Kornimate/medical-research-clean huggingface dataset:
validation of a french version of the dheq

Conditions: Dentin Hypersensitivity; Quality of Life

Summary: dentin hypersensitivity (dh) results in brief, sharp pain in response to a stimulus. it often seems to be underdiagnosed but also undertreated due to the lack of consensus on the topic. dh has been shown to affects patients' quality of life. the dentine hypersensitivity experience questionnaire (dheq)is developed and validated : which is questionnaire assessing specifically the impact of dh on patient's quality of life. the dheq aims to help diagnose dh and assess the impact and subjective experience of the patient in order to better meet their expectations in terms of treatment. a french version, the dheq-fr, has been proposed (translation-counter-translation process and pilot study); however, it has not yet been validated (psychometric tests, test-retest). the main objective of the present study is to validate dheq-fr through a multicenter clinical study (three centers in france) in adult patients. the secondary objective is to compare the results of dheq-fr with those of the general oral health assessment index and oral health impact profil for the same patients. patients are split between three dh groups (schiff scores 1, 2 and 3) and a control group (non-dh). the overall sample size (all centers considered) for the dh group is 162 subjects divided into 54 subjects for each schiff score (1 to 3; after cold air stimulation), with a control group of 54 subjects. a re-test will be performed, at 15 days, on a random sample of 60 subjects from the study population (in total: 15 non-dh subjects; 15 with a schiff score of 1; 15 with a score of 2; 15 with a score of 3). the study of psychometric properties such as acceptability, internal consistency, reproducibility and internal structure validity will allow the validation of this french version of the dheq.


Eligibility criteria:
inclusion criteria: * patients who are able to understand the study exclusion criteria: * teeth with other pathologies in addition to hd (carious lesions, cracked enamel, etc.); * abutment teeth for fixed or removable dentures and crown teeth; * teeth with restorations involving the inner third of the dentin and/or restorations involving the dentinary/root exposure area; * patients who have been on or have undergone desensitizing therapy for hd in the past three months; * patients who have received periodontal surgery within the last three months; * patients with orthodontic devices who have interrupted orthodontic treatment in the last three months; * pregnant or breastfeeding patients; * patients under guardianship, curatorship, safeguard of justice * patients deprived of liberty * patients participating in any other clinical study.

Keywords: oral health dentin hypersensitivity quality of life
screening for bleeding disorders in children

Conditions: Bleeding Disorder

Summary: the investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.

objective : to determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children. method: * retrospective inclusion of all patients \<18 years referred to the crth in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment. * data collected (by collection in the medical file): patient data: age, sex, personal and family history of hemorrhagic disease clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) biological data: pt, tck, factor assay, platelet function medical data: complete diagnosis if diagnosis of hemorrhagic disease * scores: hemostop, pbq, isth, tosetto score * analyzes: calculation of the odd ratio, auc, se, sp, vpp, vpn for different clinical / biological factors and each score.

Eligibility criteria:
inclusion criteria: * referred by their general practitioner or another caring physician for evaluation of bleeding symptoms * abnormal laboratory test results or family study * the patient being the first-degree relative of a patient with a known bleeding disorder. exclusion criteria: - older than 18 years old.

Keywords: von willebrand disease hemophilia a and b other coagulant factor deficiencies
the efficacy of preventive regenerative peripheral nerve interface(rpni) reconstruction in amputees

Conditions: Amputation Neuroma

Summary: the trial will be carried out in peking university people's hospital. the whole trial will last 3 years. amputees from orthopedics and vascular surgery will be distributed into two groups randomly and receive different treatments including traditional resection and regenerative peripheral nerve interface(rpni) surgery.the pain outcome,the impact of post-amputation pain on life and the utilization rate of prostheses will be collected to study the efficacy, safety and prognosis of preventive regenerative peripheral nerve interface reconstruction in amputees. investigators believe that rpni can effectively reduce the incidence of post-amputation pain, reduce the degree of pain, improve the wearing rate of prostheses, and help patients return to normal life.


