Kornimate/medical-research-clean huggingface dataset:
perioperative glucose and insulin changes in major urologic surgeries

Conditions: Urologic Diseases; Surgery; Blood Glucose, High

Summary: urological surgery patients will have their blood glucose measured before, during, and after surgery. blood glucose will be measured using a continuous glucose monitor (cgm) device. we hypothesize the presence of a hyperglycemic state towards the end of surgery due to increased metabolic demand.

surgical stress causes acute insulin resistance, increased circulating free-fatty acids, and reduced blood glucose uptake resulting in hyperglycemia. intraoperative and postoperative glucose levels are typically only monitored in the diabetic or cardiac surgical patient. there is a lack of data on perioperative glucose levels in most prolonged surgeries and thus a barrier in determining the best glycemic management strategy to prevent or resolve acute insulin resistance and hyperglycemia. obtaining blood glucose by cgm is less invasive and will avert disruption of current surgical pathways and standards of care while also producing reliable glucose measurements.

Eligibility criteria:
inclusion criteria: * adult (≥18 years) undergoing a major urologic surgery (proposed case duration \>4 hours) at the university of kansas medical center (kumc) * english speaking exclusion criteria: * diagnosis of type 1 or type 2 diabetes mellitus or an a1c \> 6.5% * pregnant or lactating * known allergy to milk, soy, egg, wheat, peanuts, or tree nuts * swallowing difficulties

Keywords: surgery, blood glucose, continuous glucose monitoring
acute comfort of lubricant eye drop fid 111421

Conditions: Dry Eye

Summary: to evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients


Eligibility criteria:
inclusion criteria: * documented diagnosis of dry eye * must not have worn contact lenses for 1 week preceding enrollment exclusion criteria: * age related

Keywords: dry eye artificial tears
ultrasonic vs. fluoroscopic guided pnl in pediatric renal stones

Conditions: Pediatric Kidney Disease

Summary: percutaneous nephrolithotomy (pnl) was accepted as a treatment modality for large renal stones since 1980. although radiation exposure during pnl is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. therefore, employing an alternative imaging technique during pnl would be of added advantage. so, the investigators want to compare the efficacy of ultrasound guided pnl with the conventional (fluoroscopy guided) pnl in pediatric population. if ultrasound guided pnl was as effective as conventional one, this means that many children could be protected from the variable hazards of radiation exposure.

the incidence of pediatric urolithiasis varies by geographic area. most cases of pediatric urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract infection . pnl can be performed safely and effectively in children by experienced surgeons, resulting in a high stone-free rate and lower requirement for ancillary treatment. in adults, pnl is performed under fluoroscopic or ultrasound guidance. in pediatric age group, fluoroscopic guidance was preferred in most of the reported studies. however, fluoroscopy exposes the patient to radiation. the international commission on radiological protection recommends that whole body exposure in adults should be limited to an effective dose of 20 msv per year over 5 years. in young children, it is particularly important to protect the developing gonads and thyroid gland, as the long-term effects of exposing these organs to radiation are still unclear. in contrast to fluoroscopic guidance, ultrasound guidance does not expose the patient to radiation, it also can provide real-time monitoring during the puncturing procedure. the path and depth of the needle, and the anatomy in and around the kidney, are clearly visible on ultrasound examination

Eligibility criteria:
inclusion criteria: * all kidney stones in pediatric age group and indicated for pnl. exclusion criteria: * children unfit for the procedure or non indicated for it. * parental refusal.

