Kornimate/medical-research-clean huggingface dataset:
promoting smoking cessation in carpenters

Conditions: Smoking Cessation; Health Behavior; Cancer

Summary: the purpose of this study is to test an innovative and sustainable intervention to increase participation in a union-sponsored smoking cessation program among carpenters and floor layers. the investigators will conduct a randomized controlled trial comparing targeted messaging versus standard messaging. all subjects will receive information about the free, union-sponsored smoking cessation program. subjects randomized to the intervention group will receive additional targeted materials to encourage enrollment in the union's smoking cessation program. the intervention will include monthly mailed and text messages. the investigators hypothesize that subjects who receive targeted messages will be more likely to enroll in the union-sponsored smoking cessation program, be more likely to show change in readiness to quit smoking, and be more likely to quit smoking compared to subjects who receive only standard messaging.

specific aim 1: develop targeted health messages based on audience segmentation to encourage smokers to enroll in a comprehensive union-sponsored smoking cessation program. we will craft six specific health messages that appeal to four different audience segments: workers under 30 years old without children, workers under 30 with children, workers 30 years old or older without children, and workers 30 or older with children. specific aim 2: conduct a randomized controlled trial of targeted messaging based on audience segmentation versus standard smoking cessation messaging. after conducting baseline surveys with union carpenters and floor layers, we will randomize current smokers (smoked within the last 30 days) into either the intervention or control group. * control subjects will receive one standard mailing informing them about the free smoking cessation program available to union members. * intervention subjects will receive the standard mailing in addition to six targeted smoking cessation messages delivered monthly by mail to their homes. messages will be specific to one of four audience segments determined by age and parental status. in addition to a segment-specific anti-smoking message, each mailing will have contact information for the union smoking cessation program. intervention subjects who consented to text messaging will also receive one booster text message each month with a shortened targeted message.

Eligibility criteria:
inclusion criteria: * current smoker (smoked cigarettes within the last 30 days) * eligible for union health benefits exclusion criteria: * none

Keywords: health communication smoking cessation health behavior construction industry audience segmentation
international validation study of the algoplus scale in five languages

Conditions: Pain; Elderly; Communication Disorders

Summary: acute pain is responsible for unnecessary suffering. among elderly patients, acute pain is frequent and underestimated, especially when these patients have cognitive disorders. the expression of pain is then modified and the conventional tools for evaluating pain cannot be used. thus the existence of pain must be detected on the basis of a behavioural assessment. it is nonetheless necessary to have the assistance of standardised and validated tools. in france, the doloplus group has proposed a scale called doloplus, validated in january 1999, and is now proposing a new scale for acute pain, algoplus that has been validated in french (4). doloplus has been recently translated and validated in 5 languages and an identical methodology will be used in this protocol. internationally, although several teams are working on the development of scales that can be used for non-communicating elderly subjects, there is as yet no validated tool for acute pain assessment. considering 1- the lack of tools at an international level and 2- the frequent request from many practitioners worldwide, the doloplus group has offered to validate the algoplus® scale in 5 foreign languages, english, german, spanish, italian, portuguese. a rigorous methodology with the help of a statistician will be used in this validation process.

50 patients per language will be explored : t1 = time t physician m physician n t2 = time t+4 hours physician m the methodology of the validation of our translation procedure consists of studying the reliability of the scale in two major steps: * data from a sample of 50 patients will be used to explore the test-retest reliability of the scale administered by the same trained clinician, on two occasions four hours apart, without any treatment in between. the algoplus® scores obtained from the patients at a time t will be compared with their (t + 4 hours) scores to assess test-retest reliability. * for a sample of at least 50 patients, two physicians trained for the use of algoplus, will assess pain independently. a statistical test will be used to compare the results for the inter-rater reliability.

