Kornimate/medical-research-clean huggingface dataset:
educational tools to improve beliefs about pain and reduce pain-related disability

Conditions: Beliefs; Disability Physical

Summary: this trial aims at comparing the effectiveness of different didactic tools developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain

this trial aims at comparing the effectiveness of different didactic tools (an educational website vs a booklet) developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain. participants of the 2 experimental groups will be invited to use the tool they receive during a one-month period.

Eligibility criteria:
inclusion criteria: * individuals with non-specific persistent low back pain (pain \> 6 months) who had their pain assessed by their general practitioner or a specialist within the last 3 months exclusion criteria: * specific low back pain, * educational treatment (back school, cognitive-behavioral, pain neurosciences education) in progress or planned during the study period * previous consultation of the didactic tools investigated in the present study * nerve root compromise, * recent spinal surgery (\<3 months) * not fluent in french * no regular access to a computer and the internet * present follow-up by a psychiatrist
combined flow and pressure study of craniospinal dynamic

Conditions: Intracranial Pressure; Cerebral Blood Flows; Infusion Test; Phase Contrast MRI; Hydrocephalus; Dementia

Summary: normal pressure hydrocephalus (nph) can cause a type of dementia. however, this type of dementia is the only one that is reversible. to treat this dementia it is necessary to evacuate the accumulation of csf from the brain to another body cavity using a device called a shunt. but the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the csf. to diagnose these patients, morphological mri and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms. the main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.


Eligibility criteria:
inclusion criteria: * age \> 55 years * patients with suspected active hydrocephalus (ha) known as "normal pressure": * ventricular dilatation: evans index \> 0.3 * patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms. * absence of other neurological diseases that could cause ventriculomegaly. * information and collection of the patient's non opposition exclusion criteria: * all patients with neurological disease other than active hydrocephalus will be excluded. * individuals who cannot tolerate an mri examination * all individuals with implants, pacemakers, prostheses and ferromagnetic objects * patients under guardianship, curators or safeguard of justice

Keywords: intracranial pressure cerebral blood flows infusion test phase contrast mri hydrocephalus dementia
study of relationship between vedolizumab therapeutic drug monitoring, biomarkers of inflammation and clinical outcomes

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Summary: the purpose of this study is to determine if a relationship exists between week 6 vedolizumab therapeutic drug monitoring (tdm) and week 30 faecal calprotectin (fcp).

this is a non-interventional, retrospective, and longitudinal study of participants with ibd (uc or cd) receiving vedolizumab between years 2015 and 2020. the study will determine the real-world evidence of vedolizumab, its relationship with tdm, biomarkers of inflammation, and its effect on clinical outcomes in a real-world setting. this study will enroll approximately 5,500 participants. participants will be enrolled in 2 cohorts: tdm cohort and historical cohort. the study will have a retrospective data collection of the participants from psp between the years 2015 and 2020. the study will include longitudinal analysis of data collected in a subset of takeda canada psp, specifically for those participants on vedolizumab, some of which received biomarker testing and tdm at pre-specified intervals during their treatment. this multi-center trial will be conducted in canada. the overall time for data collection in the study will be approximately 5 years.

Eligibility criteria:
inclusion criteria: 1. the participant or, when applicable, the participant's legally acceptable representative signed and dated a written, informed consent form, which specified secondary use of their data, and any required privacy authorization as part of their enrollment in takeda canada's psp. 2. received or receiving vedolizumab between the years 2015 and 2020. exclusion criteria: no exclusion criteria will be applied.

Keywords: drug therapy
combining placing a synera patch with propofol/lidocaine mixture to decrease pain with iv propofol injection

Conditions: Pain on IV Injection of Propofol.

