Kornimate/medical-research-clean huggingface dataset:
anatomical resection of the liver for hepatocellular carcinoma: a new ultrasound guided approach

Conditions: Hepatocellular Carcinoma

Summary: anatomical resection is the gold standard approach for liver resection in patients with hcc. a new method for that by means of ious-guided finger compression has been devised.

we herein describe a novel technique for the demarcation of the resection area by means of ious-guided finger compression to systematically accomplish anatomical segmental and subsegmental resections. using the ious, the tumor and the level targeted for compression are identified. than, under the ious guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. this maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. once the area is demarcated, liver dissection is started under intermittent pringle's maneuver.

Eligibility criteria:
inclusion criteria: * patients suitable for surgical approach carries of hcc * serum bilirubin level lower than 1.5 mg/dl exclusion criteria: * presence of ascites * serum bilirubin level equal or higher than 1.6 mg/dl * conditions (size, vascular relation, or infiltration) demanding resection larger than a segmental area * tumor thrombus in portal or hepatic veins

Keywords: intraoperative ultrasound segmentectomy hcc
therapeutic drug monitoring of brodalumab in psoriasis patients (bioloptim-bro)

Conditions: Psoriasis Vulgaris

Summary: biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. but they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.

patients will be included after siging informed consent. after inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). during each study visit, blood will be taken in order to quantify ctroughs and/or anti-drug antibodies towards brodalumab. in addition, the psoriasis severity and area index (pasi) and the investigator's global assessment (iga) score will be evaluated by a physician. patients complete the dermatology life quality index (dlqi) and european quality of life eq-5d instrument at each visit.

Eligibility criteria:
inclusion criteria: 1. participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. participants must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: 1. participants who have currently a predominant nonplaque form of psoriasis 2. participants who are pregnant, nursing or planning a pregnancy 3. participants who are unable or unwilling to undergo multiple venapunctures 4. participants who are treated according to a different dosing schedule than standard dosing of brodalumab

Keywords: psoriasis therapeutic drug monitoring brodalumab
study of zg005 in combination with paclitaxel＋platinum-based ± bevacizumab in patients with advanced cervical carcinoma

Conditions: Cervical Carcinoma

Summary: this is a multicenter, open-label phase i/ii study for the first-line treatment of advanced cervical cancer.


Eligibility criteria:
inclusion criteria: * fully understand the study and voluntarily sign the informed consent form. * female 18-70 years of age; * eastern cooperative oncology group (ecog) performance status of 0 or * life expectancy ≥ 3 months. exclusion criteria: * patients were deemed unsuitable for participating in the study by the investigator for any reasons.
foot posture in people with paralysis on one side after stroke

Conditions: Stroke

Summary: people who have had a stroke often have difficulty walking and problems with their balance. the purpose of this project is to examine problems with foot postures in people who have weakness on one side of their body

the specific aims of this study are to: 1. describe foot posture in individuals with hemiplegia following stroke using a quantitative navicular drop test. 2. determine differences in people with normal, hypotonic, and hypertonic foot posture with regard to ankle range of motion, ankle strength, gait, and balance. this is an observational design study to describe relationships between the variables. measurements will include both descriptive and quantitative measures. thirty subjects with stroke will participate in one session of testing which will include: clinical assessment of foot posture using a descriptive classification system, quantitative measurement of navicular drop during standing, measurements of ankle range of motion, ankle strength, gait (lower extremity biomechanics and forceplate analysis), and static and dynamic balance. a chi-square test will be used to determine goodness of fit between classification with the descriptive system and the quantitative measurement. independent one-way anovas will be used to determine the mean differences in the foot posture groups for each of the dependent variables.

Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of a single stroke with resultant hemiplegia and be able to stand up from a seated position and walk 30 feet without assistance. exclusion criteria: * subjects will be excluded if they present with significant foot or ankle pathology, other medical problem that would affect gait or balance, or language / cognitive deficits that would impair ability to give informed consent.
effects of pistachios on cardiovascular responses to stress in type 2 diabetes

Conditions: Cardiovascular Disease; Type 2 Diabetes

Summary: this study is investigating the effects of three different diets, including a diet with pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.

the study will last 12-16 weeks and requires 10-13 visits to the general clinical research center on the university park campus. all food and snacks will be provided for 10 weeks. at the end of each of three diet periods, participants will undergo a test of endothelial function, an oral glucose tolerance test, and a cardiovascular stress reactivity test.

Eligibility criteria:
inclusion criteria: * healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal) * diagnosed with type 2 diabetes exclusion criteria: * insulin, more than one blood pressure lowering medication, daily aspirin, nsaid therapy, oral steroids within the last 6 weeks, oral contraceptives, and hormone replacement therapy * chronic disease such as cardiovascular disease or any complications of diabetes (retinopathy, neuropathy, etc). * allergies or aversions to pistachios * unwillingness to consume all foods provided and no other meals or snacks for the 10 weeks of diet intervention

Keywords: cardiovascular disease type ii diabetes nutrition pistachios cardiovascular disease risk factors in adults with type ii diabetes
tetragrip ii - usability trial of an fes orthosis for people with tetraplegia.

Conditions: Spinal Cord Injuries; Tetraplegia

Summary: functional electrical stimulation is an established technique in which small electrical impulses are used to cause a contraction in muscles and thereby enable movement, in people with neurological or musculoskeletal problems who are unable to undertake those movements themselves. people with spinal cord injuries of the neck at c5, c6 and c7 account for 35% of all spinal cord injuries. despite this, there is only one commercial fes (functional electrical stimulation) based orthosis currently available. even that has limitations in that it as it has a single size rigid exoskeleton it does not fit all people who could benefit and also due to its rigidity it does not allow people with lower injuries to utilise any remaining tenodesis grip. as a result, it is not widely used within the spinal injured communities. therefore what is required is a more flexible system that can benefit a larger number of people whilst still being affordable within the constraints of the nhs. a previous inspire funded project, tetragrip i demonstrated that a surface fes system controlled by an inertial sensor, measuring movement of the opposite shoulder, could meet this specification and was successfully tried on two people with tetraplegia. what is now required is a more detailed study in which the principle components of that system are incorporated into a practical device suitable for use at home without clinical supervision. it is therefore proposed to develop and build such a system and to conduct extended home based trials in three people with tetraplegia.


Eligibility criteria:
inclusion criteria: * have a spinal cord injury that has resulted in tetraplegia affecting hand function. * minimal spasticity of wrist muscle. * able to do shoulder elevation. * upper limb passive range of motion should be within normal limit. * age group: 18 years and above. * able to understand and comply with assessment procedures. * able to give informed consent. * able to produce a muscle contraction using electrical stimulation in sufficient muscles produce a functional grip. exclusion criteria: * using a cardiac pacemaker, defibrillator or other sensitive implanted device. * pregnant or planning to become pregnant over the course of the study. * a history of poorly controlled epilepsy. * if there is malignancy on the hand or arm. * if younger than 18 * severe contracture of wrist and finger joints. * painful shoulder. * suffering from significant autonomic dysreflexia in response to fes.
first-in-human study of tsha-101 gene therapy for treatment of infantile onset gm2 gangliosidosis

Conditions: Infantile GM2 Gangliosidosis (Disorder)

Summary: gm2 gangliosidoses are a group of autosomal recessive neurodegenerative diseases characterized by a deficiency of the hex a enzyme to catabolize gm2, thereby causing gm2 accumulation within cellular lysosomes.hex a is composed of 2 subunits, α- and β-, coded by the hexa and hexb genes, respectively. the primary purpose of the current study is to assess the safety and tolerability of tsha101 administered via it injection.


