Kornimate/medical-research-clean huggingface dataset:
evaluation of sodium fluoride pet in the identification of bone metastases in patients having undergone a choline pet for occult recurrence of prostatic adenocarcinoma

Conditions: Bone Metastasis

Summary: the purpose is to evaluate if sodium fluoride pet in patients having already undergone a choline pet negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases. secondary purposes are: * to evaluate if detection of bone metastasis by sodium fluoride pet, not detected by choline pet, leads to change of treatment * to evaluate inter-technique concordance (choline vs sodium fluoride pet) of results (metastatic status and number of lesions) * to evaluate the inter-judge concordance of interpretation of sodium fluoride pet * to study the discordance of metastatic status of 2 techniques.


Eligibility criteria:
inclusion criteria: * prostate adenocarcinoma regardless of gleason score * patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy) * level of prostate specific antigen (psa) indicating recurrence: psa \> 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of psa of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month) * negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion * patient having undergone a choline pet at chru nancy * signed informed consent * affiliation to french social security * absence of contraindications to sodium fluoride pet exclusion criteria: * refusal or impossibility of informed consent * patient incapable to consent * patient deprived of liberty * person under legal protection * person in life-and-death emergency * drug addiction, alcoholism, psychological problems affecting patient compliance * severe co-morbidities * modification of hormonal therapy (if applicable) during 3 months before inclusion * renal insufficiency (creatinine clearance \< 60 ml/min) detected during last assessment before inclusion * other progressive tumors (recovered cancers are not a non-inclusion criteria)

Keywords: choline positron emission tomography occult recurrence prostatic adenocarcinoma sodium fluoride positron emission tomography
comparing two doses of midazolam with added dexmedetomidine for kids before surgery

Conditions: Preoperative Anxiety Experienced by the Pediatric Patient; Preoperative Anxiety

Summary: the goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. the main questions it aims to answer are: does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? how do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. participants will: receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. undergo sedation scoring at 15 and 30 minutes after drug administration. be assessed for ease of separation from parents and acceptance of anesthesia mask. be monitored for vital signs, recovery times, and any perioperative adverse events.


Eligibility criteria:
inclusion criteria: * pediatric patients aged 1 to 8 years * scheduled for elective surgery under general anesthesia * surgery duration \< 1 hour * asa physical status i or ii * parent or legal guardian able to provide informed consent exclusion criteria: * refusal to participate by parent/guardian * nasal infections, pathology, or epistaxis * runny nose or upper respiratory tract infection * enlarged adenoids * bmi \> 30 * known allergy to dexmedetomidine or midazolam * fever on day of surgery * coagulopathy * scheduled for cardiothoracic or neurosurgical procedures * congenital heart disease * neurological or mental disorders * pre-existing sedation (moass \< 5) on the day of surgery

Keywords: &#34;pediatric premedication&#34; &#34;dexmedetomidine&#34; &#34;midazolam&#34; &#34;sedation&#34; &#34;mask acceptance&#34;
proton pump inhibitors (ppi) and fat absorption in cystic fibrosis (cf) and exocrine pancreatic insufficiency (epi)

Conditions: Pancreatic Insufficiency; Cystic Fibrosis

Summary: this is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over and receive omeprazole or placebo for another 28 days. markers of fat absorption will be measured after each treatment course.

fat malabsorption contributes to poor nutritional status in people with cystic fibrosis (cf) and exocrine pancreatic insufficiency (epi). prescribing gastric acid-reducing agents such as proton pump inhibitors (ppis) and histamine receptor antagonists (h2ras) as an adjunct to pancreatic enzyme replacement therapy (pert) to improve pert efficacy and dietary fat absorption has become accepted clinical practice in cf, despite limited evidence to support the practice. establishing the efficacy and true health benefit of acid suppression for nutritional status and outcomes in cf is particularly important in light of potential health risks and cost associated with long-term or even lifetime use of these medications. this study aims to characterize changes in fat malabsorption using the coefficient of fat absorption (cfa) as the primary endpoint in subjects who are on and off acid suppression with a ppi in addition to pert. additionally, the smartpill® will be used to evaluate duodenal power of hydrogen (ph) while on and off acid suppression, and the malabsorption blood test (mbt) will be used to characterize changes in fat absorption. associations will be explored between changes in nutritional status (weight, height, bmi), clinical gi symptoms, and quality of life in subjects treated with ppi vs. placebo.