Summary: the main objective is to evaluate if combining placing the synera patch and using propofol /lidocaine mixture will further decrease the pain associated with the iv injection of propofol.

commonly, anesthesiologists inject propofol, a sleeping medication, intravenously to induce general anesthesia.propofol injection is commonly associated with burning pain. in a previous onsite study we concluded that placing a synera patch at least 30 minutes before placing the iv decreased the pain associated with the propofol injection. also,a study documented that adding lidocaine to the propofol decreases the pain associated with propofol injection. in our study here we are trying to evaluate if combining the use of both the synera patch and the propofol-lidocaine mixture will further decrease the pain associated with the iv propofol injection. all children will receive a synera patch, it will be placed on the dorsum of both hands for at least 30 minutes.all children will be sedated with p.o versed. 22 g iv will be started either in the holding area or in the or. children will be randomized into groups using a computer generated randomization list:- group 1 will receive propofol -lidocaine mixture. group 2 will receive propofol-saline mixture. an independent blinded observer and an anesthesia member will independently evaluate pain on propofol injection according to pain scale. 1. no pain. 2. mild pain (associated with facial expression of pain). 3. moderate pain(pulling the arm). 4. severe pain (screaming).

Eligibility criteria:
inclusion criteria: * healthy children 6-17 yrs. * scheduled to receive general anesthesia for an elective procedure. * asa classification 1-2 exclusion criteria: * children with skin disease and/or skin infections. * allergy to propofol, lidocaine or tetracaine.
food for thought: executive functioning around eating among children

Conditions: Self-regulation; Appetitive Behavior; Eating Behavior; Child Obesity

Summary: scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. this investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.

appetite self-regulation (asr) has been described as involving children's use of eating-specific, "top-down" cognitive processes to moderate "bottom-up" biological drives to eat. much of the research to date on asr has focused on the role of bottom-up drives in shaping children's behavioral susceptibility to obesity. alternatively, little is known about the cognitive-developmental processes that shape children's ability to make healthy food choices and eat in moderation during early childhood. the goal of this exploratory investigation is to produce rigorous evidence of cognitive developmental influences on healthy eating behaviors and weight status during preschool through the development of new measures of top-down asr. participants will be 125 preschoolers and their primary caregiver. existing measures of executive functioning in children will be adapted to create new measures of eating-specific, top-down asr. associations with children's eating behaviors, body mass index z-scores, food parenting will be assessed.

Eligibility criteria:
inclusion criteria: 1. child ages 4 to 6 years of age 2. caregiver reporting primary responsibility for child feeding outside of childcare 3. caregiver legal guardian exclusion criteria: 1. caregiver \<18 years of age 2. child major food allergies 3. child medication use, developmental disability, or medical conditions known to affect food intake and/or growth; color blindness 4. child in foster care
azithromycin for critical asthma - pediatrics

Conditions: Pediatric Asthma; Critical Illness

Summary: the cr-azi study will assess the immunomodulatory effects of azithromycin for pediatric critical asthma.

azithromycin (azi), a macrolide antibiotic, has been applied for adult and pediatric respiratory pathology to alter immune system response.1 for pediatric critical asthma (ca), a term used to describe a critically ill child hospitalized with an asthma exacerbation requiring an intensive care unit (picu) hospitalization, the investigator's prior research has revealed 1 in 10 will receive azi.2 yet, the application of azi in this setting is poorly studied nor is clear if, and to what degree azi alters the immune response in conjunction with systemic corticosteroids traditionally applied in ca. in this proposal, the investigators aim to characterize a respiratory epithelial inflammatory biomarker, periostin, among children with ca with and without exposure to azi. the investigators hypothesize children receiving azi will have lower periostin levels. as a secondary analysis, the investigators will describe the rates of adverse events related to azi (previously not done) and explore differences in clinical and physiologic ca efficacy markers.

