Kornimate/medical-research-clean huggingface dataset:
efficacy of intravenous lidocaine on postoperative pain and recovery in patients undergoing hepatectomy

Conditions: Primary Liver Cancer

Summary: patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group. in the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. in the placebo group, the same volume of normal saline will be administered during anesthesia.

patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group. in the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of the surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. blood samples will also be collected 24 hours after surgery for subsequent measurement of il-6, and tumor necrosis factor-α (tnf-α). the obtained samples will be labeled, centrifuged, frozen, and stored locally at -80° for subsequent testing. postoperative pain management during the first 72 postoperative hours will involve the use of a pcia device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 ml in 0.9 % normal saline. in the placebo group, the same volume of normal saline will be administered during anesthesia. the postoperative pcia device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 ml in 0.9% normal saline solution with a total volume of 200 ml. all the background infusions of pcia will set at 2 ml/h, the bolus volume of each pcia press is 2 ml and the lockout interval is 15 min.

Eligibility criteria:
inclusion criteria: * age: 18-80 years old * american society of anesthesiologists(asa) ⅰ～iii * patients scheduled for elective hepatectomy exclusion criteria: • body weight \ 100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin \> 2.5 times the upper limit of normal), renal impairment (creatinine clearance \< 60 ml/min); cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction \< 50%); with allergies to any of the trial drugs; inability to comprehend numeric rating scale.
postoperative hypofractionated intensity-modulated radiotherapy endometrial cancer

Conditions: Endometrial Cancer

Summary: to investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 gy x 16 fractions) after curative surgery for stage iii endometrial cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed endometrioid type endometrial cancer * completion of hysterectomy and surgical staging * pathologically confirmed figo stage iii * ecog performance status 0 or 1 * adjuvant chemotherapy was done or planned exclusion criteria: * presence of distant metastasis * previous history of pelvic radiotherapy * severe and unstable medical condition * previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer

Keywords: radiation therapy hypofractionation
comparative trial of maraviroc versus emtricitabine/tenofovir both with darunavir/ritonavir in antiretroviral-naive patients infected with ccr5 tropic hiv 1

Conditions: HIV-1

Summary: the purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at week 48 of treatment.

the study was terminated on october 8, 2013 following a preliminary review of the week 48 primary efficacy data by the study's external independent data monitoring committee (dmc). the dmc assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. the dmc recommended and the sponsor concurred that the study be terminated because of the inferior efficacy of the maraviroc arm as compared to the comparator arm (emtricitabine/tenofovir).

Eligibility criteria:
inclusion criteria: * plasma hiv-1 rna equal to or greater than 1,000 copies/ml measured at the screening visit. * cd4 count equal to or greater than 100 cells/mm3 at screening. * have only r5 hiv 1 at screening as verified by a randomized tropism assay. exclusion criteria: * prior treatment with any other hiv antiretroviral therapy for more than 14 days at any time. * any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine. * cxcr4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.

Keywords: double-blind comparative trial maraviroc versus emtricitabine/tenofovir both with darunavir/ritonavir antiretroviral-naive ccr5 tropic hiv 1 patients.
study to investigate the pharmacokinetics, safety, and tolerability of bmt101 in healthy male volunteers

Conditions: Hypertrophic Scar

Summary: phase i study to investigate the pharmacokinetics, safety, and tolerability of bmt101 in healthy male volunteers

a randomized, single blind, single dose, placebo-controlled, dose-escalation phase i study to investigate the pharmacokinetics, safety, and tolerability of intradermal dosage form of bmt101 in healthy male volunteers

Eligibility criteria:
inclusion criteria: 1. adults, 19 \~ 39 years of age 2. body mass index (bmi) between 19 to 25kg/㎡ (19kg/㎡ ≤ bmi \< 25kg/㎡) and weight at least 50kg on the day of screening 3. medically healthy with no clinically significant findings on vital signs during the screening period 4. medically healthy with no clinically significant findings on physical examinations during the screening period exclusion criteria: 1. subjects with clinically significant medical or surgical history described below clinically significant observations considered as unsuitable based on medical judgement by investigators * skin disorder (psoriasis or contact dermatitis) which may affect absorption of the investigational product, or scar, skin abnormality, history of surgery (excluding simple appendectomy or herniorrhaphy) which can interrupt intradermal injections 2. history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, respiratory, musculoskeletal or any other conditions which can be problems for pharmacokinetic evaluation 3. donated blood or blood components or had been transfused plasma within 60 days prior to the day of screening 4. tobacco use within 30 days prior to the day of screening

