Kornimate/medical-research-clean huggingface dataset:
ceftazidime-avibactam use in critically ill patients with carbapenem-resistant enterobacteriaceae infections

Conditions: Carbapenem-Resistant Enterobacteriaceae Infection

Summary: carbapenem-resistant enterobacteriaceae (cre) infections are a growing national and international challenge in healthcare settings. this is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with cre reaching up to 50% as per the centers of disease control and prevention. colistin-based combination regimens have been the mainstay for treating cre-related infections. ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against cre along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. however, randomized clinical trials are lacking. this non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with cre infections in comparison to colistin-based regimens.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 years. 2. admitted to an intensive care unit (icu). 3. patients with hospital-acquired pneumonia (hap) or ventilator-associated pneumonia (vap), complicated urinary tract infection (cuti), bacteremia, complicated intraabdominal infection (ciai), and complicated skin and soft tissue infection (cssti). 4. confirmed infection with cre, based on a culture and sensitivity obtained within the past 72 hours of study enrollment. 5. suspected cre infection according to one of the following: (1) positive xpert carba-r test screening for blakpc or blaoxa-48 or blandm or blavim or blaimi assessed on the admission to the icu, (2) positive culture for cre obtained within 3 months from time of enrollment. exclusion criteria: 1. acute physiology and chronic health evaluation ii (apache ii) score more than 30 2. known significant hypersensitivity reaction to beta-lactam antibiotics or colistin 3. positive culture for stenotrophomonas maltophilia or acinetobacter baumannii within the current hospitalization. 4. patients received the study intervention or control for more than 24 hours before the intended randomization. 5. patient/substitute decision-maker or caring physician's refusal to enroll in the study. 6. patient with concomitant suspected or confirmed meningitis. 7. pregnancy. 8. cystic fibrosis. 9. patients with do not attempt to resuscitate (dnar) code status. 10. prior knowledge that the index cre pathogen was resistant to colistin (mic \>2 μg/ml) or ceftazidime-avibactam (mic \> 8 μg/ml) before randomization. 11. objective clinical evidence for any of the following infections that necessitate study therapy for \>14 days: endovascular infection, including endocarditis, osteomyelitis, prosthetic joint infection, meningitis, and/or other central nervous system infections

Keywords: carbapenem-resistant enterobacteriaceae critically ill ceftazidime-avibactam colistin
comparison of the efficacy and safety of q8003 versus its individual components in bunionectomy patients

Conditions: Postoperative Pain

Summary: this is a randomized, double-blind, multicenter, fixed dose factorial study of q8003 12 mg/8 mg and q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.


Eligibility criteria:
inclusion criteria: * patient is male or female and at least 18 years of age. * females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). non-pregnancy will be confirmed by pregnancy tests conducted at screening and pre-treatment. * patient is scheduled for bunionectomy surgery, meets the criteria of an asa class i to iii, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery. * to be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point likert scale or at least 4 on the 11 point nprs scale). exclusion criteria: * in the opinion of the investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. * used opiates continuously (including tramadol) for more than ten days in the past year. * hypersensitivity or poor tolerance to ibuprofen or short term opioids. * currently receiving any medications that are not at a stable dose (the same dose for \> 2 months prior to date of surgery). * was dosed with another investigational drug within 30 days prior to the screening visit or has previously received treatment with q8003. * current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia). * current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).

Keywords: bunionectomy
lung ultrasound for assessment of patients with moderate to severe covid-19

Conditions: Corona Virus Infection; Virus Diseases; Coronaviridae Infections

Summary: this observational study will describe lung ultrasound (lus) findings over time in hospitalized patients with moderate to severe covid-19 lung disease. our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. another aim is to describe lus findings associated with clinical findings and patient condition.

study patients with moderate to severe covid-19 infection will be screened with lung ultrasound daily. lung ultrasound will be assessed by lus-score for acute respiratory distress syndrome (ards) (0-36 points, bouhemad 2015). findings of b-line artifacts and consolidations will be noted. in addition to lus, clinical parameters from physical examination and laboratory tests will be collected. participants wil be followed until either admission to intensive care unit (icu) for mechanical ventilation or until clinical improvement. a group of patients with mild covid-19 infection will be recruited and screened once as reference. apart from assessment with lus, patients are managed according to routine care.

