Kornimate/medical-research-clean huggingface dataset:
multi-site animal assisted intervention for children with dd and their family dog

Conditions: Physical Activity; Social Wellbeing

Summary: the study purpose is to evaluate a novel multidisciplinary approach to fostering a therapeutic partnership between the participants with developmental disabilities and the participants family dog. this will culminate in an animal assisted intervention aimed at increasing activity levels, enhancing social support, and increasing feeling of responsibility and wellbeing within this population.

the goal of this proposal is to evaluate a large scale novel multidisciplinary approach to fostering atherapeutic partnership between adolescents with developmental disabilities (dd) and the participants family dog. the investigators will evaluate imitative 'do as i do' (daid) training into a unique animal assisted intervention (aai) aimed at increasing activity levels, enhancing social support by promoting a stronger dog-human bond, and increasing feelings of responsibility and wellbeing within this population. the investigators propose to address the critical need for empirical evaluation of novel theoretically based multi-site animal assisted interventions through the following specific aims. specific aim 1: to evaluate a novel multi-site daid dog training intervention to promote physical activity in adolescents with developmental disabilities. specific aim 2: to evaluate the impact of a multi-site daid intervention on the adolescent's quality of life and feelings of social wellbeing. specific aim 3: to evaluate the impact of a multi-site daid intervention on the child-dog relationship and mutual wellbeing. participant population: adolescent participants with a developmental disability, between the ages of 10-17 years will be recruited through community-based programs/organizations associated with children with dds in around our sites. a dd will be confirmed through parent report (e.g., initial recruitment conversations, and documented through the initial demographic questionnaire).

Eligibility criteria:
inclusion criteria: * age 10-17 years * developmental disability (per parental report) * possesses family dog * participant can follow basis instructions. exclusion criteria: * cannot follow basic instructions. * non english-speakers.
brain-machine interface for freezing of gait

Conditions: Parkinson Disease; Freezing of Gait Symptoms in Parkinson&#39;s Disease

Summary: gait problems in parkinson's disease (pd), especially freezing of gait (fog), greatly affect quality of life. while deep brain stimulation (dbs) is a highly effective treatment for many motor symptoms of pd, it is less effective for, or can even worsen, gait issues. the primary motor cortex (m1) plays a crucial role in the network that controls gait, particularly in initiating movement. changes in local field potentials (lfps) from the subthalamic nucleus (stn) are associated with different aspects of gait. however, detecting abnormal brain activity related to fog requires a method called electrocorticography (ecog), which has revealed that during fog, there is increased beta-gamma phase amplitude coupling (pac) in the m1. brain-machine interfaces (bmis) have shown promise in understanding motor functions by decoding brain activity. it is believed that bmis could provide both accurate indicators of fog and targeted treatments for it in pd. our objectives are to use a high-density ecog-based bmi to both record and stimulate brain activity during real-world gait and fog in pd patients who are undergoing standard dbs procedures. our goals are to improve our understanding of the brain's role in fog and normal gait in pd and to develop new treatments based on cortical stimulation. aim 1 - identify gait biomarkers: brain activity from the m1/sma cortex during different phases of walking and during fog episodes, both with and without medication will be recorded. machine learning will be used to identify the brain patterns linked to fog. aim 2 - use cortical stimulation to stop fog: cortical stimulation and its effects on leg and trunk movements will be studied by measuring muscle activity, movement, and posture during different states, such as resting, standing, walking, and during fog episodes. the type of stimulation which is most effective at stopping fog will be identified.


Eligibility criteria:
inclusion criteria: * pd fulfilling standard criteria for bilateral stn/gpi dbs surgery * debilitating fog in the off-medication condition with only partial response to levodopa (defined as the witnessed occurrence of fog during the on phase of the pre-dbs l-dopa challenge) * clinically established fog (i.e. reported by patient/caregiver and seen by the examiner in the clinic) * able to provide informed consent, comply with study protocol exclusion criteria: * prior ischemic stroke, intracranial hemorrhage, or intracerebral mass * previous brain surgery * other disorders potentially biasing assessment * absence of fog in the medication on condition (a population already manageable with current standard of treatment).

