Kornimate/medical-research-clean huggingface dataset:
european (eu) post approval study of the incraft® aaa stent graft system in subjects with abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysms

Summary: insight is a postmarket clinical follow-up study in the european union. the purpose of the study is to continue to evaluate the safety and effectiveness/performance of incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. approximately 150 subjects will be enrolled and followed through 5-years post procedure. up to 25 sites in europe may participate.

insight is a postmarket clinical follow-up study in the european union. the purpose of the study is to continue to evaluate the safety and effectiveness/performance of incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. approximately 150 subjects will be enrolled and followed through 5-years postprocedure. up to 25 sites in europe may participate. subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.

Eligibility criteria:
inclusion criteria: 1. male or female age 18 years or older 2. femoral access vessels should be adequate to fit the selected delivery system 3. proximal neck length ≥ 10mm 4. aortic neck diameters ≥ 17mm and ≤ 31mm 5. aortic neck suitable for suprarenal fixation 6. infrarenal and suprarenal neck angulation ≤ 60° 7. iliac fixation length ≥ 15mm 8. iliac diameters ≥ 7mm and ≤ 22mm 9. minimum overall aaa treatment length (proximal landing location to distal landing location) ≥ 128mm 10. morphology suitable for aneurysm repair 11. provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures 12. subject is willing to comply with the specified follow-up evaluation schedule exclusion criteria: 1. subject has one of the following: 1. aneurysm sac rupture or leaking abdominal aortic aneurysm 2. mycotic, dissecting, or inflammatory abdominal aortic aneurysm 2. known allergy or intolerance to nickel titanium (nitinol), polyethylene terephthalate (pet), or polytetrafluoroethylene (ptfe) 3. known contraindication to undergoing angiography or anticoagulation 4. existing aaa surgical graft and/or a aaa stent-graft system 5. women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

Keywords: endovascular repair
prospective evaluation of t-cell immune status in patients with newly diagnosed high grade gliomas

Conditions: High Grade Glioma

Summary: the primary goal of this study is evaluate t cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed hggs undergoing the standard rt/tmz and adjuvant tmz.

numbers of t-cell subtypes at six time points in patients with newly diagnosed hggs undergoing standard rt/tmz and adjuvant tmz: 1. baseline within 2 weeks before initiation of rt/tmz 2. at the end of rt/tmz approximately week 6 3. before adjuvant tmz approximately week 10 4. after 2 cycle of tmz approximately week 18 5. after 4 cycle of tmz approximately week 26 6. three month after last cycle of tmz secondary endpoints 1. changes in serial t cell subtypes and cytokines levels 2. incidence of lymphopenia related infections 3. changes in t-cell numbers and subtypes with tmz administration 4. overall survival

Eligibility criteria:
inclusion criteria: 1. patients must be at least 18 years of age. 2. patients must have histologically confirmed new diagnosed high grade glioma by pathology (who grade iii and iv). 3. patients proposed post-operative treatment plan must include standard radiation and temozolomide. 4. patients must have a karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). 5. patients must be able to provide written informed consent. 6. steroid use is allowed. exclusion criteria: 1. patients with hiv are excluded.

Keywords: who grade iii and iv
validation of the simple adaptation of the kardia 6l ecg recorder to obtain chest lead equivalents: a multi-centre international (local-ecg) study; on behalf of the africa heart rhythm association investigators

Conditions: Cardiovascular Diseases

Summary: ecgs are routinely performed in cardiology. recently handheld ecgs have shown promise in screening for heart rhythm disorders. these are quick to perform and do not require the preparation that is needed for 12 lead ecgs. the aim is to test whether a novel adaptation to a handheld ecg recorder, kardia 6l, which has the potential to record a 6 lead ecg is able to screen for ecg abnormalities, thereby obviating the need for a full 12 lead ecg. this may allow for earlier diagnosis and treatment and has implications in the prevention of infection. the lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.


