Kornimate/medical-research-clean huggingface dataset:
piperacillin tazobactam versus meropenem for treatment of bloodstream infections caused by cephalosporin-resistant enterobacteriaceae (peterpen)

Conditions: Beta Lactam Resistant Bacterial Infection; Enterobacteriaceae Infections; Bacteremia

Summary: data regarding optimal treatment for extended-spectrum beta-lactamase (esbl) producing enterobacteriaceae blood-stream infection are lacking. observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. the investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible enterobacteriaceae. the investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.


Eligibility criteria:
inclusion criteria: 1. adults (age ≥ 18 years) 2. new onset bsi due to e. coli or klebsiella spp. in one or more blood cultures associated with evidence of infection. 3. the microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both ptz and meropenem (see microbiological methods). 4. both community and hospital-acquired bacteremias will be included. 5. we will permit the inclusion of bacteremias due to e. coli or klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants. exclusion criteria: 1. more than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.). 2. polymicrobial bacteremia. polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode. 3. patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode. 4. patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \ 15μg/kg/min, adrenalin\>0.1μg/kg/min, noradrenalin\>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior to randomization. in the absence of the use of vasopressors, a systolic blood pressure \<90 would need to represent a deviation for the patient's known normal blood pressure. 5. bsi due to specific infections known at the time of randomization: 1. endocarditis / endovascular infections 2. osteomyelitis (not resected) 3. central nervous system infections 6. allergy to any of the study drugs confirmed by history taken by the investigator 7. previous enrollment in this trial 8. concurrent participation in another interventional clinical trial 9. imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)

Keywords: bacteremia enterobacteriaceae extended spectrum beta-lactamase meropenem piperacillin tazobactam
screening of tma patients für adamts13 activity (adamscreen)

Conditions: Thrombotic Microangiopathies

Summary: screening of tma patients for adamts13 activity and the description of systemic organ damage and/or organ failure in different entities of thrombotic microangiopathies (tma)

this is a prospective diagnostic analysis enrolling 100 patients with clinically suspected thrombotic microangiopathy (tma) on the basis of laboratory findings such as thrombocytopenia, coombs negative haemolytic anemia with increased ldh and increased schistozytes. as a first step of differential diagnosis, patients are classified by determining adamts13 activity and antigen concentration and also analyzing for shigatoxin and shigatoxin producing bacteria respectively. primary objective is to determine the relative incidences of the three major entities i.e. ahus, stec-hus and ttp considering distribution of age and gender as well. mean value of adamts13 activity and antigen measured at date of first diagnosis is considered to line out a threshold value for adamts13 activity pronouncing clinical apparent tma. furthermore the present study intends to characterize clinical presentation, clinical course and outcome of different tma forms particularly with regard to treatment procedures. monitoring of how adamts13 activity and antigen changes in the course of the disease and in response to treatment is of particular concern for this study. family history and special clinical conditions should be noted identifying potential genetic predisposition and definite clinical triggers leading to disease manifestation.

Eligibility criteria:
inclusion criteria: -patients with first history of tma as patients with recurrent tma or tma in complete or partial remission are eligible for analysis exclusion criteria: -patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study
lcr35 for children with functional constipation

Conditions: Constipation

Summary: the aim of this study is to assess the effectiveness of lactobacillus casei rhamnosus lcr35 administration for the treatment of functional constipation in children.

functional constipation is a common problem which affects over 3% of children. the standard treatment does not provide sustained relief of symptoms. as a consequence, there is interest in other therapeutic options. previously, one small (n=40) randomized controlled trial (rct) involving 27 children showed that lactobacillus rhamnosus casei lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. however, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. available evidence is insufficient to draw meaningful conclusion. further studies are needed.