Eligibility criteria:
inclusion criteria: * covid-19 confirmed by positive polymerase chain reaction (pcr) * oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (hfnc) with fraction of inspired oxygen (fio2) ≥ 30% * age between 18-80 years * informed consent exclusion criteria: * patients subject to treatment-limitation "no icu" * history of heart failure * history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis * history of kidney failure requiring dialysis * any reason making lung ultrasound or daily follow up impossible * opposition to participation in the study

Keywords: ultrasonography lung ultrasound covid-19 ards
treatment patterns and real-world clinical outcomes in patients with advanced nsclc and met exon 14 skipping mutation in the united states

Conditions: Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation

Summary: this was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of advanced non-small cell lung cancer (ansclc) with met exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (io), or chemotherapy (ct) in real-world practice settings. data abstraction was performed by the participating physician.


Eligibility criteria:
inclusion criteria: * patient was aged ≥ 18 years at the time of nsclc diagnosis. * had histologically confirmed advanced (stage iiib, iiic, or iv) nsclc with met exon 14 skipping mutation. * initiated first-line (1l) treatment for ansclc between 1 january 2017 and date of data abstraction with one of the following treatment regimen: * capmatinib * io agent in monotherapy (e.g., atezolizumab, pembrolizumab) * ct regimen, single agent or combinations of ct agents (e.g., platinum agents, taxane agents, gemcitabine, pemetrexed) * combination regimen containing io and ct agents * had ≥ 6 months of potential follow-up time after the initiation of 1l treatment for ansclc, except if the patient died sooner. * living or deceased at the time of chart abstraction. exclusion criteria: * presence of other mutations (e.g., egfr, alk, ros1, ret, ntrk, braf, or kras) at any time. * treatment with other met inhibitors such as crizotinib or tepotinib at any time during the study period. * participation in clinical trials related to treatment for nsclc at any timepoint.

Keywords: ansclc
catheter early withdrawal or maintenance in sepsis or septic shock

Conditions: Catheter Related Infection

Summary: central venous catheter(cvc)-related infection is an inherent complication of this device that should be treated promptly. however, there are doubts about the need for the immediate withdrawal of cvc while there is still no confirmation of such infection. the aim of this study is to compare the resolution of cvc-related infection, testing two approaches: catheter´s early exchange, when the possibility of related sepsis is considered, versus the maintenance of the cvc and early antibiotic therapy until the infection is confirmed.

the aim of this study is to compare the strategy of immediate removal of the catheter with a conservative strategy in resolution of infection in patients with sepsis or septic shock without a defined origin. the investigators intend to demonstrate that the conservative strategy can reduce the rate of unnecessary catheter removal, without increasing morbidity. in the intervention group the investigators will adopt the conservative strategy, changing the cvc after the confirmation of infection related to it or non-improvement of sepsis. the control group is represented by the patients in whom the cvc is removed early.

Eligibility criteria:
inclusion criteria: * all patients with 18 years or more, admitted to icu that had a cvc inserted before or after icu admission and with infection with undefined origin. exclusion criteria: * less than 18 years, severe neutropenia (\<500/mm³), intravascular device (pacemaker, prosthetic valve), unequivocal signs of infection on the site of cvc insertion, patients who were terminally ill defined, bacteremia without a known source, refusal to signing the informed consent.

Keywords: catheter related infection central venous catheter cvc infection
real world study on the application of appropriate electrophysiological technology in the diagnosis and treatment of andrology diseases in northwest china

Conditions: Chronic Pelvic Pain; Chronic Prostatitis

Summary: to carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in northwest china, and establish a database for the prevention and treatment of male diseases in northwest china, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in china.


Eligibility criteria:
inclusion criteria: * patient meets the diagnostic criteria of national institutes of health (nih)ⅲ type prostatitis; * nih-cpsi score \> 10; * the symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month; * age ≥18 years old and ≤60 years old agrees and signs the informed consent; * those who did not receive other similar treatment regimens during treatment. exclusion criteria: * all kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection; * benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis; * for patients with local pain as the main manifestation, attention should be paid to the exclusion of other lesions in the lower abdomen, perineum, lsosacral sites, such as ureteral calculi, bladder calculi, inguinal hernia, pubis, varicocele, epididymitis, rectocolic diseases, lsodorsal myofascitis, etc.; * complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site; * people who have metal implants in their bodies cannot cooperate, such as patients with mental illness. * people who are allergic to the treatment of electrical stimulation or allergic to a variety of drugs.

