Kornimate/medical-research-clean huggingface dataset:
surgery or lifestyle intervention for type 2 diabetes (solid)

Conditions: Type 2 Diabetes

Summary: this research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes. eligible patients will undergo one of 2 types of weight loss surgery, roux-en-y gastric bypass, or laparoscopic adjustable gastric banding, or an intensive lifestyle modification. participants will be closely followed for one year to compare the effects of these treatments on diabetes remission.


Eligibility criteria:
inclusion criteria: * ages 18 to 65 years old. * diagnosis of type 2 diabetes. * individuals with a bmi of 30-40 kg/m2 * approval for bariatric surgery (as confirmed by medical evaluation) * insurance coverage for bariatric surgery * willingness to change diet, physical activity and weight. * ability to communicate with the investigator and be legally competent, provide written informed consent. exclusion criteria: * diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young (mody), or latent autoimmune diabetes in adults (lada) (all of which are associated with ß-cell destruction), daily insulin requirements \> 100 units, and poor preoperative glycemic control, as indicated by a hba1c \> 6.5 - ≤ 8.5 or hba1c \> 8.6 - \< 9.5 (individuals with this hba1c value will require medical clearance and approval from the study physician). * children and adolescents are not eligible to participate in the study. * pregnant women (or those who intend to become pregnant during the study period) and women who are currently breastfeeding are not eligible to participate. * use of medications known to significantly increase body weight, such as chronic systemic steroids or certain psychiatric medications (e.g., lithium tricyclic antidepressants and anti-psychotic agents). * non-ambulatory individuals, defined as those who are unable to walk at least one city block without a cane or walker. * any major illnesses that the surgical team believes present too great a risk for surgery. these include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes. * evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly controlled, or, in the opinion of the investigators, significantly interferes with daily living and functioning. * any current (past 12 months) substance abuse or dependence disorder. * participants with moderate anemia (hgb \< 12 mg/dl for men and hgb \< 11 mg/dl for women) * conditions that may falsely elevate or decrease hba1c values, including hemolytic or iron-deficiency anemia, hemoglobinopathies, and uremia. * abnormal laboratory tests which are clinically significant per the investigator.

Keywords: type 2 diabetes bariatric surgery roux-en-y gastric bypass gastric banding obesity weight loss insulin sensitivity glp-1 meal challenge euglycemic clamp
rasburicase treatment in chronic gouty arthritis

Conditions: Chronic Gout

Summary: the study will establish efficacy and safety of rasburicase in chronic gouty arthritis

the study hypothesis is that the proportion of patients who achieved the primary endpoint after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is superior to 12 weeks of treatment with oral urate-lowering therapy.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study; * male and female patients 18 to 70 years of age; * fulfill the acr/eular 2015 gout classification criteria; * tophi detected by physical examination; * serum urate\>300μmol/l (5mg/dl) after one-month maximum dose of urate-lowering therapy (allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d) unless intolerable or no reduction in size of tophi after serum urate\<300μmol/l (5mg/dl) for six month; exclusion criteria: * pregnant women, lactating women, and men or women who have recently prepared for pregnancy; * abnormal liver function with ast, alt, and ggt \>3 times uln; * blood wbc\<4.0×10\^9/l, and/or hemoglobin \<90g/l, and/or platelets;\<100×10\^9/l; or other hematologic disorders; * egfr\<15 ml/min; * receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole * psychiatric disorders, history of alcoholism, drug or other substance abuse * immunodeficiency diseases, uncontrolled infection, etc; * sericosis, glucose-6-phosphate dehydrogenase activity deficiency * allergy to biological agents and chronic active urticaria.

Keywords: chronic gouty arthritis rasburicase
vantage mobile bearing total ankle system post market clinical follow-up (outside us)

Conditions: Rheumatoid Arthritis; Arthritis of Ankle; Failure, Prosthesis

Summary: the objectives of this study are to evaluate the performance and safety of the vantage mobile-bearing total angle system. this study will follow subjects for a period of up to 10 years post-surgery.


