Kornimate/medical-research-clean huggingface dataset:
mid-term outcomes of first mtp arthroplasty with primus™ fgt implant.

Conditions: Hallux Limitus of Left Great Toe; Rheumatoid Arthritis; Arthritis of 1st Metatarsophalangeal Joint; Osteoarthritis; Bunion; Hallux Limitus of Right Great Toe

Summary: foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants. allergies to silicone, infections due to silicone and implants breakage used to be common with previous generations of silicone implants. publications relative to those implants showed that the survival rates after 5 years of follow-up were unsatisfactory. since 1998, tornier has been selling a new generation of silicone implants made of ultrasil™. the use of this new material in its manufacturing process together with its innovative geometry, make the primus™ fgt a much more resistant, anatomic and long lasting implant. the main objective of this study is to evaluate the clinical outcomes of the implantation of primus™ fgt implant in great toe arthroplasty. the study will capture long term outcomes in terms of functional metrics from documented clinical data. other objectives are to evaluate the outcomes in terms of radiological evaluation and of safety during all the follow-up.

this is an observational post-marketing surveillance study, performed by 1 (one) investigator in 1 (one) italian site. * preoperative and peroperative data were collected retrospectively. * postoperative data (minimum 5 years follow-up or until implant revision) were collected prospectively.

Eligibility criteria:
inclusion criteria: * patient has had a primus™ fgt implantation for one of the following indications: hallux limitus, hallux rigidus, hallux abducto valgus associated with severe arthritis, unstable or painful joint from previous surgery on the great toe, * patient having all necessary clinical and radiographical data available., * patient has been informed about this scientific study and has provided their consent to participate. exclusion criteria: * patient does not have clinical and radiographic follow-up data available.
thoracic computed tomography scan for diagnosis of aspirated foreign bodies.

Conditions: Aspirated Foreign Body of Lower Respiratory Tract

Summary: to access ct scan as a diagnostic tool for foreign bodies aspiration.

comparison with gold standard diagnostic tool, the endoscopy

Eligibility criteria:
inclusion criteria: * age between 6 months and 16 years * suspicion of a foreign body aspiration * health care assurance * information of parents exclusion criteria: * emergency situation * certainly of foreign body presence * delay for ct scan realization longer than 24 hours * no speaking french parents * parents refusal.

Keywords: ct scan endoscopy aspiration foreign bodies
economic-demographic assessment of the aseptic mobilization of knee prostheses through the ripo registry and radiographic analysis of the case series from the ii clinic of ior

Conditions: Aseptic Loosening; Arthropathy of Knee

Summary: the increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (tka), and, consequently, an increase in the number of revisions. the main cause of tka failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. this represents a significant impact on professional and economic resources for the italian healthcare system. aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. a careful, methodical evaluation of post-operative radiographs of tkas remains an important diagnostic tool. the analysis of the causes of aseptic mobilization of tkas and the associated economic impact in the emilia romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.


Eligibility criteria:
inclusion criteria: * patients undergoing knee prosthesis revision for aseptic mobilization * follow-up ≥ 2 years * willingness to participate in the study * both sexes * patients ≥ 18 years old exclusion criteria: * patient refusal to participate in the study and sign the informed consent * simultaneous participation in other studies
yellow versus white study

Conditions: Cataract

Summary: blue-light-filtering iols are implanted increasingly often in cataract surgery. several studies examined the effect of blue-light-filters on contrast and colour vision. however, the study outcomes were varying. the present study investigated the effect of a blue-light-filtering iol on colour perception and contrast acuity using highly sensitive measurement methods.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * age 55 to 80 years * expected postoperative visual acuity of at least 1.0 exclusion criteria: * amblyopia * corneal scars * diabetes * arterial hypertonia * pseudoexfoliation-syndrome * earlier ocular surgeries or laser treatments * intraocular tumors * color abnormalities * expected postoperative visual acuity lower 1.0

Keywords: intraocular lens blue-light filtering intraocular lens contrast acuity color vision
the factors that affect the infection of covid-19

Conditions: COVID-19 Infection

Summary: the number of new coronavirus-2019 (covid-19) cases is increasing day by day despite the warnings "stay at home! wear a mask! keep social distance!". the aim of this descriptive study is to determine the risk factors that affect the covid-19 infection in turkey. the online link of the form created on google forms was sent to the participants' phones between 18.10.2020 and 18.11.2020.

