Kornimate/medical-research-clean huggingface dataset:
ertapenem for initial empirical treatment of third generation cephalosporin resistant enterobacteriaceae bacteremia

Conditions: Bacteremia; Infection, Bacterial

Summary: this study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant enterobacteriaceae (3gcre) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.

there are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (bsis), that are due to esbl-producing enterobacteriaceae. previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.

Eligibility criteria:
inclusion criteria: * adults, either sex, ages 18 years or above * patients with 3gcre bacteremia * patients admitted to any of the study sites exclusion criteria: * discontinuation of antibiotic due to transition to hospice care * polymicrobial bacteremia * empirical antibiotic after 24 hours of first evidence of bacteremia
sexual function and wellbeing in males with rectal cancer

Conditions: Rectal Cancer

Summary: preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. for men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. to address these questions a longitudinal observational study was initiated where measurements of androgen hormone levels, semen samples and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

men with rectal cancer stage i to iii planned for resection was included in the study. men treated with preoperative rt were assigned to the exposed group and men treated with surgery alone were assigned to the unexposed group. eighteen months after start of inclusion, less than 10% of the participants were treated with surgery alone. to increase the sample size of the unexposed group, men with prostate cancer stage i to iii and scheduled for robot-assisted prostatectomy were also included. participants with rectal cancer were enrolled at two centres in stockholm (karolinska university hospital and ersta hospital) between 2010 and 2014. participants with prostate cancer were enrolled at the urology department of the karolinska university hospital in stockholm between 2012 and 2013. patient data, fasting venous blood samples, semen samples and questionnaires regarding sexual function and well being were collected before start of oncological treatment (baseline), 1 and 2 years after surgery. men treated with preoperative rt for rectal cancer had an additional venous blood sample during the week before surgery. men with rectal cancer under 55 years of age were offered semen cryopreservation. participants could choose if they wanted to participate in one, two or three of the following parts; hormone analysis, semen analysis and/ or questionnaires regarding sexual function and well being. semen sampling and cryopreservation was not performed in men with prostate cancer. changes in hormone levels, semen measurements and sexual function during follow-up were assessed, and compared between exposed and unexposed participants.

Eligibility criteria:
inclusion criteria: * males diagnosed with rectal cancer stadium i-iii, planned for surgery with or without preoperative radiotherapy or males with prostate cancer stadium i-iii planned for robot-assisted prostatectomy without preoperative radiotherapy. * informed consent * fluent in swedish * residents of the stockholm county area exclusion criteria: * rectal cancer stadium iv * previous radiotherapy to the pelvic region * history or evidence of a second pelvic malignancy * androgen deprivation therapy, testosterone replacement or androgen abuse

Keywords: rectal cancer preoperative radiotherapy pelvic surgery sexual function wellbeing hormone levels spermatogenesis
a study to evaluate the safety, tolerability and pharmacodynamics of pumosetrag in patients with gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to determine if pumosetrag is effective in treating gastroesophageal reflux disease (gerd) symptoms in patients who have a history of gerd symptoms and are currently taking an acid suppression therapy, such as a proton pump inhibitor (ppi).


Eligibility criteria:
inclusion criteria: * patients with history of gastroesophageal reflux disease (gerd) symptoms (heartburn, regurgitation, acid taste in mouth). * between ages of 18 - 70 inclusive. * develop gerd symptoms following ingestion of a refluxogenic meal. * able to take a stable proton pump inhibitor (ppi) regimen for duration of study. * understand and sign the informed consent form. exclusion criteria: * pregnant or lactating women. * allergic to pumosetrag or formulation excipients.

Keywords: symptoms of gastroesophageal reflux disease (gerd)
biomedical instrumentation in the study of mirror therapy in elderly's hands motor activity

Conditions: Muscle Weakness Conditions

Summary: check if the mirror therapy represents an effective method in improving the motor activity of the hands of institutionalized elderly.

