Kornimate/medical-research-clean huggingface dataset:
development of a versatile intra-operative on-screen audiovisual mentoring system using tileprotm program for robotic gastrectomy

Conditions: Stomach Cancer

Summary: considering the development of gastric cancer surgery using da vinci robotic surgical system, the development of educational program needs to be achieved in korea and this institute. moreover, because of the large number of gastrectomy including robotic surgery for gastric cancer treatment, the investigators can provide high quality of educational program using da vinci system. therefore, the investigators wanted to create an innovative real-time training module, which can provide an intraoperative step-by-step guide to robotic surgical procedures. this technological project was named as advanced robotic multi-display educational system (armes).

considering the development of gastric cancer surgery using da vinci robotic surgical system, the development of educational program needs to be achieved in korea and this institute. moreover, because of the large number of gastrectomy including robotic surgery for gastric cancer treatment, the investigators can provide high quality of educational program using da vinci system. therefore, the investigators wanted to create an innovative real-time training module, which can provide an intraoperative step-by-step guide to robotic surgical procedures. this technological project was named as advanced robotic multi-display educational system (armes). the four-stages of armes development are as follows: 1. standardization of the key steps of the selected procedure; 2. preparation of well edited short video clips for each of the previously determined steps using our extensive library of videos of over 350 high quality robotic gastrectomies; 3. production of a 3d animation of the key surgical steps; 4. integration of the video segments into the da vinci robot system using tileprotm. through predetermined standardized segments of short operation video clips and 3d animation, the investigators are developing a versatile intra-operative on-screen audiovisual mentoring system using tileprotm program, which will improve surgeons' capabilities to perform complex robotic operations achieving quicker operation specific competency. it will help surgeons at initial state of robotic surgery in technical as well as oncological aspect for cancer surgery in detail and step-by-step. finally this program can be applied to other robotic surgery and progressed to be a standard education program.

Eligibility criteria:
inclusion criteria: * robotic surgery for primary early gastric cancer * distal gastrectomy with billroth ii anastomosis * age: 20\~80 years old exclusion criteria: * other malignancy and inflammatory diseases * disease associated with bleeding tendency * previous major abdominal surgery * pregnancy
efficacy and safety of stent-assisted treatment for cerebral aneurysms

Conditions: Stent Embolisation

Summary: prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.

to evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.

Eligibility criteria:
inclusion criteria: * stent assisted embolization of intracranial aneurysm * 20 or more year old exclusion criteria: * not determined

Keywords: stent intracranial aneurysm embolization adverse event
a trial evaluating two subcutaneous injection techniques and intramuscular administration of degarelix in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this trial is to compare the severity of isrs (injection site reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.


Eligibility criteria:
inclusion criteria: * aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (gleason graded, all stages) where endocrine treatment is indicated. * caucasian origin. * able to provide written informed consent and willing and able to comply with trial procedures. * body mass index (bmi) between 18.5-30 kg/m2. * has a life expectancy of at least one year. exclusion criteria: * current hormonal management of prostate cancer. * previous endocrine therapy for prostate cancer within 3 months prior to the screening visit. * any medical injection therapy that might interfere with degarelix injections. * patients with advanced muscle atrophy or cachexia which in the investigator's opinion would preclude or pose risks of complications following ventrogluteal i.m. injection of degarelix. * any medical condition that could be aggravated or may cause extreme discomfort during the trial period or could cause a moderate risk to a patient (significant heart, renal or liver disease). * chronic pain syndrome or any continuous pain reported by the patient that, according to the judgement of the investigator, could limit the evaluation of injection related pain.
perdove anziani: a prospective cohort study on older patients

