Kornimate/medical-research-clean huggingface dataset:
cognitive intervention to restore attention using nature environment

Conditions: Heart Failure; Cognitive Dysfunction

Summary: heart failure is a prevalent and serious public health concern with the growing aging population. patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. in past studies, 15 - 27% of heart failure patients had attention impairment. attention is fundamental to human activities including self-care management of heart failure. however, cognitive interventions focusing on attention are scarce in heart failure literature. this study focuses on developing a novel cognitive intervention specifically targeting improved attention and testing its efficacy on improving attention, self-care, and health-related quality of life. the investigators in this study are asking the following 3 questions: 1) does the newly developed cognitive intervention using immersive virtual reality technology (nature-vr) improve attention compared with the control condition (urban-vr)?; 2) does nature-vr intervention improve hf self-care and health-related quality of life compared with urban-vr control condition?; and 3) are selected biological factors associated with attention function in hf? the virtual reality-based cognitive intervention (nature-vr) can be an efficacious intervention for the patients to use and enjoy without burdening already reduced attention. this study has great potential to improve attention and prevent attention impairment, thereby leading to healthier lives among heart failure patients.

heart failure (hf) is a prevalent serious chronic illness that affects 6.5 million american. among hf patients, prevalence of attention impairment is reported as 15-27%. attention is fundamental to human activities including hf self-care. however, cognitive interventions focusing on attention are scarce in hf. the investigators developed a new cognitive intervention with immersive virtual reality technology and created a prototype of the virtual reality-based natural restorative environment intervention (nature-vr). the prototype was feasible and showed larger effects in improving attention among 10 hf patients. in this 2-group randomized controlled pilot study, specific aims are to: 1) examine preliminary efficacy of nature-vr compared with urban-vr on improving attention; 2) examine preliminary efficacy of nature-vr compared with urban-vr on hf self-care and health-related quality of life; and 3) explore possible biomarkers of attention in hf. this study is important and novel because this is the first intervention study targeting attention using virtual reality technology and investigating possible biomarkers associated with attention in hf patients.

Eligibility criteria:
inclusion criteria: * adults (\> 21 years) * diagnosed with chronic hf stage c * able to communicate in english exclusion criteria: * uncorrected visual impairment * major neurological disease (e.g., alzheimer disease, parkinson's disease) * major psychiatric disease (e.g., schizophrenia, bipolar disease)
[18f]bf3-bpa injection for pet imaging study of gliomas in the brain

Conditions: Cerebral Gliosis; Positron Emission Tomography

Summary: in this clinical study, we proposed to perform \[18f\]bf3-bpa pet imaging in subjects with gliomas, to observe the binding ability and non-specific binding of the tracer to glioma lesions in vivo, and at the same time to evaluate the effectiveness of \[18f\]bf3-bpa in the diagnosis and differential diagnosis of glioma, and to evaluate the tolerability and safety of the tracer and the imaging method. the efficacy of \[18f\]bf3-bpa in the diagnosis and differential diagnosis of gliomas will be evaluated, as well as the tolerability and safety of this tracer and imaging method. this study will provide a new method for in vivo imaging of gliomas and provide a clear and intuitive imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * 1. patients with suspicious brain gliomas: * patients diagnosed by the investigator, based on symptoms, course of disease, and mri of the head, as having a suspected high- or low-grade brain glioma, scheduled for brain tumor resection, and with no contraindications to surgery; * no prior and/or current surgery, radiotherapy, or puncture biopsy (other than treatment for symptomatic relief) for brain tumors; * no other primary malignant tumor. 2. age ≥ 18 years; 3. eastern cooperative oncology group (ecog) 0-2; 4. adequate organ function: * platelet count \>100 x 109/l; * urea/urea nitrogen and serum creatinine \<1.5 times upper limit of normal (uln); * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 2.5 times uln. 5. subjects should be fully informed of the content, process and possible risks of the test and voluntarily sign an informed consent form. exclusion criteria: * subjects meeting any of the following criteria will be excluded from the study: 1. severe allergic reaction to any of the drugs or their components in this trial; 2. those who cannot tolerate or are contraindicated to undergo mri and pet; 3. those who cannot accept or tolerate blood sample collection; 4. those who are unable to use effective contraception from the date of signing the informed consent to 3 months after the administration of the drug; 5. pregnant or lactating women or those with positive blood pregnancy test results; 6. those who have participated in other interventional clinical trials prior to the date of informed consent and are within 5 half-lives of the trial drug, or are participating in other interventional clinical trials;
darbepoetin alfa (aranesp) following allogeneic stem cell transplantation

Conditions: Hematologic Malignancies

Summary: the purpose of this study is to find out if darbepoetin alfa is effective in treating low red blood cell levels after allogeneic stem cell transplant. darbepoetin alfa has been shown to help raise red blood cell levels without blood transfusions.