Keywords: brain-machine interface freezing of gait triggered stimulation adaptive stimulation
endobronchial ultrasound elastography: the utility of strain ratio for lymph node staging in lung cancer patients

Conditions: Lung Cancer

Summary: the aim of this pilot study is to evaluate ebus elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. strain ratios of mediastinal lymph nodes will be compared with ebus b-mode features and with tissue diagnosis as a gold standard.

evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest ct-scan. eligible patients should have either enlarged discrete n2/n3 lymph nodes, or central tumor or enlarged n1 lymph nodes with normal mediastinal lymph nodes. exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes. outcomes: sensitivity, specificity, accuracy, positive predictive value (ppv) and negative predictive value (npv) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. receiver operating characteristic (roc) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. area under the roc curve will be calculated.

Eligibility criteria:
inclusion criteria: * enlarged discrete n2/n3 lymph nodes * central tumor with normal mediastinal lymph nodes * enlarged n1 lymph nodes with normal mediastinal lymph nodes exclusion criteria: * metastatic disease * severe co-morbidity that disqualified surgical treatment * mediastinal infiltration by tumor * small peripheral lung tumor with normal-sized mediastinal lymph nodes

Keywords: endobronchial ultrasound ebus - tbna elastography strain ratio lung cancer staging
safety and efficacy study of ceftaroline in subjects with staphylococcus aureus bacteremia or with persistent methicillin-resistant staphylococcus aureus bacteremia

Conditions: Staphylococcus Aureus Bacteremia; Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia

Summary: this is a study of safety and efficacy of ceftaroline fosamil in subjects with staphylococcus aureus bacteremia or with methicillin-resistant staphylococcus aureus (mrsa) bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment.

subjects with either s. aureus bacteremia or persistent mrsa bacteremia will be treated with open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be evaluated.

Eligibility criteria:
inclusion criteria: 1. presence of bacteremia due solely to: * s. aureus on at least 1 blood culture within 72 hours of beginning study drug (cohort a) or * mrsa on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment (cohort b). 2. male or female ≥ 18 years of age. 3. if female of childbearing potential must be willing to practice sexual abstinence or dual methods of contraception during treatment and for at least 30 days after the last dose of study drug. 4. expectation of survival for at least 2 months. exclusion criteria: 1. for subjects in cohort a: previous therapy for more than 48 hours with any parenteral antibiotic with activity against s. aureus within 72 hours of positive blood culture results. 2. for subjects in cohort b: previous therapy for more than 48 hours with any parenteral antibiotic with activity against mrsa, except vancomycin and/or daptomycin, within 72 hours of positive blood culture results confirming persistence. 3. previous episode of s. aureus bacteremia within 3 months. 4. known left-sided endocarditis or prosthetic heart valve. 5. osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis. 6. history of any hypersensitivity or allergic reaction to any β-lactam antibacterial agent. 7. evidence of significant hepatic, hematologic, or immunologic impairment. 8. pregnant or nursing females.

Keywords: staphylococcus aureus bacteremia methicillin-resistant staphylococcus aureus bacteremia mrsa bacteremia blood adult infections blood culture
alk33-001: a study of rdc-0313 administered to healthy adults

Conditions: Alcohol Dependence

Summary: the purpose of this study is to determine the pharmacokinetics, safety, and tolerability of rdc-0313 following oral administration.

this is a single-center, randomized, double-blind, ascending dose, placebo controlled study. dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of rdc-0313 or volume-match placebo. dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. they will be discharged from the facility after the 36-hour postdose assessments are completed.

