Kornimate/medical-research-clean huggingface dataset:
effects of thc and alcohol on driving performance

Conditions: Cannabis; Alcohol Drinking; Accident, Traffic

Summary: low blood concentrations of thc and alcohol appear to have a minimal effect on driving performance.however, there is a gap in the literature about the combined effects of thc and alcohol. there is little empirical evidence to determine whether the combination of thc and alcohol could be additive or multiplicative. this issue is particularly important when dealing with concentrations that are just below legal thresholds - it is important to identify if someone who may have consumed cannabis and alcohol, in quantities that do not exceed legal thresholds, may nonetheless be impaired to drive. answering this question requires more research on the combined effects of thc and alcohol under tightly controlled experimental conditions. hence, the purpose of this study is to determine the additive (or multiplicative) effect of standardized low doses of cannabis, in combination with low-doses of alcohol, on a number of outcome measures related to driving. the investigators will focus specifically on the effect of low blood concentrations of thc (0, 125, and 250 µg/kg) alone and in combination with low blood concentrations of alcohol (bac 0%, .025%, and .049%). they shall determine the combined effect of thc and alcohol on physiological, cognitive, subjective measures of impairment, and simulated driving. this study will focus on younger adults because they have higher impaired driving rates than other age groups. as a secondary aim of the study, the investigators will examine whether previous driving and drug use history are correlated with driving decisions during the simulated drive and subjective measures. this study will contribute to the evidence base informing legislation, policy making, and law enforcement. this study is particularly timely given upcoming changes in legislation about cannabis, and because the combination of thc and alcohol, even below legal thresholds, may lead to impaired driving and crashes.


Eligibility criteria:
inclusion criteria: * bmi \>18 and \<30 * valid g2 or g ontario driver's license * live on-campus or within 15 minutes drive of campus * speak fluent english exclusion criteria: * history of cardiovascular or psychiatric disorders * current use of psychoactive medication * current drug or alcohol abuse problem * positive drug screen * bac level \> .000%

Keywords: thc alcohol driving dronabinol
study of durvalumab given with chemotherapy, durvalumab in combination with tremelimumab given with chemotherapy, or chemotherapy in patients with unresectable urothelial cancer

Conditions: Unresectable Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer

Summary: this is a randomized, open-label, controlled, multi-center, global phase iii study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (soc) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus soc alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).


Eligibility criteria:
key inclusion criteria: * patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) * patients who have not been previously treated with first-line chemotherapy. patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred \>12 months from the last therapy \[for chemoradiation and adjuvant treatment\] or \>12 months from the last surgery \[for neoadjuvant treatment\]. * at least 1 lesion, not previously irradiated, that qualifies as a recist 1.1 target lesion at baseline. * world health organization (who)/eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 at enrolment * adequate organ and marrow function as defined in the protocol * life expectancy ≥12 weeks in the opinion of the investigator * evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. key exclusion criteria: * prior exposure to immune-mediated therapy (with exclusion of bacillus calmette guerin), including but not limited to, other anti-ctla-4, anti-pd-1, anti-pd l1, or anti-pd-l2 antibodies, except therapeutic anticancer vaccines, which are permitted. prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment. * no severe concomitant condition that requires immunosuppression medication * untreated central nervous system (cns) metastases and/or carcinomatous meningitis * patients who may be eligible for or are being considered for radical resection during the course of the study. * any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

Keywords: renal pelvis ureters urinary bladder urethra bladder cancer
virtual realityon pain, anxiety and comfort during trigger point injection

Conditions: Virtual Reality

Summary: to determine the effects of virtual reality application during trigger point injection on patients' pain, anxiety and comfort levels.this research was planned as a randomized controlled experimental type. the population of the research was planned to include patients who applied to the algology polyclinic for trigger point injection. the sample of the research will consist of 150 patients who meet the sampling criteria and agree to participate in the research.inclusion criteria: trigger point injection applied for the first time, 18 years and over, understand and speak turkish, understand verbal and written information given.patients will be divided into two groups: experimental (virtual reality) and control groups.data will be collected with the case report form, state anxiety scale, general comfort scale and visual analog scale.patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.

patients in the experimental group will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes.patients in the control group will continue routine practice.patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.

Eligibility criteria:
inclusion criteria: * the procedure will be applied for the first time * 18 years and over * able to understand and speak turkish * able to understand verbal and written information given * having good cognitive abilities * without visual or hearing loss * patients who agreed to participate in the study exclusion criteria: * those who do not understand or speak turkish * does not understand verbal and written information * those with impaired cognitive abilities * epilepsy

Keywords: virtual reality pain trigger point injection. anxiety comfort
epsilon aminocaproic acid vs. tranexamic acid vs. placebo for prevention of blood loss in total knee arthroplasty

Conditions: Osteoarthritis

Summary: txa and eaca have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (tka). the investigators want to determine if txa or eaca compared with placebo are effective and safe for blood loss prevention in tka by comparing blood loss, transfusion rates, and total cost.


