Kornimate/medical-research-clean huggingface dataset:
prophylactic antimicrobial catheter lock

Conditions: Bacteremia

Summary: this is a randomized, double blinded, prospective, multicenter, clinical trial of the use of heparin versus gentamicin as a pos-dialysis catheter lock solution.

the study is a randomized, double blinded, prospective, multicenter, clinical trial. all patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. patients will be randomized to receive either heparin 1,000 u/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% sodium citrate with gentamicin 320 mcg/ml in a volume sufficient to fill the catheter length in both ports.we hypothesize that the device related infection rate in the citrate/gentamicin group will be less than the heparin arm.

Eligibility criteria:
inclusion criteria: * requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access. * must be at least 18 years old * compliant with a dialysis treatment schedule * plans to continue hemodialysis treatment and follow-up at the investigational site * must be able to care for the exit site independently or have someone who is able to care for the site for them * must be able to sign the informed consent document exclusion criteria: * the subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred * active exit site or tunnel infection * systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening * known to have antibodies to heparin * allergy to pork heparin * allergy to gentamicin * subject is pregnant * known intravenous drug abuse

Keywords: sodium citrate gentamicin prophylaxis hemodialysis central venous catheter
myocardial oedema in acute myocardial infarction (ami)

Conditions: Myocardial Infarction

Summary: despite recent improvements in treatment, myocardial infarction (heart attack) is still a leading cause of illness and death in the uk. following the acute event, it is difficult to predict which patients are at risk of further problems, such as heart failure and is therefore difficult to know which patients need more aggressive/intensive treatment and monitoring. there needs to be a test which is safe, reliable and reproducible that can be used shortly after a heart attack to both predict future cardiac events and to allow the efficacy of new treatments to be assessed. myocardial oedema (swelling of the heart muscle) has been demonstrated using cardiac magnetic resonance (cmr), to occur following a heart attack and has been suggested as a marker for future cardiac events. the optimum time to perform this scan, the method of data analysis and it's effectiveness as a predictor of future cardiac events has not been adequately assessed. this trial will assess the amount and natural time-course of oedema in the first 10 days following a heart attack. it will also correlate the amount of oedema with the size of scar (damaged heart muscle) and left ventricular ejection fraction (heart function) at 3 months to assess if it is a predictive marker.


Eligibility criteria:
inclusion criteria: 1. patients presenting to the london chest hospital with acute st elevation myocardial infarction and treated with primary angioplasty and stent implantation within 12 hours of symptom onset 2. acute pci / stent implantation has been successful (residual stenosis visually \< 30% and timi flow ≥ 2) 3. at the time of inclusion, the patient no longer requires intravenous catecholamines or mechanical hemodynamic support (aortic balloon pump) 4. serum troponin \>1ng/ml 12 hours after onset of pain 5. the patient is able to give written informed consent 6. the patient must be able to understand and communicate in english exclusion criteria: 1. known cardiomyopathy 2. previous documented myocardial infarction 3. previous percutaneous coronary intervention or coronary artery bypass surgery 4. significant renal dysfunction (egfr\<30) 5. systemic steroid therapy 6. current non steroidal anti-inflammatory drug use 7. chronic inflammatory disease 8. neoplastic disease without documented remission within the past 5 years 9. pregnancy 10. reduced mental capacity leading to inability to obtain informed consent 11. participation in another clinical trial within the last 30 days

Keywords: myocardial infarction myocardial oedema magnetic resonance
biometric factors changes caused by myopia orthokeratology (ok) lens

Conditions: Contact Lenses

Summary: subjects fit with vst or crt type lens are reviewed 1 day to 2 year after first wearing the lens. ocular examinations were performed, including slit-lamp biomicroscope, uncorrected distance visual acuity (udva), corrected distance visual acuity (cdva), corneal topography (medmont e300w, medmont pty ltd, melbourne, australia), corneal refractive power (autorefractometer, kr880, topcon, japan), corneal epithelial thickness (optical coherence tomography, rtvue-xr), axial length using iol-master 700 (carl zeiss meditec ag). to investigate corneal and retina changes caused by overnight ok lens.


