Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety and efficacy of bempedoic acid plus ezetimibe fixed-dose combination compared to bempedoic acid, ezetimibe, and placebo in patients treated with maximally tolerated statin therapy

Conditions: Hyperlipidemias

Summary: the purpose of this study is to determine if bempedoic acid (ba) + ezetimibe (eze) in a fixed-dose combination (fdc) is effective and safe versus its individual components and placebo in patients with elevated ldl cholesterol treated with maximally tolerated statin therapy.


Eligibility criteria:
inclusion criteria: * require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease * fasting ldl-c ≥ 130 mg/dl for primary prevention or ldl-c ≥ 100 mg/dl for secondary prevention (history of hefh and/or ascvd) * treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening exclusion criteria: * total fasting triglyceride ≥ 400 mg/dl * renal dysfunction or nephrotic syndrome or history of nephritis * significant cardiovascular disease or cardiovascular event within the past 3 months

Keywords: hyperlipidemia heterozygous familial hypercholesterolemia atherosclerotic cardiovascular disease high cholesterol ascvd hefh ldl
fate of moderate secondary mitral regurgitation in patients undergoing aortic valve surgery for severe aortic regurgitation

Conditions: Aortic Regurgitation; Functional Mitral Regurgitation

Summary: patients with severe aortic regurgitation (ar) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (mr). tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of mr which can therefore be defined as "secondary" in this case. when both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. in this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. on the other hand, little is known about the fate and prognostic implications of moderate mr secondary to severe ar and whether or not it should be treated at the time of aortic valve surgery. for this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the heart team. to date, there are few data describing the evolution of moderate mr in patients undergoing surgery for severe ar and insufficient data to support recommendations regarding the treatment of moderate mr concurrently with treatment of ar, so that this decision is now entrusted to the evaluation of the heart team. it is therefore desirable to evaluate the outcomes of these patients. the aim of this study is to evaluate the short- and long-term fate of secondary moderate mr in patients undergoing aortic valve replacement for severe ar.


Eligibility criteria:
inclusion criteria: * adult patients; * patients with severe aortic regurgitation (ar) and moderate mitral regurgitation (mr). * patients underwent isolated aortic valve surgery (study group) or concomitant mitral valve surgery (control group) and * patients operated at the cardiac surgery department of the san raffaele hospital from january 2004 to january 2019 exclusion criteria: * patient with more than moderate mr
hybrid brain computer interface for control of sensory - motor coupling in post - stroke rehabilitation

Conditions: Stroke

Summary: hybis project aims to develop an innovative and unique hybrid brain-computer interface (bci) system. this bci system is envisioned as a novel tool for targeted reinforcement of sensory motor coupling, specifically dedicated for upper-limb post-stroke rehabilitation.


Eligibility criteria:
inclusion criteria: * age over 18 years old at the time of enrolment * history of cerebrovascular insult verified by computerized tomography or magnetic resonance imaging; * stoke occurred not more than 6 months prior to study enrolment; * subject need to be medically and neurologically stable determined by medical history and documented neurological examination; * ability to understand, communicate and cooperate with the research team; * ability to sit for at least 45 minutes and the ability to adhere to the study rehabilitation protocol. exclusion criteria: * any neurologic condition (beyond the stroke) or physical condition that impaired function of the affected arm * a substantial cardiopulmonary or metabolic disorder or other major medical complication; * history of seizures; * moderate to severe hemispatial neglect or anosognosia involving the affected arm; * severe sensory deficit; * inability to understand, cooperate, and adhere to the study procedures; * severe spasticity defined as ashworth scale score of 4 in the affected arm; * contraindication to stimulation system placement; * nursing a child; * pregnancy.
a study to compare levels of capsaicin after intra-articular injection and topical application in patients with painful knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this is a phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.


Eligibility criteria:
key inclusion criteria: * body mass index (bmi) between 18.0-35.0 kg/m\^2 * subject has moderate to severe painful osteoarthritis in one knee while walking (index knee); contralateral knee may or may not have osteoarthritis, pain should be none to mild in the non-index knee * confirmation of the oa of the index knee: american college of rheumatology (acr) diagnostic criteria * subject has intact skin at the location of the dosing sites (patch or injection) key exclusion criteria: * subject has any other form of arthritis, such as, but not limited to, rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematosus, etc. * subject has a dermatological condition that may contraindicate participation, including any compromise in skin integrity at the cntx-4975-05 injection site or the qutenza® skin application site, e.g., severe or cystic acne, psoriasis, eczema, atopic dermatitis, active or treated cancer, etc.