Keywords: scar scar prevention sirna
an efficacy and safety study of inm-176 for the treatment of patients with alzheimer type dementia

Conditions: Alzheimer Type Dementia

Summary: the purpose of this study is to evaluate the efficacy and safety of two fixed dose (1200mg/day, 1600mg/day) of inm-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with alzheimer type dementia.

probable alzheimer type dementia compare inm-176 1200\~1600mg/day with donepezil 5\~10mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel phase iii clinical study.

Eligibility criteria:
inclusion criteria: 1. male or female, age range : 50 \~ 80 years old 2. informed consent signed and dated by patient or legal representative 3. subjects diagnosed with alzheimer's disease according to dsm-iv criteria 4. subjects diagnosed with probable alzheimer's disease according to the national institute of neurological and communicative disorders and the alzheimer's disease and related disorders association (nincds-adrda) criteria 5. mmse score 10 to 26 6. cdr(clinical dementia rating) score 1\~2 or gds(global deterioration scale) 3\~5 stage 7. subjects who didn't take any medication for achei (donepezil, memantine, galantamin, etc) before treating or can stop medication at least 4 weeks more prior to screening visit 8. subjects menopause women or her/his spouse consent with contraception during the study period and 90 days after end of study exclusion criteria: 1. subjects with psychiatric disorders other than alzheimer's disease, such as schizophrenia, depression, bipolar disorder, etc 2. subjects diagnosed or accompanied with dementia due to other neurodegenerative disorders (aids, syphilis, creutzfeldt-jacob disease, picks disease, huntingtons disease, parkinsons disease related dementia) 3. subjects diagnosed with vascular dementia 4. subjects diagnosed with stroke within last 3 months prior to screening visit 5. subjects who have medical history of significant hepatic disease in screening visit (2 uln≤alt, ast) 6. subjects who have medical history of significant renal disease in screening visit (1.5mg/dl≤serum creatinine) 7. subjects who have difficult with regulating blood glucose level with anti-diabetes drug (8.0%\<hba1c) 8. subjects who have medical history of myocardial infarction or arrhythmia 9. subjects who take warfarin with atrial fibrillation 10. pregnant or nursing women 11. subjects who p0articipated in other clinical trail within last 3 months 12. subjects who have hypersensitivity to achel (acetylcholinesterase inhibitor) 13. subjects who have unstable clinical laboratory result in screening visit 14. subjects doubted the pulmonary disease on the chest x-ray in screening visit 15. subjects considered unsuitable to participate in clinical trail by investigator

Keywords: alzheimer disease
enhancing health and quality of life for individuals with dementia through transitional-state snacks

Conditions: Dementia; Nutrition Poor

Summary: malnutrition significantly contributes to the disability and mortality associated with alzheimer's disease and alzheimer's disease-related dementias. thus, nutritional status is one important, modifiable clinical factor for maintaining physical and cognitive health among persons with dementia (pwd). this project will pilot an innovative approach to enhancing nutrition through the use of transitional-state snack supplements, or foods that start as one texture and change to another. specifically, this study aims to demonstrate the feasibility, acceptability, and safety of a transitional-state therapeutic nutrition supplement among adults with dementia. the central hypothesis is that access to ready-made, savory, nutrient- dense snack supplements that resemble "typical" preferred foods and eating habits will result in improved nutritional intake and status among pwd.


