Kornimate/medical-research-clean huggingface dataset:
impact of hydroxocobalamine on outcome of smoke inhalation injury admitted to the icu

Conditions: Smoke Inhalation Patients

Summary: in europe, hydroxocobalamin (cyanokit) has been used for suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). however, the impact of hydroxocobalamin on outcome has never been thoroughly evaluated. while hydroxocobalamin has long been presented as being side-effect free, recent data suggest that in patients with severe burns, its use was associated with the occurrence of acute renal failure by intra tubular precipitation of oxalate crystals (2, 3). the purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation.

in europe, hydroxocobalamin (cyanokit) is the antidote recommended by expert consensus in cases of suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). however, cyanokit has never been evaluated in this indication. clinical data suggest that in patients with severe burns, its use is associated with the occurrence of acute kidney injury by intra tubular precipitation of oxalate crystals (2, 3). the purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation. the results of this study should guide future research and advice on the benefit-risk ratio of hydroxocobalamin.

Eligibility criteria:
inclusion criteria: * admission in icu with smoke inhalation diagnosed exclusion criteria: * none

Keywords: smoke inhalation injury acute kidney injury intensive care unit burns prognosis hydroxocobalamin
phase i trial of continuous hyperthermic peritoneal perfusion (chpp) with cisplatin plus early postoperative intraperitoneal paclitaxel and 5-fu for peritoneal carcinomatosis

Conditions: Carcinoma; Peritoneal Neoplasm

Summary: two days prior to planned surgery, paclitaxel is infused iv over 24 hours. patients will undergo cytoreductive surgery, to debulk tumor. scope of procedure will vary with each patient, including a spectrum of possible procedures, such as splenectomy, liver resection, pancreatic resection or bowel resection. after cytoreductive surgery, continuous hyperthermic peritoneal perfusion (chpp) surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall. perfusion rate of cisplatin is 1.5 l/min and the duration is 90 min. postoperative intraperitoneal chemotherapy will begin 24 hours after chpp surgery. dose escalation will proceed after patients at a given dose level receive 3 courses. in order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose escalation. mtd is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity (dlt) or when 4 of 6 patients experience hematologic dlt. two to 4 months after surgery, laparotomy will be conducted to determine response to treatment. if tumor size is decreased, patients will undergo a second treatment course identical to the same techniques and chemotherapy agents.

peritoneal carcinomatosis is considered a terminal stage of tumor progression. cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of this disease. this study will define the maximum tolerated dose of paclitaxel and 5-fluorouracil (5-fu) given as an early post-operative intraperitoneal (ip) dwell therapy after cytoreductive surgery and continuous hyperthermic peritoneal perfusion with cisplatin (chpp).

Eligibility criteria:
the patients must have an ecog performance status of 0 or 1 and have no concomitant medical problems that would place them at increased risk for a major surgical procedure (eg, cardiac or pulmonary disabilities). patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age greater than 65, history of hypertension, first degree relative with atherosclerotic coronary artery disease) will undergo cardiac evaluation and performed which will include an attempt to remove all disease greater than 0.5 cm in diameter.

Keywords: gastrointestinal adenocarcinoma taxol
fdg pet-mri for the diagnosis of spinal cord lesions

Conditions: Spinal Cord Neoplasm

Summary: to compare the results and understand the possible benefits from fdg-pet/mri during different scanning time points after fdg, a type of contrast drug, is given.