* participants will receive darbepoetin alfa through an injection under the skin, about 28-35 days after their allogeneic stem cell transplant. they will continue to receive the study drug once every three weeks for a maximum of four doses. * blood tests will be performed at weeks 3, 6, 9 and 12. the blood tests done at week three will check to make sure the participant has enough iron in their system. if not, they will need to take an iron supplement. participants will also take a folate supplement to help cell growth and reproduction.

Eligibility criteria:
inclusion criteria: * hematologic malignancies undergoing ablative allogeneic stem cell transplantation for any indication * 18 years of age or older * hgb of less than 10 g/dl at the time of initiation therapy exclusion criteria: * known hypersensitivity reaction to darbepoetin alfa or any of its components * transfusion of packed red blood cells within 3 days of initiation of treatment with darbepoetin alfa * any history of grade iii or iv gvhd * use of any erythropoietic growth factor since transplantation * uncontrolled hypertension * history of seizure * baseline creatinine greater than 2 * dialysis dependence at the time of enrollment * hemolytic uremic syndrome * active gi bleeding * concurrent autoimmune hemolytic anemia * concurrent unstable angina * history of congenital hypercoagulable state or previous venous or arterial thrombosis * relapsed disease prior to the initiation of study treatment * history of renal cell carcinoma

Keywords: aranesp allogeneic stem cell transplant
renal venous flow and cardiac surgery-associated acute kidney injury

Conditions: Acute Kidney Injury; Cardiorenal Syndrome

Summary: the prospective single-center study investigates the association between changes in doppler-derived renal venous flow and cardiac surgery-associated acute kidney injury (csa-aki).

csa-aki is a common postoperative complication in patients undergoing open heart surgery, and is associated with increased mortality and morbidity. venous congestion has been identified as the principal cause of cardiorenal decompensation in patients with heart failure but the relative contribution of congestion-driven renal function decline in csa-aki is not well studied. the prospective single-center study investigates whether serial doppler-derived renal venous flow assessments could help identify subset of patients with cardiorenal syndrome and subclinical renal congestion at high risk of csa-aki.

Eligibility criteria:
inclusion criteria: inclusion criteria: 1. subjects older than 18 years 2. subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass) 3. subjects who signed informed consent forms exclusion criteria: 1. patients requiring mechanical ventilation 2. patients with mechanical circulatory assist devices or extracorporeal membrane oxygenation 3. patients with stage 3 aki with renal replacement therapy (rrt) or life- threatening volume overload treated with rrt 4. stage ≥4 chronic kidney disease (ckd) stage 5. ckd requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload, 6) 6) prediagnosed glomerulonephritis 6. autosomal dominant polycystic kidney disease, postrenal obstruction, or solid organ transplantation 7. anticipated life expectancy of \<12 months 8. likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant) 9. pregnancy or possibility of pregnancy in the next 3 months 10. rhabdomyolysis
development of an adjustment assistance tool dosage of fluoroquinolones in a population pharmacokinetic model

Conditions: Infection

Summary: fluoroquinolones (fq) are among pivotal antibiotic treatments in difficult-to-treat infections. their efficacy has been shown to be linked to the ratio area under the curve (auc) of their plasma concentrations over the minimum inhibitory concentration (mic) of the bacteria treated. eventually, forrest et al., reported in gram-negative infections that an auc/mic above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an auc/mic below this threshold. these results have been reproduced recently by zelenitsky et al. in intensive care unit (icu) patients with threshold similar to the one obtained by forrest et al. lastly, elevated concentrations of fq should be related with the onset of adverse events. thus, therapeutic drug monitoring (tdm) of fq appears of potential interest, particularly in case of severe infections (intensive care unit (icu) patients) or complicated and cost-related infections (osteoarticular infected (oai) patients), with an increasing level of evidence of its use. however, fq tdm requires access to the full auc of the drug with the need of many samples drawn to patients. this appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (pkpop) modelling. pkpop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical...) and modelling inter-individual pharmacokinetic variability. the model created allows then accessing to individual parameters of patients and thus, estimating concentrations and auc of the fq. this approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of auc with a minimum of samples.