Eligibility criteria:
inclusion criteria: * cystic fibrosis and pancreatic insufficiency (fecal elastase \<200 ug/g stool) * age ≥12 years * in usual state of good health * willing to participate in a four-month study with three visits exclusion criteria: * forced expiratory vital capacity at one second (fev1) \<40% predicted * pregnancy or breast feeding * other illness affecting growth or nutritional status * unwillingness to continue their clinically established pert dose for the duration of the study * use of other medication that affects dietary fat absorption * allergy to soy products * allergy to safflower products * for subjects ≥18 years, celiac disease or allergy to gluten

Keywords: fat absorption pancreatic enzyme
pilot dispensing evaluation of a plus power lens

Conditions: Hyperopia

Summary: the purpose of this study is to compare the performance of the acuvue® advance® plus lenses against acuvue® advance® lenses in the plus power parameters.


Eligibility criteria:
inclusion criteria: * the subject must be at least 18 years of age and no more than 45 years of age. * the subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study). * the subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00d. * any cylinder power must be ≤ 0.75d. * the subject must have visual acuity best correctable to 20/25+3 or better for each eye. * the subject must read and sign the statement of informed consent. * the subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. exclusion criteria: * ocular or systemic allergies or disease which might interfere with contact lens wear. * systemic disease or use of medication which might interfere with contact lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * pregnancy or lactation. * diabetes. * infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). * habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear. * need any near correction.
vitamin d supplementation to patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to evaluate if supplementation with vitamin d in a dose of 40.000 iu per week will result in improved metabolic control in patients with type 2 diabetes.

the purpose of the study is to evaluate if supplementation with vitamin d in a dose of 40.000 iu per week will result in improved metabolic control in patients with type 2 diabetes. we will include 70 patients with type 2 diabetes. they will be treated with 40.000 iu cholecalciferol per week (or placebo) for 6 months. metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. only subjects using insulin at bedtime combined with metformin during the day will be included.

Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 1 year * age 21-75 years * long-acting insulin at bedtime * metformin during the day * for women of child bearing age use of reliable method of birth control exclusion criteria: * serum creatinine above 130 umol/l for men and above 110 for women * systolic blood pressure \> 175 or diastolic \> 104 mmhg * heart disease * serum calcium \> 2.54 mmol/l * history of renal stones

Keywords: diabetes insulin glycated hemoglobin cholecalciferol vitamin d
study to gather information about the actual use of an adhesive patch placed on the skin to deliver oxytrol through the skin into the bloodstream.

Conditions: Overactive Bladder

Summary: with this study researchers want to gather information about the consumer use behavior of oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. an area of focus was on the potential benefits of an over-the-counter status for oxytrol and on the ongoing use behavior of the consumers. oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. the adhesive patch is placed on the skin to deliver oxytrol through the skin into the bloodstream.


Eligibility criteria:
inclusion criteria: * female * 18 years of age or older * not pregnant or suspected to be pregnant * never trained or employed as a healthcare professional * neither the subject nor anyone in their household worked for a pharmaceutical company, a pharmacy, a managed care or health insurance company, a healthcare practice, or as a healthcare professional * had not participated in any market research study, product label study or clinical trial in the past 12 months exclusion criteria: * symptoms of blood in the urine not related to menses * back pain and fever in conjunction with frequency or urgency and any of the following: dysuria, hematuria, or cloudy urine * narrow-angle glaucoma * pregnant (as determined by a urine pregnancy test among women of child bearing potential) * breastfeeding * known allergy to oxybutynin
taxus arrive: taxus peri-approval registry: a multi-center safety surveillance program

Conditions: Coronary Artery Disease

Summary: the taxus arrive study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the taxus™ express2™ paclitaxel-eluting coronary stent system in routine clinical practice and to identify low frequency taxus related clinical events.


