Kornimate/medical-research-clean huggingface dataset:
margin status after pancreaticoduodenectomy for cancer

Conditions: Pancreatic Cancer; Cholangiocarcinoma; Ampullary Cancer

Summary: this multicentric prospective randomized controlled trial (rct) compares the leeds pathology protocol (leepp) with other "conventional" pathological protocol of pd specimen for periampullary cancer. our aims were to evaluate the impact of the protocol and of the clearance on r1 rate and its prognostic value.


Eligibility criteria:
inclusion criteria: * pancreaticoduodenectomy for periampullary cancer exclusion criteria: * diagnosis of neuroendocrine neoplasm; * previous pancreatic surgery; * frozen section of each transection margins not performed or presence of positive transection margins without further resection (r1 intraoperative resection); * presence of macroscopic residual tumor (r2 resection).

Keywords: periampullary cancer margin status r1 resection clearance margin
molecular pathways involved in the pathogenesis and behavior of mesenchymal phosphaturic tumors causing oncogenic osteomalacia

Conditions: Tumor Induced Oncogenic Osteomalacia

Summary: the tumors that cause oncogenic osteomalacia (tio) express and release in the circulation phosphaturic factors such as fibroblast growth factor-23 (fgf-23) that decrease renal phosphate absorption through acting in the proximal renal tubule and decreasing type 2a and 2c sodium-phosphate co-transporter. they typically follow a benign clinical course and even in the rare malignant cases, local recurrence occurs in less than 5% and distant metastasis are very uncommon. in this study we aim to investigate the role of other molecular pathways such as erk1, erk2, mtor, egfr, mek1, mek2, vegfr3, akt1, akt2, igfr-1, igfr-2, pdgfra, pdgfrb, cmet, fgfr2, apart from fgf23, klotho and phex, in the behavior of histopathologically benign mesenchymal phosphaturic tumors.

study protocol cell culture bone marrow and tissue samples will be obtained from the patients after they will give their written informed consent. material will be maintained in rpmi culture medium (sigma, r0883, germany). peripheral blood mononuclear cells (pbmcs) from healthy donors will be used as control. for detection of cancer cells in our samples we perform flow cytometry using epcam magnetic beads (39-epc-50; gentaur), and the negative selection cells (non-cancerous) are isolated and then cultured in a 25-cm2 flask (5520100; orange scientific) with rpmi-1640 medium (r6504; sigma). molecular analysis rna is extracted from cell cultures using rneasy mini kit (74105; qiagen, hilden; germany). iscript cdna synthesis kit (1708891; bio-rad, ca; usa), is used for cdna synthesis and real-time polymerase chain reaction (pcr), is performed using the itaq universal sybr green supermix (1725124; bio-rad). specific primers for each marker and for an endogenous control gene (18s rrna) is designed using genamic expression 1.1 software. a universal reference rna consisting of 10 human cancer cell lines (740000-41; agilent) as well as human genomic dna (g304a; promega) will be used in quantitative pcr (qpcr) reactions statistical analysis the qpcr results will be tested according to the kolmogorov-smirnov test; all the reactions (molecular assays, flow cytometry) are performed in triplicates. a p value \<0.05 is considered significant.

Eligibility criteria:
inclusion criteria: patients with tumor induced osteomalacia exclusion criteria: none

Keywords: fgf-23 growth factors receptors recurrences
mri assessment of impaired glucose metabolism in alzheimer's disease

Conditions: Alzheimer Disease

Summary: diseases of dementia are chronic, untreatable, and cause a massive burden of morbidity. in this proposal, we seek to tackle the problem of better, earlier, and more efficient diagnosis using deuterium metabolic imaging (dmi). the study is divided in two sub-studies: 1) optimization and simplification of dmi protocols, and 2) a cross-sectional study of dmi in alzheimer's patients and healthy controls.