Eligibility criteria:
inclusion criteria: * all patients scheduled to receive primary unilateral total knee arthroplasty exclusion criteria: * subject requires bilateral staged total knee arthroplasty * religious beliefs that would limit blood transfusion * history of acquired defective color vision (inhibits monitoring for adverse events) * patients with a known history of upper urinary tract bleeding * history of abnormal coagulation * renal dysfunction defined by elevated bun and cr or bun to cr ratio of 20:1 within 30 days of surgery * active intravascular clotting * known allergy to either txa or eaca * myocardial infarct within 6 months * history of stroke * patient is a prisoner
emergency delirium in pediatrics undergoing tonsillectomy and adenoidectomy

Conditions: Emergence Delirium

Summary: primary outcom compare the effectiveness of study drugs on reducing the incidence of emergence delirium . secondary outcomes: sedation score intensity of pain by flacc extubation time iength of stay in post anesthetic care unite (pacu ) incidence of negative post operative behavioural changes (npobcs ) laryngeospasm ny adverse effects

emergence delirium (ed) is a common neurologic complication that can not only distress children and their families in the early postanesthetic period, but can also have adverse effects on children in the long-term emergence delirium (ed) is an acute confusion state during recovery from anesthesia; patients with ed may present with disorientation, hallucination, restlessness, and purposeless hyperactive physical behavior . ed is not fully equivalent to ea; ed can involve hypoactive signs or mixed forms and hyperactive signs similar to agitation . nevertheless, the terms ea and ed have been used interchangeably in several studies pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of poed, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. postoperative emergence delirium develops in 12% to 18% of all children undergoing general anesthesia for surgery. dexmedetomidine, is a selective alpha-2 agonist, which works in the brain and spinal cord that has sedative, analgesic and anxiolytic properties. dexmedetomidine also has the ability to lower the overall anesthetic requirements by reducing sympathetic outflow in response to painful surgical stimulation. midazolam is a widely used intravenous anesthetic agent with rapid onset, short duration of action and relatively rapid plasma clearance. it is mainly used to produce preoperative sedation and the induction of general anesthesia the action of midazolam can be explained through its action on gammaaminobutyric acid (gaba) receptors. gaba receptors mediate inhibitory neurotransmission in the central nervous system in our study we aim to compares the effectiveness of preoperative intravenous dexmedetomidine versus intravenous midazolam for the prevention of emergence delirium in pediatric patients undergoing tonsillectomy , adenoidectomy or both . .

Eligibility criteria:
inclusion criteria: - pediatric patients aged 2-12 years with asa physical status 1 or 2 who were scheduled for tonsillectomy with and without adenoidectomy under general anesthesia exclusion criteria: * emergency surgery intellectual disability neurological disease renal , hepatic, cardiac or respiratory disease allergy to the study drugs
a study of gc33 (ro5137382) in patients with advanced or metastatic hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: this randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of gc33 (ro5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. participants will be stratified according to the level of gpc-3 expression in tumors and randomized to receive either gc33 (1600 mg intravenously) or placebo on days 1 and 8 of cycle 1 and every 2 weeks thereafter. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype) * prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s) * not a candidate for curative treatments (e.g. resection, transplantation) * child-pugh a (score of 5-6) * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate hematologic, hepatic and renal function * ability to provide, for central review, a tumor tissue sample to determine the level of gpc-3 expression by ihc * measurable disease by recist criteria exclusion criteria: * child pugh b or c * known hepatocellular carcinoma with fibro-lamellar histology * known brain or leptomeningeal metastases * active infectious diseases requiring treatment except for hepatitis b and c * history of organ allograft including liver transplant * anticipated or ongoing administration of anticancer therapies other than those administered in this study * anticancer treatment within 2 weeks prior to entering the study * patients who have not fully recovered from toxicities associated with previous hcc loco-regional or systemic therapies * patients receiving interferon therapy * pregnant or lactating women * known hiv positivity or aids-related illness * history of significant hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, chinese hamster ovary products)
revascularization strategies for st elevation myocardial infarction trial

Conditions: ST Elevation Myocardial Infarction; Coronary Stenting; Primary Angioplasty

Summary: this study is being conducted in patients with a major heart attack caused by a blocked artery undergoing percutaneous coronary intervention (pci) to open up the blockage. up to 50% of people with an heart attack are found to have one or more additional narrowings that did not cause the heart attack. at present the best way to manage these additional blockages is not known. many cardiologist recommend opening these blockages at at a later time after the heart attack. the present study is examining if pci of all blockages at the same time as the pci for the artery that caused the major heart attack (ss-pci) will reduce the amount of heart damage compared to performing pci of additional blockages 2-45 days later (ira-pci). clinical follow up will be completed at 3, 12 and 24 months to determine heart function and monitor adverse events.


