Kornimate/medical-research-clean huggingface dataset:
metabolic effects of steroids in obese men

Conditions: Obesity; Insulin Resistance

Summary: subjects will be randomized into 4 study groups: 1. placebo; 2. anastrazole and testosterone; 3. dutasteride and testosterone; and 4. testosterone only. a 2 step euglycemic clamp, body composition by dual x-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. we hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. we further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with t administration.


Eligibility criteria:
inclusion criteria: * free t level in the lower 25% of the normal range or below * bmi ≥30kg/m2 * waist circumference ≥100cm exclusion criteria: * pituitary tumors * hiv infection * klinefelter's syndrome * kallman's syndrome * uncontrolled hypertension * diabetes * congestive heart failure * chronic lung disease * acute coronary syndrome * psa \>4µg/l * aspartate aminotransferase (ast)\> 3x upper limit of normal * use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance. * involvement in daily resistance training or high endurance exercise * alcohol or drug dependence * obstructive sleep apnea

Keywords: testosterone insulin obesity aromatase 5 alpha reductase
robotic therapy hybridized with mirror therapy in stroke rehabilitation

Conditions: Stroke

Summary: the goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched conventional rehabilitation as the control. the investigators will also study the factors predictive of treatment success, identify key predictors of clinical improvement, and distinguish patient profiles most likely to benefit from each regimen. the findings of this clinical trial are expected to advance knowledge about the synergistic effects of unilateral and bilateral hybrid programs. the predictive study of treatment outcomes will inform patient selection in precision rehabilitation toward personalized stroke management.


Eligibility criteria:
inclusion criteria: (1) a first ever-stroke≧3 months and less than 2 years, (2) age range between 30 to 80 years, (3) baseline fugl-meyer assessment-upper extremity subscale (fma-ue) between 18 to 56, (4) no excessive muscle spasticity of the affected extremities (modified ashworth scale \< 3 at any joints), (5) able to follow examiners' commands and study instructions (montreal cognitive assessment score≧22), and (6) no fracture of upper extremities within the past 3 months, and (7) no participation in any other experimental rehabilitation or drug studies during study period of this project. exclusion criteria: (1) acute inflammation and pain, (2) receiving botulinum toxin injections within the past 3 months, and (3) concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation in this research.

Keywords: robotic rehabilitation mirror therapy stroke rehabilitation computerized rehabilitation randomized controlled trial
gender-related characteristics of bladder cancer treatment

Conditions: Bladder Cancer; Radical Cystectomy; Muscle-invasive Bladder Cancer

Summary: the most frequent cancer of the urinary tract is the bladder cancer (bc), in italy its incidence reaches the 7% of all the new diagnosis of cancer, accounting for the fifth cause of death in the western countries, overall 140.000 new cases per year in europe. in the year 2017, the italian association for medical oncology (aiom) recorded in our country about 21.700 new diagnosis of bc men and 5.300 in women. this data show not only a relevant gender disparity on the disease incidence (in 5th to 7th decade male incidence: 11-12% of all new diagnosis of cancer versus 1% in women) but also on the outcomes of treatment. overall, the 30% of all the new diagnosis have a muscle-invasive (mibc) onset, the female gender suffer a correlation with a more advanced disease at the time of first diagnosis. as a consequence, men have lower bc-related mortality when compared to women (p\<0,001). this discrepancy in the mortality rate has been investigated by many authors, resulting in the evidence that female gender suffers higher risks, especially during the first two-years after the radical cystectomy. a comprehensive explanation has not been formulated yet, but a multiplicity of cofactors, including variations in the hormone receptors and tumor biology as well as the different anatomy between male and female, have been identified as potentially relevant. another important issue in the pre-operatory management of female patients with bc is the misleading interpretation of hematuria. it seems to directly correlate with the evidence that women suffer a more advanced stage at diagnosis, and this element has been withheld in the list of relevant risk factors for prognosis. nevertheless, a thorough analysis of their effect will only be possible in the future, as well-designed prospective and randomized clinical trials are currently not available. a part from the preoperatory disparity, it has also been described that men are more frequently candidates to an orthotopic urinary diversion, leading female patients to an irreversibly altered perception of personal integrity and body image, namely to a lower quality of life after radical cystectomy. the female anatomy has been considered as a limitation to continence recovery, resulting in preoperative counselling more frequently against in favor of ileal conduit or not-continent urinary diversions.