Eligibility criteria:
inclusion criteria: * any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part exclusion criteria: * patients who are unable or refuse to consent
sprinter legend balloon catheter

Conditions: Coronary Artery Disease

Summary: open label, single-arm trial to study the safety and effectiveness of the sprinter legend 1.25 mm angioplasty balloon.

the study examines acute outcomes when the sprinter legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during pci procedures.

Eligibility criteria:
inclusion criteria: * patient is greater than18 years of age and able to give informed consent. * patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (pci). * the patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study. * female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure. * patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the institutional review board (irb) of the respective investigational site. * patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenosis that are amenable to percutaneous treatment. exclusion criteria: * a known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated. * a serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure. * evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: q wave myocardial infarction or non-q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (ck-mb) or troponin elevated above the institution's upper limit of normal). * during the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc. * history of stroke or transient ischemic attack (tia) within the prior 6 months. * active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months. * history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

Keywords: balloon angioplasty coronary artery pci ptca heart disease myocardial ischemia
cannabinoides concentrations and hyperemesis syndrom occurrence in regular cannabis consumer (canemese)

Conditions: Chronic Consumption of Cannabis

Summary: the cannabinoide hyperemesis syndrom (chs) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. the diagnosis is linked to clinical criteria only. the physiopathology of chs is unknown and we observe an increase of cases with this syndrom since 2016 (schreck et al., 2018). the aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of chs.


Eligibility criteria:
inclusion criteria: * subjects without protection by a legal regime (guardianship, trusteeship) * subjects affiliated to an appropriate social security system * subjects must sign an informed consent form inclusion criteria for group 1: - subjects must have the chs diagnosis confirmed inclusion criteria for group 2: - subjects must be chronic cannabis consumers and never had chs exclusion criteria: * subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)
psma-pet/ct for prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is the most frequently occurring male cancer in belgium. patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker psa (prostate specific antigen) within the first few years. in these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. in so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated. with some patients, the psa-value is so low, that conventional nuclear medicine bone scanning or radiological ct or mri cannot determine where the metastases are. therefore, \[18f\]-choline pet-ct was introduced to improve diagnostic imaging performance. however, in 30 to 40 percent of patients choline-pet does not localize tumor either, especially in small tumors and/or very low psa values. the psma pet is already routinely used in many european centres, and has shown a superior accuracy in these patients as compared to conventional imaging techniques. this has been a very consistent finding in scientifically reported patient studies. most of these investigations have been performed with psma labeled with gallium-68. the investigators in ghent, as others, have labeled psma with fluor-18. this tracer provides many advantages, including a higher production yield enabling more patients to be scanned. also from a perspective of radioprotection and financial costs, fluor-18 is a better choice. moreover, several recent studies, comparing fluor with gallium modalities seem to suggest equivalent or better diagnostic results, possibly because of a lower aspecific background activity.


Eligibility criteria:
inclusion criteria: * patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after curative treatment (prostatectomy with or without lymphadenectomy or radiotherapy), or at primary diagnosis and staging. exclusion criteria: * age \ 70 years in phase-1; upper age limit is not applicable for the phase-2 trial. most patients will be \> 65 years old, an estimate may be more than 80%. * physically or mentally unfit to perform the sequential procedures * refusal of patient to be informed about accidental findings on scans.

Keywords: prostate cancer biochemical recurrence 18f-pet imaging
goal concordant care learning laboratory

Conditions: Cancer; Heart Failure; Copd; Dementia

Summary: the goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.

the goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness. the lab will test a variety of interventions, including triggered conversations and feedback to healthcare providers.

Eligibility criteria:
inclusion criteria: * duke health patient exclusion criteria: * none

Keywords: palliative care
epicondylar muscle activation in tennis players

Conditions: Epicondylitis, Lateral

Summary: epicondylitis is one of the most common pathologies in tennis players. the search for an effective treatment is necessary for the relief of symptoms and the return to sports practice. therefore, a ddry needling treatment in combination with electricity is postulated as an alternative to isolated dry needling treatment or conventional physiotherapy treatment. data will be collected in relation to pain and muscle activation by emg in order to check the effectiveness of these techniques as well as the muscle activation that is generated.


