Kornimate/medical-research-clean huggingface dataset:
comparison of mis anterior versus mis anterolateral approach

Conditions: Osteoarthritis of the Hip

Summary: aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. the investigation will compare the mis (minimally invasive surgery) anterior approach with the mis anterolateral approach to the hip.

the surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. however, a surgical approach that causes no damage to surrounding muscle is unrealistic. whether the muscle is stretched, transacted or partially torn, injury will occur. aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. the investigation will compare the mis anterior approach with the mis anterolateral approach to the hip. the investigators questioned, which technique would be the less invasive? pain and functional performance will be measured using the harris hip score, the western ontario mcmaster, and the ucla (university of california) activity score. subject quality-of-life will be determined by evaluation the short-form 36 health survey. standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. mri scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. pre- and postoperative standard blood tests and specific serum trauma markers will be obtained.

Eligibility criteria:
inclusion criteria: * unilateral, noninflammatory end-stage osteoarthritis of the hip * willingness and ability to cooperate in the required post-operative therapy * willingness and ability to provide written informed consent * age 50-80 years exclusion criteria: * inflammatory arthropathies * prior hip surgery * prior infection of the hip * severe morbidity * severe osteoporosis * inability to tolerate general anesthesia * no contraindications to mri e.g. pacemakers, claustrophobia * neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care * known alcohol or drug abuse * unwillingness to participate
comparison of two methods for assessing cough capacity in intensive care unit after cardiac surgery

Conditions: Intensive Care Unit; Cardiac Surgery

Summary: weaning from mechanical ventilation represents 50% of the time spent under mechanical ventilation (1). the risk factors identified in the failure to wean from mechanical ventilation are: * left heart dysfunction with lvef \< 30%. * an ineffective cough * presence of resuscitation neuromyopathy * mechanical ventilation time \>7 days * presence of a delirium * age \>65 years old * abundant bronchial secretion * presence of underlying lung pathology an ineffective cough is found in 40% of patients requiring reintubation. however, cough assessment is most often approximate, based on a subjective assessment of cough strength by asking the patient to cough spontaneously on his or her tube). the objective evaluation of cough is based on the measurement of the peak expiratory flow rate at cough, commonly referred to as peak expiratory flow rate at cough (pefd), the patient is asked to take a deep breath and then cough as hard as possible. subjective cough assessment does not predict the occurrence of ventilatory withdrawal failure. conversely, all studies that objectively assessed the strength of cough before extubation by measuring the pefd found a significant association with the outcome of extubation: a low pefd increases the risk of extubation failure by a factor of 5 to 9. the investigators hypothesize that the increase in parietal abdominal muscle contraction obtained by using a non-invasive ultrasound method indicates an effective cough. conversely, an ineffective cough can be detected by this simple ultrasound criterion, which can be performed at the patient's bedside and extrapolated to all intensive care units equipped with an ultrasound scanner. this evaluation will be carried out before extubation: during the spontaneous ventilation test on a tube in a half-seated position (\>45°) and within 24 hours after extubation.


Eligibility criteria:
inclusion criteria: * major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours. exclusion criteria: * pregnant patient * recent history of stroke(\<6 months ) * minor patient * neurological disorder (alzheimer's disease, delirium, confusion) * emphysemal patient

Keywords: cough evaluation intensive care unit utrasound evaluation
leukotriene polymorphisms and montelukast response - ancillary to lodo trial

Conditions: Asthma; Lung Diseases

Summary: to elucidate the mechanisms underlying inter-patient variation in response to montelukast, a drug for asthma.

