Kornimate/medical-research-clean huggingface dataset:
brain oxygenation during prehospital anesthesia

Conditions: Critical Illness

Summary: the study will evaluate the feasibility of nonin sensmart h500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. the study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. the study does not affect the treatment of the patient. the study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.


Eligibility criteria:
inclusion criteria: * sedation or anesthesia provided to facilitate endotracheal intubation, performed by hems team regardless of the reason exclusion criteria: * cardiac arrest at the time of intubation * physical barrier for nirs measuring (e.g. forehead laceration) * hems physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion) * workload too high to ensure standard level of clinical care during the study * known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients. * known or evident pregnancy
pre-stroke physical activity in patients with stroke

Conditions: Stroke

Summary: the aim of this study is to explore the level of pre-stroke physical activity in patients with stroke and to investigate associations between physical activity and sociodemographic variables, e.g. history of stroke, co-morbidities and subtype of stroke. physical inactivity is a great risk factor for stroke; thus, the investigators hypothesise that patients hospitalised with stroke will present with a lower level of pre-stroke physical activity than recommended by world health organization (who) guidelines on physical activity for health. additionally, the investigators expect to find an association between pre-stroke physical activity and specific sociodemographic variables, e.g. stroke subtype, and re-stroke.

physical inactivity and low cardiorespiratory fitness are important risk factors for stroke. to design future secondary non-pharmacological prevention strategies in stroke, detailed information on current level of physical activity is essential. in the danish adult population, 28,8% do not adhere to the who guidelines on physical activity for health, with an increasing number (33%) in the population older than 55 years of age. diverging results have been given on level of physical activity in patients with stroke which warrants further investigation. statistics: descriptive statistics will be used to characterise the study population. to evaluate whether the participants adhere to recommendations on physical activity the proportion of participants adhering will be estimated. to evaluate the association between pre-stroke physical activity using met-values (dependent variable) and sociodemographic variables (age, gender, previous event of stroke, subtypes of stroke, cardiovascular risk factors, living status and educational level) a multiple linear regression analysis will be performed. the aim is to include 120 participants in the multiple linear regression analyses. this is based on the number of variables (a maximum of seven). p \< 0.05 will be used as level of statistical significance. all tests will be two-sided. data will be analysed using microsoft excel 2019 and stata 17.

Eligibility criteria:
inclusion criteria: * clinical symptoms of acute stroke, verified by a neurologist with diagnosis of stroke (intracerebral haemorrhage, cerebral infarction, "stroke, not specified as haemorrhage or infarction" or transient ischemic attack (tia)). * acute/subacute stroke or tia verified on mri-scan or ct-scan. * able to speak, read and understand danish. * able to provide informed consent, including being awake, alert and oriented (personal data, place, and time). exclusion criteria: * aphasia that hinders responding to the pas2. * cognitive deficits that hinder responding to the pas2 (mini-mental state examination-score (mmse) ≤ 23, diagnosis of dementia at hospital admission).

Keywords: physical activity stroke questionnaire patient reported outcome measure inpatient
preterm neonates brain ultrasound with ceus and elastography

Conditions: Prematurity

Summary: the aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. different appropriate imaging sequences will be used regarding mri, including asl-perfusion. neonates recruited from the neonatal intensive care unit (nicu) of turku university hospital will be recruited.

sonovue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. it increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. the use of sulphur hexafluoride has been approved by fda and it has been in off-label use in europe for years. sonovue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation. elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. also this method has been used in europe and america for years. the aim of this study is to examine cerebral hemodynamics in preterm neonates reaching term age, using ultrasound of the brain, contrast enhanced ultrasound (ceus) and ultrasound-guided shear-wave elastography (us-swe). the brain ultrasound, ceus and us-swe to preterm babies is planned to take place while having a clinically appointed brain magnetic resonance imaging at about term. total recruitment for the study is 100 infants in total. the recruitment period will be up to seven years if needed. the injections of sonovue will be administered through pre-existing venous cannulas. the examination will be done in addition to the mr-imaging, after the parental consent has been given. the ultrasound examination altogether is estimated to take about 20 minutes per day. safety monitoring period is conducted after the injection. ceus data will be analysed with proper software. us-swe will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements. ultrasound data will be evaluated comparing preterm neonates with and without mri-proven brain pathology and comparing the ultrasound-achieved data to magnetic resonance imaging.