Eligibility criteria:
inclusion criteria: * patient is indicated for total ankle arthroplasty * patient is at least 21 years of age * patient is likely to be available for follow-up out to 10 years * patient is willing to participate by complying with pre- and postoperative visit requirements * patient is willing and able to read and sign a study informed consent form exclusion criteria: * patient with excessive bone loss at the ankle joint site * patient with severe osteoporosis * patient with complete talar avascular necrosis * patient with active osteomyelitis * patient with infection at the ankle site or infection at distant sites that could migrate to the ankle * patient with sepsis * patient with vascular deficiency in the involved limb * pateint with neuropathic joints * patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing * patient with poor soft tissue coverage around the ankle * patient with charcot arthropathy * previsous ankle arthrodesis with excision of the malleoli * excessive loads as cuased by activity or patient weight - per investigator discretion * skeletally immature patients (patient is less than 21 years if age at time of surgery) * patient with dementia * patient with known metal allergies * patients who are unwilling to provide informed consent * patients who are unlikely to be available for follow-up out to 10 years * patients who are not deemed suitable candidates for the subject device * patient is pregnant
determining optimal post-stroke exercise (dose)

Conditions: Cerebrovascular Accident; Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Summary: the investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.

participants admitted for stroke rehabilitation will be randomly assigned to either the stroke management group, stroke monitoring group or stroke supplementary group. all three groups will receive usual care, in addition to the intervention. the stroke management group will be provided with periodic information about their progress in the area of mobility using specialized activity monitors. the stroke monitoring group will be progressed according to customized protocols using feedback from specialized activity monitors. the stroke supplementary group will receive the same as the stroke monitoring group, but will also receive one additional hour of daily (5 times per week) physical exercise

Eligibility criteria:
inclusion criteria: * have been admitted to a hospital unit for stroke rehabilitation * within 10 weeks post-stroke * 19 years or older * are experiencing difficulty walking exclusion criteria: * requires greater than one person assist for transfer or ambulation * have uncontrolled medical condition or another serious medication condition in addition to stroke * unable to understand or follow directions

Keywords: exercise rehabilitation dose randomized controlled trial stroke
the reliability, validity, and responsiveness of the timed 360° turn test in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: difficulty in turning is common after parkinson's disease. patients with parkinson's disease take a greater number of steps, longer duration, narrower base of support in turning. thus, turning ability is systematically investigated in parkinson's disease. the aim of this study to invastigate reliability, validity, and responsiveness of the timed 360° turn test in patients with parkinson's disease.

at baseline, the timed 360° turn test, unified parkinson's disease rating scale, hoehn and yahr scale, berg balance scale, functional reach test, timed up and go test, four square step test and trunk impairment scale was applied to the patients with parkinson's disease when the patients were "on" period. the timed 360° turn test was repeated after seven days from the first application when patients with parkinson's disease were "on" period to evaluate its reliability.

Eligibility criteria:
inclusion criteria: * at least 40 years of age, * neurologist-diagnosed parkinson's disease * hoehn \& yahr (h\&y) stages 1 to 4, * were able to walk 10 m with or without aids exclusion criteria: * visual, auditory, and orientational problems affecting study results * orthopedic problems affecting walking, * other neurologic conditions, cardiovascular, musculuskeletal, and vestibular disease

Keywords: parkinson's disease the timed 360° turn test validity reliability
postoperative delirium in patients undergoing radical cystectomy

Conditions: Post-operative Delirium

Summary: in this study, post-operative delirium will be measured in patients undergoing surgery for bladder resection, and associated microrna biomarkers will be evaluated in patients considered delirious and non-delirious after surgery.

with voluntary participation, this study requires participants to complete a self-administered cognitive evaluation (sage) before surgery to assess baseline cognitive impairment and early dementia; vital signs will be documented prior to surgery. during surgery, participants will receive a standardized general anesthesia regimen as described in the protocol. several parameters will be measured during surgery, including bispectral monitoring to measure processed eeg. after surgery, fitness for cognitive evaluation will be determined by the richmond agitation-sedation scale (rass) scale, and then emergence delirium will be assessed using the cam-icu scale. fitness for discharge from pacu will be determined by an aldrete score of 9 or more. postoperative pain will be assessed using the 11-point numeric rating scale (nrs-11). postoperative nausea and vomiting (ponv) level will also be documented. postoperative delirium (pod) assessment will be achieved by administering the memorial delirium assessment scale (mdas) twice a day starting on day 1 through day 3 postoperatively. pain nrs-11 score and ponv levels will also be documented at each visit. for microrna testing, blood probes will be collected in 5ml purple top tube at surgical preadmission and post-surgery days one, two and three. risks associated with participating in this study include normal risk associated with having surgery and general anesthesia; no greater than minimal risk is associated with blood collection. for the participant, there are no immediate anticipated benefits for participating in this study. the importance of the knowledge that is expected to result includes lower post-operative complications as a result of post-operative delirium, faster recovery, and shorter hospital stay.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age and older * asa ii or iii * capable of and willing to consent * participants literate in english language exclusion criteria: * asa iv or v * patients with severe visual or auditory impairment * inability to read and/or write in english * presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia * dementia of alzheimer's type * parkinson's disease * multiple sclerosis (ms) * vascular dementia