primary objectives: --to identify the optimal imaging time point using f18-fdg positron emission tomography (pet) that gives the best lesion conspicuity as defined by the best lesion to background (l/b) ratio when evaluating spinal cord lesions of unknown etiology. exploratory objectives: * to identify malignancy specific factors in f18-fdg metabolism derived from metrics such as maximum standard uptake value (suvmax), mean standard uptake value (suvmean), total lesion glycolysis (tlg), metabolic tumor volume (mtv) and l/b ratio. * to identify patterns of metabolism derived from metrics such as suvmax, suvmean, tlg, mtv, l/b ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values and mean diffusivity measures. outline: patients receive fludeoxyglucose f-18 intravenously (iv) over 1 minutes and then undergo pet-magnetic resonance imaging (mri) over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose f-18 injection in the absence of unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * patients with untreated intramedullary cord lesion(s) * ability to undergo fdg pet mr examination exclusion criteria: * no prior surgery or biopsy of the spinal cord * no metal implanted in area of interest * spine radiation therapy * known allergy to fdg or gadolinium based contrast agents * blood glucose (\> 200 mg/dl) * pregnant women are excluded * children of less than 18 years of age * need for conscious sedation or anesthesia in order to tolerate study
memantine treatment study of pathological gambling

Conditions: Pathological Gambling

Summary: the goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (pg). thirty subjects with dsm-iv pg will receive 10 weeks of open-label treatment with memantine. the hypothesis to be tested is that memantine will be effective and well tolerated in patients with pg. we hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. this study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pathological gambling using the clinician-administered structured clinical interview for pathological gambling (sci-pg) (grant et al., 2004); * gambling behavior within 2 weeks prior to enrollment; * for women, negative results on a urine pregnancy test and stable use of a medically accepted form of contraception. exclusion criteria: * infrequent gambling (i.e. less than one time per week) that does not meet dsm-iv criteria for pg; * unstable medical illness or clinically significant abnormalities on laboratory tests, ekg, or physical examination at screen; * history of seizures; * myocardial infarction within 6 months; * current pregnancy or lactation, or inadequate contraception in women of childbearing potential; * a need for medication other than memantine with possible psychotropic effects or unfavorable interactions; * clinically significant suicidality; * current axis i disorder determined by the scid and scid-compatible modules for impulse control disorders (grant et al., 2005), except for nicotine dependence; * lifetime history of bipolar disorder type i or ii, dementia, schizophrenia, or any psychotic disorder determined by scid; * current or recent (past 3 months) dsm-iv substance abuse or dependence; * positive urine drug screen at screening; * initiation of psychotherapy or behavior therapy within 3 months prior to study baseline; * previous treatment with memantine; * treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.

Keywords: pathological gambling compulsive gambling gambling addiction gambling treatment memantine pharmacology
optimized acupuncture treatment for female stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female sui.

stress urinary incontinence (sui) mainly refers to the involuntary leakage of urine when abdominal pressure increases, such as sneezing, coughing, laughing or exercise. according to epidemiological studies, the global median prevalence of female urinary incontinence is 27.6% (4.8%-58.4%), of which sui accounts for more than 50%. previous study have demonstrated that acupuncture intervention can reduce the urine leakage in pad test, decrease the iciq-sf score, so as to help the patients alleviate the symptoms and improve their quality of life. this multicenter randomized controlled trial set 3 groups. patients will receive 3 different applications of acupoint combinations so that the optimization of acupuncture treatment of female sui will be find.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate sui mentioned in the diagnostic criteria above; * aged 40～75 years; * sign the informed consent. exclusion criteria: * other types of urinary incontinence (urgent, overflow or mixed). * history of urinary incontinence surgery or pelvic floor surgery; * pelvic organ prolapse ≥ stage ii; * symptomatic urinary tract infection; * residual urine volume \> 30 ml; * maximum urinary flow rate \< 20ml/s. * limitation of movement (walk and/or run and/or climb stairs); * patients who have been using drugs that may affect bladder function or receiving sui specialized treatment; * severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease; * pregnancy or lactation period. * with cardiac pacemaker, acupuncture phobia or metal allergies;
visual outcomes of a segmental refractive multifocal intraocular lens

Conditions: Visual Acuity

Summary: to evaluate visual outcomes of a segmental refractive multifocal intraocular lens (iol) after cataract surgery.