Conditions: Dementia; Motor Impairments; Stroke; Thighbone Fractures

Summary: this prospective observational cohort study aims at studying functional and clinical outcomes of patients (n = 329) admitted to 4 geriatric hospital facilities of the st john of god order in northern italy during an index period of 4 months. other areas assessed include variables that help or hinder the discharge of patients with sufficient residential autonomy and the predictive ability of clinicians compared with the evaluation of selective indicators of outcome (clinical and instrumental). patients are followed from the first day of hospitalization until discharge or up to 3 months and 1 day after the date of admission ("long-term care" patients). at admission a "patient form" including social, demographic and clinical informations and a series of standardized assessment tools is completed with the help of clinicians, nurses and caregivers (when available). for each patient, during hospitalization, an analysis of apolipoprotein apoe polymorphisms is performed and adverse events occurred during hospitalization are monitored, as well as the predictive abilities of clinicians and any recent ct and mri. patients are reassessed at discharge (or after 3 months for "long-term care" patients) and at 6 months follow-up of with a standardized telephone interview to assess clinical and functional status and possible changes in the residential status of the patient.


Eligibility criteria:
inclusion criteria: * age 65 or older * informed consent provided exclusion criteria: * younger than 65 years * informed consent not provided

Keywords: cognitive impairment. geriatrics. hospital admission. hospital discharge.
impact of renal anatomy on shock wave lithotripsy outcomes for lower pole kidney stones

Conditions: Urolithiasis; Urinary Lithiasis; Kidney Calculi

Summary: kidney stone disease affects almost 10% of overall population, often requiring a surgical intervention. currently, shock wave lithotripsy is considered a first-line treatment option for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing reasonable stone-free rate. actually, the outcomes from swl vary largely due to several factors including stone burden, stone density, stone-skin distance (ssd), and patient's body habitus. furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography scan) performed to assess the presence of residual fragments also impacts on swl outcome analysis. we aim to perform a well-controlled prospective evaluation of all variables that may impact on fragmentation and clearance of lower pole calculi after swl. these variables are assessed exclusively by a noncontrast computed tomography scan (ncct), eliminating the necessity of an intravenous urography to study renal collecting system anatomy; an imaging exam that is not routinely performed anymore for kidney stone patients.

variables in study: * age, gender, body mass index (bmi), and waist abdominal circumference * noncontrast computed tomography scan (ncct): stone density (average of 3 measurements), stone size, stone area, skin to stone distance (average of 3 measurements: zero, 45o and 90o), and collecting system anatomy: infundibular length, width, and height, and infundibulopelvic angle study design: all patients will be submitted to a noncontrast computed tomography scan before to swl. a radiologist with expertise in urolithiasis will evaluate all exams. patients will be submitted to swl under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days. patients will be followed up as follow: * one week after swl: medical visit to evaluate complications such as pain, dysuria, hematuria, steinstrasse, visit to the emergency department. * 12 weeks after swl: new ncct scan to evaluate kidney stones fragmentation and clearance. univariate (student's t test) and multivariate analysis (multiple logistic regression) will be done to assess the impact of patient's corporal habitus (bmi and abdominal waist circumference), stone characteristics (size, area, density and ssd), and renal collecting system anatomy (infundibular length, width and height, and infundibulopelvic angle) on swl outcomes (fragmentation and stone-free rates).

Eligibility criteria:
inclusion criteria: \> 17 year-old. symptomatic single stone of 5 to 20mm located in the lower pole of the kidney. informed consent signed. exclusion criteria: patients with congenital kidney abnormalities (i.e. horseshoes kidney, pelvic kidney, ectopic kidney), patients with ureteral stent (i.e. double j stent) in the ipsilateral kidney of the stone in study, patients with chronic kidney disease (glomerular filtration rate \ 4.0cm).

Keywords: tomography urinary lithiasis kidney calculi
pharmacokinetics of preoperative vancomycin

Conditions: Surgical Site Infection; Vancomycin

Summary: a study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.

background: vancomycin is used for antibiotic prophylaxis in pediatric surgical patients without a complete understanding of plasma and soft tissue pharmacokinetics. guidelines recommend incision within 60 minutes after administration; however, tissue concentrations of vancomycin at that early time may not be therapeutic. the investigators conducted a study of plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to characterize intraoperative vancomycin pharmacokinetics. patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over one hour. skin biopsies were taken at incision and skin closure. blood samples were also collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient was still in surgery. population pharmacokinetic (pk) analysis was performed to characterize pk parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin concentrations vs. time.

