Kornimate/medical-research-clean huggingface dataset:
mr-guided adaptive sbrt of primary tumor for pain control in metastatic pdac

Conditions: Pancreatic Cancer

Summary: the maspac trial investigates the added benefit of mr-guided adaptive sbrt of the primary tumor embedded between standard chemotherapy cycles for pain control and prevention of pain in patients with metastatic pdac (mpdac).

patients not progressing after 8 weeks of standard of care systemic therapy (soc-ct: minimum doublet chemotherapy) will be included and randomized between arm a, receiving mr-guided adaptive sbrt of the primary tumor combined with continuation of soc-ct, and arm b, continuing soc-ct without sbrt. arm a: the primary tumor is treated with sbrt (6.6 gy x 5) on a mr-linac in breath-hold technique. this scheme was shown to have a reasonable toxicity profile on a conventional linac. a low toxicity profile is even more important in patients with metastatic and therefore definitively incurable cancer. therefore, treatment is performed on a mr-linac to deliver high doses to the tumor while keeping the toxicity profile as low as possible. for this purpose, daily adaptive planning is performed aiming to maintain stringent dose constraints for organs at risk (duodenum / stomach / bowel / kidney). chemotherapy will be continued after sbrt. arm b: continuing soc-ct (according to clinical routine appr. 2 weeks after the previous cycle) without sbrt.

Eligibility criteria:
inclusion criteria: * male and female patients with histologically proven, metastatic pancreatic adenocarcinoma of the pancreatic head or body amenable for mr-guided adaptive sbrt with at least stable disease after 8 weeks of standard of care doublet chemotherapy * age \>18 years * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * ability to follow study instructions and likely to attend and complete all required visits exclusion criteria: * subjects not able to give consent * subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical study * simultaneous participation in another clinical study or participation in any clinical trial involving an investigational medicinal product or treatment within 30 days prior to beginning of this study * subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the study results, or may interfere with the subject's participation in this study * women of child bearing potential or sexually active males not willing to use effective contraception while on treatment and 12 weeks after the end of treatment (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases * biopsy proven tumor invasion into the stomach and/or duodenum * medically uncontrolled pain

Keywords: metastatic pancreatic cancer sbrt mr linac chemotherapy pain control
a efficacy, safety and pharmacokinetic study of xp21279 and sinemet® in parkinson's disease subjects

Conditions: Parkinson's Disease

Summary: the purpose of the study is to assess the efficacy and safety of xp21279/carbidopa in comparison to sinemet as well as evaluate the pharmacokinetics (pk) of levodopa after administration of xp21279/carbidopa and sinemet and to explore exposure-response relationships in a subset of subjects.


Eligibility criteria:
inclusion criteria: 1. subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the screening period: * wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and * an average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight. 2. subjects must be on one of the following stable qid or 5 times daily regimens for at least 4 weeks prior to screening: sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa exclusion criteria: 1. history, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism. 2. subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day 3. subjects who have significant neurological symptoms not accounted for by parkinson's disease 4. subjects who are taking sinemet® cr, parcopa®, concomitant comt inhibitors (i.e., entacapone or tolcapone), stalevo®, or benserazide containing levodopa preparations madopar® or prolopa®.
feasibility and acceptability of w-genzd vs cbt-light teletherapy for adolescents seeking mental health services

Conditions: Depression; Anxiety

Summary: the primary aim of this study is to determine the feasibility and acceptability of the w-genzd mobile application among a group of adolescents and who have screened and triaged into low-intensity treatment within the children's hospital of the king's daughters. the secondary aim of this study is to determine the preliminary comparative efficacy of w-genzd and cbt-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment relative to baseline. the third aim of this study is to investigate potential differences between group differences on working alliance. an exploratory aim of this study is to observe and describe the utilization and outcomes of the safety procedures utilized within this study.


