Kornimate/medical-research-clean huggingface dataset:
efficacy study of a novel device to clean the endotracheal tube

Conditions: Endotracheal Extubation; Airway Obstruction; Airway Control; Pneumonia, Ventilator-Associated; Breathing Mechanics

Summary: the purpose of this study is to evaluate the in-vivo efficacy of a novel device (endoclear) for cleaning the endotracheal tube (ett) lumen from secretions. the investigators hypothesize that a protocol of routine ett cleaning with endoclear may increase the ett luminal volume measured at extubation compared to the current standard of care. the device may therefore be clinically useful by better maintaining the ett original function.

after a few days of mechanical ventilation (mv), the lumen of the endotracheal tube (ett) is coated with a thick bacterial biofilm, which is a potential source for bacterial colonization of the lower respiratory tract and ventilator-associated pneumonia (vap). accumulation of mucus/secretions on the interior of the ett also effectively lowers the cross section of the ett and increases significantly the work of breathing in intubated patients, who then require increased mv support, with prolonged intubation and icu stay. a primary goal for all icus is to shorten the time of mv, to decrease the incidence of ett microbial colonization and ultimately vap incidence. to meet this goal several airways technologies to maintain the ett free from debris/bacteria have been developed in order to improve the current ventilator-liberation standards in intubated critically ill patients. based on preliminary laboratory, animal and clinical data, the investigators now wish to test the hypothesis that a novel commercially available ett cleaning device can be effective in targeting two specific issues: * specific aim 1: to evaluate the mean difference in ett luminal volume of etts cleaned with the novel cleaning device (endoclear) vs. ett cleaned in the standard manner. * specific aim 2: to determine whether etts cleaned with the novel device show a lower degree of microbial colonization for the entire period of mechanical ventilation. data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic resistance analysis, users' feedbacks and safety of the device will also be collected. the investigators will conduct a clinical trial on 74 intubated patients randomized to receive standard ett cleaning or cleaning with the endoclear.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients expected to be intubated for at least 48 hours or longer * enrollment within 24 hours from intubation time exclusion criteria: * current and past participation in another intervention trial conflicting with the present study * pregnant women and prisoners

Keywords: medical devices ventilator-associated pneumonia (vap) ventilator-associated events (vae) endotracheal tube microbial diversity anti-resistance computed tomography (ct)
effects of mindfulness training on emotion regulation and impulsivity

Conditions: Mindfulness Skills; Interpersonal Effectiveness Skills

Summary: mindfulness training has proven to be a reliable treatment for patients with borderline personality disorder (bpd).the present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. in addition, fmri data was collected pre and post intervention. 70 patients with bpd diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. assessments were conucted pre-and-post-intervention.


Eligibility criteria:
inclusion criteria: * bpd diagnosis according to two semi -structured interviews: the structured clinical interview for dsm-iv axis ii disorders and the revised diagnostic interview for borderlines * age between 18 and 50 years old * no comorbidities with schizophrenia, drug induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course * not being participating in any other psychotherapy at the moment of the study. exclusion criteria: • having participated of skills training in the past.

Keywords: mindfulness emotion regulation impulsivity
fascia iliaca compartment blockade as analgesia for hip fractures in the acute phase

Conditions: Hip Fracture

Summary: to evaluate the analgesic potential of an neural blockade (fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department.

hip fracture patients have severe pain in the acute phase. traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. the trial evaluates the fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department.

Eligibility criteria:
inclusion criteria: * primary hip fracture suspected * able to give informed consent * no substance abuse * no regular opioid therapy * no opioid treatment within the last 6 hours * morphine intolerance * allergies to local anaesthetics exclusion criteria: * fracture ruled out on x-ray

Keywords: hip fracture, pain, regional anaesthesia, analgesia
amino acids expression profiling of patients with sepsis

