Kornimate/medical-research-clean huggingface dataset:
comparing thoracolumbar interfascial plane block with erector spinae plane block

Conditions: Spinal Surgery; Quality of Recovery; Postoperative Analgesia; Postoperative Complications

Summary: major spinal surgery causes greater pain in the postoperative 24 hours. patients with severe pain may have prolonged hospital stays and delay in mobilization. in addition, chronic pain may be seen in these patients due to ineffectively managed acute postoperative pain. therefore, optimizing acute postoperative analgesia is a priority in patients undergoing major spinal surgery. recently, ultrasound-guided interfascial plane blocks such as thoracolumbar interfascial plane block (tlipb)and the erector spinae plane block (espb) have been described in spinal surgery. both blocks clinically seem to be safe and easily performed. the aims of this study are to compare the quality of recovery scores, overall morbidity and postoperative analgesia after major spinal surgery in patients receiving either tlipb or espb.

thoracolumbar interfascial plane block (tlipb)and erector spinae plane block (espb) and have been shown to provide effective analgesia after spinal surgery. espb targets ventral and dorsal rami of the spinal nerve and also spreads over the paravertebral and epidural space. however, tlipb targets only dorsal rami of the spinal nerve and spare ventral rami which may provide early ambulation. in addition, depositing local anesthetic in the fascial planes may prevent intraoperative washout. it may translate to an increase in the quality of analgesia. on the other hand, pain is an incomplete measure of postoperative recovery. no study to date has compared these two blocks in terms of the quality of recovery after major spinal surgery. this study will test the hypothesis that patients receiving tlipb have higher qor-40 scores in comparison with patients receiving espb.

Eligibility criteria:
inclusion criteria: -≥ 18 years old, * undergoing posterior lumbar spinal one to three levels fusion surgery * having signed a written informed consent form, * asai-iii exclusion criteria: * contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,...) * contraindication to nonsteroidal anti-inflammatory drugs, * patient who has already had a spinal surgery, * patient with chronic pain syndrome (use \> 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia, * a mental or linguistic inability to understand the study, * pregnant or or breastfeeding women, * patient who can not communicate in turkish

Keywords: thoracolumbar interfascial plane block erector spinae plane block thoracolumbar decompressive surgery
a retrospective review of malignant liver tumors

Conditions: Liver Cancer

Summary: this study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. patients treated with surgical resection, percutaneous radiofrequency ablation (rfa), and transarterial chemoembolization (tace) will be compared with patients not receiving these treatments. tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.

subjects will be identified by diagnosis and procedure codes from a university surgical practice and the st. john medical center cancer registry. data will be obtained by review of both the clinic and hospital charts. in addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. subjects were not exposed to risk beyond that posed by the recommended treatment. all treatments were within the scope of standard medical care. the primary investigator has no knowledge of the treatments chosen for the patients he did not manage. the subject's referring physician may be contacted to obtain follow-up data on the subject. the follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.

Eligibility criteria:
inclusion criteria: * patients with primary or metastatic hepatic malignancies exclusion criteria: * patients not diagnosed with primary or metastatic hepatic malignancies

Keywords: hepatocellular carcinoma colorectal carcinoma metastatic to liver primary liver cancer
double-blinded, placebo-controlled phase 1b study for safety, pk, efficacy, pd of ro7049665 in participants with ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the principal aim of this study is to evaluate the safety and tolerability of ro7049665 in participants with active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * diagnosed with uc for at least 12 weeks prior to screening * screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years * evidence of disease activity at time of screening * insufficient clinical response to standard of care (soc) therapy or intolerance to soc exclusion criteria: * diagnosis of crohn's disease or indeterminate colitis * history of infection with hepatitis b, human immunodeficiency virus (hiv), active hepatitis c virus (hcv) infection, or other chronic infection * active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before day -1 * history of primary or acquired immunodeficiency * abnormal hematologic values * abnormal hepatic enzyme or hepatic function values
neuromuscular ultrasound in als

Conditions: ALS

Summary: amyotrophic lateral sclerosis (als) is a progressive fatal neurodegenerative disease affecting motor neurons. early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. nerve and muscle ultrasound may provide this information. this study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in als.


Eligibility criteria:
inclusion criteria: * subjects referred to the electromyography laboratory for als. exclusion criteria: * patients with known comorbid myopathy or neuropathy will be excluded from the study. * patients unable to provide their own consent will be excluded.
impact of gabapentin on slow wave sleep in adult critically ill patient

Conditions: Sleep Deprivation; Critically Ill

Summary: the investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. increasing slow-wave sleep will improve the patients' outcomes (shortening icu length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, thailand.

up to 61% of critically ill patients have sleep deprivation in icu. sleep deprivation can cause delirium and lead to prolonged icu length of stay and mechanical ventilator days. however, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in icu patients. there were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. the objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to icus at ramathibodi hospital, a university hospital, thailand.

