Kornimate/medical-research-clean huggingface dataset:
personalized cancer stem cell high-throughput drug screening for glioblastoma

Conditions: Newly Diagnosed Glioblastoma

Summary: proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care radiation and tmz.

a panel of fda approved drugs will be tested by high throughput screening, which is clia certified allowing for clinical decisions based on the results, to identify a combination of up to 3 drug candidates for treating individual patients. lead candidates will be evaluated by pharmacists and a team of physicians, to confirm that prescribed drugs do not utilize pharmacological/ metabolic pathways that are known to increase the likelihood of toxicity, prior to initiating treatment. investigational drug therapy, targeting cscs, will be initiated alongside standard of care chemoradiation with tmz.

Eligibility criteria:
inclusion criteria: * histological diagnosis of gbm (who grade 4) * subjects ≥18 years of age * patients must have a life expectancy of \>6 months * patients must have a surgically accessible tumor with the intent for a gross or near total resection of the tumor mass (gbm, who grade 4) * patients must have a kps rating of ≥70 * patients should not have received any prior systemic anti-cancer therapy * patients must be negative for hiv, hepatitis b and c * baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria: * hemoglobin (hgb)\> 8 g/dl * absolute neutrophil count (anc) \> 1,000/mm3 * platelet count \> 100,000/mm3 * creatinine \< 2 mg/dl * alkaline phosphatase (alp), aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 3x upper limit of normal (uln) exclusion criteria: * metastatic disease * diseases or conditions that obscure toxicity or dangerously alter drug metabolism * serious intercurrent medical illness * inadequately controlled hypertension * history of myocardial infarction or unstable angina within 6 months * history of stroke or transient ischemic attack within 6 months
mic-key versus mini one family preference comparison

Conditions: Gastroesophageal Reflux; Feeding Disorder; Family Satisfaction

Summary: the objective of this study is to compare two low profile balloon gastrostomy button enteral feeding devices, both currently used as standard of medical care. the investigators aim to compare family preference and rate of complications between the two devices in a prospective cohort of children. this is the first step in comparing initial and long-term outcomes along with the need for seeking medical advice for gastrostomy site-related complications. the secondary aim of this study is to follow this population long term (4 years) to document the prevalence of: granulation tissue, infection, skin breakdown, and how long the gastrostomy tube balloon remains functional (does not lose water).

this is a single center prospective, randomized study with a crossover design, comparing two low profile balloon gastrostomy buttons (figure 1), mic-key™ and mini one™ that are routinely used at cmh. each subject will be randomly assigned to one button type at the time of initial placement. after placement, standard practice is to perform the first gastrostomy change in the clinic at 2 months where the primary caregivers replace the button under supervision. therefore, the initial device after randomization will remain in place for 2 months. at the first scheduled device change, the other type of button will replace the original gastrostomy button device. this will remain in place for another 2 months. at the routine visit at 4 months the parents will be asked to choose which button they prefer to keep. this will meet the primary outcome endpoint of the study. the investigators will continue to follow as many subjects as possible to 4 years in order to identify any potential differences in secondary end points. a caregiver satisfaction survey is routinely used in the clinics. parent responses to this survey will be also be used in the study analysis.

Eligibility criteria:
inclusion criteria: * children ages 0-5 years of age requiring 0.8 cm or 1.0 cm gastrostomy feeding devices for enteral nutrition seen in the surgery, gi or special care clinics * gastrostomy placement after irb approval (enrollment will continue until 170 evaluable subjects have completed the 4 month visit. expected attrition for the 4 year follow-up is 40%. * english-speaking families exclusion criteria: * children with dermatologic conditions influencing gastrostomy site healing and tract epithelialization * children with immunosuppression * children with active malignancy requiring treatment * inability to commit to 4 months follow up

Keywords: gastroesophageal reflux feeding disorder gastrostomy tube family satisfaction gt button enteral nutrition gastrostomy button
short-term effect of using non-immersive gamified exercises on chronic pain in people with stroke.

