Kornimate/medical-research-clean huggingface dataset:
cognitive and blood biomarker assessment after co exposure

Conditions: Carbon Monoxide Poisoning

Summary: carbon monoxide (co) is reported to cause around 30 deaths, 200 admissions and 4000 presentations to emergency departments each year in the uk. in the longer term, co poisoning is recognised to cause persistent neurological problems (including impairments of thinking and behavioural changes), which can develop days to weeks after the initial exposure. however, the incidence of these long-term sequelae is unknown. in addition, there is evidence of long-lasting inflammatory changes in the brain and on-going brain cell injury, although how long this persists is also unknown. initial assessments of co exposure can be unreliable if blood tests are not carried out within a relatively short period after the exposure and other biomarkers (such as imaging) are insensitive to detecting previous co exposure. certain proteins that are found in brain cells can be detected in the blood of individuals following brain injury and brain cell death. these proteins have been found to be raised in the acute period after minor head injury, persistently raised in patients with a traumatic brain injury and evidence of on going neurodegeneration (i.e. on going brain cell death) and in patients with various types of dementia. the investigators will assess the presence of these proteins in the blood of 50 participants with proven co exposure in the sub-acute to chronic timescale (2 weeks to 2 years). this has not been done before and will allow assessment of the presence of on going brain injury in these participants. the investigators will also assess cognitive (e.g. memory, attention and speed of thinking) and behavioural impairments in these participants to help characterise the common impairments suffered following co exposure and relate these to evidence of persistent brain injury and severity of co exposure.


Eligibility criteria:
inclusion criteria: individuals identified as having confirmed exposure to co between 2 weeks to 2 years at time of assessment. co exposure determined by either; * documented cohb levels above 1.6% in non-smokers and above 6.3% in smokers. * or, individuals with evidence of being exposed to raised levels of co and symptoms exclusion criteria: * age \<18 years * actual or suspected smoke inhalation * significant neurological or psychiatric illness prior to co exposure * inability to provide consent
daily sedative interruption in critically ill patients being managed with a sedation protocol.

Conditions: Critical Illness

Summary: the purpose of this study is to determine whether the use of both a nurse-driven sedation protocol and daily sedative interruption, compared with a sedation protocol alone, result in better outcomes for mechanically ventilated adults.

all critically ill, mechanically ventilated patients in the intensive care unit receive medications to relieve pain and anxiety. however, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the icu. two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. however, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation).we are conducting a multicenter randomized trial in which 400 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. primary outcomes are duration of mechanical ventilation and icu and hospital lengths of stay. secondary outcomes are the incidence of delirium, the use of neurologic tests, nurse and respiratory therapist effort associated with the sedation management, the incidence of patient self-removal of lines and tubes, and patient recall of the icu stay. the results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in canada and elsewhere.

Eligibility criteria:
inclusion criteria: * 18 years of age or over * mechanically ventilated, with anticipated need for mv ≥48 hrs * icu team has decided to initiate continuous sedative/analgesic infusion(s) * informed consent from patient and/or sdm exclusion criteria * admission after resuscitation from cardiac arrest * traumatic brain injury * currently receiving neuromuscular blocking agents * allergy to midazolam and lorazepam * lack of commitment to aggressive treatment * previous enrolment in sleap, or current enrolment in related trial

Keywords: icu sedation strategies daily sedative interruption sedation protocols mechanical ventilation sedation
maraviroc abacavir study - effect on endothelial recovery

Conditions: Endothelial Dysfunction

Summary: hiv infected patients treated with abacavir might have a higher risk for the occurrence of cardiovascular events. at time of writing of this protocol the underlying mechanism is not yet elucidated, however some studies find impaired endothelial function and elevated markers of chronic inflammation in these patients,suggesting a higher lever of chronic inflammation. recently maraviroc (celsentri®), a ccr5-receptor antagonist, became available for treatment of patients infected with hiv-1. improvement of endothelial function may be a potential beneficial side effect of treatment with maraviroc, due to the potential reduction of immune activation and chronic inflammation as a result of blocking the ccr5-coreceptor. moreover, treatment intensification of haart with maraviroc in patients with suppressed plasma hiv_rna may decrease plasma hivrna below the cut-off of 50 copies/ml as well. the investigators hypothesize that maraviroc intensification therapy in patients on an abacavir-containing regimen will improve endothelial function. the objectives of this study are: first, to assess the effect of addition of maraviroc to an abacavir-containing regimen on endothelial function; second, to assess the effect of this intervention on markers of immune activation and chronic inflammation, and on plasma hiv-rna below 50 copies/ml.

