Kornimate/medical-research-clean huggingface dataset:
3d prediction of patient-specific response

Conditions: Advanced Cancer; Ovarian Cancer; Glioblastoma Multiforme; Anaplastic Astrocytoma

Summary: this is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3d (ev3d) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.

this protocol defines a prospective, open-label, multi-institutional, non-interventional study for the purpose of examining the assay's clinical use and potential to impact patient outcomes. this study will establish a registry of clinical parameters, including clinical response, clinical outcomes, assay performance and potential utilization across multiple types of advanced cancers in consenting patients who have their tumor tissue tested by the assay. physicians may have access to assay results which which predict therapeutic response to cancer drugs most often prescribed to treat the specified indications. for cancers with standard of care (soc) cancer drug treatments, the assay panel tests soc systemic agents per nccn guidelines, some of which may include both fda approved and off-label fda approved therapies. the assay currently assesses the most common cancer drugs across multiple tumor types. it requires freshly obtained tumor specimen that has not been previously preserved for traditional histologic analysis. the registry will focus initially on tumor types and agents which have been analytically validated with the assay and determined to meet strict laboratory qualifications and standards. the registry will collect data on a limited number of cancer types to include epithelial ovarian cancer (eoc), high-grade gliomas (hgg) limited to anaplastic astrocytoma (aa) and glioblastoma multiforme (gbm), and high-grade rare tumors (rt).

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of or suspected diagnosis of eoc, hgg, high-grade rt * individual must undergo elective surgery or biopsy to remove tumor tissue * consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy * eastern cooperative oncology group (ecog) performance status ≤ 3 * written informed consent in accordance with institutional standards must be obtained from the patient or legal guardian exclusion criteria: * inability or refusal of the patient or legal guardian to sign a written informed consent * failure to have surgery or a biopsy as part of routine clinical practice * refusal to have the assay performed on their tissue * known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable. * inability or unwillingness to receive chemotherapy treatment beyond surgery * any coincidental medical condition that, in the investigator's opinion, would preclude participation in the study or compromise the patient's ability to give informed consent
characterization of the toll-like receptor 7-agonist imiquimod 3.75% as a new surrogate model of itch

Conditions: Itch

Summary: the aim of this research project is to design a new model of human itch by application of zyclara cream. further, the aim is to characterize the model and to verify if the mechanism of action of imiquimod follows the histaminergic or non-histaminergic pathway by using the anti-histamine drug doxepin. the last goal is to evaluate the interaction between the activation of tlr7 receptor and the activation of trpa1 and trpm8 receptors, which are two of the most important receptors involved in the transduction of noxious stimuli, and to evaluate to which extent these three channel populations functionally overlap.


Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other drugs * previous or current neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate * current use of medications that may affect the trial * skin diseases * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Keywords: imiquimod doxepin trans-cinnamaldehyde (ca) l-menthol histamine cowhage
early goal-directed volume resuscitation in severe acute pancreatitis

Conditions: Acute Pancreatitis

Summary: acute pancreatitis (ap) is a common disorder with rising incidence varying between 35 and 80 per 100,000 in europe and the usa. about 15% of patients develop necrotizing pancreatitis (np) with a mortality of up to 42% and frequently prolonged hospitalisation in the survivors. despite a fulminant pathophysiology comparable to that of sepsis, the management of np is still re-active, symptomatic and mainly based on paradigms with low grade evidence. in sepsis beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality have been clearly shown. with regard to these data and several studies of np demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission, early goal-directed fluid resuscitation has the potential of improving outcome also in np. therefore, it is the aim of this rct to demonstrate beneficial effects of early goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such as intra-thoracic blood volume index (itbi), extravascular lung water index (elwi) and stroke volume variation (svv) which can be easily and safely obtained due to recent progress in haemodynamic monitoring. the algorithm is aimed at maintaining adequate resuscitation (itbi, svv) as well as preventing pulmonary over-hydration (elwi).the use of a similar algorithm in cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate levels, duration of ventilation and icu stay.