Eligibility criteria:
inclusion criteria: * normal subjects without any history of ocular surgeries or diseases (except for refractive errors) or systemic diseases that might affect contact lens wearing. the spherical error between -1.0 and -5.0 d, cylindrical error of at most 2.0 d, and a corrected distance visual acuity of 20/20 or better. exclusion criteria: * subjects who had previously worn contact lens, were also excluded
added conversational hypnosis reduced general anesthesia side effects for day case breast surgery

Conditions: Breast Cancer

Summary: evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.

drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. however, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. these techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room interventional (sspi) and a number of postoperative adverse effects. among the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. this technique aims to suggest a pleasant environment and not anxiety. this study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.

Eligibility criteria:
inclusion criteria: * female \> 18 years * patient with asa\* score 1, 2, 3 * minor unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction...) * day case surgery (ambulatory surgery - living day0-day1) * general anesthesia required * written informed consent * french medical benefit exclusion criteria: * age \< 18 years * patient with asa score \> 4; * body mass index \< 15 or 45kg/t; * major surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction * patient refusing hypnosis * psychic or mental disorders * chronic pain * opiate therapeutic \> 3 months * not ability to speak and read french language * deaf and dumb patient * under guardianship patient or guardianship
hydrocodone for pain control in first trimester surgical abortion

Conditions: Pain

Summary: the purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (hc/apap) reduces pain during a first trimester surgical abortion.

the investigators plan to conduct a double-blinded randomized placebo-controlled trial of 120 women undergoing elective first trimester surgical abortion. these women will be premedicated with either two tabs of 5/350 hydrocodone/acetaminophen or 2 tabs of a placebo. all subjects will receive ibuprofen and lorazepam preoperatively and a pcb. this study will examine the incremental benefit of hc/apap over this standard medication regimen. randomization will be stratified into two groups. subjects less than 8 weeks gestation will comprise the early gestational age group. subjects between 8 weeks 0 days and 10 weeks 6 days will comprise the late gestational age group. the investigators will be assessing patient perception of pain, nausea, satisfaction, and anxiety at multiple points during the clinic visit using 100-mm visual analogue scales (vas).

Eligibility criteria:
inclusion criteria: * aged 18 years or older * voluntarily requesting surgical pregnancy termination * pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by ultrasound * eligible for suction curettage * english or spanish speaking * good general health * able and willing to give informed consent and agree to terms of the study exclusion criteria: * gestational ages 11 weeks or more * incomplete abortion * premedication with misoprostol * use of any opioid medication within the past 7 days * use of heroin within the past 7 days * requested opioids or iv sedation prior to start of the procedure * patients who refuse ibuprofen or lorazepam * contraindications or allergies to hc/apap, lidocaine, ibuprofen, or lorazepam * significant medical problem necessitating inpatient procedure * adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease * known hepatic disease

Keywords: pain during first trimester surgical abortion
clinical on the safety and efficacy of fosaprepitant dimeglumine for injection in the prevention of cinv.

Conditions: Neoplasms

Summary: to evaluate the safety of fosaprepitant dimeglumine injection for the prevention of nausea and vomiting caused by tumor chemotherapy drugs, analyze the characteristics of the applicable population and clinical medication of fosaprepitant dimeglumine, evaluate the risk factors that may affect the efficacy of drug use, and compare the clinical benefits of different drug use modes.

this is a prospective, one arm, open, non-interference, multi center, observational, real world clinical study. study drug: fosaprepitant dimeglumine for injection. white or almost white lump or powder, containing 150mg (calculated as c23h22f7n4o6p). this product is a nk-1 receptor antagonist, which is administered jointly with other antiemetic drugs. it is suitable for adult patients to prevent acute and delayed nausea and vomiting during the initial and repeated treatment of highly emetic chemotherapy drugs (hec).

Eligibility criteria:
inclusion criteria: * patients with nausea and vomiting caused by chemotherapy * patients who volunteered to participate in the study exclusion criteria: * hypersensitive to any component in this product * patients taking pimozide, terfenadine, astemizole and cisapride
inflammatory response as a prognostic factor of recurrence of atrial fibrillation after ablation

Conditions: Atrial Fibrillation

Summary: the aim of this study is to evaluate inflammatory response as a prognostic factor of atrial fibrillation recurrency after ablation. inflammatory response will be assessed by double measurement of c-reactive protein, fibroblast growth factor 2 (fgf2), matrix metallopeptidase 8 (mmp8) and body temperature. dynamics of change of troponin i will be measured additionally. after ablation each patient will be monitored with ecg telemonitoring system for 7 days.