Eligibility criteria:
inclusion criteria: * perform traditional amputation and nerve disconnection or rpnis in peking university people's hospital * age≥6 years * follow-up time≥12 weeks exclusion criteria: * follow-up time\<12 weeks * age\<6 years * preoperative complications included cervical spondylosis, lumbar spinal stenosis, piriformis syndrome, cubital tunnel syndrome and other peripheral nerve entrapment syndrome

Keywords: amputation regenerative peripheral nerve interface neuroma
lyell syndrome mesenchymal stromal cells treatment

Conditions: Epidermal Necrolysis; Lyell Syndrome; Toxic Epidermal Necrolysis; Overlap Syndrome; Mesenchymal Stromal Cells; Adipose Derived Stromal Cells

Summary: stevens-johnson syndrome (sjs) and toxic epidermal necrolysis (ten) are rare severe cutaneous adverse reactions (scars) to drugs. to date, no curative drug has demonstrated with a good level of evidence its ability to promote sjs and ten healing and could contribute to earlier reepithelialisation. mesenchymal stroma cells (mscs) therapy represents a new therapeutic approach. eg, in patients with cardiovascular diseases, neurological diseases, renal transplantation, lung diseases as acute respiratory distress syndrome. recently, mscs have been proposed in both burn wound healing with a significantly decrease of the unhealed burn area and in cutaneous radiation. moreover, mscs have immunomodulation properties potentially effective in refractory acute and chronic graft versus host disease (gvhd) by improving thymic function and induction of tregs. indeed, mscs are able to migrate to inflamed tissues after stimulation by pro-inflammatory cytokines and to modulate the local inflammatory reactions. mscs have also demonstrated their ability to promote tissue remodelling, angiogenesis and immunomodulation through either differentiation or secretion of several growth factors such as vegf, basic fgf and various cytokines. therefore, combining their immunomodulation effect and secretion of soluble factors involved in wound repair, mscs might be valuable as a cell therapy strategy for promoting cutaneous healing in sjs-ten syndrome and subsequently decrease the morbi-mortality.


Eligibility criteria:
inclusion criteria: * patients aged from 18 to 75 years-old * admission less than 10 days after onset of the reaction * patient with confirmed sjs-ten diagnosis hospitalized in the department of dermatology or intensive care medicine * at least 10 % of detachable-detached body surface area at any time during the first 10 days after the index date (date of the first symptoms of the disease) * written consent from patient or trustworthy person or legal representant or family member * affiliated to a social security scheme exclusion criteria: * pregnant or breastfeeding women * history of malignant disease within the past ten years and or presence of metastasis * positive serology for hiv * active infection for hepatitis b or c * decompensated cardiac failure * uncontrolled epilepsia * previous history of allogenic bone marrow transplantation * participation in other interventional drug research * patient deprived of liberty by a judicial or administrative decision or under the protection of justice * any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule * patient under tutorship or curatorship * patient under psychiatric care according to art. l1121-6 csp

Keywords: epidermal necrolysis lyell syndrome toxic epidermal necrolysis overlap syndrome mesenchymal stromal cells adipose derived stromal cells
high schools- high on life: an intervention to reduce excessive drinking in danish high schools

Conditions: Alcohol Drinking

Summary: high schools high on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among danish high school students. the study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. timeline: baseline data will be obtained from the danish national youth study 2019, collected in january to march 2019. delivery of intervention: august 2019 to january 2020. follow-up survey: april to may 2020. primary outcome measure: mean number of binge-drinking episodes within the last 30 days. secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. implementation will be monitored thorough process evaluation.

high schools high on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among danish high school students. the study will employ a cluster-randomized controlled study design: based on sample size calculations investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. timeline: baseline data will be obtained from the danish national youth study 2019, collected in january to march 2019. delivery of intervention: august 2019 to january 2020. follow-up survey: april to may 2020. primary outcome measure: mean number of binge-drinking episodes within the last 30 days. secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. implementation will be monitored thorough process evaluation.