resuscitation using crystalloids and/or colloids with the following goals: itbi: 850 -1000 ml/sqm, if elwi \ 12\*ml/kg and/or pao2:fio2 \<200 \*elwi \ 65mmhg without catecholamines \ 65mmhg svv \ 65mmhg (map: mean arterial pressure) iapp \>60mmhg (iapp: intra-abdominal perfusion pressure)

Eligibility criteria:
inclusion criteria: 1. diagnosis of pancreatitis: * typical pain * increase in serum lipase or amylase 2. onset of abdominal pain within \<=48h before admission 3. apache ii \>= 8 4. evidence of \>= 1 predictor of severe pancreatitis: * haematocrit \>44% (male) or \>40% (female), respectively * blood glucose \> 125 mg/dl; * crp \>= 10 mg/dl; * age \> 55 years; * leukocytes \>= 16 g/l * got \> 250 u/l; * ldh \> 350 u/l * calcium \< 2,0 mmol/l * ck \> upper normal range * balthazar-score(ct classification) grade c-e * any organ failure exclusion criteria: 1. pregnancy 2. nyha \>ii 3. pre-existing disease with life expectancy \< 3 months

Keywords: severe pancreatitis acute pancreatitis haemodynamic monitoring picco
patients visit prior to hospital admission & intensive care unit

Conditions: Anxiety; Depression; Intensive Care Unit Syndrome

Summary: the present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of patients in an intensive care unit.


Eligibility criteria:
inclusion criteria: * patient at hospital admission for surgery exclusion criteria: * cognitive impairment
characterization & treatment of chronic pain after moderate to severe tbi

Conditions: Traumatic Brain Injury; Pain

Summary: this is a five year multi-site, cross sectional, observational study designed to examine chronic pain and pain treatment after moderate to severe tbi.

the aims of this study are to: 1) determine chronic pain classification (musculoskeletal, headache, central/neuropathic), prevalence, location, duration, and associations with demographic, injury severity, current level of functioning and comorbidities in participants followed in ten centers participating in the national institute on disability, independent living and rehabilitation research and the department of veterans affairs tbims databases; 2) identify extreme groups based on responses to pain (interference and perception of improvement with treatment), or chronic pain extreme phenotypes, in order to define the key differences between those who have a good outcome and those who do not, across factors related to injury, pain severity/location, demographics, and treatment history; and 3) identify treatment practices by clinicians who treat comorbid tbi and chronic pain to determine gaps in availability/accessibility of guideline level treatment, highlighting underserved populations where applicable. results from this study will provide a more detailed picture of the problem of chronic pain after tbi by examining the types of pain that occur after tbi, which may be multiple types of pain for a subset of individuals, as well as the frequency of comorbid conditions. identifying extreme phenotypes, such as demographic, individual, and treatment factors associated with those who have chronic pain but have minimal interference compared to those who are significantly impacted by pain, will allow us to identify treatment targets (behavioral, cognitive, biological, and molecular) to advance a personalized medicine approach to treatment unlike any approach in tbi and chronic pain to date. outcomes from this study will include educational materials on chronic pain and pain treatment to benefit patients, family members, clinicians, and policymakers. data from this study will have a direct impact on clinical practice, informing future work, and promoting understanding of constituent factors in extreme phenotypes.

