Kornimate/medical-research-clean huggingface dataset:
bioflow-iii uk satellite registry orsiro stent system

Conditions: Coronary Artery Diseases

Summary: clinical evaluation of the orsiro less in subjects requiring coronary revascularization with drug eluting stents (des). 500 subjects will be enrolled in this registry.

for the majority of coronary artery disease (cad) treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedure success. however, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30 to 50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. therefore this observational registry has been designed for the clinical evaluation of the orsiro less requiring coronary revascularization with des. it is designed to investigate and collect clinical evidence for the clinical performance and safety of the orsiro drug eluting stent system in an all-comers patient population in daily clinical practice.

Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease * subject signed informed consent for data release * subject is geographically stable and willing to participate at all follow up assessments * subject is ≥ 18 years of age exclusion criteria: * subject did not sign informed consent for data release * pregnancy * known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for pci, stainless steel, sirolimus or contrast media * planned surgery within 6 months after pci unless dual antiplatelet therapy will be maintained * currently participating in another study and primary endpoint not reached yet

Keywords: national multicenter observational registry orsiro drug eluting stent (des) stenting treatment of coronary artery disease coronary revascularization coronary intervention stemi nstemi ischemia angina acute myocardial infarction (ami) small vessels chronic total occlusion
skin manifestations associated with adhesives in diabetes technology tools

Conditions: Diabetes

Summary: the use of technological tools in the treatment of diabetes has intensified and become common in recent years. many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. the objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.

the use of technological tools in the treatment of diabetes has intensified and become common in recent years. many of these systems adhere to the skin with an adhesive in place for between 2 and 14 days, or even longer, depending on the system under consideration. unfortunately, an increase in skin reactions has been observed in diabetic patients using these new technologies, sometimes leading to discontinuation. the number of studies evaluating the cutaneous tolerance of the patches used by these technologies is limited, so the prevalence of these skin intolerances is unknown. the objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes. it will be implemented with the following design: * observational, cross-sectional, multicentre study involving 4 diabetology centres and over a period of 6 months. * establishment of an observatory on skin reactions to freestyle libre® (fsl) and all other adhesive systems related to new technologies for the treatment of diabetes * a questionnaire will be systematically proposed to the patients concerned, during the usual diabetes follow-up consultations made by all investigators.

Eligibility criteria:
inclusion criteria: * men and women * adult (≥ 18 years old) * all types diabetes (1, 2, other) * any patient who wears or has worn an adhesive system for the treatment of diabetes (insulin pump, and/or continuous glucose monitoring system) within the last 10 years. * seen consecutively in consultation * patient who was informed on the research and are not opposed to participation. exclusion criteria: * illiteracy * refusal to participate in the study (refusals will be counted) * patient under guardianship or curatorship
impact of non-surgical periodontal therapy in the improvement of early endothelial dysfunction in subjects with peri-implantitis and peri-implant mucositis

Conditions: Atherosclerosis; Endothelial Dysfunction; Peri-Implantitis; Peri-implant Mucositis

Summary: a double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.

a double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease. 90 patients: 30 with peri-implantitis, 30 with peri-implant mucositis and 30 healthy controls and without periodontitis history. all the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. measurements are taken before and after initial periodontal treatment in the peri-implantitis/peri-implant mucositis subjects.

Eligibility criteria:
peri-implantitis group inclusion criteria: • clinically diagnosed with peri-implantitis according to the efp/aap 2017 criteria. exclusion criteria: * periodontal treatment, implant surgery, antibiotics, nsaids, immunosuppressants during the last 6 months. * pregnancy. * cardiovascular diseases. peri-implant mucositis group inclusion criteria: • clinically diagnosed with peri-implant mucositis according to the efp/aap 2017 criteria. exclusion criteria: * periodontal treatment, implant surgery, antibiotics, nsaids, immunosuppressants during the last 6 months. * pregnancy. * cardiovascular diseases. healthy group inclusion criteria: • clinically diagnosed with healthy periodontum withouth periodontitis history according to the efp/aap 2017 criteria. exclusion criteria: * scaling, antibiotics, nsaids, immunosuppressants during the last 6 months. * pregnancy. * cardiovascular diseases.
left ventricular hypertrophy among chronic kidney disease patients in assiut university hospital

Conditions: Left Ventricular Hypertrophy; Chronic Kidney Diseases

Summary: assess the prevalence and features of left ventricular hypertrophy in patients with chronic kidney disease (ckd) taking into account gender differences and stage of ckd. to detect factors those predict lvh in ckd. \*to assess the right ventricle dysfunction in ckd .