Keywords: stone disease
early detection of anastomotic leakage by microdialysis catheters

Conditions: Pancreatic Cancer; Pancreaticoduodenal; Fistula; Pancreas; Fistula; Pancreatic Fistula

Summary: anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. this observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

pancreaticoduodenectomy (whipple´s procedure) offers the only potential cure for patients with tumor in the head of the pancreas, bile duct or periampullary region. this procedure is associated with high perioperative and postoperative mortality and morbidity. postoperative pancreatic fistulae (popf) is the most feared complication, and is often discovered with significant delay resulting in development of organ dysfunction and sepsis. current standard for clinical detection of popf is limited and nonspecific. microdialysis catheters allow bedside measurements of metabolism such as lactate, pyruvate, glucose and glycerol. the method has a high sensitivity and specificity in detecting complications in several types of abdominal surgery. however, microdialysis used after pancreaticoduodenectomy is not well documented. this observational study examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

Eligibility criteria:
inclusion criteria: * tumor in the head of the pancreas, the bile duct or the duodenum detected on a computed tomography (ct) scan or magnetic resonance imaging (mri), and evaluated by a multidisciplinary team to be resectable with a pancreaticoduodenectomy. * written informed consent was obtained before study enrollment. exclusion criteria: * \<18 years * patient with tumor which was not resectable

Keywords: pancreaticoduodenectomy pancreatectomy
validation of the goodstrength system for assessment of abdominal wall strength in patients with incisional hernia

Conditions: Incisional Hernia

Summary: patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the goodstrength trunk dynamometer.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists score 1-3 * age equal to or above 18 * ventral incisional hernia or intact abdominal wall exclusion criteria: * pregnancy * severe heart disease (new york heart association class iii-iv) * severe pulmonary disease * severe musculoskeletal disease * systemic treatment with glucocorticoid

Keywords: incisional hernia hernia abdominal wall strength validation physical activity
study to assess the long-term safety and efficacy of tirabrutinib in adults with relapsed/refractory b-cell malignancies

Conditions: Relapsed/Refractory B-cell Malignancies

Summary: the primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory b-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (nct01659255). the dosing regimen will be based on the prior dosing regimen from the parent study.


Eligibility criteria:
key inclusion criteria: * currently enrolled in a prior tirabrutinib study * did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 at enrollment in this study * any grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to grade 1, or reverted to the baseline of the prior study prior to day 1 of this study * negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal) * male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol * lactating females must agree to discontinue nursing before the study drug is administered * ability and agreement to attend protocol-specified visits at the study site * able to comprehend and willing to sign the informed consent form key exclusion criteria: * known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients note: other protocol defined inclusion/exclusion criteria may apply.
long-term adverse effects after bariatric surgery on bone density

Conditions: Morbid Obesity

Summary: the goal of this trial is to examine long-term effects of laparoscopic gastric bypass (lrygb) and sleeve gastrectomy (lsg) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing, the goal of this trial is to examine long-term effects of laparoscopic gastric bypass (lrygb) and sleeve gastrectomy (lsg) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Eligibility criteria:
inclusion criteria: * patients who received laparoscopic sleeve gastrectomy (lsg) or laparoscopic gastric bypass (lrygb) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study. exclusion criteria: * lsg or lrygb as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after lsg resp lrygb (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)
a study to evaluate the effect of jnj-53718678 on the cardiac repolarization interval in healthy adult participants

Conditions: Healthy

Summary: the purpose of this study is to assess the effect of jnj-53718678 on qt interval corrected for heart rate (qtc) changes using exposure response analysis in healthy adult participants (part 2).


