Kornimate/medical-research-clean huggingface dataset:
the value of botox-a for management of low anterior resection syndrome

Conditions: Low Anterior Resection Syndrome; Rectal Cancer

Summary: low anterior resection syndrome (lars) is frequent after treatment for low rectal cancer. increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases. one possible physiopathology hypothesis suggests an ongoing spastic process; different mechanisms have been postulated. these include alteration of normal anorectal sensation with loss of the recto-anal inhibitory reflex (rair), decreased rectal compliance and reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy or during surgery. current available treatments are often ineffective, highlighting the need for more successful management. botulinum toxin a (btx-a) is a neurotoxin inhibiting acetylcholine release at the neuromuscular junction. it is currently used for the treatment of various smooth muscle spastic diseases. the hypothesis of this study is that intra-rectal btx-a injections could represent a medical treatment alternative for lars. the goal of this study is to document the effects of intra-rectal btx-a injections on sphincter function and quality of life of patients with lars.

no more information desired

Eligibility criteria:
inclusion criteria: * age 18 years or older * aptitude to sign informed consent * diagnosis of low anterior resection syndrome (lars) : more than 12 months after sphincter-preserving surgery for treatment of locally advanced rectal cancer, mild to moderate underwear soiling, baseline wexner score ranging from 0-16 (moderate symptoms, and patient-reported imperious defecation or patient-reported incomplete stool evacuation * digital rectal exam (by surgeon) demonstrating satisfying anorectal tonus considering prior radical rectal surgery. * willingness to complete questionnaires and manometric studies before and after botox-a administration * prior failed medical treatment, at least one attempt (narcotics, loperamide, cholestyramine, fibers) exclusion criteria: * inability to sign informed consent * counter-indication to botox-a administration : allergy to botox-a or its ingredients (clostridium botulinum type a neurotoxin complex, human albumin and sodium chloride, allergy to other forms of botulinum toxin (dysport, xeomin or myobloc, myasthenia gravis, eaton-lambert syndrome, lateral amyotrophic sclerosis or any other neurological disease which might interfere with neuromuscular function * prior use of any form of botulinum toxin a, for any indication * infection at proposed botox-a injection site * personal or family history of bleeding diathesis * pregnancy or breastfeeding * severe incontinence (wexner score ≥ 17 or daily use of diapers) * patient taking anticoagulant. asa ( acetylsalicylic acid) allowed

Keywords: low anterior resection syndrome botulinum toxin a quality of life incontinence rectal cancer anorectal manometry
outcome of cardiac arrest patients following guidelines implementation over the years

Conditions: Cardiac Arrest

Summary: the study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. during this time period, the european resuscitation council (erc) and the european society of intensive care medicine (esicm) introduced three new guidelines for post-cardiac arrest management, each five years apart: the 2010, 2015, and 2021 guidelines.

this study is a retrospective multicenter cohort observational study (two centers involved: fondazione irccs ca' granda ospedale maggiore policlinico and fondazione irccs san gerardo dei tintori). all patients admitted to the intensive care units (icu) of the hospitals involved in the study from january 1, 2011, to may 30, 2024, following cardiac arrest of any etiology, who meet the inclusion and exclusion criteria, will be enrolled.

Eligibility criteria:
inclusion criteria: * patients resuscitated from cardiac arrest and admitted to intensive care unit * age ≥ 18 years * out-of-hospital and in-hospital cardiac arrest * cardiac arrest of any etiology exclusion criteria: * pediatric patients (\<18 years) * patients not admitted to one of the aforementioned intensive care units.

Keywords: out-of-hospital cardiac arrest in-hospital cardiac arrest guidelines implementation resuscitation
intravitreal aavcagscd59 for advanced dry age-related macular degeneration (amd) with geographic atrophy (ga)

Conditions: Dry Age-related Macular Degeneration; Geographic Atrophy; Gene Therapy; Intravitreal Injection

Summary: patients with advanced dry amd with ga meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose aavcagscd59 with a sham injection. all enrolled subjects will be followed for 24 months to evaluate reduction in ga growth and safety of intravitreal aavcagscd59.


