Kornimate/medical-research-clean huggingface dataset:
can veinlite reduce complications of peripheral intravenous catheter placement in children

Conditions: Catheterization; Pain; Complication

Summary: this study was conducted to investigate the use of veinlite led+ (translite, sugar land, tex) to assist with pic placement. the veinlite uses led (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood. the investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.

peripheral intravenous catheterization (pic) introduces multiple risks and potential morbidities. patients with pic-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. the most serious complications due to intravenous (iv) catheters are infiltration and extravasation. the primary endpoint was to evaluate whether veinlite led+ would prevent catheter-related complications. the secondary endpoint were; 1. to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization 2. to evaluate the efficacy of the vein imaging device on catheter dwell time.

Eligibility criteria:
inclusion criteria: * children aged between 5 and 18 * children with diva (difficult intravenous access score) score 4 or more * that the child and the parent speak turkish exclusion criteria: * needing urgent treatment * a critical health condition * that the child or the parent has a communication problem

Keywords: pain children vein imaging device intravenous complications
"hemodynamic changes during endovascular revascularization for acute stroke. an observational study".

Conditions: Ischemic Stroke

Summary: neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.


Eligibility criteria:
inclusion criteria 1. adult patients aged ≥ 18 years. 2. acute supratentorial or carotid stroke. exclusion criteria 1. invasive arterial signal unsuitable to obtain hemodynamic data. 2. emergency neurosurgery needed before intra-arterial treatment. 3. once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions: 1. intraoperative technical limitations limiting or impeding the arterial re-opening 2. persistent low quality of the arterial signal. after positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.
biweekly folfiri in advanced gastric cancer (agc) with failure of prior taxane, fluoropyrimidine, and cisplatin

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is: * to observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil (fu)/leucovorin (lv) in patients with advanced gastric adenocarcinoma who have prior exposure to taxane, fluoropyrimidine, and cisplatin * to determine the activity of this combination regimen. * to evaluate the treatment-related toxicities.

there is presently no chemotherapy regimen considered to be the standard of care for patients with advanced gastric cancer. however, more and more patients will receive fluoropyrimidine, platinum, and taxane combination or sequential chemotherapy. unfortunately, about half of the patients receiving chemotherapy are unresponsive and treatment results of salvage chemotherapy are unsatisfactory. for these patients, there are currently no established palliative chemotherapy options, and there is urgent need for novel, active, and less toxic regimens for patients with advanced gastric cancer failing front-line chemotherapy. on these bases, we will investigate the activity of biweekly oxaliplatin and 5-fu/lv in patients with advanced gastric cancer who failed prior taxane, fluoropyrimidine and cisplatin chemotherapy.

Eligibility criteria:
inclusion criteria: * pathologically proven non-resectable adenocarcinoma of stomach * measurable disease based on response criteria in solid tumors (recist) * prior chemotherapy with taxane, fluoropyrimidine, and cisplatinum in combination or sequentially, there is no time limit for the last chemotherapy * age 18 to 70 years old * estimated life expectancy of more than 3 months * eastern cooperative oncology group (ecog) performance status of 2 or lower * adequate bone marrow function (white blood cell counts \>4,000/µl, absolute neutrophil count \[anc\]\>1,500/µl, hemoglobin \>9.0 g/dl, and platelets\>100,000/µl), * adequate kidney function (creatinine\<1.5 mg/dl) * adequate liver function (bilirubin\ 2.5 mg/dl) exclusion criteria: * other tumor type than adenocarcinoma * presence or history of central nervous system metastasis * obvious or impending bowel obstruction (including obvious peritoneal carcinomatosis) * evidence of active gastrointestinal bleeding * other serious illness or medical conditions

Keywords: advanced gastric cancer folfiri
extension study on safety and rebound effect of sat-001 for myopia in children

Conditions: Myopia

Summary: the objective of this clinical trial is to collect data on the rebound effect and long-term safety of sat-001, a software as a medical device (samd) under development for the inhibition and treatment of myopia progression in pediatric patients.