Eligibility criteria:
appropriate patient criteria: * patient is eligible to receive a boston scientific taxus stent. inappropriate patients criteria: * known sensitivity to paclitaxel. * known allergy to stainless steel. * patients in whom antiplatelet and / or anticoagulant therapy is contraindicated. * patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. * patients with unresolved vessel thrombus at the lesion site. * patients with coronary artery reference vessel diameters \ 3.75 mm. * patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation. * patients with diffuse disease or poor overflow distal to the identified lesions. * patients with tortuous vessels in the region of the obstruction or proximal to the lesion. * patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
erlotinib treatment beyond progression in egfr mutant nsclc

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for nsclc patients who have egfr mutant disease or who have responded to egfr tki.

a phase ii randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have egfr mutant or egfr tki responsive nsclc and have progressed on egfr tki.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage iiib/iv nsclc. * investigator confirmed progression according recist 1.1 during egfr tki treatment within 28 days of the randomization * activating mutation (g719a/c/s; exon 19 insertion/deletion; l858r; l861q) in the egfr gene or have had at least partial response with egfr tki lasting ≥ 6 months * performance status: who 0-2 * measurable disease according to recist 1.1 * patients must be able to comply with study treatments * women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study * neutrophils ≥ 1'000/μl, platelets ≥ 100'000/μl, alanine amino transferase ≤ 2.5 × upper limit of normal (uln) (\< 5 × uln if liver metastases), alkaline phosphatase ≤ 2.5 × uln (\< 5 × uln if liver metastases), serum bilirubin ≤ 1.5 × uln, serum creatinine ≤ 1.5 × uln. * patient must be able to comply with the protocol exclusion criteria: * recist 1.1 defined disease progression for more than 28 days while on previous egfr tki treatment. * patient has been treated with any investigational agent for any indication within 4 weeks of study treatment. * patient has history of hypersensitivity or intolerance to erlotinib or gefitinib. * patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study. * patient with symptomatic central nervous system metastases * patient has known active hepatitis b or c, or hiv infection * pregnant or breastfeeding. * patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

Keywords: non-small cell lung cancer egfr mutant erlotinib treatment beyond progression
clinical study to compare dental plaque control

Conditions: Dental Plaque

Summary: this clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Eligibility criteria:
inclusion criteria: * male or female volunteers at least 18 - 53 years of age * good general health * must sign informed consent form * minimum of 20 natural uncrowned teeth (excluding third molars) must be present. * no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. exclusion criteria: * subjects unable or unwilling to sign the informed consent form. * medical condition which requires pre-medication prior to dental visits/procedures * moderate or advanced periodontal disease or heavy dental tartar (calculus). * 2 or more decayed untreated dental sites at screening. * other disease of the hard or soft oral tissues. * impaired salivary function (e.g. sjogren's syndrome or head and neck irradiation). * use of medications that are currently affecting salivary function * use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * pregnant or nursing women. * participation in any other clinical study within 1 week prior to enrollment into this study. * use of tobacco products * subjects who must receive dental treatment during the study dates. * current use of antibiotics for any purpose. * presence of an orthodontic appliance which interferes with plaque scoring. * history of allergy to common dentifrice ingredients. * history of allergy to arginine (amino acid) * history of allergy to bicarbonate * immune compromised individuals (hiv, aids, immuno suppressive drug therapy)
carbon monoxide-induced coma: prognostic factors

Conditions: Coma; Carbon Monoxide Poisoning

Summary: the primary objective of the study is to determine prognostic factors for hospital-mortality following carbon monoxide (co)-induced coma. the secondary objective is to determine prognostic factors of co related cognitive sequelae, at the time of hospital discharge.

