Kornimate/medical-research-clean huggingface dataset:
the effect of influenza vaccination on the systemic inflammatory response and myocardial protection in patients undergoing cardiac surgery: a randomized controlled trial

Conditions: Systemic Inflammatory Response

Summary: to assess the impact of influenza vaccination on the overall systemic inflammatory response in patients undergoing cardiac surgery and investigate functional and clinical outcomes in vaccinated patients postoperatively.

the investigators propose to perform a single center, double-blind, randomized, placebo-controlled crossover trial analyzing the beneficial effect of the influenza vaccine in patients undergoing cardiac surgery. this study assesses the impact of the influenza vaccination on the overall systemic inflammatory response and investigates the functional and clinical outcome in vaccinated patients after cardiac surgery. the study sample will consist of patients undergoing cardiac surgery at health sciences north randomized into 2 groups: 1) those who receive the vaccine or placebo preoperatively, or: 2) those who receive the vaccine or placebo 4-6 weeks postoperatively. subjects in both groups will be compared using standard laboratory tools to assess the level of various pro- and anti-inflammatory cytokines (il-6, il-8,tnf-alpha, il-10) as well as other cardiac and inflammatory markers (troponins, crp), at different time intervals intra- and post-operatively. other clinical outcomes will also be collected prospectively and compared between the 2 groups. these include hemodynamic parameters as well as major postoperative events. further assessments will include the frailty index and scale (in patients 65+) and length of stay after surgery

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, and able to converse with study personnel) * age 18 years or older * undergoing major cardiac surgery using cardiopulmonary bypass exclusion criteria: * have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination * participant has received a community available influenza vaccine within \<6 months * history of guillain-barré syndrome * immunosuppressive disorders or medications (including oral prednisone \>10 mg daily, recent chemotherapy treatment) * emergency cases as determined by the investigator or physician
analysis of protein and emotional alterations during and after hypobaric hypoxia

Conditions: Hypoxia, Altitude

Summary: this study analyses both protein expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.

this study analyses both protein expression and emotional alterations during hypobaric hypoxia in volunteers of different groups. 15 different groups are analysed: control group, 5000ft group, 8000 ft group, 10000ft group and 15000ft group - all for 15, 30, and 60 minutes.

Eligibility criteria:
inclusion criteria: * helathy exclusion criteria: * ear problems
transfusion alternatives pre-operatively in sickle cell disease (taps)

Conditions: Sickle Cell Disease

Summary: taps is a sequential trial which aims to investigate whether the administration of a blood transfusion pre-operatively to patients with sickle cell disease (hb ss or hb sb0 thal)having low or medium risk elective surgery increases or decreases the overall rate of peri-operative complications. the proportion of patients with peri-operative complications in two randomised groups of transfused and untransfused patients will be compared.


Eligibility criteria:
inclusion criteria: * sickle cell disease, either hb ss or hb sb0 thal, confirmed by hb electrophoresis, deoxyribonucleic acid (dna) analysis or high performance liquid chromatography (hplc) * at least 24 hourse and no more than 14 days before surgery and a date for surgery has been given * surgery to be low or medium risk * surgery to be with general or regional anaesthesia * written informed consent from patient/parent/guardian is given * more than six months since previous taps trial surgery. exclusion criteria: * having a procedure involving intravascular contrast radiography or an imaging procedure * on a regular blood transfusion regime * had a blood transfusion within the last three months * the planned procedure involves local anaesthetic only * haemoglobin level at randomisation less than 6.5g/dl * children with a clinical history of stroke (history of silent infarcts would not preclude randomisation) * acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome * oxygen saturation at randomisation less than 90% * patient is on renal dialysis * already entered twice into the taps trial * the physician is unwilling to randomise the patient (such patients will be entered into a trial log).