Keywords: osteoarthritis knee
magnetic resonance imaging (mri) assessments of the heart and liver iron load in patients with transfusion induced iron overload

Conditions: Hemoglobinopathies; Myelodysplastic Syndromes; Other Inherited or Acquired Anaemia; MPD Syndrome; Diamond-Blackfan Anemia; Other Rare Anaemias; Transfusional Iron Overload

Summary: this study will evaluate the change in cardiac iron load over a 53 week period measured by mri in 2 cohorts of patients


Eligibility criteria:
inclusion criteria: * male or female with haemoglobinopathy, myelodysplastic syndromes or other inherited or acquired anaemia (e.g. mpd, diamond-blackfan anaemia and other rare anaemias) patients ≥ 18 years and weighing \>40kg. * lifetime minimum of \> 20 units of packed red blood cell transfusions * normal or minimally abnormal cardiac function exclusion criteria: * contraindication to mri scans * high risk myelodysplastic syndromes patients and patients with other haematological and non-haematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease * patients with uncontrolled high blood pressure * an organ transplant less than 3 months previously other protocol-defined inclusion/exclusion criteria may apply.

Keywords: haemoglobinopathies, myelodysplastic syndromes, transfusional iron overload, cardiac iron load
home exercise to enhance mobility for older diabetics

Conditions: Diabetes Mellitus Type 2

Summary: the goal of the proposed research is to test whether a long-term exercise program in sedentary veterans with diabetes will produce sustained improvement in mobility performance and physical activity. in this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (i) group versus a flexibility and toning, health education control (c) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. this research can lead to an exercise/pa enhancement program that can coordinate with va outreach programs, targeting older veterans who are not in the immediate vicinity of a major va site. ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.

the goal of the proposed research is to test whether a long-term exercise program in sedentary veterans with diabetes will produce sustained improvement in mobility performance and physical activity. to facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (pa) enhancement program with behavioral support. the rationale for this program is based on: 1) the feasibility of a previously funded va rr\&d controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured physical activity. in this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (i) group versus a flexibility and toning, health education control (c) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year.

Eligibility criteria:
inclusion criteria: * sedentary * type 2 diabetes * no medical contraindications to exercise exclusion criteria: * enrolled in intensive exercise program * unable to cooperate with protocol (e.g. cognitive impairment)

Keywords: type 2 diabetes mellitus mobility limitation
pupillary dilation reflex assessment for intraoperative analgesic titration.

Conditions: Pain, Acute; Anesthesia

Summary: in this double blinded randomized controlled study, the pupillary dilation reflex is used for as a nociceptive indicator for opioid administration during elective surgery under general anesthesia.

an infrared camera of the video pupillometer measures the pupillary dilation reflex (pdr) in response of a nociceptive stimulus. this autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) the pdr is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon a-delta and c fibers in both electrical or mechanic stimulation. this double blind randomized controlled trial involving american society of anesthesiologists (asa) classification i-iii patients undergoing elective surgery under general anesthesia are recruited. enrolled patients are randomized in four groups: (1) remifentanil administration depending on pdr results, (2) remifentanil administration depending on decision attending anesthesiologist, (3) sufentanil administration depending on pdr results, (4) sufentanil administration depending on decision attending anesthesiologist.