Eligibility criteria:
inclusion criteria: * preterm neonates attending brain mr-imaging at term exclusion criteria: * pre-known genetic disease * difficult congenital malformations that need surgical treatment * central nervous system tumors * weight less than 2,5 kg during examination * medical history of sonovue hypersensitivity * uncontrolled systemic hypertension * systolic pulmonary artery pressure \> 90 mmhg * unstable cardiovascular state
effectiveness & safety of promelaxin® microenemas against macrogol 4000 p.o. in chronic constipation in children 6-48 months

Conditions: Chronic Functional Constipation

Summary: the study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-

this multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of criteria of rome iii. the enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of promelaxin® (group a) while the second group will receive macrogol 4000 per os (group b) . children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks. the hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. this hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.

Eligibility criteria:
inclusion criteria: * chronic functional constipation according to rome iii criteria * no stool softeners therapy administered during the 7 days prior to baseline visit * signature of informed consent from by both parents or legal representative * willingness to follow the study schedule exclusion criteria: * suspicious or established diagnosis of organic constipation * delayed emission of meconium in the term newborn * presence of severe inflammatory bowel disease (such as ulcerative colitis, crohn's disease), toxic megacolon * presence/risk of gastroinstestinal perforation * presence/suspiceous intestinal obstruction of symptomatic stenosis * (undeterminated) abdominal pain * hypersensitivity to macrogol (polyethylene glycol) or to one or more product excipients * hereditary fructose intolerance * known hypersensitivity or allergy to any promelaxin component * presence of any other medical condition that contraindicate the use of promelaxin® or macrogol 4000
a study of tarceva (erlotinib) and gemcitabine in treatment-naive patients with advanced non-small cell lung cancer.

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this 2 arm study will assess the efficacy and safety of tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. patients will be randomized to receive either tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * non-small cell lung cancer, stage iiib (with effusion) or stage iv with measurable disease ; * ecog ps 2; * adequate organ function. exclusion criteria: * prior chemotherapy or systemic anti-tumor therapy; * hypersensitivity to erlotinib; * any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
early immunotherapy with intravenous immunoglobulin, cyclophosphamide and methylprednisolone in patients with anti-hu-associated paraneoplastic sensory neuronopathy

Conditions: Paraneoplastic Sensory Neuronopathy

Summary: paraneoplastic neurological syndromes are rare autoimmune complications linked to the presence of systemic cancer. despite their autoimmune origin, they have historically shown little response to immunotherapy. the reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. the protocol focuses on patients with anti-hu antibody sensory neuronopathy. this single arm trial consists of an early immunotherapy combining intravenous immunoglobulin (ivig) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. the percentage of patients with clinical improvement will be evaluated (onls) at 3 months. the tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * "possible" sensory neuronopathy according to the criteria of camdessanché et al. \[2\] with onls score ≥ 1 * dominant picture of sensory ataxia (damage to the central nervous system and/or the neuromuscular junction is allowed, provided that it has a minor impact on the patient's disability) * positive anti-hu antibodies in blood and/or cerebrospinal fluid * outpatient (modified rankin score (mrs) 2 or 3) * onset of neurological symptoms less than 3 months ago * free, informed, written and signed consent * affiliation to a social security or beneficiary scheme (except ame) exclusion criteria: * known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients * absolute contraindications to ivig: selective iga deficiency, known thrombophilia, patients suffering from type i or ii hyperprolinemia, hypersensitivity to human immunoglobulins * absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary infection, pre-existing hemorrhagic cystitis, urinary tract obstruction, acute bone marrow failure * contraindication to methylprednisolone: live vaccines, or live attenuated vaccines within 3 months, infectious state or evolving virus (hepatitis, herpes, chickenpox, shingles) * more than two courses of ivig administered within 3 months before recruitment * other concomitant immunotherapy * other cause of immunosuppression (acquired or congenital) * treatment with checkpoint inhibitors in progress or completed less than 3 months previously * woman or man without effective contraception * pregnant or breastfeeding woman * history of psychiatric or general illnesses that may contraindicate treatment * patients unable to complete the follow-up required by the study * patients under guardianship or curatorship * patient deprived of liberty by a judicial or administrative decision

Keywords: sensory neuronopathy paraneoplastic syndrome early immunotherapy
post market clinical follow up study of avance foam abdominal dressing kit in open abdomen

