Kornimate/medical-research-clean huggingface dataset:
innovative approach to detect recurrent colorectal lesions with surveillance via mutation analysis & clinical phenotype

Conditions: Predictive Cancer Model

Summary: it is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a correlation between mutation in exon 7 of the tp53 gene and risk of early metachronous lesions development. the results also indicate that mutation phenotype (mutation profile and burden) of all lesions detected on index colonoscopy can determine risk of metachronous lesions. as not all synchronous lesions were analyzed and the surveillance colonoscopy interval was less than 3 years, this assumption could not be confirmed. in this study it is planned to perform mutation analysis of all synchronous lesions in 200 patients and correlate the data with appearance of metachronous lesions after 1, 3 and 5 years. moreover, the mutation profile of all metachronous lesions developed during the 5 years of surveillance will be determinated and compared with mutation profile of index lesions from the same localization to verify their common biological origin. this all could help personalize the surveillance program in terms of reduction of the burden on the patient and endoscopic workplaces and risk of developing colorectal cancer in a particular patient.

the aim of this prospective study is to identify patients with recurrent colorectal lesions risk and try to design an optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype. the partial goals are: 1. determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established pcr/dce-based heteroduplex method. 2. clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period. 3. correlation of clinical and histopathological parameters with mutational phenotype of patient. 4. correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period. 5. comparison of the mutation profile of lesions from the index period withthe mutation profile of metachronous lesions. 6. analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.

Eligibility criteria:
inclusion criteria: * colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (epe, emr, esd) * signed informed consent with the study and with colonoscopy exclusion criteria: * fap, hnpcc and other hereditary crc syndromes probands * colonoscopy contraindication * severe acute inflammatory bowel disease * severe comorbidities; likely non-compliance of the patient

Keywords: phenotype surveillance colonoscopy colorectal neoplasia genetic mutation metachronous lesions
nintedanib in volunteers with hepatic impairment compared with healthy volunteers

Conditions: Hepatic Insufficiency

Summary: the primary objective of this study is to investigate the effect of mild (child-pugh a, score 5-6) and moderate (child-pugh b, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.


Eligibility criteria:
inclusion criteria: healthy subjects: * male or female subject, healthy according to the investigator's judgement based on a complete medical history, including a physical examination, vital signs (bp, pr), 12-lead ecg, and clinical laboratory * age of 18 to 79 years at screening visit hepatically impaired patients as determined by a hepatologist/ gastroenterologist: * a documented diagnosis of the impaired hepatic function, determined by hepatologist/gastroenterologist/specialist for internal medicine, must be available in the patient´s source data. * male or female chronic hepatically impaired patient as determined by screening results and classified as child-pugh a (child-pugh score of 5-6 points) or as child-pugh b (child-pugh score of 7-9 points). hepatic insufficiency must be diagnosed at least 3 months before screening. * age of 18 to 79 years at screening visit exclusion criteria: healthy subjects: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and judged as clinically relevant by the investigator * any laboratory value outside the reference range at screening visit that the investigator considers to be of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders judged as clinically relevant by the investigator * surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication based on the investigator´s judgment * women who are breast feeding or of child-bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 3 month after administration of trial medication. hepatically impaired patients as determined by a hepatologist/gastroenterologist: * medical disorder, condition or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator or the sponsor * patients with significant diseases other than underlying diagnose of hepatic impairment and concomitant diseases related to it. a significant disease is defined as a disease which in the opinion of the investigator: * put the patient at risk because of participation in the study * may influence the results of the study * is not in a stable condition * surgery of the gastrointestinal tract that could interfere with the kinetics of the trial medication based on the investigator´s judgment * women who are breast feeding or of child-bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 3 month after administration of trial medication
probiotics for the prevention of antibiotic-associated diarrhea

Conditions: Acute Diarrhea

Summary: in north america, one of the most common reasons for hospitalization in previously healthy children is for the treatment of infections with antibiotics. this study will determine if, in previously healthy children hospitalized and prescribed intravenous (iv) antibiotics, the co-administration of a probiotic milk product containing good bacteria, is safe and effective for reducing aad, as compared to a placebo (identical appearing milk product). this will be a two-center, randomized, masked, placebo-controlled clinical trial. the results of this study will help inform clinicians and families on the use of probiotics in the prevention of aad, a common side effect of antibiotic use among hospitalized children.

a two-centred randomized, multi-blind (i.e. patients, caregivers, data collectors, outcome assessors, data managers and analysts), placebo-controlled clinical trial intended to evaluate the efficacy and safety of bio-k+ (lactobacillus acidophilus cl1285, lactobacillus casei lbc80r and lactobacillus rhamnosus clr2) in the prevention of aad in hospitalized children 1 year to 17 years of age administered iv antibiotics.

