Kornimate/medical-research-clean huggingface dataset:
propofol and perioperative inflammation

Conditions: Inflammation

Summary: the inflammatory properties of propofol are still under debate. apolipoprotein a-i (apo a-i) is involved in the inflammatory process. this study was designed to determine whether and how propofol or its solvent modulate apo a-i and the inflammatory response after surgical stress. the investigators study hypothesis was that propofol might modify the apo a-i blood levels, and thus, modulate the postoperative inflammatory course.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i or ii * scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair exclusion criteria: * body mass index (bmi) \ 39.9kg/m2 * treatments with steroids (\>5mg/d prednisone equivalent, for the last 30 days) * with opioids/non-steroidal anti-inflammatory drugs (nsaids) for chronic pain during the last 30 days * immunosuppression (aids, neutropenia \<1000 cells/ml, transplant surgery, chemotherapy) * known lipid disorder (triglycerides \>2.00mmol/l, low-density lipoprotein (ldl)-cholesterol \>2.50mmol/l or high-density lipoprotein (hdl)-cholesterol \< 1.00mmol/l) * hypolipemic treatment before admission * thyroid metabolism disorder (thyroid-stimulating hormone \>6.0 mui/l or \<0.4mui/l) * renal insufficiency (creatinine \>106umol/l) * liver disorder (bilirubin \>20umol/l, thromboplastin time \<60%) * insulin dependant diabetes * parenteral nutrition or after any lipid-containing medication (propofol, intralipid, etomidate) during the last 30 days * antihypertensive medication with diltiazem or other calcium channel blockers * known chronic alcoholism (men: \>65-75 ml alcohol/day) * multidrug abuse (cocaine, heroin, methadone, or other narcotics, sedatives or stimulants) * mental illness * known allergy to propofol after randomization: * change of surgical strategy * protocol violation * major bleeding (\>0.5l)

Keywords: propofol inflammation perioperative lipids apolipoprotein a-i
diagnosis of cow's milk protein allergy among infants and children in assuit university children hospital

Conditions: Cow Milk Allergy

Summary: the study will assess the diagnosis of cow's milk protein allergy (cmpa) among infant and children in assiut university children hospital using skin prick test and specific serum ige

food allergy is a reproducible specific immune response to the exposure to a given food. cow's milk protein allergy (cmpa) is a clinically abnormal reaction to cow's milk protein (cmp) via immune mechanisms triggered by milk protein (boyce etal., 2010) . according to the european academy for allergy and clinical immunology (eaaci) and the world allergy organization (wao), a hypersensitivity reaction to cow's milk involving the immune system can be called as cmpa.there is difference between cmpa and non-allergic cow's milk intolerance (e.glactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (venter etal ., 2013) . cmpa is categorized into immunoglobulin ige mediated, non-ige mediated, or mixed cmpa(sichereretal ., 2001) . 1.9% to 4.9% prevalence of cmpa among children with a peak in prevalence (2-3%) in the first year of life and prevalence of \<1% in children aged ≥6 years(koletzkoetal ., 2012) .

Eligibility criteria:
inclusion criteria: 1. age : from first day of life - 2 years 2. exclusively breast feeding,breast-fed infants with supplementary foods and non-breast-fed infants with supplementary foods who complain from either frequentregurgitation,vomiting,diarrhea,constipation)with/without perianal rash),bloodin stool or pallor. exclusion criteria: * infant and child with gastrointestinal symptoms due to specific aetiology .
auditory intraoperative stimulation effects on pain and agitation at awakening (audiopaw)

Conditions: Procedural Anxiety; Procedural Pain; Adenotonsillitis

Summary: adenotonsillectomy (at) is one of the most common pediatric surgical procedures. the management of postoperative pain and agitation after at is still a controversial issue. safety considerations limit the use of opioids and non-steroidal anti-inflammatory drugs, leading to inadequate control of the high levels of postoperative pain experienced by at patients. along with pain killers, non-pharmacological strategies have remarkable impact on pain management in children. a systematic review and meta-analysis published in the lancet in 2015 on adult patients suggest that auditory stimulation with music in the perioperative setting, and even when patients are under general anaesthesia, can reduce postoperative pain, anxiety, and analgesia needs. the authors concluded that there is sufficient evidence to implement auditory stimulation in the treatment of all adult surgical patients, regardless of the mode of administration. up to now, no research has investigated the effects of intraoperative auditory stimulation on pain and agitation upon awakening after at in the pediatric population. objective of this study is to determine the effects of intraoperative auditory stimulation on pain and agitation upon awakening after pediatric at.


