Kornimate/medical-research-clean huggingface dataset:
mealtime anxiety in eating disorders

Conditions: Eating Disorders

Summary: the goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. anxiety wil be assessed using ecological momentary assessment (ema). the main research question is: • does post meal activity reduce anxiety in patients with eating disorders? study participation will last for two weeks. participants will be reporting current levels of anxiety/distress on an ema mobile app during treatment as usual. during one of the two study participation weeks, the participants will perform post mealtime activity.


Eligibility criteria:
inclusion criteria: * all patients admitted to the regional department for eating disorders adult in-patient unit (\>16 years old) will be invited to participate. exclusion criteria: * patients who receive tube feeding for all meals during the study period will be excluded.
neurodevelopmental disorder diagnosis during adulthood

Conditions: Neurodevelopmental Disorders

Summary: the prevalence of neurodevelopmental disorders (specific learning disorders: dyslexia, dysorthographia, dysgraphia and dyscalculia; communication disorders; developmental coordination disorders; attention deficit disorder with or without hyperactivity (adhd); intellectual disability (id) and autism spectrum disorders) in the general population is very high, representing over 15% of the paediatric population. among this population, between 40% and 90% remain symptomatic into adulthood. in addition to the part of the population diagnosed in childhood and lost to the transition to adulthood, a significant part of this population remains unidentified and therefore untreated (up to 60%). it is in adulthood that the diagnosis of neurodevelopmental disorders must be identified as being at the origin of at least some of the cognitive dysfunctions observed: failure at school, difficulties in socio-professional integration... thus, the lifelong care diagnostic pathway needs to be developed both from an organizational point of view and in terms of the scientific knowledge required to best organize a personalized health pathway for this population. the current challenge for this population is to offer a structured care pathway, from diagnosis to care and medico-social integration. this project will provide comprehensive, homogeneous data for cohorts of patients requiring diagnostic advice and lifelong management of their disorders. thesecomprehensive data will contribute to scientific publications on patient cohorts. at present, very few centers have complete, homogeneous data on late-diagnosis adults, so our project will have a scientific and academic impact in its own right.


Eligibility criteria:
inclusion criteria: * men or women aged 18 or over * men or women under 55 years of age * patients with a neurodevelopmental disorder according to the latest dsm5 criteria diagnosed after age 18 * patient with sufficient visual and auditory skills, oral and written language in french accessible to clinical and neuropsychological evaluation. exclusion criteria: * patients with intellectual disabilities * patients with serious addictive and/or psychiatric comorbidities

Keywords: neurodevelopmental disorders late diagnosis adult
a follow-up study to evaluate the safety of allo-asc-dfu in allo-asc-bi-201 clinical trial

Conditions: Burn

Summary: this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 2 clinical trial (allo-asc-bi-201) for 23 months.

this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 2 clinical trial (allo-asc-bi-201) for 23 months. allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.

Eligibility criteria:
inclusion criteria: 1. subjects who are treated with allo-asc-dfu sheet in phase 2 clinical trial of allo-asc-bi-201. 2. a subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided. exclusion criteria: 1. subjects who are considered not suitable for the study by the principal investigator.
impact of physiotherapy on spasticity, upper limb function, daily activities, and kinesiophobia in hemiplegic patients

Conditions: Hemiplegia; Stroke

Summary: this study investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke.

hemiplegia is a neurological condition characterized by paresis and movement limitations on one side of the body due to functional loss in one hemisphere of the brain caused by a vascular event after a stroke. this study aims to evaluate the effects of a physiotherapy and rehabilitation program on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with post-stroke hemiplegia. participants' spasticity levels were assessed using the modified ashworth scale, upper extremity functions with the fugl-meyer upper extremity motor assessment, activities of daily living with the barthel index, and kinesiophobia levels with the tampa scale of kinesiophobia. the treatment program consisted of 24 sessions, with three sessions per week. each session lasted 45 minutes and included transcutaneous electrical nerve stimulation (tens), range of motion exercises for upper and lower extremities, balance and coordination exercises, and weight transfer exercises. assessments were conducted before and after the treatment. as a result of the treatment program, a significant decrease in spasticity levels was observed in joints other than the hip joint, along with significant improvements in upper extremity functions and activities of daily living, and a significant reduction in kinesiophobia levels. physiotherapy and rehabilitation programs have been found to be effective in reducing spasticity, improving upper extremity functions and activities of daily living, and reducing kinesiophobia in post-stroke hemiplegic patients. these findings can contribute to the development of post-stroke rehabilitation strategies. future research should deepen these findings with larger sample groups and long-term follow-up studies.