Eligibility criteria:
inclusion criteria: 1. advanced dry amd with ga in the study eye 2. bcva in the study eye of 80 or less etdrs letters (snellen equivalent 20/25 or worse) 3. total cumulative ga lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the screening period. exclusion criteria: 1. ga secondary to non-amd etiologies in the study eye (i.e. myopia, inherited retinal diseases). 2. ga associated with the presence of an rpe rip. 3. ga contiguous with peripapillary atrophy. 4. active cnv secondary to wet amd in the study eye and currently receiving anti-vegf ocular treatment within the previous 18 months. 5. subretinal fibrosis in the macula from cnv both clinically and imaged on sd-oct in the macula. 6. previous macular laser photocoagulation (i.e. focal or grid laser for macular edema), photodynamic therapy (pdt), ocular/orbital radiation, laser to cnv, or subretinal surgery for cnv in the study eye. 7. history of conditions in the study eye which might alter visual acuity or interfere with study testing including proliferative diabetic retinopathy (pdr), clinically significant macular edema (csme), central retinal vein occlusion (crvo), hemi retinal vein occlusion (hrvo), macular branch retinal vein occlusion, and optic neuropathy. 8. active uncontrolled glaucoma with at least one of the following: iop\>30 mmhg despite maximum medical treatment with glaucoma medications, cup-to-disc ratio of \>0.9, visual field defects secondary to glaucoma that involve the macula, or optic atrophy from glaucoma. 9. active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis)
supplementation with conjugated linoleic acid (cla) as complementary therapy in the management of type 2 diabetes mellitus (women's diabetes study)

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine the role of cla as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobina1c (hba1c) in subjects with type 2 diabetes mellitus (t2dm).

the design is a double-blind, placebo-controlled, crossover study conducted at a single site. the primary variable is a change from baseline to week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobina1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * obese * postmenopausal * hba1c \>6.49 and \<14.1 exclusion criteria: * use of tobacco * substance abuse * impaired cognitive function * renal disease * abnormal liver function * gastrointestinal diseases * use of exogenous insulin * use of hormone replacement therapy currently or within past 6 months * pacemaker/defibrillator

Keywords: diabetes conjugated linoleic acid
family automated voice reorientation study

Conditions: Delirium; Cognitive Impairment; Health, Subjective; Sleep

Summary: this randomized clinical trial tests a cognitive reorientation intervention to prevent delirium in the intensive care unit using scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the icu environment to the patient (the family automated voice reorientation intervention, favor). the investigators hypothesize that providing ongoing orientation to the icu environment through recorded audio messages in a voice familiar to the patient will enable the patient to more accurately interpret the environment and reduce risk of delirium. increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.

this randomized clinical trial will test the effectiveness of a nonpharmacologic intervention to prevent delirium in the intensive care unit (icu), which affects as many as 80% of critically ill, mechanically ventilated adults.. the family automated voice reorientation (favor) intervention uses scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the icu environment to the patient; this ongoing orientation to the icu environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation and nighttime sleep, further reducing risk of delirium. the primary specific aim of the project is to test the effect of the favor intervention on delirium in critically ill, mechanically ventilated adults during hospitalization in the icu. secondary aims are to: (1) explore if the effect of favor on delirium is mediated by sleep, (2) explore if selected biobehavioral factors may potentially moderate the effects of favor on delirium, and (3) examine the effects of favor on short term (immediately after icu discharge) and long term (1 and 6 months after hospital discharge) outcomes, including cognitive function and patient-reported health status.

Eligibility criteria:
inclusion criteria: * mechanically ventilated patients * within 36 hours of icu admission * patient or legally authorized representative (lar) must be able to provide informed consent in english or spanish * a family member able to speak english or spanish must be available and willing to audio record scripted messages exclusion criteria: * dementia (because it complicates planned longitudinal cognitive assessments) * anticipation by the clinical provider of imminent patient death * medical contraindication to the intervention (for example, psychiatric history of auditory hallucinations, or profoundly deaf) * inability to speak either english or spanish

Keywords: intensive care unit critical care mechanical ventilation confusion polysomnography delirium adult
user satisfaction using the adi insulin pump

Conditions: Diabetes

Summary: approximately 250,000 people worldwide are currently being treated with an insulin pump. this number is growing dramatically as these devices become smaller and more user-friendly. insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events. the nilimedix adi insulin pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. a custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue. this type of device requires extensive user interaction and education in order to ensure its safety. this study was designed to test the independent home-use of the nilimedix adi insulin pump, and to evaluate user's satisfaction.