myopia treatments to date have included both pharmacological and non-pharmacological approaches, with some studies showing effects in reducing myopia progression. however, previous research has also identified a rebound effect, where myopia progresses rapidly after treatment cessation during follow-up. since myopia progression in children often continues for more than two years, this rebound effect could be a critical factor in determining treatment strategies for pediatric myopia. this multi-center, open-label, controlled observational study is an extension of a previous confirmatory trial (sat-001-kp-002) that evaluated sat-001, a software as a medical device (samd) designed to slow myopia progression in pediatric patients. the current study aims to assess the rebound effect and long-term safety of sat-001 in participants who completed the previous trial, and to collect additional data on rebound myopia and long-term safety outcomes following the completion of the initial trial. a total of 40 participants, aged 5 to less than 9 years, from both the treatment and control groups of the prior study will be followed for 6 months after completing the original trial. participants from the previous trial who had less than 70% compliance will be excluded from this study. both groups will continue wearing spectacles, the conventional treatment for myopia, during the extension phase. the primary endpoint is the change in cycloplegic spherical equivalent refractive error (ser) from baseline to 24 weeks, while secondary endpoints include changes in ser at 12 weeks and changes in axial length at 12 and 24 weeks compared to baseline.

Eligibility criteria:
inclusion criteria: * participants who have completed the previous clinical trial (sat001-kp-002), and their legal guardians who agree to participate in this extension study and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding) exclusion criteria: * participants in the study group of the previous clinical trial (sat001-kp-002) with a compliance rate of less than 70% (overall compliance throughout the study period). * other reasons for participation in the trial at the discretion of the investigator

Keywords: myopia rebound effect samd
contrasting dosivent with plus flow vu spacer in bronchial hyperreactivity participants

Conditions: Bronchial Hyperreactivity; Inhalant Use

Summary: this study aims to compare the efficacy, as measured by changes in forced expiratory volume in the first second (fev1) and forced vital capacity (fvc), of salbutamol inhaled with the dosivent® chamber versus the widely used aerochamber plus® flow-vu® in participants with a positive bronchodilator testing.

the investigators are conducting a non-randomized, open-label, crossover-controlled clinical trial in 50 participants with a previous positive bronchodilation testing. the protocol was approved by the local clinical ethics committee (code 03/2022). all participants provided written informed consent before any study procedure. during the study, the principles of the declaration of helsinki and the current standards of good clinical practice were followed. participants over 18 years of age are included who attended our center for a bronchodilator test, gave a positive result in this test, and provided written informed consent for participation in this study. participants are excluded if grade a quality spirometry was not obtained according to the classification in current regulations and, in the opinion of the investigator, performing a bronchodilator test could pose a risk to the participant or interrupting the usual bronchodilator treatment could worsen the underlying respiratory pathology.

Eligibility criteria:
inclusion criteria: * participants over 18 years of age * attending our center for a bronchodilator test * positive bronchodilator result with increase of forced expiratory volume in first second greater than 200 mililiters and 12% * provided written informed consent for participation in this study exclusion criteria: * grade a quality spirometry was not obtained according to the classification in current regulation * performing a bronchodilator test, in the opinion of the investigator, could pose a risk to the participant or interrupting the usual bronchodilator treatment could worsen the underlying respiratory pathology.
tranexamic acid's effects in patients undergoing laparoscopic radical prostatectomy

Conditions: Prostate Cancer

Summary: the study is randomized, placebo-controlled, double-blind clinical trial that aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

the study aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion. therefore it will be a randomized, placebo-controlled, double-blind clinical trial that intends to recruit 122 patients with radical prostatectomy indication who agreed to consent study inclusion. patients randomized to intervention group will receive 1,0g of tranexamic acid iv during anesthetic induction, followed by a maintenance dose of 1,0 mg/kg/hour of surgery. control group will be operated normally. data as hemoglobin drop, estimated bleeding volume, need to transfusion, side effects, and presence of lymphocele will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * patients over 18 years olds; * who accept to participate and sign the consent form; * compliance with the study follow-up protocol; * diagnosed with localized prostate cancer with surgical indication without or with lymphadenectomy. exclusion criteria: * coronary artery disease treated with drug-using stent; * previous coronary procedures or coronary disease using a stent; * acute or chronic liver failure; * severe chronic renal failure (clcr \< 30 ml/kg.h, according to the modification of diet in renal disease formula); * suspected allergy to tranexamic acid; * known coagulopathies and refusal to sign consent form.