the number of patients with chronic kidney disease (ckd) is growing worldwide, while patients with impaired renal function are at high or very high risk for developing cardiovascular disease (cvd). mortality due to cvd in patients with ckd is 1020 times higher than that in the general population, and the likelihood of developing cardiovascular complications (cvc) is several times higher than the risk of end-stage ckd{1} in ckd cardiovascular disease abnormalities are due to volume overload, hypertension, endothelia dysfunction, inflammation, uremic pericarditis cardiomyopathy, anemia, dyslipidemia and oxidativel stress{2} left ventricular hypertrophy (lvh) is a key feature that allows you to get an accurate picture of systolic-diastolic lesions of the left heart in patients with ckd and therefore is one of the most important factors in the development of adverse cvc lvh is initially formed as an adaptive process aimed at maintaining normal heart function under conditions of myocardial overload by pressure or volume, but then acquires the character of pathological adaptation, becoming the structural basis of heart failure, myocardial ischemia and cardiac arrhythmias {3}. it was shown that the probability of lvh increases already with a moderate decrease in egfr and increases further as ckd progresses, reaching a maximum in the terminal stage \[4\]. . in ckd lvh is associated with increased mortality and the risk of adverse outcomes, especially at the terminal stage of ckd{5-6}

Eligibility criteria:
inclusion criteria: - patients with chronic renal disease (ckd) aged between 16 and 65 years will be included. 2- ckd are diagnosed based on criteria proposed by kdigo (kidney disease: improving global outcomes) in 2002 exclusion criteria: * patients with structural heart disease (congenital or valvular heart disease). patients with primary hypertension. patients with obstructive or restrictive lung disease.
effect of probiotic supplement in alleviating functional gastrointestinal symptoms

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (ibs).

the aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with ibs according to rome iii criteria. subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. the intestinal microbiota will be analysed from faecal samples.

Eligibility criteria:
inclusion criteria: * subjects aged 18 to 65 fulfilling rome iii criteria for ibs will be recruited. sufficient general health and orientation for participating in the study is required and will be evaluated by the mds. exclusion criteria: * diagnosed or suspected organic gastrointestinal diseases or severely impaired general health.

Keywords: irritable bowel syndrome probiotic pain bloating diarrhoea constipation
citrate versus heparin in continuous renal replacement therapy :

Conditions: Acute Kidney Injury; Citrate; Cytokines; Hemodynamic Responses

Summary: this study is a prospective, multicenter, open-label randomized trial comparing regional citrate anticoagulation (rca) with heparin-free protocol. the function mode was continuous venovenous hemodiafiltration (cvvhdf) in post-dilution mode. the investigators measured hemodynamic changes at certain time points after starting crrt (0, 6, 12, 24, 48, 72 hr).levels of inflammatory cytokine (il-1β, il-6, il-8, il-10 and tnf-ɑ) were measured at day 1 and day 3

twenty patients were randomized into heparin group and 11 patients were in citrate group. the cardiac performance were not significantly different between 2 groups at every time point. the inflammatory cytokines declined similarly in both treatment arms. the maximum filter survivial time was longer in a rca group but not reach statistically significant (44.64±26.56 hr vs p=0.693 in citrate and heparin free group respectively).there was no serious side effects dung both treatment arm even in the group of liver dysfunction patients.

Eligibility criteria:
inclusion criteria: * need for crrt, * no contraindication to crrt exclusion criteria: * patients with previous history of chronic kidney disease (ckd) (baseline serum creatinine \> 2 mg/dl (male) or \> 1.5 mg/dl (female) * history of renal transplantation * known pregnancy * previous dialysis within 30 days * severe liver disease * end stage heart disease or untreatable malignancy * moribund patients with expected survival less than 30 days * previous use of heparin or other anticoagulant, antiplatelet within 7 day except use for deep vein thrombosis * active bleeding at the time of enrollment and/or severe coagulopathy * receiving blood or blood components prior to enrollment * hemoglobin less than 7.5 g/dl and/or platelet count less than 100,000/mm3 * previous underlying clotting disorders such as hypercoagulable state * severe malnutrition (body mass index (bmi ) less than 18) * underwent crrt for other reasons besides acute kidney injury (aki)
role of intrapartum ultrasound in instrumental delivery

Conditions: Obstetric Labor Complications

Summary: investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.


Eligibility criteria:
inclusion criteria: * pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound * live singleton pregnancy * fetus in a cephalic presentation * in the second stage of labor, after the decision to perform an instrumental delivery exclusion criteria: * fetal malformations * emergency situation
study on the risks of symptomatic dengue on pregnancy

Conditions: Dengue; Pregnancy

Summary: dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. this public health problem is also becoming european due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in europe. studies on the consequences of dengue fever on pregnancy find contradictory results. in fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable. the study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.


Eligibility criteria:
inclusion criteria for the case : * pregnant patients * major * affiliated with social security * symptomatic or pauci-symptomatic dengue * biological confirmation of dengue fever inclusion criteria for the control : * pregnant patients * major * affiliated with social security * asymptomatic exclusion criteria for the 2 group : * multiple pregnancy * patient's refusal * protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)

Keywords: dengue fever ; pregnancy
ivacaftor in french patients with cystic fibrosis and a g551d mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine whether the treatment with ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one g551d cftr mutation) in the real life setting, after the drug has been approved by the health authorities.

the aims of our study are: 1. to describe the treated population at initiation of treatment, 2. to evaluate clinical parameters during the year before ivacaftor was started, at initiation of treatment and during at least one year of treatment, until june 2014. 3. to evaluate the tolerance and safety of this treatment.