Conditions: Stroke Patients

Summary: rehabilitation after stroke is essential to minimize permanent disability. gamification of exercises has emerged as a promising strategy for increasing motivation and rehabilitation efficacy in people with stroke. however, there is a gap in understanding how exercise gamification can aid in pain management among people with stroke who are experiencing shoulder pain difficulties. this study aims to evaluate the short-term effect of using gamified non-immersive exercises on shoulder pain level, upper limb range of motion, and shoulder and elbow muscle activities while doing different activities in people with chronic stroke. the study will be conducted using an observational study design. various lab assessments include measuring the rom of the shoulder (mocap), emg, fnirs, pain intensity using vas scale, and muscles activities patterns across upper limb joints.


Eligibility criteria:
inclusion criteria: * experiencing motor difficulties in using the paretic arm, with some use of hand/arm as determined by therapist * not participating any other intervention studies * male/female ≥18 years old * had a stroke requiring with any degree of arm mobility. * capacity to consent to participate * able to communicate adequately in english with the research team * mild or moderate pain in shoulder or upper limb (below 6 and more than 2on the vas scale). * able to walk without any assistant at least for ten meters exclusion criteria: * any medical condition compromising the safety or the ability to take part to the study as determined by the therapist (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity) * history of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure * unable to follow two stage command * moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by rehab team * severe spasticity (more than 2 on the modified ashworth scale) * any device preventing use of emg, fnirs i.e. dbs or pacemaker
complications of exchange transfusion in neonates

Conditions: Kernicterus

Summary: exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore ,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure .

about 60% of term and 80% of preterm infants have clinical jaundice in the first week after birth but only 2% to 16% of them develop severe hyperbilirubinemia (total serum bilirubin \> 25mg/dl) ,which is an emergency because it may cause neonatal bilirubin encephalopathy (kernicterus), which can result in death or irreversible brain damage in survivor. exchange transfusion is the standard method of therapy for immediate treatment of severe hyperbilirubinemia and prevention of kernicterus. although the frequency of neonatal exchange transfusion has declined markedly in the past two decades, this procedure is still performed in many countries, especially in those with a high incidence of neonatal hyperbilirubinemia. exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure . most of these complications are transient, such as severe thrombocytopenia, apnea, hypocalcemia , bradycardia, and hyperkalemia and recovery is expected along with appropriate care and follow up. but serious complications and even death can occurs due to cardiovascular collapse during exchange , necrotizing enterocolitis, bacterial sepsis, and pulmonary hemorrhage that can be avoided by careful cardio-pulmonary and oxygen saturation monitoring.

Eligibility criteria:
inclusion criteria: * all preterm and full term neonates who need exchange transfusion exclusion criteria: * neonatal sepsis * congenital anomalies

Keywords: hyperbilirubinemia kernicterus
biomarkers of acute kidney injury following cardiac surgery

Conditions: Novel Biomarkers of Acute Kidney Injury Following Cardiac Surgery

Summary: acute kidney injury occurs in up to 30% of patients undergoing cardiac surgery. cardiac surgery associated-acute kidney injury (csa-aki) is characterized by a sudden and sustained decrease in renal function with insufficient elimination waste products. the problem is that postoperative diagnosis of csa-aki is delayed because it relies solely upon the slow and unreliable rise in serum creatinine (scr) levels that may lead to delayed start in treatment and increased risk of adverse outcomes. we hypothesize that matrix metalloproteins (mmps) -2, -9 and neutrophil gelatinase-associated lipocalin (ngal) are associated with and earlier detectors of csa-aki compared to levels of scr.

cardiopulmonary bypass (cpb), although essential to the performance of most cardiac operations, has been shown to cause injury to other organs, particularly to the kidneys and brain. matrix metalloproteins (mmps) are ubiquitous proteolytic enzymes that degrade extracellular matrix and have been shown to be involved in injury to transplant kidneys. to date, no interventions are available to decrease the risk of cardiac surgery associated-acute kidney injury (csa-aki). ngal is a known indicator of injury to kidney, thus making it a promising biomarker for csa-aki. it may be that a single biomarker will not be sensitive and specific across the spectrum of csa-aki. this research investigates mmp-2, -9 and neutrophil gelatinase-associated lipocalin (ngal) and their association with and earlier detection of csa-aki compared to levels of scr. we hypothesize that increased activity of mmps are associated with csa-aki. furthermore, mmp-2 and/ or -9 may be predictors and/ or biomarkers for the early detection of csa-aki compared to serum levels of creatinine.

