Kornimate/medical-research-clean huggingface dataset:
evaluation of krio in children and adults with epilepsy

Conditions: Ketogenic Dieting; Epilepsy; Glucose Transporter Type 1 Deficiency Syndrome

Summary: acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of krio for the dietary management of participants with intractable epilepsy or glut-1 deficiency syndrome patients on a ketogenic diet.

this is a prospective, acceptability study in fifteen (15) participants aged three (3) years and over, who are established on a ketogenic diet (kd), of krio to aid in the management of their diet. participants will be provided with a 7-day supply of krio and will be asked to complete a daily diary and short questionnaire to record information allowing assessment the following: * gastrointestinal tolerance * palatability * compliance krio is a food for special medical purposes (fsmp) and is intended for use in the kd. it has a fat to protein and carbohydrate ratio of 3 to 1. this makes it appropriate for inclusion in all versions of the kd: classical, medium chain triglyceride (mct), modified atkins diet (mad) and low glycaemic index (lgi). it is suitable from 3 years of age. krio is presented as a ready to eat solid bar (28g), with no additional preparation required. it contains fat (20g per bar), protein and carbohydrate with added sweetener and flavourings. it does not contain any added micronutrients. the recommended intake of the product for each participant will be determined by a dietitian. the quantity to be consumed daily will be recommended on an individual patient basis, but will be a minimum of 1 bar. product acceptability data from 15 participants are required in order to submit an application to the advisory committee on borderline substances (acbs) for product registration.

Eligibility criteria:
inclusion criteria: i) confirmed diagnosis of a condition requiring a kd, e.g. intractable epilepsy, glut-1 ds. ii) aged three (3) years and over. iii) currently established on a kd for at least three (3) months, taken orally. iv) participant (or parent/guardian) considered by pi and dietitian to be fully proficient at managing the kd, and able to do this competently and accurately. v) participant (or parent/guardian) considered by pi and dietitian to be able to follow the protocol requirements and complete the diary and questionnaire. vi) freely given, written, informed consent from patient or parent/guardian. vii) freely given, written assent (if appropriate). exclusion criteria: i) inability to comply with the study protocol, in the opinion of the investigator. ii) inability to comply with the ketogenic diet. iii) women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period. n.b.: women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.

Keywords: ketogenic diet epilepsy glut-1 ds krio
phase ii study of erlotinib with concurrent radiotherapy in unresectable nsclc with activating mutation of egfr in exon 19 or 21

Conditions: Non-small Cell Lung Cancer

Summary: erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage iii non-small cell lung cancer (nsclc) patients with activating mutation of epidermal growth factor receptor (egfr) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility criteria:
inclusion criteria: * nsclc confirmed by histopathology or cytology; * stage iia or iiib nsclc according to tumor node metastasis (tmn) staging of lung staging standard version 7 2009, and be unresectable; * has active mutation of egfr in exon 19 or 21; * has measurable lesion \[according to response evaluation criteria in solid tumors (recist) 1.1, must have at least one evaluable lesion with the longest dimension \>= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and \>=15mm\]; * eastern cooperative oncology group (ecog) performance status (ps) 0-1; * expectancy life \>= 12 weeks; exclusion criteria: * had be treated by her-targeting agents; * had systemic anit-nsclc treatments; * had local radiotherapy for nsclc; * has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; * diagnosed other malignant tumor besides nsclc within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); * any evidence to indicate moderate or severe chronic obstructive pulmonary disease (copd); * known hypersensitivity to platinum, etoposide, egfr-tyrosine kinase inhibitor (tki) agents or relevant components in the formulation; * uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

Keywords: nsclc egfr mutation unresectable erlotinib concurrent radiotherapy
oks for the treatment of hemispatial neglect

Conditions: Neglect, Hemispatial; Neglect, Sensory; Neglect, Hemisensory

Summary: hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. this project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.


Eligibility criteria:
inclusion criteria: * patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by behavioral inattention test or center of cancellation test exclusion criteria: * reduced vision * documented vestibular disorder
therapeutic drug monitoring of voriconazole

Conditions: Mycoses

Summary: the purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.

voriconazole is an anti-fungal agent, which is used in the treatment of invasive fungal infection, especially aspergillosis. the serious side effects of voriconazole include liver function abnormality, encephalopathy, etc. recently, the several studies showed that the blood level of voriconazole is variable and it is associated with drug side effect and treatment outcome. however, there is no randomized controlled study which proves that therapeutic drug monitoring of voriconazole can improve the clinical outcome in routine clinical practice.

Eligibility criteria:
inclusion criteria: * patients who were 16 years of age or older * receiving voriconazole in order to treat invasive fungal infections or for empirical use exclusion criteria: * who experienced the serious side effect of voriconazole * were hypersensitive to azoles * had an aminotransferase, bilirubin, or alkaline phosphatase level higher than five times the upper limit of normal
evaluation of mbl around implants placed in crestal or subcrestal positions: a rct

Conditions: Jaw, Edentulous; Partial Edentulism

Summary: the objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the iai at different positions in relation to the alveolar crest

the objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the iai at different positions in relation to the alveolar crest. subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. twenty patients will be recruited. two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.

