Kornimate/medical-research-clean huggingface dataset:
impact of propofol-based total intravenous anesthesia versus anesthesia with sevoflurane on long-term outcomes with patients undergoing elective excision of primary liver tumors

Conditions: Hepatocellular Carcinoma

Summary: this is a two-arm, parallel-group randomized clinical trial. routine perioperative care would be performed in volunteers with primary hepatocellular carcinoma. the study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.

before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. both groups were induced with propofol 1\~2.5 mg/kg propofol. the propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/ml by a target-controlled infusion system. the sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 mac). during the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and entropy (or bis) value at 40-60in both groups. the following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according clavien-dindo classification), american society of anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and karnofsky performance status score were recorded.

Eligibility criteria:
inclusion criteria: 1. twenty to eighty-year-old. 2. asa class i-iii. 3. patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia. exclusion criteria: 1. severe mental disorder 2. pregnant or lactating women 3. morbidly obese 4. allergy to any of the drugs used in this study 5. recurrent tumor or repeat surgery 6. biopsy cases 7. incomplete data collection before the surgery 8. palliative treatment after surgery 9. simultaneous treatment of other malignancies 10. combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine 11. diagnosed as benign liver tumor 12. emergency surgery
dexmedetomidine sublingual film for the ambulatory treatment of hyperadrenergic autonomic crisis in patients with familial dysautonomia

Conditions: Familial Dysautonomia

Summary: the purpose of this placebo controlled interventional study is to collect preliminary data on administering dexmedetomidine in patients with familial dysautonomia (fd) during a rapid cessation of autonomic crisis. the primary aims are to assess the feasibility and evaluate if measurements of heart rate, blood pressure and oxygen saturation can predict the start of an autonomic crisis. funding source- fda oopd


Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of familial dysautonomia. * one or more autonomic crises during the last year. * our database shows evidence of autonomic crisis, previous treatment with iv dexmedetomidine, and registered medical data within the year preceding the study. * age 16 years or older * the patient has a responsible caretaker to communicate with the medical providers. * provision of signed and dated informed consent form from the patient and responsible caregiver * able to state willingness to comply with all study procedures and availability for the duration of the study * for males and females of reproductive age: use condoms for contraception if sexually active. exclusion criteria: * at the consideration of the principal investigator, the caregiver cannot fully understand the protocol, or communicate during the crisis with the center. * the patient during the crisis, before taking the medication, has any of the following: 1. oxygen saturation less than 92% on room air or baseline need for oxygen, change from baseline oxygen dependency. 2. respiratory rate \>25 breaths per minute. 3. supine blood pressure ≤ 90/860mmhg 4. febrile illness with temperature \>100.3 f. 5. serological signs of infection (wbc count \>10 g/dl, or crp \>10 mg/l or esr\>20, or above their steady historical baseline levels) in recent (less than one month) studies. * the patient is a female and has a positive pregnancy test. * the montreal cognitive exam (moca) is below 25 points.

Keywords: familial dysautonomia hereditary sensory and autonomic neuropathy type 3 hsan autonomic sympathetic crises
parental touch trial (petal)

Conditions: Infant Development; Pain, Procedural; Parents

Summary: this is a two centre two-arm randomised controlled interventional trial. we aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.

this is a multicentre randomised-controlled interventional trial, with two research sites (john radcliffe hospital, oxford, and royal devon and royal devon and exeter hospital, devon). in this study we aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia. the primary objective is to determine whether parental touch reduces noxious-evoked brain activity following a heel lance. in addition, our secondary and exploratory objectives include investigating the effect of touch on behavioural and electrophysiological measures evoked by a heel lance. neonates will be randomised to receive parental touch either prior to or post a clinically required heel lance. we will also investigate how parental touch impacts post-procedural clinical stability and explore whether this intervention affects parental anxiety. neonates will be recruited during a 9-month period. participants will be studied on a single test occasion while they are in hospital, when they require a clinical heel lance. no extra blood tests or noxious procedures will be performed for the purpose of the study. participants will be included in the study for approximately an hour period. this will be approximately 30 min before and after the time when the heel lance is performed. individual babies will only be included in the trial once. if a neonate requires additional heel lances to acquire sufficient blood for clinical assessment at the time of the test occasion, we will also record the responses to this.

Eligibility criteria:
inclusion criteria: * participants born at the john radcliffe hospital, oxford or the royal devon and exeter hospital, devon * neonates born at or after 35+0 weeks gestation * neonates with a postnatal age of 7 days or less * neonates who clinically require a heel lance * neonates for whom parents/guardians have given written informed consent for inclusion in the trial exclusion criteria: * intraventricular haemorrhage (ivh) \> grade ii * received any analgesics or sedatives in the last 24 hours * congenital malformation or genetic condition known to affect neurological development * born to mothers who have a history of substance abuse.