Eligibility criteria:
inclusion criteria: * the inclusion criteria consisted of both sexes, 18-85 years of age, undergoing elective or urgent cardiac surgery with a hemoglobin (hgb) \>100 g/l. exclusion criteria: * the exclusion criteria included were patients for emergent surgery, pre-existing chronic kidney disease (egfr\<30 ml/min) on dialysis or prescribed nephrotoxic mediations.
bioavailability study of sirolimus tablets 2 mg under fasting condition

Conditions: Healthy

Summary: this study is to assess the sirolimus tablets 2 mg of dr. reddy's laboratories limited, india and rapamune® (sirolimus) tablets 2 mg of wyeth laboratories, philadelphia in healthy, adult,human subjects under fasting conditions.

open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of sirolimus tablets 2 mg under fasting conditions.

Eligibility criteria:
inclusion criteria: i. provide written informed consent ii. must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg iii. having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in kg/height in m2 iv. must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance) v. female subjects * of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (iud), or abstinence * surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) exclusion criteria: i. incapable of understanding the informed consent ii. systolic blood pressure less than 90 mm of 140 mm of hg iii. diastolic blood pressure less than 60 mm of 90 mm of hg iv. oral temperature is below 95.0°f or above 98.6°f v. pulse rate below 50/min or above 100/min vi. history of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs vii. any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function viii. consumption of grapefruit for the past ten days prior to the check-in, in each period ix. regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period x. habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period xi. difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period xii. intake of over the counter (otc) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing xiii. clinically significant abnormalities and / or with significant diseases xiv. confirmed positive in alcohol screening xv. confirmed positive in selected drug of abuse xvi. participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study xvii. confirmed positive in urine pregnancy test xviii. female detected to be pregnant, breast feeding or who is likely to become pregnant during the study
roux-en-y hepaticojejunostomy for hepatolithiasis with sphincter of oddi laxity

Conditions: Hepatolithiasis; Sphincter of Oddi Dysfunction

Summary: objective: evaluate the role of roux-en-y hepaticojejunostomy (ryhj) in hepatolithiasis patients with sphincter of oddi laxity (sol). summary background data: hepatolithiasis poses high risks of residual, recurrence, and re-intervention. sol significantly impacts this condition. ryhj has been recommended for hepatolithiasis concomitant sol but without prospective evidence. methods: this is an open-label randomized controlled trial recruiting patients with hepatolithiasis concurrent sol. patients were randomly assigned (1:1) to undergo ryhj or not. the primary endpoint was stone occurrence, including residual and recurrence, within a three-year postoperative period. secondary endpoints incorporated perioperative and long-term outcomes, like episodes of cholangitis and invasive re-interventions for stones and related complications. the analyses followed the intention-to-treat principle.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 80 years 2. diagnosed with sol during operation 3. suitable for a radical surgery including ryhj 4. hopeful to clear stones via operation or combined with subsequent choledochoscopy 5. provided written informed consent 6. willing to complete a 3-year follow-up an intraoperative diagnosis of sol was established if the rhythmic contraction and relaxation of the sphincter of oddi were not observed under choledochoscope and the flexible choledochoscope (chf-p20, external diameter, 4.9 mm; olympus, tokyo, japan) could navigate smoothly to the duodenum through the sphincter of oddi without any pre-dilation interventions. exclusion criteria: 1. with imaging evidences of tumor preoperatively 2. had congenital biliary malformations 3. had ever received biliary operation abandoning the oddi sphincter, such as choledochoduodenostomy

Keywords: hepatolithiasis sphincter of oddi dysfunction roux-en-y hepaticojejunostomy randomized controlled trial
assessing the impact of integrative medicine on anxiety and wellbeing of healthcare providers exposed to terror or war

