Kornimate/medical-research-clean huggingface dataset:
concordance between the measurement of whole blood fibrinogen by the qlabs®fib analyzer and its measurement by conventional method (clauss fibrinogen) in the context of severe postpartum haemorrhage

Conditions: Postpartum Hemorrhage

Summary: in france in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (pph), including 3.0% by severe pph (the bleeding volume exceeds 1000 ml). severe pph is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). these deaths were considered preventable in 90% of cases. a plasma fibrinogen concentration below 2 g/l is considered as a critical threshold which constitutes a marker of severity of pph and is significantly associated with the occurrence of severe pph. measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe pph. the qlabs®fib analyzer distributed by the stago biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

in france in 2021, 11.6% of deliveries were complicated by postpartum hemorrhage (pph), including 3.0% by severe pph (the bleeding volume exceeds 1000 ml). severe pph is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). these deaths were considered preventable in 90% of cases. a plasma fibrinogen concentration below 2 g/l is considered as a critical threshold which constitutes a marker of severity of pph and is significantly associated with the occurrence of severe pph. measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe pph. the qlabs®fib analyzer distributed by stago biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective. the hypothesis of the study is a concordance between the measurement of fibrinogen by the qlabs®fib monitoring system and by the clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level \< 2 g/l. the prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration \< 2g predictive of an unfavorable evolution in the context of severe pph.

Eligibility criteria:
inclusion criteria: adult patients having been informed of the study and not having objected to their participation and treated for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours postpartum, whatever the route delivery (vaginal route and caesarean section). exclusion criteria: * opposition to participation in the study * presence of a constitutional fibrinogen deficiency * patients under guardianship or curatorship

Keywords: severe postpartum haemorrhage fibrinogen concentration qlabs®fib monitoring system clauss fibrinogen assay
enhanced vs. routine clear liquid intake in labor

Conditions: Abnormal Labor; Failed Induction of Labor; Ketosis

Summary: the goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.

patients will be randomized to placebo or experimental arm of study. in the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. the experimental arm will receive the standard clear liquid diet, and in addition will receive accel gel every 3 hours while in labor.

Eligibility criteria:
inclusion criteria: * nulliparity (first baby) * admission with the intent to deliver vaginally * gestational age \>36 weeks * age ≥ 18 exclusion criteria: * planned cesarean delivery * renal disease * preeclampsia * diabetes (pre-gestational or gestational) * allergy to any component of sports drink * npo diet by physician

Keywords: abnormal labor prolonged induction ketosis diet
research to evaluate efficiency in u-health solution service for the chronic wound management

Conditions: Pressure Ulcer

Summary: this trial is a prospective research to evaluate efficiency in u-health solution service based on mobile for the chronic wound management.

this trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.

Eligibility criteria:
inclusion criteria: * subjects who have pressure ulcer * subjects who voluntarily decided the participation of the study and signed the informed consent exclusion criteria: * subjects who have osteomyelitis * subjects who have suppuration * subjects who participated in other clinical trial within 30 days from screening date

Keywords: u-health chronic wound management
a pilot trial of patient decision aids for implantable cardioverter-defibrillators (icds)

Conditions: Systolic Heart Failure; Sudden Cardiac Death

Summary: the purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (ptdas) for heart failure patients who are considering an icd implant.

specific aim 1: examine acceptability and feasibility of a toolkit of patient decision aids (ptdas) for patients with heart failure referred for primary prevention implantable cardioverter-defibrillators using a randomized control trial design across three diverse health care systems (kaiser colorado, the university of colorado, and the denver veterans hospital). 1. measure the acceptability of the decision aids 2. explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites. 3. conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being. specific aim 2: determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site

Eligibility criteria:
inclusion criteria: * systolic heart failure (defined as an ejection fraction less than 35%) * have been referred for a primary prevention icd * note: patients referred for an icd with cardiac resynchronization therapy are not excluded. exclusion criteria: * already have an icd * non-english speaking (as the tools we have developed are only available in english currently) * other icd indications (e.g. secondary prevention, hypertrophic obstructive cardiomyopathy) * cognitive impairment defined only as people with an inability to consent

