Kornimate/medical-research-clean huggingface dataset:
medico-economic evaluation comparing intensity-modulated radiation therapy (imrt) performed by helical tomotherapy and dynamic arc therapy in prostate, cervical and anal canal cancers

Conditions: Prostate Cancer; Cervical Cancer; Anal Canal Cancers

Summary: the aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of intensity-modulated radiation therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical tomotherapy and dynamic arc therapy using two different technologies: rapidarc or vmat.


Eligibility criteria:
inclusion criteria: * who performance index ≤ 2 * age \> 18 years * histologically proven carcinoma: anal canal cancer locally advanced (\> 4 cm and / or n1 to n3) under irradiation on pelvic and inguinal lymph nodes with concurrent chemotherapy. the boost with brachytherapy are accepted prostate cancer with pelvic lymph nodes and radiation or hormone therapy cervical cancer under a purely medical treatment involving irradiation on pelvic lymph nodes and primary tumor with concurrent chemotherapy without surgery. the boost by external radiotherapy or brachytherapy are accepted. * the investigator must ensure that the patient has not expressed its opposition to participate in this study. the signing of a consent form is optional; exclusion criteria: * history of invasive cancer other than basal cell carcinomas. * indication of re-irradiation * para-aortic radiotherapy associated with pelvic irradiation. * post-operative radiotherapy. * geographical distance

Keywords: prostate, cervical and anal canal cancers with pelvic lymph node irradiation
respiratory mechanics and gas exchange in patients with covid-19 and hypoxemic acute respiratory failure

Conditions: SARS Pneumonia

Summary: data on respiratory mechanics and gas exchange in acute respiratory failure in covid-19 patients is limited. knowledge of respiratory mechanics and gas exchange in covid-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. the objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in covid-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.

in december 2019, an outbreak of a novel coronavirus (sars-cov-2) emerged in wuhan, china and rapidly spread worldwide. the world health organization (who) declared the outbreak a pandemic on march 11th, 2020. the clinical disease (covid-19) results in critical illness in about 5% of patients with predominant acute respiratory failure. the goal of the study is the evaluation of the respiratory mechanics (peak inspiratory pressure (pip), plateau pressure (pplat), static compliance (cstat), driving pressure (dp) at different positive end-expiratory pressure (peep) levels and different tidal volumes (vt) (6-8 ml/kg ideal body weight), lung recruitability (by change of dp and oxygenation) and gas exchange (pao2/fio2 ratio and alveolar dead space) in covid-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive for selection of safe and effective peep level, vt, respiratory rate (rr) and inspiratory oxygen fraction (fio2) during the whole course of mechanical ventilation - invasive or non-invasive. this study is multicentral observational trial in 3 university clinics.

Eligibility criteria:
inclusion criteria: * all patients with covid-19 and acute respiratory failure on invasive and noninvasive ventilation exclusion criteria: * patients who reached the following goals at conventional oxygen therapy (oxygen flow \ 93%, no visible work of auxiliary respiratory muscles, no fatigue, stable hemodynamics (no need in any catecholamines and/or life-threatening heart rhythm abnormalities), * less than 24 ours in intensive care unit (icu) by any reason, * lung emphysema, * primary lung diseases (chronic obstructive lung disease-copd, interstitial lung diseases, etc) or tumour metastases in lungs, * chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure), * atonic coma.

Keywords: sars pneumonia ards covid-19 compliance recruitability
cardiometabolic effects of sweet cherry juice

Conditions: Obesity; Metabolic Syndrome

Summary: this study aims to determine the effects of consuming sweet cherry juice on cardiovascular function, glucose regulation, and lipid status in overweight human subjects. the investigators hypothesize that sweet cherry juice consumption will improve metabolic and physiological status in overweight persons compared to a placebo.

the investigators will conduct a randomized, cross-over study lasting 14 weeks and including 1 week for screening/enrollment, 1 week baseline assessment, and two intervention periods of 6 weeks each for the cherry juice and placebo interventions. two test visits, 3 to 7 days apart, will occur before the start of intervention (baseline, or week 0) and then at weeks 6 and 12. participants will be randomized to consume either the cherry juice or placebo beverage first, and will cross over to the alternate intervention immediately following the end of the first 6 weeks. test visit 1 will include measures of blood pressure, vascular tone, liver fat and stiffness, post-prandial metabolic response to the study beverage, cardiovascular activity and function, and nervous system control of cardiovascular activity and tone. acute effects of study beverages will be measured, as will the chronic effects of study beverage consumption after 6 weeks. at test visit 2, participants will take a standard 75 gram oral glucose tolerance test (ogtt). participants will be equipped with physiological monitoring devices, which will monitor cardiovascular activity and function and nervous system control of cardiovascular activity and tone, and continuously measure blood pressure. a series of cognitive function tasks will be administered, and a mental stress test will be conducted. the test visit 1 and 2 will be repeated at week 6 and week 12 following each intervention with cherry juice or the placebo beverage.

