Kornimate/medical-research-clean huggingface dataset:
the effect of inelastic compression system on quality of life in people with chronic venous insufficiency

Conditions: Chronic Venous Insufficiency

Summary: the purpose of this protocol is to measure the effect of the use of an inelastic compression system (ics) on quality of life (qol) in patients with chronic venous insufficiency (cvi) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.


Eligibility criteria:
inclusion criteria: * subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures * subject must have chronic venous insufficiency of stages c3, c4, or c5 according to the clinical-etiological-anatomical-pathophysiological (ceap) classification system * not compliant with their currently prescribed compression system exclusion criteria: * active malignancy other than non-melanoma skin cancer * study ulcer suspicious for cancer * subjects who are pregnant and/or breastfeeding * in the opinion of the pi the subject cannot comply with study procedures
filmarray and management of icu patients with pneumonia in the covid-19 context

Conditions: Infectious Disease; Pneumonia; Molecular Diagnosis; Covid-19; Antibiotic Stewardship

Summary: the research aims to determine the impact of a syndromic mutiplex pcr assay (filmarray) on the management of patients hospitalized in icu for severe respiratory disease. during the sars-cov-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. moreover, patients with covid-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods. in order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. this research will include 100 to 150 adult patients hospitalized in icu during the first half of 2020. it will take place within the nancy university hospital and the reims university hospital, france.


Eligibility criteria:
inclusion criteria: * patients \> 18 years affiliated to a social security system * patients who have received complete information about the research and who have not objected to the use of its data * patients with suspected sars-cov-2 infection * patients for which a filmarray test has been realized on its respiratory samples between 1st of march and 1st of july 2020. exclusion criteria: * none
induction of labour for lga fœtus in women without insulin-treated diabetes.

Conditions: Macrosomia; Induction of Labour; Non-insulin-dependent Diabetes

Summary: a french study published in 2015 (dame) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced. this new protocole was introduced in montpellier university hospital delivery room. the aim of this study is to evaluate the protocole in montpellier hospital and to compare our results with the dame results.

currently, large for date fœtus need an induction of labour just if the mother is an insulin diabetic. the dame's protocol included the large for date feotus witch have a estimate weight \>3500g at 36 ga, \>3700g at 37 ga, \>3900g at 38 ga.

Eligibility criteria:
inclusion criteria: age \>18 years old single pregnancy cephalic presentation no contraindications to planned vaginal delivery no fœtal pathology large-for-date foetus (estimated weight \> 95%) : * clinically suspeted or estilated weight \>90% at the 3 trimester ultrasound * estimated fœtal weight : \> 3500g at 36 ga \> 3700g at 37 ga \> 3900g at 38 ga exclusion criteria: age \<18 yeaurs old contraindications to vaginal delivery insulin-trated diabetics or imbalance diabetics. neonatal trauma or shoulder dystocia, severe urinary or faecal incontinence.

Keywords: shoulder dystocia maternal and neonatal morbidity
the effect of heel protector in intensive care units

Conditions: Pressure Ulcer, Heel; Plantar Flexion Contracture of Tarsometatarsal Joint

Summary: purpose: it was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time. design: the study is conducted as a randomized controlled study. method: heel protectors will be used in the intervention group among the patients in the intensive care unit who meet the inclusion criteria of the study, and the control group will be positioned with a pillow, which is the standard practice. as calculated in the g-power program with reference to the source, a total of 42 patients were determined to be included in the intervention group and 42 patients in the control group. these patients will be followed for a total of 14 days. heel scalp evaluation and goniometric measurements will be made according to braden pressure wound risk assessment scale, ramsey sedation scale, npuap and epuap staging system and recorded in the data collection form created by the researcher. h1: the heel protector is effective in preventing heel pressure ulcer. h0: the heel protector has no effect on preventing heel pressure ulcer. h2: the heel protector is effective in preventing plantar flexion contracture. h0: the heel protector has no effect on preventing plantar flexion contracture. h3: the heel protector is effective in improving the joint range of patients with plantar flexion contracture. h0: the heel protector has no effect on improving joint range in patients with plantar flexion contracture.


Eligibility criteria:
inclusion criteria: * high-risk patients; patients who were intubated or extubated in the icu for at least 5 days and received sedation * patients with braden pressure sore risk assessment scale 16 and below * patients with a ramsey sedation scale of 4 and above exclusion criteria: * bmi over 30 * patients with vascular disease * patients with albumin level below 2.5 mg/dl * patients mobile within 5 days * patients hospitalized with heel pressure ulcer * despite being included in the study, the patient becomes mobile before 15 days * patients with a medical condition that contraindicates the use of heel protectors

Keywords: heel pressure ulcer plantar flexion contracture heel protector
targeting self-regulatory deficits through cognitive remediation intervention

Conditions: Drug Use Disorders

Summary: we are proposing a small randomized clinical trial in which 100 substance users will complete the existing psychotherapy development center (pdc) pretreatment assessment battery as well as a novel battery of assays to evaluate cognitive-affective functioning. after completing pretreatment assessments, participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks). tasks will be completed twice per week for 4 weeks, after which assessment batteries will be repeated. finally, we will evaluate real-world behavior and the durability of the training via a one-month follow-up, which will include assessment of substance use as well as the cognitive-affective battery.