Eligibility criteria:
inclusion criteria: * medically stable * community dwelling * has a medical diagnosis of dementia or possible dementia exclusion criteria: * does not live at home * cannot participate in the protocol independently and do not have a consistent caregiver who can provide assistance * does not have smartphone access * requires 100% feeding assistance * is npo (nil per os) * has multiple food allergies * requires a strict renal, low-fat, and/or no-salt diet * is deemed unsafe for the transitional-state foods by a speech-language pathologist

Keywords: caregiver
correlation between intraocular pressure measurement by tomometer and anterior chamber depth measurement by ultrasound

Conditions: Urological Cancer; Gastrointestinal Cancer; Malignant Female Reproductive System Neoplasm

Summary: intra ocular pressure (iop) may theoretically increase due to steep trendelenberg position and studies showed that iop reaches peak levels after steep trendelenberg position on an average of 13 mmhg higher than preanesthesia induction values. major determinants of iop are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone. hassen gw et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (acd) with the intraocular pressure measured by tonometer. they concluded that bedside ultrasound could be useful in evaluating patient with suspected increased iop, who are unable to open their eyes.

intra ocular pressure (iop) may theoretically increase due to steep trendelenberg position and studies showed that iop reaches peak levels after steep trendelenberg position on an average of 13 mmhg higher than preanesthesia induction values. major determinants of iop are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone. during the robotic surgery there are two theories explaining the increase of iop, first, gravitational forces increase central venous pressure which in turn affect orbital venous pressure and increase iop. second, intraperitoneal carbon dioxide causes increased choroidal blood volume which may result in iop increase. one study reported that low end tidal carbon dioxide was a significant predictor of the iop increase. continuous absorption of carbon dioxide from peritoneum and increased pressure on diaphragm results in lower delivered tidal volumes and subsequently increased arterial carbon dioxide levels leading to increased choroidal blood flow and increased iop. hassen gw et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (acd) with the intraocular pressure measured by tonometer. they concluded that bedside ultrasound could be useful in evaluating patient with suspected increased iop, who are unable to open their eyes. it can also be used for serial examination and follow-up of treatment success. they also mentioned that, it is necessary to conduct a prospective study with a larger sample size, to evaluate if there is agreement between measurements using a tonometer and measurements of the acd using ultrasound. in addition, it is essential to determine the cut off normal acd for evaluation of iop.

Eligibility criteria:
inclusion criteria: 1. asa class i-iii 2. urological cancer patients under going robotic assisted surgeries. 3. gastrointestinal cancer patients under going robotic assisted surgeries, 4. gynecological cancer patients under going robotic assisted surgeries, exclusion criteria: 1. asa class iv and above 2. patients with a history of glaucoma. 3. patients with corneal disease, retinal vascular disease.
drug use study with intuniv® in australia

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: this study will evaluate and analyze prescribing behaviors of physicians and determine whether intuniv was correctly prescribed in australia.

this is a drug utilization study using retrospective database analysis where study will combine data from two sources of patient-level drug utilization data for intuniv: i) nostradata database: longitudinal participant level prescription database ii) physician survey: de-identified participant data provided by representative physicians in australia in the nostradata database, actual prescription data are collected, which allows generation of information on drug usage. however, these prescription data do not contain patient variables such as age and indication needed to monitor potential off-label use. therefore, these data must be supplemented with another data source. the physician survey will provide the data not included in the nostradata database.

Eligibility criteria:
inclusion criteria: * is indicated for the treatment of adhd in children and adolescents 6 to 17 years old, as monotherapy. * must be used as a part of a comprehensive adhd treatment programme, typically including psychological, educational and social measures. exclusion criteria: * use for participants with a diagnosis other than adhd. * use for children less than 6 years of age. * use in adults (greater than or equal to \[\>=\] 18 years of age) * prescribed overdose greater than (\>) 7 milligram per day (mg/day) for participants \> 12 years, or \> 4 mg/ day for children lesser than or equal to (\<=) 12 years. * if monotherapy with intuniv, no prior treatment with stimulants or atomoxetine.
pins stimulator system for deep brain stimulation in huntington's disease

Conditions: Huntington's Disease

Summary: deep brain stimulation (dbs) of the globus pallidus internus(gpi) is useful in the treatment of different forms of chorea, including huntington's disease (hd).