Eligibility criteria:
inclusion criteria: 1. neurosurgery patients between the ages of 31 days up to 18 years 2. receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (csf) shunt placement or revision. 3. orthopedic surgical patients between the ages of 31 days up to 18 years 4. receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion. exclusion criteria: 1. patients already receiving vancomycin for treatment of an active infection, 2. patients who have a creatinine ≥1.2, 3. patients who's creatinine clearance less than 50, 4. known chronic renal failure and are on dialysis, 5. patients with a known allergy to vancomycin, not including red man syndrome.
posttraumatic changes in energy expenditure and body composition in patients with acute spinal cord injury

Conditions: Spinal Cord Injuries

Summary: severe trauma induces massive metabolic changes that are characterized by hypermetabolism with increased energy expenditure and catabolism. early enteral and, if necessary, parenteral feeding is a major focus of modern intensive care medicine. after acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of muscle mass in the area below the level of injury. this dramatic muscle atrophy again leads to a decrease in energy expenditure. whereas other survivors of severe trauma typically regain muscle mass during rehabilitation, spinal cord injury patients typically continue to lose muscle mass over time, which also leads to changes in body composition. the time course of these changes is not known. continuing nutrition without adaption to the reduced energy expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury patients to the known unfavorable metabolic consequences. knowledge of the time course of these changes would help to provide adequate caloric intake to the patients and improve our ability for nutrition counseling. the investigators plan a prospective clinical trial in 25 acute spinal cord injury patients to determine the changes in energy expenditure and body composition. major inclusion criteria are acute traumatic spinal cord injury, age 18-70, neurological level above l1, ais (american spinal injury association impairment scale) a, b or c. measurements of energy expenditure, body composition and nutritional markers in venous blood are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation (at the latest after 26 weeks).


Eligibility criteria:
inclusion criteria: * patients admitted for acute treatment and rehabilitation after traumatic spinal cord injury * no longer then two weeks after onset of spinal cord injury * age 18 - 70 years * body mass index 18-30 * neurological level c4 to th12 * american spinal injury association impairment scale (ais) a, b or c exclusion criteria: * complications during acute treatment, which make study participation impossible or would endanger the recovery of the patient * pre-existing diabetes mellitus type 1 and 2 * pre-existing hypercholesterolemia * untreated hypothyroidism or hyperthyroidism * invasive mechanical ventilation * cardiac pacemaker

Keywords: spinal cord injury
mirror therapy versus pnf on le function in stroke

Conditions: Stroke

Summary: many rehabilitation strategies are being implemented to treat stroke. constraint-induced movement therapy and robotics are two potentially useful treatment options for rehabilitation. range of motion exercises, pnf, mirror therapy is also used. fitness training, high-intensity treatment, and repetitive-task training are all promising strategies that might help improve elements of gait. repeated task training may also help with transfer functions

pnf and mirror therapy has its effect on chronic stroke patients. both mirror therapy and pnf work on the concept of neuroplasticity. neuroplasticity is the ability of the nervous system to change its activity in response to intrinsic or extrinsic stimuli by reorganizing its structure, functions, or connections after injuries. because of brain plasticity, neurorehabilitation has evolved, as evidenced by numerous physiotherapeutic approaches such as proprioceptive neuromuscular facilitation (pnf) and mirror treatment (mt). the reorganization also includes the expansion of cortical regions, which offer the neural foundation for the recovery or adaption of motor activity following injury. as the literature supports the individual effects of both techniques in stroke population but as per author's access, there is no literature provide the comparison among both techniques i.e. pnf and mirror therapy in lower limb for chronic stroke patients on gait and functionality. hence the author established the research question that is there any difference among these techniques in stroke population in terms of its effects and efficiency on gait and functionality. the study will provide an insight to the clinician about which technique has the superior/ better effects for the lower extremity functions in chronic stroke patients thus telling the effects two neurorehabilitation methods i.e. proprioceptive neuromuscular facilitation (pnf) and mirror therapy (mt).