Eligibility criteria:
inclusion criteria: * men aged 20 - 65 years * post-menopausal women aged 45 - 65 years * body mass index ≥25 and \<40 kg/m2 * systolic blood pressure \>120 and \ 80 and \<90 mmhg exclusion criteria: * diagnosed metabolic disorder * diabetes mellitus * thyroid disease * cardiovascular disease * poly-cystic ovary syndrome * vasoconstrictive diseases (e.g. raynaud's phenomenon or raynaud's disease) * digestive disorder (e.g. crohn's, irritable bowel syndrome, colitis) * history of gastrointestinal surgery affecting digestion and/or absorption * use of medications for hypertension, hyperlipidemia, glycemic control, or weight loss * use of medications such as steroids, statins, or non-steroidal anti-inflammatory agents * routine use of over-the-counter medications * weight change \>5% in the past 6 months * performing exercise greater than 60 minutes/day * presence of a pacemaker or other internal electronic device controlling rhythm or pacing of heart excludes participant from mindware procedure * presence of atrial fibrillation or other arrhythmia excludes participant from mindware procedure

Keywords: cherries inflammatory disease chronic stress
a research study to see how much cagrisema lowers blood sugar and body weight compared to placebo in people with type 2 diabetes treated with once-daily basal insulin with or without metformin

Conditions: Type 2 Diabetes

Summary: this study will look at how much cagrisema helps people with type 2 diabetes lower their blood sugar and body weight. cagrisema is a new investigational medicine. doctors may not yet prescribe cagrisema. cagrisema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. participant will get either cagrisema or "dummy" medicine and which treatment they get is decided by chance. participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). for each participant, the study will last for about one year.


Eligibility criteria:
inclusion criteria: * male or female (sex at birth). * age 18 years or above at the time of signing the informed consent. * diagnosed with type 2 diabetes mellitus ≥180 days before screening. * on stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (u/kg/day) or 20 u/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening. * glycated haemoglobin (hba1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * body mass index (bmi) greater than or equal to 25 kilogram per square meter (kg/m\^2) at screening. bmi will be calculated in the electronic case report form (ecrf) based on height and body weight at screening. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * renal impairment with estimated glomerular filtration rate (egfr) less than 30 milliliters per minute per 1.73 square meter (ml/min/1.73 m\^2) as determined by central laboratory at screening. * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * known hypoglycaemia unawareness as indicated by the investigator according to clarke's questionnaire question 8. * recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
risk factors for quinolone resistance among esbl producing klebsiella species

Conditions: Quinolone Resistance; ESBL; Klebsiella Species; Infection

Summary: this is a retrospective chart review. this proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of klebsiella species. additionally, the adequacy of empiric antibiotic therapy for klebsiella bloodstream infections will be assessed.

this is a retrospective chart review. this proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of klebsiella species. additionally, the adequacy of empiric antibiotic therapy for klebsiella bloodstream infections will be assessed. this research is (c) important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. additionally, we will identify whether horizontal spread is responsible for this increasing trend.

Eligibility criteria:
inclusion criteria: * must be quinolone resistant among esbl producing klebsiella species exclusion criteria: * those not meeting entry criteria

Keywords: quinolone resistance esbl klebsiella species infection
effects of gait retraining with auditory feedback

Conditions: Ankle Injuries; Ankle Inversion Sprain

Summary: there is evidence to support individuals with chronic ankle instability (cai) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. currently, there are no interventions specifically targeting these abnormal gait biomechanics. evidence supports the use of an external focus of attention feedback to promote motor learning and retention. the overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.