among the various functions impaired by aging there is the muscle function, which indirectly affects the quality of life for seniors, since it is crucial to the progressive increase of the debilitating condition, leading to difficulties in carrying out everyday tasks and often making them dependent on the assistance of others. the possible neural mechanisms underlying this decrease in muscle function associated with aging include changes undefined in central nervous system, a delay in conduction velocity of motor nerve fibers and in transmission of the neuromuscular junction. in this context, it is necessary to develop procedures that reduce the functional losses and decrease the negative effects of the aging process, increasing the quality of life for seniors. mirror therapy (mt) is the one of those possible procedures, which is based on the activation of mirror neurons from the illusion generated by viewing the reflection of a member in a mirror. when performing a movement with a member who is in your field of vision, generated the reflection in the mirror is able to offer the brain a new, albeit illusory visual stimulus, suggesting that covert member is moving. this illusion promotes the activation of mirror neurons located in the sensorimotor cortex region and the progression of therapy, this activation drives cortical plasticity that promotes the reestablishment of functions, such as motor coordination and increased range of motion. therefore, mt is a promising technique to reduce the functional losses of aging. it is then suggested the implementation of a protocol for functional recovery of mt hands in institutionalized elderly and the measurement of electromyographic activity of the wrist, the range and speed of movement, the writing skill and the application of a questionnaire to katz index calculation in order to investigate whether the technique can benefit this public.

Eligibility criteria:
inclusion criteria: * 60 years old or more * institutionalized elderly * ability to understand and sign the informed consent form. in case of illiteracy, the term will be read to the volunteer and signed by him in the case of functional illiteracy or by officials of the asylum * ability to perform analysis of writing skills throughout the proposed protocol * cognitive preserved, being able to respond to the examiner's command exclusion criteria: * disabling pain to perform movements with their arms * active infection and rash at the application site of emg * severe uncorrected visual deficit * deficit uncorrected severe hearing * neurological disorders

Keywords: elderly mirror therapy hands
statin use in abdominal aortic aneurysm repair

Conditions: Abdominal Aortic Aneurysm

Summary: aneurysm formation is associated with a chronic inflammatory response, depletion of smooth muscle cell population and excessive matrix metalloproteinases (mmps) production. 3-hydroxy-3-methylglutaryl coenzyme a (hmg-coa) reductase inhibitors (statins) are lipid lowering agents with pleiotropic effects including anti-inflammatory activity. elective open aaa repair patients will be randomised to receive either statin (atorvastatin 80 mg) or placebo (dummy tablet) for 4 weeks pre-operatively. tissue samples will be obtained from patient's aneurysm to assess mmp's and their inhibitors timp's. it is hypothesized that patients receiving statin will have reduced mmp's.

all patients listed for elective open aaa repair will be screened for suitability to participate within the study. in this double blind randomized control trial patients will be recruited through vascular surgical outpatient clinics. after inclusion, informed consent and evaluation of base line characteristics patients will be given a prescription for study medication. this prescription was exchanged by the patient for medication at the hospital pharmacy. randomization will be carried out by pharmacy with computer generated sequence with a sub group size of 4. this will ascertain the order of prescribed drug/ placebo. pharmacy then dispensed the drug/ placebo in this order. drug used will be atorvastatin 80 mg, white, elliptical, film coated tablets debossed '80' on one side and 'pd 158' on the other side. the placebo is similar in shape and colour. drug/ placebo will be given for 4 weeks pre-operatively. full thickness infrarenal aortic samples will obtained at time of operation and the exact sample site will be recorded. samples will be washed with 0.9% saline to remove blood and clots, snap-frozen and stored at -80c for subsequent mmp 2, 8 and 9 and timp 1 and 2 analyses.

Eligibility criteria:
inclusion criteria: * patient with an aaa \>5.5cm diameter listed for open aaa repair at least 3 weeks from screening attendance. exclusion criteria: * patients already on statin, * inability to provide informed written consent, * contraindication to statin (intrinsic liver disease, * chronic alcohol abuse, impaired renal function, unstable hypothyroidism, * unexplained muscle aches, hypersensitivity to atorvastatin or any of its components), * previous unilateral or bilateral lower limb amputation and concomitant use of fibrates, * erythromycin, * immunosuppressive drugs, * antifungal drugs or lipid lowering drugs.
a study of hmpl-306 in advanced solid tumors with idh mutations

Conditions: Isocitrate Dehydrogenase Gene Mutation

Summary: an open label single-arm clinical trial to evaluate the safety, tolerability, pk, pd, and preliminary efficacy of hmpl-306 in advanced or metastatic solid tumors with idh mutation.