Eligibility criteria:
inclusion criteria: * age 2 to 17 years old * scheduled for adenotonsillectomy * recent audiometry and tympanometry evaluation (\<1 month) exclusion criteria: * no informed consent * other combined surgical procedures * comorbidities (e.g. congenital anomalies of the head-and-neck, psychomotor delay, autism spectrum disorders) * american society of anesthesiologists (asa) classification score \>2 * ongoing chronic pharmacological therapy * first language not italian * environmental noise exceeding limits in the operating room

Keywords: auditory stimulation adenotonsillectomy pain agitation awakening
real world data on gi(l)otrif® dose adjustment

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with gi(l)otrif® as part of the routine treatment according to the approved label. data from real-world will help to understand if dose modifications are done similar as in lux-lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.


Eligibility criteria:
inclusion criteria: 1. age = 18 years 2. patients with epidermal growth factor receptor (egfr) mutation (common mutations), tyrosine kinase inhibitors (tki)-naïve advanced non small cell lung cancer (nsclc), treated with gi(l)otrif® as the first-line treatment for nsclc within the approved label 3. signed and dated written informed consent per regulations. (exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.) exclusion criteria: 1. any contraindication to gi(l)otrif® as specified in label. 2. patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. usa). 3. patients still on treatment with gi(l)otrif® will be excluded unless treatment period is \> or = 6 months. 4. patients treated with gi(l)otrif® within an interventional trial.
closure of skin incision using co2 laser

Conditions: Wound

Summary: the purpose of this study is to evaluate the safety and effectiveness of using temperature controlled laser soldering system for soft tissue bonding.

skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces. the wound closure devices include sutures, staples, tapes, tissue adhesives. the applied physics group at the tel aviv university has developed a temperature controlled co2 laser soldering system for soft tissue bonding. this system includes features that make laser soldering suitable for clinical use. the temperature controlled laser soldering system is composed of co2 fiberoptic laser device, infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (clamps) and concentrated human albumin as a soldering agent.

Eligibility criteria:
inclusion criteria: * male/female age 18-65. * subject is scheduled for laparoscopic cholecystectomy surgery. * subject able to comprehend and sign informed consent for participation in this study. * ability to comply with the study procedures and follow-up visits exclusion criteria: * subject has a history of hypertrophic or keloid scar formation * subject is a pregnant and/or nursing woman * subject has a known allergy to blood products * subject is suffering from a bleeding disorders or using anticoagulant medications * subject is suffering from hepatic or renal disorder * subject is suffering from rheumatic and / or collagen disorder * subject is using steroids * subject is suffering from immunosuppressive disorder * subject is suffering from ischemic heart disease (ihd) * subject is suffering from neoplastic disorder * subject who has had an active illness within 4 weeks of study enrollment * subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment * any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.

Keywords: incision wound closure laser tissue soldering
zante: zometa and taxotere in hormone refractory prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: this phase i trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy.

docetaxel has been used alone and in combination with other anti-cancer therapies in the treatment of hormone refractory metastatic prostate cancer. zoledronic acid has been used in the treatment of bone metastasis from prostate cancer. this is a study of the combination of these two agents. the zante study will test a dose escalation of docetaxel in association with a predetermined dose of zoledronic acid (2 mg), given every 14 days for a minimum of 6 and maximum of 12 cycles. sequence a: docetaxel on day 1 and zoledronic acid on day 2 sequence b: zoledronic acid on day 1 and docetaxel on day 2 patients are enrolled sequentially in cohorts of 3 for each dose level, and a maximum of 36 patients will be enrolled.