Eligibility criteria:
inclusion criteria: * children below 5 years of age * functional constipation according to rome iii criteria i.e. 1 month of at least 2 of the following: * two or fewer defecations per week * at least 1 episode per week of incontinence after the acquisition of toileting skills * history of excessive stool retention * history of painful or hard bowel movements * presence of a large fecal mass in the rectum * history of large- diameter stools that may obstruct the toilet exclusion criteria: * irritable bowel syndrome * mental retardation * endocrine disease (e.g. hypothyroidism) * organic cause of constipation (e.g. hirschsprung disease) * spinal anomalies * anatomic defects of the anorectum * history of previous gastrointestinal surgery * functional nonretentive fecal incontinence * use of drugs that influence gastrointestinal motility
neurofibromatosis (nf) registry portal

Conditions: Neurofibromatosis 1; Neurofibromatosis 2; Schwannomatosis

Summary: the nf registry is a database of patient-reported symptoms, treatments, and experiences with their neurofibromatosis disease. it is a contact registry to relay clinical trial opportunities to targeted patient subgroups, and to supply de-identified disease data to researchers. it has the potential to become a natural history resource.

patients and parents of patients will be made aware of the neurofibromatosis (nf) registry through various non-commercial information sources such as the children's tumor foundation (ctf) website, ctf-affiliated nf clinics, social media, ctf educational and fundraising events, and other nonprofit organizations and foundations such as the national organization for rare diseases (nord) and social media. the nf registry will be accessed by individual adult (over age 18) subjects via a web-based patient portal. the portal contains an irb-approved informed consent form. following consent, the registrant creates an account which is activated after email confirmation. an account can be created by an adult patient with the disorder, or by the parent or guardian of a child with the disorder. account creators are required to enter identifiable contact and demographic data. after the account is created, the account owner enrolls themselves or a minor family member (or both) and completes an on-line survey. there are separate surveys for nf1, nf2, and schwannomatosis. the surveys ask about about the affected individual's medical and family history of the disease, testing and diagnosis, clinical manifestations (e.g., tumor types and locations) interventions and therapies, and quality of life. the account holder chooses whether to receive emails from the registry with information about relevant clinical trials and studies for which they may be eligible. participant's responses are used to compile charts and graphics of de-identified aggregate data. registered patients may view this data. researchers may apply to our data use committee for access to de-identified data or for subject recruitment emails to be sent to specific patient subgroups. data capture and security for the nf registry is done under contract by openapp (dublin, ireland), a web-based patient opt-in registry provider.participants will be asked to update their information at least once a year. their information will be stored in the nf registry for an indefinite period of time. this longitudinal study is intended as a resource for patients and researchers. there is no specific outcome measure or anticipated endpoint.

Eligibility criteria:
inclusion criteria: * diagnosed with nf1 * diagnosed with nf2 * diagnosed with schwannomatosis exclusion criteria: * failure to complete account registration

Keywords: neurofibromatosis nf neurofibromatosis 1 nf1 neurofibromatosis 2 nf2 schwannomatosis
prospective randomized observer blinded single center study comparing 90-day functional outcome in patients who received intravenous propofol infusion versus inhalational sevoflurane for general anesthesia during mechanical thrombectomy in patients who suffered from acute ischemic stroke

Conditions: Acute Ischemic Stroke Patients

Summary: this study is being done to compare outcomes after surgery for individuals who receive anesthesia through by inhaling medication and individuals who receive anesthesia intravenously by needle when experiencing treatment for their stroke. currently very little is known about the outcomes for patients when comparing these two techniques of providing anesthesia during surgery. this study will provide information regarding outcomes that will help health care providers decide which technique will be better for patients