Eligibility criteria:
inclusion criteria: * being between 22-79 years of age * having been diagnosed with a stroke (svo) * possessing adequate language and cognitive skills * willingness to participate voluntarily * not having any chronic diseases that could affect the study outcomes exclusion criteria: * no other neurological problems affecting functionality besides hemiplegia * having cognitive impairment
patch-free occlusion therapy

Conditions: Amblyopia

Summary: the purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.

this is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. participants will be referred from local pediatric ophthalmologists. following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch. children will participate in their assigned occlusion therapy at home for 12 weeks (primary outcome). adherence will be objectively monitored with a theramon sensor. vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. the patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). the standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks. the primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logmar (recovered) at 6 and 12 weeks visit and 95% cis (at 6 and 12 weeks), comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and pedeyeq domain scores. associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. in exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 12 and 24 weeks for the patch-free group (12, 18, and 24 weeks means and 95% cis).

Eligibility criteria:
inclusion criteria: * 3-10 years (3-7 primary cohort) * male and female * strabismic, anisometropic, or combined mechanism amblyopia (visual acuity: 0.3-0.8 logmar) * interocular visual acuity difference ≥0.3 logmar * wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart * child's ophthalmologist and family willing to forgo standard patching treatment during the study exclusion criteria: * prematurity ≥8 wk * coexisting ocular or systemic disease * developmental delay * myopia \> -3.00d
a study to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.

this is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response study of patients who have a diagnostic and statistical manual of mental disorders, 4th edition (dsm iv) diagnosis of schizophrenia. the duration of the study is approximately 14 weeks, including a screening period of 1 week and a 13-week double-blind treatment period. efficacy and safety will be evaluated periodically throughout the study. samples for pharmacokinetic evaluation will be collected at designated time points, and a blood sample will be collected at baseline (before the start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis. the hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. the effectiveness is measured primarily by the change in the positive and negative syndrome scale for schizophrenia (panss), and secondarily, by the investigator's clinical global impression of severity (cgi-s) and by the investigator's evaluation of the patient on a personal and social performance (psp) scale. four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent administered in the gluteal muscle (buttocks). injections will be given on days 1, 8, 36, and 64 of the double-blind treatment period of the study.

Eligibility criteria:
inclusion criteria: * a dsm-iv diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated type) for at least 1 year before the screening evaluation * a total panss score of 70 to 120 at screening and baseline (pre-treatment) evaluations * a body mass index (bmi \[weight (kilograms)\]/\[height (meters)\]²) of more than 17.0 kg/m² exclusion criteria: * a primary active dsm-iv axis i diagnosis other than schizophrenia * a decrease of 25% or more in the total panss score between screening and baseline evaluations * a dsm-iv diagnosis of active substance dependence within 3 months of screening evaluation * a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications * a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.

Keywords: schizophrenia intramuscular injection antipsychotic agents dementia praecox paliperidone palmitate mental disorders panss.
cost evaluation of robotic ventral hernia repair

Conditions: Ventral Hernia

Summary: to evaluate the procedural cost of robotic ventral hernia repair compared with open ventral hernia repair.

ventral hernia repair is one of the most frequently performed elective surgeries worldwide. the surgical approaches vary depending on the patient characteristics, type, and location the of ventral hernia, as well as the surgeons' preferences and equipment availability. the choice between an open or minimally invasive approach has been debated for years, and it seems clear that the risk of wound infection is significantly decreased when choosing a minimally invasive approach, whereas there are no significant difference in recurrence rates. in the past decades, the use of a robotic system for ventral hernia repair has gained increasing popularity due to an easy access to the preperitoneal or retromuscular plane with a minimally invasive technique. two nationwide cohort studies concluded that length of stay and postoperative morbidity was decreased for robot-assisted repairs compared to open or laparoscopic ventral hernia repairs. critics of robot-assisted surgery argue that it is time-consuming, too expensive, and that further cost-effectiveness analyses are needed to weigh the clinical benefits. the aim of these studies was to compare the procedure-specific cost of robot-assisted with open primary ventral and incisional hernia repair and thereafter with laparoscopic repairs.

Eligibility criteria:
inclusion criteria: patients undergoing elective primary ventral and incisional hernia repair - exclusion criteria: none -

Keywords: cost
comparison of norepinephrine and ephedrine on hypotension after spinal anesthesia in parturients

Conditions: Hypotension; Obstetrical Complication of Anesthesia; Complications; Cesarean Section

Summary: incidence of hypotension is high in parturients after spinal anesthesia. ephedrine could be used to treat hypotension but lead to lower fetal ph as well. this study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.

spinal anesthesia is an accepted technique in elective cesarean sections. however, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. prevention of this complication by sympathomimetic agents is of potential clinical significance. ephedrine could be used to treat hypotension but lead to lower fetal ph, which may be related to worse fetal outcome.norepinephrine could improve the hypotension to the same extent as phenylephrine. in this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective cesarean section exclusion criteria: * patients with severe pre-eclampsia * patients with contraindications for spinal anesthesia * patients with multiple pregnancy * patients with gestation \<38w

Keywords: norepinephrine ephedrine
performance of sgm-101 for the delineation of primary and recurrent tumor and metastases in patients undergoing surgery for colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the performance of sgm-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

the performance of sgm-101, a fluorochrome-labeled anti-carcinoembryonic antigen (cea) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.