Eligibility criteria:
inclusion criteria: * participants must be enrolled in the tbi model systems national database (tbnims ndb) at one of the collaborating sites and thus will meet the tbims ndb criteria which are: (1) medical documentation of tbi caused by external mechanical force with either loss of consciousness exceeding 30 minutes, post-traumatic amnesia lasting more than 24 hours, glasgow coma scale score in er of less than 13, or trauma related intracranial abnormality or neuroimaging abnormalities; (2) admitted to the tbi inpatient rehab program at study sites; and (3) minimum age of 16 \[18 for va site\] exclusion criteria: * participants unable to participate in the surveys themselves will not be included (i.e. no proxy surveys).
synbiotics and gastrointestinal function related quality of life after colectomy for cancer

Conditions: Colorectal Neoplasms

Summary: the aim of this double-blinded prospective randomised trial is to explore the potential benefits of early postoperative administration of synbiotics (combination of prebiotics and probiotics) to patients who have undergone colectomy for cancer. the patients are randomised to either synbiotics or placebo administration at the day they are able to tolerate po liquid diet and for 15 days thereafter. primary end points of the study will be: assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively by the use of the validated questionnaire giqli (gastrointestinal quality of life index) secondary end points will be: -assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months postoperatively based on the respective domains of the validated instrument eortc qlq-c30

the study patients are randomized before surgery to receive either synbiotics (synbiotics group) or placebo (control group). equal randomization is accomplished using a computer-generated random allocation schedule. the method of allocation concealment is sequentially numbered sealed opaque envelopes technique. both synbiotics and placebo preparations are in foil-sealed sachets stored in identical numbered containers. both study products are white powders, identical in weight, smell, and taste. thus, the identity of the specific product is blind to participants, support staff and investigators for the entire duration of the study period.

Eligibility criteria:
inclusion criteria: * colectomy for histologically proven colorectal adenocarcinoma exclusion criteria: * pregnancy, * hereditary cancer, * history of inflammatory bowel disease, * metastatic disease at presentation, * emergency operation, * major postoperative complications
weight loss and exercise in obese, physically limited, older women and men

Conditions: Obesity

Summary: the purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.

obesity causes serious medical complications and impairs quality of life. moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. the primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. the central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. to test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index \[bmi\] \> 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.

Eligibility criteria:
inclusion criteria: * obese (bmi 30 or greater) * elderly (age 65 years or older) * frailty exclusion criteria: * major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. * examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.

Keywords: obesity aging exercise diet weight loss physical function obesity in the elderly
enhanced quality in primary care for elders with diabetes and dementia

Conditions: Diabetes; Dementia; Alzheimer Disease

Summary: the purpose of this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (dm) in patients with alzheimer's disease and related dementia (adrd) in primary care, provider (pcp) workflow enhancements supported by a panel manager(pm) for workflow support, electronic health record (ehr) decision support and feedback, and pcp collaborative learning.


Eligibility criteria:
inclusion criteria: * patient must receive care at participating nyu fgp clinics. * patient must be english or spanish speaking. * patient must have dm diagnosis. * patient must have documented cognitive impairment or an adrd diagnosis. * patient must have someone who is identified as a family or friend who provides caregiving assistance. caregiver: * caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions. * caregiver must be english or spanish speaking. * caregiver must demonstrate capacity to consent to research participation. * caregiver must be at least 21 years old. exclusion criteria: patient: * patient does not receive care at participating nyu fgp clinics. * patient is not 65 years and older. * patient is not english or spanish speaking. * patient does not have dm diagnosis. * patient does not have documented cognitive impairment or an adrd diagnosis. * patient has severe dementia, other terminal illness with \<6 months to live, and/or is hospice eligible. * patient does not have a caregiver. caregiver: * caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions. * caregiver is not english or spanish speaking. * caregiver lacks capacity to consent to research. * caregiver is under 21 years old.
identify the genes polymorphisms related to non-familial bradyarrhythmia

Conditions: Bradyarrhythmia

Summary: bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major cause necessitating pacemaker implantation. in contrast to familial bradyarrhythmia known as by mutations at particular ion channels, limited information is available for the mechanistic study in non-familial bradyarrhythmia. possible gene polymorphisms related to non-familial bradyarrhythmia were studied. comparison of multi-locus analysis and single-locus analysis will be analyzed between the cases and controls. functional studies will perform to clarify the results of association study.