Eligibility criteria:
inclusion criteria: 1. absence of 2-4 teeth in the posterior region of the maxilla or mandibular; 2. bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment; 3. periodontally healthy. exclusion criteria: 1. systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, paget's disease, and patients with cancer; 2. uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control; 3. parafunctional habits, such as the grinding or clenching of teeth; 4. smoking habit (more than 10 cigarettes per day); 5. pregnancy and breastfeeding.

Keywords: marginal bone loss implant depth crestal or subcrestal
treatment of intrabony defects with l-prf membrane with or without collagen membranes

Conditions: Periodontal Bone Loss; Periodontal Diseases

Summary: for patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting leukocyte rich -platelet rich fibrin harvests (applied in the bony defects) with resorbable collagen membranes. clinical outcomes recorded were the plaque index (pi), gingival index (gi), probing depth reduction (pd), clinical attachment level (cal), and radiographic defect depth changes. for the biochemical evaluation: levels of pdgf-bb and vegf obtained from crevicular fluid by perio-paper strips were assessed using eliza.

* patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. they have to be free from any systemic disease that contraindicates periodontal surgeries. * baseline data are obtained including the gi, pi, pd, cal and preoperative paralleling periapical radiographs. * full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed. * for ofd group; following debridement and saline irrigation, wound closure proceeds. * for the l-prf group; l-prf is prepared and applied within the defect before primary closure. * for the l-prf + cm: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure. * from the second day postoperative; periopaper strips are used to obtain a crevicular fluid sample from the sulcus * at 6 months postoperative: the same baseline clinical measurements are obtained.

Eligibility criteria:
inclusion criteria: * minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm cal after 4 weeks from phase i execution * 2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth exclusion criteria: * systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood * patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months * vulnerable groups * interdental craters and 1 wall osseous defects * active periapical pathosis
the study of clinical value of acute physiologic and chronic health evaluation (apache) scoring system in medical intensive care unit

Conditions: APACHE Scoring Systems; Intensive Care Units; Outcome Prediction; Mortality

Summary: objective: to evaluate and compare the outcome predictive power of acute physiologic and chronic health evaluation (apache) ⅳ、ⅲ、ⅱ scoring systems for intensive ill patients in an independent medical intensive care unit (micu), and explore the best time point when they can most accurately predict outcome. design: retrospective analysis of medical records. methods and materials: collect data of patients admitted between july 2010 and july 2013 to the medical intensive care unit of the first affiliated hospital of sun yat-sen university in guangzhou, china. patients with an icu stay less than 4 hours and age less than 16 years were excluded. calculate the apache ⅳ、ⅲ、ⅱ scores and corresponding predictive mortality risks in the first 24 hours of icu admission and the 3th, 5th, 7th, 14th, 21 th, 28th day or the day of transferred out of icu or death. the predictive power of each model was assessed through the ratio of observed death rates and predictive death rates (standardized mortality ratios, smr), the calibration of observed and predictive death rates and the discriminative ability between survivors and non-survivors. hosmer-lemeshow test was employed for assessing the calibration and the discriminative ability was assessed by the area under the receiver operating curve. compare the predictive power of the three models at different time points and explore the the best time point when they can most accurately predict outcome.


Eligibility criteria:
inclusion criteria: * patients with an icu stay more than 4 hours and age older than 16 years. exclusion criteria: * patients with an icu stay less than 4 hours and age less than 16 years.

Keywords: icu
effects of neurocognitive and social cognitive remediation in patients at ultra-high risk of psychosis

Conditions: Patients at Ultra-high Risk of Psychosis

Summary: cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or ultra-high risk (uhr) state of psychosis. the cognitive deficits are known to pose a critical barrier to functional recovery. hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for uhr-patients. the investigators will examine whether: * cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in uhr- patients (null hypothesis: no difference between the two groups). * cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in uhr-patients (null hypothesis: no difference between the two groups).


Eligibility criteria:
inclusion criteria: * age 18-40 yrs. * fulfill criteria for being at ultra-high risk of psychosis (defined by one or more of the following): * vulnerability (trait and state risk factor) group: individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year. * attenuated psychotic symptoms (aps) group: individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. the symptoms must have been present during the past year. * brief limited intermittent psychotic symptoms group (blips): individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. the symptoms must have been present during the past year. * provided informed consent. exclusion criteria: * past history of a treated or untreated psychotic episode of one week's duration or longer * psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use). * diagnosis of a serious developmental disorder, e.g,. asperger's syndrome * currently receiving treatment with metylphenidate. * rejects providing informed consent.

