Kornimate/medical-research-clean huggingface dataset:
study of drug eluting peripheral vascular stent system in superficial femoral artery stenosis and /or occlusion

Conditions: Peripheral Arterial Disease; Superficial Femoral Artery Stenosis; Superficial Femoral Artery Occlusion

Summary: evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.

this is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the drug eluting peripheral vascular stent system versus the commercially available nitinol stent system (cordis corporation). patients will receive color doppler ultrasonography (cdu) imaging and dual fluoroscopic imaging at 6th month and 12th month post procedure. clinical visits are scheduled at 0\~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. furthermore, cdu will also be performed at baseline in all participants of the study.

Eligibility criteria:
inclusion criteria in preoperative: * aged from 18 to 85 years old, male or female * subject's target lesions were stenosis and/or occlusion * subject is aware of the study content, showing sufficient compliance with the research protocol and sign the informed consent exclusion criteria in preoperative: * in-stent restenosis(irs) or restenosis after drug-eluting balloon administration * serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration * subject with coagulation abnormalities should not be performed

Keywords: peripheral arterial disease drug eluting peripheral vascular stent system primary patency
icotinib combined with radiation therapy for nsclc patients with brain metastases and egfr mutation

Conditions: Non-Small Cell Lung Cancer; Brain Metastases

Summary: the purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for nsclc patients with brain metastases. the primary endpoint is pfs of intracranial lesions

non-small cell lung cancer (nsclc) is one of the malignant tumors with the highest incidence of brain metastases. patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. some research showed that icotinib alone can improve the efficiency of nsclc with brain metastases, but there is still unknow about the result about combination with egfr-tki and radiotherapy. this study is designed to evaluate the efficacy of icotinib combined with radiotherapy for nsclc patients with brain metastases.

Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of non-small-cell lung cancer (nsclc) with brain metastases * histological or cytological confirmation of egrf positive sensitive mutation * diagnosis of brain metastases on a gadolinium-enhanced mri exclusion criteria: * previous usage of egfr-tki or antibody to egfr: gefitinib, erlotinib, herceptin, erbitux * previous usage of radiation with brain * csf or mri findings consistent with metastases of spinal cord, meninges or meningeal.

Keywords: nsclc brain metastases
menopausal sleep fragmentation and body fat gain

Conditions: Menopause

Summary: this study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. the investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

while obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. we will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.

Eligibility criteria:
inclusion criteria: * healthy premenopausal women 18-45 years old * regular sleep schedule * limited alcohol and caffeine intake * regular monthly menstrual cycles * no lifetime history of hot flashes * willingness to use approved methods of contraception during study * not obese * good general health exclusion criteria: * contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists * pregnancy * breastfeeding * tobacco use * contraindicated systemic hormone medications or centrally active medications * shift workers or recent/expected time zone travel * obstructive sleep apnea * insomnia symptoms * diagnosis of osteoporosis or osteopenia * hypothalamic-pituitary-adrenal axis disorders * diabetes * gastric bypass, metabolic disorders, or other related conditions * abnormalities on screening laboratory tests * substantial hearing impairment * cardiovascular illness * neurological illness * recent psychiatric illness or substance-use disorder

Keywords: menopause sleep fragmentation leuprolide adipokine weight gain leptin
efficacy and safety of dabigatran compared to warfarin for 6 month treatment of acute symptomatic venous thromboembolism

Conditions: Thromboembolism

Summary: the purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an international normalised ratio (inr) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (vte), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. this trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic vte. after achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.


