Kornimate/medical-research-clean huggingface dataset:
concentration of ampicillin / sulbactam and amoxicillin / clavulanic acid in the blood during renal replacement therapy in longterm renal replacement therapy patients

Conditions: Infection During Hemodialysis

Summary: the study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis.


Eligibility criteria:
inclusion criteria: * age \>18 years * suspected or proven bacterial infection requiring parenteral antibiotic therapy. * renal replacement therapy (hd) exclusion criteria: * known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. * an expected survival of less than two days. * known pregnancy * co-administration of one of the following drugs: probenecid which cannot be discontinued for the duration of the study * ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections. * other reasons opposing the study participation on the discretion of the investigators.

Keywords: chronic hemodialysis ampicillin sulbactam amoxicillin clavulanic acid pharmacokinetics
a case report of nmdar encephalopathy

Conditions: Anti-NMDA Receptor Encephalitis; Mature Teratoma; Paraneoplastic Syndromes

Summary: this case illustrates the clinical, radiologic, and histopathologic features of anti-nmdar encephalitis and underscores the importance of mri in detecting ovarian teratomas when pelvic ultrasound is inconclusive.


Eligibility criteria:
inclusion criteria: * suspected anti-nmda encephalitis exclusion criteria: * inability to consent

Keywords: magnetic resonance gynecologic surgery
single-center prospective study of non-invasive methods for the diagnosis of postoperative complications in liver transplant recipients

Conditions: Rejection Acute Hepatic; Transplant; Failure, Liver; Liver Dysfunction

Summary: a lot of different early and late complications may occur after liver transplantation. they could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, acr). almost all of those complications are characterized by an elevation in liver enzymes (alt, ast and ggt) and a decline of liver function tests (serum bilirubin and inr increase) possibly leading to early allograft disfunction (ead). in this scenario there is a lack of biomarker that could predict the development of acr and/or ead. the aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.


Eligibility criteria:
inclusion criteria: * patients eligible for liver transplantation following national and international guidelines exclusion criteria: * no agreement or inability to give informed consent * re-transplant patients * liver transplant in fulminant hepatitis
orthostatic hypotension among veterans

Conditions: Hypotension, Orthostatic Hypotension

Summary: orthostatic hypotension (oh) is defined as a fall in blood pressure when standing. several different underlying diseases, conditions, or combinations of medicines may contribute to oh; therefore the cause of the condition varies among individuals. some studies have shown that oh is associated with an increase in the rate of death, but it is not clear what role oh plays in increased morbidity. by studying what the prevalence of oh is in a generalized veteran population we expect increase clinical awareness of the degree of the problem so that patient care might be improved.


Eligibility criteria:
inclusion criteria: * veterans * between the ages of 18 and 89 exclusion criteria: * current illness/infection * pregnant

Keywords: hypotension, orthostatic hypotension
mechanical ventilation parameters in hap patients

Conditions: Mechanical Ventilation Pressure High

Summary: hospital-acquired pneumonia (hap) in patients in intensive care often requires the mechanical ventilation (mv). management and weaning from mv are given by specificity of this type of pulmonary inflammation. enrolled in the retrospective, observational study were all patients older than 18 years staying at the icu of university hospital in olomouc, between 1 january 2011 and 31 december 2016. the determination of the parameters of the mv, icu length of stay, hospital length of stay and mortality in hap group were compared with the control group of patients without hap.

hospital-acquired pneumonia (hap) development influences the parameters of mechanical ventilation, intensive care unit (icu) length of stay, hospital length of stay, need of tracheostomy, bronchoscopy, reconnection to mv and mortality. we respect hap definition: acute inflammation of the respiratory bronchioles, alveolar structures and pulmonary interstitium. clinically it is defined as the presence of newly developed or progressive infiltrates on chest radiographs plus at least two other signs of respiratory tract infection: temperature \>38 °c, chest pain, purulent sputum, leukocytosis or leukopenia, signs of inflammation on auscultation, cough and/or respiratory insufficiency. hap is defined as pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission. a retrospective, observational study processing data on all consecutive intensive care patients older than 18 years of age between 1 january 2011 and 31 december 2015. the aim was to determine the incidence of potential risk factors and their impact on the development of hap. the primary outcome was investigation of the relationship between mechanical ventilation parameters and the presence of early- and late-onset hap. enrolled in the study were patients staying at the icu of the department of anesthesiology and intensive care medicine, faculty of medicine and dentistry, palacky university olomouc and university hospital olomouc, between 1 january 2011 and 31 december 2016. the participants were all patients older than 18 years of age consecutively admitted to the icu.

