Kornimate/medical-research-clean huggingface dataset:
nefopam/paracetamol fixed dose combination in acute pain after impacted third molar extraction

Conditions: Acute Pain

Summary: this study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.


Eligibility criteria:
main inclusion criteria: * male and female patient aged from 18 years up to 65 years, * patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, * patient weighing \> 50 kg, * patient who has signed a written informed consent prior to any study-related procedures. additional inclusion criteria after surgery (randomization): 1. patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity visual analogic scale (vas) score ≥ 50 mm, 2. third molar extraction(s) completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth) main exclusion criteria: * patient treated by analgesics or nonsteroidal anti-inflammatory drugs (nsaids) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest, * woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception, * patient with a history of convulsive disorders, * patient taking mono-amine-oxidase (mao) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine...), * patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm, * patient with known anaemia, * patient with known pulmonary disease, * patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding, * patient with known glaucoma, * patients with a prostatic hyperplasia or urinary retention, * patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities, * patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 ml/min),

Keywords: moderate to severe acute pain postoperative pain third molar extraction analgesics nefopam paracetamol multimodal analgesia fixed drug combination
sequencing of 14 genes from leptin melanocortin pathway in severe obesity in childhood.

Conditions: Obesity, Child

Summary: about 380 million children and adolescents suffer from overweight and obesity at the global level. obesity results from the interplay between biological (sex, age, fetal programming, gut microbiota, epigenetics, and genetics) and environmental factors (e.g., unhealthy diet, physical inactivity, stress). mutations in genes from leptin melanocortin pathway are involved in "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. exact frequencies of mutation in these genes are not precisely evaluated in french children with severe obesity. moreover new treatment, such seltmelanotide are avalaible in case of certain mutation, leading to a significative weight loss in treated patients.

obesity is a global health concern that affected more than 650 million adult people and more than 380 million children and adolescents worldwide, with no signs of slowing down despite major investments in health policy. obestiy is a multifactorial disease, but 40 to 75% of body mass index (bmi) variation is explained by genetic factors. mutations in genes from leptin melanocortin pathway lead to "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. this pathway plays a central role in regulating mammalian food intake, energy expenditure and body weight regulation. somes genes are well characterized such lep gene, lepr gene, or mc4r but others have been recently described as adcy3, sim1, sh2b1, ntrk2, bdnf, ksr2. the frequency of these mutations are not precisely estimated in a group of french children with severe obesity. moreover, a precocious identification of these mutations, could afford, in certain case the possibility of a efficient treatment with setmelanotide, leading to a significant weight loss in treated patients.

Eligibility criteria:
inclusion criteria: * severe obesity with bmi \> 3sds exclusion criteria: * genetic obesity (prader willi syndrome, bardet biedl syndrome, x fragile syndrome, alstrom syndrome) * bmi \< 3 sds * age \< 6 months * monogenic non syndromic obesity, with mutation in genes of leptin melanocortin pathway previously diagnosed * cushing syndrome
ezetimibe plus simvastatin versus simvastatin in untreated subjects with high cholesterol (p03435)

Conditions: Hypercholesterolaemia; Atherosclerosis

Summary: this study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing ldl-c concentrations when administered for 6 weeks.


Eligibility criteria:
inclusion criteria: * \>=18 years and \<= 75 years of age * ldl-c concentration \>= 3.3 mmol/l (130 mg/dl) to \<= 4.9 mmol/l (190 mg/dl) at baseline. * triglyceride concentration \<3.99 mmol/l (350 mg/dl) at baseline. * documented coronary heart disease (chd), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of mi; history of pci (primarily ptca with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-q wave mi. * stable weight history for at least 4 weeks prior to entry into study at baseline. * female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized. exclusion criteria: * body mass index (bmi) \>=35 kg/m\^2 at baseline. * subjects whose liver transaminases (alt, ast) are \>1.5 times the upper limit of normal and with active liver diseases at baseline. * subjects with evidence of current myopathy (including subjects with ck\>1.5 times above the upper limit of normal) at baseline. * subjects with clinical laboratory tests (cbc, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline. * subjects with type ii diabetes mellitus who are poorly controlled (hba1c\>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline. * subjects with type i diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control. * subjects who have known hypersensitivity to hmg-coa reductase inhibitors. * female subjects who consume \>14 units and male subjects who consume \>21 units of alcohol per week. * female subjects who are pregnant or breast feeding. * subjects who have not observed the designated washout periods for any of the prohibited medications.
retrospective study of radio-induced toxicities in the treatment of lung cancer with tomotherapy

