Kornimate/medical-research-clean huggingface dataset:
evaluation of adherent invasive e. coli eradication in adult crohn disease

Conditions: Crohn Disease; Adherent-invasive E. Coli

Summary: the primary objective of this trial is to assess whether a 12-week treatment with ciprofloxacin and rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive e. coli (aiec)-colonized patients with ileal crohn disease (cd), with or without involvement of the caecum or the right colon.


Eligibility criteria:
inclusion criteria: * cd of the ileum, with or without involvement of the caecum or the right colon * colonoscopy showing active lesions defined by a cdeism score \>6 * informed consent to participate in this study * prescription of steroid treatments : budesonide, prednisone (or prednisolone) independently from entry in study * patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in cdai between the pre-inclusion and the inclusion visit, * patients colonized with aiec on initial ileal biopsies. exclusion criteria: * ileal stenosis that cannot be crossed by the endoscope, * infliximab treatment received less than 8 weeks before inclusion in this study, * adalimumab treatment received less than 4 weeks before inclusion in this study, * vedolizumab treatment received less than 8 weeks before inclusion in the study, * hypersensitivity to ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide e171, macrogol 4000,), * tizanidine, probenecid, theophylline, xanthine derivatives, phenytoin, oral anticoagulants, and ropinirole treatment, * hypersensitivity to rifaximin, or to any excipients (sodium starch glycolate type a, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide, disodium edentate, propylene glycol, red iron oxide e172), * previous extensive ileal surgery (≥ 1 meter as measured on the pathology and/or surgical report), * short bowel syndrome, * need for an intestinal resection for fistula, abscess or intestinal obstruction, * renal failure (creatinine clearance\<30 ml/min/1.73m2), * liver failure (v factor\<50%), * past history of epilepsy, * no health insurance, * pregnant or lactating women, * refusal to have a double effective contraception, * patients already included in a biomedical research other than an observational study (e.g: registry, cohort).

Keywords: adult aiec
the effect of local application of tranexamic acid versus placebo on postoperative complications in plastic surgery

Conditions: Surgical Complication

Summary: study objective: this is a study to investigate whether applying the drug tranexamic acid (txa) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots. eligible patients: patients undergoing plastic surgical procedures with wounds that would normally receive application of txa to reduce bleeding after surgery. study intervention: participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. study drug will be identical looking ampoules which contain either txa or placebo (saline). neither participants nor study personnel will know the contents of the ampoules.

any serious postoperative complication needing intervention, specifically re-bleeding, wound infection, wound rupture, or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions: * screening of patient medical records * distribution of an electronic self-report form (eforsk®) to participating patients at postoperative day 30 * follow-up phone call to verify data after day 30. the study is terminated after the final phone call. all study data will be registered in an electronic, pseudonymous web-based registration form (ecrf/viedoc®). number of participants: to assess the effect of txa on the defined surgical complications compared to placebo, 1500 patients are needed in each group. data monitoring committee: a data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.

Eligibility criteria:
inclusion criteria: * patients are eligible to be included in the study only if all of the following criteria apply: 1. they are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical txa at the participating center. 2. they are over 18 years of age and capable of independently providing informed consent 3. they have received adequate oral and written information about the study and signed the informed-consent form exclusion criteria: * patients with known allergy to tranexamic acid. insufficient knowledge of national language or english.

Keywords: tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism
a study protocol for the validation of uaud in a clinical setting.

Conditions: Hearing Loss, Sensorineural; Hearing Impairment, Sensorineural

Summary: the objective of this study is to validate the user-operated audiometry (uaud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on uaud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the audible contrast threshold (act) test correlates to traditional measures of speech intelligibility.

the project will focus on the initial examination of patients who are referred for hearing aid treatment. this initial examination consists of an audiometry which is currently conducted manually by an audiologist. however, it is possible to conduct an audiometry as a user-operated self-test by using a computer. the project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. the project will use several types of patient reported measures as well as objective measurements in the clinic. research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination. also, the study will investigate whether thresholds obtained with the user-operated version of the audible contrast threshold (act) test correlates to traditional measures of speech intelligibility.

