Kornimate/medical-research-clean huggingface dataset:
global assessment of plaque regression with a pcsk9 antibody as measured by intravascular ultrasound

Conditions: Hypercholesterolemia

Summary: this study will evaluate whether low-density lipoprotein (ldl-c) lowering with evolocumab (amg 145) results in greater change from baseline in percent atheroma volume (pav) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.


Eligibility criteria:
inclusion criteria: * clinical indication for coronary angiography * subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening ldl-c. subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. subjects who are intolerant to statins must meet statin intolerance entry criteria * fasting ldl-c ≥ 80 mg/dl (2.07 mmol/l) with or without additional risk factors, or, ldl-c ≥ 60 -\< 80 mg/dl (1.55-2.07 mmol/l) in the presence of one major or three minor risk factors subjects must meet the following criteria at the qualifying coronary catheterization procedure: * evidence of coronary heart disease (at least one lesion in a native coronary artery that has \> 20% reduction in lumen diameter) or prior percutaneous intervention (pci) * left main coronary artery \< 50% reduction in lumen diameter by visual estimation * target coronary artery for ivus must be accessible to the ivus catheter, must not have a \> 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior pci or coronary artery bypass graft (cabg) and is not a candidate for intervention over the next 18 months. it may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (mi). exclusion criteria: * coronary artery bypass graft surgery \< 6 weeks prior to the qualifying ivus * new york heart association (nyha) iii or iv heart failure, or last known left ventricular ejection fraction less than 30% * uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization * known hemorrhagic stroke * uncontrolled hypertension at randomization * fasting triglycerides ≥ 400 mg/dl (4.5 mmol/l) at screening * type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin a1c \[hba1c\] \> 9%) at screening. * moderate to severe renal dysfunction (estimated glomerular filtration rate \[egfr\] \< 30 ml/min/1.73m²) at screening.

Keywords: cholesterol high cholesterol elevated cholesterol raised cholesterol
clinical evaluation of cervical ripening in the outpatient setting

Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn; Labor Onset and Length Abnormalities

Summary: a randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. while the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. more recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day. the main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.

Eligibility criteria:
inclusion criteria: * pregnant woman scheduled for induction of labor. * age between 18 and 45 years. * understanding and capable to sign informed consent. * singleton pregnancy. * gestational age ≥ 37 0/7 weeks. * live fetus in cephalic presentation. * intact membranes * bishop score \< 6 * estimated fetal weight \< 4500g * without contraindication to vaginal delivery * no major fetal anomaly exclusion criteria: * previous cesarean section or myomectomy * hypertension * diabetes * thyroid disease * maternal conditions with high risk of placental insufficiency

Keywords: cervical ripening mifepristone balloon catheter
robotic surgery in the seated position for benign and malignant lesions of the head and neck

Conditions: Oropharyngeal Neoplasms; Head and Neck Cancer

Summary: this study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da vinci\&#174; robotic surgical system (intuitive surgical, inc., sunnyvale, ca) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

the da vinci robotic surgical system (intuitive surgical, inc., sunnyvale, ca) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. the console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. the console is connected via computer to the mechanical arms holding the endoscope (surgical tv camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). these arms are located immediately adjacent to the patient on the operating room table. the surgeon sits at the console and controls the position and movement of the arms and surgical tools. the design of these tools is based upon well-established, commonly used surgical instruments. the da vinci robotic surgical system (intuitive surgical, inc., sunnyvale, ca) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). use of the da vinci robotic surgical system (intuitive surgical, inc., sunnyvale, ca) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.

Eligibility criteria:
inclusion criteria: * patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck. * written informed consent. pre-operative exclusion criteria: * unexplained fever and/or untreated, active infection. * patient pregnancy. * previous head and neck surgery precluding robotic procedures. * the presence of medical conditions contraindicating general anesthesia or standard surgical approaches. intra-operative exclusion criteria: * it is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. the following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting: * inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position. * in this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.