the master study is a phase iv, randomized, open label, cross-over, intervention study. study subjects who are on stable abacavir-containing regimen will be randomized into two arms. in arm a maraviroc will be added to their regimen at baseline, while study subjects in arm b will continue their abacavir-containing regimen. after 8 weeks, cross-over of the study arms will be performed. subjects in arm a will then stop maraviroc, while in subjects in arm b maraviroc will be added to their regimen (for 8 weeks again). the total duration of the study will be 16 weeks.

Eligibility criteria:
inclusion criteria: * age \> 18 years * hiv-1 infection * treatment with antiretroviral regimen containing abacavir for at least the previous 3 months * undetectable plasma hiv rna (50 cp/ml) for at least 6 months (one 'blip' allowed, which is defined as a detectable plasma hiv-rna level between 50 and 400 copies/ml, preceded and followed by undetectable (\<50 copies/ml) plasma hiv-rna measurements) * cd4+ cell count \> 200 cells/μl * signed informed consent exclusion criteria: * pregnancy * breastfeeding * allergy for peanuts or soya * hypersensitivity for maraviroc * treatment of underlying malignancy * acute infection in the preceding 30 days * renal insufficiency requiring hemodialysis * acute or decompensated chronic hepatitis * modification of antiretroviral regimen in the previous 3 months

Keywords: endothelial function ccr5 receptor maraviroc abacavir flow mediated dilatation endopat
biotronik conduction system pacing with the solia lead

Conditions: Bradycardia; Atrioventricular Block; Left Bundle-Branch Block; Cardiomyopathies

Summary: the purpose of the bio-conduct study is to demonstrate the safety and effectiveness of the biotronik solia s pacing lead when implanted in the left bundle branch (lbb) area. safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. efficacy will be assessed by evaluating implant success rate.


Eligibility criteria:
inclusion criteria: * patient is a candidate for implantation of a biotronik pacemaker system, per standard guidelines. single chamber, dual chamber, and cardiac resynchronization therapy with a pacemaker (crt-p) systems are allowed. * patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent * patient is able to understand the nature of the study and provide written informed consent * patient is available for follow-up visits on a regular basis for the expected duration of follow-up * patient accepts home monitoring® concept * patient age is greater than or equal to 18 years at time of consent exclusion criteria: * patient meets a standard contraindication for pacemaker system implant * patient is currently implanted with a pacemaker or implantable cardioverter-defibrillator (icd) device * patient has had a previous unsuccessful attempt to place a lead in the lbb area * patient has planned cardiac surgical procedures or interventional measures within 3 months after implant * patient is expected to receive a heart transplant within 12 months * patient life expectancy less than 12 months * patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder * patient reports pregnancy at the time of enrollment * patient is enrolled in any other investigational cardiac clinical study during the course of the study
atp and capsaicin cough provocation test in chronic cough and bronchiectasis

Conditions: Chronic Cough; Bronchiectasis

Summary: this is a randomized, cross-over, single-blind trial. eligible patients will be randomly assigned to undergo either capsaicin or adenosine triphosphate (atp) cough provocation test, followed by a washout period of 2 to 14 days. participants will be crossed-over to undergo another cough provocation test. patient would be under observation in the out-patient clinics for \~2 hours following the cough provocation tests in case of severe adverse events.

this is a randomized, cross-over, single-blind trial. after verification of the entry criteria, eligible patients will be, based on the randomization codes, randomly assigned to undergo either capsaicin or atp cough provocation test (the participants will inhale capasaicin or atp incremental concentration to induce cough, meanwhile the number of coughs and adverse events will be recorded in each concentration during the first 30 seconds), followed by a washout period of 2 to 14 days (no major changes in the use of concomitant medications are allowed,especially the medcines which are not allowed before test ). participants will be crossed-over to undergo another cough provocation test. patient would be under observation in the out-patient clinics for \~2 hours following the cough provocation tests in case of severe adverse events. twenty four hours after each test, a follow-up telephone visit will be scheduled for all patients to record any response which may be related to the test.

