Kornimate/medical-research-clean huggingface dataset:
tyrosine kinase inhibitors and low intensity chemotherapy in ph+ all

Conditions: Lymphoblastic Leukemia, Acute

Summary: the use of imatinib in combination with chemotherapy is now considered as the gold standard for the treatment of ph+ all. the complete remission (cr) rate is 90% versus 20% to 40% with chemotherapy alone. the combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high cr rate of 80% to 90% in patient aged 55 years and over. 2. dasatinib is indicated as first line therapy in ph+ all. results from the ewallph-01 are supporting the use of dasatinib in combination with low-intensity chemotherapy. a new ewall-ph-02 study combining nilotinib in combination with low-intensity chemotherapy is currently initiated within the ewall centers. 3. the ewall-ph-01 trial is now closed after the recruitment of 71 patients. the activation of the ewall-ph-02 trial is expected for q1 2012. based on the recruitment of the ewall-ph-01 study it could be anticipated that 50 to 100 patients aged more than 55 years will be diagnosed during this 6 months period of time. in addition, all the ewall centers are not participating to the ewall-ph-02 study and thus these centers could be offered to treat patient following the ewall backbone in addition to imatinib. 4. a minimum data set will be defined in order to collect the data of the patients treated following the ewall-ph imatinib study. the main recommendation is to follow as close as possible the procedures of the ewall-ph-01 trial (mutation analysis, mrd follow-up) in order to have a comparable data set. this imatinib treated cohort of patients would be of particular importance in order to better define the potential benefit of using one tki compared to one other. from the end of the ewall-ph-01 study recruitment to the initiation of the ewall-ph-02 study, patients were treated following the common backbone schedule in combination with imatinib or others tki. patients not included in clinical trials for other reasons were also offered a treatment with the combination of tkis and backbone low-intensity chemotherapy. the goal of this observatory retrospective and prospective is to describe the efficacy and the tolerance of the combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy (ewall backbone) in patients with ph+ all aged 55 years and over.


Eligibility criteria:
inclusion criteria: 1. male or female patients ≥ 55 years 2. philadelphia chromosome or bcr-abl positive acute lymphoblastic leukaemia 3. not included in a prospective clinical trial 4. treatment with the combination of tyrosine kinase inhibitors and low dose chemotherapy as recommended by the ewall group (ewall backbone). exclusion criteria: 1. patients deceded and having previously refused data collection.
how well does the 30-second chair stand test predict rehabilitation needs in acutely admitted elderly patients

Conditions: Acute Disease

Summary: the aims are to identify predictive indicators of hospitalized elderly medical patients' need for rehabilitation and to validate (known group validity) the chair stand test

in the emergency department the assessment of acutely admitted elderly medical patients' need for rehabilitation is difficult as it has to been performed within 48 hours. is it possible to use the the chair stand test in combination with admission complaints and identified risk factors to predict the need for rehabilitation? an investigating of the chair stand test is needed, as its validity with hospitalized patients is undocumented.

Eligibility criteria:
inclusion criteria: * can speak and understand danish * can report personal data * within the first 48 hours of admission are able to sin on an ordinary chair exclusion criteria: * patients ordinarily unable to walk
monocentric retrospective observational study; analysis of gore excluder acs device using numerical simulation

Conditions: Vascular Diseases; Surgery

Summary: andated when the risk of rupture is low and interventional treatment is offered to patients at high risk of rupture. rupture risk is driven by aneurysm diameter and growth rate. aneurysms with diameter greater than 55 mm and/or growth rate greater than 1 cm per year are at high risk of rupture. open surgery and endovascular treatment are the two types of interventions. open repair consists in replacing the aneurysmal part of the aorta using a synthetic fabric prosthesis after the abdomen has been opened and the aorta clamped. this invasive procedure is associated with a 3-10% post-operative mortality. endovascular repair (evar) consists in excluding the aneurysm sac by inserting a self-expanding prosthesis (called stent-graft) through very small groin incisions, without abdominal opening nor aortic clamping. this minimally invasive procedure is associated with a significantly reduced post-operative mortality (around 1%) . however, hostile proximal neck anatomy including high angulation is associated with higher rates of type ia endoleak, reintervention and long-term mortality . for this reason, a conformable design of the excluder stent-graft has been engineered with initial satisfactory results in patients with highly angulated or short necks . however, these satisfactory results have been obtained in carefully selected patients from experienced centers and a tool demonstrating adequate apposition of the gore acs is lacking. study device description numerical simulation has been used successfully to predict stent-graft behavior during fevar . preliminary studies have also demonstrated to applicability of the technology to standard infrarenal devices , including in the setting of very tortuous anatomies9 . the potential of numerical simulation to predict stent-graft apposition of gore acs in highly angulated necks appears very promising to enhance patient selection.