Eligibility criteria:
inclusion criteria: * written informed consent * hormone refractory prostate cancer * stage iv disease with bone metastasis * no immunotherapy, hormonal therapy or radiotherapy within the previous month * performance status \< or = 2 (ecog) * serum creatinine \< 1.5 mg/100ml * serum bilirubin \< or = 1.25 x unl (upper normal limit) (or \< or = 1.5 x unl in the presence of hepatic metastases); sgot e sgpt \< or = 1.5 x unl (or \< or = 2.5 x unl in presence of hepatic metastases) * left ventricular ejection fraction \> or = 50% (measured by cardiac ultrasound or muga scan) * neutrophils \> 1500/mm3; platelets \>100000/mm3; hemoglobin \>10 g/100 ml· life expectancy of at least 3 months exclusion criteria: * previous malignancies with the exception of radically treated epithelioma * previous chemotherapy * comorbidities that would, in the investigator's opinion, contraindicate the use of the drugs in the study * uncontrolled diabetes * severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months * severe infection * cerebral metastasis * pre-existing motor or sensory neurotoxicity \> or = grade 2 according to ctc (common toxicity criteria).

Keywords: hormone refractory bone metastasis chemotherapy biphosphonates
cognitive behavioral therapy for insomnia among different types of shift workers

Conditions: Chronic Insomnia; Cognitive Behavioral Therapy; Sleep Disorders, Circadian Rhythm; Sleep Disorders, Shift-Work

Summary: the aim of the study is to compare the implementation and effectiveness of group and self-help based cognitive behavioral treatment for insomnia (cbt-i) delivered by occupational health services (ohs) in a randomized and controlled design (rct) among different types of shift workers.

because of irregular sleep-wake pattern shift work is a challenge in the screening and treatment of chronic insomnia. earlier results has showed that cbt-i delivered by trained nurses of ohs may be effective treatment also among workers with irregular work hours. the aim of the present study is to compare the implementation and effectiveness of ohs delivered group and self-help based cbt-i in a rct design among different types of shift work. participants (n=90-120) are shift workers with insomnia disorder that has lasted at least three months. the participants are randomized to a) group-based cbt-i (6 group sessions); or b) mainly computerized self-help cbt-i (an individual session before and after the intervention) delivered by a trained ohs nurse or psychologist; or c) control group given a sleep hygiene intervention (1 individual session). outcomes are assessed using a sleep diary, questionnaires, actigraphy and cognitive performance tests. to study the effect of cbt-i program at molecular level, blood samples of participants will be collected at baseline and at the end of the program for genetic analyses. the measurements are conducted at five time points for a period of two years. the investigators expect to find that both group and self-help based cbt-i among different types of shift workers are effective low-intensity treatments of chronic insomnia compared to control intervention. through the training of ohs or general medical practitioners and by computerised self-help interventions the investigators may have better chance to make cbt-i more accessible to a larger number of insomniacs also with different types of working hours. additionally, it may be possible to decrease chronic insomnia and unfavourably consequences of insomnia to the health and performance capacity in shift workers.

Eligibility criteria:
inclusion criteria: * chronic insomnia (f51.0) * difficulty initiating and/or maintaining sleep for ≥ 30 minutes and/or the use of sleep promoting medicine on three or more nights per week for at least 3 months * motivation to treat insomnia with non-pharmacological methods * full-time shift work (at least 10 % of shifts are morning, evening and/or night shifts) * fluent finnish (due to interventions) exclusion criteria: * non-assessed or untreated somatic or mental illness which may explain insomnia * planned changes in the work (for example retirement)
evaluation of the safety of sepraspray in open abdominal surgery

Conditions: Adhesion Prevention (Abdominal)

Summary: this study will examine the performance of sepraspray in patients undergoing open abdominal surgery note regarding reason for study termination: a patient death reported during the trial warranted temporary suspension for review by the independent data review committee. although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. a preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. a full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.


Eligibility criteria:
inclusion criteria: * patients 18 years old and over that require open abdominal surgery exclusion criteria: * patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
effectiveness of atypical antipsychotics on anhedonic features in patients with schizophrenia

Conditions: Schizophrenia

Summary: this prospective, multi-center, 12 weeks naturalistic nis trial will be conducted in 25 hospitals in naturalistic treatment setting. there will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.