Keywords: decision aid patient decision making heart failure ejection fraction primary prevention implantable cardioverter defibrillator icd pilot trial patient centered health care
eliminate thromboembolism: improving anticoagulation in non-valvular atrial fibrillation patients

Conditions: Atrial Fibrillation

Summary: elite (eliminate thromboembolism: improving anticoagulation in non-valvular atrial fibrillation patients) is a two year research project to assess warfarin management issues faced by atrial fibrillation (af) patients in ambulatory settings.

elite will be a prospective, multicenter observational study of 500 participants to characterize demographics, comorbidities, risk profiles, socioeconomic status, and patient preferences related to anticoagulation management. the primary study endpoint will be warfarin discontinuation without resumption as documented in the medical record. secondary outcomes of interest include warfarin adherence and factors associated with suboptimal adherence and/or permanent discontinuation. clinical data, including demographics, medical history, and comorbidities, will be abstracted and entered by site coordinators. an internal survey developed by duke clinical research institute (dcri) will be administered to patients during regularly scheduled clinic visits. survey items will include patient treatment priorities, perceived risk of bleeding and/or stroke, barriers to adherence, and treatment satisfaction. subjects will complete a survey at baseline and at the followup visit closest to 6 months after enrollment. this study will provide the foundation for numerous potential future questions about medication adherence and barriers to treatment, such as a survey on physician preferences/ shared decision-making (concordance between physician and patient preferences), followup to capture clinical events, and interventions to improve long-term medication adherence in af.

Eligibility criteria:
inclusion criteria: * 18 years or older at the time of enrollment * electrocardiographically confirmed af * able to complete patient-reported outcomes surveys * initiated warfarin therapy in the prior 3 months * ability to adhere to regular clinical visits * ability to sign informed consent * ability to read/comprehend/speak english exclusion criteria: * anticipated life expectancy less than six months (as determined by the site investigator) * transient af secondary to a reversible condition (hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery) * recent deep venous thrombosis(dvt) or pulmonary embolism (pe) (within 6 months) * participation in a randomized trial of anticoagulation for af * use of a home international normalized ratio (inr) monitoring system

Keywords: warfarin
chronic rhinosinusitis with or without nasal polyps steroid study

Conditions: Chronic Sinusitis; Rhinosinusitis; Nasal Polyps

Summary: this is a study to evaluate the cause of chronic sinus disease. oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. however, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. for some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.

the purpose of this research study is to better understand how this potential treatment option, oral steroids, affects biochemical substances that have been associated with the development of chronic sinusitis and polyps. in order to do this, we need to study people with different forms of chronic sinusitis and compare them to individuals without allergies or sinus disease. we will also look at patients with chronic sinusitis who are treated with oral steroids and compare them to chronic sinus patients who have not received oral steroid therapy prior to surgery. this study may help pave the way to new treatments that address specific parts of the chronic sinus inflammatory pathway. hypotheses 1. oral steroid treatment of patients with crs will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage. 2. steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps. 3. changes in inflammation will correlate with clinical variables.

Eligibility criteria:
inclusion criteria: * ages 18 years to 70 years * diagnosis of chronic rhinosinusitis (crs) with nasal polyps (np) and will be undergoing sinonasal surgery for this condition * diagnosis of crs without np and will be undergoing sinonasal surgery for this condition * no diagnosis of crs and np and will be undergoing nasal surgery (septoplasty/rhinoplasty, nasal fracture repair,etc.) exclusion criteria: * ages younger than 18 years and ages older than 70 years * diagnosis of an established immunodeficiency, pregnancy, coagulation disorder, a diagnosis of allergic fungal sinusitis (afs), or cystic fibrosis * those with crs with or without np in whom systemic steroid therapy would be contraindicated * those who are dependent on systemic steroid therapy for sinonasal disease or any other condition

Keywords: chronic sinusitis chronic rhinosinusitis nasal polyps
observational survey study on the impact of myopia and its complications on quality of life.