Eligibility criteria:
inclusion criteria: 1. have completed triage at the children's hospital of the king's daughters (chkd) and have been deemed appropriate for the low-intensity intervention track, given presenting problem(s) of depressive or anxiety symptoms 2. adolescent 13-17 years of age, inclusive 3. u.s. resident 4. both adolescent participant and parent/guardian are able to read and write in english 5. own or have regular access to a smartphone (android or ios smartphone with a recent, supported operating system), that can receive sms messages, and reliable wi-fi access or sufficient data to engage with assigned treatment condition for the duration of the study 6. if currently prescribed antidepressant medications (e.g. escitalopram/lexapro, fluoxetine/ prozac), antipsychotic medications (e.g. aripiprazole, asenapine, olanzapine, paliperidone, quetiapine, risperidone), or stimulants (e.g. amphetamine/adderall, methylphenidate/ritalin) and alpha agonists (e.g. atomoxetine/strattera, guanfacine/intuniv) they are at a regular, stable dose for at least 60 days at screening 7. not currently actively engaged is psychotherapy 8. available and committed to engage with the program and complete assessments for a 8-week duration 9. family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms exclusion criteria: 1. lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder) 2. lifetime diagnosis of bipolar disorder 3. lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g. autism, asperger syndrome, rett's syndrome) 4. current diagnosis of developmental delay or intellectual disability 5. suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months 6. history of (a) drug and/or alcohol abuse within the past 12 months 7. current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon) 8. previous woebot application use 9. enrollment of more than one member of the same household

Keywords: mental health adolescence digital therapeutic cognitive behavioral therapy chatbot mental health app
subclinical nail involvement in relevant skin diseases

Conditions: Nail Diseases

Summary: onychopathies constitute one of the major challenges faced by a dermatologist in terms of its early detection and diagnosis . many disorders can affect the nails, including deformity and dystrophy, infections, and ingrown toenails. infections can involve any part of the nail and may or may not change the nail's appearance. most nail infections are fungal (onychomycosis), but bacterial and viral infections occur .

nails are characteristically affected in skin diseases such as psoriasis (speckling, psoriatic oil spot, crumbling nails, pachyonychia) ,lichen( anonychia, dystrophy) ,alopecia areata (speckling, trachyonychia, longitudinal grooves, leukonychia), atopic dermatitis (shiny nails, transverse grooves, speckling, paronychia) and other diseases. nail disorders are assessed by clinical inspection, dermatoscopy , microbiological (including mycological) testing, and histopathological examination by nail biopsy . utility of dermoscope as a tool for detection is increasing by the day and its use in onychopathies needs to be explored . nail dermoscopy has initially been used for the assessment of nail pigmentation . but its utilization has expanded for the diagnosis of all nail disorders; it became a routine diagnostic instrument, as its reveals helpful information. dermoscopy can be applied to all visible parts of the nail unit, and even the nail matrix can be studied, in conjunction with intraoperative methods . nail dermoscopy offers many advantages. mostly, it enhances visible nail features; however, it can also help identify additional unique and fascinating features, not visible to the naked eye. it is practical, noninvasive and still opens up a second microscopic level of inspection. it contributes toward confirmation of diagnosis and assessment of treatment response as well as prognosis. in a cross-sectional study to detect signs of subclinical nail involvement in 68 patients with chronic plaque psoriasis, forty-six patients showed nail dermoscopic findings. coarse pits, onycholysis, oil drop sign and splinter hemorrhages were seen . to the best of the investigator's knowledge, no available studies in the literature evaluate subclinical nail affection in skin diseases as lichen planus, atopic dermatitis and auto immune bullous diseases. hence, with the help of a dermoscope,early diagnosis and appropriate treatment can be instituted.

Eligibility criteria:
inclusion criteria: - patients complaining of common skin diseases ( psoriasis, atopic dermatitis, alopecia, lichen planus, and bullous diseases) exclusion criteria: * patients who had gross visible nail changes will be excluded
evaluation of the impact of a personalized program of adapted physical activates in patients with parkinson disease

Conditions: Parkinson Disease

Summary: our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with parkinson disease. using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. in addition, the evaluation of the caregiver's actigraphy and hardship (zarit scale) will provide interesting data from this population.


