Kornimate/medical-research-clean huggingface dataset:
first-in-human study evaluating aneurysm sac lining in aaa patients

Conditions: Abdominal Aortic Aneurysm

Summary: the goal of this clinical trial is to evaluate the safety and feasibility of the cygnum aneurysm sac management device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (evar). the main questions it aims to answer are: 1. is the cygnum device safe when used adjunctively with standard evar endografts? 2. does it effectively reduce or prevent type ii endoleaks by managing the aneurysm sac? participants will: 1. undergo evar with adjunctive implantation of the cygnum device 2. have follow-up imaging (e.g., ct scans) and clinical assessments to evaluate device position and sac behavior over time


Eligibility criteria:
inclusion criteria: * patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent * patient is willing to complete the follow-up according to the requirements of the protocol. * patient aaa anatomy complies with "instructions for use" for commercial evar devices used * ≥18 years old * abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females * maximum blood flow luminal diameter ≤ 50mm * eligible for endovascular aneurysm repair based on anatomical considerations, such as adequate iliac/femoral access * patient is american society of anesthesiology (asa) grade 1 through 3, inclusive. exclusion criteria: * concomitant common iliac artery aneurysms ≥ 25mm * life expectancy \<2 years * already participating in an investigational drug or device study * known allergy or contraindication to any study device material * coagulopathy or uncontrolled bleeding disorder * ruptured, leaking, inflammatory or mycotic aneurysm * connective tissue diseases (e.g., marfan syndrome) * unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator * aneurysmal or dissected disease of the descending thoracic aorta * previous surgical or evar repair for aaa * myocardial infarction and/or major heart surgery ≤ 90 days prior to the procedure * transient ischemic attack or stroke ≤ 90 days prior to the procedure * unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure * unable or unwilling to comply with study follow-up requirements * serum creatinine level ≥ 180 µmol/l * patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study * patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.
treatment of paclitaxel plus carboplatin followed by gemcitabine plus carboplatin for patients with epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.


Eligibility criteria:
inclusion criteria: * histologically verified epithelial ovarian cancer * figo stage iii-iv * patients with measurable disease. recist criteria with gcig modifications will be used for response and for progression assessment. * lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral ct scan. lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm. exclusion criteria: * ovarian tumors with low malignant potential (borderline tumors) * non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed mullerian tumors) * time between definitive surgery and enrollment into the study is greater than 6 weeks * patients who have received previous chemotherapy or radiotherapy
evaluation of pertuzumab-trastuzumab and taxane in the standard treatment of metastatic breast cancer

Conditions: Breast Neoplasms; HER-2 Gene Amplification

Summary: this retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of her2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of cleopatra.

in 2013 the european medicines agency authorized the use of a new antibody named pertuzumab in combination with trastuzumab in first-line setting for patients with her2-positive metastatic breast cancer. the efficacy and the safety were demonstrated in the cleopatra study. this study had inclusion and exclusion criteria that might not be representative of a real life population of women with metastatic breast cancer. few study tried to evaluate this treatment in real life settings but with discordant results. this retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of her2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of cleopatra.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer * her2 positive * received pertuzumab in combination with trastuzumab and taxane chemotherapy exclusion criteria: * no her2-positive breast cancer * no association with taxane chemotherapy * no metastatic breast cancer * refusal to consent

Keywords: pertuzumab breast neoplasms/pathology real life trastuzumab receptor, erbb-2/antagonists & inhibitors* breast neoplasms/drug therapy* multicenter study taxoids antibodies, monoclonal, humanized
a study of aln-pcssc in participants with homozygous familial hypercholesterolemia (hofh)