the number of new coronavirus-2019 (covid-19) cases is increasing day by day despite the warnings "stay at home! wear a mask! keep social distance!". the aim of this descriptive study is to determine the risk factors that affect the covid-19 infection in turkey. the majority of the lands within the republic of turkey cover anatolia, while a minor part covers thrace, the southeast extension of the balkan peninsula. the population of turkey is 83,154,997. based on the natural, human and financial characteristics, the country consists of seven regions: mediterranean, eastern anatolia, aegean, southeastern anatolia, central anatolia, marmara, and black sea. the majority of the population lives in the marmara region. the online link of the form created on google forms was sent to the participants' phones between 18.10.2020 and 18.11.2020 and participants' informed consent was obtained. a 43-item questionnaire form which had two sections and was prepared by the researcher in line with the literature was used in data collection. the first section questioned participants' personal characteristics (first letters of participants' names and surnames, date of birth, profession, employment status, risk of covid-19 infection, family type, etc.), while the second section questioned the practices of following 14 rules declared by the turkish ministry of health to prevent the covid-19 pandemic (using a mask, observing the hand hygiene and social distance, etc.) and whether participants were diagnosed with covid-19. identity details that could help identify the participants were not questioned.

Eligibility criteria:
inclusion criteria: * being over the age of 18 * be in good mental and mental health * to be able to read and write exclusion criteria: * being under the age of 18

Keywords: covid-19 risk factor symptoms protective measures
igf-1, sarcopenia and mortality: a cohort study in patient with cognitive impairment

Conditions: Cognitive Impairment; Insulin-like Growth Factor 1

Summary: insulin-like growth factor 1 (igf)-1 is an important neuromyotrophic hormone. disregulation of this hormone has been reported to influence the genesis of cognitive impairment and dementia in the elderly patients. we analyzed the possible link between igf-1 and risk of sarcopenia and mortality in a cohort of elder patients with cognitive impairment.


Eligibility criteria:
inclusion criteria: * diagnosis of cognitive impairment (mmse \< 24) * age \> 65 ys exclusion criteria: * diagnosis of pancreatic disorders * diagnosis of acromegaly * diagnosis of gh-related disorders * recent bone fractures or immobility before the enrollment (3 months) * cancer

Keywords: sarcopenia mortality
cardiovascular risk assessment for kidney transplantation - utility of computed tomography coronary angiography in the assessment of patients awaiting kidney transplantation

Conditions: Cardiovascular Diseases; Kidney Transplant; Complications

Summary: cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation. current strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes. this study will use a heart scan known as computed tomography coronary angiography (ctca) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. studies have shown it is able to do this in patients with normal kidney function. the aim of this study is to develop ctca as an effective tool to risk stratify patients prior to kidney transplantation.


Eligibility criteria:
inclusion criteria: * has kidney failure and is on the waitlist for a kidney transplant * age 16 years and over * able to give informed consent exclusion criteria: * contraindication to ct scanning, including contrast allergy * patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation * inability to give informed consent

Keywords: coronary artery disease kidney transplantation cardiovascular risk assessment heart disease chronic kidney disease
effects of arm cycling and leg cycling on postprandial blood glucose levels in healthy persons

Conditions: Hyperglycemia, Postprandial

Summary: the literature has shown that exercise is effective in decreasing blood glucose levels. however, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. the purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.


Eligibility criteria:
inclusion criteria: * apparently healthy persons * age 18 years or above exclusion criteria: * cardiovascular diseases * pulmonary diseases * metabolic diseases * other contraindications to exercise
ngs for non-unions

Conditions: Nonunion of Fracture

Summary: the purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. the study aims to compare the results of genetic testing known as ngs to standardized clinical laboratory tests for diagnosing infections to see if ngs may be a better diagnostic tool.