Eligibility criteria:
inclusion criteria: * age 18+ * need of mechanical ventilation (pressure controlled mechanical ventilation or pressure support ventilation) exclusion criteria: * organ donor * need volume controlled mechanical ventilation * no mechanical ventilation
evaluation of remote programming of cochlear implants in routine cochlear implant follow-up

Conditions: Cochlear Hearing Loss

Summary: this is a prospective and monocentric clinical investigation, non-interventional and non-randomized. the overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of target ci version 1.5 and the ab remote support app. hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * ability to give feedback on hearing impressions * aged 18 years of age or older * implanted with a hiresolution bionic ear system (hires 90k or hires 90k advantage or hires ultra or hires ultra 3d) on at least one side * group 1 - unilateral: no hearing device except contralateral routing of signals (cros) device on the contralateral side * group 2 - bilateral: implanted on both sides * group 3 - bimodal: hearing aid on the contralateral side * minimum of six months of cochlear implant experience * minimum of one month experience with a naída ci m or sky ci m sound processor * fluent in french language * ability to be tested via speech perception test in noise * smartphone user exclusion criteria: * clinical presentation indicative of potential implanted device malfunction * unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator * unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator pregnancy and breast-feeding are not exclusion criteria.
sequential cd19 and cd22 car-t therapy for newly diagnosed ph- b-all

Conditions: B-Cell Acute Lymphoblastic Leukemia, Adult

Summary: clinical trial for the safety and efficacy of sequential cd19 and cd22 car-t therapy for adult patients with newly diagnosed ph chromosome negative b-cell acute lymphoblastic leukemia

this is a prospective, single arm study. to evaluate the safety and efficacy of sequential cd19 and cd22 car-t cells in the treatment of adult newly diagnosed ph chromosome negative b-cell acute lymphoblastic leukemia. the main endpoints were dose limiting toxicity (dlt) and incidence of adverse events (teaes).

Eligibility criteria:
inclusion criteria: * age≥15 years old * newly diagnosed b-cell acute lymphoblastic leukemia according to the 2016 who classification * the immunophenotype of leukemia cells were cd19 and cd22 positive * ph- or ph- like negative * anticipated survival time more than 12 weeks; * those who voluntarily participated in this trial and provided informed consent. exclusion criteria: * history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; * pregnant (or lactating) women; * patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); * active infection of hepatitis b virus or hepatitis c virus; * concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; * previously treated with any car-t cell product or other genetically-modified t cell therapies; * creatinine\>2.5mg/dl, or alt / ast \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; * other uncontrolled diseases that were not suitable for this trial; * patients with hiv infection; * any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Keywords: cd19 car-t cd22 car-t ph chromosome negative b-all newly diagnosed
l-menthol as a topical counter-irritant to trpa1-induced neurogenic inflammation and pain

Conditions: Inflammation; Pruritus; Hyperalgesia

Summary: the aim of this study is to quantitatively characterize the effects of l-menthol as a topical counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the trpa1-agonist trans-cinnamaldehyde (ca) in healthy human volunteers.

this study is designed as an experimental model in healthy humans.