Conditions: Myopia

Summary: this study aims to assess the impact of myopia in childhood and its long-term complications in adulthood on health-related quality of life (hrqol), providing valuable data for cost-effectiveness models. it will gather country-specific information on healthcare resource utilization, including treatment costs, access to care, and reimbursement policies. in addition, the study will examine how myopia and its treatments affect daily activities and evaluate treatment satisfaction. no data on the efficacy of myopia treatments is collected in this study, and neither is the occurrence of adverse events.


Eligibility criteria:
inclusion criteria: * parents (or other proxy) of children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) defined by their spherical equivalent (ser): low myopia is from -0.5 d (inclusive) to -3.0 d (inclusive), moderate myopia is from -3.0 d to -6.0 d (inclusive) and high myopia is \<-6.0 d. * adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment. * patients where myopia is a known or likely contributing factor to the complication. exclusion criteria: * parents (or other proxy) of children aged 4 years and below. * patients where the complication is likely unrelated to myopia (e.g., cataract caused by diabetes) will be excluded
molecular classifier for the fine needle-based assessment of malignancy risk in thyroid nodules

Conditions: Thyroid Nodule; Thyroid Neoplasm; Thyroid Cancer

Summary: this study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (fnab) of thyroid nodule. all participants will undergo fnab with routine cytological assessment and molecular testing. patients will undergo surgery or be followed-up, according to the clinical guidelines. the diagnostic power of combined molecular/clinical classifier will be compared to prediction based on clinical features only, by investigators blinded to the final diagnosis of surgical assessment.

currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment of fine-needle aspiration biopsy (fnab) classified according to the bethesda system for reporting of thyroid cytopathology. this does not allow for the definitive diagnosis of cancer in significant proportion of tumors, so called indeterminate nodules (bethesda class iii, iv and v). these patients require surgery to establish a definitive diagnosis, leading to unnecessary operating procedures in at least 2/3 of subjects. molecular classifiers could significantly improve thyroid preoperative diagnostics, although they are not optimal and provide either high specificity to the detriment of low sensitivity or conversely, relatively low specificity with high sensitivity. the classifiers could be based on gene expression or mutations present in fnab specimen. in the present study the investigators plan to assess the improvement of classification power by molecular gene-expression-based multi-feature classifier when added to standard clinical parameters indicating the risk of malignancy (bethesda class, tumor size, patient age and sex). participants will undergo fnab with prospective collection of material for molecular testing and simultaneous preoperative recording of all clinical parameters. the patients will be operated on or followed-up according to the clinical guidelines. the comparison of a predictive power of clinical criteria to the combined clinical-molecular classifier will be carried out by the group of investigators blinded to the results of final surgery.

Eligibility criteria:
inclusion criteria: * a diagnosis of thyroid nodule * considerable chance for surgical procedure following biopsy result * patient's consent for collection of material during routine fine needle aspiration biopsy exclusion criteria: * age below 18 years * the presence of contraindications that make surgical treatment impossible * prior diagnosis of thyroid cancer * antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose

Keywords: thyroid nodule indeterminate thyroid nodule molecular biopsy gene expression classifier
continuous and discontinuous determination of propofol concentration in breathing gas

Conditions: General Anesthesia

Summary: this study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. propofol concentrations in breathing gas are continuously measured by a sensor. for comparison a discontinuous method is used. neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas. study hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.


Eligibility criteria:
inclusion criteria: * patient destined for general anesthesia exclusion criteria: * heart insufficiency nyha iv * allergy to propofol

Keywords: monitoring breathing gas propofol
comparison and outcomes of fluid resucitation with 0.9% normal saline and 5% albumin in cirrhosis patients with sepsis induced hypotension

Conditions: Cirrhosis With Septic Shock

Summary: 300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of institute of liver and biliary sciences, new delhi, who fulfil the inclusion criteria. this study will be a single centre prospective randomized comparative trial. patients will be randomized into two groups. group a will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and group b will receive colloid, 5% albumin (250 ml over 15 minutes).