Eligibility criteria:
inclusion criteria: * both male and female * aca stroke * ischemic and hemorrhagic stroke * mmse grade \>24 * spasticity at modified ashworth scale between 1 and 2 * modified rankin scale 4 exclusion criteria: * any orthopedic impairment of lower extremity like lld, fractures, dislocations, amputations, deformity of joint * any other neurological condition (multiple sclerosis, parkinson disease, sci)
motivators and barriers to physical activity in knee osteoarthritis patients: a qualitative study

Conditions: Knee Osteoarthritis

Summary: this study sought to better identify the motivators and barriers to osteoarthritic patients practising regular physical activity. this is a crucial step towards enabling each health professional to adapt their therapy recommendations, while taking into account the patient's overall lifestyle.

the qualitative research design is well-suited to this type of issue. this choice was justified by need to investigate and understand the actions from the participants' point of view. this exploratory method, conducted in the form of individual interviews and focus groups, enabled us to document the personal experiences, practices, and personal history of each individual

Eligibility criteria:
inclusion criteria: * symptomatic knee osteoarthritis exclusion criteria: -

Keywords: physical activity knee osteoarthritis non pharmacological treatment qualitative study
efficacy and safety of asenapine using an active control in subjects with schizophrenia or schizoaffective disorder (25517)(p05935)

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. this is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.


Eligibility criteria:
inclusion criteria: * subject with schizophrenia or schizoaffective disorder. subject must sign a written informed consent. exclusion criteria: * have an uncontrolled, unstable, clinically significant medical condition. have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
outpatient ultrafiltration therapy in heart failure patients trial

Conditions: Congestive Heart Failure

Summary: this trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting. the purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. the results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.

this is a pilot study to assess the feasibility, effectiveness, safety and patient acceptance of ultrafiltration in ambulatory patients with heart failure and hypervolemia. the results will be useful in planning a larger clinical trial.

Eligibility criteria:
inclusion criteria: * patients will be recruited from the cardiology clinic at hennepin county medical center. patients are eligible for the study if they are: 1. older than 18 2. not pregnant 3. have heart failure with worsening hypervolemia despite oral diuretics 4. have at least two of the following signs or symptoms of hypervolemia: jvd, edema \>1+, rales pulmonary edema on chest x-ray, orthopnea or pnd 5. not more than 10 kg above their usual baseline weight 6. have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal exclusion criteria: 1. systolic blood pressure \< 90 mmhg 2. serum creatinine \> 3.0 mg/dl 3. hematocrit \>45 % 4. uncontrolled arrhythmias 5. need for hospitalization 6. require renal replacement therapy 7. contraindication to anticoagulation with heparin 8. poor venous access. -

Keywords: congestive heart failure heart failure ultrafiltration therapy fluid overload
efficacy of efavirenz 400mg vs. 600mg combined with lamivudine and tenofovir in treatment naive hiv infection

Conditions: HIV/AIDS; Mental Impairment

Summary: the present study will be a randomized controlled study in which 500 treatment-naive hiv patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. the whole cohort will be followed for two years. efficacy and safety of each regimen will be evaluated throughout the study.

as efaviren has been commonly used as the first-line therapy in hiv infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and efficacy of art regimen. mental effects of efaviren have been especially critical in chinese patients, as the effective and toxic ranges of efaviren plasma concentration in chinese patients are very close to each other. in this study, 500 treatment-naive chinese patients with a body weight \< 60kg will be screened and recruited. patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. all patients will be followed regularly for 2 years, at 0, 2w, 4w, 3m and every 3 months. virological and immunological measurements will be done at each visit. meanwhile, various mental scales will be performed at each visit to evaluate the mental effects of each arm.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * willingness and availability to engage in study activities for the duration of the study * age between 18-65 * documented hiv-1 infection (confirmed by western blot) * received no prior antiretroviral therapy exclusion criteria: * pregnancy or breastfeeding or anticipated pregnancy in two years * history of aids-defining illness * hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl； * liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (uln), bilirubin level more than 2.5 times the uln) * chronic kidney disease (serum creatinine level more than 1.5 times the uln) * patients with a history of injection drug usage * patients with a history of mental disorders