Eligibility criteria:
inclusion criteria: the patient: 1. is age ≥18 at the time of inclusion. 2. underwent evar with acs gore excluder 3. aaa proximal neck angulation superior to 60 degrees 4. pre-op ct and post-operative/follow-up ct available exclusion criteria: 1. slice thickness of pre-op or post-op / follow-up ct superior to 2mm. 2. non-injected or poorly injected pre-operative ct-scan precluding technical feasibility of the aortic digital twin 3. absence of post-operative or follow-up ct-scan 4. patient refusal of his personal information/medical data to be used in the context of the study

Keywords: endoprosthesis numerical simulation proximal neck
dietary supplements for reduction of intestinal permeability levels

Conditions: Intestinal Permeability; Leaky Gut Syndrome; Zonulin

Summary: a randomised and controlled trial, in which the effect of a dietary supplement is evaluated for reduction of intestinal permeability levels of subjects with high levels of zonulin in feces

randomized clinical trial, with masking of the statistician and the evaluator, to assess the effect of a food supplement, composed of substances that promote intestinal mucosa repair, on the levels of zonulin in feces and consequently on intestinal permeability. a control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment. the main objective of this study is to determine if the use of a dietary supplement composed of glutamine, butyrate and lion's mane, among others, corrects the levels of zonulin in feces.

Eligibility criteria:
inclusion criteria: * subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml). exclusion criteria: * taking any type of antibiotic in the last month * taking prebiotics or probiotics products in the last month. * taking laxatives in the last month. * undergoing any medicinal treatment * pregnancy * subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.

Keywords: intestinal permeability leaky gut syndrome zonulin tight junctions
high dose influenza vaccine in nursing home - pilot study

Conditions: Influenza

Summary: the purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the u.s., compared to the standard-dose influenza vaccine.

influenza remains the most common preventable respiratory viral infection of older adults. older adults incur more than 90% of the disease burden, and those residing in nursing homes are the most affected subset given their immune senescence, multi-morbidity, and close living quarters. each year, the majority of influenza-related hospitalizations occur during the period with the greatest influenza activity. influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. the new high-dose influenza vaccine is considerably more immunogenic in older adults, and has recently been approved for use in individuals aged 65 years and older. no clinical data yet confirm whether the improved immunogenicity translates into added clinical benefit, such as further reduction in hospitalization or death. estimating the benefit of influenza vaccination among older adults in long-term care settings using randomized controlled trials requires extensive effort and is costly. instead, a pragmatic rct in a nursing home population has several advantages as a model for comparing therapeutic approaches. this clinical trial aims to test the feasibility of our protocol for a subsequent larger study. we aim to demonstrate that we can recruit and enroll facilities; randomly assign and coordinate vaccine delivery; collect data; conduct site audits for data validation; create outcomes using multiple data sources; and conduct analyses.

Eligibility criteria:
inclusion criteria: * long-term care facilities in one of the 122 cities that serve as center for disease control and prevention (cdc) surveillance sites exclusion criteria: * facilities already systematically administering hd vaccine to their residents * facilities for whom over half the residents are on medicare (short-stay) * facilities in which over half the residents are on medicare part a (snf) * facilities having fewer than 50 long-stay residents * hospital-based facilities * facilities with more than 20% of the population under age 65 * facilities with mandated (employment-dependent) seasonal influenza vaccination * facilities not submitting mds data

Keywords: randomized controlled trial influenza influenza vaccine flu vaccine fluzone hd fluzone nursing homes hospitalization mortality health care worker vaccination adl decline pilot effectiveness
long-term safety study of rapastinel as adjunctive therapy in patients with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: this study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (adt) in patients with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at screening * have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test. exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before screening * lifetime history of meeting dsm-5 criteria for: * schizophrenia spectrum or other psychotic disorder * bipolar or related disorder * major neurocognitive disorder * neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study * dissociative disorder * posttraumatic stress disorder * mdd with psychotic features * significant suicide risk, as judged by the investigator.
turkish version of the neurogenic bladder symptom score questionnaire: a cross-cultural adaptation, reliability and validity study

Conditions: Spinal Cord Injuries

Summary: turkish version of the neurogenic bladder symptom score questionnaire: a cross-cultural adaptation, reliability and validity study

turkish version of the neurogenic bladder symptom score questionnaire: a cross-cultural adaptation, reliability and validity study in spinal cord patients.