open, prospective, monocentric pharmacokinetic study

Eligibility criteria:
inclusion criteria: * age over 18 years * patients in intensive care : infection treated with ciprofloxacin iv * osteoarticular infected patients : infection treated with oral ofloxacin * written consent to participate in the study exclusion criteria: * pregnancy * adults subject to legal protection or deprived of their liberty

Keywords: fluoroquinolones pharmacokinetic infections
comparative study intreatment of trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: this study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and comparing between them according the different outcome parameters.

this is prospective case -series hospital based study, will be conducted on 40 patients with trigeminal neuralgia treated either by percutaneous radiofrequency trigeminal rhizotomy or microvascular decompression at sohag university hospitals, between march 2021 and june 2022 and we will divide the the patients into two groups ,one group will be treated with percutaneous radiofrequency trigeminal rhizotomy and the other group will be treated with microvascular decompression and we will asses the results with the barrow neurological institute pain intensity score .

Eligibility criteria:
inclusion criteria: * failed medical treatment more than 6 months exclusion criteria: * coagulation disorder or hemorrhagic disease; * mental illness and inability to cooperate;

Keywords: trigeminal neuralgia
effect of virtual reality on pain, anxiety, and vital signs of the patients undergoing port catheter implantation

Conditions: Pain; Anxiety; Blood Pressure; Body Temperature Changes

Summary: this study aimed to determine the effect of virtual reality on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. the study was carried out with 139 participants (69 intervention, 70 control) between september 2019 and january 2020. a patient identification form, state anxiety inventory, a table for vital signs, and a visual analog scale for pain severity were used for the data collection. data were collected from the patients before, during, and after the implantation. in the intervention group, a virtual reality device, movies, and relaxing music were provided to the patients.

to determine the effect of virtual reality (vr) on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. the study was a randomized controlled study. the study was carried out with 139 participants (69 intervention, 70 control) between september 2019 and january 2020. data were collected before, during, and after the implantation by using a patient identification form, state anxiety inventory (sai), a table for vital signs, and a visual analog scale for pain severity. in the intervention group, a virtual reality device, movies, and relaxing music were provided and patients were instructed to use it during the implantation and when they felt pain after the implantation. data of the study were analyzed with ibm spss v25.0.

Eligibility criteria:
inclusion criteria: * aged 18 years and older, can communicate in turkish, being diagnosed with cancer, and undergoing port catheter implantation. exclusion criteria: * being have chronic pain or anxiety disorders, using any type of analgesic or anxiolytic, and diagnosed with epilepsy were excluded from the study. the patients who have a visual impairment or also excluded from the study. patients diagnosed with brain cancer or have brain metastasis were excluded from the study considering the potential seizures. during the intervention, the interventions were ended for the patients who experienced headache or dizziness (two most common problems caused by vr) and data of these patients were not included in the analysis.
unfavorable mri but favorable 68ga-psma pet/mri for primary prostate cancer detection

Conditions: Prostate Neoplasm

Summary: this perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric mri but favorable 68ga-psma pet/mri who have had no prior prostate biopsy.

multiparametric mri (mpmri) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (pca) with the prostate imaging reporting and data system (pi-rads) v2. however, there are diagnostic difficulties for suspicious patients with pi-rads score 3 and not all pca are equivalently visible on mpmri. for such patients, other alternative imaging techniques are required to properly characterize and detect pca. it has been widely reported that 68ga-psma pet imaging offers excellent performance in detecting primary pca and is able to noninvasively characterize the aggressiveness of pca. recently, integrated pet/mri, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized pca to aid targeted biopsies and therapy. this perspective cohort study aims to assess the detection rate of pca through prostate biopsy within suspicious patients harboring unfavorable mpmri but favorable 68ga-psma pet/mri who have had no prior prostate biopsy.