hmpl-306 is a dual idh1/2 inhibitor this is a phase 1, open-label, multicenter study to evaluate the safety and tolerability of hmpl-306 administered orally in the treatment of subjects with advanced or metastatic solid tumors with idh mutation. the study consists of 2 parts: part 1 (dose escalation) and part 2 (dose expansion). the dose escalation part will determine the mtd/rp2d. the dose expansion part will administer the mtd/rp2d to midh-positive solid tumor malignancies including, but not limited to, cholangiocarcinoma, skeletal chondrosarcoma, low-grade glioma, perioperative low-grade glioma

Eligibility criteria:
key inclusion criteria: subjects are eligible for enrollment into this study if they meet any of the following criteria (note: this is not an exhaustive list): * subjects aged ≥18 years. * ecog performance status 0 or 1 * subjects must have a documented idh mutation per immunohistochemistry (ihc), polymerase chain reaction (pcr), or next generation sequencing (ngs) testing of tumor tissue. * subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists. key exclusion criteria: subjects are not eligible for enrollment into this study if they meet any of the following criteria (note: this is not an exhaustive list): * subjects who received an investigational agent \<14 days prior to their first day of study drug administration * subjects who are pregnant or breastfeeding * subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever \>38.3°c during screening visits or on their first day of study drug administration. * subjects with some current or prior heart conditions * subjects taking medications that are known to prolong the qt interval may not be eligible * subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation * some subjects with some current or prior gastrointestinal or liver diseases * subjects with inadequate organ function as defined by the protocol

Keywords: cholangiocarcinoma skeletal chondrosarcoma glioma idh mutation
the effect of therapeutic play on children's pain and fear and parents and students' satisfaction levels

Conditions: Child Behavior; Pain; Anxiety; Anxiety and Fear

Summary: this study aims to determine the effects of playing with therapeutic toys made by nursing students on children's fear and pain levels towards treatment and the satisfaction levels of student nurses and parents.

there are a limited number of studies in the literature examining the effects of therapeutic play implemented by nursing students. although there are many studies showing that therapeutic play intervention is an effective intervention for sick children, it is seen that these studies are mostly conducted by researchers or clinical staff, and nursing students who have been in pediatric wards for a long time due to their clinical practices are far from therapeutic play practices. therapeutic play may be a way for nursing students to initiate communication with children more easily. therefore, there is a need for large-scale studies including nursing students. starting from their student years, nursing students using therapeutic play as a means of communication with sick children may make them more willing to use such activities in their professional lives. in addition, determining the satisfaction levels is important for the continuation of such studies in clinical practice.

Eligibility criteria:
inclusion criteria: * having a child aged 3-6 * having at least two days of inpatient treatment in the hospital (to gain experience with medication administration) * being accompanied by a parent * having one invasive drug treatment ordered by a doctor - knowing and speaking turkish * being willing to participate in the study exclusion criteria: * those who are in intensive care, * those who have undergone surgery, * those who do not have a companion with their mother, * children with neurological and psychological disorders and parents, * children who only receive oral medication (as the level of pain and fear related to treatment will be low)

Keywords: pain anxiety children nursing student therapeutic play
impact of exercise on cognitive impairment in end-stage renal disease

Conditions: Cognitive Impairment; End-Stage Renal Disease

Summary: the purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.

patients with end stage renal disease have higher cognitive impairment than general population. they also have decreased physical and functional capacity. exercise has shown to improve cognition in general population. this study will evaluate if exercise improves cognition in dialysis patients. it will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.

Eligibility criteria:
inclusion criteria: * patients with esrd on dialysis * age greater than 20 years * have means of transportation to and from the exercise session * speak english (as the neuropsychological tests will be performed in english) exclusion criteria: * recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (\> nyha grade ii) * history of stroke in the last 2 months * active respiratory disease * uncontrolled hypertension * severe uncontrolled diabetes * persistent predialysis hyperkalemia * active decompensated liver disease * symptomatic peripheral vascular disease * musculoskeletal abnormalities that will be prohibit their participation in the exercise program * health conditions needing frequent hospitalizations * other health conditions causing inability to follow exercise program correctly * unwillingness to participate in structured exercise program * current use of antipsychotics or anti-epileptics * inability to hear, read or write which will limit their ability to perform the cognitive tests