Eligibility criteria:
inclusion criteria: * male/female age 18 years and up. * subject is diagnosed as type 1 diabetes. * pump users for at least 6 months * hba1c: less than 8.5% * capable of reading pump screens in english. * subject understands the study procedure. * subject is willing to sign the informed consent form and comply with the study requirements. exclusion criteria: * major physical, motor, mental, behavioral, or psychiatric limitations. * subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months. * subject experienced an episode of ketoacidosis during the last 6 months, while using an insulin pump. * concurrent additional major illness. * subject objects to the study protocol. * physician objection * concurrent participation in other study.

Keywords: insulin delivery
blue light imaging (bli) for optical diagnosis of colorectal polyps

Conditions: Colonic Polyp

Summary: several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. the real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology or invasive carcinoma. thus, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment or left in place without resection, with an enormous cost-saving potential. recently, the american society of gastrointestinal endoscopy (asge) has set the preservation and incorporation of valuable endoscopic innovation (pivi) which defined accuracy threshold to be met, in order to consider a new technology ready to be incorporate into clinical practice. blue light imaging (bli) is a new chromoendoscopy technology integrated in the latest generation eluxeotm 7000 endoscopy platform (fujifilm co, tokyo, japan), based on the direct (i.e. not filtered) emission of blue light with short wavelength (410nm), that enhances visibility of both microvascular and superficial mucosal pattern. in a recent randomized trial bli was superior to high-definition white light (hdwl) in the real time characterization of subcentimetric and diminutive colonic polyps. nevertheless, in this study the paucity of diminutive rectosigmoid polyps analyzed does not allow to draw definite conclusions as the meeting of pivi thresholds are concerned. similarly, the low numbers of patients evaluated limited the per-patient analysis. therefore further studies adequately powered to this clinically end-point were advocated. additionally, when the study was performed a bli dedicated classification for optical diagnosis of colonic polyps was not available, whereas recently a specific classification (the bli adenoma serrated international classification-basic) has been developed and a specific training set has been settled. in the present study the investigators prospectively evaluate whether the use of bli-assisted optical characterization of diminutive polyps using basic classification by specifically trained endoscopists may met pivi thresholds and particularly if it allow the endoscopists to achieve \> 90% correct assignment of post-polypectomy surveillance intervals when combined with the histopathology assessment of polyps \>5 mm in size.


Eligibility criteria:
inclusion criteria: * consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the fobt based screening program or for crc primary prevention, in which at least one diminutive (\<5 mm) rectosigmoid polyp is detected. exclusion criteria: * patients with crc history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer * patients with inadequate bowel preparation * patients in which caecal intubation was not achieved or scheduled for partial examinations * polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
application of digital impression technology in children's dental trauma

Conditions: Dental Trauma

Summary: we will choose patients with tooth loosening caused by tooth trauma and requiring fix in the department of pediatric dentistry and emergency of stomatology hospital, zhejiang university school of medicine, from july 2022 to may 2025. these patients will be randomly divided into digital impression module (experimental group) and ordinary impression group (control group).the operation time, comfort index and efficacy index of the two groups were compared to investigate the advantages of digital impressions in the application of traumatic dental injuries in children.

1. information on medical history, physical examination, and ancillary tests were collected and recorded by the pediatric dentistry and emergency department to determine the inclusion subjects, and the grouping was determined according to a randomized controlled design. 2. in the experimental group, digital impressions + 3d printed models were used and fitted pads were made; in the control group, alginate impressions + plaster model infusion were used to make models and fitted pads were made. the included subjects were routinely examined intraorally before and after treatment. patients were instructed to wear the hinge pad for 24 hours and x-ray films were taken and intraoral examination was performed at 2 weeks and 4 weeks. 3. the observation indexes included： (1) operation time: operation time for the child's chair position, (2) comfort index: pain assessment of patients using visual analog scale, (3) efficacy indexes: a. tooth sensitivity, gingival margin irritation, and lip irritation were assessed using visual analog scale (vsa); b. fixation efficiency.

