Kornimate/medical-research-clean huggingface dataset:
the use of fish oil to reduce inflammation caused by a peripheral vascular intervention

Conditions: Peripheral Arterial Disease

Summary: investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (pufa) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (pvi).

the omega-pvi trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with pad. eligible patients will be screened according to specified inclusion and exclusion criteria. all patients will be treated per our current practice as reflected in the american heart association practice guidelines on pad. n-3 pufa supplementation will be achieved with 4 capsules of pro-omega twice daily (nordic naturals, watsonville, california, usa), corresponding to a total of 4.4g/day given prior to and immediately after the operation. each proomega capsule contains 325mg of epa and 225mg of dha. the placebo group will take the same number of capsules containing inactive substance (soybean; nordic naturals), designed to be the same color and shape as the treatment capsules. blood draws, questionnaires, and ultrasounds will be done periodically. specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of pvi patency. the study proposed here has the potential to provide important new insights on the role of nutritional interventions in pad, as well as to improve outcomes related to surgical revascularization.

Eligibility criteria:
inclusion criteria: * disabling claudication or cli as indication for pvi (rutherford class ii-v) * objective evidence of pad e.g. abi \< 0.9, tbi \< 0.6 or absent pedal pulses * currently not taking high-dose n-3 pufa, as defined by \>2 g/day * able to provide written informed consent and * undergoing a pvi (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery. exclusion criteria: * age \ 90 years * undergoing open surgical revascularization * evidence of active infection in limb or foot or osteomyelitis * extensive tissue loss (rutherford class vi disease) * diagnosed hypercoagulable state * non-atherosclerotic/aneurysmal disease as indication for procedure * chronic liver disease or myopathy * end-stage renal disease (ckd 5) * poorly controlled diabetes (hba1c \> 8%) * recent other major surgery or illness within 6 weeks * use of immunosuppressives or chronic inflammatory disorders * history of organ transplantation * pregnancy or plans to become pregnant * condition in which patient life expectancy is less than one year

Keywords: claudication critical limb ischemia endovascular procedure atherosclerosis
trial on innovative technologies in colonoscopy

Conditions: Polyps; Neoplasms; Inflammatory Bowel Disease

Summary: the trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination. * electronic colonoscopes olympus cf-hq190f with following options: magnetic positioning (scope guide), responsive insertion technology (rit), dual focus function, narrow band imaging (nbi) will be used for innovative colonoscopies * electronic colonoscopes olympus cf-h180dl with scope guide and nbi options will be used for conventional colonoscopies endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. all endoscopes will be attached to olympus evis exera iii system. biopsy of all pathological lesions will be performed to establish final diagnosis. the main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.

a total of 600 consecutive patients undergoing screening unsedated colonoscopy will be randomly assigned to innovative or conventional examination. randomization will be based on computer-generated randomization lists. all patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. in innovative colonoscopy group narrow band imaging (nbi) and dual focus (df) function will be used to identify and classify all lesions acc. to sano and kudo classification. endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and youden index will be calculated. as secondary endpoints total examination time, coecal intubation rate and pain intensity (vas scale) will be established. this study will help to establish whether new technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Eligibility criteria:
inclusion criteria: * written informed consent * no previous abdominal surgery * no colonoscopy during last 10 years exclusion criteria: * age \ 65 years * large bowel resection in history * colonoscopy performed during last 10 years * contraindications for general anaesthesia * asa \> iv * pregnancy * confirmed neoplastic disease * cirrhosis (child b or c) or ascites * immunosuppressive therapy or steroids intake * malabsorption syndrome

Keywords: narrow band imaging dual focus responsive insertion technique scope guide colonoscopy colorectal cancer screening
ofsep high definition cohort

Conditions: Multiple Sclerosis

Summary: for neurologists and patients, it appears that one major unmet need, beside of course a cure to multiple sclerosis (ms), is to better appreciate the causal factors of disease progression, and even to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course. the overarching objective of the ofsep-hd cohort is to determine prognostic factors of the evolution of disability in ms in real life, looking at disease characteristics, care practices potentially modifying the evolution of the disease since ms clinical onset and along specific post-onset landmarks. this general framework leads to study 3 specific research objectives: 1. to identify determinants (socio-demographic characteristics, clinical characteristics, health related quality of life (qol), changes in classification, and biomarkers) for the progression of ms disease and its consequences; 2. to study the effectiveness of treatments in real life; 3. to merge both determinants and treatments for creating patient-centered prognostic tools for identifying specific subgroups of patients and helping making decision to start, maintain or adapt care management. to achieve these objectives, the ofsep (the french multiple sclerosis registry) infrastructure, managed under a quality insurance system, offers a unique opportunity for the first time in france to create a large cohort of ms cases, providing high-definition and sequential multimodal data.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis according to the most recent criteria at entry into the hd cohort * followed in one ms clinical reference centre (crc sep) * newly diagnosed after the study start or * if ms onset occurred before study start, regular follow-up in a crc sep * irreversible disability ≤ 7.0 (permanent use of a wheelchair) on edss at inclusion in the study non-inclusion criteria: * inability to answer questionnaires * pregnant women at the time of inclusion