according to the national center for health statistics, stroke is a leading cause of disability and in 2021 the number five cause of death in the united states1. endovascular thrombectomy for patients experiencing acute ischemic stroke from the occlusion of a larger cerebral vessel has become a mainstay of treatment.2 patients undergoing thrombectomy have significantly reduced disability when compared to patients who do not receive this therapy. several studies have compared outcomes of patients receiving local anesthesia only or sedation versus general anesthesia during endovascular thrombectomy treatment.3,4 while questions remain, current consensus is that when these procedures are done on patients under general anesthesia, there are higher rates of recanalization (opening of the occluded blood vessel) and improved functional recovery. currently, less is known about the impact of the general anesthesia technique (inhalation vs. intravenous) on disability and functional outcomes in stroke patients. aim: the aim of this study is to compare functional outcomes and disability in patients undergoing endovascular thrombectomy for acute ischemic stroke under general anesthesia using a volatile inhalational versus total intravenous anesthesia (tiva) technique. hypothesis: we hypothesize that patients receiving total intravenous anesthesia will have better functional outcomes and less disability compared to those receiving volatile inhalational anesthesia as measured by the 90 day modified rankin score and compared in both groups. background and significance

Eligibility criteria:
inclusion criteria: * \>18 years acute ischemic stroke requiring endovascular treatment. exclusion criteria: * \<18 years * pregnant patients * patients with malignant hyperthermia * allergies or any contraindications to either inhalational or intravenous agents * patients already on intravenous anesthetic infusions * prisoners * students and employees

Keywords: inhalation anesthesia intravenous anesthesia
hyaluronan-enriched medium and euploid blastocyst transfers

Conditions: Infertility; Implantation Rate; Clinical Pregnancy Rate; Live Birth Rate; Blastocysts; FET

Summary: it has been proposed that enriching transfer media with hyaluronan (embryoglue medium) improves pregnancy outcomes compared with media containing lower concentrations of this molecule. however, none of previous studies included preimplantation genetic testing for aneuploidy (pgt-a) embryos. in order to investigate the impact of this hyaluronan-enriched on pregnancy outcomes, it is essential to evaluate its efficacy on euploid-only embryo transfers. the aim of the present study is to evaluate whether a short period of exposure of euploid blastocysts to embryoglue prior to and during transfer positively impact on pregnancy outcomes of frozen embryo transfer (fet) cycles.

the study period will be determined by the completion of the predetermined sample size, with two interim analyses planned when 35% (n=274) and 70% (n=548) of the target sample size is achieved to calculate conditional power. if conditional power is estimated to be lower than 15% at first interim analysis or lower than 30% in the second interim analysis, the trial will be stopped due to futility. the study will be performed in abu dhabi-fertility clinic. during the period of this prospective study, euploid blastocysts of enough quality that have been biopsied only on day-5 for pgt-a, will be warmed for single blastocyst transfer. the patient´s endometrial preparation protocol for fet will be restricted to hrt only. the study will be double-blinded (blinded to patient and doctor performing transfer).

Eligibility criteria:
inclusion criteria: * all frozen embryo transfer (fet) cycles with euploid blastocysts biopsied and vitrified on day 5 after pgt-a. * rank of randomization based on embryo quality. * only hormonal replacement theraphy (hrt) cycle regimen. * women aged 18 years to 46 years. * having at least 1 chromosomally normal vitrified blastocyst(s) on day 5 available for transfer. * all sperm samples. * bmi between 18 and 35. exclusion criteria: * fet cycles with preimplantation genetic testing for monogenic disorders (pgt-m) and for structural rearrangements (pgt-sr). * fet cycles with mosaic / aneuploid blastocysts. * fet cycles with unknown outcome. * fet cycles with day 6 or day 7 biopsied blastocysts. * fet with patients' endometrium preparation with treatments other than hrt. * fet where pgt-a was performed for gender selection.

Keywords: hrt pgt-a next-generation sequencing (ngs) miscarriage rate single embryo transfer (set) embryoglue bmi embryo quality hyaluronan-enriched medium transfer medium
the use of diadynamic in association with a manual therapy program for patients with impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: the aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure.