Eligibility criteria:
inclusion criteria: * signed consent; * criteria for ablation of atrial fibrillation. exclusion criteria: * previous pulmonary veins isolation; * ablation other than pulmonary veins isolation during the procedure; * atrial fibrillation at the beginning of ablation procedure; * usage of 'single shot' devices.

Keywords: atrial fibrillation biomarkers inflammatory response c-reactive protein fgf2 mmp8 troponin i body temperature
eus-fnb with mose vs eus-fna with rose

Conditions: Pancreatic Neoplasms

Summary: endoscopic ultrasound-guided fine needle aspiration (eus-fna) is an indispensable tool for tissue acquisition for pancreatic lesions. however, fna alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. the use of rapid on-site evaluation (rose) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for eus-fna. unfortunately, it is not widely available due to limited resources. in order to overcome these limitations, new fine needle biopsy (fnb) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. early results comparing fnb with fna showed the superiority of fnb over fna in the absence of rose. data comparing fnb and fna with rose are limited. in order to study to true merits of fnb over fna, comparison with the most optimal method is necessary.

the purpose of this study is to compare the diagnostic yield of eus-fnb with mose vs eus-fna with rose.

Eligibility criteria:
inclusion criteria: * aged between 18 and 80 years * referred for eus-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter exclusion criteria: * coagulopathy * altered anatomy * contraindications for conscious sedation * pregnancy * those who cannot provide informed consent
fall risk assessment in a population of charcot-marie-tooth disease type 1a (cmt 1a) by timed up and go test

Conditions: Charcot-Marie-Tooth Type 1A Neuropathy

Summary: the main objective of this study is to explore the relationship between the onset of fall and the time taken to complete the timed up and go test (tug) in this cmt1a patient population. the investigators hypothesize that patients with balance disorders and therefore a risk of major fall will require a longer time to perform the timed up and go test. in addition, it seems important to confirm that the severity of the disease has a negative impact on the frequency of balance disorders.

charcot-marie tooth disease is the most frequent and common inherited neuropathy with the various forms and subtypes. the cmt-1a is the most frequent form of the disease and represents more than eighty percent of the all subtypes. in view of different clinical elements (muscular strength deficit, walking and balance disorders, podological impairment), patients with cmt seem to be able to present an increased risk of fall. in 2017 pilot study supports this. more recently, a study by ramdharry et al. appears to confirm this with a cohort of 252 patients with cmt, 86% of whom have experienced at least one major fall or loss of balance. this increased incidence of falls is also found in children and adolescents with cmt with consequences in terms of injury and management. systematic screening of the risk of falls in this population is necessary, but no prospective studies on the occurrence of falls and its detection have yet been carried out in this population. a study focusing on this issue in order to standardize the assessment of postural control disorders using a simple test of common clinical practice seems necessary.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * diagnosis of charcot marie tooth disease, type 1a confirmed by molecular biology (duplication 17.p11.2) and by a pathological electromyogram, that is to say with demyelinating impairment (+/- axonal) dependent length * listening and written french * strength of the quadriceps superior to 2/5 mmt mrc * agreement after written information, clear and honest about the purpose of the study, the nature of the tests and their possible side effects or bothersome * health insurance cover exclusion criteria: * presence of other neurological comorbidity * presence of coronary artery disease unstabilized * peripheral neuropathy of other causes: diabetes, monoclonal gammopathy, malignancy, solid cancer, systemic autoimmune disease (lupus, sjögren's disease, wegener sarcoidosis ...), infectious disease (viral hepatitis, hiv ...), drugs known to be responsible for iatrogenic neuropathy. * gait trouble of other origin * patients unable to give their consent. * intellectual deficit that does not allow to comply with tests * patient under guardianship, or protection of justice.

