Kornimate/medical-research-clean huggingface dataset:
neutrophils to lymphocytes ratio in predicting the response to bcg in non-muscle invasive bladder cancer

Conditions: Urinary Bladder Cancer; Urinary Bladder Neoplasm; BCG; Trans Urethral Resection of a Bladder Tumor; Non-Muscle Invasive Bladder Urothelial Carcinoma

Summary: there is a relation between inflammatory cells and the prognosis of tumors (cancer colon, renal, liver, and urinary bladder). in this study, the investigators will link the neutrophils to lymphocytes ratio to the response to intravesical bcg therapy post trans-urethral resection of urinary bladder tumors for the non-invasive urinary bladder tumors.

the gold standard treatment for non-invasive urinary bladder tumors is by transurethral resection of bladder tumor (turbt) and a re-turbt when indicated, followed by adjuvant intravesical immunotherapy (bcg). however, the recurrence and progression rates of non-muscle invasive bladder cancer (nmibc) for 5 years range from 31% to 78% and from 1% to 45%, respectively. to improve personalized care, prognostic models have been developed to help in prediction of the high-risk patients and recurrence helping in clinical and therapeutic decision-making. these models are based on standard clinic-pathological features such as t stage, grade, multifocality, sex, tumor diameter, recurrence rate, and concomitant carcinoma in situ. according to the current theories, the systemic inflammatory response triggered by cancer leads to relative neutrophilia and lymphocytopenia, creating a pro-oncogenic inflammatory condition. an elevated nlr (neutrophil to lymphocyte ratio) implies that cell-mediated immunity is impaired and systemic inflammation is increased in inflammatory processes. among patients with non-invasive urinary bladder tumors, an elevated nlr (neutrophil to lymphocyte ratio) was described in the literature to be associated with advanced pathologic stage, invasiveness, and bad prognosis. the study aims to assess the role of preoperative neutrophils to lymphocytes ratio as a predictor for the response to bcg in patients with non-muscle invasive bladder cancer in patients following trans-urethral resection of bladder tumor (turbt).

Eligibility criteria:
inclusion criteria: * patients with non-muscle invasive urothelial tumor of the urinary bladder exclusion criteria: 1. concomitant malignancy. 2. hematological disorders. 3. history of radiation or chemotherapy. 4. concomitant infection or chronic inflammatory diseases. 5. missing preoperative differential blood cell count. 6. patients with low grade non muscle invasive urinary baldder tumors. 7. patients missing bcg after biopsy revealing nmibc. 8. patients with non-compliance to bcg doses or the scheduled follow up.
diagnosis of myocardial ischemia with mcg using spect as a reference standard

Conditions: Chest Pain; Stenosis; Myocardial Ischemia

Summary: this is a prospective clinical study aiming to investigate the efficacy of magnetocardiography (mcg) in detecting myocardial ischemia in patients of a suspected non-st-elevation-acute coronary syndrome (nste-acs) by using single photon emission computed tomography (spect) as the gold standard for determining the presence and severity of myocardial ischemia.


Eligibility criteria:
inclusion criteria: * age 18 years or older; * patients with symptoms of myocardial ischemia such as angina pectoris, who have cag showing \<70% stenosis at the most severe site or cta showing non-severe stenosis * signed informed consent. exclusion criteria: * patients with absolute or relative contraindications to spect-loaded myocardial perfusion, including acute myocardial infarction within 48 hours, significant left main coronary artery stenosis, bronchial asthma, and adenosine injection allergy; * patients with non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease; * patients with hemodynamic instability (systolic blood pressure\<90 mmhg, or who requires vasoactive drugs), or patients with tachyarrhythmia, ⅱdegree atrioventricular block and above that have not returned to normal; * patients who have severe renal abnormality with egfr \<30 ml/min, or patients who are on dialysis; * patients with malignant tumors with predicted survival of less than 1 year; * pregnant or breastfeeding women; * patients who are unable to enter the mcg device, who are unable to perform mcg examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.
pharmacokinetics of micafungin in children on extracorporeal membrane oxygenation