Eligibility criteria:
inclusion criteria: * documented clinical diagnosis of schizophrenia meeting the diagnostic and statistical manual of mental disorders,(dsm-iv-tr) criteria * patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion exclusion criteria: * meeting the criteria for any other (than schizophrenia) dsm-iv axis i * patients with antipsychotic combinations (more than two agents) * patients who are already on any mood stabilizers and antidepressant * known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment * patients who have been treated with antipsychotics in depot formulations for the last two months * previous enrollment or randomisation of treatment in the present nis * patients who had participated in other clinical trials within 4 weeks prior to enrollment period * pregnant women or women who are breast-feeding

Keywords: anhedonic features in patients with schizophrenia
men's prostate awareness church training

Conditions: Prostate Cancer

Summary: the objective of the prostate cancer education in african american churches project is to develop and evaluate a spiritually-based educational intervention for informed decision making (idm) for prostate cancer screening to be delivered to african american men in church settings.

the specific aims of the project are to 1) develop, and 2) test the efficacy of a spiritually-based cancer communication intervention to increase idm for prostate cancer screening among african american men in church settings, and including women as supportive "health partners". a randomized controlled trial is utilized, in which churches will be randomized to: 1) male-only educational groups; and 2) co-educational groups where women supportive "health partners" are invited to attend with the men in dyads, and then break out into men's and women's discussion groups. these two approaches are compared through use of cluster randomized design to determine whether the addition of the women health partner increases the intervention efficacy in the study outcome of informed decision making for prostate cancer screening.

Eligibility criteria:
inclusion criteria: male study participants * african american men church attending men * 40-69 years of age advisory panel * knowledgeable about the community where the intervention is implemented, adults ages 21+, review materials and provide input for intervention development and program implementation pastors * willing to conduct the intervention at church * support the program * designate two individuals to serve as community health advisors * identify a ministry in the church which will champion the project community health advisors * attend a 6 hour training and 1 hour certification * assist in recruitment of study participants * recruit up to 24 men * recruit up to 24 females to attend sessions with men in 10 health partner churches * prepare and conduct the 4 part workshop series * serve as liaisons between the project and study team workshop participants * self-identified, african american men (40-69), health partners --over 18 years of age, able to complete self-administered paper-and-pencil surveys exclusion criteria: * workshop participants with a history of prostate cancer, do not meet the age criteria

Keywords: prostate cancer disparities african american spiritually based intervention men's health informed decision making community based participatory research health communication health information technology community health advisors
the acute impact of sit-stand desks on post-meal blood sugar levels

Conditions: Insulin Sensitivity; Glucose Tolerance; Sedentary Behaviour; Physical Activity

Summary: context and rationale: uninterrupted sitting is associated with increased risk of diabetes, heart disease, and death, even among people who are physically active. these relationships are likely due to increases in post-meal blood sugar observed when people sit for long periods (e.g. \> 1 hour) without interruption. in contrast to sitting, standing results in large reductions in post-meal blood sugar levels. our group has recently shown that sit-stand desks result in large (e.g. 2.5 hour/day) reductions in occupational sitting time. taken together, these findings suggest that sit-stand desks may help to reduce post-meal blood sugar levels. however, this has yet to be examined in the field. theoretical approach and objectives: the objective of this randomized crossover study is to determine whether people have lower blood sugar when using a sit-stand desk, in comparison to a desk that can only be used while sitting. methods and procedures: sixteen participants will be asked to wear a continuous glucose monitor to measure their blood sugar levels during 2 separate conditions. during one condition, they will be asked to use a sit-stand desk to sit and/or stand as much as they like during 1 workday. during the other condition, they will be asked to work at a seated desk for 1 workday. participants will be provided with identical meals to eat during each of the two conditions. we hypothesize that participants will have lower blood sugar levels on the day when they use the sit-stand desk, in comparison to the day using a traditional seated desk. significance and future use: if our results support this hypothesis, this would suggest that sit-stand desks may be a useful way to reduce blood sugar levels in people at risk for diabetes. this could also lead to larger population-based interventions studying the health impact of sit-stand desks.


Eligibility criteria:
inclusion criteria: * to participate in this study, participants must be between the ages of 20 and 65, and have access to a sit-stand desk (depending on your workspace, we may be able to provide you with a sit-stand desk during the study if you do not already have one). exclusion criteria: * participants will be excluded if they are currently taking any diabetes medications targeting blood sugar or insulin sensitivity as this will impact our primary outcome of postprandial glucose. participants will also be excluded if they are unable to stand or walk independently, as these are secondary outcomes in the present study.