Keywords: cancer oropharynx
rice anthocyanin bioavailability in humans

Conditions: Healthy

Summary: aims of the project 1. to determine the rice anthocyanin content via high-performance liquid chromatographycoupled to mass spectrometry, hplc-ms 2. to study the oral bioavailability of anthocyanins in healthy volunteers after the intake of a serving (80 g) of black rice (venere and artemide varieties). 3. to determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, hplc-ms.

to limit the interindividual variability, the protocol will be designed as a prospective, randomized, cross-over pharmacokinetic study on healthy volunteers. participants will be randomly divided into three groups (black rice venere, black rice artemide and white rice/control) by an allocation software ( http://graphpad.com/quickcalcs/randomise1.cfm ) which will generate different random sequences of the treatment assignment. subjects will be deprived of anthocyanin-rich food sources 7 days before experimentation (wash-out period). each volunteer will receive a complete list of anthocyanin-rich foods to be avoided, including berry fruits (i.e. blueberries, cranberries, raspberries, blackcurrants and elderberries), red/violet fruits/vegetables (i.e. grapes, cherries, pomegranates, red apples, plums, eggplants, tomatoes and peppers), red wine and other colored products (i.e. marmalade, jams and juices containing berries). breakfast, lunch and dinner will be standardized 1 day before the experiment. each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences: 1. 80g of black rice venere (group a) 2. 80g of black rice artemide (group b) 3. 80g of white rice (group c) therefore, each subject will be involved in three experimental days. the three treatments will be separated by a 7 day wash-out period. after an overnight fast, volunteers will consume the rice serving within 10-15 min, immediately after the first basal blood collection at 8:00 a.m. (baseline). other blood withdrawals will be collected after 30 minutes, 1 hour, 2 hours, 3 hours. chemical analyses. the extraction protocols of anthocyanins from body fluids will be developed, in order to reach the maximum yield of the analytes from the samples. plasma anthocyanins will be measured by spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, hplc-ms.

Eligibility criteria:
inclusion criteria: * healthy status * age: 18-45 * normal weight (bmi 18.5-24.9) who voluntarily accept to join the study, after informed consent. exclusion criteria: * \<18 years; * pregnancy and lactation; * systemic disorders; * dietary supplements intake (vitamins, antioxidants, botanicals, phytochemicals) * abnormal hematological parameters; * heavy smoking and alcohol drinking; * high-intensity physical activity.
optimizing chronic low back pain exercise therapies with cerebral electrical stimulation

Conditions: Low Back Pain, Recurrent; Chronic Low Back Pain

Summary: chronic low back (clbp) pain is an important public health and socioeconomic problem worldwide and, despite the volume of research in the area, it remains a difficult condition to treat. the neuromatrix pain model and new findings on the pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. transcranial direct current (tdcs) stimulation is a noninvasive neuromodulation technique that has been presenting recent advances in the treatment of chronic pain. however, when applied alone the magnitude of its effect is small in chronic musculoskeletal conditions such as chronic non-specific back pain. one option that could optimize the analgesic effect of tdcs would be the combination with therapeutic exercises, which play a central role in spinal rehabilitation programs as well as higher levels of evidence. the combination of these treatments (tdcs and exercise) may present an analgesic effect superior to the isolated interventions. this study aims to investigate the efficacy of tdcs combined with therapeutic exercises in people clbp for pain relief, affective aspect of pain, disability, kinesiophobia and global perception. sixty patients will be randomized into two distinct groups to receive either tdcs (anodal) + therapeutic exercises or tdcs (sham) + therapeutic exercises for 12 sessions over a four-week period. the primary clinical outcome (pain relief) and secondary outcomes (disability, affective aspect of pain, kinesiophobia, and perception of overall effect) will be collected before treatment and four weeks, three months and six months post randomization. the data will be collected by a blind examiner to the treatment allocation.


