Kornimate/medical-research-clean huggingface dataset:
compare preperitoneal analgesia to epidural analgesia for pain control after colon and rectal surgery

Conditions: Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Summary: this is a prospective randomized study of 114 patients. the purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the numeric pain scale (nps) and by the need for supplemental narcotic analgesics. this study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed on-q silver soakertm catheters (cpa) is equivalent to continuous epidural analgesia (cea).

background perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. these techniques, however, are labor-intensive and expensive. alternatively, local analgesics may be administered directly to the surgical wound via silver catheters. aim two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use. study design this is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. the primary outcomes are post-operative pain control and supplemental narcotic usage. other variables of interest * surgical site infections * the post-operative time to return of bowel function * the hospital expenses/cost differences * quality of life measured with the sf- 36 questionnaire

Eligibility criteria:
inclusion criteria: * age \> = 18 years * scheduled for elective colon or rectal surgery * surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic) * able to provide informed consent * able to complete patient questionnaire exclusion criteria: * documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl * contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc) * urgent surgery precluding epidural catheter placement * systemic infection contraindicating epidural catheter placement * unwillingness to participate in follow up assessments * prisoners
iron status of women and young children in the united states

Conditions: Iron-deficiency; Nutritional Deficiency

Summary: this analysis describes the distribution of tbi and the prevalence of iron deficiency (id) and iron deficiency anemia (ida) among toddlers, non-pregnant women, and pregnant women.

background: total body iron stores (tbi), which are calculated from serum ferritin (sf) and soluble transferrin receptor (stfr) concentrations, can be used to assess the iron status of populations in the united states. objective: this analysis describes the distribution of tbi and the prevalence of iron deficiency (id) and iron deficiency anemia (ida) among toddlers, non-pregnant women, and pregnant women. design: investigators analyzed data from nhanes; toddlers aged 12-23 mo (nhanes 2003-2010), non-pregnant women aged 15-49 y (nhanes 2007-2010), and pregnant women aged 12-49 y (nhanes 1999-2010). investigators used sas survey procedures to plot distributions of tbi and produce prevalence estimates of id and ida for each target population. all analyses were weighted to account for the complex survey design

Eligibility criteria:
included: * children ages 12-23 months and women ages 12-49 years * those who completed the mec excluded: - those missing data on iron biomarkers
exploring the links between hearing, cognition and brain activity in people with tinnitus

Conditions: Tinnitus

Summary: the goal of this observational study is to understand the mechanisms underlying tinnitus, and improve the clinical assessment strategies needed to develop targeted therapeutic interventions by comparing endogenous attention capacities in healthy subjects and subjects with tinnitus


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * good written and oral comprehension of the french language * normal or corrected vision group of people with tinnitus : - chronic tinnitus \> 3 months, uni or bilateral, stable (no period of remission) control group : - no tinnitus exclusion criteria: * presence of a known neurological disorder * presence of a known degenerative pathology * presence of a known hearing impairment * presence of a motor disability of the upper limbs * severe or profound deafness on one or both sides * person under legal protection (guardianship, curatorship, etc.) * use of hearing aids

Keywords: tinnitus
effects of simvastatin and ezetimibe on cardiovascular risk markers in patients with dyslipidemia

Conditions: Dyslipidemia

Summary: coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with statins and ezetimibe generally constituting the medication of choice. by acting at different levels, the combination of these drugs allows the therapeutic objective to be achieved. however, it is not known how these drugs qualitatively affect the composition of lipoprotein subfractions, which differ in size and atherogenic potential. the investigators set out to evaluate this effect as well as their effects on inflammatory, oxidative stress and endothelial function parameters.

the study consisted of a randomised parallel trial and took place during a period of 2 months. a total of 42 hyperlipidemic patients were randomly assigned to one of 2 groups: one received simvastatin (40 mg/day) and the other received ezetimibe (10 mg/day) for 4 weeks, after which both groups were administered combined therapy for an additional 4-week period. lipid profile, lipoprotein subfractions of ldl and hdl, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Eligibility criteria:
inclusion criteria: * ldl cholesterol concentration of between 160-190 mg/dl in patients with less than 2 cardiovascular risk factors * ldl concentration of between 130-160 mg/dl in patients that presented 2 or more cardiovascular risk factors. cardiovascular risk factors were defined as: age (≥ 45 years in men and ≥55 years in women), a smoking habit, hypertension (≥140/90 mmhg), diabetes mellitus, a high-density lipoprotein (hdl) cholesterol concentration of ≤ 40mg/dl, and a family history of cardiovascular disease. exclusion criteria: * triglyceride concentration \> 400 mg/dl * diabetes mellitus * kidney, liver, or thyroid disease