Eligibility criteria:
inclusion criteria * sensorineural hearing loss with hearing thresholds exceeding 20 db hl at two or more frequencies in the frequency range of 0.5 to 4 khz. * symmetric hearing loss with a maximum pure-tone average (pta) (mean of 0.5-1-2-4 khz) difference between the ears of 15 db hl. * danish native speaker. * no previous experience with has. * capable of answering questionnaires through an online mailbox. exclusion criteria * air-conduction audiometry thresholds exceeding 80 db hl at two or more frequencies. * treatment affected by conductive hearing loss (air-bone gap \>10 db on more than one frequency below 1 khz). * conditions with fluctuating hearing loss, e.g., menière's, on-going treatment with ototoxic drugs. * ear, nose, or throat surgery in the past 12 months. * evidence that the participant has made minor use of the has during the study (e.g., \< 2h per day). * visual or motor impairment that might affect the use of the uaud system.
lorcaserin: real world experience in an insurance-based weight management clinic

Conditions: Obesity; Weight Loss; Overweight

Summary: this is a retrospective, descriptive study that involves de-identified data consisting of weight changes, pertinent vital signs and laboratory values influenced by body weight, and healthcare utilization of patients prescribed lorcaserin at the center for weight management at the scripps clinic in san diego, ca.

all patients who initiated treatment with lorcaserin during the review period will undergo chart review. the primary endpoint will be weight change in patients on lorcaserin and average duration of lorcaserin treatment over time (up to 1 year). secondary endpoints will include changes in vital signs, liver function, glucose, and lipids. in addition, time on treatment, reasons for discontinuation of medication, and changes in healthcare utilization (to include inpatient and outpatient utilization) will be examined. this is a retrospective, one-arm observational study that will include chart reviews of 157 patients who have been treated in the clinic.

Eligibility criteria:
inclusion criteria: * received at least one prescription for lorcaserin treatment * at least 18 years of age or with guardian/parent able to consent for a minor exclusion criteria: - patient under the age of 18 at time of index date

Keywords: lorcaserin belviq
biliary drainage in patients with duodenal metal stent

Conditions: Jaundice

Summary: this is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (mbo) in relation to gastric outlet obstruction (goo) and the location of goo.

this is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal sems. endoscopic ultrasound-guided biliary drainage (eus-bd), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ercp) with stenting are to be compared. specifically, the outcomes are to be evaluated according to the timing of distal mbo in relation to goo and the location of goo.

Eligibility criteria:
inclusion criteria: * patients who underwent endoscopic placement of a duodenal sems for nonresectable malignant goo. * patients who underwent endoscopic biliary drainage for nonresectable mbo. * mbo was located ≥ 2 cm from the bifurcation. * patients who could be followed up more than three months after completion of both biliary drainage and duodenal sems placement. * age ≥20 years. * irrespective of sex and a primary disease. exclusion criteria: * patients who underwent surgical bypass for goo. * patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal sems. * patients with altered gastrointestinal anatomy (billroth-ii reconstruction, roux-en-y reconstruction, etc.). * patients who would not give a consent to the report of their own data. * patients considered ineligible for inclusion in the study by an investigator for other reasons.

Keywords: distal malignant biliary obstruction endoscopic retrograde cholangiopancreatography endoscopic ultrasound gastric outlet obstruction stent
non-invasive measurement of neonatal central and peripheral hemodynamics

Conditions: Pre-Term; Neonatal Infection

Summary: non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. it is accurate, but needs a long training for new users to assess cardiac function. continuous-wave doppler ultrasound monitor uscom is a relatively new monitor which can perform faster and less complex cardiac function measurement, also it is easier for the operator to get trained. the aim of the study is to assess the level of agreement between cardiac output measured with conventional echocardiography and with uscom, to present normal ranges for neonates of different gestational age and to look for early signs of hemodynamic changes during sepsis.