Eligibility criteria:
investigational group: inclusion: 1. patients undergoing open biopsy / surgical intervention for nonunion following a traumatic (open or closed) long bone fracture (femur shaft, tibia, humerus) which was initially treated operatively.inclusion criteria: 2. nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. no specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites. 3. presumed septic and aseptic nonunions 4. \>18 years old and able to provide informed consent exclusion criteria: exclusion: 1. pathological fractures at index injury 2. patients on antibiotic therapy \<2 weeks prior to surgery inclusion/ exclusion criteria for control group: inclusion: 1. patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus) 2. \>18 years old and able to provide informed consent exclusion: 1. pathological fractures at index injury 2. patients on antibiotic therapy \<2 weeks prior to surgery
electrical stimulation in patients with prolonged mechanical ventilation

Conditions: Respiratory Failure

Summary: muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (pmv) and is associated with increased rate of weaning failure and days of hospitalization. electrical stimulation (es) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. the purpose of this study is to examine the effects of es on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with pmv.

background and purpose: muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (pmv) and is associated with increased rate of weaning failure and days of hospitalization. electrical stimulation (es) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. the purpose of this study is to examine the effects of es on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with pmv. methods: patients who have been on mechanical ventilator for more than 21 days will be recruited from respiratory care center (rcc). all subjects will be randomly assigned into three groups: es in abdominal muscles (es-abd, n=30),es in brachial biceps (es-bicep, n=30) and sham group(sham). subjects in both groups will receive es in muscles for 30 min/session, 2 sessions/day for 10 days with the same setting except area of es. the muscle function will be assessed by skin-fold thickness and muscle strength. the pulmonary function will be assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal inspiratory pressure. the hospitalization outcome will be followed up until patients are discharged from rcc. the outcomes variables include: weaning rate and duration, mortality, days of ventilator, and length of rcc stay.

Eligibility criteria:
inclusion criteria: * age\>20 years old * mechanical ventilation for more than 6 h/ day for more than 21 days -- medical stability (arterial blood gas value hydrogen power(ph): 7.35-7.45, atrial oxygen pressure(pao2): 60 mmhg at 40% fraction of inspired oxygen inspired oxygen fraction (fio2), absence of signs and symptoms of infection, and hemodynamic stability); exclusion criteria: * signs of acute infection (bt\>38.5℃，wbc\>12000 or \<3000 per unit * neuromuscular disease at acute stage * diagnosis of cancer at end-stage * pregnancy * bmi\>35kg/m2

Keywords: prolong mechanical ventilator, electrical stimulation, activities of daily life, hospitalization outcomes.
study in advanced parkinson's disease patients with predictable motor fluctuations

Conditions: Parkinson's Disease; Motor Fluctuations

Summary: the primary objective of this study is to explore the efficacy and tolerability of dm-1992 compared to a standard carbidopa/levodopa immediate-release (cd/ld ir) tablet (sinemet ir) as measured by: * "on" time with no dyskinesia or non-troublesome dyskinesia * "off" time


Eligibility criteria:
inclusion criteria: 1. men and women at least 30 years and older at the time of informed consent with advanced idiopathic parkinson's disease with predictable wearing-off motor fluctuations with hoehn and yahr stage ii-iii when "on." 2. patients should be able to differentiate between the "on" and "off" states with an average daily "off" time of ≥ 2.5 hours at study entry. 3. on a stable daily dose of ld of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit. 4. non cd/ld containing anti-parkinson's medications should be kept at stable doses for 1 month prior to screening visit. patients should be willing to keep their non ld containing medications consistently throughout the study duration. 5. female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as nova ring, oral, injected, transdermal patch, implanted, or barrier). 6. mini mental state examination (mmse) ≥ 26 at screening visit. 7. able to provide informed consent and willing to sign health insurance portability and accountability act (hipaa) authorization. 8. able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. must be under the observation of a competent care giver throughout the study participation. exclusion criteria: 1. patients with atypical or drug-induced parkinson's disease. 2. patients with a known history of hypersensitivity to levodopa or carbidopa. 3. patients who receive treatments with dopamine receptor blocking agents 4. patients with a history of seizures except of childhood febrile seizure. 5. patients with dementia. 6. patients with a significant history of gi diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years. 7. patients with any history of gastric surgery other than vagotomy and pyloroplasty. 8. patients with an immune-compromised state. 9. patients with clinically significant hepatic insufficiency with child-pugh total score of ≥ 5. 10. patients with a calculated creatinine clearance (clcr) \< 50 ml/min using the cockcroft-gault equation. 11. patients who have a difficulty swallowing tablets. 12. patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit. 13. patients with any other serious medical condition that, in the opinion of the investigator would jeopardize the safety of the patient or affect the validity of the study results.