Keywords: cystectomy urology surgery
clinical outcomes of femtosecond laser-assisted pterygium surgery (flaps)

Conditions: Pterygium

Summary: the study will be a pilot interventional case series aiming to treat 30 patients with femtosecond laser-assisted pterygium surgery (flaps). all patients included will undergo flaps in one eye. all procedures will be performed in snec by fully qualified surgeons. the doctor is informed of the procedure on the day of.


Eligibility criteria:
inclusion criteria: * a pterygium will be defined as a wing-shaped growth of fibrotic connective tissue onto the cornea originating from the nasal conjunctiva. * only patients older than 21 years will be included. * no gender criteria are applied. * only individuals with the mental capacity to provide informed consent will be included. more specifically, all the following inclusion criteria must be met: * patients have primary pterygium encroaching onto the cornea by a minimum of 1 mm. * patients are willing and able to sign a written informed consent form prior to any study-specific procedures. * patients are willing and able to return for scheduled follow-up examinations for 12 months after the surgery. exclusion criteria: * patients with prior history of pterygium surgery. * patients with a prior history of glaucoma filtration surgery. * patients with optic atrophy. * patients with ocular pathology or disease that might confound the outcome or increase the risk of adverse events. * patients with a prior history of vitrectomy. * patients with central corneal scarring. * patients with residual, recurrent, active or uncontrolled eyelid disease. * patients with any conjunctival scarring other than pterygium, that could affect surgery outcome. * patients with anterior segment pathology. * patients with any corneal abnormality. * patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application. * patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing. * patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
analysis of the functional impact of total knee arthroplasty using quantified gait analysis and proprioceptive evaluation

Conditions: Total Knee Arthroplasty for Gonarthrosis

Summary: total knee arthroplasty remains the gold standard in the management of disabling gonarthrosis. improved functional results, increased availability of care and an ageing population have all contributed to the rise in total knee replacement surgery in western countries. surgical techniques have been steadily improving for several decades in terms of implant positioning and joint alignment. however, 10% of patients are dissatisfied with the clinical and functional results. the challenge is to understand why these patients remain dissatisfied despite these surgical advances. our aim is to understand the functional impact of knee prosthesis through a quantified analysis of gait, the performance of certain tasks of daily living, and pre- and post-operative proprioceptive assessments. we will link these results with patient feedback to identify factors potentially responsible for poor postoperative outcomes.


Eligibility criteria:
inclusion criteria: * adult patient * gonarthrosis on imaging with indication for total knee arthroplasty (tka) * isolated gonarthrosis exclusion criteria: * patient objecting to study participation * patient with an associated pathology causing balance and/or proprioceptive disorders (parkinson's, stroke sequelae, etc.). * patients with a history of cognitive disorders, either confirmed or currently being assessed. * iadl score below 3, indicating major dependence in daily life. * patients unable to walk without technical aids for 6 months. * patients unable to get up from a chair without armrests * parker score below 6 * protected persons covered by articles l1121-5 to l1121-8 of the french public health code

Keywords: gonarthrosis proprioception functional recovery patient-reported outcomes measures (proms) quantitative gait analysis
interest of cardiac computed tomography to optimize and improve the procedure of tavi

Conditions: Aortic Stenosis

Summary: this is a pilot prospective, comparative, monocentric, randomized study with 2 groups. people with a severe aortic stenosis and a high risk of surgery are referred to a trans catheter aortic valve implantation (tavi).

the proposed study is to show the interest of a cardiac computed tomography (ct) to improve the tavi procedure. the cardiac computed tomography (ct) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. the hypothesis is that performing a cardiac ct before the tavi could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.