Eligibility criteria:
inclusion criteria: * spinal cord injury patients * aged \> 18 years old exclusion criteria: * spinal shock patients * urinary tract operation in the last month * quality of life changes in the last month * urinary tract infections in the last month * bladder management changes or drug changes in the last month

Keywords: neurogenic bladder quality of life spinal cord injury
the relationship between vitamin d levels, inflammatory parameters and disease severity of covid-19 infection

Conditions: Vitamin D Deficiency; Covid19

Summary: vitamin d deficiency increases the susceptibility to respiratory virus infections and the severity of infections. inflammation plays a key role in pathogenesis in covid19 while identifying clinical course and prognosis covid19.the aim of this study was to determine the relationship between 25oh vitamin d levels, inflammatory laboratory parameters of neutrophil to lymphocyte ratio (nlr), platelet to lymphocyte ratio (plr), c-reactive protein (crp) levels and disease severity of covid19 infection.

in this retrospective study 300 patients diagnosed with covid19 were included. according to clinical classification of cases with covid19 the patients were divided into three groups; mild (group1), moderate (group2) and severe/critical (group3). the 25oh vitamin d values below 20 ng/ml were defined as deficiency, 21-29 ng/ml were defined as insufficiency, and 30 ng/ml and above were defined as normal. patients' age, gender, comorbid diseases and laboratory values were recorded

Eligibility criteria:
inclusion criteria: * the study included 300 polymerase chain reaction (pcr) test positive patients and whose 25-oh vitamin d levels were measured in the last 6 months exclusion criteria: * patients with covid-19 whose 25-oh vitamin d levels were not measured in the last 6 months before the covid-19 diagnosis were excluded from the study

Keywords: covid-19 vitamin d disease severity inflammatory markers
a study to evaluate the effect of renal impairment on jnj-42847922 in adult participants

Conditions: Renal Impairment

Summary: the purpose of this study is to evaluate the pharmacokinetic of a single oral dose of jnj-42847922 in adult participants with renal impairment compared with healthy participants with normal renal function.


Eligibility criteria:
inclusion criteria: * body mass index (bmi; weight \[kilogram {kg}\]/height \[meter {m}\]\^2) between 18 and 40 kilograms per meter square (kg/m\^2) (inclusive) with a body weight not less than 50 kg * all female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (hcg) pregnancy test at screening and a negative urine pregnancy test on day 1 * must not donate blood for up to 3 months after study * participants with normal renal function (group 1) must meet the following additional inclusion criteria to be enrolled in the study: must have normal renal function defined as: estimated glomerular filtration rate (egfr) greater than or equal to (\>=) 90 milliliter (ml)/minute (min) at screening * participants with moderate (optional group 3) or severe (group 2) renal impairment must meet the following additional inclusion criteria to be enrolled in the study: must have a egfr of less than (\ = 30 to 59 ml/min); severe renal impairment (egfr \>= 15 to 29 ml/min) * participants with moderate (optional group 3) or severe (group 2) renal impairment must meet the following additional inclusion criteria to be enrolled in the study: must have stable renal function, that is, no significant change in renal function as evidenced by the (mean) screening serum creatinine value within plus minus (+ -) 25 percent (%) from the determination obtained at least 3 months prior to screening, and expected to remain stable during the study, and not planning to initiate dialysis exclusion criteria: * participants who: are on a vegetarian diet or who take creatine supplements, have a non-standard muscle mass, such as, amputation, malnutrition, or muscle wasting, because these factors are not accounted for in the prediction equations for glomerular filtration rate (gfr) * donated blood or blood products or had substantial loss of blood (more than 500 ml) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study * received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before study drug is scheduled * unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug) * participants with renal impairment (cohort 2 and cohort 3) have kidney failure, requiring dialysis
evalecgcardio study

Conditions: Cardiac Arrhythmia

Summary: ecgs are routinely performed in cardiology. recently handheld ecgs have shown promise in screening for heart rhythm disorders. these are quick to perform and do not require the preparation that is needed for 12 lead ecgs. we wanted to test whether a novel handheld ecg recorder, kardia 6l, which has the potential to record a 6 lead ecg is able to screen for ecg abnormalities, thereby obviating the need for a full 12 lead ecg. this may allow for earlier diagnosis and treatment.

the aim of analysis is to determine if the handheld 6 lead ecg can be used as a simple screener to identify patients who do not need a 12 lead ecg.