Keywords: parental touch brain activity stroking anxiety clinical pain score heart rate respiratory rate
akershus cardiac examination (ace) 1950 study

Conditions: Atrial Fibrillation; Heart Failure; Mild Cognitive Impairment; Cardiovascular Diseases; Cerebrovascular Disorders

Summary: akershus cardiac examination (ace) 1950 study is a large, observational, prospective, longitudinal, population-based cohort study. the overall aim is to establish an extensive cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal long-term follow-up studies of cardiovascular and cerebrovascular disease.

design: the akershus cardiac examination (ace) 1950 study is a population-based, prospective, cerebro- and cardiovascular age-cohort study of all men and women born in 1950 in akershus county, norway. time schedule: study inclusion and baseline examinations took place in the period september 2012 - may 2015. current status: 10-year follow-up examinations of all participants are undertaken in 2023-2025, and sub-studies are ongoing.

Eligibility criteria:
inclusion criteria: * resident in akershus county (as per october 2011, prior to study invitation) * born in the year of 1950 * ability to consent to participation

Keywords: cardiovascular epidemiology prospective, observational cohort study biomarkers cardio- and cerebrovascular imaging
three-dimensional printed hand orthoses

Conditions: Hand Injuries and Disorders

Summary: in persons with chronic hand conditions, orthoses are often prescribed to improve daily-life functioning. in most cases, orthoses are custom manufactured based on a plaster hand model, which is a time-consuming and labor-intensive process. it has been demonstrated that the production time to custom manufacture hand orthoses can be greatly reduced by using three-dimensional (3d) scanning and printing, offering a promising cost-effective alternative to conventional costum manufactured hand orthoses. however, before setting up a cost-effectiveness study in persons with chronic hand conditions, insight into the effectiveness of 3d-printed orthoses on performance of activities of daily living (adl) is needed, as well as insight into potential cost reductions. to date, this information is largely unknown. the aims of this feasibility study are 1) to collect data on the preliminary effectiveness of 3d-printed orthoses on performance of adl, satisfaction with the orthosis and quality of life compared to conventional orthoses in persons with chronic hand conditions, and 2) to compare the production time and costs of 3d-printed orthoses with conventional orthoses.


Eligibility criteria:
inclusion criteria: 1. having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder, neuromuscular disorder, or neurological disorder; 2. minimum age of 18 years; 3. currently wearing a conventional custom manufactured hand orthosis (including a wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use; 4. indicated for a new hand orthosis. exclusion criteria: 1. already wearing a 3d-printed orthosis 2. wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis 3. wearing an orthosis prescribed for a dysfunctional hand; 4. wearing a broken orthosis; 5. wearing the orthosis only at night; 6. worsening of disease; 7. insufficient mastery of the dutch language.

Keywords: feasibility hand orthotic device printing; three-dimensional activities, daily living satisfaction production time costs
a study of pep503(radio-enhancer) with radiotherapy and chemotherapy for patients with rectal cancer

Conditions: Rectal Cancer

Summary: this phase ib/ii study is a prospective, open-label, single arm, nonrandomized study of pep503(radio-enhancer). there are 2 portions in this study. * escalation phase (part ib): a 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of pep503 for intratumor injection. * expansion phase (part ii): following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.

the target population is composed by patients who have confirmed adenocarcinoma of the rectum which is t3-4, n any, or locally unresectable, with tumor distal margin within 10 cm of the anal verge, with no evidence of distant metastatic disease, ecog performance 0-1, and adequate bone marrow, renal and hepatic function.

Eligibility criteria:
inclusion criteria * histologically proven adenocarcinoma of the rectum which is t3-4, n any, or locally unresectable disease , without evidence of distant metastases (m0) * distant border of the tumor must be located ≤ 10 cm from the anal verge * staging with mri, transrectal ultrasound or ct-scan to confirm stage and resectability * ecog performance 0 - 1 * age: 20 - 80 years old * adequate bone marrow, renal, and hepatic function as: * absolute neutrophil count (anc) ≥ 1,500/mm3 * platelet count ≥ 100,000/mm3 * total bilirubin ≤ 1.5x the upper limit of normal (uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5x uln * alkaline phosphatase (alp) ≤ 2.5 x uln * calculated creatinine clearance ≥ 50 ml/min, or creatinine within normal range * all female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with pep503. patients must agree to use effective contraception during the study exclusion criteria: * prior history of pelvic radiation therapy * hypersensitivity to fluoropyrimidine * uncontrolled serious medical or psychiatric illness * myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months * no more than 4 weeks since prior participation in any investigational drug study * major surgery within 28 days * other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum * cardiovascular disease that would preclude study treatment or follow-up * informed consent not duly signed and dated to participate in the study
zinc-mnp trial for prevention of diarrhea and promotion of linear growth

Conditions: Diarrhea; Stunting

Summary: this is a randomized, double-blind, community-based efficacy trial of different doses, forms, and frequencies of zinc supplementation for the prevention of diarrhea and promotion of linear growth among children 9-11 months of age in dhaka, bangladesh.

zinc is essential to support growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children but, the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (mnp) on child growth and diarrheal disease are mixed and pose programmatic uncertainties. thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9-11 months in an urban community in dhaka, bangladesh. the primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. therapeutic zinc will be provided as part of diarrhea treatment, in accordance with bangladesh's national policy. therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention.