Conditions: Open Abdomen

Summary: the investigation is a post marketing follow-up study for the avance foam abdominal dressing kit conducted as part of mölnlycke health care's quality system. the primary objective is to evaluate the dressing kit as part of a negative pressure system. the secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent from subject or family member 2. subjects with open abdomen suitable for temporary closure with npwt therapy 3. subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (ocl) 4. subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at intensive care unit 5. male or female, 18 years and above exclusion criteria: 1. synthetic mesh inserted in the abdomen 2. non-enteric fistulae or unexplored fistulas 3. untreated osteomyelitis 4. malignant wounds 5. abdominal wall hernia 6. subjects previously treated with an npwt abdominal dressing 7. known allergy or hypersensitivity to any of the components in the dressing 8. pregnancy 9. subjects not suitable for the investigation according to the investigator's judgement 10. subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator
phenotypic and functional study of 4bl b cells in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: recent works highlight the b cells involvement in multiple sclerosis (ms) pathology but their role remains poorly understood. it was previously described that activated memory b cells called 4bl due to the increased expression of 4-1bbl, an activation marker, induce pro-inflammatory response by activating t cd8+ lymphocytes. those 4bl cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. those 4bl cells can also induce anti-tumoral t cell response. the hypothesize is that 4bl may induce a pathogenic inflammatory response in ms.

the aim to compare the proportion of peripheral (blood) 4 bl cells but also 4-bl cells in cerebro spinal fluid (csf) in ms compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease. for all groups of patients and controls it will collect blood and csf only once (at diagnosis time for patients). blood collect from healthy controls will come from transfusion volunteers and we won't have csf from them. for patients from the ms group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up. in the blood and csf we will evaluate: * percentage of 4 bl cells. 4 bl cells are found using cytometric parameters * capacity of 4 bl cells to induce inflammatory response in vitro: percentage of induced activated tcd8 proliferation after cell culture using extracellular and intracellular cytometric parameters

Eligibility criteria:
inclusion criteria for ms group: * ms defined by mcdonald 2017 criteria with a disease duration of less than 1 year * between 18 and 60 years old patients * naïve of any immune therapy or steroid intake * patients who signed consent to the study inclusion criteria for controls with inflammatory of non inflammatory neurological disease: * patients who signed consent to the study * between 18 and 60 years old patients * naïve of any steroid intake or immune therapy inclusion criteria for healthy controls: * control who signed consent at transfusion center for their blood collect to be used for study * between 18 and 60 years old patients * naïve of any steroid intake or immune therapy exclusion criteria: * pregnancy or breast-feeding * patients or controls unable to sign the consent or to consent

Keywords: immunology b cells
study of the effect of the rox ac1 on exercise capacity and quality of life in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to demonstrate the efficacy of rox ac1 (with respect to exercise capacity and quality of life) in patients with copd.

chronic obstructive pulmonary disease (copd) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. the irreversible changes to the lungs can be seen in limitations in the pulmonary function. the purpose of this clinical investigation is to evaluate the performance and efficacy of the rox ac1 on exercise capacity and respiratory quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced chronic obstructive pulmonary disease (copd) must be made on the basis of current findings, medical history and physical examination. exclusion criteria: * subject not qualifying because of physical or psychological condition that may put them at risk of participating.

Keywords: lung disease chronic airflow obstruction chronic bronchitis chronic emphysema
optimizing access to care through new technologies: a randomized study evaluating the impact of telephone contact and the sending by the general practitioner of suspicious lesions melanoma photographs taken with a smartphone, on the time limit to the consultation with a dermatologist

Conditions: Patients at Risk for Melanoma

Summary: early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. one challenge is to improve the modalities. decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues. direct contact between the general practitioner (gp) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision. the objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the gp (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives). expected results: the procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients"). this should facilitate the identification of thinner lesions. the benefit for the patient is then direct with a survival at 5 years higher. in public health terms, it is expected a benefit as better optimization of resources. in a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.


Eligibility criteria:
inclusion criteria: patients: * consulting a general practitioner participating in the study, * having a suspicious cutaneous lesion of melanoma according to the mg, * referred to a dermatologist who agreed to participate in the study, * \> = 18 years of age, with written informed consent, * affiliated to a social security scheme exclusion criteria: patients: * consulting a general practitioner who does not participate in the study, * having no suspect melanoma lesion according to mg, * referred to the dermatologist for symptoms or pathologies unrelated to a suspicion of melanoma * wishing to consult a dermatologist who refused to participate in the study, * refusing the transmission by mail of 2 anonymised photos, * \<18 years of age, or with no written informed consent. * major under tutelage, under curatorship

Keywords: public health general medicine dermatology