Kornimate/medical-research-clean huggingface dataset:
nebulized heparin for prevention of acute lung injury in smoke inhalation injury

Conditions: Smoke Inhalation Injury; Acute Lung Injury

Summary: this study aims to examine the effects of nebulized heparin on the clinical outcomes in adult patients suffering smoke inhalation injury. patients will be randomized to receive nebulized heparin or an equal volume of normal saline for 14 days and the incidence of acute lung injury will be compared in either group.

adult patients who suffered smoke inhalation injury and who are candidates for elective intubation, have evidence of bronchial burn by fiberoptic bronchoscopy, have no evidence of acute lung injury and no more than 24 hours since inhalation injury will be included. patients will be randomized into 2 groups: group a (intervention): patients will receive 5000 iu heparin mixed with 3 ml saline and nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier. group b (control): patients will receive 4 ml of normal saline nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier. the primary end point is the vfds.

Eligibility criteria:
inclusion criteria: 1. adult patients indicated for elective intubation: * history of being trapped in a house or industrial fire. * production of carbonaceous sputum. * perioral facial burns affecting nose, lips, mouth, or throat . * altered level of consciousness at any time after the incident and including confusion. * symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes. * signs of respiratory distress including stertorous or labored breathing, and tachypnea or auscultatory abnormalities, including crepitations or rhonchi. * hoarseness or loss of voice. 2. evidence of bronchial burn by bronchoscopy to assess severity of inhalational trauma * no injury: absence of carbonaceous deposits, erythema, oedema, brochorrhea, or obstruction. * mild injury: minor patchy areas of erythema or carbonaceous deposits in proximal or distal bronchi. * moderate injury: moderate degree of erythema, carbonaceous deposits, bronchorrhea, or bronchial obstructions. * sever injury: sever inflammation with friability, copious carbonaceous deposits, bronchorrhea, or obstruction. * massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration. 3. no evidence of acute lung injury at presentation (either by radiology or abg) * radiological findings: normal lung without increased interstitial markings, ground glass opacification, or consolidation. * abg findings : pao2/ fio2 \> 300. 4. time between inhalational injury and intubation not longer than 24 hours. exclusion criteria: 1. burn injury \> 24 hours. 2. history of pulmonary diseases. 3. pregnancy or breast feeding. 4. history of allergy to heparin or hit. 5. history or laboratory evidence of coagulopathy. 6. burns area \> 50% of total body surface area. -

Keywords: smoke inhalation injury acute lung injury heparin
study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the main purpose of this study is to assess preliminary efficacy and safety of cfz533, lys006, mas825 , lou064 and vay736 in patients with moderate to severe hidradenitis suppurativa and to determine if cfz533, lys006, mas825, lou064 and vay736 have an adequate clinical profile for further clinical development.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe hs based on the number of lesions, fistulae and anatomical areas involved * minimal body weight of 50 kg * able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule exclusion criteria: * use of other investigational drugs at the time of screening or before * women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception * pregnant or lactating women other protocol-defined inclusion/exclusion criteria may apply

Keywords: hidradenitis suppurativa, acne inversa, platform study
angiotensin converting enzyme inhibition in children with mitral regurgitation

Conditions: Heart Defects, Congenital; Heart Septal Defects, Ventricular; Heart Failure, Congestive

Summary: this study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ace-i) therapy for the treatment of mitral regurgitation (mr).

background: mr causes volume overload and hemodynamic burden on the left ventricle. initial compensatory mechanisms may fail, leading to increased severity. patients who have had repair of an atrioventricular septal defect (avsd) are selected for this study as they have a relatively high incidence of moderate mr and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy. design narrative: this is a randomized, double-blind, placebo-controlled trial of ace-i therapy in children less than 18 years of age with at least moderate mr who are at least 6 months postoperative from repair of an avsd. a non-randomized observational phase enrolled 181 children who were less than 6 months postoperative from repair of an avsd, who were then evaluated at 6 months for trial eligibility.