Keywords: parkinson's disease pd stage2/3parkinson's advanced parkinson's disease with motor fluctuations
efficacy of a brown seaweed extract rich in polyphenols on glycemic response to sucrose in human

Conditions: Hyperglycemia

Summary: the primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.


Eligibility criteria:
inclusion criteria: * healthy volunteer aged 18 to 60 * bmi between 20 and 30 * non-smoking * using valid contraceptive method (women of childbearing age) exclusion criteria: * iodine allergy, or allergy to components of the test product or placebo or standard meal * diabetes * use of dietary supplements for duration of study * history of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract

Keywords: amylase glucosidase glycemic response sucrose seaweed
sintilimab plus bevacizumab as adjuvant therapy in hcc patients at high risk of recurrence after curative resection

Conditions: HCC; Adjuvant Therapy; Immunotherapy

Summary: this is an open label, multi-center, randomized, controlled phase iii study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (hcc) patients who are at high risk of recurrence after radical resection

there is no stardard adjuvant treatment for hcc. this study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hcc patients who are at high risk of recurrence after radical resection.

Eligibility criteria:
inclusion criteria: * patients with a first diagnosis of hcc who have undergone a curative resection * radiologic evidence of disease free ≥4 weeks after complete surgical resection * full recovery from surgical resection or post-operative transarterial chemoembolization before randomization * randomization needs to occur within 12 weeks of the date of surgical resection * high risk for hcc recurrence as protocol defined * child-pugh score, class a * ecog performance status 0 or 1 * no prior systemic anticancer therapy for hcc * adequate hematologic and organ function exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc or mixed cholangiocarcinoma and hcc * evidence of residual, recurrent, or metastatic disease at randomization * history of hepatic encephalopathy or organ transplantation * patients who are in the waiting list for liver transplantation * patients with vp4 portal vein thrombosis * prior therapy with an anti-pd-1, anti-pd-l1, or anti pd-l2 agent or other immunotherapy * pregnant or lactating women
madit-crt long-term international follow-up registry - europe

Conditions: Heart Failure

Summary: the registry is designed to determine the long-term mortality and morbidity benefit as a result of cardiac resynchronization therapy with defibrillation (crt-d) vs. implantable cardioverter defibrillator (icd) therapy in the madit-crt study patient population. the registry will collect data on patients that previously participated at madit-crt sites within europe through five years of participation from their orginal enrollment in the madit-crt ide study.


Eligibility criteria:
inclusion criteria: active patients who were enrolled in the madit-crt ide within europe exclusion criteria: patients who are unable or unwilling to comply with the protocol requirements

Keywords: crt heart failure
crossboss and stingray catheter and entera guidewire chronic total occlusion (cto) study

Conditions: Coronary Artery Disease; Coronary Artery Chronic Total Occlusion

Summary: this study is to determine if the bridgepoint medical system (crossboss catheter, stingray catheter, entera guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (cto). the hypothesis is that the bridgepoint medical system can do this without an increase in major complications.


Eligibility criteria:
inclusion criteria: * suitable for coronary intervention * de novo or restenotic cto at least 3 months old, in proximal or mid coronary artery segment, 3.0-5.0 mm in diameter * mild/moderate proximal vessel tortuosity * mild/moderate lesion angulation * mild/moderate calcification * satisfactory distal vessel visualization * mild/moderate side branch interference * 19 years old * bmi\<40 * lvef\>20% * signed informed consent exclusion criteria: * extensive dissection from guidewire manipulation * svg or in-stent cto * aorto-ostial cto * unable to take aspirin, clopidogrel, or ticlopidine * thrombus/vessel filling defects * severe cerebrovascular disease/stroke within 1 month * intervention within 2 weeks * renal insufficiency * gi bleeding * active infection * life expectancy \<2 years * significant anemia * uncontrolled hypertension * severe electrolyte imbalance * anaphylaxis to contrast * nyha class iv * unstable angina requiring intervention * mi within 2 weeks * uncontrolled diabetes * participating in another protocol * unwilling/unable to comply with protocol * angina/ischemia caused by target vessel