Eligibility criteria:
inclusion criteria: * history of at least one ankle sprain * index ankle sprain \> 12 months prior to study enrollment * most recent ankle sprain \> 12 weeks prior to study enrollment * score \>10 on the identification of functional ankle instability (idfai) survey. * score \<95% on the foot and ankle ability measure (faam) activities of daily living and a \<85% on the sport subscales * be physically active by participating in some form of physical activity for at least 20 min per day, three times per week. exclusion criteria: * history of ankle surgery * history of other musculoskeletal injuries within the past 6 weeks * any condition affecting plantar pressure distribution * neurological or vestibular disorders affecting balance * current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
effect of evolocumab on carotid plaque composition in asymptomatic carotid artery stenosis (evocar-1)

Conditions: Carotid Artery Stenosis

Summary: this is a phase iv, randomised, placebo-controlled, double-blind, parallel group study to determine the effect of evolocumab treatment on carotid plaque morphology and composition in asymptomatic patients with \>50% carotid artery stenosis.

in this study patients will be randomised in a 1:1 ratio to receive evolocumab 140 mg every two weeks or matching placebo, to be administered for 12 months. after 12 months of treatment, patients will remain in follow-up for a further 12 months. high resolution magnetic resonance imaging (mri) will be used to serially monitor the impact of evolocumab on carotid plaque morphology and composition in patients with significant carotid stenosis who do not meet clinical criteria for carotid endarterectomy. this approach will reveal if clinically beneficial plaque regression occurs, without requiring the large patient cohorts or long follow-up needed for cardiovascular outcome trials. results from this study will establish whether treatment with evolocumab is likely to be beneficial to patients with asymptomatic carotid stenosis.

Eligibility criteria:
inclusion criteria: * age ≥18 years * sufficient english language ability to adequately understand the study * able to give informed consent * significant carotid artery plaque with 50-70% stenosis on ultrasound or mri performed prior to screening * significant asymptomatic carotid artery plaque with \>70% stenosis on ultrasound or mri performed prior to screening, but carotid endarterectomy or carotid artery stenting has been deemed unsuitable by multidisciplinary team during routine clinical care * lipid-rich necrotic core (lrnc) on baseline mri scan * adequate image quality for mri analysis. * ldl-c ≥2.6 mmol/l (100 mg/dl) * on stable dose of maximally-tolerated lipid-lowering therapy in accordance with uk national clinical guidelines (nice cg18120) for ≥2 months prior to screening. acceptable non-statin lipid-lowering medications include ezetimibe or a fibrate. exclusion criteria: * any medical condition which, in the opinion of the investigators, would present an unacceptable risk to the participant if they were to take part in the trial, or prevent them from following the trial protocol * current or previous treatment with a pcsk9 inhibitor * eligible for pcsk9 inhibitor treatment under current nice guidelines * contra-indication to or inability to use evolocumab treatment, including: * sensitivity to evolocumab or any associated excipients * unable to tolerate or perform self-administration of evolocumab by auto-injector * lack of suitable refrigerated storage * contra-indication to or inability to tolerate mri * estimated glomerular filtration rate (egfr) ≤45 ml/min/1.73 m2 prior to mri scan * pregnancy or breast-feeding * women of childbearing potential who are unwilling or unable to use a highly effective method of contraception

Keywords: carotid plaque morphology carotid plaque composition evolocumab
hybrid approach to unilateral vs. bilateral upper limb rehabilitation in subacute and chronic stroke

Conditions: Cerebrovascular Accident

Summary: in the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate clinical trials: one to recruit subacute stroke patients and another to recruit chronic stroke patients. the two trials will have identical study designs and interventions. the overall goal of this research project is to provide scientific evidence of the treatment effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients and thus to contribute to evidence-based stroke rehabilitation and translational research for neurorehabilitation.

the first aim of the project will be to compare treatment effects between hybrid rehabilitation and conventional rehabilitations (cr) on motor function, daily functions, mobility, quality of life, and kinematic variables. we hypothesize that patients receiving hybrid rehabilitation will gain more recovery than patients receiving cr in proximal (e.g., motor function) and in distal outcomes (e.g., quality of life) and that patients in the hybrid rehabilitation groups will show more genuine upper extremity motor recovery than those in conventional rehabilitation groups, as indicated by kinematic measures. the second aim will be to examine the comparative treatment effects between unilateral hybrid and bilateral hybrid rehabilitation on various aspects of outcomes. we hypothesize that the unilateral group will improve more on outcomes associated with distal upper limb (ul) control and that the bilateral rehabilitation group will improve more on outcomes associated with proximal ul control. third, we will collect biomarker indexes before and after the interventions to monitor the changes of oxidative stress and inflammatory levels.