Keywords: epidemiology prognostic factors stratified medicine quality of life economic assessment
three new ideas to protect special forces from the stress of high altitude

Conditions: Mountain Sickness

Summary: acute mountain sickness (ams) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of ams. symptoms of ams are characterized by headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping. moreover, when people travel to high altitude, cognitive performance and endurance exercise capacity are impaired. therefore, the goal of this research is to identify effective pharmacological agents that will help reduce the symptoms of ams and improve physical and cognitive performance at high altitude. the investigators will study the efficacy of the dietary supplement, quercetin, the drugs nifedipine (extended release) and methazolamide taken together, the drug metformin, and the drug nitrite in reducing symptoms of ams and improving cognitive and exercise performance at high altitudes.


Eligibility criteria:
inclusion criteria: * healthy, * young (18-30 years old) men who can meet apft requirements for special operation forces (sof) training as outlined by the us army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in \< 15 min 54 s) exclusion criteria: * women; * smokers; * participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes; * participants with a history of significant head injury, migraines or seizures; * participants taking any medication (over-the-counter or prescription) or herbal supplements; * participants with known flavonoid allergies; * participants with known allergies to metformin; * participants with known hypersensitivity reaction to nifedipine; * participants with known allergies to sulfonamide-based drugs; * participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day; * exposure to high altitude above 1000m in the previous three months; or * participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude); * participants who are unable to achieve the minimum physical criteria required for sof training

Keywords: exercise, aerobic cognitive function
the role and dynamics of liver dysfunction in patients undergoing cardiac surgery

Conditions: Cardiac Surgery; Hepatic Impairment; Heart Failure

Summary: the aim of the present study is the evaluation of the occurrence and effect of hepatic dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in liver haemodynamics in the early postoperative period.

prospective, consecutive study of patients undergoing cardiac surgery in heart and vascular center, semmelweis university, budapest. registered data: * anamnestic and demographic data * liver dysfunction prior surgery, etiology of liver dysfunction * perioperative clinical data: laboratory tests, imaging, haemodynamic measures * risk prediction score of the american society of anesthesiologists(asa), european system for cardiac operative risk evaluation (euroscore), acute physiology and chronic health evaluation ii (apache ii), simplified acute physiology score (saps ii), canadian cardiovascular society grading of angina pectoris (ccs) * model for end-stage liver disease (meld), meld excluding international normalised ratio (inr) (meld-xi), modified meld score (modmeld), child-pugh the occurrence and etiology pattern of hepatic impairment are going to be evaluated according to age and type of cardiac illness. correlations between perioperative haemodynamical alterations and structural, functional changes in hepatic status will be investigated. the impact of hepatic impairment on surgical outcome is going to be examined by multivariate regression models.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age admitted for elective cardiac surgical procedures exclusion criteria: * not willing to participate. * pregnant women. * during active psychiatric hospital care. * patients with defined legal incapability or limited capability. * non-evaluable patient due to insufficient clinical information * patients with a transplanted heart.

Keywords: meld score hemodynamics liver abnormalities
valveless trocar versus standard trocar in robot-assisted complex partial nephrectomy

Conditions: Cancer of Kidney

Summary: the goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. the main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.

in the literature there are studies on the benefit of valveless trocars in robotic surgery. there are no studies on the potential effects even in complex kidney surgery. through this randomized study we want to investigate whether the ability to clear co2 is better using valveless trocars

Eligibility criteria:
inclusion criteria: * asa status 1-3 * surgical classification renal or padua score \>9 exclusion criteria: * bmi\>30

Keywords: robotic nephrectomy pneumoperitoneum trocar valveless general anesthesia mechanical ventilation
impact of sleep disturbance on cognition and quality of life in breast cancer

Conditions: Breast Cancer; Sleep; Quality of Life

Summary: patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. of the sleep disturbances experienced by patients, insomnia is the most common complaint. the prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). a recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. however, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. in particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. the links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.


Eligibility criteria:
inclusion criteria: * patients aged 39 to 69 years * patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy * patient with education level 3 "end of primary education" * patient with a good command of the french language * patient with access to the internet from a computer at home * patient having signed the consent to participate in the study * patient with no pre-existing cognitive impairment at the time of cancer diagnosis * patient with a sleep complaint (isi \> 7) exclusion criteria: * patient with metastatic cancer * patient with a primary cancer other than breast cancer * patient with a history of neurological damage * patient with treated sleep apnea * patient with drug use or alcohol abuse (≥3 drinks/day on average and/or \>10 drinks/week) * patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics) * patient with a personality disorder and/or an evolving psychiatric pathology * patient with a contraindication to mri (claustrophobia, metallic objects in the body) * patient with an uncorrected vision problem
correlation between serum progesterone level and primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: this study will be conducted to determine the correlation between the levels of serum progesterone and menstrual symptoms in young females with primary dysmenorrhea.

one hundred adult females with primary dysmenorrhea will participate in this study. they will be recruited from the gynaecological outpatient clinic, kasr el ainy university hospital, cairo, egypt many studies reported that primary dysmenorrhea was the result of increased prostaglandin, especially prostaglandin f2α (pgf2α) and prostaglandin e2 (pge2) which produced the effect through the cyclooxygenase pathway, and further led to uterine ischemia hypoxia. nevertheless the relationship between the serum progesterone level and menstrual symptoms was not completely clear. hence, this study will investigate the association between the serum progesterone level and menstrual symptoms in young females with primaryf dysmenorrhea.