Eligibility criteria:
inclusion criteria: ad-patients: * aged 55-85 years. * male or female. * ad diagnosis by the nia-aa 2011 research criteria.8 * able to give written informed consent. * mini-mental state examination (mmse) equal to or above 18.9 * brain fdg-pet performed at aarhus university hospital consistent with ad. healthy participants: * aged 18-85 years. * male or female. exclusion criteria: all participants: * diabetes or any other metabolic disease. * other significant brain disease: * strokes. * tumors. * chronic small vessel disease (clinically suspected, or fazekas ≥ 2 if clinical mri is available). * epilepsy. * other neurodegenerative or -inflammatory disease. * contraindications for mri: * pacemaker, neurostimulator or cochlear implant. * metal foreign bodies such as fragments and irremovable piercings. * unsafe medical implants (safety of heart valves, hips and the like must be confirmed). * claustrophobia. * largest circumference including arms \> 160 cm. * pregnant - women must be post-menopausal or confirmed non-pregnant by an onsite test.
efficacy evaluation of actigraft in secondary closure of abdominal surgical wound dehiscence

Conditions: Dehiscence Wound

Summary: this is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. the participants will receive a weekly application of actigraft for 4 weeks, or until complete healing of the wound (the earlier of the two). an historic matched-control group of 20 patients will be compared retrospectively


Eligibility criteria:
inclusion criteria: * age \>18 years * women that had a laparotomy no more than 3 weeks before accrual. * surgical wound dehiscence that requires a secondary closure. * time from wound dehiscence \>24 hours and \<6 days. * the open wound includes epidermis, dermis and sub cutaneous fat. * the patient can sign an informed consent form. exclusion criteria: * patients with necrotizing fasciitis * patients with fascial dehiscence * cannot withdraw blood in the required amount (up to 18 ml per week). * known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded. * pregnancy * subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (prednisone- more than 10mg/d or equivalent).
oral manifestations in egyptian children with short stature

Conditions: Oral Manifestations; Short Stature

Summary: children with short stature have been reported to show a higher prevalence of enamel hypoplasia, delayed tooth eruption, and malocclusion compared to children of normal growth status

normal growth is a process in which a single cell develops into a fully grown adult. the growth rate decelerates from the embryonic stage to adulthood, except during puberty. most adults fall within a narrow range of stature, typically between 1.5 to 2 meters. variations in height among children are largely determined by a set of genes inherited from their parents. these genes influence stature distribution within the normal range for nearly 95% of the population, with variation generally being benign. short stature in children-defined as a height-for-age below -2 standard deviations (sd) from the who growth reference-typically corresponding to the 2.3rd percentile, though many texts use the 3rd percentile as the cutoff. short stature can be assessed using various anthropometric instruments. the condition may be physiological, with no abnormalities other than stature (polygenic short stature), or pathological, resulting from systemic illnesses, nutritional deficiencies, psychosocial factors, hormonal imbalances, genetic disorders, or musculoskeletal pathologies. a subset of infants born small for gestational age (sga) may be at risk of persistent short stature. children with short stature have been reported to show a higher prevalence of enamel hypoplasia, delayed tooth eruption, and malocclusion compared to children of normal growth status . these oral manifestations may result from shared pathogenic mechanisms, such as nutritional deficits, systemic disturbances during enamel formation, or hormonal imbalances affecting growth and development. a clearer understanding of these associations may enhance multidisciplinary screening and care. this study aims to investigate the prevalence and characteristics of oral manifestations in egyptian children with short stature, contributing to the limited regional data on this topic.

Eligibility criteria:
inclusion criteria: * • - egyptian children aged 6-12 years. * - diagnosed with short stature (height-for-age \< -2 sd based on who standards). * - diagnosed and confirmed by a pediatric endocrinologist. controls: * - age- and sex-matched children with normal height (height-for-age between -1 and +1 sd). * - recruited from the same geographic and socioeconomic backgrounds. exclusion criteria: * 1- presence of syndromic conditions (e.g., turner syndrome, down syndrome). * 2- chronic diseases (e.g., renal, cardiac, or endocrine conditions other than idiopathic short stature). * 3- long-term medication use known to affect growth or oral development.
lifebio memory digital reminiscence platform

Conditions: Dementia; Cognitive Impairment

Summary: non-pharmacological interventions and person-centered care strategies are important elements of care for people with alzheimer's disease and related dementias. life story work, which uses written and oral life histories to elicit conversation and memories, is an effective intervention for individuals with dementia; however, because of the time-consuming nature of generating useful life story materials, has not been widely implemented in nursing homes and other care environments. lifebio inc. will develop an easy-to-use reminiscence therapy platform - lifebio memorytm - with a novel machine-learning-based application that converts speech to text and generates life stories to serve as an interactive tool to cultivate communication between people living with dementia and their family and caregivers.