Conditions: Invasive Candidiasis

Summary: determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ecmo).

extracorporeal membrane oxygenation (ecmo) is a cardiopulmonary bypass device that provides life-saving, complete respiratory and cardiac support for children who suffer refractory heart or lung failure. while on ecmo, children are at increased risk of infection, including fungal infection. antifungal prophylaxis can potentially reduce the burden of disease in children on ecmo. because fungal infections can result in biofilms that are difficult to treat, treatment includes not only antifungal medications but also removal of any large intravenous lines. however, catheter removal for children on ecmo is impossible; therefore, therapy relies upon optimal antifungal management alone. micafungin is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. micafungin may be particularly efficacious in children on ecmo because of the drug's ability to penetrate biofilms. however, the ecmo circuit is known to substantially alter drug levels for many drugs, resulting in important dosing changes. appropriate micafungin dosing in this setting is unknown and sub-optimal dosing might result in therapeutic and prophylactic failure. standard dosing of micafungin are 4 and 2 mg per kilogram of body weight given intravenously once daily for treatment and prophylaxis, respectively. based on preliminary data and modeling from other studies, investigators hypothesize that 8 and 4 mg per kilogram given once daily will achieve proper drug levels to respectively treat and prevent fungal infections in children under 2 years of age who are supported by ecmo. because the ecmo circuit should have less of an impact on volume of distribution in larger children, investigators hypothesize that in children from 2 to 18 years old, standard dosing of micafungin will achieve proper drug concentrations. investigators hold the fda investigational new drug application (ind #115255) to give micafungin to children on ecmo at the doses described above. blood samples will be collected at specific times around the first and fourth micafungin doses to describe the pharmacokinetics and drug extraction by the ecmo circuit.

Eligibility criteria:
inclusion criteria: * \<= 17.85 years at the time of enrollment. * sufficient venous access to permit administration of study medication. * supported with either venoarterial (va) or venovenous (vv) ecmo. * availability and willingness of the parent/legal guardian to provide written informed consent. * for treatment dosing arm: confirmed or suspected infection exclusion criteria: * subject with a history of anaphylaxis attributed to an echinocandin. * any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study. * previous participation in this study. * pregnancy

Keywords: extracorporeal membrane oxygenation ecmo extracorporeal life support micafungin mycamine pharmacokinetics
flipped learning and escape room method on nursing students

Conditions: Nursing Students

Summary: the impact of interactive education methods on nursing education will be evaluated.

this study aims to evaluate the effects of reverse learning and escape room methods on nursing students' infection control knowledge and learning skills. the study is an original study in terms of focusing on infection control with relevant interactive methods. the study will contribute to the literature in terms of the development of knowledge-based skills such as providing hand hygiene, opening sterile bundles, opening and placing sterile materials in sterile bundles, wearing and removing personal protective equipment, and disposing of waste materials within the scope of infection control. in addition, the questions to be answered in the study are listed below.

Eligibility criteria:
inclusion criteria: * receiving training on infection control for the first time exclusion criteria: * having received training on infection control before * not attending the final test, follow-up test * not attending class

Keywords: escape room flipped learning infection control nursing students
capsulized fecal microbiota transplantation in pediatric ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: fecal microbiota transplantation(fmt) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis. this is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed pediatric patients with mild-moderate uc. the primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation, in newly diagnosed pediatric patients with mild-moderate uc. all processing will occur at the center for microbiome research at assaf harofeh medical center, under gmp conditions.


Eligibility criteria:
inclusion criteria: * patients newly diagnosed (\>9 months) with mild to moderate ulcerative colitis as per colonic biopsy and clinical disease activity (sccai 5-12). * patients not started on immune-suppressive or anti-inflammatory medications (mesalamine is allowed). * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. women of childbearing potential will have a urine pregnancy test, which must be negative, on study day 1, prior to receiving fmt. men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after fmt. * ability to understand and the willingness to sign a written document, including the willingness to accept risk of unrelated donor stool. * ability of parents or other legal guardian to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool. * ability to swallow oral medications. exclusion criteria: * severe, uncontrolled ulcerative colitis. * at time of enrollment, immune-suppressive or anti-inflammatory medications, except mesalamine. * patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. * delayed gastric emptying syndrome * known chronic aspiration * patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs) * pregnant and breast-feeding women * participants who are unable to swallow pills.