carbon monoxide is a leading cause of poison related lethality in france. moreover, survivors may develop severe neuro-cognitive sequelae. few studies sought to determine prognostic factors related to co induced coma. coma is defined as a glasgow coma score of \< 8. neurological sequels will be considered persistent when present at hospital discharge. this is a retrospective observational study. all comatose patients with glasgow coma score \< 8 due to carbon monoxide poisoning, treated by hyperbaric oxygen therapy in a tertiary hospital in the île de france area, will be included in the study. clinical, biological, iconographic and electrophysiological data collected from patient's medical files between january 2000 to december 2018 will be analysed retrospectively. statistics base-line characteristics will be summarized using tabulated statistics, namely median \[interquartile range, iqr\] or percentages (\*"statistics") unless specified. exact fisher tests will be used to compare distribution of binary outcomes, while nonparametric wilcoxon rank sum tests will be used for comparison of continuous variables. logistic regression models will be used to measure the strength of association of the variables with the outcomes, by odds ratio (or), either unadjusted or adjusted in multivariable models. multivariate imputation by chained equations (mice) will be used as the method of dealing with missing data in covariates. it operates under the assumption that given the variables used in the imputation procedure, the missing data are missing at random (mar), which means that the probability that a value is missing depends only on observed values and not on unobserved values. a total of m = 30 imputed datasets will be generated, with rubin's rules applied thereafter to provide mean estimates of the ors. the package mice implemented the mice procedure within r. all tests are 2-sided with p-values of 0.05 or less denoting statistical significance. statistical analysis will be performed on r 3.5.1

Eligibility criteria:
inclusion criteria: * all comatose patients (glasgow coma score \<8) due to carbon monoxide poisoning, treated by hyperbaric oxygen therapy in a tertiary hospital in île de france area; * aged ≥ 18 years; * hospitalized in hyperbaric medicine unity of raymond poincaré hospital in garches. exclusion criteria: * pregnant woman; * patient present clinical signes of stroke and without co detection. in case of unusable data, patient will be excluded from study.

Keywords: carbon monoxide poisoning oxygen coma hyperbaric oxygen
adherence of a 1.600 mg single tablet 5-asa treatment of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: several oral mesalazine (5-asa) formulations exist, but the regimes require several tablets per day. such regimens are not ideal and can interfere with normal daily activities of patients. non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. recently, a new formula for 5-asa has been approved by the danish medicine agency, with a single tablet regime per day. primary purpose: • to investigate whether a simplified treatment regimen for 5- asa (1600 mg as one tablet per day \[intervention\]) improves adherence with preserved remission rates compared to conventional therapy. secondary purposes: * compare levels of endoscopic, mucosal and histological inflammation in predicting risk of relapse between the intervention group and the conventional therapy group. * investigate whether a simplified treatment regimen improves the disease course compared to the conventional therapy. * to assess the correlation between different endpoints and the disease courses, with the use of clinical, endoscopic, histological, self-reported and biochemical markers. * improve, correlate and assess patient-reported outcomes in a prospective manner. * to establish a biobank of cases with quiescent/mild ulcerative colitis (uc) for identification of future biomarkers.


Eligibility criteria:
inclusion criteria: * signed informed consent * age between and including 18 and 60 * diagnosed with uc according to the copenhagen diagnostic criteria * length of disease of max. 10 years * stable remission on 5-asa (defined as partial mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion. * endoscopic remission defined as mayo clinic endoscopic score \< 2 * have had a relapse within the last 2 years * defined as the need of escalation of treatment or change medical treatment. exclusion criteria: * evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or clostridium difficile toxin in stool culture) within the last month * on immunomodulators, including methotrexate * on any biological therapy * any previous abdominal surgery related to uc * any chronic infections (e.g. hbv, hcv, hiv) * any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results * well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators. * participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial. * any previous documented allergic reaction to tested the medical drugs