purpose: this prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (iol) after cataract surgery and was performed at the department of ophthalmology, goethe university, frankfurt, germany. methods: fifty eyes (25 patients) were included. inclusion criteria were bilateral cataract, age \> 45 years, corneal astigmatism ≤ 0.75 d postoperatively, pupil size 3 to 6 mm (mesopic), and center shift \< 1 mm (pentacam). exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (dcva) \< 0.3 logmar, intervention or observation: uncorrected (ucva) and dcva in 4 m, 80 cm, 40 cm; contrast sensitivity (cs) under photopic and mesopic conditions; reading skills (radner reading charts); defocus curve, questionnaire on optical quality (oq) and spectacle independence were assessed after 3 months. main outcome measures: at 3 months postoperatively, ucva and dcva in 4 m, 80 cm, 40 cm (logmar); defocus curves; cs; reading skills; and oq questionnaire results.

Eligibility criteria:
inclusion criteria: * bilateral cataract * age \> 45 years * corneal astigmatism ≤ 0.75 d postoperatively * pupil size 3 to 6 mm (mesopic) * center shift \< 1 mm exclusion criteria: * previous ocular surgeries * amblyopia * potential postoperative distance-corrected visual acuity (dcva) \< 0.3 logmar

Keywords: visual outcomes mulitfocal intraocular lens patient satisfaction spectacle independence contrast sensitivity
duloxetine vs placebo in the treatment of general anxiety

Conditions: Anxiety

Summary: to see if duloxetine 60 to 120 mg once daily (qd) is better than placebo in the treatment of generalized anxiety disorder (gad).

duloxetine 60 to 120 mg once daily (qd) and placebo 11 weeks

Eligibility criteria:
inclusion criteria: * male and female outpatients at least 18 years of age presenting with generalized anxiety disorder (gad) based on the disease diagnostic criteria the patient must suffer from gad and not from an adjustment disorder or anxiety disorder not otherwise specified (nos). symptoms of gad should not be situational in nature. * females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding; test negative for pregnancy at the time of enrollment based on a urine pregnancy test; and agree to use a reliable method of birth control during the study and for 1 week following the last dose of study drug. * must have a clinical global impressions of severity (cgi-severity) score of greater than or equal to 4 at visit 1 and visit 2. * at visit 1, patient must have a covi anxiety scale (cas) score of greater than or equal to 9, no item in the raskin depression scale (rds) may be greater than 3, and the cas must be greater than the rds. * must have a hospital anxiety and depression scale (hads) anxiety subscale score of greater than or equal to 10 at visit 1. exclusion criteria: * any current and primary dsm-iv axis i diagnosis other than gad. * patients diagnosed with or who have a history of major depressive disorder (mdd) within the past 6 months or * patients diagnosed with or who have a history of panic disorder, post-traumatic stress disorder (ptsd), or an eating disorder within the past year or * patients who have been diagnosed with obsessive compulsive disorder (ocd), bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime. * the presence of an axis ii disorder or history of antisocial behavior, which, in the judgment of the investigator, would interfere with compliance with the study protocol. * benzodiazepine use 14 days prior to visit 2. * patients judged clinically to be at serious suicidal risk, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study completion. * have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
toccata - touch+™ for catheter ablation

Conditions: Atrial Fibrillation; Tachycardia, Supraventricular

Summary: the main objective of this study is to demonstrate the clinical safety of a contact force sensing rf ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. in addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.

safety: the primary safety endpoint assesses the incidence of procedure or device related saes from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided svt or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure. performance: the primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. the secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations. efficacy: secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters

Eligibility criteria:
inclusion criteria: * patients with right-sided svt (including: atrioventricular nodal re entry tachycardia \[avnrt\], accessory pathway wolff parkinson white \[wpw\] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation exclusion criteria: * recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery * moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (tte) or transesophageal echocardiogram (tee) of all four chambers of the heart * known cerebrovascular disease, including a history of stroke or transient ischemic attack * left ventricular ejection fraction of \<35% * previous heart ablation procedure (surgical or catheter) to the target chamber

