Kornimate/medical-research-clean huggingface dataset:
smart trial longitudinal follow-up:off-pump versus on-pump coronary artery bypass surgery

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at \> 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or without heart-lung bypass (off-pump). the hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery.

the surgical management of arterial revascularization therapies (smart) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 unselected patients referred for elective, isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass. these patients were enrolled between march 2000 to august 2001. the primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass (opcab)are no less durable than the patency of those constructed during conventional cabg with cardiopulmonary bypass (cabg/cpb)after \> 5 years of follow-up (non-inferiority hypothesis). the secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at \> 5 years: 1. neurocognitive function 2. stroke/cerebral injury 3. health-related quality of life 4. myocardial perfusion and ischemia 5. major adverse cardiac events (mace) 6. cardiac functional status 7. incidence and severity of angina 8. all cause mortality and cardiovascular mortality 9. cost of hospital re-admissions since 1 year follow-up

Eligibility criteria:
inclusion criteria: * referred for primary or re-operative elective coronary artery bypass graft (cabg) with coronary targets suitable for off-pump bypass graft and currently enrolled in phase 1 of smart trial exclusion criteria: * emergent cabg * required pre-operative intra-aortic balloon pump (iabp) * cardiogenic shock * evolving acute myocardial infarction * coronary artery targets unsuitable for off-pump bypass surgery * inability or unwillingness to provide informed consent
assessment of liver cancer response to tace using multihance-enhanced mri.

Conditions: Hepatocellular Carcinoma

Summary: this research is being done to find out if using the contrast agent multihance can be used to show how a liver tumor responds to the chemotherapy given during transcatheter arterial chemoembolization (tace).

multihance is approved by the food and drug administration (fda) for use as a contrast material for magnetic resonance imaging (mri) scans of the central nervous system. it is believed that using multihance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. in this way, multihance may improve the way patients with hepatocellular carcinoma are managed clinically. we hypothesize that the multi-hance contrast material will provide better image definition of treated liver tumor(s) on mri imaging in comparison to other commercially available contrast agents.

Eligibility criteria:
inclusion criteria: * outpatients between the ages of 18 - 80 seen in the cardiovascular and interventional radiology clinic who are scheduled for tace. * international normalized ratio (inr) \<1.4 * platelet count \> 80,000 exclusion criteria: * contraindications to tace procedure * unable to have an mri scan * allergy or hypersensitivity reactions to gadolinium or any other ingredients, including benzyl alcohol * patients with sickle cell anemia , hemoglobinopathies and other hemolytic anemias * known clinical hypersensitivity or a history of asthma or allergic respiratory disorders * patients with advanced renal failure (those currently requiring dialysis or with a glomerular filtration rate\<15cc/min) * pregnancy

Keywords: liver cancer transarterial chemoembolization
study to validate the questionnaire called idsiq™ in patients with insomnia disorder

Conditions: Insomnia Disorder

Summary: the main study objective is to assess the content validity and the psychometric characteristics of the insomnia daytime symptoms and impacts questionnaire™ (idsiq™).

zolpidem will be used as an active intervention to assess the sensitivity to change of idsiq™ in patients suffering from insomnia disorder. idsiq™ will be administered during the screening period (within 14 days before enrollment in the study) and the treatment period (from day 1 to day 14). end of study (phone call) will take place 30-37 days after the end-of-treatment.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure; * male or female aged ≥ 18 years; * body mass index (bmi): 18.5 ≤ bmi (kg/m2) \< 32.0; * insomnia disorder according to dsm-5 criteria; * insufficient sleep quantity evaluated according to the self-reported history and data collected in the sleep diary; * insomnia severity index score greater than or equal to 15; * complete the idsiq™ and the sleep diary questionnaire as required. exclusion criteria: * any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy; * self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week; * caffeine consumption ≥ 600 mg per day; * shift work within 2 weeks prior to the screening visit, or planned shift work from v1 to v3; * travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel ≥ 3 time zones from v1 to v3; * known severe renal impairment or know moderate or severe hepatic impairment; * history or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments; * any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Keywords: insomnia
the effectiveness of a topical palmitoylethanolamide (pea) formulation (levagen+) for reducing symptoms of eczema

Conditions: Eczema, Atopic

Summary: this is a double blind, randomised, non-clinical study with 2 groups (1 investigational group and 1 comparator group) aiming to assess the effectiveness of pea for reducing eczema severity compared to a base comparator moisturiser in healthy adults aged over 18 years.