Eligibility criteria:
inclusion criteria: * patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. this patient will be selected for a tavi. in this study, we only randomized patient for a tavi with an edwards prosthesis * male or female patient, older than eighteen years old * who have given their written consent * who are affiliated to the french social security system * which has a too high risk of surgical valvular replacement (euroscore logistic \> 20% or society of thoracic surgeons score \> 10, or contre indicated to a cardiac surgery by a heart team * severe aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure exclusion criteria: * patient who can't give his written consent because of his physical or mental status * adult patient protect by law (article l1121-8), * person deprived of liberty (article l1121-8), * pregnant women * patient in terminal phase of illness, * terminal kidney failure * allergy to iodine * bicuspids ou unicuspid aortic, * diameter of the left ventricular outflow tract \ 25mm, * diameter of the femoral artery \< 7mm, tortuosity or calcifications * septal hypertrophy * apical thrombosis.

Keywords: cardiac computed tomography transcatheter aortic valve implantation safety and efficacy
c-reactive protein as a predictor of stem cell transplant complications

Conditions: Cancer; Leukemia; Stem Cell Transplantation

Summary: the purpose of this study is to determine if c-reactive protein levels are predictive for complications post transplant.


Eligibility criteria:
inclusion criteria: * age 6 months to 20 years * patient undergoing a stem cell transplant (allogeneic, syngeneic, or autologous) at childrens' memorial hospital * irb approved informed consent (and assent for children age 12-17)

Keywords: cancer leukemia stem cell transplant complications
genetical background of non-alcoholic fatty liver disease (nafld) in diabetes mellitus and in chronic kidney disease

Conditions: Non-alcoholic Fatty Liver Disease; Chronic Kidney Disease; Diabetes Mellitus

Summary: the present study investigates relationship between non-alcoholic fatty liver disease and its risk factors, such as genetic background and diseases, such as chronic kidney disease and diabetes mellitus.

non-alcoholic fatty liver disease (nafld) is a multisystemic disease, also affecting extrahepatic organs (1,2,6). according to former data, not only the prevalence of chronic hepatic disease, chronic cardiovascular diseases, but also the prevalence of chronic kidney disease (ckd) is higher in nafld (4,7). a strong association has been shown between diabetes mellitus (dm) and nafld as well (3,5,10). many genetical factors have been studied in the background of nafld. many studies have proved the effect of patatin-like phospholipase domain-containing protein 3 gene (pnpla3) (8,9). effect of numerous genetical polymorphisms has been suggested behind oxidative stress responsible for nafld (8).

Eligibility criteria:
inclusion criteria: * ckd (renal replacement therapy non excluded) * dm * ckd+dm exclusion criteria: * alcohol abuse

Keywords: non-alcoholic fatty liver disease chronic kidney disease diabetes mellitus cross-sectional
the effect of manual therapy and therapeutic exercises on pain and functional status in persons with low back pain

Conditions: Low Back Pain

Summary: non-specific chronic low back pain (lbp) can be managed with a variety of treatments such as educational programmes, behavioural therapy, acupuncture, medication, electrophysical agents, manual therapy and exercise therapy. although the above therapies are widely used, they show limited effect at best, with frequent recurrences of lbp. there is insufficient data to prove that one type of exercise is superior to another. manual therapy is a common therapeutic method used in the treatment of lbp. therefore, we hypothesised that manual therapy combined with therapeutic exercises would lead to a greater reduction in back pain and improvement in functional status. the aim of the study was to evaluate the effect of 6 weeks of manual therapy combined with therapeutic exercise on pain and functional status in subjects with chronic non-specific low back pain.

the individuals with chronic non-specific low back pain participated in the study. subjects were randomly divided into two groups: physiotherapy and manual therapy. all the participants received 12 intervention sessions. in addition, all subjects exercised at home 5 days a week. subjects' back static strength endurance was assessed by the ito test, abdominal muscle static strength endurance was assessed by the kraus-webber test, fear of movement by the tampa kinesiophobia test, torso mobility by the schober test, pain by the numerical analogy scale. functional status was assessed by oswestry and roland-morris questionnaires.

Eligibility criteria:
inclusion criteria: * non-specific low back pain (\>8 weeks); * persons of working age; * must be able to perform therapeutic exercises. exclusion criteria: * severe cardiovascular disease; * oncological disorders; * neurological symptoms of disorders; * osteoarthritis; * spondylolisthesis and spondylosis; * radiculopathy; * myelopathy; * spinal fracture. * pregnancy or lactation.

Keywords: low back pain manual therapy exercise therapy