Eligibility criteria:
inclusion criteria * age 3-17 years * admission to the picu * primary diagnosis of critical asthma * prescription for continuous inhaled beta-agonist therapy and/or intravenous (iv) beta-agonist therapy * prescription for intravenous systemic corticosteroids exclusion criteria * critical congenital heart disease unrepaired * tracheostomy dependence at admission * ongoing exposure to azithromycin or macrolide antibiotics for any indication * past medical history of prolonged qt syndrome or arrhythmias * concomitant respiratory pathology including acute chest syndrome, interstitial lung disease, cystic fibrosis, and pulmonary hypertension
use of bip-needles in rheumatologic injections

Conditions: Intra-articular Injections

Summary: the study focuses on needle guidance in rheumatologic operations - glucocorticoid injections inside joint capsules specifically. the main purpose of the study is to assess and validate the clinical feasibility and performance of bioimpedance probe (bip) needles and assess the benefits, drawbacks and risks related to use of the bip needles.

clinical device investigation

Eligibility criteria:
inclusion criteria: * adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection. exclusion criteria: * exclusion criteria are the same as generally for intra-articular glucocorticoid injections (e.g. bacterial infection or recent surgical operation relating the joint). * in addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion. * in addition pregnant women are excluded

Keywords: arthritis bioimpedance glucocorticoid intra-articular injection needle guidance
a comparison of anatomically aligned versus conventional in unilateral total knee arthroplasty

Conditions: Knee Osteoarthritis; Anatomically Aligned Total Knee Arthroplasty

Summary: total knee arthroplasty(tka) is a successful orthopedic surgery with excellent clinical outcome and survival. however, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(proms) of some studies. therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. the knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. new implants are being developed to overcome the limitations of conventional tka implant, including the journey ii bi-cruciate substituting total knee system (jii-bcs; smith \& nephew). jii-bcs implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo. the clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. the purpose of this study is to compare outcomes between anatomically aligned tka(jii-bcs) and conventional tka(legion total knee system, smith \& nephew). this study is a randomized controlled study in patients undergoing unilateral total knee arthroplasty. a patient will undergo unilateral tka with anatomically aligned or conventional tka implant. the implant is determined using a random number table. radiologic parameter, patients preference and clinical results was investigated in patients who received unilateral tka during minimum 2 year follow up.


Eligibility criteria:
inclusion criteria: * patients for bilateral total knee arthroplasty * having medicare insurance exclusion criteria: * rheumatoid arthritis * other inflammatory arthritis * crystal-induced arthritis * septic arthritis * neuropsychiatric patients * previous knee operation history * neuropsychiatric patients * patients with preoperative severe limitation of motion (flexion contracture ≥ 20, range of motion ≤ 90) * patients with preoperative severe defomity of knee alignment (varus or valgus angle ≥ 15) * severe obese patients (bmi ≥ 40)
efficacy & safety of sch 900435 in schizophrenia (study p06079)(withdrawn)

Conditions: Schizophrenia

Summary: the purpose of this study is to assess whether sch 900435 (org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.


Eligibility criteria:
inclusion criteria: * subjects eligible to participate: * present a substantial and recent exacerbation of schizophrenia * have responded positively to treatment with an antipsychotic other than clozapine in the past * are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation exclusion criteria: * schizoaffective disorder; * single episode of schizophrenia in partial remission * concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives * substance abuse or dependence (excluding nicotine and caffeine) * uncompensated medical illness (including clinically relevant eye disorder)
identification of pathophysiological pathways and therapeutic targets in primary stomatodynia by salivary metabolomics

Conditions: Primary Burning Mouth Syndrome

Summary: burning mouth syndrome (bms) is defined by a chronic oral pain affecting especially postmenopausal women. its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. the recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. the aim of this study is to analyze the salivary metabolomic in bms patients compared to healthy controls.

burning mouth syndrome (bms) is defined by a chronic oral pain affecting especially postmenopausal women. its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. the recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. the aim of this study is to analyze the salivary metabolomic in bms patients compared to healthy controls.