background: asthma is a common disease caused by a complex interaction between genetic and environmental factors. asthma afflicts 17 million americans. in 1999, more than 5000 persons died from asthma. given the significant mortality and morbidity associated with asthma, it is important to continue to develop new strategies for intervention. leukotriene antagonists are thought to be the most innovative approach to asthma therapy in 20 years. despite their demonstrated efficacy, safety and popularity, the leukotriene antagonists are associated with a significant degree of inter-patient variability in response, which can limit their safety, efficacy and cost-effectiveness. several polymorphisms in leukotriene pathway genes can contribute to variability in response. the project will determine if polymorphisms in genes encoding 5-lipoxygenase, leukotriene a4hydrolase, ltc4 synthase, multi-drug resistance protein 1 (mrp1) and lt1 receptor proteins are determinants of response to montelukast treatment. the study is in response to an request for applications entitled ancillary studies in heart, lung, and blood disease trials which was released by the nhlbi in june 2000 to conduct mechanistic studies in clinical trials related to heart, lung and blood diseases. specifically, this initiative focuses on the utilization of patients and patient materials from such trials to study the mechanisms underlying the interventions, the mechanisms of disease pathogenesis, surrogate markers or biomarkers of disease activity and therapeutic effect and the mechanisms of human cardiopulmonary and hematologic function. studies aimed at accelerating the development of new technologies within the context of the mechanistic investigations are also encouraged. design narrative: dna will be collected from patients participating in a parent clinical trial entitled: effectiveness of low dose theophylline as add-on therapy in the treatment of asthma (lodo trial). 627 patients from 19 asthma clinical research centers will be randomly assigned to receive placebo, or low dose theophylline (300 mg/day) or montelukast, 10 mg daily, for 6 months. stepwise linear and poisson regressions will be performed on outcomes including treatment and genetic covariates, and interaction terms between treatment arm and genetic makeup. polymorphisms that are highly associated with response can lead to the development of genetic tests that will identify patients most likely to benefit from montelukast treatment. this information may lead to individualization of asthma medications based on the genetic make-up of the patient.

Eligibility criteria:
no eligibility criteria
biomarkers in obese patients with knee osteoarthritis; weight loss

Conditions: Osteoarthrtis; Obesity

Summary: this is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (nct02905864). this substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

in the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

Eligibility criteria:
inclusion criteria: * same as parent trial (nct02905864) exclusion criteria: * same as parent trial (nct02905864)

Keywords: osteoarthrtis obesity liraglutide 3 mg liraglutide biomarkers
cohort for bardet-bield syndrome and alström syndrome for translational research monocentric interventional study

Conditions: Bardet-Biedl Syndrome; Alström Syndrome

Summary: alms and bbs syndromes are rare diseases with overlapping features of multiple sensory and metabolic impairments, including diabetes mellitus. there are to date no specific treatments available and limited information on the natural history of the diseases. the investigators aim to establish a french cohort for these diseases to improve patient care and assess the effect of actual therapies on quality of life. the purpose of this study is to establish a cohort of bardet-bield syndrome (bbs) and alström syndrome (alms) patients in order to formalize and address questions concerning the in-depth natural clinical and biological history of the disease on the long term for a given patient, establish the impact on the quality of life of various clinical manifestations


Eligibility criteria:
inclusion criteria: * patients of both sex * age minimum\* * patients with social protection * written informed consent form signed prior initiating any trial related procedure: * by \> 18-year old patients * by both parents for minor patients \> 4 months or legal representative for protected adults, and by minor and protected adults patients if able to understand and/or give their assent. * for foreign patients, a third party will translate, if required, the information prior to the consent. * a diagnosis of bbs or alms based on molecular assessment or clinical evaluation/or patient with mutation and none of the diagnosis criteria * and/or an identified mutation in bbs genes or alms1 gene * the inclusion of children is essential to a cohort study that is attempting an early identification of visual, metabolic and renal abnormalities. many of the age-dependent manifestations of bbs develop during childhood and the average age of diagnosis is 9.2 years exclusion criteria: * serious active intercurrent pathology that may impact the collected data * patient under judicial protection * participation in another interventional clinical trial which includes an exclusion period * non protected adult with difficulty of comprehension, or inability to understand the delivered information (emergency situation ...).
use of the gardex™ embolic protection device during percutaneous coronary interventions of saphenous vein graft

Conditions: Saphenous Vein Graft Disease; Myocardial Ischemia; Embolism

Summary: this is a multi center, prospective study designed to demonstrate the safety and performance of the gardex embolic protection system when used as an adjunctive device during saphenous vein graft (svg) interventions.