Keywords: atrial fibrillation supraventricular tachycardia contact force rf ablation radiofrequency pulmonary vein isolation paroxysmal atrial fibrillation
one year glargine treatment in cfrd children and adolescents

Conditions: Cystic Fibrosis; Glucose Metabolism Disorders

Summary: glargine treatment can improve the clinical features in cystic fibrosis patients affected by glucose derangements

to evaluate the effect of glargine treatment on bmi, lung function, acute pulmonary infections and hba1c in cystic fibrosis (cf) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. they were classified on the basis of a "gluco-score" ranging 0-5. patients with gluco-score \> 1 were treated with glargine. we report on the results of the first 20 patients who completed 12 months of treatment. bmi z-score, forced expiratory volume in the first second (fev1), number of acute lung infections in the previous year and hba1c were the study outcomes.

Eligibility criteria:
inclusion criteria: * patients affected by cystic fibrosis who had shown glucose derangements. exclusion criteria: * patients with/without cystic fibrosis without glucose derangements.

Keywords: cystis fibrosis glucose intolerance glargine fev1%
using informatics to enhance care of older emergency department patients

Conditions: Elderly; Renal Insufficiency

Summary: the subjects in this study are physicians working in the wishard emergency department. the purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. the objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department. interventions: the interventions in this study are computer reminders. when releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the regenstrief medical record system. the computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders: 1. the medication prescribed is generally considered unsafe for use in older patients. the reminder will then list appropriate alternatives for this medication. 2. the dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function). 3. this patient may be eligible for influenza vaccination. the physician will then choose to order or disregard the recommendation. the computer system will automatically record what the physician selected to do. the general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. this outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).


Eligibility criteria:
inclusion criteria: * the subjects of this study will be physician providers and residents and medical students practicing under the supervision of a faculty emergency physician. specific study subjects will include emergency medicine faculty physicians; emergency medicine and internal medicine residents; emergency medicine, surgery, and internal medicine interns; and medical students taking care of patients in our emergency department. exclusion criteria: * we will not include the members of the research team in this study.
pediatric msc-afp sub-study for crohn's fistula

Conditions: Fistula in Ano; Crohn Disease

Summary: the purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (msc) coated fistula plug in people with fistulizing crohn's disease. autologous means these cells to coat the plug come from the patient.

the investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the gore bio-a fistula plug) in a phase i study using a single dose of 20 million cells. 5 patients (age 12 to 17 years) with crohn's perianal fistulas will be enrolled. subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. six weeks post placement of the draining seton, the seton will be replaced with the msc loaded gore fistula plug as per current clinical practice. the subjects will be subsequently followed for fistula response and closure for 24 months. this is an autologous product derived from the patient and used only for the same patient.

Eligibility criteria:
inclusion criteria 1. males and females 12-17 years of age. 2. residents of the united states. 3. crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below). 4. concurrent therapies with corticosteroids, 5-aminosalicylate (5-asa) drugs, thiopurines, methotrexate (mtx), antibiotics, and anti-tumor necrosis factor (tnf) therapy are permitted. 5. all patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition 6. have no contraindications to mr evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia 7. ability to comply with protocol 8. competent and able to provide written informed consent (and assent where appropriate). 9. must have failed standard medical therapy including anti-tnf agents exclusion criteria 1. inability to obtain informed consent (and assent where appropriate). 2. clinically significant medical conditions within the six months before administration of mscs: e.g. sepsis, pneumonia active serious infection or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. 3. specific exclusions; a. evidence of hepatitis b, c, or hiv 4. history of cancer including melanoma (with the exception of localized skin cancers) 5. investigational drug within thirty (30) days of baseline 6. a resident outside the united states 7. pregnant or trying to become pregnant, or breast feeding. 8. history of clinically significant auto-immunity (other than crohn's disease) or any previous example of fat-directed autoimmunity 9. previous allergic reaction to a perianal fistula plug. 10. if adipose tissue is not technically feasible 11. weight less than 35 kg 12. allergic to local anesthetics 13. non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)