Keywords: transcutaneous electric nerve stimulation andrology
a validation study of genzyme diagnostics osom trichomonas rapid test and bvblue test

Conditions: Bacterial Vaginosis; Urogenital Infection by Trichomonas Vaginalis

Summary: this research is being done to see if two rapid bedside tests (osom trichomonas rapid test and bvblue test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.

this research is being done to see if two rapid bedside tests (osom trichomonas rapid test and bvblue test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (trichomonas and bacterial vaginosis). both rapid tests (osom and bvblue) are approved by the food and drug administration (fda) to be used by healthcare professionals to aid in the diagnosis of these infections. this study is being done to validate (or confirm)the accuracy of these tests. this study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

Eligibility criteria:
inclusion criteria: * at least 15 years of age at time of enrollment * ability to provide written informed consent exclusion criteria: * currently menstruating or bleeding * use of an antibiotic to treat bacterial vaginosis or trichomonas within the past 7 days
using honest placebos to improve pain management in hand surgery patients

Conditions: Hand or Wrist Surgery

Summary: america is in the midst of an opioid epidemic. one of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. if it is possible to develop new ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis. although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. in fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo. the goal of the proposed study is to examine the feasibility of using an honest placebo to relieve pain for up to 20 real patients. people who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the emergency department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. the investigators hypothesize that: 1) at least 50% of eligible participants will agree to enroll, 2) at least 80% of participants who are enrolled will be retained, and 3) participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill


Eligibility criteria:
inclusion criteria, university orthopedics \& department of plastic \& reconstructive surgery: * 18 years or older * english speaking * have a working phone * scheduled for hand or wrist surgery * able to provide informed consent inclusion criteria, miriam hospital emergency department * 18 years or older * english speaking * have a working phone * able to provide informed consent * present for upper extremity trauma * are expected to be prescribed opioids at discharge * are expected to be discharged from the emergency department exclusion criteria, university orthopedics \& department of plastic \& reconstructive surgery:: * known history of substance use disorder * chronic pain * chronic opioid use * the prescribing physician deems opioid medication not appropriate as part of standard care for any reason exclusion criteria, miriam hospital emergency department * known history of substance use disorder * chronic pain * chronic opioid use * unlikely to follow-up (discretion of investigator and treating provider) * likely to receive surgical repair of the indicated injury
comparison of different objective nociceptive measurement methods during surgery

Conditions: Nociceptive Pain

Summary: traditionally, hemodynamic response e.g. pulse and blood pressure are used to evaluate pain in humans who are anesthetized. these values, however, can be affected by factors other than pain response . in this observational study, different types of digital methods are used that can distinguish signs of pain. however, the study aim to collect data and correlate in between different methods to ensure its reliability.

in humans who undergoing anesthesia or only receiving sedation with the addition of painkillers medication under surgery. nociceptive response usually treats on the basis of hemodynamic and/or respiratory changes. these are interpreted together with a number of other parameters. the anesthetist can't be totally sure if it is nociceptive response or to light anesthesia given. today, there are new monitors included techniques for measuring pain (nociception), but these are not used routinely. by put sensors (adhesive patches) on the skin and connect to these new devices perhaps the anesthetist can be more sure what stimuli patient are responding from, pain or light anesthesia. these techniques measure muscle activity including sweat gland which have been shown in other research studies demonstrate a higher accuracy regarding the response to nociception. the parameters are presented on a monitor as a value, 0-10 or 0-100. this research study is an observational study and intends to observe values / figures that arise from two different types of commercial monitors and manufactures. after the anesthesia, these values will be compared and evaluated in resect as well to hemodynamic response and in between monitors. the two techniques have never before been studied simultaneously on the same human been (control).

Eligibility criteria:
inclusion criteria: * all patients over 18 yrs old, * patients who will be anesthetized or sedated under intervention surgery or surgery exclusion criteria: * not speaking swedish * neuro cognitive diorders e.g. dementia or can't respond on information given. * chronic pain * acute brain trauma * pregnancy
left atrial ablation of paroxysmal atrial fibrillation with implantable loop recorder follow up study: the laapitup 2 study

Conditions: Paroxysmal Atrial Fibrillation

Summary: this study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. namely, the medtronic multi-electrode phased radiofrequency ablation system, the biosense webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. the study hypothesis is that surgical and biosense webster ablation are non-inferior to medtronic ablation.

a target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. each participant will have an implantable loop recorder (ilr) prior to ablation in order to assess af burden. after ablation, each participant will be followed up for a year. the ilr will be used to assess reduction in af burden.

Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal af suitable for af ablation * age \> 18 years old * informed consent to participate in this study. exclusion criteria: * pre-existing ilrs or permanent pacemakers that do not allow for continuous monitoring for af occurrence, or are not mri-safe. * unable to undergo general anaesthesia for af ablation. * previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery. * scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery. * previous thoracic surgery. * participation in a conflicting study. * potential participants who are mentally incapacitated and cannot consent or comply with follow-up * pregnancy * other cardiac rhythm disorders

Keywords: atrial fibrillation ablation implantable loop recorder
a non-interventional pilot study to explore the role of gut flora in diabetes mellitus

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. may be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. male or female of all ages 3. diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin a1c exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition