Kornimate/medical-research-clean huggingface dataset:
oxidative stress and lipidomics in male infertility

Conditions: Male Infertility

Summary: infertility is a common problem, affecting perhaps one couple in six, the majority of whom now seek medical care. it is becoming a social challenge because it is responsible for personal and interpersonal discomfort and anxiety. a major obstacle to meaningful study of the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence or absence of a problem. traditionally, the diagnosis of male infertility is facilitated by the conventional assessment of the semen profile - constructed according to recognized guidelines (i.e. who) and including ph, cell count and motility - but no specific biomarkers are available. we sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid biomarker useful for the diagnosis of male infertility.

subjects referring to an outpatient infertility laboratory will be enrolled in the study. a complete clinical record is collected as well as a sperm and a fasting blood sample. patients are stratified according to current guidelines focusing on sperm and anatomical characteristics. sperm characteristics will be studied on fresh samples immediately after collection; blood samples will be centrifuged and plasma stored at -80°c until analysis that include routine glucose and lipid profile by commercial kits. vitamin e (alpha- and gamma-tocopherol), oxysterols profiling, and fatty acids profiling is analyzed by state of the art gas chromatography-mass spectrometry (gc/ms) using isotope dilution methods.

Eligibility criteria:
inclusion criteria: * clinically healthy subjects and clinical healthy subjects with infertility exclusion criteria: * subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer * subjects taking medicines and/or supplements

Keywords: oxidative stress oxysterols fatty acids seminal fluid
zilver ptx delivery system

Conditions: Peripheral Vascular Disease

Summary: the objective of this study is to evaluate the performance of the zilver ptx stent thumbwheel delivery system.


Eligibility criteria:
inclusion criteria: * patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries * patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery exclusion criteria: * patient is \< 18 years of age * patient unable to complete required follow-up assessments * patient unwilling to sign and date the informed consent * simultaneous participation in another investigational drug or device study * pregnant, breastfeeding or planning to become pregnant in the next 5 years * additional medical/anatomical restrictions as specified in the clinical investigation plan

Keywords: peripheral vascular disease femoral artery drug-eluting stent
assessment of carotid artery stenosis and lower limb peripheral ischemia prior to cabg

Conditions: Carotid Artery Diseases; Peripheral Artery Disease

Summary: from our experience among egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. thus, increasing the risk of post-operative morbid complications.we aim to evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic patients undergoing coronary artery bypass grafting in the egyptian populationit is a prospective, non-randomized, comparative study including two groups of patients. the study will start from the day of approval of the ethical committee. it will include 260 patients, on basis of "all new comers". patients will be examined and classified as "high-risk" group (ɳ = 130) or "low-risk" group (ɳ=130). all patients will have the "routine" preoperative investigations along with evaluation of extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by non-invasive bilateral lower limb arterial duplex.


Eligibility criteria:
inclusion criteria: 1. the acceptance of the patients to participate in the study in the form of a written consent. 2. patients of both sexes. 3. three vessels disease for cabg. 4. patients' age: from 35 to 75 years old. 5. elective, isolated, primary cases of cabg. 6. patients with ejection fraction above 40%. 7. inclusion criteria for the high-risk group will include: 1. patients with preoperative history of cerebrovascular events or symptoms suggestive of cvs eg.tia, transient blindness in one eye, dizziness, confusion, drowsiness, headache, temporary inability to speak or move. 2. carotid bruit 3. left main stem coronary artery disease 4. presence of other peripheral vascular disease exclusion criteria: 1. patients refusing to participate in the study. 2. age 76 years or above 3. morbid obese patients (body mass index more than 35). 4. patients who underwent coronary stenting before. 5. patients who underwent previous cardiac operation before. 6. patients with impaired renal functions (serum creatinine \> 1.5 mg/dl, blood urea \> 100 mg/dl and k+ \> 5 meq/l). 7. patients with preoperative hemoglobin \ 15,000 cells/mcl,platelets count \< 140,000 per microliter. 8. patients with rhythm defects by electrocardiography (ecg). 9. patients with preoperative o2 saturation \< 90 % by pulse oximetry.

Keywords: carotid peripheral arterial disease endarterectomy
surgery combined with rad-p53 gene in treatment advanced non-small-cell carcinoma

Conditions: Non-small Cell Lung Cancer

Summary: the primary objectives of this study are to investigate the efficacy and safety of surgery combined with rad-p53 gene therapy in treatment of advanced non-small-cell lung carcinoma (nsclc). the study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. the safety endpoint is complications and adverse effects. the study hypothesis: rad-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.


Eligibility criteria:
inclusion criteria: * historically diagnosed advanced non-small lung cancer * has surgery indication * age 18 years old or greater * life expectancy greater than 12 weeks * ecog: 0-2 * no prior chemotherapy, radiotherapy in 2 weeks * neutrophils≥1.5×10\^9/l,platelet≥80×10\^9/l, hb≥≥80g/l,bilirubin≤1.5×2mg/dl, alt and ast≤2×institutional upper limit of normal,cr≤1.5×institutional upper limit of normal,coagulation tests(inr and ptt)within normal range * subject provides signed informed consent exclusion criteria: * hypersensitive to study drug * with a coagulational test unnormal or a bleeding disorder * infections * with serious condition which can't stand a surgery * pregnant or lactating * principle investigator consider not suitable

Keywords: p53 gene therapy non-small cell lung cancer post-surgery chemotherapy
endotracheal tube obstruction in covid-19 patients requiring mechanical ventilation

Conditions: Sars-CoV2

Summary: the covid-19 pandemic is very present in our region, the grand-est region is considered as one of the first covid-19 epicentres in france. covid-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years) * subject with covid 19 (radiological suspicion or microbiological confirmation) * subject hospitalised in the intensive care unit at the nhc of the university hospitals of strasbourg between 01/03/2020 and 03/04/2020. * subject treated by mechanical ventilation * subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research translated with www.deepl.com/translator (free version) exclusion criteria: * subject who expressed opposition to participating in the study * subject under guardianship, curatorship or safeguarding of justice

Keywords: endotracheal tube ett intubation mechanical ventilation endotracheal tube obstruction icu covid-19 sars-cov-2 ards
a study of herceptin (trastuzumab) in combination with a taxane in participants with her2-positive breast cancer who relapsed after (neo)adjuvant herceptin treatment

Conditions: Breast Cancer

Summary: this single arm, open-label study will evaluate the efficacy and safety of herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with her2-positive breast cancer who relapsed after neoadjuvant or adjuvant herceptin treatment. participants will receive herceptin (loading dose of 4 mg/kg intravenously \[iv\], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * female participants , \>/= 18 years of age * locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease) * her2-positive primary disease * participants must have received herceptin in the adjuvant and/or neoadjuvant setting * relapsed breast cancer \>/= 6 months after discontinuing last drugs of herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for her2-positive breast cancer * measurable disease according to recist 1.0 * eastern cooperative oncology group (ecog) performance status 0-2 * maximum cumulative dose of doxorubicin \</= 360 mg/m2 or of epirubicin \</= 720 mg/m2 or no prior anthracyclines * at least 3 weeks after prior surgery or radiotherapy exclusion criteria: * pregnant or breastfeeding women * previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed) * pleural effusions, ascites or bone lesions as only manifestation of disease * brain metastases * invasive malignancy other than metastatic breast cancer * inadequate bone marrow, hepatic or renal function * prior treatment with anti-her therapies other than (neo)adjuvant herceptin
study to improve outcomes in aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: multi-centre, multi-national, observational, prospective registry in four central full access centres in germany (2), france (1) and the united kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (obc) without access to surgical and percutaneous aortic valve (av) interventions). the hypothesis is that the management of patients with severe as will differ between sites with on-site access to all treatment modes and those without such facilities.

data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. this lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. while this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access. the aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.

Eligibility criteria:
inclusion criteria: * age over 18 years * identified on echocardiography with severe aortic stenosis, defined as at least one of: * aortic valve area \< 1 cm2 * indexed valve area \< 0.6 cm2/m2 * maximum jet velocity \> 4.0 m/sec * mean transvalvular gradient \> 40 mmhg exclusion criteria: * non-severe aortic stenosis * previous aortic valve repair

Keywords: quality of care aortic stenosis transcatheter aortic valve implantation surgical aortic valve replacement facilitated data relay
study evaluating gefitinib (iressa®) in subjects with solid malignancies that are locally advanced, recurrent or metastatic

Conditions: Tumors

Summary: this study will determine the safety profile and maximum tolerated dose (mtd) of orally administered gefitinib on a weekly and twice weekly schedule.


Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists * life expectancy of \> 12 weeks * world health organization (who) performance status of \< 2 exclusion criteria: * known severe hypersensitivity to gefitinib or any of the excipients of this product * less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-c which must have a wash out period of 6 weeks) * incomplete healing from previous oncologic or other major surgery

Keywords: solid tumors
is there room for butter in a healthy diet?

Conditions: Atherosclerosis

Summary: the aim of this study is to examine the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols). the primary parameters are total cholesterol, ldl- and hdl cholesterol and triglycerides. the secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-crp.


Eligibility criteria:
inclusion criteria: * sign written consent * age: 20-70 y * bmi: 18.5 - 32 kg/m2 * healthy men and women (with no known diseases) exclusion criteria * current or previously cardiovascular disease, high blood pressure * diabetes mellitus or other severe chronic disease, including severe allergies * use of dietary supplements and blood donations prior to, and during the study * known or suspected abuse of alcohol, drugs or medication * pregnant or are planning pregnancy during the study period * extreme physical activity level (more than 10 hours tough physical activity pr. week) * participation in other research studies * inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
dose finding study for combination of capecitabine, lapatinib and vinorelbine in metastatic breast cancer

Conditions: Metastatic Breast Cancer; HER2 Positive; First or Second Line Therapy; Failure or Contraindication of Trastuzumab Therapy

Summary: the purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.

the combination of lapatinib with capecitabine ist a standard therapy für her2 positive metastatic breast cancer. this study combines this therapy with the additional antimitotic mode of function by vinorelbine.

Eligibility criteria:
key inclusion criteria: * written informed consent * able to comply with the protocol * ecog performance status 0-1 * adequate contraception * confirmed her2/neu-positive, adenocarcinoma of the breast * at least one measurable lesion according to recist 1.1 criteria * first or second chemotherapy after diagnosis of metastasis * lapatinib treatment indicated (adjuvant trastuzumab treatment \<12 months ago or progressive disease with trastuzumab treatment) * no signs and symptoms of chf (chronic heart failure), lvef (left ventricular ejection fraction) at study start at least 55% * adequate hepatic and renal function value * adequate hematologic function values exclusion criteria: * pregnant or lactating women * concurrent participation in another clinical trial. prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization * asymptomatic with regards to tumor illness * previous treatment with lapatinib, capecitabine or vinorelbine * necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy * major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study * evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia * history of vascular or cardiovascular disease within the past 6 months * all illnesses that result in malabsorption of oral medication or inability to take oral medication * concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides * concurrent treatment with any drug interfering with study medication, especially, those that induce cyp3a * concurrent treatment with allopurinol * other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years * concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient

Keywords: dose finding study combination
the role of the fujinon intelligent chromo endoscopy (fice™) in barrett's esophagus

Conditions: Barrett's Esophagus

Summary: the purpose of this study to assess post ablation, if there are areas of barrett's mucosa post ablation and to assess the ability of the fujinon fice system to detect this, as compared to white light endoscopy. a subgroup will also be compared with laser confocal microscopy


Eligibility criteria:
inclusion criteria: * visible barrett's esophagus * scheduled for surveillance endoscopy * able to undergo endoscopy exclusion criteria: * unable to undergo endoscopy * unable to stop blood thinning medications

Keywords: barrett's esophagus surveillance
the 400m-walk-test for stable coronary patients

Conditions: Chronic Coronary

Summary: the objective of this project is to clarify and improve the efficiency of the standardized walk-test in cardiovascular rehabilitation. the psycho-metric properties of the 400m walk test at a self-selected speed will be evaluated. such tests, made at a self-selected ("comfortable", "free") speed particularly assess the endurance capacities. the results of the physiological measurements during the tests will be compared with those of tm6min of test of fast walking of 200m (tmr200m) and a maximal treadmill exercise. stable coronary patients, aged over 55 years old, will be included. this study should permit a simplification and a better understanding of the clinical-use of walk tests. in the future, two kinds of tests might be proposed with different distances, 1- 200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2- self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic capacities of the adaptation of the body in response to effort.


Eligibility criteria:
inclusion criteria: * patient received enlightened information on research. * patient affiliated to healthcare insurance. * patients who agreed to participate in the study. * patient male or female aged 55 or more. * chronic coronary patient who completed his rehabilitation program. * patient able to understand simple orders. * indication of outpatient rehabilitation in coronary angioplasty + stenting, surgical coronary revascularization (coronary artery bypass), acute coronary syndrome (stemi or no stemi) or stable angina suites. exclusion criteria: * patient under guardianship or tutelage * arrhythmia or pace maker (making criterion heart rate unusable). * congestive heart failure with left ventricular ejection fraction \<45% measured by trans-thoracic echocardiography according to simpson's method or assay plasma n-terminal pro-brain natriuretic peptide (nt-pro-bnp-3) times the values used in healthy subjects by the analytical laboratory of the university hospital of dijon. * severe obstructive cardiomyopathy. * aortic valve. * thrombus intra cavitary. * severe pulmonary hypertension (\> 70 mm hg). * history of venous thromboembolism in the last 3 months. * heart transplantation. * chronic motor impairments associated with neurological (e.g. sequelae of stroke, impaired balance and coordination) or musculoskeletal origin (e.g., osteoarthritis, osteoarthritis), because the secondary functional impairment will limit the ability to work predominantly in relation to the adaptation to stress. * severe medical disorder associated to a significantly alteration of the functional capacity (respiratory failure, metabolic disorders such as non-stabilized progressive renal failure) and involving the vital prognosis in the short or medium term (neoplasic pathology progressive, systemic disease, non-stabilized).
posture analysis for patients with haemophilia

Conditions: Hemophilia; Postural; Defect; Muscle Disorder

Summary: hemophilia a and b are inherited disorders characterized by deficient or missing coagulation factors viii or ix, respectively, of which the main long-term clinical manifestation is joint damage. patients with haemophilia (pwh) are susceptible to clinical joint bleeding that may cause irreversible joint damage. some degree of damage may already occur after the first haemarthrosis or even in children who never experienced clinically evident joint bleeds. joints are mechanical systems with a structure strictly related to functioning. therefore, any alteration in structure may have an impact on function (starting from the primary level of posture and anti-gravity muscles), which might in turn stress the joints and increase the risk of bleeding.the primary aim of this study is to investigate the changes in posture and the mechanical properties of anti-gravity muscles of adolescent pwh. the secondary aim is to determine the effect of joint dysfunction on posture in adolescent pwh.


Eligibility criteria:
inclusion criteria: * adolescent boys with haemophilia a or haemophilia b (for experimental group) and healthy adolescent boys (for control group). exclusion criteria: * to be with another congenital coagulopathy such as von willebrand syndrome. * to be unable to stand without support due to hemophilic arthropathy. * to be having another musculoskeletal problem. * to be having factor viii or ix level in the plasma above 6%

Keywords: haemophilia posture anti-gravity muscles joint health
buprenorphine detox with two types of treatment. bbd ii - 11

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to compare overall treatment outcome between behavioral versus enhanced behavioral treatment types.


Eligibility criteria:
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