Eligibility criteria:
inclusion criteria: complaining of back pain for more than three months. presence of a chronic pain measurable with the number rating scale (nrs 0-10) not less than 4 during a 1 week daily nrs monitoring. seeking care for low back pain. - exclusion criteria: previous surgery on the spine, spondylolisthesis previous treatment with tens \<6 months previous treatment with tdcs disc herniation with nerve compression neurological, psychiatric and rheumatologic diseases impaired sensibility use of pacemakers or other implanted devices pregnancy -
feasibility of an artificial intelligence phone call after cataract surgery

Conditions: Cataract

Summary: to analyze the evidence for clinical safety, usability, acceptability, satisfaction, appropriateness, and cost-effectiveness of dora for recognizing patients who require additional in-person evaluation post cataract surgery. to assess dora's sensitivity and specificity in cataract surgery management to determine what can be learnt to enhance ai technology in the field of ophthalmology especially when working with culturally diverse patients such as punjabi and chinese speaking patients.

background: cataract is defined as the degradation of the optical quality of the crystalline lens that affects vision and is the current leading cause of blindness worldwide. ai is set to revolutionize post-cataract surgery management by enhancing automation, increasing effectiveness, decreasing burdens placed on patients and the health care system. ultimately, using ai-enabled automation could enhance patient management during and post cataract surgery.cataract post-operative contact will be delivered by dora agent, a natural language ai assistant. aim and objective: dora is a clinically safe, usable, appropriate, satisfactory and cost-effective ai technology for recognizing patients who require additional evaluation post cataract surgery.

Eligibility criteria:
inclusion criteria: * patients who are undergoing uncomplicated cataract surgery at a high volume surgical centre. exclusion criteria: * clinically significant complications during surgery that require more than the standard postop treatment or follow-up

Keywords: artificial intelligence
prevalence of periodontal diseases in ibd

Conditions: Inflammatory Bowel Diseases; Periodontal Diseases

Summary: periodontal diseases are highly prevalent inflammatory diseases. it is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. recently, periodontal diseases have been correlated with inflammatory bowel diseases (ibd). ibd include two types, crohn's disease and ulcerative colitis. it could be a significant risk factor for the pathogenesis of periodontal disease. these diseases present common features : a high prevalence worldwide, multifactorial pathogenies with common mechanisms. to date, no study has linked activity of ibd and periodontal diseases. the authors hypotheses that the prevalence of periodontal diseases could be increased in patient presenting an active ibd

the present study explores the prevalence of periodontal diseases regarding to the activity status of ibd (active versus non-active). diseases activity will be assessed by hbi (crohn's disease) or partial mayo score (ulcerative colitis) associated with fecal calprotectin and/or crp and/or inflammatory/ulcerative lesions. periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases (chicago 2017) and based on the decision-making algorithms by tonetti and sanz. a periodontal screening, socio-demographic data and clinical data will be collected. then, oral mucosa dermatological manifestations relative to ibd, treatment need (icdas) and quality of life related to oral health (gohai) will be evaluated. these data will be collected by a periodontist. the principal hypothesis of this study is that the prevalence of periodontal diseases could be increased in patient presenting an active ibd. the primary objective is to evaluate if patients presenting active ibd present more stage iii and iv periodontal diseases than non-active ibd ones. the second objectives are : * to compare periodontal diseases, gingivitis and oral mucosa dermatological manifestations rates according to the diseases activity, the ibd type and the treatment used to treat ibd, * to compare oral treatment need according to the activity and the type of ibd, * to compare quality of life related to oral health according to the activity and the type of ibd

Eligibility criteria:
inclusion criteria: patients * consulting gastroenterology departments in the university hospital of reims or amiens-picardie for the management of crohn's disease or ulcerative colitis * signed informed consent form * affiliated to the french social security system exclusion criteria: patients presenting: * a medical history likely to compromise protocol (psychiatric disorders, other inflammatory diseases, antibiotics, nsaids within the last 3 months) * diabetes * inflammatory rheumatism * cancer or radiotherapy up to5 years before inclusion * x-ray therapy in the area of interest * pregnancy or breastfeeding * eating disorders * patients under legal protection, trusteeship or guardianship
synuclein-one study