Eligibility criteria:
inclusion criteria: * st elevation myocardial infarction evidenced by new st elevation at the j point in at least 2 contiguous leads of ≥ 2 mm (0.2mv) in men or ≥ 1.5mm (0.15mv) in women in leads v2-v3 and/or ≥ 1mm (0.1mv) in other contiguous chest leads or limb leads. * mvd as evidenced by \> one significant (\>70% by visual assessment or ffr \ 2mm in diameter. * successful ira-pci with \<30% residual angiographic stenosis and timi iii flow * written informed consent exclusion criteria: * age ≤ 18 years * prior coronary artery bypass graft (cabg) surgery * administration of thrombolytic therapy. * hemodynamic instability as evidenced by sbp\<90 mmhg, killip class ≥3, and/or need for inotropes/vasopressors. * known renal insufficiency (estimated gfr \< 30 ml/min/1.73m2) * non-ira stenosis is a chronic total occlusion (cto) * plan by treating physician to treat non-ira stenosis with coronary artery bypass surgery
a study of irinotecan plus cetuximab with or without enzastaurin in participants with colorectal cancer

Conditions: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumor

Summary: to see how well enzastaurin in combination with irinotecan and cetuximab works versus irinotecan and cetuximab in participants who have progressed within 3 months.


Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if they meet all of the following criteria: 1. histologic diagnosis of colorectal cancer. 2. performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) performance status schedule. 3. have had documented disease progression according to response evaluation criteria in solid tumors (recist v1.0; therasse et al. 2000) within 3 months after receiving 5-fluorouracil, leucovorin, and oxaliplatin (folfox) plus bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving folfox with or without bevacizumab in the adjuvant setting. 4. standard radiation therapy for rectal cancer is allowed. participants must have recovered from the toxic effects (except for alopecia) of the treatment prior to study enrollment. prior radiotherapy must be completed 4 weeks before study entry. lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. 5. at least one uni-dimensionally measurable lesion meeting recist v1.0 guidelines (at least 10 millimeters \[mm\] in longest diameter by spiral computerized tomography (ct) scan, or at least 20 mm by standard techniques). positron emission tomography (pet) scans and ultrasounds may not be used. exclusion criteria: participants will be excluded from the study if they meet any of the following criteria: 1. have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry. 2. have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab. 3. have a serious concomitant systemic disorder \[such as active infection including human immunodeficiency virus (hiv), or cardiac disease\] that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol. 4. have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the new york heart association class iii or iv. 5. have a prior malignancy (other than colorectal cancer, or adequately treated carcinoma in-situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. participants with a history of low grade (gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
ultrasound evaluation of the jugular venous pulse (us-jvp)

Conditions: Emergencies; Cardiovascular Diseases; Neurovascular Disorders

Summary: the jugular venous pulse (jvp) reflects changes in the right atrial pressure and its evaluation can be useful in managing many emergency conditions for guiding the fluid administration as well as in the diagnosis and/or prognosis of many heart and lung diseases. the present study aims: i) to validate a novel ultrasonographic (us) technique for obtaining the jvp from a high-resolution b-mode sonograms sequence, recording the changes of the cross-sectional area (csa) of the internal jugular veins (ijv) over the cardiac cycle; ii) to develop physical and mathematical models capable of providing an indirect estimate of central venous pressure (cvp) from the changes in ijv-csa acquired through the us investigation, and iii) to test the transferability of the novel us-jvp technique in a clinical setting.

the study will be articulated in different phases, encompassing data collection, development of physical and mathematical models, statistical evaluations, and software implementation. the clinical experimental phase of the study (data collection) will involve hospitalized adult patients requiring a scheduled central venous catheterization and measurement of the cvp as part of their usual care. the latter will be used as the gold standard measure of cvp for the subsequent data processing and analysis. a small sample of healthy adult volunteers will also be recruited only for the non-invasive us evaluation of the jvp. the validation processes will include assessment of the diagnostic power of the us-jvp estimated cvp values and us-jvp waveforms, including evaluation of sensibility, specificity, predictive positive and negative values, accuracy and precision.

Eligibility criteria:
inclusion criteria: * adult (age ≥18 years) hospitalized patients, spontaneous breathing, requiring a scheduled central venous catheterization and measurement of the central venous pressure as part of their usual care; * capacity to give informed consent. exclusion criteria: * central venous catheterization via the internal jugular venous access

Keywords: jugular venous pulse central venous pressure ultrasounds validation studies software validation
combination effect of nefopam with propacetamol for postoperative pain after thyroidectomy

Conditions: Thyroidectomy; Pain

Summary: patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. however, there has been little attention of posterior neck pain. nefopam and propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. the aim of this study is evaluation of combination effect of nefopam and propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.


Eligibility criteria:
inclusion criteria: * patient who undergone open thyroidectomy * 20\~70 years old * asa i\~iii exclusion criteria: * hypersensitivity on nefopam and propacetamol * liver failure, chronic alcohol addiction * severe hemolytic anemia, chronic nutrition deficiency * history of seizure * mi, mao inhibitor * pregnant, breast-feeding * foreigners