Eligibility criteria:
inclusion criteria: * adults (over 18) * suffering from atopic eczema with symptoms of redness, dry skin, scaling and/or itchiness on hands or arms * otherwise healthy * able to provide informed consent exclusion criteria: * active allergic skin responses * unstable or serious illness (eg kidney, liver, git, heart conditions, diabetes, mood disorders, cancer) * use of immunosuppressive medication within the last 3 months * pregnant or lactating women * smokers * chronic past and/or current alcohol use (\>14 alcoholic drinks week) * allergic to any of the ingredients in active or comparator formula * an unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. a serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
advanced platelet-rich fibrin combined with open debridement in management of suprabony periodontal defects

Conditions: Periodontitis, Adult

Summary: in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement

two groups of patients with suprabony defects, one will be treated with advanced platelet-rich fibrin in conjunction with open debridement and the other will be treated with open debridement alone. subjects will be evaluated for evidence of bone formation after 6 months of therapy

Eligibility criteria:
inclusion criteria: * patients with periodontal suprabony defects. exclusion criteria: * pregnant females. * smokers. * systemic disease that contraindicate surgery
metformin and 5-fluorouracil for refractory colorectal cancer.

Conditions: Metastatic Colorectal Cancer

Summary: this is a phase ii trial to evaluate efficacy and safety of metformin and fluorouracil in patients with metastatic colorectal cancer (crc) who have progressed after oxaliplatin and irinotecan based chemotherapy.

primary outcomes measures: - disease control rate at 8 weeks according to recist 1.1 (tumor response was defined as the percentage of patients with complete response, partial response or stable disease as best overall response). secondary outcome measures: * progression-free survival * overall survival * adverse events (assessed according to the common toxicity criteria for adverse events (ctcae) version 4.0)

Eligibility criteria:
inclusion criteria * histological diagnosis of metastatic colorectal adenocarcioma previously treated with at least two lines of chemotherapy (oxaliplatin and irinotecan regimens) if mutated kras or treated with at least 3 lines of chemotherapy (oxaliplatin, irinotecan and cetuximab) if kras wild type. * disease progression according to radiological or clinical assessment. * measurable disease. * ecog performance 0-1. * age above 16 years. * normal organic function as defined for the following criteria: * aspartate aminotransferase (ast), alanine aminotransferase (alt) ≤ 2.5 times the upper normal limit of the local laboratory (lsn-ll); * total serum bilirubin ≤ 2.0 x uln-ll; * absolute neutrophil count ≥ 1,500 / mm3; * platelet count ≥ 100,000 / mm3; * hemoglobin ≥ 8.0 g / dl; * serum creatinine ≤ 1.5 x uln-ll * written informed consent before enrollment exclusion criteria * diabetic patients taking metformin. * patients already treated with mtor inhibitors. * hypersensitivity to metformin, renal or hepatic impairment or other conditions that predispose to lactic acidosis. * history of acute myocardial infarction in the last 6 months * serious illness or psychiatric condition. * current participation in other protocols with experimental drugs. * suspicion of dihidropirimida dehydrogenase(dpd)deficiency. * presence of active infection. * no ability to ingest food orally. * patients with metastatic disease to cns. * patients who underwent major surgery in the last 4 weeks. * patients who received chemotherapy in the last three weeks. * patients who underwent radiotherapy in the last 2 weeks or who received radiotherapy in the target lesion, if this is the only target lesion. * patients using oral anticoagulation (warfarin). * pregnant or lactating patients

Keywords: metformin metastatic colorectal cancer fluorouracil
bnp therapy observation unit outcomes study (boost)

Conditions: Congestive Heart Failure

Summary: the investigators hypothesize that patients admitted to an emergency department (ed) observation unit will have a decreased rate of hospital admissions and ed recidivism when treated with nesiritide versus standard therapy. the investigators also hypothesize that decreasing b-type natriuretic peptide (bnp) levels during treatment in an ed observation unit will predict improved patient outcomes.