Keywords: esrd kidney failure exercise cognitive impairment
an ai platform integrating imaging data and models, supporting precision care through prostate cancer's continuum

Conditions: Prostate Cancer; Prostate Cancer Metastatic; Prostate Cancer Recurrent; Prostate Cancer Aggressiveness

Summary: in europe, prostate cancer (pca) is the second most frequent type of cancer in men and the third most lethal. current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced ai models to go beyond soa by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. to date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available pca public datasets (e.g. us tcia) are only few hundred cases making model generalizability impossible. the procancer-i project brings together 20 partners, including pca centers of reference, world leaders in ai and innovative smes, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure european image infrastructure with tools and services for data handling. the platform hosts the largest collection of pca multi-parametric (mp)mri, anonymized image data worldwide (\>17,000 cases), based on data donorship, in line with eu legislation (gdpr). robust ai models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral ai models for addressing 8 pca clinical scenarios. to accelerate clinical translation of pca ai models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. a roadmap for ai models certification is defined, interacting with regulatory authorities, thus contributing to a european regulatory roadmap for validating the effectiveness of ai-based models for clinical decision making.


Eligibility criteria:
inclusion criteria: 1. histological confirmed pca or suspicion of pca (abnormal psa values and/or positive dre); 2. magnetic resonance imaging examination, including at least a high-resolution axial t2-weighted imaging and axila diffusion-weighted imaging (dynamic contrast-enhanced imaging is recommended, but not mandatory); 3. age ≥ 18 years at the time of diagnosis 4. signed written informed consent form (only for prospective enrollement).

Keywords: prostate cancer repository open image space annotated and under donorship images quality of image providers cloud infrastructure tools to build ai applications advanced ai techniques
a randomized, placebo-controlled study to assess the efficacy of propantheline for the treatment of overactive bladder

Conditions: Overactive Bladder Associated With HTLV-1

Summary: it's a double blind, placebo controlled study to assess the efficacy of propantheline bromide to treat overactive bladder (oab) in htlv 1 infected patients. we think that the treatment of the oab with propantheline could reduce nocturia and frequency in sixty percent.

double blind, placebo controlled study to assess the efficacy of propantheline bromide to treat overactive bladder (oab) in htlv 1 infected patients treatment group propantheline bromide: 15mg, three times daily for 08 weeks. control group placebo 03 times daily case definition clinically defined oab patients (ics criteria), infected by htlv-1. frequency was defined as more than 08 daytime voids. nocturia was defined as more than 02 voids after sleeping. inclusion criteria more than 18 year. htlv-1 infected patients with overactive bladder. negative culture of urine. without neurological impairment. exclusion criteria persistently positive urine culture history of: allergy to medication, head or spinal trauma. head and neck, neurological,spinal, lower abdominal or pelvic surgery. stroke. users of urinary catheters.

Eligibility criteria:
inclusion criteria: * htlv-1 infection * more than 18 years * negative urine culture * no neurological damage exclusion criteria: * diabetes * persistently positive urine culture * pelvic, head, urological or gynecological surgery * stroke

Keywords: overactive bladder htlv-1 propantheline anticholinergic
closed loop ventilation strategy in intensive care unit (icu) patients

Conditions: Respiratory Failure; All Intubated Patients

Summary: adaptive support ventilation (asv) is a closed loop ventilation mode that can act both like pcv and psv automatically. some studies suggest that asv can reduce the weaning time in icu patients. the investigators hypothesized that using asv from the beginning of intubation can reduce the total duration of mv and los in the icu when compared to conventional modes such as pcv+psv


Eligibility criteria:
inclusion criteria: * intubated and mechanically ventilated icu patients for more than 24 hours exclusion criteria: * patient with a tracheostomy * patients under home mechanical ventilation
effect of anesthesia on optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.

the purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

Eligibility criteria:
inclusion criteria: patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study. exclusion criteria: patients with a history of cerebral hemorrhage or cerebral infarction, patients \< 20 years of age, patients ≥ 80 years of age, patients with unexpected hemodynamic instability during surgery, failure to measure optic nerve sheath diameter.