Eligibility criteria:
inclusion criteria: * children less than 18 years of age and at least 6 months post avsd repair or reoperation * at least moderate mr * asymptomatic or minimally symptomatic, defined by ross heart failure class i or ii * atrioventricular synchrony (paced or intrinsic) exclusion criteria: * tetrology of fallot, total or partial anomalous venous connection * more than trivial ms or outflow obstruction * other sources of lv volume overload * hypertrophic obstructive cardiomyopathy * significant residual coarctation
measures of obesity and co-morbid conditions in maori

Conditions: Body Composition

Summary: it has been proposed that a higher cut off for bmi (body mass index) is to be used in maori to define overweight and obesity. however, no one has assessed the prevalence of co-morbid conditions associated with bmi. it is well known that maori are at greater risk of diabetes and cardiovascular disease compared to non-maori and a delay in the identification of those who are overweight and obese may be detrimental for maori. we will assess bmi, other measures of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched non-maori population.

this is a body composition analysis study of people self-identifying maori and non-maori participants from both dunedin and invercargill. the study consists of a clinical visit for anthropometry and oral glucose tolerance test (ogtt), followed by a single dexa scan visit. participants meeting all the inclusion criteria were invited to participate in the study. outcome will be determined by examining dexa scan data and surrogate clinical endpoints. the clinical endpoints include: anthropometric measurements, dexa analysis, bioelectric impedance, and bp measurements, and the biochemical measures of: lipid profile, fasting insulin and glucose, liver functions and uric acid levels.

Eligibility criteria:
inclusion criteria: * self identify as maori and non-maori aged between 18-68 years * male and female * non-diabetic * resident of dunedin and invercargill exclusion criteria: * the presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which they are currently having active treatment

Keywords: maori body composition dexa cardiovascular disease diabetes
treatment patterns, outcomes and testing in egfrm nsclc patients with egfr tki 1l across europe (reflect)

Conditions: Lung Cancer

Summary: multinational, multi-center medical record review to describe the treatment patterns, clinical outcomes, and egfr / t790m testing practices in egfr-mutated advanced nsclc patients receiving first-line egfr tki therapy in europe.

the aim is to generate real-life data on treatment patterns of the egfr-mutated advanced nsclc patients receiving first- or second-generation egfr tki in first line of therapy as provided per routine practice in eight countries. an approximate number of 820 patients will take part in the reflect study. it is anticipated that data, generated from the proposed large cohort across centers in europe, will facilitate a better understanding of unmet medical needs in first line of treatment and will provide a platform for improving patients' management.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of locally advanced unresectable or metastatic nsclc; * aged at least 18 years at first diagnosis of locally advanced/metastatic nsclc; * lab-confirmed egfr mutation; * received a first- or second-generation egfr tki as first-line treatment for advanced/metastatic disease; * first-line egfr tki (afatinib, gefitinib, erlotinib) initiated between january 1, 2015 and june 30, 2018; * patients may be alive or deceased at the time of medical record review. exclusion criteria: * patients enrolled at any time in an interventional clinical trial for an experimental treatment related to egfr-mutated nsclc; * patients receiving any systemic therapy for locally advanced or metastatic nsclc prior to first-line egfr tki treatment in the locally advanced/metastatic setting; * missing or unknown data on any of the following key study dates: * date of initial nsclc diagnosis; * date of first diagnosis of or progression to advanced/metastatic nsclc; * date of first-line egfr tki initiation for advanced/metastatic disease; * date of death or last available follow-up.

Keywords: egfr tki retrospective treatment patterns real world evidence
finger food, pleasure at your fingertips: randomized pilot study, open-label and parallel groups

Conditions: Undernutrition; Elderly Person

Summary: food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. this new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents.

according to the haute autorité de santé (has), undernutrition affects between 15 and 38% of elderly people living in institutions and between 50 and 60% of hospitalized elderly people. in addition, a significant decrease in satisfaction with meals was observed with increasing level of dependence. the objective of the study is to evaluate the feasibility of implementing the finger food in care settings that could have a positive impact on the nutritional status of elderly people living in ehpad.