Eligibility criteria:
inclusion criteria: * patients should be scheduled for curative colorectal cancer surgery of primary ct4 colon cancer or primary ct3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer. * female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection. exclusion criteria: 1. other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma; 2. primary appendiceal cancer; 3. laboratory abnormalities defined as: * aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase) or alkaline phosphatase levels above 5 times the uln or; * total bilirubin above 2 times the uln or; * serum creatinine above 1.5 times the uln or; * absolute neutrophils counts below 1.5 x 109/l or; * platelet count below 100 x 109/l or; * hemoglobin below 4 mmol/l (females) or below 5 mmol/l (males); 4. known positive test for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibody or patients with untreated serious infections; 5. any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Keywords: fluorescence cancer sgm-101 surgery colorectal
improving the quality of radiotherapy by multi-institution knowledge-based planning optimization models (acronym: mikapoco, multi-institutional knowledge-based approach in plan optimization for the community)

Conditions: Breast Cancer; Prostate Cancer

Summary: investigators central hypothesis is that it is possible to create libraries of "consistent" knowledge-based plan-models derived from large institutional experiences. these libraries can be used to guide automated rt planning and serve as tools to assist centers for plan quality assurance (qa) and plan prediction. quantifying inter-institute variability of rt planning and building libraries of interchangeable and validated multi-institutional kb plan prediction models is expected to impact on the quality of planning at the national level. the project has the potential of facilitating the introduction of ai approaches in plan optimization, thus reducing intra and inter-institute planning variability. improving plan quality is expected to translate into better outcome after rt in terms of local control and, even more, of side effects and quality of life. positive impact is also expected in patient selection for advanced techniques, in plan audit and plan optimization in clinical trials, in technology comparison and cost-benefit analyses as well as in the rt educational field.

major aims 1. to create libraries of consistently generated kb models for patients treated with rt for breast and prostate cancer and for selected stereotactic-body rt (sbrt) applications based on the experience of many italian institutions; to quantify planning inter-institute variability in homogeneous classes of patients. 2. to group models based on their characteristics and interchangeability. to assess groups of highly interchangeable models to be considered for multi-institutional dose-volume histogram (dvh) prediction purposes.

Eligibility criteria:
inclusion criteria: * real life consecutive (or randomly chosen) plan data of patients treated for prostate cancer during the last 10 years; * real life consecutive (or randomly chosen) plan data of patients treated for breast cancer during the last 10 years; * real life consecutive (or randomly chosen) plan data of patients treated for selected sbrt situations (spine and prostate, according to rtog 0631 and 0938 schemes respectively) during the last 10 years. exclusion criteria: -
a pilot study of the immediate effects of dlpfc tdcs on attention bias in depression

Conditions: Depression

Summary: depression and other psychiatric conditions are marked by exaggerated, preferential processing (or attention bias) of negative information relative to neutral or positive information. this depression-related attention bias can be measured using the dot probe task and visual search, that allow assessment of the degree to which one shows bias toward negative information in the presence of neutral or positive information. a clinically effective treatment for depression is noninvasive brain stimulation with transcranial direct current stimulation (tdcs), targeting the dorsolateral prefrontal cortex (dlpfc), delivered in repeated sessions across a period of time. the study will test the effect of a single session of dlpfc tdcs on attention bias in patients with mild to moderate depression.

this prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to moderate depression (based on bdi-ii score range 14-19 for mild and 20-28 for moderate) to determine if a single-session of tdcs can alter negative attention bias. the primary objective is to study if single-session tdcs will affect attention bias in depression and is not meant to treat depression. subjects may or may not be receiving treatment for mild-moderate depression.

Eligibility criteria:
inclusion criteria: * aged 18-45 * female * mild to moderate depression (determined by bdi-ii scores of 14-19 and 20-28, respectively) * if taking antidepressants, medication must be stable ≥ 30 days prior to screening exclusion criteria: * wide-range achievement test-fourth edition (wrat-4) reading subtest standard score \<85 (to ensure understanding of test procedures) * insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff * primary psychiatric disorder other than depression (based on mini) * primary neurologic condition that would prevent ability to participate (as determined by study clinician). * history of head trauma in the last year * medical device implants in the head or neck * history or current uncontrolled seizure disorder * current substance abuse disorder * . pregnant or lactating women * skin disorder/sensitive skin near stimulation locations