Eligibility criteria:
inclusion criteria: * the patient and their carer have given their free and informed consent and signed the consent form * the patient must be insured of the beneficiary of an insurance policy * the patient is available for the 6 month follow-up * the patient is between 40 and 80 years old * the patient has experienced symptoms of parkinson disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month) * the functional impact and duration of fluctuations is ≥3 (mds updrs) * the patient can walk autonomously, including using a technical aid * the patient does not have any regular physical activity excluding physiotherapy sessions * the patient has daily help from a caregiver exclusion criteria: * the subject and/or their caregiver is participating in another study * the subject and/or their caregiver is in a period of exclusion determined by a previous study * the patients is under judicial protection or state guardianship * it proves impossible to give the patient and/or the caregiver clear information * the patients and/or the caregiver reuses to sign the consent form * the patient is pregnant or breast feeding * the patient has anxiety or depression (score had≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities * the patient cannot walk * muscular tremor preventing the actigraphy measurement. outside normal range values for updrs measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor
multimodal brain monitoring as an early warning and prognostic tool for acute brain injury

Conditions: Acute Brain Injury

Summary: the primary aim of this study is to evaluate the effectiveness of multimodal brain monitoring technologies as both an early warning system and a prognostic tool in patients suffering from acute brain injuries. this research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.

acute brain injury, including traumatic brain injury (tbi) and stroke, presents significant challenges in clinical management, primarily due to the complexity of the brain's response to injury and the critical timing required for effective intervention. multimodal brain monitoring, which integrates various physiological data points like brain electrical activity, cerebral blood flow, and brain tissue oxygenation, offers a comprehensive view of a patient's cerebral status. this study builds on the premise that a better understanding and real-time monitoring of these variables can significantly improve patient outcomes by enabling timely and targeted interventions.

Eligibility criteria:
inclusion criteria 1. must be 18 years of age or older. 2. diagnosed with traumatic brain injury (tbi) or has suffered from acute brain injury due to intracranial hemorrhage or subarachnoid hemorrhage. 3. defined as an admission glasgow coma scale (gcs) eye response score of 1 (unable to open eyes) and a gcs motor response score of ≤5 (unable to obey commands). 4. occurs within 48 hours of admission, where the patient does not open eyes and motor score drops to 5 or below. exclusion criteria 1. patients who were not admitted to the intensive care unit (icu) are excluded. 2. patients with forms of acute brain injury other than those specified (tbi, intracranial hemorrhage, subarachnoid hemorrhage) are also excluded. 3. patients with known severe liver or kidney dysfunction are excluded. 4. patients whose vital signs are extremely unstable after admission, with a very poor prognosis and considered unable to survive, and whose family has decided to forgo further treatment. 5. patients who had a modified rankin scale greater than 2 before the onset of the current illness. 6. patients with a history of congenital or acquired hemorrhagic diseases, coagulation factor deficiencies, or thrombocytopenic disorders. 7. pregnant or lactating women, as well as those planning to become pregnant within the next 90 days. 8. patients with severe psychiatric disorders or dementia who are unable to provide informed consent or complete follow-up requirements. 9. patients who have participated in other interventional clinical trials within 30 days prior to randomization, or who are currently participating in other clinical research. 10. any other reasons that the researcher deems unsuitable for participation in this trial.
the effect of food hedonics on appetite hormones levels

Conditions: Eating Behavior

Summary: 30-40 healthy male subjects with a bmi between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. the two versions will differ only in palatability and will be equicaloric. subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. the quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. the visual analogue scale will be used for huger ratings.


Eligibility criteria:
inclusion criteria: * gender: male * age: 18-50 years * body mass index (bmi): 18.5-24.9 kg/m2 * stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status) exclusion criteria: * smoking * substance abuse such as alcohol or drugs * medical or psychological illness * use of medications * previous gastrointestinal surgery * history of weight fluctuation (weight loss of greater than 5% within the past 3 months)

Keywords: hedonics, ghrelin, hunger
postprandial differences after herring and beef

Conditions: Cardiovascular Disease

Summary: while observational studies often find that diets rich in fish reduce the risk of disease, and that diets including a high intake of red meat are associated with increased risk of cardiovascular disease and cancer, the difference in health effects between red meat and fish are rarely researched in intervention studies. the investigators hypothesise that the post-prandial plasma response of lipids and markers of cardiovascular disease risk will be more favourable after intake of herring compared to beef. in addition, while pickling herring in a brine/sugar solution is a common form of preparation, little is known if there is a difference in potential health effects based on the preparation of herring. the investigators will compare baked and pickled herring to understand if preparation is potentially an important factor to be considered when looking at intake of fish and health.