Eligibility criteria:
inclusion criteria: 1. participants will be children aged 1 year to 17 years admitted to the general pediatric inpatient unit at the hospital for sick children (site 1) or mcmaster children's hospital (site 2). 2. participants will be prescribed iv antibiotics with a planned duration of 1 or more days, and a total course of both iv and oral antibiotics, if applicable, of no more than 28 days. 3. parent (if parent-report) or patient (if patient-report) is able to communicate in english (read, write, speak). exclusion criteria: 1. parental or patient (e.g. child \> 12 years old) report of current diarrhea, diarrhea within the last week. 2. lactose intolerance. 3. allergies to strawberry, dried citrus pulp, or any other components of the study product. 4. immuno-compromised patients or those on immunosuppressive agents (e.g. heart or kidney transplant, complex care, sickle cell disease, chemotherapy agents, oral prednisone). 5. patients with known or potentially compromised gut integrity (e.g. short gut, inflammatory bowel disease, celiac disease, irritable bowel syndrome, nasogastric, nasojejunal or gastrostomy tube). 6. children with serious and/or unstable medical conditions (e.g. diabetes, cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.). 7. children admitted to a medical or surgical subspecialty unit. 8. patients enrolled in another study. 9. patients previously randomized to this study. 10. patient is pregnant.

Keywords: probiotics, diarrhea, antibiotic, children, hospital
computer-guided versus conventional eminectomy

Conditions: TMJ - Dislocation of Temporomandibular Joint

Summary: temporomandibular joint (tmj) dislocation represents a non-self-limiting condylar hypermobility due to its displacement from the glenoid fossa, most commonly in an anteromedial non-functional positional stuck. the pathogenesis of (tmj) dislocation is multifactorial, as the topography of the bony eminence, ligamentous and capsular laxity, muscular hyperaction or discoordination, as well as the presence of occlusal disturbance, would all contribute to its incidence, with a typical presentation of pain, open mouth, and masticatory muscle spasms

the surgical treatment modalities of the recurrent anteromedial condylar dislocation are directed to ligamentous, musculature, and bony alteration. since it was first described by myrhaug in 1951, eminectomy has been recognized as the gold standard and the salvage surgical intervention for the management of recurrent condylar dislocation by the unrestricted free posterior translation of the mandibular condyle after the elimination of the bony interference by the excision of the obstructing eminence. however, the procedure carries out the potential risks of dislocation recurrence as the attention is usually directed to the excision of the lateral aspect of the bony eminence rather than its anteromedial extension and the anterior portion of the glenoid fossa or the invasion of the middle cranial fossa as a result of excessive unplanned bone removal, fracture propagation due to improper surgical technique, or eminence pneumatization the current study designates a randomized controlled clinical trial that compares an eminectomy-based computer-guided digital workflow versus a free-hand conventional eminectomy for the treatment of patients with bilateral recurrent (tmj) dislocation concerning the recurrence rate as a primary outcome and the maximum interincisal opening (mio) as a secondary outcome, stating a null hypothesis that the digital workflow is indifferent to the conventional technique regarding recurrence rate and (mio). furthermore, the study assesses the accuracy of the innovative digital workflow within the computer-based eminectomy group.