Eligibility criteria:
inclusion criteria: * for cases : primary burning mouth syndrome, based on the ihs diagnosis criteria * for cases : being able to realise the salivary collection * for controls : no primary bms * for controls : being able to realise the salivary collection exclusion criteria for both groups: * treatment by antibiotics in the previous month * new treatment in the previous two weeks * active smoking * active infectious or inflammatory oral disease * systemic disease that could have an impact on the salivary metabolome or on the neurological system * being under legal guardianship * opposition to the processing of personal data

Keywords: primary burning mouth syndrome salivary metabolomic
nutrition recommendation intervention trials in children's healthcare

Conditions: Obesity, Childhood; Nutrition; Health Risk Behaviors; Breastfeeding; Exclusive Breastfeeding; Diabetes

Summary: nurish is a suite of clinical trials for children from low-income families which will determine whether primary healthcare prescription for: 1) optimal breastfeeding with support from a mobile lactation consultant vs. usual care and 2) high-quality childcare starting at 1 year vs. usual care can prevent childhood obesity, and improve cardiovascular, developmental and mental health at 2 years of age.

canada's children are falling behind. one in 4 are overweight or obese and more than 1 in 3 have factors that put them at risk for cardiovascular disease as adults. children from low income families are 70% more likely to be overweight or obese. research across disciplines has shown that early life nutrition has profound effects on childhood obesity, development, mental health, and lifetime success. optimizing early life nutrition to reduce inequalities in childhood obesity and its consequences is a promising approach. through this application, we will be using a longitudinal factorial design within an ongoing cohort study(target kids!). the longitudinal factorial design involves randomizing the same children to multiple interventions, providing the opportunity to evaluate the effect of individual interventions as well as the multiplicative effects of a combination of interventions over time. this design increases the feasibility and lowers the cost relative to conducting 2 separate trials. this will be a pragmatic, randomized, longitudinal factorial trials within cohorts (twics) clinical trial. this study will be a direct comparison of two primary healthcare interventions provided randomly at the individual level: 1) lactation consultant (lc) support vs. usual care; 2) childcare navigator (cn) support vs. usual care.

Eligibility criteria:
inclusion criteria: * healthy by parental report * \<32 weeks gestation * 0-1 week of age * first birth /first time parents exclusion criteria: * children with a syndrome associated with obesity or developmental delay

Keywords: lower adiposity higher breastfeeding self-efficacy higher centre-based childcare attendance improved child development and mental health lower cardiovascular risk factors better dietary quality lower healthcare and overall societal costs
study of inclisiran to prevent cardiovascular (cv) events in participants with established cardiovascular disease

Conditions: Atherosclerotic Cardiovascular Disease

Summary: study ckjx839b12302 is a pivotal phase iii trial to evaluate the benefits of inclisiran on major adverse cardiovascular (mace) events in participants with established cardiovascular disease (cvd).

purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on day 1, month 3 (day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ascvd will significantly reduce the risk of 3-point-major adverse cardiovascular events (3p-mace) defined as a composite of cv death, non-fatal myocardial infarction (mi) and non-fatal ischemic stroke. this will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.

Eligibility criteria:
inclusion criteria: 1. fasting ldl-c ≥ 70 mg/dl at randomization visit 2. stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg qd or rosuvastatin greater than or equal to 20 mg qd 3. established cv disease defined as any of the following three conditions 1. spontaneous myocardial infarction ≥ 4 weeks from screening visit 2. history of ischemic stroke occurred ≥ 4 weeks prior to the screening visit 3. symptomatic peripheral arterial disease (pad) evidenced by either intermittent claudication with ankle brachial index (abi) \< 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease. exclusion criteria: 1. acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 weeks before screening visit 2. treatment with pcsk9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit 3. planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit 4. heart failure nyha class iii or iv 5. active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver 6. previous exposure to inclisiran or any other non-mab pcsk9-targeted therapy, either as an investigational or marketed drug within 2 years 7. severe concomitant non-cv disease that is expected to reduce life expectancy to less than 5 years 8. history of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit 9. pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply.

Keywords: atherosclerotic cardiovascular disease hypercholesterolemia dyslipidemia high cholesterol hyperlipidemia inclisiran sirna kjx839