Keywords: ibd uc fecal-transplantation capsules microbiota microbiome colitis pediatric
crps - diagnostics, pathophysiological mechanisms, and response to treatment with noninvasive brain stimulation

Conditions: Transcranial Magnetic Stimulation; Complex Regional Pain Syndrome of Upper Limb (Disorder)

Summary: this is a sham controlled, randomized, double-blind, navigated repetitive transcranial magnetic stimulation (nrtms) study for the treatment of complex regional pain syndrome (crps types 1 and 2). the investigators study factors that may contribute to development, maintenance, or treatment responses with clinical, sleep, and psychiatric questionnaires and clinical examinations, quantitative sensory testing and neurophysiologic recordings, genetics, and mri techniques.

rtms hypothetically disrupts the default networks related to chronic pain and renders the brain more susceptible to drugs, rehabilitation, or cognitive behavioral therapy. in addition, there is experimental evidence that rtms releases factors that are involved in endogenous top-down modulation of pain and neural plasticity. thus, the analgesic effect of rtms may be mediated via enforcing endogenous pain control systems at the brain level, in addition to its effects on neuroplastic effects. for active, navigated stimulation targets the investigators have the parietal opercular cortex overlying the secondary somatosensory cortex ("s2") and the primary motor cortex (m1). the investigators randomize participants to first receive nrtms to the right "s2" or sham stimulation. after ten sessions the investigators follow up the participants up to three months. at three months, if the average pain is ≥5/10 in numeric rating scale (nrs), the participant is offered an active, open nrtms treatment phase depending on which treatment the participant first received. if the participant benefits from the open label treatment, a maintenance therapy is offered (6 months with gradually reducing nrtms treatment frequency). the symptoms and quality of life are followed with questionnaires and diaries. after the maintenance period, the rn calls a structured interview at 1, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * crps 1 or 2 of the upper limb * duration ≥ 6 months * mean pain (nrs) intensity ≥5/10 * medical and other therapies have failed exclusion criteria: * other stimulation therapies apart from transcutaneous nerve stimulation * psychotic disorder * severe depression * use of strong opioids * epilepsy * any contraindication for mri * abuse of alcohol or drugs * ongoing insurance or other entitlement cases

Keywords: tms crps pain fmri quality of life mood cognitive function dna
evaluation of the quality of life after a multidisciplinary auditory rehabilitation program

Conditions: Acquired Deafness

Summary: in 2008, the handicap-santé survey counted 10 million people with hearing difficulties in france, i.e. 16% of the national population. for 5.4 million of these people, the hearing limitations considered to be moderate to total, are likely to have repercussions on their daily life. in 2010, 600,000 people with hearing loss wore hearing aids, including 360,000 with very severe to total limitations who were unable to follow a conversation with others. hearing loss can impact hearing skills (comprehension in noisy environments or with multiple speakers) and be a source of cognitive decline. it can also limit the quality of exchanges, communication and information taking. several studies have shown that hearing loss can also have a negative effect on quality of life, psychological well-being, personal fulfillment, social relationships and can lead to social isolation, depression and/or anxiety. currently, the treatment of people with hearing loss is often limited to hearing aids from a hearing aid specialist. hearing rehabilitation and lip-reading training with a speech therapist may be offered at a later stage. however, many people who have been fitted with a hearing aid describe a decrease in their quality of life despite the fitting. current treatment seems to deal mainly with auditory-cognitive problems. to date, no multidisciplinary rehabilitation services seem to be offered in france to take into account the other consequences of this condition: anxiety, depression, and limitations in social participation.