Eligibility criteria:
inclusion criteria: 1. subject clinically symptomatic and genetically confirmed huntington disease (number of cag repeats\>= 36) 2. moderate stage of the disease (uhdrs motor\>= 30) 3. predominant movement disorder 4. compliance of the patient, stable cognition during a 6 months phase prior to inclusion (mattis dementia rating scales（mds）\>/= 120) 5. signed informed consent. exclusion criteria: 1. patients with hearing impairment; 2. failures of important organs and in severe conditions; 3. be reluctant or disabled to receive neuropsychological assessments; 4. participate in other clinical trial; 5. has a life expectancy of \< 1 year. 6. the investigator and/or enrollment review committee, would preclude participation in the study.
pain and infection after transvaginal colectomy

Conditions: Colonic Resection Procedures

Summary: this study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for colonic resection in adult women that eliminates the need for an abdominal incision to remove surgical specimens. it is hypothesized that this lanos technique will improve patient outcomes such as postoperative surgical site infection (ssi) rates, thereby improving patient satisfaction and also reducing hospital length-of-stay and cost.


Eligibility criteria:
inclusion criteria: 1. females ≥ 18 years of age 2. diagnosed with one of the following benign or malignant conditions for which they require colonic resection with a specimen that may be removed transvaginally if randomized to that group: * adenomatous polyposis * chronic gi bleeding * chronic obstruction * colon cancer * colonic inertia * diverticular disease * rectal cancer * colorectal polyps * rectal prolapse * slow transit constipation / colonic inertia 3. require one of the following elective operations that may be safely performed by current laparoscopic-assisted techniques: * right hemicolectomy * left hemicolectomy * subtotal colectomy * total abdominal colectomy * sigmoid colectomy * rectosigmoid resection * low anterior resection 4. willingness and ability to comply with the requirements of the study protocol including follow-up 5. willingness and ability to sign the study specific informed consent exclusion criteria: 1. current pregnancy or considering becoming pregnant during the follow-up period or within 6 months of surgery 2. any anatomical consideration that in the investigator's opinion would make the traditional laparoscopic or transvaginal approach to resection excessively risky or impossible. patients with bulky tumors that would require open operations are not candidates for this study. 3. body mass index (bmi) \> 35 4. vaginal stenosis 5. prior reconstructive surgery of the vagina not including hysterectomy 6. asa classes 4 and 5 7. advanced renal insufficiency (estimated creatinine clearance ≤30 ml/min/1.73 m2) 8. any history of pelvic radiation 9. anticipated need for an ostomy at the time of operation 10. patients requiring urgent or emergent surgery 11. patients with prior or suspected diagnosis of inflammatory bowel disease such as crohns disease or ulcerative colitis.
use of fluorescein dye for the removal of brain tumors

Conditions: Brain Neoplasms

Summary: fluorescein is a dye agent that can be injected through an intravenous line. it has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. the investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.


Eligibility criteria:
inclusion criteria: 1. age of 18 or greater 2. plan for elective removal of a brain tumor at upmc shadyside with either dr. engh or dr. amankulor. exclusion criteria: 1. history of adverse reaction to fluorescein. 2. emergent surgical procedure (consent not feasible). 3. creatinine of \> 2.0 (drug is excreted renally). 4. known ongoing pregnancy.

Keywords: glioma neoplasms
dose escalation study of mln4924 in adults with melanoma

Conditions: Metastatic Melanoma

Summary: this is an open-label, multicenter, phase 1, dose escalation study that will evaluate the safety profile, establish maximum tolerated dose (mtd), and inform the recommended phase 2 dose of mln4924 as well as evaluate antitumor activity in patients with metastatic melanoma.


Eligibility criteria:
inclusion criteria: each patient must meet all of the following criteria to be enrolled in the study: * diagnosis of metastatic melanoma * measurable disease * female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse * male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse * willing and able to give written informed consent * suitable venous access for study-required blood sampling * appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol exclusion criteria: patients meeting any of the following exclusion criteria are not to be enrolled in the study: * major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug * systemic antineoplastic or radiation therapy within 14 days or treatment with any investigational products within 21 days before the first dose of study treatment * cyp3a inducers within 14 days of study treatment. moderate and strong cyp3a inhibitors and cyp3a inducers are not permitted during the study * no prior history of amiodarone in the 6 months before the first dose of mln4924 * diarrhea that is greater than grade 1 as outlined in the protocol * evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months * known human immunodeficiency virus (hiv) positive, hepatitis b surface antigen-positive status, or known or suspected active hepatitis c infection. * serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol * other clinical and laboratory assessments that do not meet the criteria specified in the protocol

Keywords: melanoma