congestive heart failure (chf) is a growing problem in the united states. the increasing number of decompensated heart failure patients presenting to emergency departments (ed) for treatment is worsening the burden on already strained and limited health care resources. in addition, many of these patients will return to the ed for treatment within three months of being treated for decompensated heart failure. the emergence of ed observation units has provided a viable and cost effective alternative to inpatient treatment for many diseases including chf. it has been shown that intensive, directed therapy in ed observation units has decreased the revisit rates for chf patients. in addition, the introduction of nesiritide has shown promising results in the treatment of decompensated congestive heart failure. the primary aim of this study is to compare nesiritide versus standard heart failure therapy in an ed setting. a secondary aim is to determine if serial bnp levels during this observation unit stay will predict clinical outcomes. the treatment of heart failure in the ed places a tremendous burden on already limited resources. the costs of treatment as well as the morbidity and mortality associated with the disease are worsening and are predicted to increase as the general population ages. the ability to safely treat and discharge patients from an ed observation unit while reducing return visits would be invaluable in managing the growing number of heart failure patients.

Eligibility criteria:
inclusion criteria: * adult patient \> 18 years of age * have a working diagnosis of hf, as determined by the emergency physician using the boston criteria. a score of 8-12 is required for inclusion in the study. * alert, oriented and able to provide informed consent. * able to be contacted by telephone for follow up after discharge, and have none of the study exclusion criteria. exclusion criteria: * dialysis dependent renal failure * temperature \> 38.5 degrees celsius * pneumonia (infiltrates on chest x-ray) * requiring iv vasoactive agents (other than nesiritide) * killip class iii/iv * systolic blood pressure \< 90 mmhg * ekg diagnostic or suggestive of acute myocardial infarction or ischemia * abnormal cardiac markers * lack of a telephone * inability to provide informed consent due to cognitive impairment or a severe psychiatric disorder

Keywords: congestive heart failure observation unit nesiritide
a pilot trial of the use of recell® autologous cell harvesting device for venous leg ulcers

Conditions: Venous Leg Ulcers

Summary: this is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the recell autologous cell harvesting device (recell) for the management of chronic leg ulcers associated with venous insufficiency. outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving recell in addition to standard care.


Eligibility criteria:
inclusion criteria: 1. chronic venous leg ulcer (ceap clinical classification of 6) 1. confirmed, actively managed venous reflux 2. no exposed tendon or bone 3. ulcer is \>4 weeks in duration 4. ulcer surface area between 2cm2 and 80cm2 2. abi ≥ 0.8 3. the patient is 18 years of age or older 4. the patient is willing to complete all follow-up evaluations required by the study protocol 5. the patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary 6. the patient agrees to abstain from enrolment in any other clinical trial for the duration of the study 7. the patient is able to read and understand instructions and give voluntary written informed consent 8. the patient is able and willing to follow the protocol requirements (including compression therapy) 9. patients enrolling at any site in france must have an affiliation to a social security scheme exclusion criteria: 1. study treatment area has exposed bone or tendon 2. poorly controlled diabetes 3. arterial insufficiency (abi \< 0.8) 4. pregnant/lactating females (self-reported or tested, per institutional requirements) 5. the patient has an active wound infection requiring antibiotic therapy 6. the patient has had a prior surgical treatment of the ulcer within the past 60 days 7. the patient has a life expectancy of 1-year or less 8. the patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum). 9. the patient is unable to follow the protocol 10. the patient is taking, or has taken in the past 60 days, mycophenolate mofetil or \>10mg of corticosteroids per day. 11. the patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives 12. the patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (hartmann's) solution. 13. the patient is a vulnerable or protected adult. 14. the patient is unable to provide consent
cardiac fibroblast activation detected by 68ga-fapi pet/mr

Conditions: Myocardial Remodeling After AMI

Summary: myocardial infarction is the most common cause of high mortality in the modern world. the short-term survival rate of st-elevated myocardial infarction (stemi) has been dramatically increased in the past decades thanks to primary coronary intervention and standardization of treatment. however, the long-term prognosis of patients with acute myocardial infarction (ami) is still poor, especially in the aging population, due to heart failure related to inappropriate myocardial fibrosis and subsequent left ventricular (lv) remodeling. despite the amelioration of stemi management, lv remodeling still occurs in approximately 1/3 of all stemi patients. therefore, early identification of such patients may help the optimization of therapy and eventually the outcomes. one characteristic of activated cardiac fibroblasts is the expression of fap (fibroblast activation protein). a tracer (fap inhibitor) for positron emission tomography that targets fap has been used to measure relative fap density indicative of activated fibroblasts in different cancer entities. however, whether it can reliably assess myocardial fibrosis and predict the poor prognosis caused by lv remodeling is not yet known. therefore, we aim to observe active myocardial fibrosis process in patients with ami, and analyze its relationship with the patients'prognosis in a longitudinal study through 68ga-fapi pet/mri.