participants will be 100 individuals (aged 18 to 50) enrolled in outpatient (non- methadone/buprenorphine) treatment for any substance use disorder (other than pcp) at the substance abuse treatment unit in new haven. as the goal of this project is to develop interventions that address self-regulation across multiple disorders, we will recruit individuals who have a range of substance use disorders and levels of severity. our primary specific aim will be to evaluate the efficacy of the cognitive-remediation program relative to the control condition control on the indicators of cognitive-affective functioning and substance use, testing the hypothesis that individuals randomized to the cognitive remediation program will demonstrate improved functioning on the cognitive-affective battery as well as reduced real-world substance abuse. we will also explore potential moderators of response to the training, including baseline measures of cognitive-affective function.

Eligibility criteria:
inclusion criteria: * meet current dsm-5 criteria for an alcohol, stimulant, cannabis, or opioid use disorder. * are sufficiently stable for 4 weeks of outpatient treatment. * are willing to provide locator information. * are fluent in english and have a 4th grader or higher reading level exclusion criteria: * meet dsm-5 criteria for a bipolar or schizophrenic disorder. * who have a legal case pending such that incarceration during the 4-week protocol is likely. * are physically dependent on alcohol, opioids or benzodiazepines or who report recent pcp use. * have a baseline shipley estimated iq less than 70 * have 3 or more head injuries with loss of consciousness for over 30 minutes or lasting effects * have a history of chronic illness or neurological disorders (e.g., epilepsy or stroke) that would complicate evaluation of effects of cognitive training

Keywords: drug use disorders cognitive remediation
the use of direct puncture technique with mini-pcnl

Conditions: Urolithiasis

Summary: * a single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy. * 60 patients * inclusion criteria: 1. all patients aged 18 to 70 years who are planning mini-pcnl, ready to consent to the study 2. asa scale 1-3 3. solitary stone up to 2.5 cm 4. single access to the caliceal system * exclusion criteria: 1. active infectious process 2. coagulopathies 3. abnormalities of the urinary system

all patients will be randomized into 2 groups: direct puncture - patients who underwent directive puncture under ultrasound or rg control. the number of patients is 30 people. non-direct puncture - patients who underwent a pcs puncture with retrograde contrast. the number of patients is 30 people. patients will be assigned a randomization number that matches their treatment. block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm. primary assessed indicators: 1. gender 2. age 3. body mass index 4. localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup) 5. density of the stone 6. the presence of hydronephrosis indicators assessed during the operation - will be assessed by the physician-researcher: 1. installation of the ureteral catheter 2. duration of puncture 3. puncture method (ultrasound, x-ray) 4. the success of the insertion of a flexible guidewire into the calyceal system 5. problems during dilation of the puncture course 6. visualization (excellent, moderate, poor) 7. type of drainage (stent, nephrostomic tube) at the end of the operation using the visual analogue pain scale (vas), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery. in the postoperative period, the patient independently controls the intake of analgesics from the nsaid group (ketorolac 100 mg) (patient-controlled analgesia). if the patient requires analgesics, the time of taking the drug will be recorded (pain relief on demand). secondary assessment: postoperative assessment 1. complications (clavien) 2. hemoglobin level 24 hours after surgery 3. creatinine level 24 hours after surgery 4. assessment of stone-free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast

Eligibility criteria:
inclusion criteria: * patients aged 18 to 70 years who are scheduled for mini-pcnl, ready to consent to the study * asa scale 1-3 * solitary kidney stone up to 2.5 cm * one access to the caliceal system exclusion criteria: * active infectious process * coagulopathies * abnormalities of the urinary system

Keywords: urolithiasis pcnl direct puncture
lipid emulsion infusion and covid-19 patients

Conditions: Covid19

Summary: investigators suggest that early administration of intravenous lipid emulsion (ile) affect the inflammatory response and improve outcome in covid-19. the aim of this trial is to study the effect of fish-oil-based intravenous lipid emulsion (foble) supplementation added to enteral nutrition on shift to icu for upgrading oxygenation \&/or ventilation in moderate cases of covid-19 diseased patients requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen (during 7 days admission).

a written informed consent will be taken from the patients or their relatives. patients will be randomly assigned to receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days as the control group (group c) or intravenous fish-oil-based lipid (smof lipid 20% which contains a unique 4-oil mix containing soya bean, medium-chain triglycerides, olive oil and fish oil) (fresenius kabi, bad homburg, germany) emulsion supplementation to standard enteral nutrition (group l) in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.finally, 20 ml of 0.9% normal saline was injected into the burette to flush the system. the entire apparatus was disposed of when each infusion was completed. the whole process was repeated for each infusion.