Keywords: sickle cell disease pre-operative transfusion blood transfusion
procedure sedation with dexmedetomidine in children with autism spectrum disorders during magnetic resonance imaging

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorders (asd) is a neurodevelopmental disorder and is characterized by functional impairment in social communication, restricted interests, and repetitive behaviors.the children with asd has been shown different drug responses from the normal population of children. the children with asd maybe more prone to elevate anxiety and the difficult of sedation during mri scanning.the purpose of this investigation was to compare the effectiveness of dexmedetomidine sedation in children with and without asd undergoing mri scanning.

the use of medications in adolescents and young adults with asd is extremely common. however, few data address the effectiveness and harms of medications for procedural sedation in this population. it's advisable to be used as a first line medication with alpha-2 agonists for procedure sedation. the primary goal of this study was to compare the effectiveness of dexmedetomidine sedation, also determine the 50% and 95% effective doses in children with and without asd undergoing mri scanning.

Eligibility criteria:
inclusion criteria: * asa physical status i or ii, * patients aged 2 years through 12 years of age scheduled for procedure sedation during mri scanning * patients must have a diagnosis of autism spectrum disorder (asd) according to the dsm v (autism group) or no history of neurodevelopmental concerns (control group). child in control group is matched to an autism spectrum disorder participant according to age, gender, and asa level. exclusion criteria: * known allergy or hypersensitive reaction to dexmedetomidine * organ dysfunction, and significant developmental delays or behavior problems * cardiac arrhythmia * known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination

Keywords: autism spectrum disorder dexmedetomidine
local anaesthetic effects of transcutaneous amitriptyline

Conditions: Healthy Volunteers

Summary: the aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. the solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug \[1\]. considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain \[2,3\], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.

sixteen male healthy volunteers are enrolled for this study. they receive in a randomised order on six regions of dorsal skin (after previous targetting by ink marks) the six following treatments : lidocaïne-prilocaïne anaesthetic cream (emla (r)), normal saline, amityptiline hydrochloride diluted in solution of water (%), isopropanol (%) , glycerol (%), titrated with sodium hydroxide for ph=8.5, at four different concentrations (0,25, 50 and 100 mm). the person in charge of local application does not participate to further examination. immediately after one hour of application, the volunteer is examined, and then every 2 hours during 8 hours, and 24 hours after the end if application. every trial includes, for every treated area, (a) measurement of sensitive and nociceptive threshold to von frey hair application, (b) assessment of sensation induced by cold and heat after rolltemp tm application, (c) measurement of sensitive threshold to cold, then sensitive and nociceptive thresholds to heat with thermotest tm, (d) clinical evaluation of tolerance to the treatment, (e) blood sampling for measuring amitriptylinemia (hplc). the possible residual anaesthetic effects of the treatment are assessed one and three weeks after the application, by measurement of sensitive and nociceptive threshold to von frey hair application. the statistical analysis will use two-way anova, considering the following factors : treatment, time, order, subject, subject/order.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * history of intolerance to amitriptyline, lidocaine or prilocaine * cardiac predisposition to intolerance to tricyclic antidepressants

Keywords: tricyclic antidepressants neuropathic pain local anaesthesia transcutaneous
study to evaluate the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults (av024)

Conditions: Influenza

Summary: to assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (flumist).

the primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (flumist). safety will be demonstrated by similar fever rates (oral temperature ≥101°f) in vaccine and placebo recipients.

Eligibility criteria:
inclusion criteria: * 18-64 years of age (not yet reached their 65th birthday); * in good health; * available by telephone; * ability to understand and comply with the requirements of the protocol; and * signed informed consent. exclusion criteria: * any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year; * acute febrile (\>100.0°f oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment; * hypersensitivity to egg or egg protein; * signs or symptoms of any immunosuppressive or immune deficiency disease, including hiv infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household; * participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and * any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
clinical study of treating type 2 diabetic nephropathy with alfacalcidol and irbesartan

Conditions: Type 2 Diabetic Nephropathy

Summary: this is a prospective, multi-center, randomized, open-label, parallel-arm controlled study, for which a total of 216 patients with type 2 diabetic nephropathy (stage ii-iv) will be enrolled. the subjects will be randomized to three groups in 1:1:1 ratio. one group receive alfacalcidol 0.25ug/day and irbesartan 150mg/day for 16 consecutive weeks. the second group receive alfacalcidol 0.25ug/day alone for 16 consecutive weeks. the third group receive irbesartan 150mg/day alone for 16 consecutive weeks. all subjects will be followed up for 4 weeks after medication is over. a total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20.