Eligibility criteria:
inclusion criteria: * enrolled in high school that participate in the danish national youth study 2019 * general high schools exclusion criteria: * non general high schools students * non participation in the danish national youth study 2019

Keywords: adolescence alcohol use high school
observational study of golimumab intravenous infusion

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the incidence and management of infusion reactions with golimumab intravenous infusion.

this is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (ra) in canada. only data available from source documentation will be collected. the participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled. all aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants must have a confirmed diagnosis of rheumatoid arthritis * participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study * participants are golimumab-naive (never have used golimumab both sc and iv formulations) * participants are prescribed golimumab intravenous by an appropriate physician as per the canadian product monograph exclusion criteria: * participant who has been treated with golimumab in the past * participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis * participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point * participant is currently enrolled in an interventional study

Keywords: rheumatoid arthritis observational golimumab simponi intravenous infusion
a study to evaluate the safety, tolerability and pharmacokinetics of ivt mhu650 in macular edema patients

Conditions: Macular Edema; Diabetic Macular Edema; Neovascular Age-related Macular Degeneration; Retinal Vein Occlusion

Summary: this was an open-label, multi-center, fih study with a single ascending dose (sad) design that assessed the safety, tolerability and pharmacokinetics (pk) of a single ivt dose of mhu650 in up to 24 participants with macular edema.

a total of up to 4 cohorts were planned to be enrolled, with an additional lower or intermediate cohort of participants. first to third generation japanese participants could be enrolled in all cohorts but were not required to be enrolled. the screening period for this study will be up to 60 days. a single dose of mhu650 intravitreal injection will be administered at baseline / day 1 in the study eye. the follow up period will last until day 60 / end of study (eos). a post study safety phone contact call will occur 30 days after the eos visit.

Eligibility criteria:
key inclusion criteria: * patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (dme), neovascular age-related macular degeneration (namd), or retinal vein occlusion (rvo). in the opinion of the investigator, the decrease in vision in the study eye must be due to macular edema. * early treatment diabetic retinopathy (etdrs) letter score in the study eye must equal to or worse than 60 letters (approximately snellen equivalent of 20/63) but better than 14 letters (20/500) at screening and baseline. the etdrs score in the non-study eye should be ≥ 60 letters at screening and baseline. * sufficiently clear ocular media and adequate pupil dilation to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins * vital signs as specified in the protocol key exclusion criteria: * concomitant conditions or ocular disorders in the study eye which may, in the opinion of the investigator, confound the interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period * high risk and/or/ active proliferative diabetic retinopathy in the study eye, as per investigator assessment at both screening and baseline. * participants with the following conditions in the study eye at screening or baseline must be excluded: structural damage of the fovea, vitreous hemorrhage, retinal detachment, vitreomacular traction, macular hole, retinal arterial occlusion, neovascularization of iris of any cause. * laser photocoagulation (macular or panretinal) in the study eye during the 6-month period prior to baseline. * patients with type 1or type 2 diabetes who have hemoglobin a1c of ≥ 12 at screening * other ocular conditions as specified in the protocol * systemic conditions as specified in the protocol

Keywords: macular degeneration age-related macular degeneration dry macular degeneration wet macular degeneration diabetic macular edema dme neovascular age-related macular edema namd retinal vein occlusion rvo mhu650 macular edema
prebiotic intervention for autism spectrum disorders

Conditions: Autism

Summary: the purpose of this study is to determine the effect of a prebiotic (bgos) on gut microbiota and metabolites in children with autism spectrum disorders.

children with asd have a higher incidence of dietary and/or bowel problems than typically developing children. it has been postulated that imbalances in the gut bacteria and/or metabolites present in the gut may be a contributing factor to these symptoms, with potentially bad (toxin-producing) bacteria colonising the gut. certain carbohydrates (so-called 'prebiotics') are not digested by the human gut and they provide food for beneficial bacteria and thus they improve the composition by preventing the growth of bad bacteria. individuals could therefore benefit from these safe and effective dietary interventions to maintain the healthy gut bacteria and overall health. this study is being carried out to establish the effect of one such prebiotic, called galactooligosaccharide (b-gos) on the relative balance of gut bacteria and metabolites in children with asd. the aim is to enrol 42 children, ages 5-10 with formal asd diagnosis and with signed informed consent from their parents, into double-blind, placebo controlled, parallel study. the trial will last 10 weeks in total (2 weeks run in period, 6 weeks treatment and 2 weeks follow up). children will be required to take food supplement daily during the treatment period and their parents will collect stool, saliva and urine samples. various questionnaires will also be used for assessments. children will not be required to make other extra changes to their diet, medication or lifestyle.