Eligibility criteria:
inclusion criteria: 1. patients with an age range of 18-60 years with no sex predilection, with bilateral recurrent episodes of condylar dislocation of a minimum of three per month with previously failed conservative management. 2. proper general health and medically classified as asa i or asa ii. exclusion criteria: 1. the patients with unilateral condylar dislocation, facial nerve motor functional affection, and those with the radiographic interpretation of pneumatized articular eminence or zygomatic arch. 2. asa iii medically classified patients and those with a history of previous (tmj) surgery.
training educators to conduct functional behavior assessment via telehealth

Conditions: Autism Spectrum Disorder

Summary: this study evaluates the effects of delivering training services via telehealth to educators in rural schools. the investigators hope to increase the accuracy with which educators implement functional behavior assessments in schools. during the study, participants will receive training on functional behavior assessments at different periods. when one school is receiving training, other schools will not be receiving training. the purpose will be to show increased accuracy of functional behavior assessments only occur following training.

training services for educators typically occurs in-vivo with experts providing immediate feedback and modeling to shape behavior. these types of training experiences may not be accessible for all educators though. the current study will evaluate delivering behavioral skills training (e.g., feedback and error correction) via telehealth for educators conducting functional behavior assessments. the components of the functional behavior assessment that will be targeted are open-ended interviews, stimulus preference assessments, direct observations of problem behavior, and a functional communication training program. with at least three different schools, the investigators will introduce training delivered via telehealth one at a time to show that increases in acquisition of the various components of the functional behavior assessment only occur following telehealth-based training.

Eligibility criteria:
inclusion criteria: * must be an educator who conducts functional behavior assessment. * must be training to become a registered behavior technician. exclusion criteria:

Keywords: telehealth functional behavior assessment
evaluation of the accelerated traction of impacted canines in terms of speed and changes in the dental arches

Conditions: Impacted Tooth With Abnormal Positioning

Summary: the time required for orthodontic traction of impacted canines after surgical exposure is a particularly troubling clinical problem because it prolongs the orthodontic treatment duration. during traction process, several complications could result in alveolar bone loss, root resorption of the adjacent teeth, ankylosis, discoloration, loss or vitality and gingival recession. accordingly, and due to the lack of studies concerned with accelerating the traction movement of the impacted canines, we conducted this study to evaluate the effectiveness of some surgical interventions (corticotomy and piezocision) in increasing the rate of orthodontic traction movement. we also aimed to evaluate dentoalveolar changes associated with the use of such accelerating procedures compared with the conventional traction method.

adult patients with unilateral palatally impacted canines will be included in this study. one of patient groups will be treated using fixed orthodontic appliances in combination with some accelerated surgical interventions, while the second patient group will be treated using the traditional treatment method. the velocity of traction movement will be assessed in the two groups. the differences between the two groups in terms of the total treatment duration and the traction duration will be evaluated. dentoalveolar changes associated with the use of such accelerating procedures will be assessed by several variables studied on cone-beam computed tomography (cbct) images. in this study, two groups are going to be evaluated: (1) patients treated in the traditional manner, (2) patients will undergo corticotomy-assisted traction of the impacted canines.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 28. 2. unilateral palatally or mid-alveolar upper impacted canine. 3. the impacted canine crown not exceeding the middle of the lateral incisor root. 4. absence of root resorption of the lateral incisors. 5. no contact between the canine crown and the lateral incisor root. 6. individuals not previously receiving orthodontic treatment. 7. no use of any medications that may affect the orthodontic movement. exclusion criteria: 1. bilateral or buccal canine impaction cases. 2. more than 45-degree angle between the canine's longitudinal axis and the vertical facial plane. 3. any medical condition that prevents oral surgery. 4. oral structural abnormality that is inherited or congenital.

Keywords: canine impaction acceleration of tooth movement corticotomy minimally invasive acceleration maxillary canine impaction withdrawal of an impacted canine piezosurgery
neurological and physiological effects of animal-assisted therapy for patients in a minimally conscious state

Conditions: Minimally Conscious State

Summary: this study aims to explore the impact of animal assisted therapy (aat) on brain signal complexity in patients with minimally conscious state (mcs) by analyzing electroencephalogram (eeg) entropy. mcs patients typically exhibit reduced brain entropy compared to healthy individuals, indicating lower brain complexity. the study will assess whether aat can enhance this complexity, which is crucial for understanding consciousness levels. entropy, a measure of randomness in brain activity, will be used to evaluate aat's effectiveness. in addition, electrocardiography (ecg), electrodermal activity (eda) and behavioral measurements will also be collected.