Eligibility criteria:
inclusion criteria: * out-patients of either gender, ex- or never-smokers, aged between 18 and 60 years * cough symptoms lasting for more than 8 weeks * remaining free of acute upper respiratory tract infection for at least 4 weeks * agreed to participate in the trial and signed informed consent. exclusion criteria: * patients with serious systemic diseases (such as malignant tumors), bullae, severe uncontrolled asthma, and a history of major hemoptysis * systemic antibiotic use (except for maintenance low-dose macrolides) within 4 weeks * pregnancy or lactation * any known history of sensitivity to atp or capsaicin * poor understanding of the test procedure * diagnosed with cough variant asthma or eosinophilic bronchitis

Keywords: adenosine triphosphate capsaicin cough provocation test
interest of smartguard technology (predictive system for stopping insulin before hypoglycemia) in children with type 1 diabetes treated with insulin pump

Conditions: Diabetes Mellitus, Type 1

Summary: management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance. however, the risk of hypoglycaemia inherent to the treatment persists. hypoglycemia is an acute complication in the management of diabetes. it can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. it can be responsible for asthenia, difficulty concentrating and attention and memory problems. in order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia. the aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia "medtronic minimed with smartguard technology" in type 1 diabetic children, especially on the time spent in hypoglycemia .

management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance. however, the risk of hypoglycaemia inherent to the treatment persists. hypoglycemia is an acute complication in the management of diabetes. it can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. it can be responsible for asthenia, difficulty concentrating and attention and memory problems. in order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia. the aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia "medtronic minimed with smartguard technology" in type 1 diabetic children, especially on the time spent in hypoglycemia .

Eligibility criteria:
inclusion criteria : * children aged between 1 and 17 years * type 1 diabetes * duration of type 1 diabetes \> 1 year * insulin pump therapy \> 3 months exclusion criteria : * other diseases predisposing to hypoglycemia * oral glycemic medications * have used continuous glucose monitoring during the last 3 months * hba1c \>10%
effect of symbicort on gr localisation in asthma

Conditions: Asthma

Summary: to investigate a possible interaction between formoterol and budesonide on gr-translocation and to compare the effect of different doses of symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on gr translocation, and to investigate the effect of the study drugs on exhaled no (bronchial and alveolar fraction.

combination therapy with inhaled corticosteroids (ics) and long-acting β(2)-adrenergic agonists (laba) is reported to have superior effects on controlling asthma symptoms to ics alone; however, there is no molecular-based evidence to explain the clinical effects. here, the effect of the ics/laba combination was compared with ics on glucocorticoid receptor (gr) activation in sputum macrophage. in a randomised, double-blind cross-over placebo-controlled 6-visit study, 10 patients with mild asthma were given placebo, formoterol (oxis(®) 12 μg), budesonide (pulmicort(®) 200 μg :bud200, or 800 μg :bud800), or budesonide/formoterol combination (symbicort(®)) as a single 100/6 μg (sym100) or double 200/12 μg (sym200) dose. sputum macrophages were separated by plate adhesion from induced sputum. gr binding to the glucocorticoid-response elements on oligonucleotides (gr-gre binding) was evaluated by elisa. mrna expression of map-kinase phosphatase (mkp)-1 and il-8 were measured by quantitative rt-pcr.