Eligibility criteria:
inclusion criteria: * anticipated patient life expectancy of at least 1 year from enrollment. * patient (or their legal guardian) has provided a signed informed consent. * patient is willing to comply with the protocol requirements. * candidate for pci, stenting and cabg. * total ck verified to be within hospital normal limits at the time of enrollment. * myocardial ischemia as evidenced by one or more of the following: * diagnosis at time of enrollment of stable or unstable angina pectoris * reversible 12 lead ecg changes consisted with ischemia * positive function study (e.g. stress test) * recent myocardial infarction (\>24 hours prior to enrollment with total ck verified to be within hospital normal limits at the time of enrollment). * lesions amendable to pci. * lesion(s) is located within svg and has ≥50% and \<100% stenosis (angiographic visual assessment). * only single svg graft to be treated. * vessel has thrombolysis in myocardial infarction (timi) grade 1 or higher flow before the passage of a guidewire. * reference vessel diameter where the gardex™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation. exclusion criteria: * a hypersensitivity or contraindication to heparin and bivalirum (angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids. * myocardial infarction with documented total ck\> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction. * a stroke or transient ischemic attach (tia) within the past 2 months. * a history of bleeding diathesis or coagulopathy. * major gastrointestinal (gi) bleeding within 3 months of index procedure. * baseline creatinine ≥ 2.5 mg/dl. * a planned invasive surgical procedure within 30 days. * undergone cardiac surgery within the past 60 days. * the lesion is in a svg that is less than 2 months post implant. * left ventricular ejection fraction \< 20% * the lesion is an arterial conduit. * anatomical exclusions that preclude placement of the gardex™ system per the instruction for use. * more than one svg graft that need to be treated at the index procedure. * chronic occlusion of the target lesion/severe calcification.

Keywords: heart disease embolic protection device pci svg
edoxaban in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention

Conditions: Non-valvular Atrial Fibrillation

Summary: this study is designed to gain real-world clinical data on the peri- and post-procedural usage of anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation (nvaf) undergoing successful percutaneous coronary intervention (pci) treated with edoxaban.

the study will assess real-world evidence data of anticoagulation and antiplatelet therapy in patients with nvaf undergoing pci treated with edoxaban. the observation period will start 4 to 72 hours after removal of the guiding catheter of successful pci in a hospital and ends 1 year after procedure. follow-up telephone calls will take place approximately 1 month and 1 year after pci. real-world data of effectiveness of edoxaban and antiplatelet therapy, clinical events of interests, safety and quality of life (qol) data of edoxaban will be collected.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * providing written informed consent (icf) for participation in the study * nvaf treated with edoxaban * successful pci * no planned elective cardiac intervention for the whole duration of the study (up to 1 year) * capability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year) * availability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year) * willingness of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year) * not simultaneously participating in any interventional study * life expectancy \> 1 year exclusion criteria: * not applicable

Keywords: non-valvular atrial fibrillation antiplatelet therapy anticoagulation therapy percutaneous coronary intervention edoxaban
maximizing benefit of lung cancer screening incidental findings of cardiovascular, respiratory and breast measures

Conditions: Coronary Disease; Emphysema or COPD; Breast Density

Summary: the investigators will implement a patient-centered outcomes tool for participants in lung cancer screening programs that receive clinically important incidental findings relevant to heart, breast and lung health. the study objective is to evaluate participant response and clinical follow-up following implementation of a patient-centered incidental findings communication tool.

a computer assisted personal interview survey will be administered by study personnel to capture information about perceived risk, cues to action and self-efficacy among lung cancer screening participants. participants eligible for recruitment will have had incidental findings from the low dose ct: moderate to severe cac, grade 3 or 4 breast density, moderate to severe emphysema, or multiple incidental findings. the interview-administered survey will be conducted by telephone with responses entered by study personnel into a redcap database. the redcap questionnaire will be adapted to a given patient's if status. the survey questions will be based on the health belief model that has been used effectively in the context of secondary prevention. for each participant the survey will be conducted before and after system level implementation of a patient-centered incidental findings communication tool.