Eligibility criteria:
key inclusion criteria: * male or female with age less than or equal to 15 months * diagnosis of gm2 gangliosidosis with genetic and enzymatic documentation of infantile disease key exclusion criteria: * a second neurodevelopmental disorder independent of the hexa or hexb * inability to tolerate sedation or intrathecal administration * invasive ventilatory support * concomitant illness, allergies or known hypersensitivity to the required immunosuppression regimen

Keywords: tay-sachs disease sandhoff disease gm2 gangliosidosis
impact of intensive computerized cognitive training

Conditions: Acquired Brain Injury; Mild Cognitive Impairment; Mild Neurocognitive Disorder

Summary: to investigate factors that predict cognitive enhancement following engagement in an intensive computerized cognitive training protocol.

to investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the abi wellness bears platform and brainex software symbol relations module. the study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) bdnf levels in blood and salivary, 3) erp measures of working memory, and 4) resting state fmri and structural mri.

Eligibility criteria:
inclusion criteria: * patient of the mass general brigham health system with primary attention and executive functioning difficulties and/or a diagnosis of mild cognitive disorder or mild neurocognitive disorder (non-amnestic profile), due to an acquired brain injury (abi) sustained at least 12 months prior to study contact. * ages 25-65 years old * proficiency in english * willing and able to complete all study-related activities for 12 months, including travel to brigham and women's hospital (boston) for four in-person assessment visits and two serum and saliva sample collections. * access to a computer with webcam and stable internet. * a reliable study informant who can complete one questionnaire about participant's cognition/daily functioning, at four time points. exclusion criteria: * history of alcohol or substance abuse, or dependence, within the past 2 years, as per dsm-5 criteria. * high likelihood of an underlying progressive neurodegenerative disorder. * evidence of moderate to severe cognitive disorder, based on a score of 21 or less on the mini-mental status examination (mmse) (tombaugh \& mcintyre, 1992). * patient health questionnaire (phq)-9 (kroenke et al., 2010) score ≥ 19, unless deemed by treating provider not to have active depression (e.g., adjustment disorder, grief reaction). * active psychotic symptoms. * severe sensory losses such that participants would unlikely be able to participate in the study training, even with substantial accommodations (self-report of extreme difficulty reading ordinary newspaper print or a performance-tested corrected vision test score of worse than 20/30). * communication difficulties that prevent the participant from effectively participating in this highly interactive study protocol (based on interviewer's rating of a person's ability to be understood and to understand others). * current participation in a pharmacological, or other interventional research trial. * life expectancy of \< 2 years.

Keywords: computerized cognitive training working memory acquired brain injury mild neurocognitive impairment neuropsychological testing bdnf event-related potentials
diet in pediatric crohn´s disease treated with biologics

Conditions: Crohn's Disease

Summary: cded in remission patients with high calprotectin

due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of cd receiving biologic therapy (infliximab or adalimumab) and presenting active disease.

Eligibility criteria:
inclusion criteria: * patients under 18 years of age * with a diagnosis of cd * who have completed remission induction with biologic therapy * who are on maintenance biologic therapy * present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g). exclusion criteria: * children who are unable to receive enteral dietary intake * comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development * children already on special diets
echocardiographic findings in infants of diabetic mothers and its relation to maternal glycemic control

Conditions: Infant of Diabetic Mother

Summary: the aim of this work was to: 1. evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns. 2. determine the prevalence of congenital heart diseases or any cardiac abnormalities in infants born to diabetic mother in relation to the glycemic control of their mothers


Eligibility criteria:
inclusion criteria: * infant of diabetic mother (idm) (pregestational and gestational diabetes) born in alexandria university children 's hospital (auch) whatever their weight or their gestational age exclusion criteria: * neonates aged more 7 days. * patient born outside the tertiary center of alexandria university children 's hospital.
secondary prevention trial of rapamycin in patients with resected non-muscle invasive bladder cancer

Conditions: Bladder Cancer

Summary: the study is a multi-site phase 3 double-blinded randomized placebo-controlled trial. subjects are randomly assigned to receive either a placebo or oral sirolimus: 0.5 mg daily. all subjects will be treated for 2 years or until disease recurrence. patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. selection of bcg immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. patients concurrently receiving bcg immune therapy will receive standard bcg therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).