Keywords: charcot-marie-tooth disease type 1a neuropathy fall risk walking timed up and go test 6-minutes walk test
effects of magnesium sulphate on sugammadex reversal of rocuronium induced blockade in gynaecology patients

Conditions: Pre-eclampsia Aggravated

Summary: background: the aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex. methods: eighty patients, aged 18 to 60 years, american society of anesthesiologists i-ii, undergoing elective gynecological surgery were enrolled. anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and oxygen in sevoflurane. the magnesium group received 50 milligram/kilogram (mg/kg) magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. the placebo group received the equivalent volume of isotonic saline. for intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when train of four (tof) counts reached 1 or more during the procedure. at the end of the surgery at a tof count of 1, 4 mg/kg sugammadex iv was administered. patients were observed until a tof ratio of 0.9 was achieved. patient-controlled analgesia with intravenous morphine was used postoperatively.

inclusion criteria: * american society of anesthesiologists physical status i or ii * 18-60 years of age * undergoing elective gynecological surgery * requiring endotracheal intubation exclusion criteria: * patients who had body mass index \> 35 * gastroesophageal reflux * a history of allergy * used medication known to interact with the drugs being used in this trial * who experienced expected or unexpected difficulty during intubation or ventilation * had neuromuscular disease * hepatic or renal insufficiency * pregnant * were american society of anesthesiologists iii or iv * had a family history of malignant hyperthermia * detection if low or high control plasma magnesium levels

Eligibility criteria:
inclusion criteria: * female patients * american society of anesthesiologists (asa) physical status i or ii * 18-60 years of age who were undergoing elective gynecological surgery * requiring endotracheal intubation were enrolled in this prospective study. exclusion criteria: * patients who had body mass index \> 35 * gastroesophageal reflux * a history of allergy * used medication known to interact with the drugs being used in this trial * who experienced expected or unexpected difficulty during intubation or ventilation * had neuromuscular disease * hepatic or renal insufficiency * were pregnant * had a family history of malignant hyperthermia * detection if low or high control plasma magnesium levels

Keywords: sugammadex rocuronium magnesium female
study of oral ridaforolimus in combination with standard chemotherapy for soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been tested in combination with the standard of care chemotherapy for sarcoma as this study will. we will be looking to see if ridaforolimus given with soc chemo (aim or tg) is well tolerated and to determine a phase 2 dose.


Eligibility criteria:
inclusion criteria: * advanced or metastatic soft tissue sarcoma with histological or cytological proven disease. no more than 2 lines of chemotherapy in the metastatic setting in the dose escalation phase, and no more than one line of prior therapy in the expansion phase. * ecog performance status of ≤ 1 * a minimum life expectancy \> 3 months * at least 4 weeks must have elapsed between prior investigational therapy, chemotherapy or radiotherapy and the first dose of ridaforolimus * adequate hematological, hepatic and renal function (hemoglobin ≥ 9g/dl, absolute neutrophil count \[anc\] ≥ 1.5 x 109/l; platelets ≥ 100 x 109/l; bilirubin ≤ uln; alkaline phosphatase ≤ 2.5 x uln; ast, alt ≤ 2.5 x uln; albumin ≥ 2.5mg/dl; creatinine ≤ 1.5 x uln) * serum cholesterol ≤ 350 mg/dl and triglycerides ≤400 mg/dl * signed informed consent * women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of therapy and must use an approved contraceptive method as appropriate from the time of screening until 30 days after the last dose of study drug. exclusion criteria: * uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis. * clinically significant unexplained bleeding within 28 days prior to entering the trial * uncontrolled systemic vascular hypertension * clinically significant cardiovascular disease * newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2 diabetes * have received \>350 mg/m2 total dose of doxorubicin * active infection requiring prescribed intervention * other concurrent illness * major surgery within 28 days before trial entry, or incompletely healed surgical incision; minor surgery or procedures within 7 days * previous anthracycline lifetime exposure more than 350 mg/m2 would exclude patient form aim arm enrollment * pregnant or breastfeeding * known allergy to macrolide antibiotics * concurrent treatment with medications that induce or inhibit cytochrome p450 (cyp3a). * known history of hiv sero-positivity

Keywords: sarcoma ridaforolimus soft tissue sarcoma unresectable sarcoma