Keywords: dyslipidemia simvastatin ezetimibe lipid profile inflammation oxidative stress endothelial function
pain, function and quality of life before and after treatment of hamstring avulsion

Conditions: Hamstring Injury

Summary: the aim of the study is to investigate pain, function and quality of life before and 10-12 months after surgical repair and/or rehabilitation of hamstrings avulsion


Eligibility criteria:
inclusion criteria: * patients eligible for treatment of hamstring avulsion exclusion criteria: * conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions * patients that do not speak or understand danish
effects of weight loss from bariatric surgery on intraocular pressure (iop)

Conditions: Intraocular Pressure

Summary: the purpose of this study is to determine if there is an effect on the eye pressure from extreme weight loss by bariatric procedures. the hypothesis is that excess fat in the orbit of the eye compresses on the outflow system, which causes an elevated eye pressure. this can have many consequences, including the risk for glaucoma. we hope to establish if there is an effect between eye pressure and weight.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * written informed consent obtained * bmi \> 40 kg/m2 without associated comorbidities or \> 35 kg/m2 with associated comorbidities. in the normal indication for routine bariatric surgery, comorbidities include hypertension, type ii diabetes, venous stasis, sleep apnea, polycystic ovary syndrome, pseudotumor cerebri, nonalcoholic steatohepatitis, gastroesophageal reflux disease, coronary artery disease, degenerative joint disease, cancer, and hypercholesterolemia. exclusion criteria: * current use of systemic steroids * any systemic medication which is unstable and can affect iop * history or evidence of glaucoma * any ocular trauma or ocular surgery * outside normal range of corneal thickness (500-600 microns) * unable to follow-up for 3 years * participating in any investigational device or medication study within 30 days of baseline
cardiac output monitoring by transpulmonary thermodilution and transthoracic echocardiography in critically ill patients

Conditions: Sinus Rhythm

Summary: cardiac output monitoring is a key component for the diagnosis and management of critically ill patients. the two less invasive methods commonly used in intensive care are transthoracic echocardiography and transpulmonary thermodilution. the objective of this study is to compare accuracy and trending ability of co measurement by tptd and tte in critically ill patients with sinus rhythm.

tte is an easy noninvasive device now recommended as the first evaluation of the patient in circulatory failure but it present some limits due to poor echogenicity of patients, operator-dependent variability and cannot provide continuous hemodynamic data. tptd is an invasive technique for co monitoring recommended especially in shock not responsive to initial therapy. few studies have evaluated the level of agreement of each method (tte and tptd) with the reference method (pulmonary artery catheter) but they have never been compared between them with strong statistical analysis in particular trending ability. it could be interesting to determine the level of concordance of these two methods of co monitoring and trend ability by tptd relative to tte. the investigators hypothesize that co-tptd are concordant with those performed by tte. mechanically ventilated patients requiring hemodynamic assessment will be included. co-tptd will be measured via intermittent thermodilution. blindly, a second investigator will use standard-view tte to estimate co-tte as the product of stroke volume and the heart rate obtained during the measurement the blood flow velocity (using a doppler technique) at the left ventricular outflow tract. a second measurement will be done with the two devices after a fluid challenge when patient requires it to compare trending ability.

Eligibility criteria:
inclusion criteria: * mechanically ventilated and sedated patients * with sinus rhythm * hospitalized in intensive care unit * fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure exclusion criteria: * age under 18 * arrhythmia * severe aortic regurgitation or stenosis * intracardiac shunt * poor echogenicity * tamponade * major subject to a legal protection regim.