Conditions: Homozygous Familial Hypercholesterolemia

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of aln-pcssc in participants with homozygous familial hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * males and females, ≥12 years of age with a diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated low-density lipoprotein cholesterol (ldl-c) concentration \>500 mg/deciliter (dl) \[13 millimoles/liter (mmol/l)\] together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents. * stable on a low-fat diet. * stable on pre-existing, lipid-lowering therapies (such as statins, cholesterolabsorption inhibitors, bile-acid sequestrants, or combinations thereof) for at least 4 weeks with no planned medication or dose change for the duration of study participation. * fasting central lab ldl-c concentration \>130 mg/dl (3.4 mmol/l) and triglyceride concentration \<400 mg/dl (4.5 mmol/l). * body weight of 40 kilograms (kg) or greater at screening. exclusion criteria: * ldl or plasma apheresis within 8 weeks prior to the screening visit, and no plan to receive it during the study because of the attendant difficulty in maintaining stable concentrations of ldl-c while receiving apheresis. * use of mipomersen or lomitapide therapy within 5 months of screening. * previous treatment with monoclonal antibodies directed towards pcsk9 within 8 weeks of screening. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
acute effect of mmt peel powder on glycemic response, satiety, and food intake in adults at risk for type 2 diabetes

Conditions: At Risk of Type 2 Diabetes Mellitus

Summary: open-label, randomised, placebo-controlled, crossover study with two intervention arms. the study was conducted in 30 respondents and the primary objective is to show an improved glycemic response after melon manis terengganu (mmt) peel powder consumption in people at risk of type 2 diabetes.

the main aim of the study is to investigate the acute effect of mmt peel powder on glycemic response in people at risk of type 2 diabetes. besides, the acute effect of mmt peel powder on perceived satiety and energy intake were explored.

Eligibility criteria:
inclusion criteria: * modified finnish type 2 diabetes risk assessment tool (findrisc) score ≥ 4 * capillary fasting blood glucose (fbg) \< 7.0 mmol/l * malaysian * live, work or study in kuala nerus, terengganu * both gender * age 18 to 59 years old * non-smoker * those taking supplement agree to undergo washout period of one week exclusion criteria: * had clinical history of type 2 diabetes mellitus (t2dm) * capillary fbg ≥ 7.0 mmol/l * take oral antidiabetic agents * participate in other weight management programme or interventional research * on a prescribed medical diet * gi illnesses or conditions * allergy or sensitivity to study products * pregnant, currently breastfeeding, or planning to become pregnant * on dietary restrictions * smoker

Keywords: melon manis terengganu peel glycemic response perceived satiety food intake at risk of type 2 diabetes
effects of iron therapy and exercise training in patients with heart failure and iron deficiency

Conditions: Heart Failure With Reduced Ejection Fraction; Exercise Training; Ferric Carboxymaltose

Summary: it is the aim of the study to prove, if intravenous supplementation with ferric carboxymaltose in iron-deficient patients with heart failure with reduced ejection fraction (hfref) leads to better exercise training effects compared to exercise training without previous iron supplementation.

in patients with heart failure with reduced ejection fraction (hfref) exercise training (et) is recommended. in iron-deficient hfref patients iron supplementation by ferric carboxymaltose (fcm) is recommended. both treatment options (et and iron supplementation) affect oxidative metabolism. in this study iron-deficient hfref patients are included and randomly assigned to two study arms: study arm a: intravenous iron supplementation with fcm, subsequent (after 2 months) et program. study arm b: et program, subsequent (after 2 months) intravenous iron supplementation with fcm. primary study endpoint is exercise capacity (peak vo2). secondary endpoints are 6-minute walking distance, nyha class, echocardiographic parameters and the combined endpoint cardiovascular hospitalizations and death.

