Kornimate/medical-research-clean huggingface dataset:
assessment of the efficacy of an intradiscal injection of corticoids in modic i discopathies.

Conditions: Low Back Pain; Lumbago; Modic I Discopathy

Summary: the treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. a correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. in this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a modic i discopathy.

this is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * signed informed consent * low back pain for more than 6 months associated with modic i discopathy (diagnosed by mri) exclusion criteria: * past history of lumbar surgery * patient under anticoagulant or antisludge treatment, or with coagulation troubles * patient with unbalanced diabetes mellitus (blood glucose \> 1.30 g/l) * patient with unstabilized high blood pressure (\> 160/95 mmhg) * patient with evolving infection * patient with iodine allergy or one of the hydrocortancyl® or lidocaine components * porphyria, hypersensitivity to local anaesthetic * patient with sphincter troubles showing a cauda equine syndrome * untreated psychotic state * pregnant women or of childbearing age without effective contraception means * impossible 6 months follow-up * participation to another trial * vulnerable persons protected by the law * persons under guardianship * persons unable to express their consent

Keywords: discopathy modic i corticoids local anaesthetic intradiscal injection
artificial intelligence and dysplasia detection in ulcerative colitis (cudisia study)

Conditions: Ulcerative Colitis; Dysplasia

Summary: prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (discoverytm) compared to virtual chromoendoscopy with iscan in the detection of colon dysplasia in patients with long-standing ulcerative colitis.


Eligibility criteria:
inclusion criteria: * ulcerative colitis confirmed by endoscopy and histology. * involvement 30% of the colonic surface (or any extent if concomitant with psc). * duration of the disease \>7 years (or any duration if concomitant with psc). exclusion criteria: * personal history of colorectal cancer or high-grade dysplasia. * previous colectomy (partial or complete). * coagulopathy that prevents biopsies or polypectomy. * colonoscopy performed in the previous 6 months. * pregnant or nursing women. * inadequate bowel preparation. * presence of endoscopic ulcerative colitis activity. * colonic stenosis and incomplete colonoscopy.

Keywords: virtual chromoendoscopy artificial intelligence iscan dysplasia
bolus vs. continuous iv lidocaine against post-extubation cough in post-thyroidectomy patients

Conditions: Cough

Summary: the goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. the main questions it aims to answer are: * cough incidence on both groups * which method is preferable to reduce post-extubation cough incidence


Eligibility criteria:
inclusion criteria: * asa class 1 and 2 * thyroidectomy patients in hasan sadikin bandung hospital exclusion criteria: * subjects' refusal * had history of drug allergy, specifically lidaocaine * had history of asthma or other lung diseases * active smoker * history of arrhythmia * bradycardia subjects (\<60 beats per minute) * pregnant people * perioperative upper respiratory tract infusion * routinely consume ace inhibitor / bronchodilators / steroid * renal dysfunction * liver dysfunction
safety and efficacy of insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ana/dcd/035.


Eligibility criteria:
inclusion criteria: * the subject must have completed the six month controlled treatment period in trial ana/dcd/035
effect of a high-protein diet and/or high-intensity training on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the objective of this study is to determine the combined effects of a high-protein diet and high-intensity training on metabolic syndrome risk factors in women aged 30-65.

high-protein diet interventions have been shown to be effective in reducing triglycerides and increasing high-density lipoprotein cholesterol concentrations. low-volume, high-intensity cycling exercise has shown to elicit positive effects on metabolic syndrome risk factors such as triglyceride concentrations. the objective of this study was to determine the combined effects of a high-protein, reduced carbohydrate diet and high-intensity interval training on metabolic syndrome risk factors in women. the second primary aim is to investigate the effect of the macronutrient content of the post-exercise meal consumed following an acute bout of interval training on postprandial metabolism.

Eligibility criteria:
inclusion criteria: * women aged 30-65 yrs of age, inclusive * waist circumference \> 88 cm. * weight stable (within 2 kg) for past 6 mo * sedentary/low-active (defined as \<300minutes/wk light or moderate activity, with no vigorous activity in last 6 months) * at risk for mets \[defined as having 2 of the following 4 factors: 1) hypertriglyceridemia defined as \> 150 mg/ml, 2) low hdl cholesterol defined \ 130/\>85 hg or taking medications or 4) hyperglycemia defined as fasting blood glucose \> 100 or glycated hemoglobin \> 6.5 or taking medications. * willing to be randomized to the four treatment groups exclusion criteria: * any chronic disease/condition that would not permit exercise or dietary restriction (including egg allergy or refusal to incorporate eggs into the diet) or alter interpretation of data. examples include, but are not limited to: 1. cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease; 2) severe orthopedic, musculoskeletal or neuromuscular impairments that would contradict exercise; 3) sensory impairments that interfere with following directions; 4) diagnosis of dementia; 5) history of malignancy during the past 5 yr; 6) medication use that impacts primary outcomes of interest (e.g. statins); 7) weight greater than 400 pounds due to dxa weight and size limitations; 8) uncontrolled blood pressure defined as \> 160/\>100 hg.