Eligibility criteria:
inclusion criteria: * \> 18 jaar * elective abdominal or gynaecological operation * asa (american society of anesthesiologists classification): i - ii - iii exclusion criteria: * history of invasive ophthalmological surgery * known bilateral eye disease * known optical of oculomotor nerve deficit * active psychiatrical disease * proven active pheochromocytoma * opioid usage \> 7 days preoperative * ongoing oncological treatment with chemotherapeutic agents * usage of a-1 adrenergic of beta-blocking agents * preoperative usage of benzodiazepines * topical atropine or phenylephrine (eye droplets) * planned perioperative usage of dopamine antagonists

Keywords: pupillary reflex nociception heart rate intraoperative monitoring
ctdna-based minimal residual disease detection for resected pancreatic adenocarcinoma

Conditions: Pancreatic Cancer Resectable

Summary: short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (paad) after surgeries. despite the importance of adjuvant treatments for resected paad patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. in this study, we aim to examine whether postoperative circulating tumor dna (ctdna) could be used as a biomarker for early detection of minimal residual disease (mrd) and predicting relapse in resected paad through high-depth targeted next-generation sequencing.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed pancreatic adenocarcinoma (stage i-iii) * kras mutations identified in resected tumor tissues * margin negative (r0) or no imaging recurrence/metastasis and ca 19-9\<37 u/ml in postoperative 4-8 weeks (before adjuvant chemotherapy) * receiving adjuvant chemotherapy * ecog 0-2 * signed informed consent exclusion criteria: * with serious internal medicine diseases, infectious diseases, other solid tumors (except paad) or hematologic disorders * distant organ metastasis or malignant ascites * receiving neo-adjuvant therapy before surgery * imaging recurrence/metastasis or ca 19-9\>37 u/ml in postoperative 4-8 weeks (before adjuvant chemotherapy) * pregnant or breastfeeding at time of enrollment * prior transplantation of bone marrow, stem cell or organ

Keywords: circulating tumor dna minimal residual disease
decurarisation kinetics of rocuronium in cervical surgery

Conditions: Non-morbidly Obese Patients (BMI<35); Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube; Thyroid and Parathyroid Surgery

Summary: recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. a recent formalized expert guideline (rfe 2018) from the french society of anesthesia and resuscitation, sfar recommends administering a curare to facilitate tracheal intubation and limit laryngeal trauma . this study aims to determine if the level of neuromuscular recovery is consistent with monitoring the recurrent nerve after the use of rocuronium for intubation. primary endpoint: achievement of quality intraoperative laryngeal recurrent nerve monitoring.

the monitoring of the recurrent nerves, innervating the vocal cords, in thyroid and parathyroid surgery has developed in recent years because of its interest as a parameter to reduce the risk of recurrent paralysis. monitoring of the recurrent nerves requires contraction of the laryngeal muscle and therefore contraindicates the pharmacologically active presence of muscle relaxants at the time of dissection. thus, intubation was performed either without curare or with a depolarizing curare (succinylcholine) whose short duration of action allowed optimal intubation conditions without intraoperative residual effect. this practice is being questioned due to : (i) a recent formalized expert referential (rfe) of the french society of anesthesia and resuscitation, sfar, which recommends administering a curare to facilitate intubation of the trachea and limit laryngeal trauma (grade 1 +) and (ii) a restriction of the indications of succinylcholine by the french national agency for the safety of medicines and health products, ansm, as an adjuvant of general anaesthesia (induction in rapid sequence and electroconvulsive therapy). in summary, thyroid surgery requires curarisation for intubation and sufficient intraoperative decurarisation to allow monitoring of the recurrent nerves. we hypothesize that the time between intubation and the actual start of recurrent monitoring is consistent with the time to recovery of laryngeal adductor neuromuscular block after injection of rocuronium at a dosage of 0.5 mg/kg.

Eligibility criteria:
inclusion criteria: * adult subjects requiring general anesthesia for cephalic surgery (thyroid and parathyroid) with an nim-type intubation tube. * subject informed of the study and not having opposed it exclusion criteria: * allergy to any of the products used * morbidly obese subjects (bmi\> 35) * pregnancy * predictive criteria for difficult intubation in pre-anesthetic consultation * subjects under tutorship or curatorship * subjects not affiliated to social security

Keywords: thyroid and parathyroid surgery recurrent nerves monitoring rocuronium
arthr-is (arthroplasties' infections due to staphylococcus aureus)

Conditions: Staphylococcus Aureus; Prosthetic Joint Infection; Arthroplasty Complications