Eligibility criteria:
inclusion criteria: * eligible for lung cancer screening program * presence of one of three incidental findings on low dose ct: coronary artery calcification, extensive breast density (for females), or emphysema exclusion criteria: * no incidental findings from lung cancer screening low dose ct
mm-302 plus trastuzumab vs. chemotherapy of physician's choice plus trastuzumab in her2-positive locally advanced/metastatic breast cancer patients

Conditions: Breast Cancer; HER2 Positive Breast Cancer

Summary: this study is an open label, randomized, multicenter trial of mm-302 plus trastuzumab. the trial is designed to demonstrate whether mm-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (cpc) plus trastuzumab in locally advanced/metastatic her2-positive breast cancer patients. patients may not have been previously treated with an anthracycline in any setting. patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed invasive cancer of the breast * patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent. * patients must have her2-positive breast cancer as defined by asco/cap 2013 guidelines that is confirmed by a sponsor-designated central laboratory * patients must have progressed on, or be intolerant to pertuzumab in the labc/mbc setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. * patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the labc/mbc setting * patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab) * ecog performance status of 0 or 1 exclusion criteria: * patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative * subjects with central nervous system (cns) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment * patients with any class of new york heart association (nyha) chf or heart failure with preserved ejection fraction (hfpef) * patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months * patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia) * patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity * patients with a history of lvef decline to below 50% during or after prior trastuzumab/lapatinib or other her2 directed therapy.

Keywords: her2-positive her2+ her2 locally advanced breast cancer metastatic breast cancer trastuzumab herceptin pertuzumab ado-trastuzumab emtansine tdm-1 perjeta kadcyla
vitamin c and zinc in patients with enterocutaneous fistulas.

Conditions: Enterocutaneous Fistulas

Summary: various micronutrients play an important role in the process of closure and recurrence of enterocutaneous fistulas, such as vitamin c and zinc. however, there is no specific recommendation on the dose of these nutrients by parenteral route.

this is a randomized, control trial to investigate the effect and safety of doses of vitamin c and zinc in patients with high enterocutaneous fistulas receiving who need nutrition parenteral therapy on closure and recurrence. screening will be made to select eligible participants before intervention. participants were randomly assigned to one of two groups: group a) 25-35 kcal/k/d, 1.3-1.5 g/k/d of amino acids and c 100-300 mg/d y zinc 3-5 mg/d; group b) 25-35 kcal/k/d, 1.3-1.5 g/k/d of amino acids and vitamin c 1000-2000 mg/d y zinc 10-15 mg/d. demographic variables and subjective global assessment scale will be recorded and applied. anthropometric measurements (weight and body mass index) will be evaluated upon admission and weekly until hospital discharge. biochemical markers (albumin, lymphocytes, prealbumin, transferrin, cholesterol, creatinine) and serum metabolic profile (glucose, liver function test) will be measured weekly. during hospitalization, patients will be evaluated daily until the closure of the fistula and/or follow-up at 30 days, monitoring capillary blood glucose, insulin expenditure, and fistula volume.

Eligibility criteria:
inclusion criteria: * women and men * \>18 years and \<70 years old. * diagnosis of high-output enterocutaneous fistula for the first time * need for parenteral nutrition exclusion criteria: * octreotide use * palliative care * steroid use * oxalate nephropathy * g6pd deficiency * hemochromatosis * abdominal surgeries in the last 6 months * hospitalizations for more than 15 days in the last 6 months

Keywords: enterocutaneous fistulas vitamin c zinc parenteral nutrition