Eligibility criteria:
inclusion criteria: * children aged 5-10 years with formal asd diagnosis * children's parent or guardian has given written informed consent to participate and is willing to participate in the entire study exclusion criteria: * consumption of antibiotics, prebiotic or probiotics in the last 4 weeks prior to or during the study * participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study * undergone surgical resection of any part of the bowel
the effect of milk components on the response to the pneumonia vaccine in senior citizens

Conditions: The Effect of Milk Components on the Response to Pneumococcal Vaccines in the Elderly

Summary: the purpose of this study is to determine if the daily use of a certain amount and type of milk component for 2 months provides a significant stimulation to the immune system and specifically increases the chances of being protected against pneumonia after the vaccination.


Eligibility criteria:
inclusion criteria: * age and a willingness to participate exclusion criteria: * • smoking history within 10 years * underlying neoplasia or immunological disease * use of oral cortisone or other immunosuppressive agents * current consumption of milk and milk products greater than 1 unit of milk, 1 yogurt, or 1 serving of fresh cheese a day. * food faddists or those taking a non-traditional diet * current consumption of dietary supplements * people with a known history of milk allergy * people with chronic renal failure * people with chronic inflammatory diseases taking daily doses of nsaids for longer than 4 weeks at the time of enrollment. * previous administration of the pneumomax vaccine * reduced physical activity (i.e. nyha classes iii-iv)
bufei jianpi granule for delaying pulmonary function decline in early-stage copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study aims to establish the treatment scheme of bufei jianpi granule for early-stage (gold stage 1 or 2) chronic obstructive pulmonary disease (copd), delaying pulmonary function decline and forming high quality evidence.

copd is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in china. copd has become the third leading cause of death worldwide. more than 70% of patients with copd are in gold stage 1 (mild) or 2 (moderate), with very mild or no apparent respiratory symptoms such as dyspnea. the tiotropium in early chronic obstructive pulmonary disease patients in china (tie-copd) trial was designed to investigate the effect of tiotropium on the fev1 in copd patients with gold stage 1 or 2. the investigator's previous studies also suggested that traditional chinese medicine (tcm) has effect on gold stage 1 or 2 copd. this is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of bufei jianpi granule for delaying pulmonary function decline in early-stage (gold stage 1 or 2) copd subjects. after a 14-day run-in period, 612 subjects will be randomly assigned to treatment group or control group for 104-week treatment. the primary outcomes include pulmonary function and frequency of acute exacerbation. the secondary outcomes include clinical symptoms, dyspnea, exercise capacity, quality of life and treatment satisfaction. safety will also be assessed.

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of early-stage (gold stage 1 or 2) copd. * syndrome differentiation meets criteria of qi deficiency of the lung syndrome, qi deficiency of the lung and spleen syndrome or qi deficiency of the lung and kidney syndrome. * age ranges from 40 years to 80 years. * with informed consent signed. exclusion criteria: * pregnant and lactating women. * patients with severe cardiovascular and cerebrovascular diseases. * patients with severe liver and kidney diseases. * patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases. * patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years. * patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases. * patients with severe cognitive and psychiatric disorders. * patients with diabetes. * people who are allergic to the treatment drugs. * patients who have participated in other clinical studies in the past 4 weeks. * patients who have experienced one or more acute exacerbation in the past 4 weeks.

Keywords: chronic obstructive pulmonary disease bufei jianpi granule randomized controlled trial