Kornimate/medical-research-clean huggingface dataset:
detection and volumetry of pulmonary nodules on ultra-low dose chest ct scan with deeplearning image reconstruction algorithm (dlir)

Conditions: Pulmonary Nodules, Multiple

Summary: evaluate the diagnostic performance of ultra-low dose ct using deep learning-based reconstruction in the detection of pulmonary nodules.

* background: lung cancer is the leading cause of cancer deaths. patients with pulmonary nodules often undergo multiple computed tomography (ct) examinations for diagnostic and follow-up purposes. * purpose: the main objective of this study is to evaluate the diagnostic performance of ultra-low dose ct using deep learning-based reconstruction in the detection of pulmonary nodules. * abstract: despite recent advances, lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer death worldwide because it is often diagnosed at advanced stages that are not surgically curable. nevertheless, early detection of lung cancer allows surgical resection, offers curative treatment and the best chance of survival. there is currently no screening program in france, but individual screening can be carried out depending on risk factors. many pulmonary nodules are discovered each year, most of which are benign. the challenge is to distinguish malignant lesions from the multitude of benign lesions. one of the most effective criteria is the doubling time of the nodules which leads to multiple follow-up examinations requiring ionizing radiation to assess the size and growth of the nodules. great efforts are currently being made by ct manufacturers in order to reduce the radiation with equivalent diagnostic performance. patients who were referred to our department for an unenhanced low-dose chest ct (ld ct) for pulmonary nodules check-up or follow-up, and had consented to participate in the study, will undergo an additional ultra-low dose acquisition (uldct, \<0,25 msv, similar to standard two-view chest x-ray) with deep learning-based reconstruction (dlir). the main objective of this study is to evaluate the diagnostic performance between uld and ld ct protocols for the detection of pulmonary nodules. the impact of dose reduction will be assessed in this context. the data from each examination will be blindly interpreted from the results of the other one. no follow-up will be required for the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * patient referred for non-enhanced chest ct for lung nodule check-up or follow-up, * affiliation to a social security program, * ability of the subject to understand and express opposition exclusion criteria: * age \<18 years old, * person under guardianship or curatorship, * pregnant woman, * any contraindications to ct

Keywords: lung nodules pulmonary nodules lung cancer radiation dose dose reduction low dose ct ultra-low dose ct dlir deep learning reconstruction
blood volume and hemodynamic analysis in patients with chronic heart failure

Conditions: Congestive Heart Failure

Summary: the primary hypothesis is that patients with hfref (heart failure with reduced ejection fraction) will demonstrate a markedly expanded intravascular volume which will correlate with elevated right heart hemodynamics and increased venous capacitance parameters, whereas patients with hfpef(heart failure with preserved ejection fraction) will demonstrate euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous compliance parameters.

the purpose of this study is to learn more about how the heart, blood vessels and blood volume interact in patients with heart failure and how measuring blood volume and vein capacity may help us develop better ways of treating and managing heart failure patients. this study will use two tests to measure blood volume and test the capacity of your veins and arteries in your limbs. the blood volume test (also called a plasma volume test or a red cell mass test) is a standard clinical nuclear lab procedure used to measure the volume (amount) of blood in the body. the test also measures the volume of plasma and of red cells in the blood. the other test is called a venous plethysmography, which is a non-invasive test to measure how well your veins and arteries in your forearm and calf work. venous plethysmography measures the changes in the dimensions of your limbs by the use of strain gauges placed on the skin.

Eligibility criteria:
inclusion criteria: * age \>18 years * patients identified with heart failure and diagnosed clinically to require right heart hemodynamic evaluation, new york heart association functional class ii-iv status/stage c-d heart failure * ischemic or nonischemic etiology heart failure * left ventricular ejection fraction measured within 6 months of study enrollment exclusion criteria: * known significant intrinsic chronic kidney disease (baseline glomerular filtration rate \<15 ml/min/1.73m²) or patients receiving hemodialysis * known renal artery stenotic disease * females who are pregnant * allergy to iodine contrast, intravenous pyelogram dye, shellfish or eggs.

Keywords: heart failure heart failure reduced ejection fraction heart failure preserved ejection fraction venous plethysmography blood volume study
assessment of growth of infants fed a new formula

Conditions: Infant Nutrition

Summary: the purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.