Keywords: prostate cancer radical prostatectomy video laparoscopic prostatectomy tranexamic acid
evaluation of safety and efficacy of tocosol(r) paclitaxel as initial treatment for metastatic breast cancer

Conditions: Breast Cancer

Summary: this is an open label study where each patient will receive tocosol(r) paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of tocosol paclitaxel.

this is an open label, non-randomized phase 2 study of weekly administration of tocosol paclitaxel at a dose level, 120mg/m2, known to be tolerated based on phase 2a studies of this investigational agent in patients with other histological diagnoses. this study is a fixed sample size design with no planned early stopping decision. the goals of the study include the determination of the safety of tocosol paclitaxel, and the objective response rate, defined by recist criteria as complete responses plus partial responses.

Eligibility criteria:
inclusion criteria: * female patient with histologic diagnosis of breast carcinoma * stage iv (m1) disease * no prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer * adult (18 years of age or older) patients * adequate hematologic function (anc \>=1500 cells/mm3 and platelets \>100,000/mm3 * serum creatinine \<=2.0 mg/dl * total bilirubin \<=1.5 mg/dl * ast/sgot and alt/sgpt \<=3 times the upper limit of institutional normal values * pt and ptt within institutional normal range * ecog performance status of 0-2 * at least one unidimensionally measurable lesion as defined by recist criteria assessable by radiographic evaluation * a signed irb/ethics committee approved informed consent * life expectancy of at least 12 weeks * fully recovered from any previous surgery * a negative pregnancy test prior to study entry if premenopausal * agree not to take vitamin e supplementation while receiving study medication exclusion criteria: * any prior taxane-containing chemotherapy including taxol or taxotere * patients who are pregnant or lactating * peripheral neuropathy nci-ctc grade 2 or greater * wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of study drug; cytotoxic chemotherapy within 6 months of first dose of study drug * treatment with an investigational agent within 4 weeks of first dose of study drug * patients with a history of carcinomas of primary sites which can not be distinguished histologically from metastatic breast carcinoma * bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic breast carcinoma * brain metastases * active bowel obstruction * active, serious infection or other serious medical problems (other than metastatic breast cancer) likely to impair completion of the study protocol * concurrent therapy with known substrates or inhibitors of the cytochrome p450 isoenzymes cyp2c8 or cyp3a4 * concurrent therapy with warfarin or other coumarin derivatives

Keywords: breast cancer tocosol paclitaxel
chicken-diet vs. enalapril to reduce albuminuria

Conditions: Microalbuminuria; Diabetic Nephropathy

Summary: diabetic nephropathy (dn) is a chronic diabetic complication and affects up to 40% of patients. the first line treatment for dn is angiotensin blockers drugs that are used to reduce the protein concentration in urine.previous data showed that this protein, namely albuminuria, could also be reduced in a short term-period by the replacement of red meat in the diet with chicken. the aim of this study is to compare the effects of this chicken diet with enalapril on albuminuria in a long-term period( 12 months)in type 2 diabetic patients.

replacement of red meat in the diet with chicken reduces urinary albumin excretion rate (uaer) and improves lipid profile in type 2 diabetic patients with micro- and macroalbuminuria in short term studies. the aim of this study was to compare the long-term effect of a chicken-based diet (cd) versus enalapril treatment on renal function and lipid profile in microalbuminuric type 2 diabetic patients. in this 12-month controlled clinical trial 28 patients were randomized to an experimental diet (cd plus active placebo) or enalapril treatment (enalapril 10 mg/day plus patient's usual diet). uaer (immunoturbidimetry), blood pressure levels, anthropometric indices, and compliance with the diet were evaluated monthly. glomerular filtration rate (51cr-edta), lipid, glycemic, and nutritional indices were measured at baseline, and quarterly. uaer was reduced after cd \[n=13; 62.8 (38.4-125.1) to 49.1 (6.2-146.5) mcg/min; p\<0.001\] and after enalapril treatment \[n=15; 55.8 (22.6-194.3) to 23.1 (4.0-104.9) mcg/min; p\<0.001\]. the reduction of uaer was already significant at 4th month, and there was no difference between the uaer reduction after cd \[32% (95% ci: 6.7-57.6) and after enalapril treatment \[44.7% (95% ci: 28.3-61.1); p=0.366\]. in conclusion, cd and the ace inhibitor enalapril promoted similar uaer reduction in patients with type 2 diabetes and microalbuminuria. a chicken-based diet might represent an additional therapeutic approach to management of diabetic nephropathy.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus (according to world health organization criteria) attending the endocrine division's outpatient clinic at hospital de clínicas de porto alegre, brazil. patients were selected according to the following criteria: age \<75 years, a1c \<10%, 24-hour uaer 20 mcg/min and 199 mcg/min confirmed at least twice in a 6-month period, serum triglycerides \<400 mg/dl and normal liver and thyroid function tests. exclusion criteria: * patients were excluded from the study if they had bmi \>34 kg/m2, serum creatinine \>1.5 mg/dl, repeated episodes of urinary tract infection, other renal diseases, symptomatic autonomic neuropathy, heart failure, and acute myocardial infarction, coronary artery revascularization procedures or stroke within the last 6 months.