Eligibility criteria:
inclusion criteria 1. acute deep vein thrombosis (dvt) of the leg involving proximal veins, and/or pulmonary embolism (pe) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate 2. male or female, being 18 years of age or older 3. written informed consent for study participation exclusion criteria 1. overt symptoms of vte for longer than 2 weeks prior to enrolment 2. pe satisfying at least one of the following criteria: haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of pe is other than the legs 3. actual or anticipated use of vena cava filter 4. contraindications to anticoagulant therapy 5. patients who in the investigators opinion should not be treated with warfarin 6. allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications 7. patients who in the investigators judgement are perceived as having an excessive risk of bleeding 8. known anaemia 9. need of anticoagulant treatment for disorders other than vte 10. recent unstable cardiovascular disease 11. elevated ast or alt \> 2x uln 12. liver disease expected to have any potential impact on survival 13. patients who have developed transaminase elevations upon exposure to ximelagatran 14. severe renal impairment 15. women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception 16. participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study 17. patients considered unsuitable for inclusion by the investigator
effect of closed tracheal aspiration associated with expiratory pause in pediatrics randomized, crossover clinical study

Conditions: Respiratory Insufficiency in Children

Summary: introduction: patients on mechanical ventilation suffer alterations in the viscoelastic characteristics of the mucus due to changes in the humidity and temperature of the inhaled air and in the respiratory volumes and flows. the literature has pointed out the use of mechanical ventilators as a tool for mobilizing secretions and closed-system aspiration associated with expiratory pause has been shown to be effective in mobilizing secretions. objectives: to assess whether there is a difference in the mass of aspirated secretion with the application of the expiratory pause during aspiration. methods: a crossover, randomized study. applied to children aged 0 to 5 years and 11 months who are intubated for 24 hours with orotracheal tubes or tracheostomy. there will be an exclusion of patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study. the technique will be during aspiration in the tube with where to apply or not the expiratory pause on the mechanical ventilator. this secretion will be weighed so that there is fidelity in the results.

a prospective, crossover, randomized clinical study will be carried out in the pediatric icu of hospital israelite albert einstein.

Eligibility criteria:
inclusion criteria: * patients aged 0 to 5 years and 11 months who have been on invasive mechanical ventilation for more than 24 hours through an orotracheal cannula or tracheostomy will be included in the study. exclusion criteria: * patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study will be excluded from the study.

Keywords: respiratory insufficiency, respiratory artificial
epidemiologic register on diabetes and covid-19 in tunisia

Conditions: COVID-19 Disease

Summary: covidtun is a multicenter observatory set up by a steering committee to determine the presentation and evolution of diabetes in covid-19 and study its pathogenesis. the observatory comprises a dataset consisting of routinely collected clinical information anonymously to be entered by the investigator as a participating clinician/researcher. the study will be an opportunity to understand the relationship between covid-19 and diabetes, to enrich tunisian data on diabetic and de novo diabetic patients who have contracted covid-19 and to evaluate the prognostic severity factors for better management of these patients.

it is a multicentric tunisian observatory for covid-19 patients. confirmed covid-19 patients, treated on an outpatient basis, in containment centers or hospitalized in covid-19 units were included retrospectively from march 2020 and had continued prospectively til june 2022. the study had selected eligible patient recorded for inclusion by free practice physicians and hospital physicians. general data, medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, nfs, crp, d-dimer, etc.), clinical course and complications were therefore recorded in a structured and anonymized database. data collection was carried out by dacima clinical suite® solution, in accordance with the normative and regulatory provisions in force in the management of health data.

Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 infection confirmed by an evocative clinical picture according to ineas score or a positive polymerase chain reaction \[pcr\] test and/or chest ct specific radiological signs and/or a rapid diagnostic antigen test. * diabetes known before covid-19 (known diabetes patient before covid-19: diabetic patient before covid-19: history in medical record and/or presence of antidiabetic therapy and/or hba1c ≥ 6.5%). or - de novo diabetes (the de novo diabetic patient is defined as: fasting blood glucose ≥ 1.26 g/l (7mmol/l) or postprandial blood glucose ≥ 2g/l (11.1 mmol/l) within 2 weeks of covid-19 infection, no history of diabetes before the covid-19 episode)). exclusion criteria: * children * pregnant women
peristomal skin complications and quality of life

Conditions: Colorectal Cancer; Quality of Life; Stoma Ileostomy; Stoma Colostomy; Complication

Summary: this study is a single blind semi-experimental study. aim: to investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery. h1: standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy. h2: standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.

in order to ensure blindness in the study design, patients were not informed about which group they belonged to. patient with ostomy in the study group were trained in accordance with the standard stoma care. patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure. all patients were followed up at 2, 6, and 12 weeks. peristomal complications were evaluated by the researcher with the peristomal skin tool at the 2nd, 6th and 12th weeks. the patients were asked to fill the stoma quality of life scale in the 2nd, 6th and 12th weeks.