Eligibility criteria:
inclusion criteria: * patient undergoing radical cystectomy since september 2016 december 2020 * development of bladder cancer confirmed histologically * written informed consent exclusion criteria: • lack of clinical and prognostic data on selected patients
early neuromuscular electrical stimulation for quadriceps muscle activation deficits following total knee replacement

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (nmes) for muscle strengthening immediately after total knee arthroplasty (tka) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

osteoarthritis (oa) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million americans. to alleviate pain and disability associated with knee oa, over 400,000 total knee arthroplasty (tka) are performed each year in the united states, and future projections indicate that by the year 2030, more than 750,000 tkas will be performed per year. while tka reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. a month after tka, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. neuromuscular electrical stimulation (nmes) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery. the overall goal of this study is to evaluate the efficacy of nmes initiated 48hrs after tka as an adjunct to standard rehabilitation. nmes is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + nmes.

Eligibility criteria:
inclusion criteria: * 50-85 years of age * scheduled for a primary unilateral tka * cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study exclusion criteria: * history of uncontrolled hypertension or uncontrolled diabetes * body mass index greater than 35 kg/m\^2 * neurological, vascular or cardiac problems that significantly limit function * moderate or severe osteoarthritis or other orthopedic conditions in the non-operated lower extremity that limit function

Keywords: electrical stimulation total knee arthroplasty quadriceps muscle arthroscopy
elevated ldh serum levels and fdg-pet in metastatic melanoma patients

Conditions: Melanoma

Summary: a retrospective study investigating the relationship between fdg-pet uptake and ldh levels.

patient characteristics, tumour characteristics including the braf mutation status and baseline serum s100b and ldh levels of each patient will be retrospectively determined from the electronical patient file. in each patient, tumour burden and 18f-fdg uptake of the tumour lesions will be measured using multiple standard quantification parameters of the baseline 18f-fdg-pet scan. tumour burden will also be measured on the baseline contrast enhanced ct scan. the correlation of each fdg-pet parameter with baseline ldh and s100b levels, respectively, will be analyzed using univariate and multivariate regression analysis.

Eligibility criteria:
inclusion criteria: - all patients \>18 years with histologically proven metastatic melanoma (american joint committee on cancer \[ajcc\] stage iv melanoma) treated in the umcg between may 2014 and december 2015. exclusion criteria: * participation in interventional studies * missing baseline 18f-fdg pet scan and/or baseline contrast enhanced ct scan * missing baseline serum ldh level * missing braf mutation status, concurrent malignancies or a history of previous malignancies.
food and gastrointestinal habits after bariatric surgery

Conditions: Bariatric Surgeries

Summary: the worldwide epidemic of overweight and obesity affects about 1.7 billion people around the world. since 1991, many international medical societies have established as recommendation for bariatric surgery the unsuccessful clinical treatment in patients with imc \> 40kg/m2 or imc \> 35kg/m2 in the cases with serious co-morbidities related to the possible reversion of them with the lose of weight due to the surgery. in front of the new anatomical condition from the gastrointestinal tract the patients present changes in food preferences and in the food intake, which include modifications in food choices, perception of hungry and satiety and in the tolerance to determinate food. these changes in food intake of the patients are observed mostly in the first year after the surgery an adaptive phase to a new condition.

after the new anatomical condition of the gastrointestinal tract, provided by bariatric surgery leads patients to experience changes in food intake and behavior. the aim of this study was to assess alimentary habits, food intolerances and gastrointestinal symptoms in patients who underwent bariatric and metabolic procedures: roux-en-y gastric bypass, biliopancreatic diversion and duodenal exclusion. we studied 34 patients of both sexes, from outpatient clinics in surgery of obesity and the metabolic surgery at university of campinas. they were submitted to bypass gastric in roux-en-y (n=15), biliopancreatic diversion (n=9) and duodenal exclusion (n=10). validated questionnaire for assessment of food tolerance was applied in patients with more than six months of follow-up after surgery addressing diet and gastrointestinal symptoms. the descriptive and comparative analyses were performed by analysis of variance and bivariate correlation. in patients who underwent to bypass gastric food intolerance was greats regarding to ingestion of rice (33%) and red meat (33%) in comparison to others groups. the flatulence and diarrhea were more prevalent in patients who underwent biliopancreatic diversion. the vomiting was more prevalent in patients who underwent gastric bypass. each procedure presents peculiarities to the anatomical and functional changes that affect the food absorption. this may have negative effects on the nutritional status of patients and affect the quality of life. the nutritional therapy for each individual procedure may assist in the management of clinical concerns of operated patients