this project offers the unique and timely opportunity to evaluate the feasibility, acceptability, and efficacy of lifebio memory's effectiveness as a solution for improving quality of life and quality of care for older adults in long-term care settings, as well as relationships with staff caregivers. this project will implement the the newly developed lifebio memory platform and train caregivers in x sites across the state of ohio, with x residents and x staff participating in a feasibility trial. the program will be evaluated using three waves of data collection from staff during training and throughout implementation, as well as pre-post resident data to evaluate the effectiveness of the new intervention. the lifebio memory platform addresses the need for an intuitive, artificial intelligence-driven solution to the traditionally labor-intensive process of collecting, sharing, and celebrating the life stories of older adults, as well as the development of tools for staff caregivers to enhance person-centered care practices and care-planning. it has great potential for improving psychosocial outcomes for participants, enhancing relationships between care staff and residents, and a cost-effective way to identify ways in which life stories can be used to provide a foundation for preference-based, personalized care. residents will be interviewed at baseline, then again at follow-up (4 weeks later), staff members being trained to utilize the lifebio memory application and provide feedback on the materials, as well as completed a survey at baseline, again at follow-up

Eligibility criteria:
inclusion criteria (staff): * work within a residential care facility participating in the study * speak and read english * able to provide own transportation to and from interviews with residents inclusion criteria (residents * must reside within a participating residential care facility * must be at least 55 years of age * must speak and read english * have a dementia diagnosis * have a score of at least 15 on the mini mental state examination exclusion criteria (residents) * residents will be excluded from the study if they show signs of rapid cognitive decline or physical deterioration over the last 6 months, as evidence by information gained during screening.
unmasking the prevalence of ac in an unselected echocardiographic population

Conditions: Amyloid Cardiomyopathy

Summary: this study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (ac) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of ac among ac-suggestive echocardiograms (interventional phase).

prospective multicenter italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocardiography) and interventional (specific clinical and instrumental work-up to detect the prevalence of amyloid cardiomyopathy among amyloid cardiomyopathy-suggestive echocardiograms).

Eligibility criteria:
inclusion criteria: all the following: * interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women; * left ventricular ejection fraction ≥ 50%; * indexed end-diastolic left ventricular volume ≤ 85 ml/m2. and at least one of the following criteria: * "granular sparkling" appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections; * pericardial effusion regardless of severity; * increased interatrial septum thickness (\> 5 mm); * restrictive filling pattern (dec. time e wave \<120 ms or dec. time e wave ≤150 ms e e/a ratio ≥2) or increased ventricular filling pressures (e/e'15); * speckle tracking derived global longitudinal strain with apical sparing pattern; * increased thickness (\> 5 mm) of mitral and tricuspid valve leaflets. exclusion criteria: * patients aged \ 100 years * echocardiography performed due to known or suspected amyloid cardiomyopathy; * echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies; * refuse to sign the informed consent to the study

Keywords: amyloid cardiomyopathy echocardiography red flags epidemiology bone tracer cardiac scintigraphy
upregulation of psma receptors after androgen deprivation therapy on psma pet/ct imaging in prostate cancer

Conditions: Prostate Cancer

Summary: prostate specific membrane antigen (psma) is a unique membrane bound glycoprotein, which is overexpressed on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. studies have shown that psma pet/ct can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. psma imaging is considered the gold standard in imaging of biochemical recurrence, with detection rate of recurrence in 79.5% of patients, in the largest series of 1007 patients. despite these excellent results, there remains approximately 20% of patients in whom the site of biochemical recurrence cannot be identified and further research is needed into improving detection rates. androgen deprivation therapy (adt), represents the standard of care treatment for most men with a rising serum psa and no evidence of disseminated disease on imaging modalities. there has been some preliminary data that imaging patients early after initiation of adt therapy may increase detection rates of recurrence sites. the objective of this study is to evaluate if prostate cancer patients with biochemical recurrence and negative psma pet/ct can demonstrate in-vivo upregulation of psma receptors in an attempt to improve detection rates of recurrent prostate cancer. patients who are started on adt when clinically indicated, will have repeat psma pet/ct at 4 weeks following initiation of adt therapy.