Eligibility criteria:
inclusion criteria: * participants must have a body mass index (bmi) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than (\<) 50 kg at screening * participants must have a blood pressure between 90 and 140 millimeter of mercury (mmhg) systolic, inclusive, and no higher than 90 mmhg diastolic at screening * participants must have a 12-lead electrocardiogram (ecg) consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate (hr) between 45 and 100 beats per minute (bpm), inclusive); b) qt interval corrected for hr according to fridericia's formula (qtcf) between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) qrs interval of ecg \<110 ms; d) pr interval of the ecg less-than or equal to (\<=) 200 ms; e) morphology consistent with healthy cardiac conduction and function * a female participant must be of non-childbearing potential, defined as: a) postmenopausal or b) permanently sterile * a female participant must have a negative serum beta-human chorionic gonadotropin (b-hcg) pregnancy test at screening and a negative urine pregnancy test (except if postmenopausal) on day -1 (or day -2 in the first treatment period in part 2) exclusion criteria: * participants has a history of current clinically significant medical illness or certain laboratory abnormalities at screening * participant has a history of hepatitis a virus immunoglobulin m (igm) antibody, hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) antibody positive, or other clinically active liver disease, or tests positive for hepatitis a virus igm antibody, hbsag or hcv antibody at screening * participants with unusual t wave morphology (such as bifid t wave) likely to interfere with qtc measurements * participants with a past history of heart arrhythmias or with a history of risk factors for torsade de pointes syndrome (for example, hypokalemia or family history of short/long qt syndrome, or sudden unexplained death at a young age \[\<=40 years\], drowning or sudden infant death in a first degree relative \[that is, sibling, offspring, or biological parent\]) * participants with any skin condition likely to interfere with ecg electrode placement or adhesion
rate of spontaneous stone passage as assessed using urinary ultrasonography and direct urinary system radiography

Conditions: Ureteral Calculi; Masturbation

Summary: to evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.

this prospective randomized controlled study was performed between february 2018 and march 2020 after obtaining ethics committee approval.a total of 128 men with distal ureteral stones were randomly divided into 3 groups. all patients received standard medical therapy. patients in group 1 (n=43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n=41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n=44) received standard medical therapy alone. rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups.

Eligibility criteria:
inclusion criteria: * age ≥18 years * presenting with renal colic and inguinal or lumbar pain * being diagnosed as having distal ureteral stones ≥5 mm and \<10 mm in size exclusion criteria: * age \<18 years, * stones \<5 mm or ≥10 mm in size, * intermediate (stones on the ureter-iliac artery cross) * proximal ureteral stones, multiple ureteral stones, * presence of urinary infection, * renal insufficiency, * high creatinine level, * severe hydroureteronephrosis, * history of open or endoscopic ureteral surgery, * vesicoureteral reflux, * neurogenic bladder, * erectile dysfunction, * inability or refusal to masturbate for any reason (such as religious beliefs)
induction chemotherapy with tp+5-fu or tp+cetuximab followed by radioimmuptherapy for locally advanced or not resectable scchnn

Conditions: Squamous Cell Carcinoma of the Hypopharynx Stage III; Squamous Cell Carcinoma of the Hypopharynx Stage IV; Squamous Cell Carcinoma of the Larynx Stage III; Squamous Cell Carcinoma of the Larynx Stage IV; Squamous Cell Carcinoma of the Oropharynx Stage III; Squamous Cell Carcinoma of the Oropharynx Stage IV; Squamous Cell Carcinoma of the Oral Cavity Stage III; Squamous Cell Carcinoma of the Oral Cavity Stage IV

Summary: this multicentre, randomised phase ii pilot study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or cetuximab, followed by cetuximab with radiotherapy.

it will be evaluated whether 5-fu can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. as 5-fu causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed local advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx or cavum oris stage iii and iv * one measureable lesion (ct oder mr) * age 18 - 75 (including) * performance score ecog 0 - 1 exclusion criteria selected: * distant metastases * ecog score \>1 * prior radiation (head and neck area) * creatinin clearance below 60 ml/µl * acute infections * neuropathy grade 3 or 4 * myocardial infarction within the last 12 months * acute coronary syndrome or othe clinically significant cardiovascular diseases

Keywords: local advanced squamous cell carcinoma larynx hypopharynx oropharynx cavum oris docetaxel cisplatin 5-fluorouracil cetuximab
the effectiveness of antibiotic cement (abc) compared to regular cement in reducing the rate of infection following total knee arthroplasty: the abc trial