Eligibility criteria:
inclusion criteria: * inpatients in one of the study sites * acquired brain injury resulting from either traumatic or non-traumatic events * diagnosis of mcs defined by crs-r according to the aspen criteria (giacino, 2005) * informed consent as documented by signature by the patient's legal representative * physiologically stable * aged 18 or over exclusion criteria: * phobia or allergies to any of the involved animals * medical contraindications: acute or chronic disease (e.g. chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) * radical changes in medication (decision made with responsible physician)
pain diabetic peripheral neuropathy（dpn) in china

Conditions: Diabetic Neuropathies

Summary: to understand the clinical characteristics of dpn patients in china; to investigate the distribution of dpn patients with depression and anxiety symptoms; to investigate the related factors of moderate and severe pain in dpn patients; to investigate the treatment of pain and depression and/or anxiety in dpn patients.

pain diabetic peripheral neuropathy (dpn) is a heavy global economic burden. an american observational study in 2013 showed that the total average annual adjusted direct medical cost/person for dpn patients was $4,841, and the total average annual adjusted indirect medical cost/person was $9,730. a retrospective study in the united states in 2015 showed that the total annual direct medical cost per person for diabetes was $6,632, dpn ($12,492), dpn ($27,931), and severe dpn ($30,755) were 4.6 times higher than those for patients with diabetes alone. according to the 2015 european survey, the total annual direct medical cost per person for dpn patients in the united kingdom was €2,963 (£2,511), of which 40% was used for hospitalization. at present, there are no studies on the population epidemiology, depression and drug use of dpn in china. this study mainly investigates the above problems.

Eligibility criteria:
inclusion criteria: * outpatients who are elder than 18 years old with history of type 1or type 2 diabetes * the presence of symptoms, signs and/or electrophysiological evidence of diabetic peripheral neuropathy * the patient presents spontaneous pain (continuous or intermittent acupuncture pain, electric shock pain, burning pain, etc.) or induced pain (sensory hypersensitivity, paresthesia, etc.) * the pain lasts for at least 3 months * informed consent has been signed exclusion criteria: * patients with other causes of neuropathic, non-neuropathic, or mixed pain: for example, cervical/lumbar degenerative diseases, arthritis, nerve root compression, paraneoplastic syndromes, cerebrovascular diseases, spinal diseases, other peripheral neuropathies (immunological, toxic, nutritional peripheral neuropathies, etc.) * dementia, substance abuse, etc., severely affect cognitive and communication skills

Keywords: pain diabetic peripheral neuropathy
prostate active surveillance study

Conditions: Prostatic Neoplasms

Summary: the prostate active surveillance study (pass) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. this study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.

this is a multi-center, prospective active surveillance study with selective intervention in patients with previously untreated, clinically localized prostate cancer at diagnosis. candidates are assessed based on an extended core biopsy, serum psa (including psa kinetics, if available), digital rectal examination (dre), and assessment of cancer grade and extent. active surveillance is defined as serial psa measurements and prostate examination with routine prostate biopsy and therapeutic intervention considered at the time one or more of the following: * grade or volume progression * clinical progression the objectives of the study are as follows: primary objective • to discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, psa, clinical criteria, or outcomes based on these variables. secondary objectives * to determine the proportion of patients on active surveillance who progress based on the above criteria. * to determine the clinical predictors of disease progression. * to measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate from a prostate biopsy. * clinically localized prostate cancer: t1-2, nx or n0, mx or m0. * no previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). * ecog performance status 0 or 1. * patient has elected active surveillance as preferred management plan for prostate cancer. * patient consent has been obtained according to local institutional review board for acquisition of research specimens. * patient is accessible and compliant for follow-up. * prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date. * no more than two prostate biopsies including the initial biopsy in which cancer was diagnosed. * if cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. the subsequent biopsy may occur on the same day as the baseline visit. * biopsies must have at least 10 cores. exclusion criteria: * unwillingness or inability to undergo serial prostate biopsy. * history of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (ta) or other solid tumors curatively treated with no evidence of disease for \> 5 years.

Keywords: prostate cancer