Eligibility criteria:
inclusion criteria: * male sex * age 18 years or older * previous diagnosis of prostate cancer following radical prostatectomy or primary radiation therapy, with biochemical recurrence. * prior negative psma pet/ct within 2 months prior to study entry * ecog performance status 0 - 3, inclusive * able to understand and provide written informed consent * initiation of androgen deprivation therapy within 5 weeks prior to study psma pet/ct * able to tolerate the physical/logistical requirements of a pet/ct scan exclusion criteria * medically unstable patients * patients who exceed the safe weight limit of the pet/ct bed (200 kg) or who cannot fit through the pet/ct bore (70 cm diameter) * patients with unmanageable claustrophobia
use of hyperbaric oxygen therapy to improve umbilical cord blood stem cell homing and subsequent engraftment

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome (MDS); Hodgkins Lymphoma; Non-Hodgkins Lymphoma

Summary: by doing this study, researchers hope to learn the following: * if providing hyperbaric oxygen (hbo) therapy prior to an umbilical cord blood (ubc) transplant will help to improve the homing process * the safety of hbo administration in the setting of the ubc transplant * the effects of hbo therapy on the engraftment process

research has suggested that high levels of erythropoietin (epo) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. the investigators will investigate the use of hyperbaric oxygen (hbo) therapy to decrease the plasma concentrations of epo prior to ubc transplant and evaluate the resulting impact on ubc homing.

Eligibility criteria:
inclusion criteria: * voluntary written informed consent * subjects must be \>/= 17 yrs and \</= 70 yrs for non-myeloablative transplant * subjects must be \>/= 17 yrs and \</= 55 yrs for myeloablative transplant * subjects with acute myeloid leukemia (aml), acute lymphoblastic leukemia (all), myelodysplastic syndrome (mds), hodgkin's lymphoma (hl) and non-hodgkin's lymphoma (nhl) who are considered for ucb transplant * use of approved form of contraception * karnofsky performance status of \>/= 70% * adequate hepatic, renal, pulmonary and cardiac function. criteria include: * alt (alanine aminotransferase), ast (aspartate aminotransferase: \< 4x iuln (institutional upper limit of normal) * total bilirubin \</= 2 mg/dl * serum creatinine \< 2.0 mg/dl * left ventricular ejection fraction \>/= 45% * fev1 (forced expiratory volume), fvc (forced vital capacity) and dlcd (diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin) exclusion criteria: * pregnancy or breast feeding * severe chronic obstructive pulmonary disease requiring oxygen supplementation * history of spontaneous pneumothorax * history of seizures * claustrophobia * asthma * uncontrolled viral or bacterial infection at the time of enrollment * active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval

Keywords: umbilical cord blood (ucb) stem cell transplant hyperbaric oxygen leukemia lymphoma mds
engaging parents in neuropsychological rehabilitation for childhood cancer survivors: the impact program - a pilot study

Conditions: Pediatric Cancer; Cognitive Dysfunction

Summary: the aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.

cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment. indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions. the "i'm aware: parents and children together (impact)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. the present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.

Eligibility criteria:
inclusion criteria: * cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor * completed primary treatment at least 6 months ago * not terminally ill * attend school * living with one or more parents who speak danish and are willing to co-participate * screened as having parent-reported cognitive and/or neurobehavioral impairment exclusion criteria: • confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment

Keywords: pediatric cancer cognitive dysfunction neuropsychological rehabilitation neurobehavioral impairment
assessing the impact of elelyso on bone involvement currently treated with other erts

Conditions: Gaucher Disease, Type 1

Summary: the objective of this study is to assess elelyso treatment on bone disease in gaucher patients currently treated with other enzyme replacement therapy. experience from early access program (2009-2012) has suggested that some patients who have been stable on imiglucerase have shown poor scores of qcsi with fat fraction below the cut off point of 0.23 which is considered "bone at risk", and have demonstrated remarkable improvement upon switching to elelyso, including particularly 2 patients who did not have any change in dose or any drug interruption prior to the switch. these findings may be explained by the better glycan structure of imiglucerase (see tekoah et al, 2013). the fact that in many patients prevention of bony complications is the main indication for ert highlights the importance of this study, as all clinical trials of all erts heretofore did not include the bones as primary or secondary end-points but only as exploratory, and as such had only limited value,

open-label study in patients with gaucher disease currently treated with commercial erts. eligible patients will receive intravenous (iv) infusions of elelyso every two weeks. the infusions will be administered at the selected medical center or in the home care setup. the dose of elelyso will be the same dose of the other erts . bone parameters qcsi and bmd will be assessed at baseline, 12 months and 24 months. the intention is to open 3 more sites in israel thereby making this iir a multi center national trial

Eligibility criteria:
inclusion criteria: * gd patients, male and female, 18 years or older * currently treated with enzyme replacement therapy for 5 years and more, with a stable unchanged dose in the previous 6 months * imaging features of significant residual bone disease defined as qcsi under 0.3 bone at risk * able to provide written informed consent exclusion criteria: * currently taking another experimental drug for any condition * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the patient's compliance with the requirements of the study. * past exposure to elelyso