Keywords: ultra-high risk psychosis schizophrenia prodrome cognitive remediation
a correlative study of biomarkers of resistance in patients with castrate resistant prostate cancer treated with abiraterone

Conditions: Prostate Cancer (Adenocarcinoma)

Summary: adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. the most practical way of approaching this question is to explore surrogate biomarkers of prostate cancer including quantification of pharmacodynamic endocrine biomarkers.

goals of this study include: * explore which circulating endocrine markers or endocrine related markers have the best potential to predict clinical response to abiraterone acetate in crpc patients * explore the utility of microrna, circulating dna and exosome analyses in complementing the previous objective

Eligibility criteria:
inclusion criteria: * signed written informed consent. before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel * be suitable for receiving treatment with abiraterone acetate and prednisone * patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * patients may not receive any other investigational agent or dose escalation of abiraterone acetate during study participation * patient consents to comply to treatment with abiraterone acetate as directed by their physician exclusion criteria: * taking a dose of abiraterone acetate other than 1g daily or lack of compliance to daily dosing of abiraterone acetate and prednisone * patients receiving spironolactone or any other steroidogenic compounds in excess of the associated prednisone 5mg bid are excluded due to the potential for androgen receptor agonism

Keywords: adenocarcinoma abiraterone abiraterone acetate zytiga correlative study castrate resistant prostate cancer abiraterone correlative study
diagnostic investigation of sudden cardiac event risk

Conditions: Arrhythmia; Cardiovascular Diseases; Heart Failure; CVD

Summary: the overall objective of the discern study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (scd).

this is a prospective, multi-center, observational study. the research will be performed in three phases, each using distinct patient cohorts: phase i: discovery - genes/biomarkers/clinical factors phase ii: algorithm development phase iii: assay validation the final algorithm (assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). participation in the study does not alter clinical care. the procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. all other data collected is in accordance with the participating institution's standard patient care.

Eligibility criteria:
inclusion criteria: * implantable cardiac defibriliator (icd) or cardiac resynchronization therapy defibrillator (crt-d) implanted for primary prevention * left ventricular ejection fraction (lvef) ≤ 50 % * ability to collect clinical follow-up and endpoint information, including device interrogation data exclusion criteria: * congenital heart disease * known inherited arrhythmia disorder * organ transplantation * inability to give informed consent

Keywords: heart failure implanted cardioverter defibrillator biological markers molecular genetics coronary heart disease gene expression ges cvd chd precision medicine genome-wide association study cardiovascular disease cad gwas discern
lisa vs insure in extremely low birth weight infants. a manikin study

Conditions: Respiratory Distress Syndrome; Preterm Birth; Surfactant Deficiency Syndrome Neonatal

Summary: this is an unblinded, randomized, controlled, crossover (ab/ba) trial of surfactant treatment with lisa vs. insure in a manikin simulating an extremely low birth weight infant. participants will be level iii nicu consultants and residents. randomization will be performed using a computer-generated random assignment list. the primary outcome measure will be the total time of device positioning. the secondary outcomes will be the success of the first and the participant's satisfaction.

background: although lisa offers some advantages in ventilation procedure and neonatal outcomes over insure, the use of a catheter during lisa may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device. this is likely to aggravate the invasiveness of the procedure, resulting in stressful consequences such as bradycardia, hypoxia and hemodynamic changes. objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction. methods: this is an unblinded, randomized, controlled, crossover (ab/ba) trial of surfactant treatment with lisa vs. insure in a manikin simulating an extremely low birth weight infant. participants will be level iii nicu consultants and residents. randomization will be performed using a computer-generated random assignment list. the primary outcome measure will be the total time of device positioning. the secondary outcomes will be the success of the first and the participant's satisfaction.

Eligibility criteria:
inclusion criteria: * level iii nicu consultants and residents will be eligible to participate in the study. exclusion criteria: * there are no exclusion criteria for this study.
intraoperative music therapy in gynecological oncology

Conditions: Music Therapy; General Anesthesia; Surgery; Pain; Gynecological Cancer; Pain, Postoperative

Summary: background perioperative anxiety and postoperative pain can impact surgical morbidity. we aimed to evaluate the effect of intraoperative music therapy in the reduction of immediate postoperative pain in patients undergoing gynecological oncology surgery within an enhanced recovery after surgery (eras) protocol. secondary objectives include reduction in preoperative anxiety, postoperative pain overtime, neurohormonal response, morbidity, length of hospital stay (los) and patient satisfaction. methods prospective, randomized, double-blinded single-center study including patients undergoing surgery for ovarian, endometrial or cervical cancer over a period of 12 months. patients were randomly assigned to receiving intraoperative music therapy (group a) or undergoing standard management (group b). a reduction in immediate postoperative pain was defined as a reduction in ≥2 points in the verbal rating scale(vrs) at 4h postoperatively. hemodynamic variables and blood samples were collected during the procedure for determination of cortisol levels. a scale of closed numeric questions (likert-like) was used to assess patient satisfaction.


Eligibility criteria:
inclusion criteria: * all patients undergoing gynecological oncology surgery for ovarian, endometrial or cervical cancer by laparotomy, laparoscopy or robotic surgery. * asa grade i-iii * signed an informed consent prior to inclusion exclusion criteria: * asa iv * active ischemic cardiopathy * hearing impairment * hormonal disfunction * active treatment with steroids * ppsychiatric disorder * contraindication for epidural anesthesia or failure of the technique in the peri-operative period.