Eligibility criteria:
inclusion criteria: * patients with mild steroid-naïve asthma (ats criteria) of either sex with fev1 \>70 % pred * able to produce sputum after sputum induction * exhaled no (flow 50 ml/s) ≥ 20 ppb * written informed consent exclusion criteria: * current upper respiratory tract infections * use of inhaled and/or oral gcs within 4 weeks prior to visit 1 * treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit * hypersensitivity to any of the investigational drugs or lactose * use of any beta blocking agent (including eye-drops) * women who are pregnant, breast-feeding or planning a pregnancy during the study. women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator * any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study * inability to tolerate temporary withdrawal of bronchodilatory therapy * subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason * previous randomization in this study

Keywords: asthma glucocorticoid long-acting beta2-adrenoceptor inhaled corticosteroids
post-market registry for the evaluation of refluxstop in gerd treatment

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: this post-market registry aims to assess safety and performance of refluxstop™ in the treatment of gastroesophageal reflux disease (gerd) in standard of care procedures.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent and to participate in the registry study, 2. patient's age ≥ 18 years or according to local legal age of adulthood if older, 3. documented gerd present for \> 6 months, 4. patient has a 24-hour ph monitoring proven gerd with ph and/or impedance ph measurement, off ppi therapy for at least 7 days prior to testing. (total distal esophageal ph must be \ 4.5% of time during a 24-hour monitoring and/or total reflux episodes of acid \>55 or weakly acid \>26 for \>5 seconds at 5 cm above les) 5. suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator. exclusion criteria: 1. presence of para-esophageal hernia or sliding hernia \> 3 centimeters, 2. known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed, 3. history of bariatric surgery wherein the stomach fundus has been extirpated, 4. female patients who are pregnant or nursing, 5. known sensitivity or allergies to silicone materials, 6. intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the ifu); 7. patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).
pharmacokinetics of multiple ascending doses of vch-222 in subjects with chronic hepatitis c infection

Conditions: Hepatitis C

Summary: the purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. this study will also evaluate the safety and tolerability of treatment with vch-222 when given alone or in combination with peginterferon and ribavirin. the study will also evaluate the pharmacokinetic profile of vch-222 in hcv infected subjects.


Eligibility criteria:
inclusion criteria: * male and female subjects, 18-65 years of age (females non-child bearing potential in part b) * have laboratory evidence of hcv infection for 6 months, defined by (1) presence of anti-hcv antibody (genotype 1a and 1b infection), or (2)documented hcv rna presence by a sensitive and specific assay and (3 histologic evidence of chc (fibrosis on a standardized histological grading system) * plasma hcv rna of 100,000 iu/ml * hiv 1 and hiv2 ab seronegative * body mass index (bmi) ≤ 35 kg/m2 bmi * treatment naive subjects exclusion criteria: * contraindications to peginterferon or ribavirin therapy * have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score \> 5 * have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes

Keywords: vx-222
reactivate: physiotherapist led intervention for adolescents with pain and psychological distress.

Conditions: Chronic Pain; Emotional Distress

Summary: recurrent or persistent pain and psychological distress are alarmingly common problems among adolescents, in sweden as well as globally. they often co-occur and have been shown to be predictors of sustained problems in adulthood. adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. there is thus a need for treatment development, not in the least for (secondary) preventative purposes. the aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent pain and psychological distress based upon graded exposure to physical activity and reactivation.

see description of arms and intervention.

Eligibility criteria:
inclusion criteria: * age 12-19 * psychological distress, such as anxiety, depressive symptoms or stress, ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent) * persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent) * presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); \> 50 on at least one activity of the phoda. * swedish speaking and able to fill out questionnaires exclusion criteria: * serious/malignant disease * participation in other rehabilitation program * severe mental health problems * substance abuse * severe learning disabilities
blood transfusion education using blended virtual reality and simulation for nursing undergraduate students

Conditions: Blood Transfusion Complication

Summary: nurse-administered blood transfusion (bt) is a common form of medical treatment, but nursing students are often excluded from participating in and observing bts during clinical placements. to address clinical placement limitations, nursing educators have increasingly adopted technology-guided simulation pedagogies, including virtual reality (vr) simulation, for nursing students' clinical skills education.


Eligibility criteria:
inclusion criteria: * all undergraduate nursing students enrolled in the 'nursing of adults' course in a pre-licensure program at a hong kong university. exclusion criteria: * students who had vision impairment to watch vr videos; * students who had neck pain/ injury to move their head, or open wound to wear the vr headset; * students who experienced nausea and dizziness when watching vr videos; * students who had epileptic symptoms

Keywords: blood transfusion nursing education nursing practice simulation virtual reality