Eligibility criteria:
inclusion criteria: * tennis players of both sexes * federated and non-federated of castilla y león * playing tennis for at least 2 years * presence if one trigger point in epicondilar musculature exclusion criteria: * not informed consent signature * nervous, vascular, articular or musculoskeletal system alterations * tests or techniques performed fear (belonephobia) * pregnancy * allergic to any type of metal or body oil * active febrile proces * current pain treatments in the area involved * surgery in the last year for upper limb pathologies * cognitive alterations * taking painkillers or anti-inflammatory drugs 24 hours before the start of the study or taking them during the duration of the study

Keywords: electrical dry needling emg tennis physiotherapy
micronutrient levels and nutritional status in critical illness

Conditions: Post Intensive Care Unit Syndrome; Malnutrition

Summary: rationale: a significant proportion of patients admitted to the intensive care unit (icu) is unable to fully recover, even when the initial cause of their illness has been treated. inadequate dietary intake prior to admission and during the recovery phase may leave patients in a frail physical state, limiting rehabilitation potential. commonly used methods to assess nutritional intake and nutritional status are highly impacted by various disease-related confounders and reporting bias. we hypothesise that a combined assessment of biomarkers in plasma and urine may provide a more accurate overview of nutritional status at icu-admission. objective: main: assess nutrition-related biomarkers in plasma and urine samples at icu admission secondary: identify the number of micronutrient deficiencies at icu admission compare biomarker profile and dietary intake of short and long-stay icu patients at baseline compare subjective dietary intake, nutritional status and muscle thickness between patients with and without micronutrient deficiencies at baseline study design: observational study study population: adult patients admitted to the icu. two groups will be recruited: patients with a short length of stay (\<48 hours) and patients with a longer length of stay (≥48 hours). main study parameters: biomarker status in blood and urine at icu admission. nature and extent of the burden and risks associated with participation, benefit and group relatedness: in addition to standard care icu treatment, the following measurements will be performed: * within 24 hours after admission blood and urine samples will be collected from existing venous line and urinary catheter * within 72 hours an ultrasound measurement of the upper leg will be performed. * during icu stay, when the patient is capable to do so, they will be asked to complete a retrospective dietary intake assessment. the risks and negative effects of these tests are limited. however, this study asks for a time investment and physical and mental effort of the patients.


Eligibility criteria:
inclusion criteria: * age: 18 years and above. exclusion criteria: * not proficient in speaking and/or understanding dutch * comorbidity highly affecting gut absorption (e.g. post-bariatric surgery)
cost utility analysis of erythropoietin for anemia treatment in hemodialysis patients

Conditions: Chronic Renal Failure

Summary: to study the cost utility analysis of erythropoietin (epo) for maintaining the different hemoglobin (hb) target levels in anemic hemodialysis patient in routine clinical practice.

in thailand, the studies that were conducted to find the most useful target hb have not included the cost effectiveness and/or cost utility analyses. the level at which quality of life is maximized and risk is minimized would be the optimal target. dialysis patients carry higher risk of death than general population. anemia is the common complication found in dialysis patients that could lead to mortality. risk of anemia is occurred in hd patients more than capd patients because blood loss is less marked and residual renal function maybe better preserved in patients who receive peritoneal dialysis.although epo has been included in the national list of essential drugs (nled) for the treatment of anemia caused by end stage renal disease for maintaining the target hemoglobin but the cost of epo is so expensive. cost utility analysis is economic technique for assessing the efficiency of healthcare intervention measuring combined outcomes as the effectiveness, i.e., survival and quality of life in combination as quality adjusted life years (qalys).this study is a benefit measure at the care giving level by using as a part of planning patient management program and at the policy level for decision making.