Eligibility criteria:
inclusion criteria: * pathologically (histologically) proven diagnosis of non-muscle invasive (ta, tis or t1) bladder cancer within 60 days prior to enrollment * be able to give informed consent * be age 18 or older * not be in an immunosuppressed state (e.g. hiv, use of chronic steroids) * not have active, uncontrolled infections * not be on agents known to alter rapamycin metabolism significantly * not have a reported history of liver disease (e.g. cirrhosis) * not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin. * not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy. exclusion criteria: * have muscle-invasive (≥t2) bladder cancer * unable to give informed consent * age \< 18 * immunosuppressed state (e.g. hiv, use of chronic steroids) * active, uncontrolled infections * on agents known to alter rapamycin metabolism significantly * another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) * patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy. * individuals with a reported history of liver disease (e.g. cirrhosis)
umbilical cord mesenchymal stem cells infusion for diabetes related vascular complications

Conditions: Peripheral Vascular Disease; Ischemia; Diabetic Foot

Summary: stem cell therapy has been a new and effective therapy in recent years for diabetic foot.this study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments. stem cell therapy has been a new and effective therapy in recent years for diabetic foot. combined with the previous studies of the investigators research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 or type 1 * age between 18-80 years * chronic foot ulcer more than 6 weeks * no sufficient response to best standard care delivered for six weeks. * pad up to fontaine stage iii or iv period * cli with the ankle brachial index (index ankle-brachial, abi) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, tcpo2) \<30mmhg exclusion criteria: * hba1c \>12% * hemoglobin \<10 mg/dl * creatinine clearance rate \<30ml/min * systemic bacterial, viral infections (mei du, hepatitis, cytomegalovirus infection, - hiv, b19 infection, herpes virus infection) and sepsis * have accepted the treatment of stem cells or growth factors * have a history of malignant disease * pregnancy * mental illness history * abnormal coagulation function * allergic reaction * severe cardiac insufficiency (iii-iv nyha) * using vasoactive substances

Keywords: umbilical cord mesenchymal stem cells
body composition & ree responses to bariatric surgery

Conditions: Weight Loss; Weight Change

Summary: the aim of this study is to measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass (ffm) (bone mineral density, skeletal muscle, and specific organs) at 60 months (t60) and 84 months (t84) post-surgery, and to compare compartment sizes with stable weight controls.

consenting, eligible patients previously enrolled in the ancillary study, "longitudinal assessment of bariatric surgery" (labs), from weill cornell and the university of pittsburgh will undergo the following measures: total body water by deuterium dilution (fat and fat-free mass (ffm)), extracellular water by sodium bromide tracer, body density by the bodpod, whole-body magnetic resonance imaging (mri) (adipose tissue and its distribution; skeletal muscle mass; mass of liver, kidneys, heart, and brain), dual energy-x-ray absorptiometry (femur bone mineral density (bmd), total body fat, fat-free mass, and bone mineral content), and resting energy expenditure (ree). mri will describe body composition changes at the tissue/organ level and adipose tissue distribution allowing us to address questions of biological and clinical importance including the body composition changes' influences on ree. the specific aims are to: 1) measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and ffm (including bone mineral density, skeletal muscle, and specific organs) at t60 and t84 months following surgery, and also to compare compartment sizes with those seen in stable weight controls; 2) measure the amount of change in ree at t60 and t84 compared to t0, following weight loss induced by bariatric surgery and to determine its relation to changes in body composition compartments, and its duration over the follow-up period. secondary research questions relate to changes in cardiac structure and function, physical activity associations with skeletal muscle changes, and adipose tissue depot changes as predictors of cardiometabolic parameters (glucose metabolism and serum lipid composition). subjects will be women and men (n=100) equally distributed between the new york and pittsburgh sites.

Eligibility criteria:
* had to have been enrolled in the ancillary study prior to having bariatric surgery * are able to come to the laboratory for testing.

Keywords: body composition weight loss fat fat distribution fat free mass organ resting energy expenditure