Eligibility criteria:
inclusion criteria: * french patients with cf aged 6 or older who are homozygous or heterozygous for the g551d mutation * treated with ivacaftor * first prescription of ivacaftor before june 1st 2013 (including patients randomized in the vx770 clinical trials) exclusion criteria: * cf patients younger than 6 years old * cf patients who have received lung transplantation * cf patients without a g551d mutation.

Keywords: cystic fibrosis cftr g551d mutation novel treatments potentiator ivacaftor
cannabis use and outcomes in black and white patients with cancer

Conditions: Cancer

Summary: the goal of the observational study is to learn how black and white patients with solid tumor cancer use cannabis, opioids and tobacco. the investigators are using momentary ecological assessment through a smart phone app and surveys to assess patient-reported pain and other symptoms as to inform clinical practice and guidelines for underrepresented populations.

using an observational design with momentary ecological assessment on a smartphone app (mema), the investigators propose a strong prospective cohort design with repeated-measures for 12 months regarding patients with cancer and their pain, use of opioids and cannabis. the design was selected to allow for real-time, real-world assessments, while minimizing risks due to attrition and burden to the participants. the staff will enroll 100 cannabis users (50 african american, 50 white) and 100 cannabis non-users (50 african american, 50 white) diagnosed with cancer in the last 3 years and prescribed opioids from each of the three sites, university of pennsylvania, pa, university at buffalo, ny and thomas jefferson university, pa. assessments will begin at baseline (month 0) and continue for 12 months. to reduce participant burden in terms of travel time, cost and inconvenience, patients will complete measures remotely via video/phone at 12 time points (months 1-12). daily measures of pain, cannabis and opioid use will be collected via ema for one week per month for 12 months. patients will report on multiple indices of cannabis use. opioid prescription information and other covariates and potential moderators will be collected over the 12-month study period. many factors affect opioid use, there is little insight into the longitudinal impact of cannabis use on when or how often patients self-dose opioids. ema will give much needed insight into when and why cannabis users do or do not take opioids. moreover, the focus on the co-use of cannabis and opioids allows better understanding of the interplay and timing in self-administration of one or both.

Eligibility criteria:
inclusion criteria: * 21 years or older * black or white race * solid tumor cancer within 3 years of enrollment * cannabis use of at least once a week or non cannabis use for 3 months * experience pain but spend less than 50% in bed or chair * prescribed or take opioid for at least 30 days for pain * not pregnant or planning to become pregnant in the next 12 months * english speaking exclusion criteria: * lymphoma, leukemia, and melanoma * cbd only use * synthetic cannabis use in past 3 months = prescribed medically-prescribed synthetic cannabis (e.g., dronabinol \[marinol, syndros\], epidiolex) * race other than black or white

Keywords: solid tumor, opioids, cannabis
a study to investigate interleukin-6 (il-6) and il-6/soluble il-6 receptor (sil-6r) complex levels in subjects with active inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to measure il-6 and il-6/sil-6r complex levels in subjects with active moderate to severe ulcerative colitis or crohn's disease.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with active moderate to severe ulcerative colitis (\*partial mayo ≥ 5) or crohn's disease (harvey \& bradshaw ≥ 8) \*partial mayo: 9-point scale that excludes the endoscopic components of the mayo score exclusion criteria: * presence of another inflammatory disease, except for mild cutaneous psoriasis * concomitant gastrointestinal infection or otherwise serious infection including crohn's disease infectious complication * treatment with infliximab, adalimumab, certolizumab pegol or other immune-modulating biologics within 8 weeks prior to the visit * having a known or suspected gastrointestinal or otherwise serious infection within 8 weeks prior to the visit * concomitant diagnosed or suspected malignant disease
cognitive rehabilitation of deficits in patients with multiple sclerosis

Conditions: Telerehabilitation; Multiple Sclerosis; Cognitive Disorders; Neurorehabilitation

Summary: non-inferiority study, post-market clinical investigation with a device, single-blind randomized controlled trial in a cohort of patients diagnosed with multiple sclerosis (ms). the aim of the study is to assess whether a computer-based cognitive treatment delivered via telerehabilitation produces effects from t0 to t1 that are not inferior to those of an in-person treatment on sustained attention in a cohort of patients with ms. the secondary objective is to evaluate the effects of telerehabilitation compared to the same treatment delivered in person on attentional shifting, memory, executive functions, and daily functioning (including cognitive fatigue, quality of life, and mood) in patients with ms.


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting multiple sclerosis (rrms), or primary progressive (ppms) or secondary progressive (spms), defined by at least 3-6 months. * age between 18 and 65 years. * expanded disability status scale (edss) between 3 and 5 to include patients with overall neurological disability from mild to moderate. * presence of one or more of the following cognitive disorders (reported by the patient and subsequently confirmed through the oxford cognitive screen-ocs): * memory disorders * attention disorders * executive function disorders * availability of internet at the patient's home necessary for the tele-rehabilitation procedures. * adequate visual and auditory abilities to use the rehabilitation device. exclusion criteria: * presence of other neurological conditions; * psychiatric disorders in medical history; * alcohol and/or drug abuse; * presence of uncorrected severe visual deficits.

Keywords: telerehabilitation multiple sclerosis cognitive disorders