Eligibility criteria:
inclusion criteria: * male or female residents over 75 years old living in a accommodation facility for dependent elderly people for at least 3 months * presenting at least one of the following 3 criteria: * unintentional weight loss ≥ 5% in 1 month * involuntary weight loss ≥ 10% in 6 months or compared to the usual weight or compared to the weight at entry to the ehpad * confirmed sarcopenia: * male (at least one of the 2 criteria): * dynamometer (kg): \< 27 and calf circumference (cm): \< 31 * impedancemetry: appendicular muscle mass index \< 20 kg or appendicular muscle mass index \< 7 kg/m² * woman (at least one of the 2 criteria): * dynamometer (kg): \< 16 and calf circumference (cm): \< 31 * impedancemetry: appendicular muscle mass index \< 15 kg or appendicular muscle mass index \< 5.5 kg/m² * loss of autonomy according to the tully scale \< 12/18 with a score of 2 or 3 on the item "able to bite, chew, swallow without making false routes" * person having given free, informed and express consent * person having an affiliation to a social security scheme exclusion criteria: * protected person: safeguard of justice * swallowing disorder having a contra-indication to the texture of hand-eating meals. * lack of motor skills in both hands * specific diet: pleasure diet, salt-free, sugar-free, fiber-free, artificial nutrition * wearer of a pacemaker

Keywords: undernutrition elderly person nursing home nutrition
the effect of pre-incisional local xylocaine injection on post operative pain and scar formation after cesarean section

Conditions: Pain Relief

Summary: this study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. one hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. we will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.

among all other abdominal operations cesarean section is unique in two aspects. first, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain. application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section. the above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). others suggested possible benefit due to antimicrobial activity (12) conversely, al- asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. interestingly, drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15). our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. it will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.

Eligibility criteria:
inclusion criteria: * candidates for non-emergency cesarean section exclusion criteria: * emergency cesarean section * known or suspected sensitivity to local anesthetics * pre-eclamptic toxemia * deranged liver function * deranged hemostasis * lack of adequate verbal communication

Keywords: xylocaine casarean section post operative pain scar quality
bedside renal ultrasound assessment in patients with acute kidney injury

Conditions: Critical Illness

Summary: exploring the predictive and evaluative value of various indicators of bedside critical renal ultrasound in critically ill patients with acute kidney injury (aki)

this study aims to perform bedside renal ultrasound examinations on critically ill patients admitted to the icu (including sepsis, respiratory failure, shock, multiple trauma, etc.) and prospectively observe the relationship between ultrasound parameters and the occurrence and progression of aki, in conjunction with traditional renal function indicators. this will provide clinicians with a rapid, non-invasive, and visual examination tool at the bedside for early diagnosis and treatment of aki.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 70 years * criteria for sepsis patients exclusion criteria: * pregnant women. * patients with malignant tumors, severe heart failure, chronic renal insufficiency, end stage renal disease, kidney transplantation.

Keywords: critical illness ultrasound therapy kidney injury
staging candidiasis in icu patients

Conditions: Candidiasis

Summary: our primary objective is to evaluate the relevance of the early determination of candida infection status among non-neutropenic patients hospitalized over 48 hours in icus.


Eligibility criteria:
inclusion criteria: * polynuclear neutrophils \> 500/mm\^3 * hospitalized for \> 48 hours in participating icus exclusion criteria: * patients discharged from icu in \< 48h * patient diagnosed with invasive candidosis before entry to icu * patient is taking an anti-fungal treatment * polynuclear neutrophils \< 500/mm\^3 * patient transferred to another icu * patient included in the abmidex protocole