Eligibility criteria:
inclusion criteria: * 18 healthy men and women aged 18-50 years willing to abstain from alcohol, nicotine, caffeine and pain medication 24 hours before experimental sessions exclusion criteria: * pregnancy * skin disorders (e.g. contact eczema) * chronic pain conditions * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate
a study of participants ages 21-65 diagnosed with dyspareunia and the effects of low intensity shockwave treatment

Conditions: Female Dyspareunia

Summary: dyspareunia is defined as a complaint of persistent or recurring pain or discomfort associated with attempted or complete vaginal penetration e purpose of this study is to determine the effectiveness of low intensity shockwave treatment for patients with dyspareunia and their ability to tolerate sexual activity, (i.e., penetration of vagina, self or partnered pleasure). participants will: * be given a preliminary physical therapy examination and evaluation. * be asked to attend weekly low intensity shockwave treatment visits. * be asked to complete 3 month follow up questionnaires

this study seeks to determine the effectiveness of low intensity shockwave (liswt) for patients with dyspareunia, with the primary objective being the ability to tolerate penetration of the vagina and sexual activity, (self or partnered pleasure). a secondary objective of the study is an improved quality of life. this is a single blind, randomized controlled trial, with randomized placebo phase design. a total of 60 participants enrolled at 4 clinical sites will be blinded to the group they are assigned to, (treatment or sham). clinical investigators cannot be blinded to treatment or sham in order to deliver the treatment. there are two arms of the study: the intervention arm where subjects receive active low intensity shockwave treatment plus typical physical therapy. intervention is the delivery of shockwaves to the pelvic floor region using softwave tissue regenerationtechnologies orthogold 100 mts op155 unfocused parabolic probe electrohydraulic device. the control arm subjects receive sham shockwave treatment plus typical physical therapy. each clinical site will have an envelope with pre-determined even and odd numbers determining randomization. upon enrollment a random number from the envelope will be drawn and assigned to the participant. at 4-6 weeks participants in the control arm will be given the option of moving to the shockwave (intervention) arm. participants will spend 4 to 4 1/2 months in the study receiving treatment once per week, 4-6 weeks duration for both treatment arms. subjects will then be contacted for a 3-month follow-up by phone completing their study participation.

Eligibility criteria:
inclusion criteria: * primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration) * cisgender female or have natal vaginal tissu * has not started hormonal therapy within the past 2 weeks * has not received pelvic floor physical therapy within the past 2 weeks * is able to electronically access informed consent and outcomes measures forms exclusion criteria: * have a diagnosis of lichen sclerosis * have an active infection (e.g. herpes) * are earlier than 12 weeks post-surgery * are earlier than 6 weeks postpartum * have a history of gynecological cancer * have a history of pelvic radiation * are actively undergoing cancer treatments * are currently pregnant * currently using lidocaine or cortisone
effect of pentoxifylline on proteinuria in korean type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: this multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in korean type 2 diabetic patients.

the investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements. enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks. fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks. the investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age \>=20 years * spot urine albumin/creatinine ratio \> 30mg/g in two consecutive measurements * patients on ace-inhibitor or arb as an anti-hypertensive drug * blood pressure \<= 150/100 mmhg * hba1c \<10% exclusion criteria: * taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months * ischemic heart disease, stroke, malignant disease, severe infection in 6 months * serum creatinine \> 2.0mg/dl * severe liver disease or ast, alt \> 3\* ulm * taking systemic steroid in 1 month * pregnant or plan to become pregnant during the clinical trial * lactation

Keywords: type 2 diabetes pentoxifylline proteinuria
a prospective observational cohort study of awake prone position ventilation strategy in patients with acute respiratory failure

Conditions: Acute Respiratory Failure

Summary: awake prone positioning has been used widely for patients with covid-19.many research results are not uniform on the key issue of whether the prognosis of patients can be improved，and most of the subjects were patients with sars-cov-2 infected who are not intubated.the investigators will conduct a prospective observational study on patients with acute respiratory failure induced by various causes to determine whether awake prone position can reduce the need to upgrade to invasive mechanical ventilation and improve the prognosis of patients compared with standard treatment.