Conditions: Infection; Osteoarthritis of the Knee

Summary: rationale: infection following total knee replacement (tka) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. for primary tka, prophylactic antibiotic-loaded cement (abc) may not only reduce the rate of infection it may also reduce the rate of revisions due to implant loosening. current controversy about the use of abc exists around the world. without a definitive trial, patients will be exposed to a treatment of uncertain efficacy that may cause antibiotic resistant bacterial strains and will certainly generate high costs to the healthcare system. purpose: to determine, 1) the extent to which abc compared to regular cement reduces the infection rate in patients over the first two years following tka and, 2) the resource use implications associated with the use of abc for tka. methods: this is a randomized clinical trial in which 8,800 patients with undergoing primary tka are allocated to either simplex™ p with tobramycin or simplex™ p bone cement. we will exclude patients with a prior joint infection, an allergy to tobramycin, and those with no fixed address. all patients will be administered iv antibiotics immediately prior to surgery. patients and surgeons will be blind to group allocation. the primary outcome measure is infection. follow-up visits will take place at 6 weeks and 3, 12 and 24 months postoperative. a blinded adjudicator will review all reported infections and determine whether the putative infection is a study event. blinded radiologists will interpret the 2 year series of radiographs for each patient. we will compare the rates of infection and implant loosening between the two treatment groups using survival analyses. this study includes a full economic analysis.


Eligibility criteria:
inclusion criteria: * patients with osteoarthritis of the knee, * patients who are undergoing primary knee replacement, * patients who are able to provide informed consent. exclusion criteria: * patients with a prior joint infection, * patients who have a known allergy to tobramycin, and * patients who have no fixed address.

Keywords: total knee arthroplasty infection antibiotic bone cement
efficacy of sublingual immunotherapy in polysensitized allergic rhinitis patients

Conditions: Allergic Rhinitis

Summary: recently, interest has increased in sublingual immunotherapy (slit) for treating allergic rhinitis. it is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. this study compared the efficacy of slit with standardized house dust mite extract in mono- and polysensitized allergic rhinitis patients. patients who were sensitized to house dust mites and treated with slit for house dust mites for at least 1 year between november 2007 and march 2010 were included. the mono-allergen sensitized group (mgr) was defined as the patients who were sensitized to dermatophagoides pteronyssinus (dp) or d. farinae (df; n = 70). the poly-allergen sensitized group (pgr) was defined as the patients who were simultaneously sensitized to house dust mites and other allergens (n = 64). a standardized extract of house dust mites was used for immunotherapy. anti-allergic medication and the total nasal symptom score (tnss), including rhinorrhea, sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after slit. this study enrolled 134 patients. the tnss improved significantly after slit in both groups, while the change in the tnss did not differ significantly between the groups. the anti-allergic medication scores also decreased significantly in both groups, but there was no significant difference between the groups. in polysensitized allergic rhinitis patients, slit for dp/df gave comparable improvements in both nasal symptoms and rescue medication scores to those in monosensitized patients, regardless of other positive allergens. slit for dp/df might be considered in polysensitized allergic rhinitis patients.


Eligibility criteria:
inclusion criteria: * patients who had sneezing, itching, rhinorrhea, and nasal congestion with or without eye symptoms * patients who were sensitized to dermatophagoides pteronyssinus (dp) or d. farinae (df), as confirmed by skin prick testing (a/h ratio ≥ 1) or mast exclusion criteria: * patients who had immunotherapy in the preceding 3 years * patients who had systemic immunological disorders

Keywords: allergic rhinitis immunotherapy sublingual
constructed intervention by home and school diabetes nurse visits on diabetic control of children with type i diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.

the investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. in this group the following changes will occur: * a decrease in hba1c levels. * a decrease in hypoglycemia events. * a decrease in dka events. * a decrease in patients' visits in er and hospitalizations. * an improvement in the knowledge of the patients and their families about the disease.

Eligibility criteria:
inclusion criteria: * type 1 dm diagnosis from at least 8 months/ * hba1c levels \>8 * signed inform consent. exclusion criteria: - children who are not in educational settings and are not hebrew or arabic speakers.

Keywords: children