Eligibility criteria:
inclusion criteria: * patients submitted of bypass gastric, biliopancreatic diversion and duodenal exclusion exclusion criteria: * presenting no diseases that could compromise their nutritional status, such as liver disease, kidney or cancer.

Keywords: tolerance alimentary morbid obesity type 2 diabetes mellitus
the effect of mashed potato composition on food intake, satiety and blood glucose

Conditions: Obesity; Overweight; Diabetes; Metabolic Syndrome

Summary: potato is one of the world's most popular foods and is widely accepted as a staple food. the objective of this study is to determine the effect of consuming instant mashed potatoes with and without fat on glycemic response, subjective appetite and food intake. it is hypothesized that mashed potato with added fat (as it is usually consumed) will result in lower glycaemic response and subjective appetite, and reduced subsequent food intake.


Eligibility criteria:
inclusion criteria: * •healthy men with a body mass index (kg/m2) of 20-24.9 exclusion criteria: * •smocking, medication, breakfast skipping, restrained eating
triplet combination of cytotoxics as first-line treatment for metastatic gastric cancer

Conditions: Metastatic Gastric Cancer

Summary: this parallel, randomized, open-label study will evaluate the effect on overall survival of irinotecan on oxaliplatin and 5-fluorouracil (5-fu) in patients with her2-negative and pmmr metastatic gastric cancer. irinotecan will be administered as intravenous infusion of 150 mg/m2 every 2 weeks. oxaliplatin will be given 85 mg/m2 and 5-fu will be given 400mg/m2 iv and 2400mg/m2 civ 48 hours fortnightly. treatment will continue until disease progress or untolerable toxicity appears. the target sample size is 350-400 patients.

eligible patients will be randomly assigned to folfoxiri group and folfox group. stratification factors include ecog ps, disease extent and pathological subtypes. efficacy will be evaluated every 3-4 cycles with recist. toxicity will be assessed with who ctc 3.0 every 2 weeks.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, gender is not limited; 2. inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction; 3. pathologically confirmed adenocarcinoma; 4. expected survival time ≥ 3 months; 5. ecog ps 0-3; 6. adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / l, neutrophil count ≥ 1.5 × 10\*9/ l; platelet count ≥ 100 ×10\*9/ l; hemoglobin ≥ 90 g / l; 7. ast and alt ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value; 8. be able to understand the research process, volunteer to participate in the study, and sign an informed consent form. exclusion criteria: 1. patients known to be allergic to active or other components of chemotherapeutic drugs; 2. patients with severe peritoneal dissemination and gi obstruction; 3. her-2 overexprssion or d-mmr; 4. severe or uncontrolled infections that may affect the evaluation of the study treatment or study results; 5. history of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin); 6. participated in other clinical trials within 4 weeks prior to the start of the study; 7. pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study period.

Keywords: irinotecan
exenatide and weight loss for diabetes prevention

Conditions: Pre Diabetes; Insulin Resistance

Summary: exenatide, a glp-1 agonist approved for lowering blood glucose concentrations in patients with type 2 diabetes, has been associated with restoration of the first-phase insulin response when administered intravenously to patients with type 2 diabetes. in longer clinical trials, it is associated with progressive decreases in body weight, and improvement in the dyslipidemia that characterizes insulin resistance, although insulin resistance was not quantified. the investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints. the investigators will compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and one group on exenatide and the other on placebo. the investigators will evaluate restoration of first phase insulin response, potential glucose lowering effects, including both reversal of prediabetes and hypoglycemia, and improvement in insulin resistance.