Eligibility criteria:
inclusion criteria: * newborns of any gestational age * parental consent acquired exclusion criteria: * congenital malformations * hemodynamic instability in control group * any respiratory support in control group * infection in control group

Keywords: cardiac output; echocardiography; uscom; neonates
reservoir of invasive salmonellosis in children, drc

Conditions: Salmonella Infections; Infection of Bloodstream

Summary: bloodstream infections caused by non-typhoid salmonella (nts) are a major killing disease in sub-saharan africa. despite the high case fatality rate, the main reservoir -human, zoonotic or environmental- for invasive nts rests unknown. the main objective of this study is to assess 1. the household environment (household member, cattle and pets, rats) for intestinal carriage of nts and 2. the household water supply for presence of nts . households of children with proven nts invasive infection will be addressed.

this study will be a case-based microbiological assessment of the household environment of index patients presenting with nts infection. index patients with laboratory confirmed nts bloodstream infections will be randomly addressed for the collection of samples from their household (household members, animals (domestic animals and rats) and water supply). the collection of those samples will be done as close as possible to the timing of diagnosis in the index patient. the sites of blood culture collection are the general hospitals of makiso and kabondo and the centre hospitalier village de pédiatrie. blood cultures will be drawn by nursing staff according to the standard procedures of the surveillance study. a total of 1500 blood cultures is expected with a positivity rate of 10% (falay, 2016). according to previous prevalence data in dr congo, the expected number of nts in this sample group will be 50 isolates. the isolates of salmonella sp. conserved on tsa agar will be shipped to itm and the molecular identity of the isolates will be determined and pairs of isolates (index patient-household environment) will be compared for clonal identity, by whole genome sequencing or equivalent technique as appropriate. a database will be completed that contains the study data. data that can have a link to the patient identity will be coded.

Eligibility criteria:
inclusion criteria: * households where at least one child is diagnosed with nts bloodstream infection * willing to give informed consent exclusion criteria: * refusal of participation

Keywords: non-typhoid salmonella invasive blood stream infections reservoir household environment children
targeted lifestyle change group prenatal care

Conditions: Pregnancy; Gestational Diabetes

Summary: to conduct a randomized trial to determine the effect of targeted lifestyle change group prenatal care (tlc) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (gdm).

long term, the investigator aims to test the central hypothesis that those in tlc will have better maternal and neonatal outcomes than those in tc. the objective is to conduct a randomized trial to determine the effect of tlc group prenatal care on birthweight and neonatal body composition, maternal healthy lifestyle and diabetes-related outcomes, delivery and neonatal outcomes, and psychosocial stress and depression.

Eligibility criteria:
inclusion criteria: * english speaking * ≤16 weeks gestation * two or more of the following gdm risk factors: * bmi ≥ 25 * physical inactivity * first degree relative with diabetes * high risk race or ethnicity (african american, latino, native american, asian american, pacific islander) * prior infant weighing ≥ 4,000 g * prior gdm * hypertension (140/90 mm hg or receiving treatment) * high-density lipoprotein cholesterol level \ 250 mg/dl * polycystic ovarian syndrome * a1c ≥ 5.7% * impaired glucose tolerance * impaired fasting glucose on previous testing * history of cardiovascular disease * ability to attend group prenatal visits at specified days and times * willingness to be randomized * ability to give informed consent exclusion criteria: * type 2 diabetes (eligible for diabetes group care) * positive glucose challenge test during early pregnancy * multiple gestation (require extra care) * major fetal anomaly (require extra care) * serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care) * serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)

Keywords: group prenatal care diabetes
vaso-am :impact of oral appliance therapy on endothelial function in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea Syndrome

Summary: this is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (cpap) therapy.


Eligibility criteria:
inclusion criteria: * ahi \> 30 * intolerance to cpap therapy * signed informed consent exclusion criteria: * epworth sleepiness scale \> 16/24 * severe cardiac and/or respiratory disease * bmi\>32 kg/m2 * dental contraindication to oral appliance
eu multicenter registry to assess outcomes in cabg patients: treatment of vascular conduits with duragraft [vasc]

Conditions: Cardiovascular Diseases; Coronary Artery Disease

Summary: the duragraft® registry is a european registry of patients who have undergone cabg and whose vascular grafts have been treated with duragraft. all participating sites will be from countries in europe. the duragraft registry will collect pre-cabg, intraoperative and post-operative data, major post-cabg cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.

objectives: (i) to evaluate the safety and performance of duragraft® (ii) to characterize the use of duragraft and the outcomes of patients whose vascular grafts were treated with duragraft in daily clinical routine (iii) to further characterize the incidence of macce outcomes associated with cabg in patients whose vascular grafts were treated with duragraft in daily clinical routine (iv) to compare the use of duragraft among hospitals and practices (v) to obtain patient reported quality of life information (vi) to obtain important health economics outcomes