Eligibility criteria:
inclusion criteria: * - males or females aged 65 or above 65, with communication disorders * with or without suspected acute pain exclusion criteria: * - are too agitated, * have acute pain needing immediate pain management, * change of treatment between the two evaluations ( t and t+4 hours ), * refuse to participate

Keywords: pain elderly aged 65 or above 65 communication disorders algoplus® scale
evaluation of early association of terlipressin and norepinephrine during septic shock; the terlinor study

Conditions: Septic Shock

Summary: in guidelines norepinephrine is the first line vasopressor recommended in case of septic shock. use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 65mmhg or in salvage. several studies failed to show a superiority of vasopressin over norepinephrine but none evaluated the effect of an early association on organ failure. terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor effect. we hypothesize that the early association of terlipressin and norepinephrine during septic shock reduces organ failure. this bi centric, double-blinded, randomised, controlled versus placebo study includes 40 patients. randomisation will be stratified between centers (two university affiliated intensive care units of assistance-publique-hôpitaux de marseille, marseille, france). all patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach pam objectives are randomised, after hemodynamic evaluation and optimisation, to receive continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). the 2 groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this time. clinicians are blinded of perfusion used. use of terlipressin remains possible in salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision. patients with acute ischemic or septic heart failure are excluded of the study. primary objective is sepsis related sequential organ failure assessment (sofa) score difference between the groups at day 3. secondary objectives are mortality at day 28, lactates clearance in the first 48hours, renal function (evaluates with akin criteria) and use of renal replacement therapy.


Eligibility criteria:
inclusion criteria: * older than 18 years * dose of norepinephrine greater than 0.3 μg / kg / min * lactate greater than 2.0 mmol / l exclusion criteria: * a left heart failure objectified in ultrasound transthoracique by a fraction of left(awkward) ejection of the ventricle lower than 30 % either by thermodilution transpulmonaire with a cardiac index lower than 2,5 l / min / m2 after optimization of the volémie or a central venous saturation in oxygen ( svco2) lower than 60 % after optimization of the blood volume. * minors * pregnant * not having terlipressin allergy * not having excipient allergy * a history known for recent acute coronary syndrome (\< 3mois) * an acute coronary syndrome defined by an increase of the troponine and a rise of the segment st in the electrocardiogram

Keywords: terlipressin norepinephrine
linked color imaging based cmv diagnosis for gastric mucosal lesions

Conditions: Gastric Disease

Summary: the newly developed linked color imaging (lci) system (fujifilm co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of bli technology. this system can obtain bright endoscopic images even at a distant view because lci has more intense white light than the short-wavelength narrow-band laser light. short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa. therefore, lci may facilitate the detection of gastric mucosal lesions. further studies are needed to confirm the clinical utility of lci.

lci enhances differences in hue, in the red region of the spectrum, through digital processing. this makes red areas appear redder and white areas appear whiter. thus, it is easier to recognize a slight difference in color of the mucosa. based on previous experience, a new lci based endoscopic diagnosis criteria called cmv (color- microstructure-vessel) criteria has been proposed, which could be used for judging the gastric mucosal lesions. lci has the advantage of detecting color changes of the mucosa, and this could provide very valuable and useful evidence for making endoscopic diagnosis. in this study, a blinded random controlled clinical trial is designed to further validate the diagnostic value of lci based cmv criteria for gastric diseases.

Eligibility criteria:
inclusion criteria: * above 18 years old patients * who agree to participate in the study * patients with the indications for gastroduodenoscopy exclusion criteria: * patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (ppi) or antibiotics in the last 3 weeks. * severe uncontrolled coagulopathy * prior history of gastric surgery. * pregnancy and lactation
compassionate use of stiripentol in dravet syndrome

Conditions: Dravet Syndrome

Summary: compassionate use of stiripentol in dravet syndrome. this is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

this is a treatment protocol for compassionate use, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Eligibility criteria:
children with genetic confirmation of dravet syndrome (a documented sodium channel, voltage-gated, type i, alpha subunit (scn1a) mutation) or clinical confirmation of dravet syndrome by two pediatric neurologist will be considered to have dravet syndrome. in order to enter the treatment protocol there will be documented treatment failure of at least two therapeutic anticonvulsants excluding na channel blockers. anticonvulsants that are na channel blockers such as carbamazepine and lamotrigine as known to provoke seizures in this patient population.
polygenic risk-based detection of subclinical coronary atherosclerosis and change in cardiovascular health

Conditions: Coronary Artery Disease

Summary: the goal of this randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health over one year.

the main question proact 1 aims to answer is whether cardiovascular health improves following disclosure of high polygenic risk result for coronary artery disease compared to standard of care. this is a 1:1 randomized controlled trial of middle-aged participants with no known cardiovascular disease, are not on lipid-lowering therapy, who have high polygenic risk score for coronary artery disease, and do not have quantifiable plaque on coronary computed tomography angiography. participants will be randomized into two equal groups: one group will receive their high polygenic risk result for coronary artery disease at baseline, and the other group will receive their result after study completion at 1 year. change in cardiovascular health as measured by the american heart association life's essential 8 score from baseline to one-year will be compared.