Eligibility criteria:
inclusion criteria: * patients use epo at least 6 months with titration of epo therapy is permitted exclusion criteria: * patients under 18 years old. * patients who have blood transfusion for anemic treatment within 6 months before epo treatment and before the study starts * patients who change the modality of dialysis * patients who switch to other anemia treatment method between the study * patients who cannot answer the questionnaire and are not willing to participate in the study

Keywords: erythropoietin hemodialysis cost utility incremental cost-effectiveness ratio quality adjusted life year quality of life
hip abductor function during trendelenburg test

Conditions: Weakness, Muscle

Summary: this study will use electromyography and dynamometry to evaluate gluteal muscle activation during the trendelenburg hip abduction test in different hip positions.

the trendelenburg test is commonly used to assess hip abductor weakness. however, it is unclear which hip position during this test best isolates gluteal muscle function. this study will measure gluteus medius and minimus activation and hip abduction force in 30 healthy participants performing the trendelenburg test. different hip flexion, extension, adduction and abduction angles will be evaluated to determine which position optimally targets the gluteal muscles. results may enhance utilization of the trendelenburg test in clinical practice.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18-45 years * no history of hip disorders exclusion criteria: * contraindications to emg * neurological or muscular disorders
the safety and efficacy of an enzyme combination in managing knee osteoarthritis pain in adults

Conditions: Wobenzym; Osteoarthritis

Summary: the aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as wobenzym®, in adults with moderate-to-severe osteoarthritis (oa) of the knee.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis confirmed by radiography or tomography * lequesne functional index score of 10-14 * womac-a pain subscale score greater than or equal to 25 exclusion criteria: * history of knee trauma * history of joint infection * history of joint surgery * history of intra-articular injection (viscotherapy) * history of gastrointestinal diseases * use of corticosteroids * use of cox-ii inhibitors * use of glucosamine/chondroitin * known sensitivity to paracetamol * known sensitivity to non-steroidal anti-inflammatory drugs (nsaids) * known sensitivity to oral enzymes
prognosis association of hypocalcemia on moderate-severe tbi, cohorte study

Conditions: Calcium , Prognosis in Patients

Summary: will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe tbi that the patients that do not developed this condition?

through the years the investigators have seen that the patients with low calcium after moderate-severe tbi had bad prognosis including more complications, and more days in hospital. the investigators want to make an association between the patients that developed this condition and the patients that do not developed this condition

Eligibility criteria:
inclusion criteria: * man - woman between 16-65 years old with moderate -severe tbi less as 24 hrs,count with tomographic study exclusion criteria: * use of steroids, use of statins, administration of tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides. * unclassifiable lesions in brainstem

Keywords: calcium , tbi,complications, days in hospital
standardized lycium chinense fruit extract enhances attention and cognitive function in healthy young people

Conditions: Attention Deficit Hyperactivity Disorder

Summary: lycium chinense fruit (lcf) is widely distributed in east asia that has been used traditionally for anti-aging purposes. this study was performed to examine the effects of lcf on attention and cognitive function in healthy young people. an 11-week, double-blind, randomized, placebo-controlled, crossover trial was conducted.

the computerized neurocognitive function test (cnt), the korean version of the attention-deficit/hyperactivity disorder (adhd) rating scale-iv (k-adhd-rs-iv), the clinical global impression (cgi) rating scale, the frankfurt attention inventory (fair), and resting-state electroencephalogram (eeg) were conducted before and after the experiment.

Eligibility criteria:
inclusion criteria: * age between 14 and 24 years old * male or female * ability to understand the objectives of the study and agreed to abide by the required rules during the study. * if participants were aged between 14 and 20 years old, they and their parents had to provide informed consent. exclusion criteria: * diagnosis of adhd (any subtype) according to the diagnostic and statistical manual of mental disorders (dsm-iv) criteria * diagnosis of a developmental disorder * pregnant or breastfeeding women and women with the possibility of getting pregnant * gastrointestinal disease or history of gastrointestinal surgery, which might affect the absorption of study materials * significant neurological (epilepsy, mental retardation, or stroke) or medical illnesses (diabetes, hypertension, or cardiovascular diseases), * participation in other clinical studies during the four weeks preceding the start of the study * more than 1.5 times normal limit of alt or ast.

Keywords: lycium chinense fruit