Eligibility criteria:
inclusion criteria: * adult chinese subjects, at age 18-65, diagnosed with type 2 diabetic nephropathy (stage ii-iv) who meet the who diagnostic standards of diabetes in 1999. the international mogensen staging standard for diabetic nephropathy is used. specifically, in stage ii (normal albuminuria stage), the uaer is normal (\ 200μg/min or urine protein quantitation is \>500mg /24h. exclusion criteria: * renal damage caused by other causes; * uncontrolled hypertension (blood pressure constantly greater than 140/ 90mmhg); * type 1 diabetes * any acute and chronic infections; * glycosylated hemoglobin (hba1c)\>7.5%; * 24h urinary protein quantity\>3g, serum albumin\<25g /l and estimated glomerular filtration rate (egfr)\<60 ml/min; * patients who suffered from malignant tumors or any illness that endanger life, such as liver, kidney, heart and lung function insufficiency over the past 5 years; * people who have received the gastrointestinal operation, which may affect absorption of vitamin d; * people who have taken such drugs as angiotensin receptor blocker, calcium, and angiotensin converting enzyme inhibitor that affect excretion of urine protein, and who have been allergic to vitamin d; * pregnant or lactating women; * other candidates that are deemed not suitable by investigators.

Keywords: type 2 diabetic nephropathy alfacalcidol
rotem-guided transfusion protocol in attempt to reduce blood transfusions in major oncological surgery

Conditions: Blood Loss, Surgical; Blood Loss Requiring Transfusion; Coagulation Defect; Acquired

Summary: need for perioperative blood transfusion is still high in certain types of oncological abdominal surgery. allogeneic blood transfusion may be detrimental in cancer patients undergoing a potentially curative resection of malignant tumor, although the detailed mechanism of this effect is still under debate. we plan to evaluate whether a new, rotational thromboelastography-guided algorithm (rotem) to guide hemostatic resuscitation intra-operatively decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. its effect on each patient's post-operative hemostatic profile is also measured. 60 patients having a potentially curative pancreaticoduodenectomy (or resection of cauda of pancreas), total removal or partial resection of kidney and open radical cystectomy are recruited when an active blood loss of more than 1500 ml is estimated and/or measured and are randomized into two groups: one will be treated conventionally, ie. using massive transfusion protocol (mtp) if necessary, clinical judgement and conventional coagulation tests, the other treated using a rotem-based algorithm.


Eligibility criteria:
inclusion criteria: * age over 18, radical cystectomy, total or partial nephrectomy for malignant disease or pancreaticoduodenectomy planned and estimated intraoperative hemorrhage over 1500ml, written and informed consent exclusion criteria: * known hemophilia or von willebrandt's disease (treatment planned beforehand in collaboration with haematologist), unacceptance of allogeneic blood products (jehovah's witnesses).