Eligibility criteria:
inclusion criteria: * adults (18 years and older) * patients admitted to icu not more than 24 hours at the time of randomization exclusion criteria: * patients admitted to icu less than 72 hours * patients receiving gabapentin within 14 days prior to randomization * patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization * patients having contraindications to gabapentin * patients receiving high dose vasopressors more than 1 hour during icu admissions * patients presenting with severe respiratory failure (pf ratio \< 100) * patients presenting with rass \< -2 at the time of randomization * patients having target rass of \<-2 during icu admissions * terminal ill patients * pregnancy

Keywords: gabapentin sleep deprivation critically ill patients slow-wave sleep
collecting and storing blood and brain tumor tissue samples from children with brain tumors

Conditions: Childhood Atypical Teratoid/Rhabdoid Tumor; Childhood Central Nervous System Germ Cell Tumor; Childhood Cerebral Anaplastic Astrocytoma; Childhood Cerebral Astrocytoma; Childhood Choroid Plexus Neoplasm; Childhood Craniopharyngioma; Childhood Grade I Meningioma; Childhood Grade II Meningioma; Childhood Grade III Meningioma; Childhood Infratentorial Ependymoma; Childhood Oligodendroglioma; Childhood Supratentorial Ependymoma; Ependymoma; Newly Diagnosed Childhood Ependymoma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified; Recurrent Childhood Visual Pathway Glioma

Summary: the purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.

objectives: i. collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at children?s oncology group institutions. ii. provide a repository for long-term storage of specimens from these patients. iii. make these specimens available to qualified researchers to understand the biology of pediatric brain tumors. outline: this is a multicenter study. brain tumor tissue and blood specimens are collected from patients and banked for future study.

Eligibility criteria:
inclusion criteria: * diagnosis of brain tumor * previously treated at a children?s oncology group (cog) institution * patients are eligible at time of diagnosis, second-look surgery, recurrence, or development of a second malignant neoplasm * must have brain tumor biological specimens derived from primary tumors of the cns available for submission
efficacy, safety and tolerability of balcinrenone/dapagliflozin compared to dapagliflozin in adults with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (ckd) and albuminuria. this study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (uacr), compared with dapagliflozin in patients with ckd. this is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future phase iii study in patients with ckd.

this is a phase iib, multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy study aiming to determine the effect on albuminuria, as well as safety and tolerability, of balcinrenone/dapagliflozin compared with dapagliflozin, when given once daily on top of other standard of care (soc) to patients with ckd and albuminuria. study population will include participants with ckd (egfr ≥ 25 to \ 100 mg/g to ≤ 5000 mg/g. participants with or without a diagnosis of t2dm and with or without an sglt2 inhibitor treatment at screening are eligible for the study. the study will be conducted at approximately 110 sites in approximately 16 countries globally. at least 300 participants will be randomised in order to have 300 evaluable participants. participants will be randomised to one of 3 treatment arms in a 1:1:1 ratio: * balcinrenone/dapagliflozin 15 mg/10 mg * balcinrenone/dapagliflozin 40 mg/10 mg * dapagliflozin 10 mg for each participant, the total duration of participation will be approximately 23 weeks: an up to 3-week screening period followed by a 12-week treatment period, and an 8-week follow-up period after end of investigational medicinal product (imp) treatment.

Eligibility criteria:
inclusion criteria: - age ≥ 18 years old - diagnosis of ckd and egfr ≥ 25 to \ 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol). - serum potassium ≥ 3.5 mmol/l to ≤ 5.0 mmol/l. - stable raas inhibitors treatment for 4 weeks before screening. participants who cannot tolerate or are not treated with raas inhibitors can also participate in the study. exclusion criteria: - uncontrolled arterial hypertension (sbp \> 160 mmhg or dbp \> 100 mmhg). - hypotension defined as sbp \ 3 × uln; or tbl \> 2 × uln. - serum hco3 \< 18 mmol/l at screening. - adrenal insufficiency (eg, addison's disease, prolonged use of glucocorticoids). - any use of the following within 4 weeks prior to screening: - mra (or planned initiation of mra treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - strong or moderate cyp3a4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment.
iloprost in gas exchange/pulm mechanics in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Summary: the investigators believe that iloprost will improve gas exchange in copd patients with pulmonary hypertension.

pulmonary hypertension and right heart failure can complicate the management of the patient with advanced copd. attempts to treat this pulmonary hypertension with systemic vasodilators frequently result in a worsening of ventilation perfusion matching and an increase sense of dyspnea. this study will look at the effect of an fda approved pulmonary vasodilator, iloprost, on gas exchange and pulmonary mechanics in patients with copd. ten clinically stable patients will be enrolled. they will report to the lab on the morning of the study and after an arterial line is placed, pulmonary function measurements and arterial blood gases will be obtained. iloprost (2.5 mcg via nebulizer) will be administered and the effect upon arterial blood pressure, respiration and arterial saturation will be monitored. pulmonary function tests (pfts) and blood gases will be repeated after 30 minutes. patients who remain clinically stable without evidence of a fall in arterial po2 or systemic blood pressure would inhale a second dose of 2.5 mcg of iloprost. the patient will be monitored for a minimum of 2 hours after their last dose of iloprost. primary outcome variable will be the alveolar arterial o2 difference while secondary outcomes will include pao2, venous admixture, fvc and fev1, dlco and ventilatory equivalents for o2 and co2. all comparisons will be made using student's t-test with a bonferroni correction. the number of study patients was chosen on the basis of a power analysis to provide an alpha of 0.05 at a level of 0.9.