Eligibility criteria:
inclusion criteria: * between 18-75 years old * diagnosed with coronary angiography * performed percutaneous coronary intervention，with successful myocardial reperfusion exclusion criteria: * unstable hemodynamics * mr contraindications (such as pacemaker or nerve stimulator or metal foreign body, high fever, severe renal failure, etc.) * claustrophobia
early functional proprioceptive stimulation post-stroke

Conditions: Stroke (CVA) or TIA

Summary: the main objective of our study is to evaluate the impact of the use of functional proprioceptive stimulation (fps) on the recovery of the postural and motor functional capacities of the patient in the subacute phase of a stroke. the hypothesis is that the use of fps has a positive impact on the recovery of the patient's functional abilities, as well as on the duration of treatment until the sit/stand transfers are completed. to evaluate this potential effect,there will be a randomization with two groups : one will have 5 sessions a week for 6 weeks maximum of spf and the other groupe will have the same sessions but with the device stettled but not activated.


Eligibility criteria:
inclusion criteria: * adult patient hospitalized at cimiez university hospital; * ischemic or hemorrhagic cerebrovascular accident (cva) of less than two weeks; * hemiparesis requiring rehabilitation treatment; * patient with a sfpass score ≤ 6; * patient affiliated to or beneficiary of a social security scheme; * signature of informed consent exclusion criteria : * nihss \> 20; * muscle spasticity of the lower limbs requiring botulinum toxin injection * inability to understand rehabilitation instructions; * vulnerable people * pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than research, * adults who are subject to a legal protection measure or who are unable to express their consent.
effect of empowerment program on children's knowledge, attitude, self-efficacy, and practice of nail biting.

Conditions: Nail Biting

Summary: the study aims to evaluate the effect of an empowerment program based on the basnef model on children's knowledge, attitude, self-efficacy, and practice of nail biting. research hypothesis h1: the application of an empowerment program based on the basnef model has a positive impact on children's knowledge, attitude, self-efficacy, and practice of nail biting.

nail-biting or onychophagia is a common phenomenon affecting children where excessive nail-biting is associated with several adverse consequences beyond mere appearance. the aim is to evaluate the effect of an empowerment program based on the basnef model on children's knowledge, attitude, self-efficacy, and practice of nail biting. a quasi-experimental study was conducted in the pediatric wards of menoufia university hospital and benha university hospital. a convenience sample of 135 children aged 6 to 18 was randomly assigned to two groups. the study group attended four empowerment sessions based on the bansef model, emphasizing age-appropriate information, fostering a positive attitude towards quitting nail-biting, discovering the subjective norms that influence nail-biting behaviors, and equipping children with enabling factors to quit. the control group received routine health education.

Eligibility criteria:
inclusion criteria: * had nail-biting habits * willing to attend the educational sessions exclusion criteria: * had history of mental illness

Keywords: basnef model children knowledge nail biting practice self-efficacy
prophylactic mesh implantation for the prevention of incisional hernia

Conditions: Incisional Hernias

Summary: incisional hernias are primarily repaired using prosthetic meshes. in switzerland such meshes are mainly implanted via open or laparoscopic approach. the differential impact of these two types of surgical technique on recurrence rate will be investigated with this study. with this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. hernia recurrence is the main outcome measure.

background incisional hernia is one of the most common complication in general abdominal surgery. an overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity. in the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. with this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients'symptoms and to prevent progression of the hernia an possible complications. consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution. objective * occurrence of at least two of the following factors: * male gender * malignant tumor present * body mass index above 25kg/m2 * previous laparotomy * elective operation * patient \>18 years * written informed consent methods prospective,two armed, controlled, randomized study

Eligibility criteria:
inclusion criteria: * occurrence of at least two of the following factors: * male gender * malignant tumor present * body mass index above 25 * previous laparatomy * elective operation * patient \> 18 years * written informed consent exclusion criteria * previous intra-abdominal mesh placement * emergency procedures * previous incisional hernia * inflammatory bowel disease

Keywords: incisional hernias prophylaxis preperitoneal mesh