Eligibility criteria:
inclusion criteria: * history of anterior lateral and unilateral shoulder pain * with more than 3 months duration * intensity of at least 4 points on the numerical rating pain scale * positivity in at least 2 of 3 orthopedic tests for impingement syndrome: neer, hawkins or jobe * associated with these characteristics volunteers should submit myofascial trigger points unilateral and active, centrally located in the trapezius muscle descending fibers associated with painful shoulder exclusion criteria: * diagnosis of bilateral impingement syndrome shoulder * fibromyalgia * muscle injury * history of trauma on the shoulder * ruptured tendons * ligamentous laxity * symptoms of numbness and / or tingling in the upper limbs * corticosteroid injection use shoulder * making use of anti-inflammatory * they performed surgery or physical therapy treatment in the last 6 months in the affected shoulder.
clinical performance of a monthly replacement silicone hydrogel lens

Conditions: Refractive Errors

Summary: the purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.


Eligibility criteria:
inclusion criteria: * able to understand and sign an informed consent form approved by an institutional review board (irb); * successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * best-corrected visual acuity (bcva) 20/25 or better in each eye; * willing to stop wearing habitual contact lenses for the duration of study participation. exclusion criteria: * any conditions or use of medications that could contraindicate contact lens wear; * history of or plan to have refractive surgery in either eye; * irregular cornea in either eye; * ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; * current or history of intolerance, hypersensitivity or allergy to any component of the study products; * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear; * habitual biofinity contact lens wearers.
carbetocin versus oxytocin and ergometrine for the prevention of postpartum haemorrhage following caesarean section

Conditions: Bleeding; Anemia

Summary: the investigators compare the effectiveness and adverse effects of i.v carbetocin versus oxytocin \& ergometrine i.v for prevention of postpartum haemorrhage following cesarean section.

* postpartum hemorrhage (pph) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the uk for the 2000-2002 triennium. * caesarean section is a recognized risk factor for pph and the worldwide caesarean delivery rate is increasing .2 * a combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension. * a recent guideline on pph prevention developed by the world health organization recommended the use of oxytocin for prevention of pph in settings in which active management of labor is not practiced. * ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia. * carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. it is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects . * a prospective double blinded randomized study . the study population will include 200 patients. the study will take place in beni_suef university hospitals. * inclusion criteria: • women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation. * exclusion criteria * women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only. * women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies) * hypertension with pregnancy. * cardiac and coronary diseases with pregnancy * women included in the study were divided into 2 groups: .group (a): including 100 patients who will receive carbetocin 100 µg i.v after delivery of the fetal head. .group (b): including 100 patients who will receive a combination of intraoperative oxytocin 5 i.u \& ergometrine 0.2 mg.

Eligibility criteria:
inclusion criteria: * • women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation. exclusion criteria: * women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only. * women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies) * hypertension with pregnancy. * cardiac and coronary diseases with pregnancy

Keywords: postpartum hemorrhage, cesarean section, uterotonics
extension to a study on the efficacy and safety of vildagliptin compared to metformin in drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. the purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * only patients successfully completing study claf237a2309 are eligible * written informed consent * ability to comply with all study requirements exclusion criteria: * premature discontinuation from claf237a2309 * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
dailies total1® - comparative assessment of tear film evaporation

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

this study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. each subject will be randomized to a crossover sequence of 4 periods. different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Eligibility criteria:
inclusion criteria: * sign an informed consent document; * adapted, current soft contact lens wearer; * symptoms of contact lens discomfort as defined by the symptomatology (eligibility) questionnaire; * can be successfully fitted with study lenses; * willing to wear lenses for a minimum of 8 hours prior to each study visit; * willing to discontinue artificial tears and rewetting drops usage on the days of study visits; * other protocol-specified inclusion criteria may apply. exclusion criteria: * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * monocular (only 1 eye with functional vision) or fit with only one lens; * history of herpetic keratitis, ocular surgery, or irregular cornea; * known pregnancy and lactation; * other protocol-specified exclusion criteria may apply.