Eligibility criteria:
inclusion criteria: * undergoing colorectal surgery, * permanent or temporary ileostomy or colostomy * end or loop ileostomy or colostomy exclusion criteria: * individuals who have previously had stoma surgery, * having two or more stoma, * individuals with crohn's disease * individuals who do not want to participate in the study
the effect of sensory motor training on postural stability in post-menopausal women with non-specific low back pain

Conditions: Low Back Pain

Summary: the study will be conducted to determine the effect of sensory-motor training on postural stability in post-menopausal women with non-specific low back pain.

low back pain (lbp) primarily affects postmenopausal women between the ages of 45-60, and it causes distress on social and economic levels postmenopausal women with non-specific low back pain (nslbp) and decreased function often feel anxious and sad, which affects their work, sexual and social lives neuromuscular rehabilitation techniques addressing sensory deficiencies have emerged in recent years and have received increasing therapeutic attention. these techniques could broadly be summarized as sensorimotor training (smt) methods aiming at increased proprioceptive input to improve motor response in dynamic environments. this might lead to improved quality of postural control, which in turn may alleviate postural specific musculoskeletal pain. as it promotes proximal stability and distal mobility, core muscles stabilization exercises (cse) are becoming a more significant part of the treatments. the use of cse is promoted as a general physical therapy approach for nslbp. overtime, ces have improved, focusing more and more on maintaining spinal stability. theoretical ideas for the treatment of spinal ailments that aid in reducing pain and enhancing function in patients with lbp significantly support the use of cse. cse trains muscle activity patterns without unnecessarily overloading the tissue, enhances aerobic fitness, spinal mobility, muscle strength, motor co-ordination and can help to stabilize the spine at a quite cost affordable price and reduce low back pain.

Eligibility criteria:
inclusion criteria: * all women suffering from non-specific low back pain for at least 3 months. * their ages will be ranged from 50-65 years. * they will be at least 3 years post menopause. * their body mass index (bmi) will be less than 30 kg/m2. exclusion criteria: * musculoskeletal injuries. * cardiovascular, respiratory or neurological disorders or psychiatric problem. * spinal deformity, bone fracture. * back surgery experience. * hormone replacement therapy and females with cancer. * sensory neuropathy and nervous system problems. * middle ear or vestibular problems.
cardioversion of atrial fibrillation accompanied by chronic heart faliure

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with htea or usual medicine.

the purpose of this study is to explore the efficacy of low energy (30j) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with htea or usual medicine.

Eligibility criteria:
inclusion criteria: * congestive heart failure accompanied by atrial fibrillation. exclusion criteria: * valvular heart diseases.
totally robotic versus surgeon-assisted robotic lung resection for early-stage nsclc

Conditions: Lung Cancer

Summary: robotic-assisted thoracoscopic surgery (rts) is safe and effective for patients with early-stage non-small cell lung cancer (nsclc). during rts, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (surgeon-assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (totally robotic). totally robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. there also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in rts. this rct aims to evaluate the costs and perioperative patient outcomes of totally robotic lung resection using the vessel sealer extend energy device (for vessels \<7mm) and the sureform robotic stapler (intervention) versus surgeon-assisted robotic lung resection using the signia stapler (control) during rts for nsclc using the da vinci system.


Eligibility criteria:
inclusion criteria: * age between 18 and 120 years at time of consent * ability to speak and understand english * clinical stage i, ii or iiia nsclc * candidate for rts, as determined by the operating surgeon exclusion criteria: * anticoagulation with inability to cease anticoagulant therapy prior to surgery * incurable coagulopathy * systemic vascular disease or vasculitis * not a candidate for rts
effects of regional nerve block on cancer recurrence

Conditions: Cancer Patient

Summary: it has been reported local anesthetics could inhibit tumor cell proliferation, metastasis and invasion ability，but it is still lack of clinical evidence. our study aims to explore the effects of regional nerve block on cancer recurrence and the mechanism.