Eligibility criteria:
inclusion criteria: * heart failure with reduced ejection fraction ≤ 40% * new york heart failure asssociation class ii-iii * iron deficiency (ferritin \< 100 ng/ml or 100-299 ng/ml, if transferrin saturation \< 20%) exclusion criteria: * planned cardiovascular interventions (such as bypass surgery or valve interventions) * acute coronary syndrome * malignant rhythm disturbances * acute or chronic infection * reduced prognosis or exercise capacity by non-cardiac comorbidities * missing informed consent

Keywords: heart failure with reduced ejection fraction exercise training program iron deficiency
effects of task oriented training in patients with stroke

Conditions: Stroke

Summary: the aim of the randomized controlled study is to investigate the effects of task-oriented training on motor and cognitive functions combined with bobath training in patients with stroke.

patients who meet the criteria will be informed about the study and volunteers will be included. when initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (sg) or control group (cg). all volunteers will recieve bobath training program with the duration of 8 weeks. additionally, task oriented training will be applied in sg, 5 days a week for 8 weeks. all patients will be assessed in terms of motor functions and orientation, awareness, spatial perception, visuomotor construction, visual perception, praxis and thinking operations domains of cognitive funtions at the baseline and at the end of the study. data will be collected from all the patients at baseline and at the end of the study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.

Eligibility criteria:
inclusion criteria: 1. volunteering to participate in the study 2. be in the age range of 18-80 years 3. clinical diagnosis of hemiplegia following stroke 4. time since stroke between 2 and 8 weeks 5. having stable vital signs 6. a score between 18-23 on the mini mental state examination (mmse) exclusion criteria: 1. having global aphasia and/or severe apraxia 2. diagnosis of dementia or alzheimer's prior to stroke 3. participants who discontinued treatment 4. receiving rehabilitation service before

Keywords: stroke task-oriented training bobath training motor functions cognitive functions
open multi-centre investigation to evaluate signs and symptoms of local inflammation/infection on chronic ulcers and partial thickness burns when using mepilex border ag as an anti-microbial wound dressing

Conditions: Inflammation; Burns; Ulcers

Summary: the purpose of this study is to evaluate the change in signs of inflammation/local infection when mepilex border ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need\* of topical antimicrobial treatment according to the physician.

the investigation is designed as an open, non-controlled, post-marketing clinical follow-up. subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. all dressing changes will be done according to clinical routine practices and will follow ifu (instruction for use)

Eligibility criteria:
inclusion criteria: * subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated\* as judged by the investigator * male or female, 18 years and above, both in- and out-patients * signed informed consent form exclusion criteria: * wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation * subject not expected to follow the investigation procedures * tbsa \> 10% (partial thickness burns only) * hba1c value \> 7.2. (to be measured if bmi \> 30) * pregnant and breastfeeding women * pressure ulcers deeper than stage 3 * deep pressure ulcers in need of a filler * subjects with known sensitivity to silver or any other dressing materials * subjects receiving radiation treatment or examinations e.g. x-ray, ultrasound, diathermy or magnetic resonance imaging * subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide * subjects previously included in this investigation * subjects included in other ongoing clinical investigation at present or during the past 30 days

Keywords: the change in signs of inflammation/local infection to evaluate the comfort, conformability, pain during wear
a trial on the role of community pharmacist in improving adherence and clinical outcomes in post-infarction

Conditions: Myocardial Infarction, Acute; ST Segment Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction (nSTEMI)

Summary: the purpose of this pilot study is to evaluate the effectiveness of the active involvement of community pharmacists in improving adherence to medical prescriptions in patients with acute myocardial infarction (ami), reducing the rate of adverse events and / or re-admissions due to cardiovascular disease and reducing overall health costs. the hospital and community pharmacists will collaborate with each other, the patients, heart specialists and primary care physicians, throughout 12 months from the hospital discharge.