Conditions: Sepsis; Amino Acids

Summary: the patients with sepsis are in the state of hypermetabolism, increased resting energy expenditure, protein and fat catabolism disorder, negative nitrogen balance, insulin resistance, hyperglycemia, and amino acid metabolism disorders. however, it is remain unclear the changes of amino acids expression profiling in sepsis patients. in this study, the investigators has planned to enroll 100 subjects, including 20 cases with systemic inflammatory response syndrome (sirs), 20 cases with sepsis, 20 cases with severe sepsis and 20 with septic shock. in addition, this study also include 20 normal cases as control. the serum sample of patients with sepsis is draw on days 1, 3, 5, 7, 10, and 14 after first icu admission. high-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of amino acids. the amino acids expression profiling contain arginine, ornithine, histidine, cystine, isoleucine, cystathionine, leucine, homocystine, lysine, α-amino-n-butyric acid, methionine, alanine, phenylalanine, anserine, threonine, β-alanine, tryptophan, β-amino-isobutyric acid, valine, carnosine, γ-amino-n-butyric acid, ethanolamine, glycine, δ-hydroxylysine, serine, hydroxy-l-proline, taurine, 1-methyl-l-histidine, tyrosine, 3-methyl-l-mistidine, α-amino-adipic, phospho-ethanolamine, asparagine, phospho-l-serine, aspartic acid, proline, citrulline, sarcosine, glutamic acid, argininosuccinic acid, glutamine, homocitrulline. the investigators speculate that measurement of amino acids expression profiling could be taken as an indicator for assessment in critically ill patients.


Eligibility criteria:
inclusion criteria: 1. male and female aged 18 years old and over; 2. clinically confirmed infection; 3. fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °c or lower than 36 °c (b)respiratory rate above 20/min, or pco2 below 32 mmhg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands. exclusion criteria: 1. parenteral nutrition; 2. diabetes and other metabolic-related diseases; 3. chronic liver disease; 4. neutropenia (≤ 500 neutrophils/mm3); 5. hiv infection; 6. patients or their relatives refused.
randomized comparison of exoseal® and angio-seal vascular closure devices: the close-up ii trial

Conditions: Coronary Disease

Summary: is the exoseal vsd non-inferior to angio-seal vascular closure device (vsd) in the incidence of adverse access site related events at 30 days.

prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (pci) patients comparing the exoseal vcd (test device) to the angioseal vcd (standard comparator). in-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.

Eligibility criteria:
inclusion criteria: * should be able to provide valid informed signed consent * pci procedure including treatment by balloon and/or stent * pci indicated by silent ischemia, stable angina pectoris, non-st elevation myocardial infarction (nstemi) or st elevation myocardial infarction (stemi) exclusion criteria: * only coronary angiography * multiple punctures * active infection * groin haematoma before the closure procedure * sheath size \> 7 french * known pseudoaneurysm or arteriovenous (av)-fistula in the ipsilateral groin * prior arterial surgery in abdomen and/or lower extremities * cardiogenic shock * life expectancy less than one year * the patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating * simultaneous or planned subsequent femoral vein access * allergy to any of the components in the closure material left in the groin * puncture on same site \< 30 days * peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the vcd

Keywords: pci
safety and pharmacokinetics of clindamycin in pediatric subjects with bmi ≥ 85th percentile

Conditions: Bacterial Infections; Obesity

Summary: the purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (bmi - a ratio of weight to height). the results of the study will help better understand if children in higher bmi ranges process the medication differently and whether dosing should be adjusted in these children.

this is a prospective, open-label pharmacokinetic and safety study of multiple doses of iv and oral clindamycin in overweight and obese children ages 2 to 17 years of age. the total study duration is expected to be approximately 24 months; each subject will participate in the study for up to 18 days (screening day; treatment days 1-14 \[may be as short as 2 days\] followed by an observation period of 3 days post discontinuation of clindamycin therapy or after day 17 (on day 18) of therapy in those who are treated with more than 14 days of clindamycin).

Eligibility criteria:
inclusion criteria: * 2 years - \< 18 years of age at the time of first dose of study drug * suspected or confirmed infection or receiving iv clindamycin per routine care * negative serum pregnancy test (if female and has reached menarche) within 24 hours of first dose of study drug and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy test through the last dose of study drug * bmi ≥ 85th percentile for age and sex, based on centers for disease control (cdc) recommendations * signed informed consent/health insurance portability and accountability act (hipaa) documents by the parent/legal guardian and assent (if applicable) exclusion criteria: * the following apply only to those who are not already receiving clindamycin per routine care: 1. history of hypersensitivity or allergic reaction to clindamycin or lincomycin 2. history of c. difficile colitis with previous administration of clindamycin 3. aspartate aminotransferase (ast) \> 120 units/l 4. alanine aminotransferase (alt) \> 210 units/l 5. total bilirubin \> 3 mg/dl 6. serum creatinine \> 2 mg/dl 7. receiving a neuromuscular blocker as part of their therapy * previous participation in the study * subject is on prohibited medication or herbal product (see appendix ii) * subject is receiving extracorporeal life support (ecls) * subject is post-cardiac bypass (within 24 hours) * subject on inotropes/pressors * any other condition or chronic illness that, in the opinion of the principal investigator, makes participation unadvised or unsafe