Conditions: Quality of Life

Summary: the study assesses integrative medicine intervention effects on healthcare providers' quality-of-life during wartime.

the study is prospective, non-randomized and non-controlled, and taking place at the carmel medical center in haifa, northern israel, from october 2023. the study was launched in proximity with the outbreak of the october 2023 war in the middle east. as this timing was and is still regarded in israel as an emergency life-threatening situation and considering the research limitation to healthcare providers only, the carmel medical center institutional review board has exempted the study from requiring written consent from participants, after reviewing the study protocol. however, participation in the study was voluntary, and no incentive, financial or other was offered. the hospital administration and department refer healthcare providers (hcps) to integrative medicine intervention those if reporting emotional, physical, or other qol concerns directly or indirectly related to the current conflict in israel. the im intervention entails a 30-minute treatment session, with an additional 10 minutes allocated for both pre- and post- treatment assessment. im treatments are individually tailored to the hcp's qol-related concerns, taking into consideration their willingness to undergo the recommended modalities. in all cases, a multi-modal im program is recommended, which includes at least one of the following: acupuncture; manual-movement therapies (e.g., acupressure, anthroposophic medicine touch therapies, reflexology, qi gong, and feldenkrais method); and mind-body medicine (e.g., relaxation and breathing techniques). during these treatments participants are asked to lay on a treatment bed, with relaxed non-paced breathing throughout the session. the im treatments are provided by im-trained therapists who work in an integrative oncology setting.

Eligibility criteria:
inclusion criteria: * healthcare providers reporting war-related concerns affecting their quality of life exclusion criteria: \* healthcare providers with no quality-of-life related concerns they attribute to the war r

Keywords: resilience integrative medicine healthcare providers acupuncture
anti-cancer effects of carvedilol with standard treatment in glioblastoma and response of peripheral glioma circulating tumor cells

Conditions: Glioblastoma; Glioblastoma Multiforme

Summary: the purpose of this pilot study is to evaluate the addition of carvedilol with standard of care treatment to determine if it will improve progression-free survival in the front line setting in patients with glioblastoma multiforme (gbm). in addition, monitoring of circulating tumor cells (ctcs) by a real-time reverse transcriptase polymerase chain reaction (qrt-pcr) assay to correlate with the clinical findings.

this is a pilot study to assess efficacy of the addition of a non-selective beta-blocker to standard of care treatment in the front-line setting of glioblastoma multiforme. and to also evaluate the level of peripheral glioma circulating tumor cells via teleomescan assay to correlate disease response determined by neuro-imaging. peripheral blood samples will be collected at baseline, on day 1 of cycle 1 and then after on day 1 of cycle 4 and at the end of cycle 6 of adjuvant chemotherapy. in order to correlate the biological effects of treatment response. the investigators will evaluate the quantity of peripheral glioma circulating tumor cells and want to apply the information seen in the periphery to the status of the cancer on imaging studies. subjects will start oral carvedilol at 6.25 mg orally twice daily and will evaluate the patient and vital status if they tolerate this dose at 1-2 weeks after initiation. if tolerated well, will increase the dose to the maximum anticipation of 12.5 mg orally twice daily. treatment will proceed for 6 cycles and carvedilol will stop at the end of 6 cycles. patients will be monitored with neuroimaging prior before chemoradiotherapy, before adjuvant temozolomide and every 2 months on adjuvant temozolomide. following the completion of 6 cycles of adjuvant therapy, patients will continue to receive neuroimaging on every 3 months' basis until disease progression based upon standard of care.

Eligibility criteria:
inclusion criteria: * subjects must have histologically or cytologically confirmed who grade iv glioblastoma * subjects must have not received previous chemotherapy or radiation therapy for gbm * subjects must have systolic blood pressure greater than or equal to 90 and heart rate \>59 * subjects who are on beta-blockers for other etiologies may enroll on study and switch therapy to carvedilol if deemed medical appropriate per treating physician exclusion criteria: * subjects receiving any other investigational agents * subjects who have severe and uncontrolled asthma, copd * systolic blood pressure \<90 mmhg or hr \<60 bpm without antihypertensive medications at baseline * subjects with uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * allergy to beta blockers