Summary: the number of arthroplasties is expected to grow in the next few years. staphylococcus aureus (sa) is a primary cause of prosthetic joint infection (pji) with serious consequences. this microorganism is frequently associated with treatment failure, hospitalizations and need of prosthesis removal, leading to an important morbidity and an increase in healthcare costs. arthr-is is a retrospective multi-center study which aims to estimate the burden of sa-pji after a hip or knee arthroplasty and their risk factors. other objectives are to quantify the costs, the number of hospitalizations and the surgical procedures needed to treat and control the infection and finally the factors influencing therapeutic failure. through a case-control design, arthr-is will group 20 hospitals across 5 european countries in order to include 150 cases and 450 controls. the results of this study will provide critical information to develop strategies to prevent and treat sa-pji and reduce treatment failures. also, the results from arth-is study will help in the design of future clinical trials in prosthesis infections by providing reliable estimates on the incidence of sa-pji and the subsequent burden on health care services.


Eligibility criteria:
inclusion criteria: * patients who underwent a primary hip or knee arthroplasty between 2013 and 2016. * diagnosis of sa -pji in the first 12 months after primary arthroplasty. exclusion criteria: • patients with a previous sa infection or prosthesis revision on the index joint (joint which was replaced during arthroplasty).
evaluation and validation of novel diagnostic tool for allergists (abioscope)

Conditions: Allergic Rhinitis; Asthma

Summary: in this study, investigators evaluated for the first time the diagnostic efficacy of abioscope® versus phadia laboratory system as an aid in the diagnosis of allergic diseases. investigators targetted the agreement between test results obtained in abioscope® and a laboratory reference method (phadia laboratory system, thermofisher scientific, uppsala, sweden), considered as a quasi-gold standard in ige (immunoglobulin e) antibody assays. investigators also reported the medical decision taken by a panel of allergy experts who had access to patient history, skin tests and ige antibody assay, but blinded to the method used, i,e, the reference method or the abioscope® .


Eligibility criteria:
inclusion criteria: * subjects examined at ambulatory medicine medicine center chuv / pmu and for wich serum sample is required for the research of specific ige (allergic patients, allergic group) or for any other reason (immunological) (non-allergic control patients, control group) * subjects for which it is expected (allergic group subjects) or who will be asked (non-allergic control group) to perform a panel of standard prick tests as basic allergological investigation, including pollen birch, grasses, mites (d pter, d far), cat dander. * obtain informed consent from each subject before any study procedure. exclusion criteria: * presence of positive hiv-1 viremia by the ultra-sensitive method in the 12 months preceding the study. * use of any investigational or non-registered product (drug or vaccine) * chronic administration (more than 14 days) of immunosuppressive or immunomodulatory drugs in the 6 months preceding the study for corticosteroids. this means a dose of prednisone or equivalent substance greater than or equal to 0.5 mg per kg / day. inhaled topical steroids are allowed. * administration of any immunoglobulin, any immunotherapy or administration of some blood products in the 3 months preceding the study, or planned during the study period. * any health condition or patient history, in the opinion of the investigator, could interfere with the evaluation of the study's objectives. * participation in another experimental protocol during the period of the study. * demonstration, confirmation or suspicion of a condition of immunosuppression or immunodeficiency (including hiv infection) based on medical history and physical examination (no laboratory test). * a family history of congenital or hereditary immunodeficiency. * subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of hpv is allowed) or treated with systemic chemotherapy.

Keywords: ige skin prick tests diagnosis rhinitis asthma allergy laboratory
a study evaluating the safety and efficacy of cura-100 in subjects with rheumatoid arthritis and osteoarthritis

Conditions: Rheumatoid Arthritis; Osteoarthritis

Summary: the purpose of the study is to evaluate the safety and efficacy of cura-100 in treating rheumatoid arthritis and osteoarthritis.

this is the phase i/ii trial, which monitors both safety and efficacy of cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. the open-label clinical study will be used in the study. the study is expected to last for one and a half year after it has been officially started, which include recruitment, study treatment and follow-ups. the healthy volunteers are also included to study the safety of the intervention.

Eligibility criteria:
inclusion criteria: * having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage * able and willing to comply with study visits and procedures specified in this protocol for at least six months period * able to understand and willing to sign and date the written informed consent form prior to admission of the study * able and willing to provide adequate information for locator purposes * able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation exclusion criteria: * pregnant women * over-weighted * hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation * patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded * unable to spend 3 hours for treatment at the study center