Eligibility criteria:
inclusion criteria: * anyone attending cardiology outpatients or the ward who has had a recent ecg (within 6 hours) exclusion criteria: * patients who do not consent to the study
point of care rapid sti test optimization and validation extension

Conditions: Chlamydia Trachomatis Genital Infection; Gonorrhea; Trichomoniasis

Summary: the purpose of this sub-study (prove) is to support and facilitate the validation of commercially available point of care (poc) sexually transmitted infection (sti) diagnostic test kits/devices for potential on-site laboratory use as well as bedside use in parallel to gold standard established testing methodologies. a further extension of bedside testing would include self-testing.

screening and enrolment procedures for the arise study (hrec ref no. 210614) involves adolescent girls and young women (agyw) being screened for neisseria gonorrhoea (ng), chlamydia trachomatis (ct), and trichomonas vaginalis (tv) as determined through testing of clinician-collected genital swabs followed by genexpert, osom rapid tv testing or through wet mount visualisation of the micro-organisms of interest. this will generate a pool of agyw with known sti diagnoses who, if positive, will be treated on-site on the day of sti detection. it will also create an ideal opportunity to leverage access to samples from willing participants (prior to sti treatment if sti positive) for validation of a range of alternate sti test kits. samples provided will enable same-day parallel testing on additional platforms for validation of the sensitivity and specificity of these alternate tests against the known validated platformsthis initiative will expand the menu of cost effective and user friendly sti test kits that may ultimately be used in other research studies, in public clinic settings and as self-tests performed discretely in the convenience and privacy of one's home.

Eligibility criteria:
inclusion criteria: participants must meet the following criteria to be eligible for inclusion in the study: * cisgender adolescent girls and young women (18-25 years of age, inclusive), screened for or enrolled in the arise study. * willing to provide written informed consent to participate in this sub-study. * willing to provide additional samples including vaginal and endocervical swabs, urine and those collected through the use of tampons and disposable menstrual cups. exclusion criteria: * cisgender male or transgender woman or transgender man * age \<18 years * unable or unwilling to provide written informed consent * have any condition that in the opinion of the investigators will interfere with successful completion of sub-study procedures
impact of fascia iliaca block in hip fracture patients

Conditions: Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)

Summary: the study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures.

regional anesthesia is an important element of multimodal pain control regimen for surgical patients. recently, regional anesthesia using a fascia iliaca block (fib) to help treat pain in patients who present with hip fractures has been gaining popularity and has been incorporated as part of a multi-modal pain control protocol in many centers. it is commonly offered in addition to oral and intravenous medications to help patients deal with pain in the perioperative period. the block is done by an anesthesiologist under anesthesia using ultrasound guidance. we propose a prospective, randomized study evaluating the efficacy of the fib as an adjunct in the pre-operative or postoperative period for pain control as measured by visual analog scale (vas) scores and morphine equivalent dosing (med), as well as its efficacy in promoting patient participation in physical therapy postoperatively in patients who present with hip fractures. we hypothesize that those patients who receive fibs will report lower vas scores as well as decreased narcotic requirement at all time points; and have improved participation in therapy when measured by ambulation distance.

Eligibility criteria:
inclusion criteria: * patients with femoral neck and intertrochanteric hip fractures * at least 18 years of age * require operative management exclusion criteria: * poly-trauma patients * pathologic fractures * patient who required revision procedures * patients with chronic opioid use * patients with a clinical status that precludes verbal pain assessment such as dementia, head injuries, and unwillingness to participate.
aspirin resistance following coronary bypass surgery

Conditions: Ischemic Heart Disease

Summary: aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. it appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.


Eligibility criteria:
inclusion criteria: * patients undergoing coronary artery bypass surgery * patients who signed informed consent form exclusion criteria: * concomitant valve surgery or carotid surgery or off-pump surgery * need for anticoagulation therapy for any reason * another antiplatelet medications at least 7 days prior to surgery * contra-indication for aspirin treatment * thrombocytopenia / thrombocytopathia * nsaids treatment for chronic medical conditions * reluctance to participate in the study

Keywords: aspirin treatment aspirin resistance coronary bypass surgery