Eligibility criteria:
inclusion criteria: 1. one hundreds adult females were suffered from primary dysmenorrhea. 2. their age was ranged from 17 to 24 years. 3. their body mass index was ranged from 20 to 25 kg/m2. exclusion criteria: * any participant will be excluded from the study if they have: 1. irregulars or infrequent menstrual cycles. 2. pacemaker, myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis. 3. pelvic pathology.

Keywords: dysmenorrhoea serum progesterone level visual analogue scale menstrual symptoms questionnaire
prognostic relevance of high-sensitivity troponin in patients with acute decompensated heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.

patients admitted for acute decompensated heart failure are included in the study. after gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. the aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.

Eligibility criteria:
inclusion criteria: * hospital admission for acute cardiac decompensation * systolic and / or diastolic heart failure exclusion criteria: * myocardial infarction in the last 4 weeks * serum creatinine \>2.5 mg/dl * pulmonary embolism

Keywords: troponin concentration in heart failure
copenhagen baby heart

Conditions: Congenital Heart Disease

Summary: copenhagen baby heart is an observational, cohort study of \>30.000 children born in the copenhagen area 2016-2018. newborns are examined with echocardiography, electrocardiogram, measurements of oxygen saturation and analyses of umbilical cord blood. the main objectives of the baseline assessments in copenhagen baby heart are to assess the prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the yield of routine echocardiography shortly after birth and to establish reference values for echocardiography in danish neonates. prospective follow-up of the birth cohort is planned with the purpose to assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors.

copenhagen baby heart is an observational, cohort study of \>30.000 children born in the copenhagen area 2016-2018. purpose * to assess the prevalence of congenital and inherited heart disease not detected prenatally, e.g. bicuspid aortic valve. * to assess the diagnostic and clinical yield of routine echocardiography in neonates. * to establish reference values for echocardiography and ecg for danish neonates. * to establish reference values for routine biochemical analyses in umbilical cord blood. * to assess the prevalence of familial hypercholesterolemia in danish newborns. * to assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors. methods approximately 18.000 children are born yearly in the copenhagen area. from 1. april 2016 - 1. april 2018 the parents of all newborns will be offered enrollment in the research project when attending a routine prenatal ultrasound. investigators plan to enroll \>30.000 newborns. after birth, blood is drawn from the umbilical chord and immediately analyzed for routine biochemical markers. samples will also be stored for future biochemical analyses and dna sequencing. within the first 14 days of life the children are examined with standardized echocardiography, electrocardiogram and measurements of oxygen saturation. information about maternal and paternal health including inherited disorders within the family as well as information about the pregnancy and birth are collected in a central database. follow-up when indicated children will be followed clinically. for research-purposes, prospective, register-based follow-up is planned for the entire birth cohort and with clinical visits for sub-groups of the population.

Eligibility criteria:
inclusion criteria: * born at one of three hospitals in the copenhagen area exclusion criteria: * failure of providing consent (parents)
chemotherapy and radiotherapy for osteolymphoma

Conditions: Osteolymphoma

Summary: this trial is intended to determine the results obtained when standard treatment for non hodgkin's lymphoma is applied to the disease in a rare subtype which arises in bone. patients in the study undergo a detailed assessment, then treatment with chemotherapy and radiotherapy, followed by close monitoring.

patients with non-hodgkin's lymphoma arising primarily in bone have been studied using a number of different names making literature searching difficult. the term osteolymphoma has been proposed to make searching easier in the future. patients in this study undergoing staging which includes isotope bone scanning and pet scanning where available. eligible patients then undergo treatment with three cycles of chop chemotherapy at conventional doses and shrinking field radiotherapy to a total of 45 gy. monoclonal antibodies are not included as good results have been obtained without using them. after treatment the patients are regularly monitored. the trial is presented twice per year at the meetings of trog, allg and arolg.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-hodgkin's lymphoma in a bony site * limited extraosseous disease * ann arbor stage ie * age \>17 * ecog performance status \<3 * expected survival \> 6 months * patients capable of childbearing are using adequate contraception. * written informed consent exclusion criteria: * previous radiotherapy * previous malignancy * medically unfit to undergo treatment

Keywords: osteolymphoma chemotherapy radiotherapy lymphoma