Eligibility criteria:
inclusion criteria: * 1.older than 17 years, admitted to the icu;2.patients with acute respiratory failure meet the following conditions：①under the condition of breathing air at rest, pao2 of subjects is lower than 60mmhg and/or paco2 is higher than 50mmhg; ②under the support of cot and hfnc, pao2/fio2 of the subject is less than 250; ③ under the support of niv ; exclusion criteria: * 1.refusing to cooperate with active treatment; 2.immediate need for intubation as determined by the treating team.3patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)；4.contraindication to pp (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy \>20/40 gestation, severe brain injury)；
bariatric scalable internet treatments

Conditions: Bariatric Surgery; Weight Loss

Summary: the purpose of the study is to conduct a randomized clinical trial examining the feasibility and effectiveness of two guided self-help behavioral weight loss (gshbwl) treatments delivered via the internet for individuals struggling with weight loss one year following bariatric surgery. the two treatments will consist of 1) gshbwl delivered through the internet only (gshbwl-i) and 2) gshbwl delivered via the internet with additional complementary phone sessions (gshbwl-ip).


Eligibility criteria:
inclusion criteria: * gastric bypass and sleeve surgery patients from yale's bariatric/gastrointestinal surgery program * surgery 1-2 years prior * \<60% excess weight loss * able to read english proficiently enough to read the patient self-help materials and study assessments * available for the duration of the treatment * availability of internet and phone to participate in study interventions * agree to the study procedures exclusion criteria: * medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability) * unable to ambulate * current medications that influence eating/weight * current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment.
gwpcare2 a study to investigate the efficacy and safety of cannabidiol (gwp42003-p) in children and young adults with dravet syndrome

Conditions: Epilepsy; Dravet Syndrome

Summary: to investigate the potential antiepileptic effects of cannabidiol (gwp42003-p) in children and young adults with dravet syndrome.

this study was a 2:2:1:1 randomized, double-blind, 14-week comparison of two dose levels of gwp42003-p (10 milligram/kilogram \[mg/kg\]/day and 20 mg/kg/day) versus placebo (10 mg/kg/day dose-volume equivalent and 20 mg/kg/day dose-volume equivalent; presented as pooled placebo in the study). a 28-day screening period prior to randomization (to establish baseline parameters) preceded the treatment period, which consisted of a 2-week titration period followed by a 12-week maintenance period. the study aimed to determine the efficacy, safety, and tolerability of gwp42003-p compared with placebo. 20 mg/kg/day was recommended by the data safety monitoring committee (dsmc) after assessment of safety and pharmacokinetic data from part a of study gwep1332 (nct02091206). the first participant did not enroll into this study until the dsmc reviewed the safety data from part a of study gwep1332 (nct02091206). following study completion, all participants were invited to continue to receive gwp42003-p in a separate open-label extension study (gwep1415; nct02224573).

Eligibility criteria:
key inclusion criteria: * participant must have been male or female, aged between 2 and 18 years (inclusive). * participant must have had a documented history of dravet syndrome that was not completely controlled by current antiepileptic drugs. * participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks. * all medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study. key exclusion criteria: * participant had clinically significant unstable medical conditions other than epilepsy. * participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy. * participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study. * participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products. * there were plans for the participant to travel outside their country of residence during the study. * any history of suicidal behavior or any suicidal ideation of type four or five on the columbia-suicide severity rating scale (children's) at screening.

Keywords: cannabidiol cbd gwp42003-p epidiolex
a study of ly3002813 in participants with early symptomatic alzheimer's disease (trailblazer-alz)

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of ly3002813 in early symptomatic alzheimer's disease.


Eligibility criteria:
inclusion criteria: * gradual and progressive change in memory function reported by participants or informants for ≥ 6 months. * mmse score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir pet scan within 6 months prior to baseline that meets the central read criteria. * meet 18f flortaucipir pet scan eligibility criteria. * meet 18f florbetapir pet scan (central read) eligibility criteria. exclusion criteria: * have a history of long qt syndrome. * have received treatment with a stable dose of an acetylcholinesterase inhibitor (achei) and/or memantine for less than 2 months before randomization. * contraindication to mri.

Keywords: trailblazer-alz