Eligibility criteria:
inclusion criteria: * the patients with non-familial bradyarrhythmia exclusion criteria: * familial bradyarrhythmia reversible bradyarrhythmia bradyarrhythmia after open heart surgery and severe organic heart diseases
automation oxygen flow titration in spontaneously breathing infants

Conditions: Bronchiolitis

Summary: the objective of this study is to assess the efficacy of the freeo2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age. freeo2bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

this is a controlled, randomized, open-label, multicentre trial. patients will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. patients will be randomized either in the "freeo2" group for automatic oxygen flow titration or in the "manual" group for oxygen therapy with manual flow titration. the spo2 will be recorded continuously in both groups of the study using the freeo2 device throughout the duration of hospitalization; in the group "freeo2 ", the device will record the data continuously and allow the automation of oxygen titration - in the group "manual", the device will only be used to monitor spo2 and heart rate.

Eligibility criteria:
inclusion criteria: * infants from 1 month of age and less than 1 year of age who present a first episode of bronchiolitis and require oxygen therapy * informed consent of parents (written informed consent will be obtained from the patients' parents or legally authorized representatives) * affiliation to the french social security system exclusion criteria: * need for oxygen flow higher than 3 l / min to maintain spo2 greater than 92% * patient with severity criteria according to the 2019 french national authority for health (has) guidelines and for whom it's indicated to maintain spo2 above 94% * criteria of severity justifying from the start another technique of assisted ventilation: * polypnea: respiratory rate (fr)\> 80 c / min. * consciousness with glasgow score (gsc) \<or = 12. hemodynamic instability (mean arterial pressure (map) \<- 2 sd for age or use of vasopressors). * cardiac or respiratory arrest. * pco2\> 55 mm hg and ph \<7.20 when blood gas are performed * need for urgent surgery * contraindication to the freeo2 device as described in the user manual * lack of informed consent from parents * premature birth with a gestational age at birth under 36 weeks * severe co-morbidities (cystic fibrosis, immune deficiency, congenital heart disease, neuromuscular illness)

Keywords: hypoxemia infants oxygen therapy bronchiolitis
the role of neurofeedback training and pain management in post-operative shoulder rehabilitation

Conditions: Pain, Shoulder; Post Operative Pain

Summary: the primary aim is to compare the efficacy of neurofeedback training (nft) and pain management protocol (pmp) in pain reduction, restoration of shoulder function, and improved cognitive performance as the post-operative rehabilitation protocols in shoulder pain patients.

the primary aim is to compare the efficacy of neurofeedback training (nft) and pain management protocol (pmp) in pain reduction, restoration of shoulder function, and improved cognitive performance as the post-operative rehabilitation protocols in shoulder pain patients. while the former modulates neural activity, the latter focuses on biopsychosocial aspects of pain, respectively. also, we will measure the peripheral cytokine levels of rotator cuff injury to clarify the possible role of peripheral inflammation on central neural activities. by incorporating the behavior (both motor and cognition), peripheral inflammation, and neural activity, we believe this study would bridge the gap between mind and body as the "whole person" approach to understanding musculoskeletal pain and its appropriate therapy.

Eligibility criteria:
inclusion criteria: * pain ≥3months and ≥3 days per week * pain intensity ≥ 40 (vas scale from 0 no pain to 100 very painful) * participants in the neurofeedback training group and pain management group were asked not to involve other treatment when they are in the 6th-12th week intervention period. * the surgical indication would be based on orthopedics opinions. exclusion criteria: * shoulder surgery in the prior 3 years * osteoporotic vertebral fractures or rheumatologic diseases * chronic wide- spread pain syndromes (fibromyalgia or chronic fatigue syndrome) * pain at any other location in addition to shoulder pain * neurological disease, i.e., stroke, parkinson's disease, etc.. * cancer

Keywords: shoulder pain post operative pain pain management neurofeedback