Eligibility criteria:
inclusion criteria: * healthy men and women, bmi 27-37kgm2, fasting plasma glucose = or \> 100 mg/dl and = or \ 140 mg/dl or = or \< 199 mg/dl exclusion criteria: * diabetes, active cardiac, kidney, liver, pulmonary, or other major organ diseases are cause for exclusion. other exclusionary criteria include: use of corticosteroids, diet medications, antipsychotic medications, history of eating disorder, history of bariatric surgery, active malignancy, recent weight change of more than 2%, inability to attend follow-up visits, excessive alcohol use, investigator's discretion that it is not in patient's best interest

Keywords: prediabetes exenatide weight loss insulin resistance acute insulin response insulin secretion
sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping in reducing incidence and severity of arm lymphedema in stage 0-2 patients.

Conditions: Lymphedema; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer

Summary: lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. this randomized phase ii trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-ii breast cancer

primary objectives: i. to evaluate the ability of axillary reverse mapping (arm) to reduce the incidence of lymphedema (le) following axillary nodal staging. secondary objectives: i. to document the use of a standardized le screening and le level-specific management protocol on the outcome of le among patients who develop le. ii. to document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients undergo sentinel lymph node biopsy (snb) and/or axillary lymph node biopsy (alnd) using technetium tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. patients then undergo and axillary reverse mapping. arm ii: patients undergo snb and/or alnd using technetium tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. after completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.

Eligibility criteria:
inclusion criteria: * stage 0, i, and ii breast cancer * not pregnant or breastfeeding * breast cancer or prophylactic mastectomy requiring axillary nodal staging * ability to read and/or comprehend consent form and questionnaires * ability to follow-up per protocol * unilateral axillary staging exclusion criteria: * stage 3 * previous axillary lymph node dissection * neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration * allergy to blue dyes or iodine; note: a non-blue dye or non-iodine-containing dye may be used in these patients * patients with implanted medical devices such as a pacemaker may undergo perometry, but not bis (bioelectrical impedance spectroscopy) * previous diagnosis of le (lymphedema) of either extremity * bilateral axillary staging
aneurysm diameter and surgical outcome

Conditions: Abdominal Aortic Aneurysm; Surgery; Outcome, Fatal

Summary: aneurysm diameter is an important risk for rupture and related death in affected patients. this study will evaluate whether aneurysms size may even influence post procedural outcomes both in open surgical repair and in end-vascular aneurysm repair. we will retrospectively review clinical data of operated patients with abdominal aortic aneurysm. we will consider both open surgical repair and endovascular aneurysm repair procedures in order to assess the influence of aneurysm size at the time of intervention.

since the publication by szilagyi et al, size of aneurysms has been recognized as the predominant risk factor for rupture. in fact, a low risk is associated with small aneurysms, an intermediate risk with medium-sized aneurysms, and dramatically an increased risk with large aneurysms. current guidelines suggest that the threshold diameter for aneurysm surgery being 5.5 cm for male patients and 5.0 cm for female patients, as measured on the largest section of the aneurysm. the correlation aneurysm diameter may also have an impact on early and late postoperative outcomes both for open surgery and endovascular surgery. the study by peppelenbosch n et al. showed that size differences were strongly associated with adverse outcomes during follow-up of patients that underwent endovascular aneurysm repair. the aim of this is to assess the influence of aneurysm size on the early and late outcomes of open surgical repair (osr) and endovascular aneurysm repair (evar) of abdominal aortic aneurysms (aaa). preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be retrospectively reviewed in order to correlate with the results of the procedures (osr and evar) and with adverse outcome that may have been occurred during follow up.

Eligibility criteria:
inclusion criteria: * patients with abdominal aortic aneurysm who underwent open surgery or endovascular procedures with complete anatomic data of aneurysms and clinical data with a minimus of 5 years of follow up. exclusion criteria: * none

Keywords: open surgery endovascular repair aneurysm size outcome
0.15 mg spinal morphine vs. no treatment for morphine requirement after vats.

Conditions: Postoperative Pain

Summary: postoperative pain after video-assisted thoracoscopic surgery (vat) is still debating. therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.


Eligibility criteria:
inclusion criteria: * age 18 year or over * patient asa physical status i-iii. * scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion * can operate a patient-controlled analgesia (pca) device. exclusion criteria: * known hypersensitivity to morphine * history of bleeding tendency. * known case of infection at the back * patient refuse for spinal anesthesia * history of cerebrovascular disease. * need mechanical ventilatory support during postoperative period

Keywords: spinal morphine vats lobectomy