Kornimate/medical-research-clean huggingface dataset:
photobiomodulation with red and infrared led device for temporomandibular dysfunction

Conditions: Temporomandibular Disorder

Summary: temporomandibular dysfunction - tmd is considered the main cause of orofacial pain of non-dental origin, and a public health problem. due to their complexity there are already treatments using various forms of therapy. photobiomodulation using different light sources, in a single or combined form, makes it possible to use it as another therapeutic resource to be explored. the objective of this study will be to evaluate the effects of photobiomodulation with simultaneous use of light emitting diodes (leds), red and infrared, on clinical aspects in individuals with tmd. a randomized, controlled and blind clinical trial is proposed, which will involve 33 individuals (n = 11 per group) of both genders, aged 18-45 years in three groups: group 1 - led; group 2 - placebo and group 3 - control, submitted to 6 nonconsecutive sessions of photobiomodulation totaling 2 weeks of treatment. the research diagnostic criteria for temporomandibular disorders - rdc/tmd will be used to determine the tmd and evaluate the participants. pain will be assessed using the visual analog scale (vas), mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. a mixed plate of 18 red leds - 660 nm and 18 infrared leds - 850 nm with power of 3.5 mw per led, 4.45 mw/cm2, radiant exposure of 5,35 j/cm2, irradiated area of 14.13 cm2, and energy of 75.6 j, in the temporomandibular joint (tmj) region and in the masseter and temporal muscles, bilateral in 6 sessions. participants from all groups will be reassessed after the first therapeutic intervention, and again at the end, following the same evaluation procedures used initially.


Eligibility criteria:
inclusion criteria: * present tmd; * complete dentition (except third molars); * present mandibular deviation and/or deflection. exclusion criteria: * occlusal changes; * use of any type of dental prosthesis; * current orthodontic or physiotherapeutic treatment; * use of any type of medication during the phases of the study.
effect of feeding jejunostomy on sarcopenia in patients with esophageal cancer

Conditions: Esophageal Cancer; Esophageal Carcinoma; Sarcopenia; Feeding Tube

Summary: participants were diagnosed with esophageal cancer needing chemo- or radiochemotherapy before the potentially curing surgery consisting of esophagectomy. at the time of diagnosis, in all participants, a laparoscopy to complete staging was performed. in some patients, a feeding jejunostomy tube (fjt) was placed at the time of staging laparoscopy; in others, the fjt was placed at the time of esophagectomy. a common risk factor for higher morbidity and mortality is sarcopenia, a condition associated with low skeletal muscle. this study aims to determine whether the timing of the fjt placement affects the progress of sarcopenia.

at the city hospital zurich triemli, an fjt tube is inserted in approximately two-thirds of patients before commencing neoadjuvant therapy. another third receive an fjt at the time of esophagectomy to ensure postoperative enteral feeding. to this day, no prospective, randomized study exists as to whether placing an fjt at diagnosis or esophagectomy impacts sarcopenia. retrospectively collected data is limited due to small sample sizes and observational character. this is a retrospective, single-center cohort study using disease-related data already collected. the study design includes statistical balancing techniques to achieve comparability between the two groups and estimate an unbiased treatment effect of the timing of fjt placement. all data is extracted from the clinical information systems and radiological systems and is credible, protected data. it is taken exclusively from the medical records; patients are not contacted for data collection.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years and above at the time of diagnosis. * advanced-stage esophageal cancer or cancer of the esophageal junction and treated with curative intent, including neoadjuvant treatment. * patients who received an fjt either before neoadjuvant treatment or during definitive surgery. exclusion criteria: * insufficient data for analysis * written rejection of general consent

Keywords: feeding jejunostomy tube enteral feeding route before or after neoadjuvant therapy feeding jejunostomy tube at staging laparoscopy feeding jejunostomy in esophagel cancer sarcopenia in esophageal cancer effect of enteral feeding on sarcopenia sarcopenia in esophageal cancer patients
reversal of remimazolam by a single dose of flumazenil

Conditions: Flumazenil Adverse Reaction; Ambulatory Surgery; Postoperative Nausea; Remimazolam

Summary: remimazolam, a brand-new sedative which has benzodiazepine property. it is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.

as ambulatory surgery has been increased last two decades, 'enhanced recovery after surgery (eras)' also has become an important issue in clinical fields. it is very critical that managing postoperative pain, postoperative nausea and vomiting (ponv) and rapid recovery with less complication or side effect to anesthesiologists. even though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. fortunately, remimazolam has its own antidote, called 'flimazenil'. with flumazenil, the time to recovery of consciousness dramatically reduces. common side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain. in this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery.