Eligibility criteria:
inclusion criteria: * fev1 \< 65% of predicted and fev1 to fvc ratio \< 70% * baseline pao2 while stable between 60-75 mmhg and * the ability to provide informed consent exclusion criteria: * clinical instability as evidenced by an acute exacerbation requiring an intensification of therapy and/or the need for hospitalization with the preceding 3 months. * presence of an additional cause of lung disease as suggested by history, clinical or radiographic findings, or pulmonary function tests * presence of left ventricular dysfunction and/or left atrial enlargement by echo, echo or catheterization * heparin allergy * pregnancy or breast feeding

Keywords: chronic obstructive pulmonary disease pulmonary hypertension
indocyanine green and portal pressure in viral and alcoholic cirrhotic patients with hepatocarcinoma

Conditions: Carcinoma, Hepatocellular; Alcoholic Cirrhosis; Viral Cirrhosis; Postoperative Hepatic Failure

Summary: the aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., icg) and the preoperative value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. these differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy. the investigators' hypothesis is that at a comparable icgr-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.


Eligibility criteria:
inclusion criteria: * resectable or amenable to resection hcc in cirrhotic child a patients of alcoholic or viral etiology exclusion criteria: * cirrhosis child-pugh b * absence of patient consent * psychiatric pathology

Keywords: hepatic functional reserve hepatocellular carcinoma (hcc) indocyanine green retention rate at 15 minutes (icg-r15') portal pressure (pp) hepatic portal venous gradient (hpvg) alcoholic and viral cirrhosis makuuchi criteria barcelona clinic of liver cancer (bclc) hepatic resection
an observational pilot study to develop a behavioral economics electronic health record module to guide the care of older adults with diabetes

Conditions: Diabete Mellitus

Summary: this study will develop a new electronic health record module to improve guideline-compliant care of older adults with diabetes. the module will incorporate effective behavioral economics (be) principles to improve the degree to which care of older adults is compliant with choosing wisely guidelines; this generally involves less aggressive targets for hba1c, and reductions of medications other than metformin. the implementation of the module will ultimately be triggered by medication prescribing in epic. the be principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior. the study will involve provider workflow analysis based on observation, module user testing, and live usability testing with direct observation and semi-structure interviews.

the primary objective of this study is to develop a scalable, ehr customization toolkit that applies be insights to promote appropriate diabetes care in older adults based on the american geriatric society's choosing wisely guideline, as to assess the acceptability of the resulting module.

Eligibility criteria:
inclusion criteria: * providers in nyu outpatient primary care, geriatrics, or endocrine clinics at nyu who care for older adults with diabetes exclusion criteria: * none
polyacrylamide injection in patients ineligible for surgery

Conditions: Urinary Incontinence

Summary: transurethral injection using polyacrylamide hydrogel (bulkamid®, contura a/s, denmark) is an established treatment for stress urinary incontinence. the rates of women reporting improvement or cure after bulkamid injection for stress urinary incontinence range between 64-77% with a very low morbidity. however, the indications for use are unclear. although transurethral polyacrylamide hydrogel injection is inferior to midurethral slings with regard to expected cure rates, the procedure is associated with very low rates of adverse events in general and serious adverse event in particular. as such, it may be an important alternative for patients where surgery is not considered a safe option either because of co-morbidity or because of complicated incontinence. the investigators performed a prospective study to determine the effects of transurethral polyacrylamide hydrogel injection in patients considered ineligible for midurethral sling surgery.

in this prospective observational study the investigators included female patients who received treatment with transurethral polyacrylamide hydrogel injection (bulkamid®). patients were considered ineligible for surgery based on significant co-morbidity, one or more previously failed invasive treatments, complex urinary incontinence, or previous pelvic radiation therapy. at the baseline visit patients underwent a routine gynecological exam including pelvic ultrasonography. patients completed validated questionnaires at the baseline visit and follow-up for evaluation of subjective treatment success. at baseline, women were asked to self-report any concomitant diseases or health conditions which were noted in the patient records together with a standard gynecological, urological and general health history. follow-up visits were scheduled at 2 and 6 months after first injection at which time a second injection was administered at patients' discretion.

Eligibility criteria:
inclusion criteria: * women with stress urinary incontinence considered ineligible for surgery based on significant co-morbidity, one or more previously failed invasive treatments, complex urinary incontinence, or previous pelvic radiation therapy. exclusion criteria: * patients who do not want treatment or to participate in study follow-up * below 18 years of age