Keywords: cardiac output monitoring transthoracic echocardiography transpulmonary thermodilution intensive care
safety and effectiveness of nxy-059 for the treatment of patients who have suffered from a stroke

Conditions: Cerebral Stroke; Ischemic Attack, Transient

Summary: this study will determine if nxy-059 will reduce functional disability from an acute stroke. the study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility criteria:
inclusion criteria: * males and females * acute ischemic stroke with limb weakness, onset of symptoms within 6 hours * full functional independence prior to the present stroke exclusion criteria: * unconsciousness * subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition * severe illness with life expectancy less than 6 months * known severe kidney disorder * current known alcohol or illicit drug abuse or dependence * pregnant or breast-feeding * treatment with acetazolamide and methotrexate is not permitted during the infusion * participation in a previous clinical study within 30 days

Keywords: stroke, acute cerebrovascular stroke
comparison of the efficacy of rtms and tdcs of the motor cortex in patients with chronic neuropathic pain

Conditions: Lumbar Radiculopathy

Summary: the present study aims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.

the present study ims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation (rtms) and transcranial direct electrical current (tdcs) of the motor cortex in patients with chronic lumbar radiculopathy on average pain intensity. this will be a sham controlled crossover design : patients will be randomized to receive either active rtms or tdcs during 3 consecutive days followed by the alternative treatment within 3 weeks apart, or sham rtms or tdcs during 3 consecutive dats followed by the alternative treatment within 3 weeks apart. the investigator will be blind to the treatment. assessments will be performed before each treatment, then 1 hour after the end of the third day session, then 2 days and 1 week after the stimulation. assessments will include pain questionnaires, quality of life, anxiety and depression, catastrophizing and evaluation of treatment effect on experimental pain using quantitative sensory testing.

Eligibility criteria:
inclusion criteria: patients aged more than 18 years and less than 60 years, males of females lumbosciatica or lumbocruralgia with predominant neuropathic components with dn4 score ≥ 4/10 chronic pain with an intensity of at least 4/10 stable analgesic treatment for at least 15 days before inclusion able to speak and understand french social security exclusion criteria: work accident or litigation contraindication to rtms (sismotherapy in the preceding month, epilepsia, past head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy or lactation major depressive episode intermittent pain consent refusal impossible to follow up during the duration of the study pain more severe than neuropathic pain

Keywords: neuropathic pain lumbar radiculopathy rtms tdcs placebo controlled study
hemodynamic matched comparison of the balloon-expandable transcatheter heart valves myval and sapien-3 for the treatment of aortic stenosis

Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation

Summary: transcatheter aortic valve implantation (tavi) is recommended for patients with severe aortic stenosis (as) at high to intermediate surgical risk. despite similar mortality rates compared to surgical aortic valve replacement (savr) in this setting, the rate para-valvular leak (pvl) remains higher and has been associated to higher mortality even at mild degree. this is one of the major concerns to extend tavi to low surgical risk, although the favorable results from partner 3. the presence of moderate to severe pvl after tavi is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29). prosthesis-patient mismatch (ppm) adversely affects functional improvement and exercise tolerance, left ventricular (lv) mass regression, and late structural valve deterioration. many studies have previously investigated ppm after surgical avr suggesting the presence of this problem in more than 40% of the surgically treated patients. this rate was significantly lower with the balloon-expandable sapien (edwards lifesciences, irvine, california), with ppm that varied from 8% to 18%, but in both cases (patients harboring tavi and those with savr) the mortality rate was higher in the presence of ppm. under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable tavi devices available in the market, the aim of the match-ball study is to compare the hemodynamic performance of two balloon-expandable tavi devices, sapien 3 (edwards lifesciences, irvine, ca, usa) and myval (meril life sciences pvt. ltd., india).


Eligibility criteria:
inclusion criteria: * all patients diagnosed with aortic stenosis (effective aortic\<1.0 cm2) accepted for a tavi procedure by the heart team. * implantation of sapien-3 transfemoral valve or myval transfemoral prosthesis. * availability of the variables selected for the matching process: left ventricular ejection fraction, aortic annulus diameter and area, eccentricity index, and calcium score (all measured using computed tomography), body surface area, and body mass index. * availability of imaging studies at baseline and at discharge or 30-day follow up. exclusion criteria: * failure to comply with matching criteria. * failure to properly analyse images in the echo core-lab.