Eligibility criteria:
inclusion criteria: * 18 - 65 years of age * body mass index of 19-30 kg/m2 at screening * if subject is female and of childbearing potential, she must agree to use an acceptable method of contraception * if subject is male, he must agree to reduce the risk of a female partner becoming pregnant exclusion criteria: * pregnancy and/or currently breastfeeding * clinically significant medical condition or observed abnormalities * clinically significant illness within 30 days of the first study drug administration * history of opioid dependence * positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines * positive resolut for any serology test performed at screening * use of alcohol-, caffeine-, or xanthine-containing products * tobacco use within 90 days before the first study drug administration * participation in a clinical trial within 30 days before screening * requirement of a special diet other than vegetarian, or significant food allergy or intolerance

Keywords: alcohol dependence opioid antagonist rdc-0313
physical activity in university students around covid-19 confinement

Conditions: Physical Activity

Summary: the period of confinement due to covid-19 may lead to reduced physical activity levels with negative consequences for health and quality of life in the short and long term, in case the sedentary habits are maintained over time. it is therefore essential to know the physical activity and health habits of university students during the confinement, as it could help in the design of effective strategies for the post-confinement period, as well as for any similar future situations. the general objective of the study is to know how university students have adapted their physical activity and health habits to the situation of confinement generated by covid-19, as well as to identify the determining factors and the possible consequences. it is expected that there will be modifications in the patterns of physical activity in this situation, which could vary based on sociodemographic and economic determinants, and could affect parameters of health and quality of life. a survey will be sent to all students by email through the corresponding vice-rectorates of the sixteen participating universities (https://covid19.ehu.es/). the survey will be completed "online" anonymously. among those participants who wish to keep participating in the study, a follow-up will be carried out one month and one year after the end of the confinement period. in this case, those subjects must indicate their willingness to keep participating and provide a contact email. the follow-up period will allow to know how physical activity and health habits are modified in the long term.


Eligibility criteria:
inclusion criteria: * university students of any degree (bachellor's degree, master's degree, doctorate degree or any other university studies exclusion criteria: -

Keywords: university students survey covid-19 confinement physical activity quality of life health sleep pain
excision limits of oral cavity tumor by narrow band imaging

Conditions: Cancer

Summary: this study evaluates the feasibility of the nbi technique in the detection of early cancer lesions.


Eligibility criteria:
inclusion criteria: * primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery * no previous surgery for this cancer * age \> 18 years * patient affiliated to health insurance * consent signed by the patient exclusion criteria: * metastatic or recurrent disease * health care impossibilities for geographic, social, psychic reasons

Keywords: oral cavity tumor narrow band imaging subclinical cancer lesion
methylation of cfdna in diagnosing and monitoring pulmonary nodule

Conditions: Pulmonary Nodule, Solitary

Summary: patients found pulmonary nodules by ct screening by will be enrolled in this study prospectively. plasma cfdna sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.

this study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by ct. methylation of plasma cfdna in these patients will be performed. evaluation of benign and malignant diagnostic efficacy of cfdna methylation in pulmonary nodules with definite pathological findings. pulmonary nodules that temporarily not require invasive examination will be performed ct follow-up and dynamically monitored methylation changes of cfdna. and the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.

Eligibility criteria:
inclusion criteria: * 1. inclusion criteria: 1. aged 40-80; 2. lung nodules were detected by ct (≥5mm，≤3cm); 3. patients fully understand the informed consent and can sign the informed consent in person. exclusion criteria: * 2. exclusion criteria: 1. patients diagnosed with malignant tumors in the past; 2. this image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement； 3. pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies； 4. past diseases or conditions that affect plasma cfdna content, such as rheumatoid immunity and diseases of the blood system. 5. the researchers concluded that there were other conditions that made it inappropriate to participate in this study

Keywords: cfdna methylation ct follow-up plasma pulmonary nodule
a study to evaluate efficacy and safety of zolpidem modified release formulation in insomnia patients

Conditions: Sleep Initiation and Maintenance Disorders; Primary Insomnia

Summary: the purpose of the study is to investigate the efficacy and safety of zolpidem modified release (mr) tablet using estazolam (eurodin) as a comparative drug in patients with primary insomnia.


Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia based on dsm-iv criteria (307.42) * written informed consent has been obtained exclusion criteria: * patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome * patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem * patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) * patients who are pregnant, lactating or intend to become pregnant during the study period * patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study * any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial * participation in any clinical trial within 1 month prior to randomization

Keywords: insomnia zolpidem estazolam
folic acid supplementation as an appetizer in primary malnourished egyptian infants and children

Conditions: Primary Malnurtrition

Summary: folic acid as a appetizer in primary malnutrition


Eligibility criteria:
inclusion criteria: primary malnourished children exclusion criteria: * previous folic supplementation in the past 3 months
erythritol vs ultrasonic scaler prophylaxis systems on dental implants with crowns made by different materials

Conditions: Dental Implant Failed; Peri-implant Mucositis; Peri-Implantitis

Summary: the aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts. a randomized clinical trial will be conducted on the patient. patients will be randomly divided into two groups: * erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (airflow® plus ems) * ultrasonic scaler group: a piezoelectric handpiece with peek inserts (mini piezon ems; pi ems) will be used. different subgroups will be defined according to the material of the dental crown of the related implant. the oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the probing depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), bleeding on probing and plaque index.

the aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts. a randomized clinical trial will be conducted on the patient. patients will be randomly divided into two groups: * erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (airflow® plus ems) * ultrasonic scaler group: a piezoelectric handpiece with peek inserts (mini piezon ems; pi ems) will be used. different subgroups will be defined according to the material of the dental crown of the related implant: feldspathic ceramic, zirconia and lithium disilicate. the oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the probing depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), bleeding on probing and plaque index.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 * presence of at least one dental implant * good compliance exclusion criteria: * patients with cardiac stimulators * patients with neurological disorders * patients with psychological disorders * pregnant women
patient perceptions of robotic, endoscopic and open thyroid surgery

Conditions: Thyroid Diseases; Surgery

Summary: robotic thyroid surgery offers certain improvements in cosmesis and postoperative recovery. the study aimed to describe patients' concerns in choosing surgical approach and how these attitudes affect preferences for robotic thyroidectomy (rt), endoscopic thyroidectomy (et) and conventional open thyroidectomy (ot), with the long-term goal of promoting rt.

patients admitted for surgical treatment for thyroid disease, after sufficient counselling on the main differences and traits among open, endoscopic and robotic approach completed an anonymous questionnaire. size of incision, cost, postoperative recovery, postoperative hospitalization, operation duration and absence of the anterior neck incision were respectively assessed the degree of importance when patients chose the surgical approach in thyroid disease. in addition, patients underwent rt and et rated their satisfaction in terms of scars and cosmesis.

Eligibility criteria:
inclusion criteria: * patients underwent thyroid surgery and were willing to complete the questionnaire exclusion criteria: * the completeness of the questionnaire was less than 80% * drop of follow-up

Keywords: patient perception robotic thyroidectomy minimally invasive surgery cosmesis
a 12-month open label safety study of aptensio xr® in children ages 4-5 years diagnosed with adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (aptensio xr®) in children aged 4-5 years who have been diagnosed with attention-deficit/hyperactivity disorder (adhd). safety and tolerability will be evaluated by assessing treatment-emergent adverse events (teaes) blood pressure, pulse, height, weight, electrocardiograms (ecgs), laboratory the primary objective of this study is to evaluate the long-term (12-month) safety and tolerability of aptensio xr® in children aged 4 to less than 6 years who have been diagnosed with adhd. safety and tolerability will be evaluated by assessing treatment-emergent adverse events (teaes) blood pressure, pulse, height, weight, electrocardiograms (ecgs), laboratory values and columbia suicide severity rating scale (c-ssrs). disturbances in sleep (quantity and quality) patterns will also be assessed using the child sleep habits questionnaire (cshq). secondary objectives include assessment of long-term efficacy of aptensio xr®. secondary measures include: * investigator administered attention-deficit/hyperactivity disorder rating scale preschool version (adhd-rs-iv preschool version) * clinical global impressions-severity scale (cgi-s ) * connors early childhood behavior-parent short form \[conners ec beh-p(s)\]


Eligibility criteria:
inclusion criteria: * male and female subjects aged 4 to less than 6 years inclusive at the time consent was given to participate in prior studies. new subjects must be at least 4 years but less than 6 years of age when written consent is given to participate in this trial.

Keywords: adhd children methylphenidate