Conditions: Parkinson Disease; Multiple System Atrophy; Dementia With Lewy Bodies; Pure Autonomic Failure

Summary: the synuclein-one study will be evaluating α-synuclein in patients with parkinson's disease, multiple system atrophy, dementia with lewy bodies and pure autonomic failure. using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.

phosphorylated α-synuclein pathology in the diagnosis of synucleinopathies through qualitative and quantitative measurements of cutaneous phosphorylated α-synuclein in patients with parkinson's disease, multiple system atrophy, dementia with lewy bodies and pure autonomic failure. an effective tissue biomarker will provide an accurate diagnosis of α-synuclein in clinical practice, will differentiate between synucleinopathies, enable assessment of target engagement in the development of disease modifying and neuroprotective therapies and accelerate the development of neuroprotective and disease modifying therapies.

Eligibility criteria:
inclusion criteria: * male and female between 40-99 years of age * prior clinical diagnosis of parkinson's disease, multiple system atrophy, dementia with lewy bodies or pure autonomic failure * health subjects, no history of clinical or symptoms suggestive with synucleinopathy exclusion criteria: * clinical evidence of severe vascular disease (history of ulceration, poor wound healing, vascular claudication) * clinically active coronary artery or cerebrovascular disease * current smoker or alcoholism * history of allergic reaction to local anesthesia for skin biopsies * use of blood thinners (aspirin or plavix alone is allowed) * significantly impaired wound healing or history of scarring or keloid formation * healthy individuals or individuals with synucleinopathy is disease may be explained by other causes: recent history of encephalitis, cortical dementia of alzheimer's type, whipple's disease, toxin exposure, repeated head injury and stepwise disease progression suggestive of vascular etiology

Keywords: neurodegenerative diseases
effects of atazanavir treatment on type 2 diabetes mellitus related endothelial dysfunction

Conditions: Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Summary: the purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria (most important): * 18 - 70 years * type 2 diabetes mellitus treated with diet, oral medication and/or insulin * bmi of 18 to 35 * determinants of renal and hepatic function within twice the upper limit of normal range, abnormalities in lipid profile permitted exclusion criteria (most important): * history of smoking within past year * history of or current abuse of drugs, alcohol or solvents * current use of antihypertensive, cardiac or other vasoactive medication * clinical evidence of cardiac or pulmonary disease
use of a nurse pain educator for patients with chronic pain

Conditions: Chronic Pain; Opioid Use; Nurse's Role

Summary: this multicenter randomized (block randomization) controlled parallel arm pilot study comparing the incorporation vs no incorporation of a nurse pain educator into clinics that treat chronic non cancer pain patients with opioid analgesics. subjects who are either opioid naïve or opioid experienced will be enrolled into the study.

the nurse pain educator arm shall have two phases: a pre-teaching phase and a teaching/knowledge maintenance phase. during the pre-teaching phase, all subjects who are enrolled will complete different baseline assessments and will be prescribed an opioid. subjects will then enter the teaching/knowledge maintenance phase. subject enrolled into the nurse pain educator arm will be educated on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics. subjects will meet monthly with the nurse educator for up to 5 months for reinforcement of their training and to assess their use of their medication, their quality of life and their physical and mental well-being. subjects who are enrolled into the study arm with no nurse pain educator will be monitored every month to assess their use of their medication, their quality of life and their physical and mental well-being. no intervention will be conducted with these subjects beyond that of standard of care at the facility. subjects will be evaluated monthly but primary differences in outcomes will compare baseline to 6 months.

Eligibility criteria:
inclusion criteria: * ability to read, understand, and provide written informed consent * male or female patients ≥ 18 years of age * diagnosed with non-cancer pain for \>3 months * ability to meet study requirements (i.e., can attend monthly visits, able to complete questionnaires, etc.) * prescribed an oral opioid that will last duration of the study period * provide a completed opioid patient prescriber agreement exclusion criteria: * diagnosed with chronic cancer pain * personal or family history of alcohol or drug abuse in the past 5 years * personal or family history of major mental illness