Eligibility criteria:
inclusion criteria: * males and females between 40 and 75 years of age capable and willing to provide informed consent * participant has high cad prs as defined on a clinical test exclusion criteria: * participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease * participant with quantifiable plaque on a coronary computed tomography angiography * participant with a history of liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to gilbert syndrome) * participant with estimated glomerular filtration rate \<60 ml/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal * patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins * patient currently taking ldl cholesterol lowering or anti- inflammatory medications including colchicine * participants requiring regular drugs known to be potent cy2p inhibitors (eg. ketoconazole, clarithromycin) * female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study * participant with bmi ≥ 40 kg/m2 * participant unable to provide informed consent * participant unable to hold breath for 10 seconds

Keywords: coronary artery disease polygenic risk score genetics genomic medicine precision medicine preventive cardiology risk prediction cardiovascular health coronary ct angiogram coronary plaque atherosclerosis
verubulin, radiation therapy, and temozolomide to treat patients with newly diagnosed glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: this, international, multi-center, phase 2 study of verubulin will be conducted in patients with newly diagnosed glioblastoma multiforme (gbm). the study will be conducted in two parts. part a is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. part b is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in part a, in combination with standard treatment versus standard treatment alone.


Eligibility criteria:
inclusion criteria: 1. have histologically proven, newly diagnosed glioblastoma multiforme 2. age ≥ 18 years and \< 70 years 3. have an ecog performance score of 0, 1, or 2, or kps ≥ 70 4. have adequate bone marrow function , liver function, and kidney function before starting therapy 5. begin study therapy no more than 6 weeks after surgery or biopsy 6. subjects that have had surgery must have an mri ≤ 72 hours after surgery exclusion criteria: 1. have a carmustine implant (e.g., gliadel® wafer) 2. have uncontrolled hypertension (sbp \> 140 mmhg or dbp \> 90 mmhg for more than 1 week) 3. have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (muga) or echocardiogram (echo) 4. have troponin-i or troponin t at screening visit elevated above the upper limit of the reference range of the local institution 5. have an increasing steroid requirement, indicative of a rapidly progressive disease 6. have evidence of new, active intra tumor hemorrhage ≥ ctcae grade 2 7. have had prior cranial radiotherapy 8. have history of stroke and/or transient ischemic attack within 2 years of screening 9. have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening 10. be pregnant or breast feeding 11. have a history of hypersensitivity reaction to cremophor® el 12. have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (dtic)

Keywords: glioblastoma brain neoplasms brain cancer verubulin
comparison of the efficacy of comprehensive respiratory physiotherapy in children with cystic fibrosis and non-cystic fibrosis bronchiectasis

Conditions: Cystic Fibrosis; Bronchiectasis

Summary: the effect of comprehensive respiratory physiotherapy applications on respiratory function, functional capacity and peripheral muscle strength in children with cystic fibrosis and non-cystic fibrosis will be compared.

bronchiectasis may be a congenital cause such as cystic fibrosis (cf) or non-cystic fibrosis such as primary ciliary dyskinesia, post-infectious conditions, aspiration and immunodeficiency; it is a disease characterized by irreversible dilatation of airways. symptoms; purulent sputum production, chronic cough, hemoptysis, recurrent fever and pleurisy. mucociliary clearance disorder secondary to inflammation and involvement of exocrine glands in cf plays a major role in the development of symptoms; in non-cystic fibrosis bronchiectasis (ncfb), the development of similar symptoms may occur regardless of these reasons. however, in the examinations of cf, proximal airways; in ncfb, distal airways have been affected more intensively. as part of pulmonary rehabilitation, comprehensive respiratory physiotherapy (crp) has an important role in the treatment and management of bronchiectasis. airway cleaning techniques, approaches to reducing respiratory work, and patient education form the basis of crp and play an active role in the treatment and management of the disease. in the literature, there are studies in which the effects of crp are given in both cf and ncfb patients and studies comparing evaluation results in both groups without treatment. however, no study was found to compare the efficacy of crp in these two groups of diseases. therefore, in this study, the investigators aimed to investigate the differences between the efficacy of crp among the groups in children with cf and ncfb.