Eligibility criteria:
inclusion criteria: * patient undergoing isolated cabg procedure or cabg plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts * patient is ≥18 years of age * patient (or a legally authorized representative) is willing and able to provide consent * duragraft is being used for the cabg procedure exclusion criteria: * participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment

Keywords: vein graft failure coronary artery bypass graft surgery vascular grafts saphenous vein grafts vein graft disease vein graft treatment vein graft handling
a study of safety and efficacy of mk0859 (anacetrapib) in japanese patients with dyslipidemia (0859-029)

Conditions: Dyslipidemia

Summary: this study will investigate the effect of mk0859 when administered alone and when in combination with atorvastatin in lowering low density lipoprotein -cholesterol (ldl-c) in japanese patients with dyslipidemia.

this is the dose ranging study to evaluate efficacy and safety of mk-0859 in japanese patients. eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period. as an additional follow-up, the pregnancy information from women of childbearing potential who were treated with mk-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of mk-0859.

Eligibility criteria:
inclusion criteria: * patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia exclusion criteria: * patients has coronary heart disease (chd) or chd-equivalent disease (except diabetes) * patients has uncontrolled diabetes * patient is currently participating or has participated in a study with an investigational compound within the last 3 months
transcapillary plasma refill in advanced chronic kidney disease

Conditions: Haemodynamic Instability

Summary: background: haemodynamic instability during haemodialysis has long been linked to poor cardiovascular outcomes. it does not always reflect overall hydration but rather plasma volume depletion, with a delay in plasma refill from other body compartments, and vasodilatation, mediated by endothelial factors. our understanding of these processes remains largely incomplete. despite our ability to monitor relative blood volume during haemodialysis our knowledge concerning the factors affecting plasma refill remain incomplete. this may be due to variations observed between individuals. understanding the pattern of fluid shifts variation between the different body compartment and the factors affecting these behaviours in different individuals or at different hydration states could be a vital component of our management of intradialytic haemodynamic instability but also overhydration. aims and objectives: the aim of this study is to describe plasma refill rate, during haemodialysis using a non-invasive, continuous, real-time data capture during ultrafiltration. the study will attempt to describe different refilling phenotypes in the study population and seek association with biochemical and haematological parameters linked to variability in refilling rates. methodology: this study will attempt to describe variations in the plasma refill rate of prevalent dialysis patients during their normal haemodialysis treatment and during a session of 3 hours of haemodialysis preceded by 1 hour of isolated ultrafiltration using the in-built blood volume monitoring module of their haemodialysis machine and the tmon software that collects continuous, real-time data by interfacing with the computer network. to achieve this, a bolus of 100-300ml of intravenous dialysis replacement fluid will be administered at the beginning of each of the 2 studied sessions.


Eligibility criteria:
inclusion criteria: * prevalent haemodialysis patient at cmft and satellite units exclusion criteria: * withdrawal of consent. * inability to provide informed consent.
vascular endothelial factor gene polymorphism in preeclampsia

Conditions: Preeclampsia

Summary: in this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. they evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with doppler changes in the pulsatility index of the umbilical artery.

preeclampsia is a syndrome characterized by occurrence of hypertension and proteinuria after 20 weeks of gestation. the pathophysiology of preeclampsia involves abnormalities in the development of placental vasculature early in pregnancy may result in relative placental under perfusion/hypoxia/ischemia, which then leads to release of factors into the maternal circulation that alter maternal endothelial function and cause hypertension and other manifestations of disease .vascular endothelial growth factor (vegf) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis. it is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. human vegf gene is located on chromosome 6 and consists of 8 exons with alternate splicing, forming a family of proteins. there are several common single nucleotide polymorphisms (snps) in the vegf gene, which could alter gene expression and protein production, and alter the risk of developing diseases characterized by deranged angiogenesis including preeclampsia.

Eligibility criteria:
inclusion criteria: more than 20 weeks gestation. preeclamptic patients exclusion criteria: association with chronic disease (cardiac, hepatic, renal) and if the patient was known to have chronic hypertension. association with auto-immune disease.