Eligibility criteria:
inclusion criteria: * discharged with a primary diagnosis of acute myocardial infarction (ami, icd-9 code: 410.x1) from a cardiological ward; * required treatment with antiplatelet therapy, beta-blockers, lipid-lowering therapy, angiotensin-converting enzyme inhibitors (acei), renin angiotensin system inhibitors (rasi) and/or mineralocorticoid/aldosterone receptor antagonists at the hospital admission, alone or in combination; * agreeable to participate in adherence plan (if randomized to interventional arm) performed by the community pharmacist who has in charge the patient; * agreeable to understand and accept the purpose of the study; * signed of the informed consent to participate; * be complying with the protocols' procedures within the entire period of study. exclusion criteria: * any prior history of acute myocardial infarction within 6 months prior to study entry; * presence of physical or cognitive impairment or dementia; * permanent long-term residence in hospice or facility residents; * history or presence of any other cardiovascular disease with a life expectancy of \< 1 year, hypertension excluded. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myocardial infarct medication adherence community pharmacist patient counseling pill counts hospital re-admission antiplatelet therapy beta-blockers lipid-lowering therapy angiotensin-converting enzyme inhibitors (acei) renin angiotensin system inhibitors (rasi) mineralocorticoid/aldosterone receptor antagonists
defining the basis of fibromuscular dysplasia (fmd)

Conditions: Fibromuscular Dysplasia; Spontaneous Coronary Artery Dissection; Cervical Artery Dissection

Summary: the purpose of this study has evolved and expanded since its inception. originally the intent was to establish the functional, molecular and genetic profile of fibroblasts from fibromuscular dysplasia (fmd) patients as compared to carefully matched control subjects. while this remains among the objectives, the study has been expanded to undertake a fully powered cross-tissue systems genetics analysis of fmd, and now also the related arteriopathies spontaneous coronary artery dissection (scad) and cervical artery dissection (cvad). the overall objective is to disclose the core biologic mechanisms of these disorders.

specific aims * specific aim 1: to establish a library of fibroblasts, dna, plasma and serum from patients with fmd, scad and cvad and unaffected healthy control subjects. * specific aim 2: to perform a fully powered cross-tissue systems analysis of the key regulatory gene networks and disease drivers underlying fmd, scad and cvad. * specific aim 3: to cross-compare the molecular and genomic profiles of fmd, scad and cvad to establish the degree of biologic similarity among these disorders.

Eligibility criteria:
inclusion criteria: * patients of any age and freely willing to participate. for patients \< 18 years of age consent will be via parents. * fluency in either english or spanish. * signed, informed consent * for fmd, scad or cvad subjects - a clinical diagnosis of fmd, scad or cvad with fulfillment of standard diagnostic criteria. * for healthy controls - no clinical features of fmd, scad or cvad and absence of any major ongoing systemic disease including any condition requiring hospitalization, immune suppression, intravenous or injected medications or that result in functional impairment in the performance of activities of daily living. healthy controls will be matched to enrolled fmd patients on the basis of gender and approximate age (within a 5 year window of another fmd subject). exclusion criteria: * patients who have co-morbidities which reduces life expectancy to one year. * patients with any solid organ or hematological transplantation, or those in whom transplantation is considered. * active autoimmune disease. * illicit drug use. * hiv positive. * prior malignancy. * any other form of vascular disease, including other arteriopathy coronary artery disease or peripheral vascular disease * family history of arteriopathy other than fmd, scad or cvad (e.g. ehlers-danlos syndrome)

Keywords: cross-sectional study fibromuscular dysplasia fibroblast spontaneous coronary artery dissection cervical artery dissection
hipoenergetic effect of diet associated or not with the consumption of coconut flour in women with overweight

Conditions: Obesity; Cardiovascular Risk Factor

Summary: this study aimed to evaluate the effect of weight loss with diet combined coconut flour consumption improvement weight loss and reduction in glucose, cholesterol in obese women.

this is a clinical trial with two groups, one receiving hipoenergetic diet for 180 days and another group with hipoenergetic diet for 90 days, a washout period for another 90 days and another period for another 90 days diet meal plus hipoenergética coconut. in order to assess body mass, waist circumference and neck, assess the lipid profile, glucose and uric acid.

Eligibility criteria:
inclusion criteria: women \> 20 years old bmi \>25 kg/m² exclusion criteria: performing diets and / or making use of drugs for the reduction of body weight; supplements of any kind; pregnant and lactating women; in use of statins; with voluntary water restriction. -

Keywords: obesity coconut flour diet quality cardiovascular risk factor