Keywords: icu
hemodialysis without anticoagulation in intensive care unit

Conditions: Kidney Failure; Critically Ill; Hemorrhage

Summary: the purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or nephral 400st in patients at high risk of bleeding

hemodialysis in patients who are at high risk of bleeding complications represents a challenge of balancing the needs for establishment of an adequately functioning extracorporeal circuit for dialytic therapy with the requirement of not exacerbating existing bleeding or precipitating bleeding in predisposed subjects. several methods of nonheparin dialysis have been used. the method most commonly used to effect such treatment is "saline flushing": saline boluses are delivred at frequent intervals. this method is far from optimal for several reasons, including failure to maintain a patent circuit in significant proportion of patients, an added logistic burden on dialysis nurses. an alternative method of avoiding systemic heparinization is priming the dialysis membrane with heparin before hemodialysis. the method is based on fact that an69st (nephral 400st , hospal, france) dialysis membrane have a high affinity for binding heparin, and that the bound heparin exerts a localized antithrombotic effect without systemic spillover. comparison: heparin free hemodialysis with saline flushes compared heparin free hemodialysis with nephral 400st.

Eligibility criteria:
inclusion criteria: * age \> 18 years * patient with high risk bleeding * patient requiring dialytic therapy in intensive care unit exclusion criteria: * pregnancy * history of heparin-induced thrombocytopenia or serious heparin allergy * history of serious membrane dialysis allergy * treatment by any of following medications 24h within the inclusion: prophylactic or therapeutic anticoagulation with unfractioned heparin or low molecular weight heparin nonsteroidal anti-inflammatory agents direct thrombin inhibitors, antithrombin concentrate, activated protein c, anti-factor xa pentasaccharide * treatement by acetylsalicylic acid or other antiplatelet agent excluding platelet glycoprotein iib/iiia antagonists 7 days within the inclusion.

Keywords: intensive care unit patients with bleeding high risk intermittent hemodialysis without anticoagulation blood lost
reduction of fluoroscopy exposure during atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: to evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

the novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to x-ray for physician, staff and patients. this randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. group 1 (cartounivu): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. group 2 (carto3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. the ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (pv) and voltage map guided substrate modification. according to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration. the primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Eligibility criteria:
inclusion criteria: * documented atrial fibrillation in the 12-lead ecg or holter ecg * paroxysmal symptomatic atrial fibrillation * ineffectiveness of antiarrhythmic medication ( at least 1 medication ) * age 18-75 years * left atrial diameter \<60 mm ( transesophageal echocardiography, parasternal ) * a signed consent form exclusion criteria: * reversible etiology of atrial fibrillation * pregnancy * women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure * intracardiac thrombus * contraindication to anticoagulation * thromboembolic event in the last 6 months * previous left atrial ablation

Keywords: fluoroscopy exposure paroxysmal atrial fibrillation ablation fluoroscopy atrial fibrillation ablation
safety and efficacy study of sar 1118 to treat dry eye conducted in a controlled adverse environment (cae) (opus-1)

Conditions: Keratoconjunctivitis Sicca; Dry Eye Disease

Summary: the purpose of the study is to evaluate the efficacy of sar 1118 ophthalmic solution (5.0%) compared to placebo in the treatment of dry eye. the safety and tolerability of sar 1118 ophthalmic solution (5.0%) compared to placebo in subjects with dry eye when administered bid for 12 weeks will also be evaluated.


Eligibility criteria:
inclusion criteria: * willing and able to read, sign, and date the informed consent and hipaa documents * willing and able to comply with all study procedures * be at least 18 years of age * patient-reported history of dry eye in both eyes * demonstrate a positive response when exposed to the controlled adverse environment model * a negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period exclusion criteria: * any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy * unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period * any blood donation or significant loss of blood within 56 days of visit 1 * any history of immunodeficiency disorder, positive hiv, hepatitis b, c, or evidence of acute active hepatitis a (anti-hav igm), or organ or bone marrow transplant. * use of any topical ophthalmic preparations (including artificial tear substitutes) 72 hrs prior to visit 1 and during the study * any significant chronic illness that could interfere with study parameters * history of laser-assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery within 12 months prior to visit 1, and/or any other ocular surgical procedure within 12 months prior to visit 1; or any scheduled ocular surgical procedure during the study period. * known history of alcohol and/or drug abuse * subjects with dry eye secondary to scarring or destruction of conjunctival goblet cells (as with vitamin a deficiency)

Keywords: ophthalmic delivery dry eye