibromyalgia. moreover, non-pharmacological techniques, like transcranial direct current stimulation (tdcs), have been shown effective for pain management. this study aims to evaluate the analgesic and neuromodulatory effect of combined ldn followed by tdcs in fibromyalgia patients. this is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. patients will be allocated into 4 groups: tdcs+ldn (n=21), sham-tdcs+ldn (n=22), tdcs+placebo (n=22), and sham-tdcs+placebo (n=21). ldn or placebo (p.o.) intervention lasts 26 days, in the last five, tdcs will be applied (sham or active, 20min, 2ma). questionnaires assessed are: sociodemographic, visual analog pain scale (vas), pain catastrophizing scale (pcs), state-trait anxiety inventory (stai), fibromyalgia impact questionnaire (fiq), beck depression inventory (bdi-ii), chronic pain profile scale (cpp). also, pain measures were taken: pain pressure threshold (ppt) and conditioned pain modulation (cpm). blood samples will be collected to analyze brain derived neurotrophic factor (bdnf) serum levels.


Eligibility criteria:
inclusion criteria: * signed the consent form * women from 18 to 65 years * confirmed diagnosis of fibromyalgia according 2016 american college of rheumatology criteria * read and write * pain higher than 6 in the visual analogue scale (vas), in the last 3 months * chronic stable treatment in the last 3 months. exclusion criteria: * in use of opioid drugs; * pregnancy or not using anticontraceptive * history of alcohol or drug abuse in the last 6 months * history of neurological pathologies * history of arrhythmia * history of use of drugs that might change vascular response * history of head trauma * history of neurosurgery * decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, sjogren syndrome, reiter syndrome) * history of non-compensated hypothyroidism * personal history of cancer.

Keywords: tdcs ldn transcranial direct current stimulation low dose naltrexone
study with seletracetam (ucb 44212) in adult subjects (18 to 65 years) with partial onset seizures

Conditions: Epilepsy, Partial

Summary: this trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.


Eligibility criteria:
inclusion criteria: * males/females from 18 to 65 years of age (minimum body weight of 40 kg) * subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized * subjects who have been treated for epilepsy for \>=6 months and are currently uncontrolled while being treated with 1-3 concomitant antiepileptic drug (aeds) * female subjects without childbearing potential; female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method exclusion criteria: * seizures occurring in clusters. * status epilepticus within 6 months of visit 1 * history of non-epileptic seizures * subjects on vigabatrin * subjects on felbamate, unless treatment has been continuous for \>2 years * ongoing psychiatric disease other than mild controlled disorders. * subjects with clinically significant organ dysfunction * known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients * pregnant or lactating women * subjects currently taking levetiracetam (lev) * use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant antiepileptic drug (aeds)

Keywords: epilepsy partial onset seizures seletracetam
impulsivity with borderline personality disorder/tms

Conditions: Borderline Personality Disorder

Summary: this is a prospective, randomized, double-blind, parallel-group controlled trial. the aim of this research project is to compare the clinical benefits achieved in patients with borderline personality disorder (bpd) following two types of intervention: ccpas active or ccpas sham.

borderline personality disorder (bpd) is a mental disorder characterized by unstable interpersonal relationships, emotional lability and marked impulsivity. the latter manifests itself through risky behaviors such as substance abuse, self-harm and suicidal behavior. studies suggest that 1.3% of the general population suffers from bpd. however, in clinical settings, bpd patients represent 20% of all inpatients in psychiatric wards and up to 50% of patients hospitalized in emergency departments following a suicide attempt (sa). moreover, it is estimated that nearly 84% of bpd patients will make at least one sa in their lifetime and up to 10% of them will die by suicide, a rate 50 times higher than the general population. impulsivity, reflected in difficulties holding back action or stopping an action that has already begun, is one of the key symptoms of bpd. recent advances in non-invasive brain stimulation have led to the emergence of a new stimulation protocol known as paired cortico-cortical associative stimulation (ccpas), which consists of repeating paired stimulations using two tms coils placed respectively on two cortical regions of interest. paired stimulations' repetition induces plasticity by strengthening synaptic connectivity between the two targeted regions. the aim of this project is to test the efficacy of a ccpas protocol in enhancing effective connectivity between the ifc and pre-sma in order to reduce impulsivity in bpd patients. the sponsor hypothesized that one ccpas session, using two coils simultaneously, targeting the ifc and pre-sma with a 'physiological' inter-stimulus interval of 4ms will improve motor inhibition abilities (reduce ssrt), compared to the group receiving 'control' ccpas (100ms inter-stimulus interval (ccpas100-ms)).

Eligibility criteria:
inclusion criteria: * diagnosis of bpd (established by a psychiatrist and confirmed in a structured interview using the mini) based on the diagnostic and statistical manual of mental disorders (dsm v). exclusion criteria: * contraindications to tms/mri (pacemakers or other devices likely to interfere with the magnetic field). * pregnant or breast-feeding women. * ongoing anxiolytic treatment (benzodiazepines), neuroleptic treatment or anticonvulsants acting on gabaergic transmission ; 24 hours prior to the protocol. * diagnosis of other chronic psychiatric pathology including bipolar disorder type i or ii and addictions (except tobacco). * protective measure (curatorship or guardianship)

Keywords: borderline personality disorder brain stimulation impulsivity