Keywords: bacterial infections obesity pharmacokinetics clindamycin
non-invasive hemoglobin monitoring in congenital heart diseased children

Conditions: Congenital Heart Disease

Summary: the investigators will evaluate the accuracy of non-invasive hemoglobin monitor (sp-hb) compared to traditional laboratory hemoglobin (lab-hb) in children with congenital heart disease. the investigators will also compare the accuracy of sp-hb in cyanotic children to acyanotic children.

blood hemoglobin is measured daily in clinical practice. laboratory measurement (lab-hb) of is the gold standard for assessment of blood hemoglobin. recently, non-invasive monitors had been introduced. non-invasive measurement of hemoglobin (sp-hb) would save time and minimize the risk of infection. blood sampling in children is usually more difficult and stressful; moreover, it also carries the risk of iatrogenic anemia. radical-7 (masimo corporation, irvine, ca) is a device that operates using the principle of co-oximetry . radical-7 had been validated in various clinical purposes. measurement of blood hemoglobin is an important application for radical-7 device. non-invasive hemoglobin (sp-hb) measurement has been frequently validated in adults; as well as in pediatric patients; however, its accuracy in children with congenital heart disease was not investigated. congenital heart disease infants usually undergo major operations and frequently need transfusion of blood. moreover, these patients have special circulatory physiology that might impact the device accuracy. it had been recently reported that the performance of co-oximetry in congenital heart disease children is poor in measurement of oxygen saturation specially at oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not investigated yet. in this study, the investigators will evaluate the accuracy of sp-hb compared to traditional lab-hb in children with congenital heart disease. the investigators will also compare the accuracy of sp-hb in cyanotic children to acyanotic children.

Eligibility criteria:
inclusion criteria: * infants and children less than 8 years * with congenital heart disease exclusion criteria: * refusal of the patient surrogate to share in the study
ph 2 trial of adi peg 20 plus concurrent transarterial chemoembolization (tace) vs tace alone in patients with unresectable hepatocellular carcinoma

Conditions: Unresectable Hepatocellular Carcinoma

Summary: certain cancers require the amino acid arginine. arginine deiminase (adi) is an enzyme from microbes that degrade arginine. adi has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. in this study, the investigators will evaluate the response rate, as determined by the revised international working group recommendations.


Eligibility criteria:
inclusion criteria: 1. diagnosis of hcc confirmed clinically or histologically or cytologically. a clinical diagnosis of hcc, using the 2010 guideline of the american association for the study of liver diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, ct or mri) compatible with hcc, and no evidence of other gastrointestinal tumors (bruix \[2011\] - guideline, 2010). 2. solitary hepatic tumor \<8 cm in diameter or multifocal disease as evidenced by ct or mri scan. tumor volume ≥50% of liver organ or infiltrating hcc should be excluded. 3. not a candidate for surgical resection or ablation of the tumor. 4. the target lesion must not have been treated previously with local therapy, including tace. prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable. 5. the subject must have received no more than 2 tace (n≤ 2) or the previous tace was performed longer than 2 months before enrollment. 6. local therapy must have been completed at least 4 weeks before baseline scan. 7. measurable disease using mrecist criteria (appendix a) and recist1.1 (appendix b) criteria. at least 1 measurable lesion must be present. 8. barcelona clinic liver cancer (bclc) staging classification b (intermediate stage) (appendix c). exclusion criteria: 1. 1. candidate for potential curative therapies (i.e., resection or transplantation). 2. prior allograft transplantation including liver transplantation. 3. significant cardiac disease (new york heart association class iii or iv; appendix f). 4. serious infection requiring treatment with systemically administered antibiotics. 5. pregnancy or lactation. 6. expected non-compliance. 7. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements. 8. subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.