1. to study the effects of tap block under ultrasound guide on the recurrence of gastric carcinoma, colon cancer, rectal carcinoma and liver cancer and the underlying mechanisms. 2. to clarify the effects of lateral thoracic nerve block under ultrasound guide on the recurrence of lung cancer and the underlying mechanisms.

Eligibility criteria:
inclusion criteria: * patients with primary cancer undergoing elective surgery under general anesthesia exclusion criteria: * disagree to participate，drop out,lose track, infectious abdominal wall，abnormal puncture point，coagulation dysfunction，allergy of local anesthetic ，immune disease,cancer metastasis,mental disease, acute and chronic infectious disease or other severe disease.

Keywords: regional nerve block cancer recurrence
frequency of pompe disease in patients with myalgia with or without hyper ckemia - data from the reference center (cerca)

Conditions: Pompe Disease

Summary: pompe's disease is a lysosomal storage disease of autosomal recessive genetic transmission due to a deficiency in acid alpha glucosidase. this enzyme deficiency leads to glycogen overload in all cells but with a more marked expression in muscle cells. there is a great variability in the clinical manifestations and in the age of onset of symptoms depending on whether the enzyme deficiency is partial or total. the prevalence is estimated at 1 in 40,000. there is a specific treatment based on enzyme replacement therapy

patients include: clinical examination, enzyme activity assay, muscle testing, cardiological and respiratory workup. lowered enzyme activity suggests a pathogenic genetic variant to be identified. the secondary objective is to propose genetic counselling and a family investigation in order to identify relatives who are also affected.

Eligibility criteria:
inclusion criteria: * • both sexes * with permanent myalgia, spontaneous or on effort, * with or without muscle deficit, * with or without hyperckemia * without known etiologies * age from 6 to 80 years * consulting for the first time or followed at cerca * giving their free and informed consent to participate after information on the research * affiliated to the social security system exclusion criteria: * person placed under guardianship and/or curatorship * myalgias related to a known etiology

Keywords: frequency, martinique observational study myalgia reference center for rare diseases
a study to evaluate the safety and efficacy of rituximab in combination with methotrexate compared to methotrexate alone in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * adult patients 18-80 years of age. * rheumatoid arthritis (ra) for ≥ 6 months, diagnosed according to the revised 1987 american college of rheumatology (acr) criteria for the classification of rheumatoid arthritis. * receiving outpatient treatment for ra. * swollen joint count (sjc) ≥ 8 (66 joint count), and tender joint count (tjc) ≥ 8 (68 joint count) at screening and baseline. * at screening, either * c-reactive protein (crp) ≥ 0.6 mg/dl (6 mg/l), or * erythrocyte sedimentation rate (esr) ≥ 28 mm/hour. * inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks. exclusion criteria: * rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra. * inflammatory joint disease other than ra, or other systemic autoimmune disorder. * diagnosis of juvenile rheumatoid arthritis, or ra before the age of 16. * surgery within 12 weeks of study or planned within 24 weeks of randomization. * previous treatment with any approved or investigational biological agent for ra, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.

Keywords: ra rituxan serene
mid-point to pleura transverse process block versus thoracic intervertebral foramen block

Conditions: Pain, Acute; Rib Fractures; Polytrauma

Summary: the analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures.

the analgesic effect of continuous mid-point to pleura transverse process block will be compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures, by using the numeric rating scale (nrs) for pain.

Eligibility criteria:
inclusion criteria: * ribs fracture after polytrauma exclusion criteria: * pregnancy * allergy to anesthetics * head trauma * history of neurological impairment (primary or secondary) * history of cancer * history of chronic obstructive pulmonary disease * infections of skin close to the block site * systemic infections

Keywords: analgesia local anesthetics myofascial block ultrasound guidance