Conditions: Lung Cancer

Summary: lung cancers treated by tomotherapy represent between 60 and 100 patients per year at the chr of metz-thionville. some patients were observed to present acute toxicities during treatment such as dysphagia or esophagitis of ctcae grade \> 2. beyond well known therapeutic and comorbidities factors, the pathophysiology of these events is largely ruled by a constitutional factor - the enzymatic equipment allowing more or less good repair of the dna lesions induced by radiotherapy (rt). this equipment is characteristic of each individual, hence the term individual radiosensitivity (ir).the scientific literature is rather poor in data describing the frequency of these toxicities in patients receiving rt for lung cancer. the objective of this study is to describe the frequency of acute and late toxicities after normofractionated radiotherapy of 66 gy in 33 fractions in patients with small cell or non-small cell lung cancer, stage 2 or 3.


Eligibility criteria:
inclusion criteria: * stage ii-iii non-small cell or small cell lung cancer treated with normo-fractionated radiotherapy of 66gy in 33 fractions using tomotherapy exclusion criteria: * patient who refused to be included in the study.

Keywords: tomotherapy toxicity
automated edss score calculation by smartphone application

Conditions: MS CHRONIC PROGRESSIVE

Summary: the edss score is the reference tool for rating disability in patients with multiple sclerosis. it is used in both daily monitoring and clinical research studies. its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. this variability is the consequence of the complexity of the score rating and also of its subjective nature. the application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.


Eligibility criteria:
inclusion criteria: * patients with multiple sclerosis seen at the central nervous system day hospital as part of their follow-up and requiring neurological examination. * age ≥ 18 years * no opposition to the use of their data exclusion criteria: - neurological or general pathology, other than multiple sclerosis, that may interfere with edss score scoring
analysis of naïve patients with age-related macular degeneration of the neovascular type and treated with aflibercept (eylea®) in "treat-and-extend" at chu brugmann

Conditions: Age-related Macular Degeneration

Summary: age-related macular degeneration (amd) is a leading cause of blindness in people over 50. neovascular amd, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. one of the major molecular mediators is vascular endothelial growth factor (vegf). intra-vitreous (ivi) injection of an anti-vegf can slow the progression of neovascular amd and stabilize vision in the majority of cases. aflibercept (eylea®) is one of the anti-vegf molecules approved in belgium to treat neovascular amd. at the start of its use, aflibercept was first injected monthly and then according to the prn "reactive" protocol (pro renata). over time, a new treatment strategy has emerged: the "treat-and-extend" (t\&e). this is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. this begins with the loading dose, i.e. 3 injections given 4 weeks apart. thereafter, the interval is lengthened in increments of 1 or 2 weeks provided that the visual and anatomical results remain stable. in the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each ivi. the efficacy and safety of aflibercept, when used in a proactive t\&e regimen, was demonstrated in the randomized controlled trial, altair. however, data on t\&e used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period. the aim of this retrospective study carried out at the chu brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.