Eligibility criteria:
inclusion criteria: * healthy newborn infant * full-term (\>37 weeks gestation) * birth weight between \> 2500 and \< 4500 g * infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment * tolerating a cows milk based formula for at least 3 days * study explained and written information provided with parent/caregiver demonstrating understanding of the given information * informed consent signed (parent/legal representative) * parent/caregiver has a working freezer * lives within 45 minutes of a study site exclusion criteria: * congenital illness or malformation that may affect infant feeding and/or normal growth * suspected or known allergy to cow's milk protein * significant pre-natal and/or post-natal disease * any readmission to hospital (except for hyperbilirubinemia) prior to enrollment * infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment * infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements * infant currently participating in another clinical study * infant's family who in the investigator's assessment cannot be expected to comply with the protocol

Keywords: infant formula growth weight
powered vs. manual toothbrushing in stage 3-4 periodontitis

Conditions: Periodontitis; Dental Plaque; Gingival Bleeding

Summary: this study compares the effectiveness of powered and manual toothbrushes in reducing gum bleeding and dental plaque in people with stage 3 or 4 periodontitis. all participants are trained to brush for at least two minutes twice a day. the goal is to find out whether using a powered toothbrush leads to better oral hygiene results than a manual one, when brushing time is standardized. the study will measure bleeding and plaque levels at the beginning and over a 6-month period.

this single-blind, randomized controlled trial evaluates the clinical effectiveness of powered versus manual toothbrushing in patients newly diagnosed with stage 3 or 4 periodontitis. participants are randomly assigned to one of two groups: powered toothbrush (oral-b io6) or manual toothbrush (tepe select soft). all participants receive standardized oral hygiene instructions and are instructed to brush twice daily for a minimum of two minutes. manual brush users are required to use a smartphone app to monitor and record brushing duration. the use of adjunctive oral hygiene aids, such as mouthwash or interdental cleaners, is restricted throughout the study period. the primary clinical outcomes are full-mouth bleeding score (fmbs) and full-mouth plaque score (fmps), measured at baseline and at follow-ups of 7 days, 1 month, 3 months, and 6 months.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 75 years * diagnosis of stage 3 or 4 periodontitis based on clinical and radiographic examination * retaining at least 16 natural teeth * ability to follow oral hygiene instructions and compliance with the study protocol * willingness to refrain from using additional oral hygiene products (e.g., mouthwash, interdental cleaners) during the study * ability to provide informed consent exclusion criteria: * presence of systemic conditions that may affect oral health (e.g., uncontrolled diabetes, immunocompromised states) * pregnancy or breastfeeding * ongoing use of antibiotics or other medications that could interfere with gum health * severe dental conditions (e.g., tooth mobility \> 2, advanced root resorption) * prior use of a powered toothbrush within the last 6 months * participation in another clinical trial that could interfere with study outcomes * inability or unwillingness to comply with study requirements or provide informed consent

Keywords: periodontitis full-mouth plaque score full-mouth bleeding score home oral hygiene
in vivo confocal microscopic analysis of corneal nerve changes after prokera slim® for dry eye

Conditions: Dry Eye Disease

Summary: prospective controlled pilot study to compare the outcome of prokera® (pk) and conventional treatment in patients with moderate to severe dry eye disease (ded)


Eligibility criteria:
inclusion criteria: * subjects with moderate to severe ded (grade 2-4 dews) * age range: 21 years and older. * both genders and all ethnic groups comparable with the local community. * subjects able to understand and willing to sign a written informed consent. * subjects able and willing to cooperate with investigational plan. * subjects able and willing to complete postoperative follow-up. exclusion criteria: * symblepharon or lid abnormality preventing prokera placement. * ocular infection within 14 days prior to study entry. * active ocular allergies. * previous ocular surgery or injury within 3 months before enrollment. * previous brain surgery, or trigeminal nerve damage. * other conditions that may affect corneal nerves such as diabetes, thyroid disorders. * contact lens wearers. * pregnancy or subject expecting to be pregnant. * inability or unwillingness of subject to give written informed consent. * subjects with known intolerance to pk. * subjects use concomitant therapy that affects tear functions or ocular surface integrity. * subjects currently engaged in another clinical trial.
systemic management in extremely preterm and extremely low birth weight infants

Conditions: Bronchopulmonary Dysplasia; Death

Summary: to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in northern china

to estimate incidences and risk factors of bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in northern china

Eligibility criteria:
inclusion criteria: 1. born between january 1, 2015, and december 31, 2018; 2. a birth weight \<1000grams or a gestational age \<28 weeks; 3. admitted within 72 hours after birth. exclusion criteria: no medical history in the electronic record
natural history of infantile neuroaxonal dystrophy

Conditions: Infantile Neuroaxonal Dystrophy; INAD

Summary: this is a retrospective and cross-sectional review of the natural history of inad.

after obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. if needed, a telephone or video conference will be scheduled with the patient's family to confirm and clarify information in the medical record. deceased patients may be eligible for inclusion the retrospective registry if medical records are sufficient and indicate eligibility. data will be pooled and presented in aggregate, without identification of individual subjects.