Eligibility criteria:
inclusion criteria: * participants aged over 20 years scheduled for ambulatory gynecologic surgery. exclusion criteria: * allergy or hypersensitivity to flumazenil, benzodiazepines, nsaids, 5-ht3 * arrhythmia, myocardial infarction, coronary artery disease * obstructive sleep apnea * severe or acute respiratory distress * tricyclic anti-depressant * lactose intolerance * bmi over 30kg/m2 * asa classification 4 or 5
a registry study of biomarkers in heart valve disease

Conditions: Cardiovascular Diseases

Summary: valvular heart disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. the primary conditions within this category are aortic stenosis and mitral regurgitation. these conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. pathophysiology of valvular heart disease remains poorly known. the aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches


Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with heart valve disease in beijing anzhen hospital exclusion criteria: * age \< 18 years * failure to obtain medical records and ultrasound data * refuse follow-up
predictors for quality of life after sigmoidectomy for diverticular disease

Conditions: Diverticular Disease of Colon; Quality of Life

Summary: to identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.

according to current international guidelines, indications for surgical treatment of diverticular disease are inhomogeneous. to date, the measurement of pre- and postoperative quality of life (qol) is underrepresented. to ensure an individually tailored therapeutical approach, and to avoid unnecessary surgery as well as the risk of a hazardous chronification of the disease, qol importantly needs to be focused within the decisional process for the best treatment option. the aim of the predic div-study is, to identify predictors for a better postoperative quality of life in patients who undergo elective sigmoidectomy for diverticular disease. predic div is a prospective observational study.

Eligibility criteria:
inclusion criteria: * patients, scheduled for elective sigmoidectomy for diverticular disease (indication: foregoing acute diverticulitis with pericolic or pelvic abscess \>1cm, ongoing complaints after acute uncomplicated diverticulitis, recurrent uncomplicated disease (three or more diverticulitis episodes in combination with the patients wish for surgery), recurrent complicated disease (three or more diverticulitis episodes+complications: stenosis, fistula, chronic pain), urgent wish of patients for surgery after uncomplicated disease. * age \>18 years * asa 1-3 * informed consent exclusion criteria: * age \<18 years * asa 4 * acute diverticulitis with free perforation * acute or forgoing diverticular bleeding * colorectal malignancies (current or foregoing) * immunosuppression (corticoids \> 20 mg prednisolon/d, status post transplant) * advanced malignancy with systemic metastases
child health improvement through computer automation - child neurology (chica-cn) evaluation

Conditions: Neurologic Disorder

Summary: the study will evaluate a computer decision support system for child neurology, child health improvement through computer automation - child neurology (chica-cn) using patient chart review, family phone surveys, and physician interviews in a before-after study design.

(chica-cn) child health improvement through computer automation - child neurology is software that works with the electronic health record (ehr) to improve the efficiency and quality of care in the outpatient setting. built in partnership with the child neurology foundation, chica's guidance is based on authoritative guidelines from the american academy of neurology and others. the plan is to implement chica-cn in the child neurology clinics at wake forest baptist health. to evaluate chica-cn the proposal is to look at data derived from three sources: 1. chart review to evaluate quality of care based on measures derived from four algorithms developed from american academy of neurology quality measures and typically documented in the medical record. this will be a before-after study design in which measurements will be obtained before and after the installation of chica-cn. 2. parent phone surveys to document the parent experience in terms of physician-patient communication, parent engagement, and satisfaction with use of the patient facing tablet interface. these data will be collected from families of patients identified for the chart review after the intervention. 3. physician user satisfaction measures, including perceived value of the system and ease of use in general and as regards individual clinical issues. surveys will be administered to physicians and clinic staff who used chica-cn.