Eligibility criteria:
inclusion criteria: * patients\> 50 years old diagnosed with neovascular age related macular degeneration, * patients who have never received anti-vegf treatment, * patients who started intra-vitreous injections of aflibercept between 01 january 2014 and november 30, 2019, * treatment by "treat-and-extend" directly after the loading dose of aflibercept, * availability of the medical file reporting treatment with aflibercept. exclusion criteria: * participation in an interventional clinical study during treatment with aflibercept, * patients with ocular pathologies who required surgery during the first 24 months of treatment with aflibercept (eg advanced glaucoma or cataracts).
examining different modes of exercise for acute reduction in blood pressure

Conditions: Hypertension

Summary: the purpose of the study is to compared different modes of exercise for eliciting post-exercise hypotension. the study will randomize 10 healthy participants to 30 minutes of either aerobic exercise, isometric exercise, stretching, or rest (control). blood pressure and heart rate will be assessed before and for one hour post-exercise.

the purpose is to compare different modes of exercise (aerobic vs. isometric vs. static stretching) for reducing blood pressure post-exercise. : using a randomized crossover design, 5 male and 5 female (n=10) normotensive university students will participate in four different exercise sessions for 30 minutes: aerobic (cycle ergometer at 70% of vo2max), isometric (alternating wall-sit for 70% of max, and handgrip dynamometer at 30% of max for 2 minutes), stretching (targeting the larger muscle groups of the body), and control (rest). participants' blood pressure and heart rate will be measured before each exercise session and monitored for 60 minutes afterwards to analyze the post-exercise hypotensive response.

Eligibility criteria:
inclusion criteria: * able to safely perform exercise according to the get active questionnaire exclusion criteria: * taking blood pressure medications

Keywords: blood pressure exercise
evaluation of a new mr pulse sequence to quantify liver iron concentration

Conditions: Hemochromatosis

Summary: the purpose of this study is to determine if a new mr pulse sequence is accurate in determining how much iron is in the liver.

quantification of liver iron requires liver biopsy and histological assessment. new rapid mr techniques allow determination of liver relaxation times that can be altered with increasing iron deposition. the purpose of this study is to compare the results obtained with mri to liver biopsy and iron quantification in patients undergoing liver biopsy in the setting of hemochromatosis.

Eligibility criteria:
inclusion criteria: * undergoing liver biopsy for suspected or known hemochromatosis * undergoing liver biopsy for living-related liver donation evaluation exclusion criteria: * contraindication to mri

Keywords: hemochromatosis liver cirrhosis liver diseases
phase 1b safety, tolerability, and pk study to assess gs-5737 in subjects with cf

Conditions: Cystic Fibrosis

Summary: this study will determine the safety, tolerability, and pharmacokinetics of a single dose of gs-5737 administered with a 2.8% saline solution vehicle in adult subjects with cf.


Eligibility criteria:
inclusion criteria: * males or females, ≥ 18 years of age, at screening * diagnosis of cf as determined by the 1997 cf consensus conference criteria, with at least 1 of the following: documented sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis test or abnormal nasal transepithelial potential difference (npd) test or two well-characterized, disease-causing genetic mutations in the cf transmembrane conductance regulator (cftr) gene and 1 or more accompanying clinical features consistent with cf * fev1 ≥ 40% and ≤ 90% predicted * bmi ≥ 19 and ≤ 30 kg/m2 * clinically stable with no evidence of significant new or acute respiratory symptoms * chest radiograph without significant acute findings; or chest radiograph, ct, or mri obtained and interpreted within 90 days prior to enrollment, without acute findings and no significant intercurrent illness; chronic, stable findings are allowed * history of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year) and non-smokers of at least 60 days duration prior to screening * estimated creatinine clearance ≥ 80 ml/min at screening * negative drug tests; including alcohol * hepatitis b, c, \& hiv negative * surgically sterile or ≥ 12 months post-menopausal * non-pregnant females exclusion criteria: * experienced symptoms of recent acute upper or lower respiratory tract infection or acute pulmonary exacerbation requiring treatment within 2 weeks prior to screening * plasma potassium ≥ 5 meq/l * changes in chronic azithromycin use, bronchodilator (bd), dornase alfa, hs, physiotherapy technique or regimen, antibiotics or corticosteroid medications within 28 days prior to screening * history of sputum or throat swab culture yielding burkholderia species within 2 years of screening