Eligibility criteria:
inclusion criteria: * male or female 18 months to 10 years of age * medical history consistent with the symptoms of classic inad (onset of symptoms between the ages of 6 months and 3 years) * homozygous for pla2g6 deficiency (variant alleles may be mixed heterozygotes) * signed informed consent form (icf) prior to entry into the registry exclusion criteria: * diagnosis of atypical nad (anad) * unwilling or unable to allow medical record review

Keywords: infantile neuroaxonal dystrophy inad pla2g6
observational cohort of pancreatic echo-endoscopy

Conditions: Metabolic Syndrome; Obesity; Hepatic Steatosis

Summary: metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter\> 94 cm in men, 80 cm in women, high triglycerides, low hdl cholesterol, hta and hyperglycemia. the metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). what is the impact of this syndrome on pancreatic echogenicity?

little is known about the pathogenesis of the fatty pancreas. fat can replace acinar cells and / or pancreatic endocrine cells (1). to date, there are no biomarkers allowing the detection of a fatty pancreas. it appears that older age, male, obesity, alcohol consumption, high triglycerides, high alt, diabetes or insulin resistance, fatty liver and metabolic syndrome are risk factors for a fatty pancreas (2,3,4).to the investigator's knowledge, these different factors have not been evaluated on the impact of pancreatic echogenecity in endosonography. the objective of this study is to correlate the factors making up the metabolic syndrome with pancreatic echogenecity.

Eligibility criteria:
inclusion criteria: * any consecutive patient, having a high echo-endoscopy * for an extra pancreatic cause, such as the search for a cholelithiasis, (the pancreas will be studied completely) * for esophageal pathologies, (the pancreas will be studied completely) * for gastric pathologies, (the pancreas will be studied completely) * for cystic lesions of the pancreas (pancreas studied upstream and downstream) * for submucosal tumors (esophageal / gastric / duodenal) * for abdominal pain of undetermined origin exclusion criteria: * patients with pancreatic and / or tissue damage with dilated wirsung canal and / or acute or chronic pancreatitis. * patients having contraindication to general anesthesia

Keywords: pancreatic echogenecity hepatic steatosis metabolic syndrome obesity
comparison of recurrence of atrial fibrillation post cryoballon ablation during the 90-day blanking period-with and without anti-arrhythmic drug therapy

Conditions: Atrial Fibrillation

Summary: this study is being done to find out if patients taking anti arrhythmia drugs (aads) after cryoballoon ablation for atrial fibrillation, compared to patients who do not take anti- arrhythmic drugs after an ablation affect atrial fibrillation from coming back. the study will also look at the side effects of the aads.

pulmonary vein isolation (pvi) is a cornerstone ablation strategy used in the management of paroxysmal atrial fibrillation (paf), and it is a class ia indication for anti-arrhythmic drug (aad) refractory symptomatic paf. however, the consensus statements are vague about the utility of aad management during the 90-day blanking window post-pvi. moreover, there is no specific guidance to cryoballoon users on the usage of aads during the 90-day blanking period that exists anywhere in the published literature. simply, these studies have not been conducted with the cryoballoon procedure.

Eligibility criteria:
inclusion criteria: * drug refractory and recurrent paroxysmal atrial fibrillation * the subject meets medical criteria for cryoballoon ablation to treat paroxysmal af * age 18 to 80 years * the subject has a cardiovascular implantable electronic device (cied) that captures af episodes, such as an implantable loop recorder, pacemaker, or implantable cardioverter defibrillator (icd) with a properly functioning atrial lead. exclusion criteria: * use of any anti- arrhythmic drugs for ventricular arrhythmias * ejection fraction (ef)\<45% * prior a. fib. ablation * pregnant women

Keywords: antiarrhythmic agents catheter ablation, electric cardiac arrhythmias anti-arrhythmia drugs
evaluation of hiv-1, hcv and hbv blood screening tests with human blood donor specimens

Conditions: Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

Summary: the purpose of this study is to validate the performance characteristics of an assay that tests for hiv-1, hcv and hbv on an automated blood bank instrument for registration submission.