Eligibility criteria:
inclusion criteria: * age 6-12 years old ② loosening or dislocation of anterior teeth caused by trauma; ③ degree i, ii and iii of tooth mobility, excluding normal physiological mobility; ④ no jaw fracture, root fracture, avulsion injury and individual malocclusion; ⑤ children can cooperate with treatment and follow up on time exclusion criteria: ① children have clear systemic disease factors (various syndromes, hormone level disorders, metabolic diseases, etc.); ② patients with periodontal disease; ③ children or family members do not agree to participate in the study; ④ uncooperative or intolerable examination and treatment

Keywords: immature permanent teeth ；dental trauma；digital impressions
efficacy of combined microneedling with methotrexate in treatment of alopecia areata

Conditions: Alopecia Areata

Summary: alopecia areata (aa) is a common cause of non-cicatricial hair loss it is the second-most frequent non-scarring alopecia, after androgenic alopecia. the prevalence of the disease is 0.2% in the general population with higher prevelance in younger (21-40 years of age) patients but no significant difference in incidence between males and females. several treatment options such as corticosteroids, anthralin, topical minoxidil, immunotherapy, and systemic therapy are commonly used with varying response . unfortunately the traditional treatment options are frequently disappointing available treatments may induce regrowth but do not modify the disease course . methotrexate (mtx) is a folic acid analog that binds to the dihydrofolate reductase enzyme, blocking the formation of tetrahydrofolate and so inhibits purine and pyrimidine metabolism and consequently nucleic acid synthesis. it acts as an immunosuppressant used in the treatment of several skin diseases systemic mtx has been used in the treatment of aa, with satisfactory results. microneedling is a minimally invasive procedure that utilizes multiple fine needles to create micropunctures in the skin.the act of creating these two to four cell-wide puncture holes triggers neovascularization, release of growth factors, and stimulates the expression of wnt proteins. it has specifically been demonstrated to increase hair regrowth in alopecia via the release of platelet-derived growth factor, epidermal growth factors and activation of the hair bulge, all of which are triggered by the wound healing response .increased expression of wnt proteins, namely wnt3a and wnt10b, is also evident following microneedling. these particular proteins have been demonstrated to stimulate dermal papillae stem cells and hair growth.


Eligibility criteria:
inclusion criteria: - the study will include patients with alopecia areata exclusion criteria: * children below 18 years , pregnant and lactating women . * patients with chronic hepatic, hematological disorders or immunocompromised patients. * patient recieved any treatment for alopecia areata in the last 3 months before the study. * patients with extensive types (alopecia totalis, universalis and surface area \>50%).
cognitive behavioral factors and central sensitization in chronic shoulder pain

Conditions: Chronic Shoulder Pain

Summary: the objective of this study is to examine the relationship between symptoms of central sensitization (cs) and important cognitive behavioral and psychosocial factors in patients with chronic shoulder pain.

participants, both male and female, with chronic shoulder pain for at least 3 months will be included in the study. they will complete several questionnaires and a functional test. spearman's correlation will be used to analyze associations between symptoms of cs and pain behavior, functioning, pain, pain catastrophizing, kinesiophobia, and illness perceptions. additionally, a between-group analysis will be performed to compare patients with and without clinically relevant symptoms of cs.

Eligibility criteria:
inclusion criteria: (1)chronic unilateral shoulder pain (chronic pain will be defined as pain lasting for 3 or more months. also, pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months). exclusion criteria: 1. recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, fibromyalgia and/or polymyalgia rheumatic 2. shoulder pain considered to be originated from the cervical region, and other traumas, 3. neurological dysfunction (ie, multiple sclerosis or stroke), osteoporosis, haemophilia and/or cancer 4. shoulder surgery 5. participants with shoulder pain after post fracture 6. being pregnant or given birth in the preceding year 7. overconsumption of alcohol or any other recreational drug2 8. cognitive impairment 9. inability to provide informed consent and/or complete written questionnaires if participants use medication with a known influence on the central nervous system (eg, anti-epileptic and antidepressant, analgesics, and/or nsaid's), it should be stable in medication intake for at least 1 month prior to his/her participation to be included in this study (kuppers et al. 2017). patients are required to continue usual care at least 6 weeks prior to study participation to obtain a steady state.

Keywords: csi kinesiophobia central nervous system sensitization catastrophizing illness behavior