Keywords: type 2 diabetes microalbuminuria chicken-based diet ace inhibitor
purastat prevention delayed bleeding duodenum

Conditions: Lesion; Duodenum

Summary: purastat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. it is indicated for haemostasis in a variety of surgical indications. in this study the efficacy of purastat in reducing delayed bleeding following duodenal endoscopic mucosal resection (emr) will be assessed. purastat will be applied to the emr defect after the resection. the presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (egd) performed 1 day after the duodenal emr. furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of purastat application will be assessed.


Eligibility criteria:
inclusion criteria: * duodenal non-ampullary mucosal lesion ≥ 10 mm * ≥ 18y of age * informed consent obtained exclusion criteria: * ampulloma * submucosal lesion * lesion \< 10 mm * \>1 lesion resected * active use of anticoagulant or antithrombotic medication other than aspirin * known clotting disorder * inability to give informed consent * \< 18y of age

Keywords: purastat emr duodenum
bortezomib in treating patients with advanced non-small cell lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: phase ii trial to study the effectiveness of bortezomib in treating patients who have stage iiib, stage iv, or recurrent non-small cell lung cancer. bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth

primary objectives: i. determine the response rate, time to progression, and survival of patients with advanced non-small cell lung cancer treated with bortezomib. ii. determine the toxicity of this drug in these patients. iii. correlate toxicity and activity of this drug with markers of proteasome inhibition in blood and peripheral mononuclear cells in these patients. outline: patients receive bortezomib iv over 3-5 seconds on days 1, 4, 8, and 11. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer * mixed tumors allowed unless small cell elements are present * stage iiib or iv or recurrent disease * at least 1 measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * no known brain metastases * performance status - ecog 0-1 * more than 3 months * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * bilirubin ≤ 2 mg/dl * ast and alt ≤ 2.5 times upper limit of normal (uln) (5 times uln if liver involvement present) * creatinine ≤ 2 mg/dl * creatinine clearance ≥ 60 ml/min * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no peripheral neuropathy \> grade 1 * no other concurrent uncontrolled illness * no ongoing or active infection * no psychiatric illness or social situation that would preclude study participation * no more than 1 prior chemotherapy regimen * two prior chemotherapy regimens allowed provided 1 of the 2 regimens was gefitinib monotherapy as second-line therapy * at least 4 weeks since prior chemotherapy (6 weeks for carmustine, mitomycin, or nitrosoureas) and recovered * at least 4 weeks since prior radiotherapy (except localized radiotherapy for symptom relief) and recovered * prior bortezomib allowed provided patient achieved at least a partial response (of at least 6 months duration), received no other therapy since the last dose of bortezomib, and has no residual toxicity greater than grade 1 * no other concurrent investigational or commercial agents or therapies for malignancy
comparison of hypotension during spinal anaesthesia for c-section

Conditions: Hypotension; Cesarean Section; Aortocaval Compression

Summary: maternal hypotension during c section has been reported due to aortocaval compression (acc) by full term uterus in supine position. this study aimed at reporting the effect of left tilt on maternal hemodynamics.

c-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. the choice lies with the mother. in spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (ivf) and aorta. this aortocaval compression (acc) can also cause hypotension during c- section after spinal block. the aim of our study was to study the effect of left tilt on systolic (sbp) and diastolic blood pressure (dbp), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.

Eligibility criteria:
inclusion criteria: * participants ≥ 18 years, undergoing elective caesarean section for term singleton pregnancy, asa i/ii, were included after their consent for the participation of the study. exclusion criteria: * participants with co-morbidities (hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index \> 30 kg.m2), intrauterine growth were excluded from the study.

Keywords: hypotension cesarean section aortocaval compression left titl