Keywords: unresectable hepatocellular carcinoma liver cancer adi adi-peg 20
stop addiction stigma

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial evaluates the impact of a stop addiction stigma (sas) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. reviews have shown that patients with substance abuse disorders have experienced negative attitudes from their health care providers. negative attitudes may lead to less involvement from the provider and the patient and may lead to less effective care. using case vignettes with a sas workshop may be an effective method to help people learn about addiction, reduce the stigma toward addiction and improve the quality of health care.

primary objective: i. to describe the impact of sas training on participants' responses to people with a substance impairment. secondary objectives: i. to evaluate the feasibility of stigma training workshops on stigmatizing attitudes health care personnel. ii. to explore the maintainability of responses over time. iii. to explore relationships between language and stigmatizing attitudes. outline: participants are randomized to 1 of 6 group case vignettes. group a (chronically relapsing brain disease): participants view the chronically relapsing brain disease vignette and attend a sas workshop on study. group b (brain disease): participants view the brain disease vignette and attend a sas workshop on study. group c (disease): participants view the disease vignette and attend a sas workshop on study. group d (illness): participants view the illness vignette and attend a sas workshop on study. group e (disorder): participants view the disorder vignette and attend a sas workshop on study. group f (problem): participants view the problem vignette and attend a sas workshop on study.

Eligibility criteria:
inclusion criteria: * employee of ohio state university wexner medical center (osuwmc) * age ≥ 18 years * participants must be able to read and comprehend survey items
the effect of physical therapy on sexual function

Conditions: Sexual Dysfunction; Low Back Pain

Summary: sexual function in low back pain and after lumbar surgery has been evaluated in many studies in a few studies, sexual function problems after surgery have also been reported. in the literature, there is no study that investigates the effectiveness of physical therapy on sexual function in patients with low back pain. in this study, the effectiveness of physical therapy on sexual function in patients with low back pain will be evaluated.

63 patients who had chronic low back pain who applied to city hospital, physical medicine and rehabilitation department between january 2021 and january 2023 were enrolled in the study. sexually active patients between the ages of 18 and 60, for whom physical therapy was planned for low-back pain related to lumbar pathologies, were included in the study. informed consent was obtained from all patients. exclusion criteria were defined as having contraindications for any physical therapy agents, having cardiovascular, neurological, psychiatric disease, or sexual disorders. short form-12 (sf-12), oswestry disability index (odi), and hospital anxiety and depression scale (had) were recorded. international index of erectile function (iief) and female sexual function index (fsfi) were utilized to evaluate sexual function fifteen sessions of physical therapy were planned for each patient. the physical therapy program included 15 minutes of conventional transcutaneous electrical nerve stimulation, 10 minutes of ultrasound, and 15 minutes of superficial heaters such as hot packs or infrarouge. all patients were evaluated the day before the first physical therapy session, the one-month and three-month after the last physical therapy session.

Eligibility criteria:
inclusion criteria: * low back pain due to lumbar pathologies * being sexually active * have no contraindications for physical therapy agents exclusion criteria: * known sexual function problems, * known psychiatric disease and/or are taking antidepressant * diabetes mellitus, * cardiovascular disease * neurological diseases
the effect of arista on post-operative bleeding and wound drainage following mastectomy

Conditions: Seroma

Summary: study aim was to evaluate topical mph on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.

seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. microporous polysaccharide hemospheres (mph) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. an animal model evaluating mph and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. study aim was to evaluate topical mph on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days. prospective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. mph was applied to the surgical site in the study group and no application in the control group. fifty patients were enrolled; eight were excluded due to missing data. forty-two patients were evaluated, control (n=21) vs. mph (n=21). no difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. on a subset analysis, body mass index (bmi) greater than 30 was identified as an independent risk factor for high drain output. post hoc analyses of mph controlling for bmi also revealed no statistical difference. unlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of mph in patients undergoing mastectomy for the treatment of breast cancer. bmi greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by mph use.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * undergoing simple mastectomy with or without sentinel lymph nodes biopsy or modified radical mastectomy for the treatment of breast cancer exclusion criteria: * undergoing partial mastectomy * sentinel lymph node biopsy requiring conversion to axillary lymph node dissection * immediate reconstructive surgery * systemic anticoagulation * choosing not to participate in the study