Keywords: tavi tavr balloon-expandable transcatheter heart valve
a clinical study of uft/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer (peru)

Conditions: Pancreatic Cancer

Summary: the purpose is to assess the overall survival of patients receiving either uft/lv + radiotherapy (rt) or uft/lv + cetuximab + rt after neo-adjuvant chemotherapy.

locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of crt over chemotherapy alone. 4 phase ii- iii studies patients without disease progression after 3 months of systemic chemotherapy and crt had a longer survival than those continuing on chemotherapy. therefore chemotherapy followed by crt may be a better approach. also the effect of blocking egfr will be evaluated in locally advanced pancreatic cancer. gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * age \>18 * histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas. * considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the smv or smv/portal vein confluence, direct involvement of sma, coeliac axis, inferior vena cava or aorta. * performance status 0-2 * no evidence of metastatic disease as determined by ct scan/ other investigations * adequate bone marrow function with platelets\>100\^9/l; wbc\>3x10\^9/l;neutrophils\> 1.5x10\^9/l * serum bilirubin ,1.5 x uln and transaminases \< 2.5 x uln * calculated/measured gfr \>50ml/min * no concurrent uncontrolled medical condition * no active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years * life expectancy \> 3months * adequate contraceptive precautions * informed written consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent * presence of met. disease * concurrent uncontrolled medical conditions * any previous chemo/rt or any investigational treatment for advanced pancreatic cancer. * adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry * adjuvant rt with/without chemo for pancreatic cancer. * pregnancy/breast feeding * patients with known malabsorption syndromes ro a lack of physical treatment of the upper gi tract. * patients with a known hypersensitivity to 5-fu or with a dpd deficiency. * clinically significant cvd
safety of accelerated infliximab infusions in patients with inflammatory bowel disease (ibd)

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: this study aims to test the hypothesis that the accelerated infusion of infliximab is not inferior to the conventional 2 hour infusion with respect to the frequency of infusion reaction.

the standard protocol of infliximab administration is the infusion for 2 hours. however, due to the discomfort of patients and limitation of medical resources, the accelerated infusion is more desirable if accelerated infusion does not increase the frequency of infusion reaction. recent observational studies showed that the accelerated infusion of infliximab for 1 hour or 30 minutes did not increase the frequency of infusion reaction if patients had not shown infusion reactions during previous 4 infusions for 2 hours. however, there are no randomized trials comparing the safety of accelerated infusion protocol and standard infusion protocol yet.

Eligibility criteria:
inclusion criteria: * patients receiving infliximab for crohn's disease or ulcerative colitis * ethnicity: korean * patients who did not show any infusion reactions during 4 times of infliximab (5mg/kg) infusions for 2 hours * informed consents exclusion criteria: * sever cardiopulmonary diseases * allergic diseases * bronchial asthma * allergic rhinitis * atopic dermatitis * other allergic diseases determined not suitable for study participation by investigators * severe liver disease * severe renal disease * body weight over 100 kg * other medical or surgical disease determined not suitable for study participation by investigators

Keywords: crohn's disease ulcerative colitis infliximab infusion reaction
intensive versus conventional treatment in patients with primary amyloidosis

Conditions: Primary Systemic Amyloidosis (AL)

Summary: al amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal ig light chains, leading to multisystem organ failure and death. the prognosis for al amyloidosis with conventional treatment remains poor, autologous stem cell transplantation (asct) for al amyloidosis produces high hematologic and organ responses. however, treatment-related mortality remains high and reported series are subject to selection bias.

a prospective randomized trial was conducted to compare in al amyloidosis asct (melphalan 140 or 200 mg/m2 depending on age and clinical status supported with asct collected with g-csf alone) and the oral regimen m-dex (melphalan 10 mg/m2 and dexamethasone 40 mg for 4 days each months up to 18 months). the objectives were to compare survival and hematologic and clinical responses.

Eligibility criteria:
inclusion criteria: * below 70 years of age * biopsy proven systemic al amyloidosis * no more than 2 prior courses of chemotherapy * ecog performance status \< 3 * informed written consent exclusion criteria: * localized amyloidosis * hiv seropositivity * previous myelodysplasia * concomitant serious disease

Keywords: al amyloidosis autologous stem cell transplantation melphalan dexamethasone
deliver study: deliverability of the resolute integrity stent in all-comer vessels and cross-over stenting

Conditions: Coronary Artery Disease

Summary: the primary objective of the deliver study is to assess the deliverability of the resolute integrity stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.


Eligibility criteria:
inclusion criteria: * minimum legal age (18) * acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines * patient has consented to participate and authorized in writing the collection and release of medical information exclusion criteria: * pregnancy * participating in another study that interferes with study endpoints * untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media * patients in whom anti-platelet and/or anticoagulation therapy is contraindicated