Eligibility criteria:
inclusion criteria: * must be patients in the participating clinical practices meeting inclusion criteria for one of the four cohorts exclusion criteria: * n/a

Keywords: quality of care child health improvement
the effect of an inter-disciplinary program, including mbsr, in breast cancer survivors with chronic neuropathic pain

Conditions: Breast Cancer; Painful Neuropathy; Chronic Pain; Worries; Pain or Disability; Quality of Life

Summary: chronic neuropathic pain is a common problem for breast cancer survivors. even with the best medical treatment, some survivors continue to experience disabling pain. it is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. the investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (mbsr) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. the investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.

the investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. all will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group mbsr program or a wait-list. all participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to mbsr or waiting, after the completion of mbsr as well as at 3-month follow-up. a sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in mbsr. the primary outcome is pain interference. the investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the brief pain inventory-interference scale, in each group. the primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean brief pain inventory interference score) in the interdisciplinary program in comparison to medical treatment alone.

Eligibility criteria:
inclusion criteria: * female. * 18 years or older. * completed treatment for breast cancer a minimum of 1 year prior to study enrollment. * have been experiencing neuropathic pain following their cancer treatment for a minimum of 6 months. * report pain intensity levels ≥4 (moderate to severe). exclusion criteria: * metastatic disease or current evidence of cancer recurrence * pregnancy or breastfeeding * unable to complete questionnaires in english or french.

Keywords: mindfulness breast cancer painful neuropathy chronic pain fmri disability quality of life cytokines cortisol
efficacy and safety evaluation of glepaglutide in treatment of short bowel syndrome (sbs)

Conditions: Short Bowel Syndrome

Summary: the primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. glepaglutide is the international nonproprietary name and usan for zp1848.

a phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (sc) injections in patients with short bowel syndrome (sbs).

Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activity. * diagnosis of sbs defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to ps need. no restorative surgery planned in the trial period. * requiring ps at least 3 days per week and maintains a stable ps volume for at least 2 weeks. * in case of remnant colon: documented colonoscopy which does not give rise to any safety concerns. exclusion criteria: * more than 2 sbs-related or ps-related hospitalizations within 6 months prior to screening. no sbs-related hospitalizations within 30 days prior to randomization. * poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial. * bowel obstruction. * known radiation enteritis or significant villous atrophy. * cardiac disease defined as: decompensated heart failure (new york heart association \[nyha\] class iii-iv), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening. * clinically significant abnormal ecg. * repeated systolic blood pressure measurements \> 180 mm hg. * human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease. * any history of colon cancer. history of any other cancers unless disease-free state for at least 5 years. * estimated creatinine clearance \< 30 ml/min. * severe hepatic impairment. * use of glp-1, glp-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to screening. * use of dipeptidyl peptidase (dpp)-4 inhibitors within 3 months prior to screening. * unstable systemic immunosuppressive therapy within 3 months prior to screening. * unstable biological therapy within 6 months prior to screening. * females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. * previous exposure to glepaglutide. * current, or within 30 days prior to screening, participation in another interventional clinical trial that includes administration of an active compound. * any condition or disease or circumstance that in the investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.
the influence of silicone oil on nerve fiber layer thickness after pars plana vitrectomy

Conditions: Rhegmatogenous Retinal Detachment; Toxic Effect of Silicone; Glaucoma Due to Silicon Oil

Summary: the aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (oct) in patients following pars plana vitrectomy.

the aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (oct) in patients following pars plana vitrectomy. the study will include 60 patients with a temporary silicone oil tamponade who will be surgically treated with pars plana vitrectomy for rhegmatogenous retinal detachment and proliferative vitreoretinopathy. all subjects will be subdued to complete ophthalmologic examinations, measurements of the retinal nerve fiber layer thickness by an oct examination, tests of the visual field with the use of an octopus computed perimeter (automated static perimetry) and fdt-perimetry - both prior to the surgery, and on control visits for check-up during the postoperative period. all results provided by postoperative examinations will be compared with one another. the study is expected to provide data on the effect of the silicone oil on thickness of the retinal nerve fiber layer. it is also planned to show possibilities and advantages of oct as a method of choice in the follow-up of patients with intraocular silicone oil tamponade.