Eligibility criteria:
inclusion criteria: 1. cirrhotic patients of any aetiology with infection - suspected or documented and mean arterial pressure less than 65 mm of hg exclusion criteria: 1. cirrhosis patients in septic shock who are already on vasopressors and/or inotropes 2. cirrhosis patients in septic shock with structural heart disease 3. cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state 4. cirrhosis patients in shock, caused by other reasons, other than septic shock 5. cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present 6. age less than 18 years 7. previous episode of septic shock during the same hospital stay 8. pregnant or lactating women 9. patients in need for emergent surgical interventions 10. cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure 11. cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dl or requiring urgent transfusions of blood and blood products 12. a previous adverse reaction to human albumin solution
a pilot therapeutic trial using hydroxyurea in type ii and type iii spinal muscular atrophy patients

Conditions: Muscular Atrophy, Spinal

Summary: the objectives of this trial are: to establish a safety profile for use of hydroxyurea in children with types ii and iii spinal muscular atrophy; to identify reliable outcome measures for hu treatment in types ii and iii sma; and to detect the clinical efficacy of hu treatment in children with types ii and iii sma.

sma is a neuromuscular disorder characterized by degeneration of spinal cord motor neurons and muscular atrophy. sma is classified into three clinical subtypes according to the severity and age of onset (types i, ii and iii). type ii (intermediate) sma has its onset in early childhood (prior to 18 months) and is characterized by the failure to stand or walk unassisted. individuals with type iii sma (mild sma or kugelberg-welander disease) typically develop symptoms after 18 months of age and display a wide range of clinical heterogeneity. the clinical spectrum ranges from rapid progressive weakness resulting in wheelchair dependence in late childhood to patients being able to walk in adult years and living productive and independent lifestyles for the majority of their lives. in our laboratory, our preliminary results indicate that hu treatment significantly increases both smn mrna expression and intact smn protein levels in vitro. these data confirm previous observations that in vitro treatments of sma lymphocytes with hydroxyurea resulted in augmentation of the smn2 gene expression in a dose and time related manner. based on these exciting pre-clinical data, coupled with the well-documented side-effect profile of hu in children, we are conducting a pilot clinical trial using hu in children with types ii and iii sma. this clinical trial study is intended to establish the safety profile in children with types ii and iii sma; to identify reliable outcome measures; and to detect the possible clinical efficacy of hu treatment in children with types ii and iii sma.

Eligibility criteria:
inclusion criteria:1. laboratory confirmation of a homozygous deletion or mutation of the smn1 gene 2. (type ii) can sit independently but cannot walk without support by the age of 16 months and never achieve independent walking thereafter; or (type iii) can walk independently within the first 2 years of life, but showing rapid progression of weakness resulting in the loss of independent ambulation by 6 years of age 3. patient is older than 16 months and younger than 8 years old at the time of enrollment exclusion criteria:1. known hematological disorders, other systemic disorders, or severe birth asphyxia 2. participation in sma clinical trials for other experimental drugs 3. requiring continuous respiratory support before the initiation of hu treatment
treatment of bedsores with vip light

Conditions: Light; Therapy; Bedsore

Summary: difficulty healing wounds have a significant effect to the general fitness of the patient and his quality of life. on account of the frequency of their appearing, constitute the serious health and social problem. in comprehensive dealing with such patients physiotherapy will matter greatly. the visible polychromatic polarized light is most often used physical factor assisting comprehensive treatment bedsores. purpose of the work: analyze of using the visible polychromatic polarized light in the comprehensive process of healing bedsores at elderly people with the limited motor activity. material and methods: participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. the study was conducted in people over 65 years old, with bedsores grade iii and iv in torrance scale. the therapy included radiation of bedsores with vip light. effectiveness of the method of treatment was examined using photographic images and to measure the extent of the wound.

18 people were examined. in all subjects, were assessed the risk of developing bedsores according to the scale dutch consensus prevention of bedsores cbo. all bedsores were irradiated with a bioptron lamp (20 sessions, twice a day). photo and measurement of bedsores size and torrance score, were made:on the first, 9, 18 and 36 day of therapy.

Eligibility criteria:
inclusion criteria: * a high risk of bedsores development (dutch consensus prevention of bedsores cbo) * having a bedsore(s) * permanent stay in a nursing home * recommended light therapy (vip light) exclusion criteria: * ability to locomotion * age under 65 years old