Eligibility criteria:
inclusion criteria: * an acceptable blood donation health history and an eia negative donation sample result with licensed eia procedures in routine use at each facility exclusion criteria: * a positive (reactive) hiv and/or hcv and/or hbv test

Keywords: nucleic acid test hiv-1 hepatitis hbv hcv tma hiv seronegativity
to assess the risk of acute pancreatitis in patients with type 2 diabetes mellitus treated with empagliflozin

Conditions: Diabetes Mellitus, Type 2

Summary: to compare the risk of acute pancreatitis in patients with type 2 diabetes mellitus (t2dm) newly initiating empagliflozin to that of patients newly initiating other oral non-incretin/non-sodium glucose co-transporter-2 inhibitor (sglt2i)-containing hypoglycemic agents.


Eligibility criteria:
inclusion criteria: * patients \>= 18 years old * a diagnosis of type 2 diabetes mellitus (t2dm) as demonstrated by at least one qualifying diagnosis code from any encounter type recorded in the claims in the 6 months prior to the drug initiation. * patients initiating empagliflozin (as monotherapy, on a background of metformin, or on a background of metformin and sulfonylurea (su)) or qualifying comparator (metformin monotherapy, su on a background of metformin, or thiazolidinediones (tzd) on a background of metformin and su) during the study period. * have at least 6 months of continuous registration in the database prior to initiation of empagliflozin or a comparator drug. exclusion criteria: * patients with missing or ambiguous age or sex information. * use of a sodium glucose co-transporter-2 inhibitor (sglt2i), dipeptidyl peptidase 4 inhibitors (dpp-4i) or glucagon-like peptide-1 receptor agonist (glp-1 ra) in the 6 months prior to study drug initiation. * chronic use of insulin in the outpatient setting in the 6 months prior to the study drug initiation. this criterion will help us to remove severe cases of diabetes and reduce the risk of residual confounding as diabetes is a risk factor for developing acute pancreatitis. * patients with type 1 diabetes mellitus (t1dm) defined as at least 1 inpatient or outpatient international classification of diseases ninth revision, clinical modification (icd-9-cm) diagnosis code of 250.x1 or 250.x3 or international classification of diseases, tenth revision, clinical modification (icd-10-cm) diagnosis code of e10.x in the 6 months prior to the study drug initiation. * patients with secondary diabetes or gestational diabetes in the 6 months prior to the study drug initiation. * claims for acute or chronic pancreatitis, pancreatic cancer, or other disease of the pancreas any time prior to the study drug initiation.
efficacy and safety of asaq and pd for the treatment of uncomplicated falciparum malaria in mainland tanzania

Conditions: Uncomplicated Falciparum Malaria

Summary: the world health organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. the tanzanian national malaria control programme (nmcp) in collaboration with its partners have been implementing therapeutic efficacy studies (tes) to monitor the performance of different antimalarials in the country. most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in mainland tanzania. however, data on the performance of other artemisinin based combination therapy (acts) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. this study was undertaken in the same nmcp framework to assess the efficacy and safety of alternative acts used or with potential use in tanzania. the study assessed the efficacy and safety of artesunate-amodiaquine (asaq) and dihydroartemisinin-piperaquine (dp) for the treatment of uncomplicated malaria in tanzania. the study was undertaken at two nmcp sentinel sites of kibaha and ujiji from july to december 2017.


Eligibility criteria:
inclusion criteria: * patients aged 6 months to 10 years. * mono-infection with p. falciparum detected by microscopy; * parasitaemia of 250 - 200,000/μl asexual forms; * presence of axillary temperature ≥37.5 °c or history of fever during the past 24 hours * ability to swallow oral medication; * ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and * informed consent from the parents or guardians of children. exclusion criteria: * mrdt negative * presence of general danger signs in children aged 6 months to 10 years or signs of severe falciparum malaria according to the definitions of who (appendix 1); * weight under 5 kg * mixed or mono-infection with another plasmodium species detected by microscopy; * presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm in children ≤ 59 months; or bmi of \<16 in children aged 5 years and above) * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, hiv/aids); * regular medication, which may interfere with antimalarial pharmacokinetics; * history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);