Eligibility criteria:
inclusion criteria: * patients whose age ≥ 18 years * patients with acquired hearing loss (mild, moderate, severe or profound) * patients with hearing aids * patients participating in a complete rehabilitation program * patients who master the french language exclusion criteria: * patients with proven cognitive impairment * implanted patients * patients under guardianship or curatorship * patients deprived of liberty * patients under court protection * interruption of the rehabilitation program before a minimum of 6 half-days of hdj * patients objecting to the use of their data for this research
emergency stroke unit for acute cerebrovascular events ( esu-ace-c )

Conditions: Ischemic Stroke, Acute

Summary: to compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in emergency stroke unit (a new stroke unit based on low-field magnetic resonance imaging).

the first mri machines in the 1970s and 1980s were low-field due to technological limitations. as technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. recently, there has been renewed interest in low-field mri due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). research has demonstrated that low-field mri can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. by providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field mri is not readily available. this prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in emergency stroke unit (a new stroke unit based on low-field magnetic resonance imaging).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. patients who arrive at the emergency department within 4.5 hours of symptom onset\* (\*symptom onset is defined by the "last seen normal" principle); 3. presenting with ischemic stroke symptoms; 4. pre-stroke mrs score 0-1; 5. baseline nihss score ≥ 5; 6. eligible for rt-pa/tnk thrombolysis; 7. informed consent signed. exclusion criteria: 1. baseline nihss score \< 5; 2. unable to undergo mri because of claustrophobia; 3. patients with cardiac pacemaker/brain pacemaker/insulin pump implantation; 4. definite contraindication for rt-pa/tnk thrombolysis; 5. patients with postictal hemiparesis (todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate; 6. pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial; 7. participation in other interventional randomized clinical trials within 3 months before enrollment; 8. patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.

Keywords: emergency stroke unit low-field magnetic resonance imaging reperfusion therapy
management of prelabor rupture of the membranes at term

Conditions: Fetal Infection; Chorioamnionitis; Endometritis; Cesarean Section Complications

Summary: prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. in this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

prelabor rupture of the membranes (prom) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions. prom at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. furthermore, expectant management has been shown to increase the risk for cesarean deliveries (cd), chronic lung disease, cerebral palsy and neonatal mortality. it is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. others disagree with those associations. in this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with prom at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.

Eligibility criteria:
inclusion criteria: 1. primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes. 2. women at gestational age 370/7 or more. 3. vertex presentation. exclusion criteria: 1. age 18 and under. 2. high order gestation. 3. women with contraindication for a vaginal delivery. 4. active labor. 5. documented fetal anomalies. 6. known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis). 7. non reassuring fetal heart rate tracing. 8. positive group b streptococcus status.
the efficacy of cobitolimod in patients with moderate to severe active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

this was a phase iib study in patients with moderate to severe left-sided ulcerative colitis. patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. to ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. primary endpoint was evaluated at week 6. duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * established diagnosis of ulcerative colitis (uc) * moderately to severely active left sided uc assessed by central reading * current oral 5-aminosalicylic acid (5-asa)/ sulphasalazine (sp) use or a history of oral 5-asa/sp use * current glucocorticosteroids (gcs) use or history of gcs dependency, refractory, or intolerance * demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents: * immunomodulators * tumor necrosis factor alpha (tnf-α) inhibitors and/or anti-integrins exclusion criteria: * suspicion of differential diagnosis * acute fulminant uc and/or signs of systemic toxicity * uc limited to the rectum (disease which extend \<15 cm above the anal verge) * history of malignancy * history or presence of any clinically significant disorder * concomitant treatment with cyclosporine, methotrexate, tacrolimus, tnf-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators * treatment with rectal gcs, 5-asa/sp or tacrolimus * long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (nsaids) * serious active infection * gastrointestinal infections * currently receiving parenteral nutrition or blood transfusions * females who are lactating or have a positive serum pregnancy test * women of childbearing potential not using reliable contraceptive methods * concurrent participation in another clinical study * previous exposure to cobitolimod

Keywords: colitis, ulcerative gastrointestinal diseases inflammatory bowel disease immunomodulator therapy glucocorticoids anti-inflammatory agents therapeutic uses kappaproct idx0150 dims0150