Eligibility criteria:
inclusion criteria: - patients with rhegmatogenous retinal detachment exclusion criteria: * preexistent glaucoma * previous retinal surgery * placement of scleral buckle during surgery * patients with more than 1/2 of emulsified silicone oil in anterior chamber postoperatively * patients who develop silicone oil keratopathy postoperatively * patients who develop silicone oil cataract which blocks visualization of posterior segment

Keywords: rhegmatogenous retinal detachment pars plana vitrectomy silicone oil retinal nerve fibre layer
characterization of olfactory perception in post-traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: the core symptoms of post-traumatic stress disorder (ptsd) include flash backs, intrusive pictures and thoughts related to the traumatic event, hyperalertness, avoidance of traumatic relevant environmental triggers and emotional dysregulation. some studies suggest that ptsd is also associated with impaired olfactory perception, which seems quite intuitive regarding the close anatomical-functional connections between olfactory and emotional circuits. furthermore, some studies reported that olfactory stimuli can trigger flashbacks in subjects with ptsd. however, up to know available data is scarce and heterogeneous concerning that topic. the goal of the study is to determine the olfactory phenotype of subjects with ptsd. more precisely, this project aims at filling the above mentioned gap by systematically assessing the olfactory perception of subjects with ptsd along five dimensions: olfactory identity, hedonic value, familiarity, desirability and edibility. as a secondary goal, the relative weight of olfaction compared to the other senses in the relived memories of subjects with ptsd will be assessed. the investigators here hypothesize a global impairment in olfactory processing (intensity, hedonicity, familiarity and edibility judgments) in ptsd subjects, compared with healthy subjects.


Eligibility criteria:
inclusion criteria: * age between 18 to 50 * subjects with ptsd exclusion criteria: * patients with a neurological history such as stroke, head trauma (e.g. exposure to explosions, sports injury...), neurodegenerative disease... * any psychiatric condition except ptsd and major depressive disorder * current or recent use of psychotropic drugs that may affect olfactory function. * any current or remitted addictive disorder. * pregnancy and breast-feeding women

Keywords: post traumatic stress disorder olfactory perception olfaction odor
effects of customized silicone digital orthoses in people with diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: the present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the international working group on diabetic foot.

the present study aims to evaluate the effects and safety of the use of customized silicone digital orthoses for six months in the plantar pressure distribution during gait, in the reduction of pre-ulcerative lesions and plantar ulcers at forefoot, in functional balance, foot deformities, quality of life and foot health and functionality in people with diabetes and and diabetic neuropathy with risk category 2 and 3, according to the international working group on diabetic foot. the sample will consist of 60 participants, who will be randomly allocated, in a randomized controlled clinical trial, in the control or intervention groups and evaluated at baseline, 3 and 6 months of follow up. the assessment includes (1) classification of the risk of foot ulceration, (2) analysis of plantar pressure during gait, (3) quality of life, (4) foot deformities, (5) pre-ulcerative lesions, (6) functionality and general health of the feet. the hypothesis of this study is that the intervention group will present a reduction in the peak pressures during gait, a reduction in hyperkeratosis at forefoot, a reduction in the incidence and recurrence of forefoot ulcerations, and improved quality of life and in the functionality and health of the foot, when compared to the control group after six months of use of silicone digital orthoses.

Eligibility criteria:
inclusion criteria: * diagnosed type 1 or 2 diabetes, with diabetic peripheral neuropathy confirmed by loss of sensitivity measured by 10 g semmes-weinstein monofilament or 128hz tuning fork and by the fuzzy score (www.usp.br/labimph/fuzzy); * presence of 1 or more deformities at the forefoot region (claw toes, hammer toes, mallet toes, overlapping toes, hallux valgus, prominence of the metatarsal heads or reduction/displacement of the fat pad); * ability to walk independently with or without the aid of a walking device; exclusion criteria: * presence of other diagnosed neurological diseases; * presence of dementia or inability to give consistent information; * presence of major vascular complications; * receiving any physiotherapy intervention; * major vascular complications (ischemia) * presence of an active ulcer at the time of baseline assessment; * major amputations; * minor amputations, except toes.

Keywords: diabetes mellitus diabetic foot plantar pressure orthosis digital quality of life