Eligibility criteria:
inclusion criteria: * 9-11 months of age * weight-for-length z score \>= -3 according to the 2006 world health organization growth standards * hemoglobin concentration \> = 7.0 g/dl exclusion criteria: * presence of severe acute malnutrition, defined as a wlz \<-3 and/or the presence of bipedal edema and/or mid-upper arm circumference \<115 mm; * presence of severe anemia, defined as a hemoglobin concentration \< 7.0 g/dl * congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding; * chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis) * currently consuming mnps with no intention of stopping

Keywords: zinc multiple micronutrient powders diarrhea stunting
pcornet opioid surveillance study

Conditions: Opioid Use; Opioid Abuse

Summary: the overarching objective of this project is to demonstrate and assess the feasibility of using the patient centered outcomes research network (pcornet) common data model for opioid surveillance to complement existing and support future initiatives. this project will characterize risk factors, processes, and outcomes related to opioid use, misuse, and abuse. it will quantify the utility of data stored in the pcornet common data model format stewarded by healthcare organizations participating in pcornet.

this is a two phase retrospective study. the goal of phase i is to assess the utility of pcornet common data mode (cdm) data to study risk factors, processes, and outcomes related to opioid use, misuse, and abuse. based on the results of the phase i feasibility examination, phase ii will be conducted and will analyze the relationships between patient- and provider-level risk factors and policies, and opioid-related outcomes over time and within geographic regions. the study will leverage the existing data pcornet data infrastructure and resources to achieve its objectives and answer its research questions. standardized analysis programs will be distributed to participating sites within the pcornet distributed research network. sites will return aggregate, descriptive counts and summary statistics from regression analyses. when data are unavailable or analysis is determined infeasible, results will be reported as such. the aims of phase i are: 1. generate counts and proportion of patients with exposure (or potential exposure) to opioids though prescription or dispensing records within a health system. a. compare results to cdc. 2. characterize data elements in pcornet data and assess suitability for opioid surveillance. 1. identify the relevant data elements 2. examine data completeness and validity 3. identify data limitations and gaps that limit surveillance the aims of phase ii are: 1. examine whether and to what extent patient-level risk factors, provider processes, and policies are associated with declines in outcomes of interest. 2. examine whether and to what extent prescribing guidelines, related policies, processes, and/or care procedures are associated opioid-related outcomes.

Eligibility criteria:
inclusion criteria: • patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17. exclusion criteria: • patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
changes in respiratory effort in preterm infants

Conditions: Premature Birth

Summary: continuous positive airway pressure (cpap) is used to treat preterm infants with an immature respiratory center and having respiratory distress. cpap requires intensive care monitoring and special qualified staff. continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.the fixture of the binasal prongs can cause nasal trauma after to tight attachment.minimizing the time on cpap is considered important for the child. recently high-flow nasal cannula (hfnc) has become widely used in modern newborn intensive care units.hfnc is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. hfnc gives warm humified air with high flow through a nasal cannulae. hfnc is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation. there is still uncertainty about safety and effectiveness of hfnc. the aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (edi max and edi min), respiratory parameters and a clinical observation using a scoring system inspired by silverman- andersen retraction score. it is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from cpap to hfnc.

data material will be stored on a separate computer in a sheltered home directory. all data will be anonymous. edi signals are transported from servo-i ventilator with neural access through a communication port to a personal computer.respiratory parameters will be stored in picis (high performance hospital information system). for the statistical analyzes a t-test will be carried out, and data from the pilot study will decide the power to see whether we reject or retain the 0 hypothesis: " there are no changes in the preterm infants respiratory effort in transition from cpap to hfnc".

Eligibility criteria:
inclusion criteria: * preterm infants who are stable on nasal continuous positive airway pressure (ncpap) with flow 8l/min * \ 28 gestational weeks, respiratory stable last 72 hours. * 1 kilo * fi02\< 30% * c02\<9 * written informed consent by parents/caregivers exclusion criteria: * need for sedation * damage on the phrenic nerve * anomalies in the upper airways

Keywords: respiration noninvasive ventilation work of breathing infant, premature electromyography diaphragm