Keywords: cardiovascular disease diabetes mellitus
lung function and patient preference with qva149 vs. tiotropium in copd patients

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Summary: the study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with qva149 versus tiotropium on lung function. similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of copd (gold 2013) and a moderate to severe airflow limitation who are symptomatic (defined as cat score of at least 10) at screening despite being treated with tiotropium


Eligibility criteria:
inclusion criteria: * signed an informed consent form * stable copd according to current guidelines (gold 2013) * airflow limitation indicated by a post-bronchodilator fev1/fvc ratio of \<0.70 and a post-bronchodilator fev1 of ≥30% and \<80% of predicted normal values at visit 2. * current or ex-smokers who have a smoking history of at least 10 pack years * patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before visit 1 * symptomatic patients defined as patients with cat score ≥ 10 at visit 1 (screening). exclusion criteria: * pregnant or breast feeding mothers * patients with conditions contraindicated for treatment * patients with a history of clinically significant diseases * patients who have a clinically significant renal disease * patients with myocardial infarctions less than 6 months prior to study entry * patients with recent (less than 1 year) history of nyha class iii/iv left ventricular failure. * patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention * patients with a history of malignancy of any organ system * patients who have had a copd exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with any history of asthma.
rapid detection of covid-19 by portable and connected biosensor : biological proof of concept

Conditions: SARS-CoV Infection; Covid19

Summary: the main objective of this cordial-s proof-of-concept study is to evaluate the ability to detect covid-19 infection in nasopharyngeal swabs with cordial-s and compare it to the pcr technique currently in use. saliva analysis will be the subject of secondary analysis. the cordial-s medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary. the benefits would be 1. greater sensitivity 2. a great speed because 8tests could be performed at the same time with a result in a few minutes 3. a very high specificity at least equivalent to pcr. this new diagnostic strategy could become extremely valuable in the fight against covid-19, especially in the case of very long-term persistence and incomplete vaccination of the french and foreign population.


Eligibility criteria:
inclusion criteria: * male or female or child without age limit * admitted to a reference health establishment (rhs) in an emergency unit, hospitalization or intensive care unit for suspicion of sars-cov-2 infection regardless of clinical presentation and degree of severity. * patient to be diagnosed by pcr test on nasopharyngeal swab. * social insured exclusion criteria: * refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting) * pregnant and breastfeeding women * protected majors
is screening for esophageal pathology in asymptomatic patients post-treatment for head and neck cancer beneficial?

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the prevalence of esophageal pathology in asymptomatic patients with a history of head and neck cancer.

there are certain factors (i.e. alcohol, tobacco, decreased saliva production from radiation) that predispose patients with a history of head and neck cancer to have esophageal disease. often, in the initial stages of the disease, patients do not have symptoms. however, the early detection of precancerous lesions or small cancers improves patients' chances of being cured. there is no direct data supporting the practice of screening patients with a history of head and neck cancer after treatment for esophageal disease if they are not experiencing symptoms. however, many argue that screening endoscopy is justified in high risk patients to detect early esophageal cancer or dysplasia at a curable state. we are, therefore, performing this study to determine the value of endoscopic screening of the esophagus after treatment for head and neck cancer in patients without symptoms.

Eligibility criteria:
inclusion criteria: * head and neck cancer patients that are six months post treatment and asymptomatic for esophageal disease. exclusion criteria: * none if meets the inclusion criteria.

Keywords: esophageal cancer, head and neck cancer, dysplasia
a comparison study to evaluate the pharmacokinetics and safety of nk-104-cr in healthy adult volunteers

Conditions: Hyperlipidemia

Summary: the purpose of this study is to compare the pharmacokinetics and safety of a controlled release (cr) version of pitavastatin (also referred to as nk-104) to immediate release (ir) pitavastatin in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * subject provides written informed consent before any study-specific evaluation is performed. * subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive. * subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the investigator. * subject is able and willing to comply with the protocol and study procedures. exclusion criteria: * subject is a woman who is pregnant or breastfeeding. * subject has clinically relevant abnormalities in the screening or check-in assessments. * subject has received an investigational drug within 30 days before the first dose of study drug.
telerehabilitation in individuals over 65 years of age having social isolation due to coronavirus (covid-19)

Conditions: Telerehabilitation

Summary: in december 2019, new coronavirus pneumonia (covid-19) erupted in wuhan (hubei, china) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. covid-19 causes a large number of deaths due to its occurrence in many cases. this virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. all the countries of the world take some precautions to prevent the spread of this epidemic disease, which who declared it as "pandemic". staying home and social isolation are at the top of these precautions. for this purpose, in turkey on march 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. however, not leaving the house and social isolation brings with it the limitation of physical activity. physical activity (pa) is defined by who as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. recommended pa levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). at the global level, approximately 45% of people over the age of 60 do not meet the recommended level of pa. studies investigating the relationship between social isolation and health behavior report consistent findings. individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. the effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. the decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. when today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. the purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the covid-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. it is aimed to use an innovative model based on the digitally supported, home-based exercise program.