Eligibility criteria:
inclusion criteria: 1. men more than 18 years old with clinical suspicion of prostate cancer; 2. serum prostate-specific antigen (psa) \> 4 ng/ml within the previous 3 months; 3. pi-rads score no more than 3 or normal mpmri of prostate; 4. suspicious lesion(s) within prostate on 68ga-psma pet/mri; 5. no evidence of psa increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 6. able to provide written informed consent. exclusion criteria: 1. prior prostate biopsy or prostate surgery; 2. prior treatment for prostate cancer; 3. contraindication to mri or pet (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); 4. contraindication to prostate biopsy.
continuous renal replacement therapy for acute kidney injury by cooling blood

Conditions: Acute Kidney Injury; Continuous Renal Replacement Therapy

Summary: acute kidney injury (aki) is common in intensive care unit (icu) patients and is associated with longer hospital stays and worse survival. the mortality rate of critically ill patients in the icu who receive renal replacement therapy for aki ranges between 50-80%, cardiovascular disease being the second largest cause of death. a previous pilot study from the investigator's group showed that myocardial stunning occurs in aki patients during continuous renal replacement therapy (crrt) and may explain the high cardiovascular mortality in this population. in the chronic intermittent dialysis setting, mild dialysate cooling was shown to improve intradialytic hemodynamic stability and prevent myocardial stunning. the aim of this study is to find out whether cooling the blood in the crrt circuit is an effective intervention to prevent myocardial stunning in aki patients undergoing crrt and improve patient outcomes.

this is a single center, prospective, randomized, open label, controlled trial comparing standard-of-care temperature management with blood cooling crrt. we will recruit approximately 140 patients (70 in each group) from the medical surgical intensive care unit at university hospital and the critical care trauma center at victoria hospital in london, ontario. the study team will randomize patients with acute kidney injury requiring continuous dialysis therapy into one of two groups; either to standard of care continuous dialysis therapy or to cool blood continuous dialysis therapy. all therapy will be delivered using the baxter prismaxtm crrt machine with thermaxtm blood warmer. all participants will undergo a series of echocardiograms (ultrasound of your heart) prior to continuous dialysis therapy initiation, 4-12 hours into therapy, for up to 7 days after therapy initiation, and at discharge from the intensive care unit. blood work will be collected at 4 time points, prior to continuous dialysis therapy initiation, 4-12 hours into therapy, 24 hours into therapy, and at icu discharge. hourly nasopharyngeal and skin temperatures will be collected. oral temperature will be collected every four hours.

Eligibility criteria:
inclusion criteria: * aki as defined by 2012 aki kdigo guidelines requiring crrt. * patient's core temperature between 35°c and 40°c at the time of recruitment. * age 18 years old and older. exclusion criteria: * hypothermia (patient core temperature \<35°c) at the time of recruitment * extreme hyperthermia or hyperpyrexia (patient core temperature \>40°c) at the time of recruitment. * contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy) * patients undergoing targeted temperature management for cardiac arrest. * chronic kidney disease stage 5 as defined by ckd kdigo guidelines \[19\] requiring renal replacement therapy prior to recruitment. * receiving palliative care or immediate plans for withdrawal of life sustaining therapy at the time of recruitment.

Keywords: cooling crrt
novel endoluminal clinical treatment of reflux

Conditions: GERD

Summary: this is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of aluvra for the treatment of gerd.


Eligibility criteria:
inclusion criteria: 1. history of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (ppis) therapy. 2. history of gerd symptoms of at least six months despite continuous ppis. 3. gerd-hrql score ≥15 after discontinuing ppi therapy. 4. gerd-hrql score improvement of at least 6 points while on ppis, with at least 4-point improvement in heartburn subscore. 5. a minimum gerd-hrql score while on ppis of 2. 6. pathologic acid exposure time, a baseline ph \<4.0 for ≥ 5.3% of time during a 48-hour evaluation period. 7. twenty two years of age or older. 8. life expectancy of at least two years. 9. willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study. 10. is capable of understanding clinical study procedures and giving informed consent. exclusion criteria: 1. unable to tolerate an endoscopic procedure 2. presence of esophageal or gastric varices 3. presence of erosive esophagitis (la classification of c or d) 4. presence of a hiatal hernia \> 2 cm 5. presence of barrett's esophagus 6. presence of esophageal motility disorder 7. history of or known esophageal stricture or gross esophageal anatomic abnormalities 8. symptoms of dysphagia more than once per week within the last six months 9. obesity (bmi ≥ 35) 10. gastric or esophageal cancer undergoing active treatment 11. received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites 12. had an ablation procedure in the lower esophageal sphincter area 13. has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder 14. enrolled in a concurrent clinical trial 15. inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator) 16. pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months 17. prior gastric or gerd surgery