Eligibility criteria:
inclusion criteria: * being between 6-18 years old * clinically diagnosed as cystic fibrosis or non-cystic fibrosis bronchiectasis exclusion criteria: * previous history of lung or liver transplantation * have had an acute exacerbation in the last month and / or have a history of hospitalization * having a diagnosis of orthopedic problems affecting mobility or a history of musculoskelatal surgery

Keywords: cystic fibrosis bronchiectasis respiratory physiotherapy pulmonary function exercise capacity six minute walk test muscle strength
comparison of 2 methods to achieve tight glucose control in cardiovascular icu patients

Conditions: Hyperglycemia in Critically Ill Patients

Summary: there is current evidence that maintaining icu patient's blood sugar between 4.4-6.1 saves lives. however, this is difficult to do in the icu and carries risks of lowering the blood sugar too much. in addition, the best way to achieve this control is not known. many strict nomograms that provide a standardized approach for nurses have been developed and validated, including one here at smh. however, these nomograms cannot apply to all patients at all times, especially icu patients whose needs are rapidly changing. icu nurses are at the bedside constantly, are very familiar with their patient's needs, and have decades of experience in titrating medication doses without a nomogram to achieve a pre-determined response (i.e. medications to achieve pre-selected blood pressure). indeed, once the bedside nurse has bought into the importance of the concept of tight glucose control and have been introduced to the nomogram here at smh, their experience and intuition may be more adaptable to the changing needs of the patient than an inflexible paper nomogram. this study will compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse directed) in order to determine whether the nomogram should continue to be used.


Eligibility criteria:
inclusion criteria: patients: * adult cvicu pts * requires insulin therapy for glucose greater than 8 mmol/l * anticipated icu stay \> 24 hrs * not in dka/hhnk * mechanically ventilated exclusion criteria: * md refusal * no iv access for insulin * allergy to insulin * dnr or moribund as determined by the clinical team

Keywords: intensive insulin therapy glucose control nurse directed nomogram directed
subclinical delirium and clinical outcome

Conditions: Delirium

Summary: delirium has been associated with clinical outcomes in critical care setting. however, its subclinical form has not been investigated. the investigators aimed to establish the association of subclinical delirium with outcome.

delirium has been associated with clinical outcome in critical care setting. this syndrome has been associated with longer length of stay in icu and hospital, longer duration of mechanical ventilation and higher mortality rate. however, its subclinical form has not been investigated. the subclinical syndrome is defined by cam-icu, in which several features of delirium are fulfilled but the diagnostic criteria are not fulfilled. the investigators aimed to establish the association of subclinical delirium with outcome.

Eligibility criteria:
inclusion criteria: * patients enter icu * gcs \> 10 * rass \> -2 exclusion criteria: * unable to cooperate * coma

Keywords: delirium outcome
postexercise hot-water immersion on exercise performance in hypoxia

Conditions: Heat Exposure; Exercise Training

Summary: the purpose of this study is to determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude.

human performance is compromised at altitude due to a lower partial pressure of oxygen and subsequent reductions in the convective transport of oxygen to tissue. long-term acclimation to attitude incurs physiological adaptations that result in a near return to sea-level performance; however, the time required (\~2 weeks) for such adaptations is often logistically challenging for athletes, military personnel or other individuals who reside at sea level. recent research suggests that physiological acclimation to heat stress (i.e., heat acclimation) and altitude (i.e., hypoxia) share similar cellular adaptations, namely an up-regulation of hypoxia-inducible factor 1 (hif-1) and various heat shock proteins. therefore, it is hypothesized that heat acclimation may provide physiological protection from reduced oxygen transport to the tissue and enhance performance at altitude. this cross-tolerance model is supported by traditional heat acclimation protocols (i.e., submaximal exercise in hot ambient temperature); however, it has not been tested with passive exposure to heat stress through post-exercise hot water immersion.

Eligibility criteria:
inclusion criteria: * physically active (minimum of 90 minutes of moderate-intensity exercise per week) exclusion criteria: * cardiovascular disease * resident of \>1500 m above sea-level in the past year; * history of fainting