Eligibility criteria:
inclusion criteria: * being 65 years old and over * being in social isolation due to the coronavirus epidemic. * spending at least 1 week at home different from routine life. * not to be obstructed from doing physical activities. * to have access to online exercise training. exclusion criteria: * having a serious cognitive impairment * having serious hearing and vision problems * having vestibular disorders that can cause loss of balance * having diabetes, hypertension or a neurological disease

Keywords: covid-19 exercises social isolation
safety and immunogenicity study of the hepatitis b vaccine, heplisav™, compared to engerix-b® vaccine

Conditions: Healthy

Summary: the purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis b vaccine (heplisav) in adults 18 to 70 years of age.


Eligibility criteria:
a subject must meet all of the following criteria to be eligible for the trial: inclusion criteria: * be 18-70 years of age, inclusive * able to comprehend and follow all required study procedures and be available for all visits scheduled in the study * if a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the screening visit through week 28. * able and willing to provide informed consent a subject with any one of the following criteria is not eligible for the trial: exclusion criteria: * previous receipt of any hepatitis b vaccine * history of hepatitis b or human immunodeficiency virus (hiv) infection or positive test for hbsag, anti-hbs, antibody to hepatitis b core antigen (anti-hbc), or antibody to hiv * history of autoimmune disorder * history of sensitivity to any component of study vaccines * has received the following prior to the first injection: 1. within 28 days: * any vaccine * systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication * granulocyte colony-stimulating factor (g-csf) or granulocyte-macrophage colony-stimulating factor (gm-csf) * any other investigational medicinal agent 2. within 90 days: blood products or immunoglobulin 3. at any time: an injection of dna plasmids or oligonucleotide * if female: pregnant, nursing, or planning to become pregnant during the trial * is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin * any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments

Keywords: hbv vaccine heplisav-b hepatitis b vaccine hepatitis b hepatitis hepatitis b virus (hbv) prevention and control healthy healthy volunteers
study to evaluate aro-apoc3 in adults with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: the purpose of aroapoc3-2001 is to evaluate the efficacy and safety of aro-apoc3 in participants with severe hypertriglyceridemia. participants will receive 2 subcutaneous injections of aro-apoc3.


Eligibility criteria:
inclusion criteria: * based on medical history, evidence of tg ≥ 500 mg/dl and ≤ 4000 mg/dl at screening * fasting tg ≥ 500 mg/dl at screening * willing to follow diet counseling per investigator judgment based on local standard of care * women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements exclusion criteria: * active pancreatitis within 12 weeks prior to first dose * any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study * acute coronary syndrome event within 24 weeks of first dose * major surgery within 12 weeks of first dose * planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study * uncontrolled hypertension * human immunodeficiency virus (hiv) infection, seropositive for hepatitis b (hbv), seropositive for hepatitis c (hcv) * uncontrolled hypothyroidism or hyperthyroidism * hemorrhagic stroke within 24 weeks of first dose * malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) note: additional inclusion/exclusion criteria may apply per protocol
genetic predisposition in cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is a major neurodevelopmental disorder with an estimated prevalence of approximately one in 500 children. it is characterised by permanent developmental disorders of movement and posture, responsible for activity limitations, caused by non-progressive damage to the brain of the fetus, newborn or infant during development. the neurobiological mechanisms involved in cp remain poorly understood, although the interruption of cerebral oxygen supply during pregnancy or at the time of delivery is classically considered to be the main factor causing neurodevelopmental sequelae. cp also occurs in full-term infants without a clearly identifiable etiology. data from the literature suggest the existence of other pathophysiological processes than only acquired brain lesions related to pregnancy and delivery, such as genetic or epigenetic factors. according to some research teams, nearly one third of cp could have a genetic cause or could be favoured by genetic variants. preliminary research has made significant progress in revealing unusual copy number variants and/or mutations in single genes in children with cp. several of the identified genes are involved in neurodevelopment and neuronal connectivity. nevertheless, the identification of these abnormalities in cp may contribute to a better understanding of the pathophysiology of this complex and multifactorial disorder. it could also shed new light on the analysis of medico-legal files and bring encouraging perspectives by targeting new therapeutic interventions. the main hypothesis is that a certain number of cerebral palsies are related to - or favoured by - genetic abnormalities that we will search for with genetic screening tests.


Eligibility criteria:
inclusion criteria: * child between 2 and 15 years old with a clinical diagnostic of cerebral paralysis with unilateral or bilateral somatic involvement * child born from 34 sa * agreement of the legal representatives for the genetic study * both parents available for a parental genetic study (if detection of class 3 variant) * affiliation to the social security system exclusion criteria: * genetic syndrome identified or malformative or infectious etiologies identified * neonatal encephalopathy criteria in a clear obstetrical etiological context responsible for major perinatal anoxia with sarnat 2 or 3 * unilateral motor disorders in perinatal stroke of identified etiology (coagulation anomaly)

Keywords: cerebral palsy genetic predisposition neurodevelopmental disorder