Eligibility criteria:
inclusion criteria: * male * 35-67 years * bmi \>30 kg/m2 * normally eats lunch and dinner exclusion criteria: * smoke or oral tobacco use * use of prescription or recreational drugs likely to interfere with primary outcome * change in body weight in the month prior to the study * abnormal blood biomarker values (assessed by a clinician)

Keywords: fish herring meat beef
antibacterial tactics based on presepsin level in thoracic aorta surgery patients

Conditions: Aortic Aneurysm and Dissection; Cardiac Valve Disease; Thoracic Aortic Aneurysm; Thoracic Aortic Dissection

Summary: according to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. previous study carried out in petrovsky nrcs related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis.

various biomarkers are being used to improve the quality of prediction models aiming to improve clinical outcomes and reduce mortality in the cardiac surgery patient population. in particular, presepsin and procalcitonin have comparable prognostic value for adverse renal, cardiovascular and respiratory outcomes in cardiac surgery patients. in addition, presepsin has in-hospital, 30-day, and 6-month prognostic mortality rate value and is also highly effective for the early diagnosis of sepsis in patients in the intensive care unit. in the previous study the absence of an increase in the level of presepsin in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period (or 4.15, 95% ci: 1.83-9.41). the combination of two risk factors - a presepsin level at the end of surgery \>519.5 pg/ml and the absence of an increase in the presepsin level in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period (or 5.80, 95% ci: 2. 19-15.35). the hypothesis of this study suggests that in case of insufficient prevention of infectious complications, based on the dynamics of presepsin, it is permissible to administer the broad-spectrum drug ampicillin/sulbactam 3 g. every 6 hours for at least 72 hours from the date of surgery. it is expected that changes in the tactics of antibacterial therapy will reduce the number of inflammatory complications in patients undergoing surgery on thoracic aorta.

Eligibility criteria:
inclusion criteria: thoracic aorta aneurysm/dissection exclusion criteria: blood sample hemolysis

Keywords: biomarkers presepsin complications aortic arch aorta aortic aneurysm ascending aorta cardiac surgery
stimulation and validation of the pupillary dilation for the detection of pain in analgosedated patients under mechanically ventilation in intensive care unit

Conditions: Pain

Summary: this project has 2 phases. phase 1: diagnostic test study, to evaluate the efficacy of the variation of pupillary size (pdr) to detect pain in icu patients regarding to behavioural pain scale (bps) and escid (conductual scale pain index). phase 2: controlled and aleatorized clinical trial to evaluate efficacy in pdr monitoring after painful assessed minimum stimulus with the best diagnostic efficiency on phase 1, as a need of analgesia indicator tool. the sample will be patients over 18 years, sedated and mechanically ventilated, with an initial bps of 3, rass between -1 and -4, not able not to communicate , with inform consent signed. exclusion criteria will be: ophtalmologic pathology and administration of drugs interfering pupillary reflexes. measurements before/during pain/non-pain situations, aspiration of secretions and calibrated intensity stimulus through the pupilometer algiscan. the investigators will study association between pain according to bps/escid and pupillary dilatation according to pupillometry and percentage of patients with pain and preanalgesia according to pupillometry and standard clinical practice.


Eligibility criteria:
inclusion criteria: * patients over 18 years. * analgosedated patients under mechanical ventilation. * unable to communicate (verbal or motor). * patients with initial bps of 3, and rass from -1 to -4. * familiar prior informed consent. exclusion criteria: * patients treated with muscle relaxants. * severe critical polyneuropathy. * pupillary reflex affectation in diabetic patients (diabetic papillopathy,glaucomatous optic neuropathy) or any other pathologies like adie´s syndrome, argyl-robertson pupil. * patients with tansmisible ocular infections. * patients with possible injury of the third carnial nerve (horner´s syndrome) due to injury to the brainstem, cervical cord, cancer of the upper lobe the lung, dissection of the carotid and/or cluster headache. * acute cerbrovascular conditions with glasgow coma scale less than 6, or increased intracranial pressure, or pontine base infarction. * drugs that interfere with the pupillary reflex (clonidine, dexmedetomidine, metoclopramide, tramadol, droperidol, ketamine, nitrous oxide). * patients under metoclopramide, if given 10 minutes prior the measurement of the pupillary reflex (pdr). * patients during the first 24 hours after cardiac arrest (crp). * severe unestable comorbidity with doses of norepinephrine\> 0.6 microg/kg/min and/or dobutamine\>10 microg/kg/min or drenalin any doses. * patients with untreated pheochromocytomas. * refuse to participate in the trial.

Keywords: pupillary dilation analgosedated mechanically ventilation