Keywords: cf cystic fibrosis pk
atomoxetine phase 2 study in japanese adult patients with attention deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in japanese adult patients who meet diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for adhd


Eligibility criteria:
inclusion criteria: * at least 18 years of age * meet conners' adult adhd diagnostic interview for dsm-iv™ (caadid) diagnostic criteria for current adhd as well as meeting criteria for a historical diagnosis of adhd during childhood * have a clinical global impression-adhd-severity (cgi-adhd-s) score of 4 (moderate symptoms) or greater exclusion criteria: * patients who meet dsm-iv diagnostic criteria for current major depression and also patients who have total score of more than 12 on the hamilton depression rating scale-17 items (hamd-17) at visit 1 and visit 2. patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of visit 1. * patients who meet dsm-iv diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited. * patients who have any history of bipolar disorder (dsm-iv), any history of schizophrenia or any history of a psychotic disorder (dsm-iv) will be excluded from the study. * patients who have been diagnosed (dsm-iv) with a pervasive developmental disorder.
microbiome involvement with barrett's esophagus and progression to esophageal adenocarcinoma

Conditions: Barrett Esophagus; Esophageal Cancer

Summary: this study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (eac). the aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at university of queensland diamantina institute (uqdi). second, to generate a tissue microarray resource future tissue in-situ validation of microbes. and finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.

gastroesophageal reflux disease, gerd, can lead to a change of the esophagus lining to a protective cell type, termed barrett's esophagus (be). a diagnosis of be greatly increases the risk of developing esophageal adenocarcinoma (eac). the incidence of eac has been rapidly rising in the last 30 years, and the cancer has a high mortality rate. understanding the involvement of the esophageal microbiota could lead to prevention strategies to this increasing health concern. this study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (eac). the aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at university of queensland diamantina institute (uqdi). second, to generate a tissue microarray resource future tissue in-situ validation of microbes. and finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.

Eligibility criteria:
inclusion criteria: * male or females \>18 years of age with known or suspected gerd, barrett's esophagus and or esophageal adenocarcinoma or from patients who have a history of either condition. exclusion criteria: * none

Keywords: microbiome
ticagrelor vs clopidogrel in non-st elevation acute coronary syndrome patients undergoing pci with bivalirudin.

Conditions: Non-ST Elevation Acute Coronary Syndrome

Summary: the purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-st elevation of acute coronary syndrome (nste-acs) undergoing ad hoc percutaneous coronary intervention (pci) with bivalirudin.

multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during pci on a background therapy of aspirin in patients with nste-acs.

Eligibility criteria:
inclusion criteria: * hospitalised for chest pain and potential acute coronary syndrome. * onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: st segment changes on electrocardiogram (ecg) indicative of ischemia, or positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction. * females must be either surgically sterile or post-menopausal. * activated clotting time (act) \</= 300 at the time of study treatment exclusion criteria: * participation in another clinical study with an investigational product during the last 30 days. * current acute complication of percutaneous coronary intervention or coronary bypass surgery. * any contraindication to ticagrelor, clopidogrel or bivalirudin. * st elevation myocardial infraction within 24 hours of study entry. * any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily. * planned use of omeprazole or esomeprazole. * patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication. * patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed. * use of intravenous (iv) heparin less than 2 hours before procedure. * sustained uncontrolled high blood pressure

Keywords: percutaneous coronary intervention
elevated triglyceride levels and later type 2 diabetes

Conditions: Type 2 Diabetes

Summary: subjects with elevated serum triglycerides in the 4th tromso study in 1994/1995 were re-examined with an oral glucose tolerance test to see predictive value of triglycerides regarding development of type 2 diabetes


Eligibility criteria:
inclusion criteria: * participants in the 4 tromso study 1994 and with elevated serum triglyceride levels exclusion criteria: * type 2 diabetes

Keywords: vitamin d triglycerides type 2 diabetes