Eligibility criteria:
inclusion criteria: * 1 to 6 months onset from a first-ever unilateral stroke for the subacute randomized controlled trial (rct), and more then 6 months after onset for the chronic rct * minimal motor criteria to receive cit (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits) * an initial fma-ue score of 18 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment * no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers) * able to follow instructions and perform the study tasks (mini mental state examination ≥ 24) * without upper extremity fracture within 3 months * no participation in any rehabilitation experiments or drug studies during the study period * willing to provide written informed consent exclusion criteria: * acute inflammatory disease * major health problems or poor physical condition that might limit participation

Keywords: comparative efficacy research combination therapy neurorehabilitation robotic rehabilitation restraint therapy
a study to determine if mesh placement during bladder surgery can reduce the chances of developing a hernia

Conditions: Radical Cystectomy

Summary: the purpose of this study is to compare any good and bad effects of using ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.


Eligibility criteria:
inclusion criteria: * patients undergoing rc and ic formation in an elective setting,for cancer. exclusion criteria: * expected survival \< 12 months * salvage rc * distant metastatic disease

Keywords: mesh placement radical cystectomy 16-1285
relationship between trunk control and hand function and quality of life

Conditions: Cerebral Palsy; Quality of Life; Hand

Summary: increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. trunk control is important for these parameters in children with hemiparetic and diparetic cerebral palsy.

trunk control, hanf function and quality of life measurements were carried out by a physiotherapist using the trunk control measurement scale, 9-hole peg test and pediatric quality of life inventory. participants were informed about the procedure of the tests. the evaluation period lasted 30-40 minutes for each child.

Eligibility criteria:
inclusion criteria: * being between the ages of 5-18, * having a diagnosis of hemiparetic or diparetic cp, * to be at the level of i-ii-iii according to the gross motor function classification system, * not having had orthopedic surgery on the upper extremity in the last 6 months, * not having been injected with botulinum toxin-a in the last 6 months, * accepting the study and signing the consent form. exclusion criteria: * children who could not understand and follow simple verbal commands, * did not meet the inclusion criteria, * incomplete assessments.

Keywords: cerebral palsy trunk control hand function quality of life
effect of prophylactic tmr and rpni on neuroma and phantom limb pain

Conditions: Amputation; Neuroma Amputation; Phantom Limb Pain; Residual Limbs

Summary: the purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically targeted muscle reinnervation and regenerative peripheral nerve interface) on post-amputation pain and functional outcomes at the time of amputation. these novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

the investigators plan a randomized control trial of all eligible patients undergoing major limb amputation at parkland memorial hospital. eligible patients undergoing an amputation will be consented for all possible interventions and randomized to either receive targeted muscle re-innervation (tmr), regenerative peripheral nerve interface (rpni), or standard post-amputation surgical care at the time of their operation. key pre-operative data including patient sex, age, bmi, past medical history, past surgical history, medications, allergies, social history, social support systems, exposure to narcotic medication, and reason for amputation will be analyzed. intra-operatively, patients randomized to the treatment arm will receive tmr or rpni and the transected nerve ends addressed will be recorded. post-operative data that will be recorded include hospital stay, complications related to the procedure, complications leading to reoperation, functional results, need for pain medication, incidence of phantom limb pain, incidence of painful neuromas, length of follow-up, and all adverse events/complications. analyses will be conducted using data obtained from patient medical records from the parkland health \& hospital system.

Eligibility criteria:
inclusion criteria: * patients ≥18 years old * patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) as a primary or secondary sequela of trauma. * patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for primary or secondary sequelae of malignancy. * secondary sequalae include but is not limited to metastatic disease and osteolytic disease. * patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for vasculitic diseases. exclusion criteria: * patients less than 18 years old * patients with cognitive impairment * patients who are imprisoned at the time of randomization * patients currently enrolled in other studies relating to neuropathic pain * patients actively undergoing radiation therapy * patients with existing neuroma or underwent prior neuroma surgery * patients with amputations scheduled congenital reasons

Keywords: targeted muscle re-innervation regenerative peripheral nerve interface tmr rpni