Keywords: rotem thromboelastometry blood transfusion cancer surgery abdominal oncological
nbi-3001 followed by surgery in treating patients with recurrent glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: nbi-3001 may be able to locate cancer cells and stop them from growing. this may be an effective treatment for glioblastoma multiforme. purpose: randomized phase ii trial to compare different regimens of nbi-3001 followed by surgery to remove the tumor in treating patients who have glioblastoma multiforme.

objectives: i. determine the safety, tolerability, and optimal clinical dose of interleukin-4(38-37)-pe38kdel cytotoxin (nbi-3001) followed by surgical resection in patients with recurrent glioblastoma multiforme. outline: this is an open-label, dose-escalation, multicenter study. patients receive interleukin-4(38-37)-pe38kdel cytotoxin (nbi-3001) intratumorally as a continuous infusion over 4-5 days beginning within 12-36 hours after ventricular catheter placement. patients then undergo surgical tumor resection approximately 3 weeks after drug infusion. cohorts of 6 patients receive escalating doses of nbi-3001 until the maximum tolerated dose is determined. patients are followed within 1 week and then at 8, 16, and 26 weeks. projected accrual: approximately 30-36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent or progressive glioblastoma multiforme previously treated with cytoreductive surgery unilateral, unifocal tumor with a volume of 5-80 ml not eligible for further radiotherapy due to prior external beam radiotherapy no multifocal, brain stem, or infratentorial tumor or tumor invading midline no tumor with a clinically significant mass effect (greater than 5 mm midline shift) while on stable dose of corticosteroid no clinical symptoms attributed to uncontrolled increased intracranial pressure and/or edema of the brain patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no focal or generalized seizure(s) within 30 days prior to enrollment no other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer no medical instability due to non-malignant systemic disease no other prior or concurrent condition that would preclude study compliance not pregnant fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior antineoplastic chemotherapy endocrine therapy: see disease characteristics stable dose of dexamethasone for at least 72 hours prior to catheter placement radiotherapy: see disease characteristics no prior radiosurgery boost (e.g., gamma knife or stereotactic radiosurgery) at least 8 weeks since prior radiotherapy surgery: see disease characteristics at least 4 weeks since prior craniotomy

Keywords: recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
an exercise intervention to prevent gestational diabetes

Conditions: Gestational Diabetes

Summary: women diagnosed with gestational diabetes mellitus (gdm) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the united states. gdm, therefore, identifies a population of women at high risk of developing type 2 diabetes and thus provides an excellent opportunity to intervene years before the development of this disorder. it is well recognized that acute as well as chronic physical activity reduce fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. recent studies have suggested that women with higher levels of physical activity have reduced risk of gdm. therefore, we will test the hypothesis that an exercise intervention is an effective tool for preventing gdm among women with a history of gdm.

the primary goals of the application are to investigate the effects of a motivationally-tailored, individually targeted 12-wk physical activity intervention on 1) risk of gdm in women at high risk of the condition, 2) serum biomarkers associated with insulin resistance, 3) and the adoption and maintenance of exercise during pregnancy. secondary goals are to investigate the impact of the intervention on gestational weight gain and selected birth outcomes. the overall goal of the intervention is to encourage pregnant women to achieve the american college of obstetricians and gynecologists (acog) guidelines for physical activity during pregnancy (30 minutes or more of moderate- intensity activity on most days of the week) through increasing walking and developing a more active lifestyle. the intervention draws from the theory of stages of motivational readiness for change and social cognitive theory constructs for physical activity behavior and will take into account the specific social, cultural, economic, and physical environmental challenges faced by women of diverse socioeconomic and ethnic backgrounds. the application is innovative in being the first, to our knowledge, to test a physical activity intervention designed to prevent gdm among high risk women. the intervention protocol can readily be translated into clinical practice in underserved and minority populations.

Eligibility criteria:
inclusion criteria: * history of gestational diabetes or overweight (\>25 kg/m2) with family history of type 2 diabetes * sedentary exclusion criteria: * history of diagnosis of diabetes, hypertension, heart disease or chronic renal disease * current medications which adversely influence glucose tolerance * not planning to continue the pregnancy to term * \>16 weeks gestation * contraindications to participating in moderate physical activity * inability to read english at a 6th grade level * self-reported participation in \>30 min of moderate or vigorous-intensity exercise on \>3 days/wk * prior participation in the study * non-singleton pregnancy

Keywords: gestational diabetes physical activity behavior change glucose tolerance pregnancy