Eligibility criteria:
inclusion criteria: * patients are with diagnosis of moderate cases of covid-19 (a person who may have lower respiratory illness, such as pneumonia. however, their blood oxygen levels remain ≥94%) * requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen admitted in the intermediate care attached to our icu with good enteral nutrition. exclusion criteria: * hypersensitivity (peanut,eggs and soya bean) * uncontrolled hyperlipidemia * severe primary blood coagulation diseases * acute pancreatitis * acute thromboembolic diseases * liver failure (bilirubin \>40 mmol/l, alanine aminotransferase \>100 u/l and aspartate aminotransferase \>100 u/l) * rifle (risk, injury, failure, loss of kidney function and end-stage kidney disease) stage iii and iv renal failure * pregnancy or lactation * severe neutropenia (\<500 cells/mm3)
clinical outcomes study using a new implantable neurostimulation system for chronic intractable pain

Conditions: Chronic Pain

Summary: the primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.


Eligibility criteria:
inclusion criteria: * chronic intractable pain of the trunk and/or limbs * documented history of trunk and/or limb pain of at least 180 days * overall pain intensity of at least 5 on a 0-10 numerical rating scale (opi-nrs-11) over the past 180 days based on subject recall * pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent * subject is willing and able to comply with all protocol-required follow-up evaluations * 18 years of age or older when written informed consent is obtained * subject signs informed consent exclusion criteria: * unable to operate the precision spectra™ system either by self or with a caregiver * primary source of pain is cancer-related, pelvic, visceral, anginal or migraine * overall pain intensity of always 10 on a 0-10 numerical rating scale (opi-nrs-11) over the past 180 days based on subject recall * is a high surgical risk * currently on any anticoagulant medications that cannot be discontinued during perioperative period * subject requires magnetic resonance imaging (mri) while implanted with lead(s) and/or the precision spectra ipg * subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study * subjects already implanted with an active implantable device(s) to treat their pain (ipgs, implantable drug pumps, etc) or pacemaker or implantable cardiac defibrillator * patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial. * failed to achieve satisfactory relief during the stimulation trial phase

Keywords: neurostimulation spinal cord stimulation peripheral nerve stimulation
psychosocial predictors of poor outcomes after a knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to explore the association between the psychosocial variables: pain catastrophizing, fear of movement, coping skills, pain attitudes, anxiety and depression with postoperative outcomes (pain, health functioning, physical performance, and quality of life) after a knee arthroplasty (ka). the prevalence of ka has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. however, only a third of the patients report no functional problems after surgery, the 20% of them are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. this results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but seems to be related to other psychological aspects. chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain catastrophism, kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain. this study is a single centre, prospective observational study of subjects undergoing primary ka. the study is designed and aimed to examine the relationship between postoperative psychosocial factors and the development of post-operative persistent pain and disability.


Eligibility criteria:
inclusion criteria: 1. to have sufficient spanish or catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools. 2. be able to provide the informed consent. 3. be scheduled to undergo in a total or unicompartimental knee arthroplasty. 4. knee osteoarthritis diagnosis. 5. patients 18 years old or more. exclusion criteria: 1. patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture. 2. patients scheduled to undergo in a bilateral total knee arthroplasty. 3. patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention. 4. patients with other pathologies with characteristic features of a central sensitization. (i.e. fibromyalgia) 5. co-existing other inflammatory or rheumatic conditions (i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis) 6. co-existing other mental condition and/or major depression.
treat primary and metastatic liver tumors

Conditions: Intrahepatic Cholangiocarcinoma; Liver Tumor; Metastatic Cancer; Metastatic Liver Cancer

Summary: the use of radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. methodist dallas medical center has a large volume of ir procedures with radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.

a retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. only patients treated at mdmc are included and data will be obtained from meditech and epic. a non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means. intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. the standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. at mdmc, this therapy has been used effectively and it is important to describe the investigator's experience.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of intrahepatic cholangiocarcinoma from january 2006 until april 2017 at methodist dallas medical center (mdmc) * patients 18 years old or older exclusion criteria: * patients without the diagnosis of intrahepatic cholangiocarcinoma * patients under 18 years of age

Keywords: intrarterial glass radiospheres liver cancer intrahepatic
jaguar trial: objective analysis to gauge evar outcomes through randomization

Conditions: AAA; AAA - Abdominal Aortic Aneurysm

Summary: prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary evar in a real-world population. patients will be randomized into two device cohorts and compared across the primary endpoints. patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).


Eligibility criteria:
inclusion criteria: * adult age 21 and older * subjects with minimum of 2 year life expectancy * subjects have signed the informed consent document * subjects with unruptured infrarenal aaa who are assessed by the investigator to be eligible for endovascular abdominal aortic aneurysm repair with the trial devices. * patient must be able and willing to comply with all required follow-up exams. exclusion criteria: * currently participating in another trial where the primary endpoint has not been reached yet. * known allergy to any of the device components * pregnant (females of childbearing potential only) * known connective tissue disorders * known active infection * subjects with pre-existing evar, i.e., in need of repair/intervention of a previously failed evar. * patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Keywords: randomized