Kornimate/medical-research-clean huggingface dataset:
ileocolic resection for complex crohn's disease

Conditions: Crohn Disease of Ileum

Summary: laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal crohn's disease (cd). objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of cd through a mc burney incision, in patients who already had a previous appendectomy.

from january 2016 to december 2017, all consecutive cd patients with primary or recurrent complex disease referred for ic resection were evaluated for the study purpose.complex disease patients presenting mcburney incision for a previous open appendectomy were included in the group of study. this group was compared with a control group of cd patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic ic resection, pooled out from the database of ic resections for cd of the minimally invasive and gastrointestinal surgery unit of tor vergata hospital, rome, italy. data on demographics, bmi, type and behavior of cd, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (mr enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to eras protocols and length of hospital stay were collected for the study purpose.

Eligibility criteria:
inclusion criteria: * diagnosed crohn's disease * previous appendectomy trough a mcburney incision exclusion criteria: * patients with major comorbidities * age\>75 * previous midline laparotomy

Keywords: crohn disease ileocolic resection appendectomy single-port incision mcburney laparoscopy
omic technologies applied to the study of b-cell lymphoma for the discovery of diagnostic and prognosis biomarkers

Conditions: Lymphoma, B-Cell; Neoplasms; Cancer; High-grade B-cell Lymphoma; Diffuse Large B Cell Lymphoma; Non Hodgkin Lymphoma; Metabolomics

Summary: the goal of this observational study is to determine the plasma metabolomic profile in diffuse large b-cell lymphoma and high-grade b lymphomas patients before, during and after treatment by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (uplc-qtofms)

the main question it aims to answer is the correlation between the plasma metabolomic profile of diffuse large b-cell lymphoma and high-grade b lymphomas patients before and after treatment determined by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (uplc-qtofms) and analysed with metaboanalyst web platform to identify specific over- or under-expressed markers.

Eligibility criteria:
inclusion criteria: * 18 years and older; * both sexes; * patients with confirmed histopathological diagnosis of diffuse large b-cell lymphoma and high-grade b-cell lymphoma; * eastern cooperative oncology group (ecog) performance status 0 to 2; * patient intending to receive full-dose treatment (monoclonal antibodies plus anthracycline based combination chemotherapy); * staged with pet-ct or ct. exclusion criteria: * patients with comorbidities that may interfere with the interpretation of the results (ckd in dialysis phase, autoimmune diseases, uncontrolled diabetes mellitus (dm), symptomatic heart failure (chf), hiv positive, positive serology for hepatitis b and c); * patients requiring multiple blood transfusions (4 or more blood components for the same period or cause); * pregnant women; * first-line treatment in another institution; * diffuse transformed diffuse large b-cell lymphoma and high-grade b-cell lymphoma

Keywords: metabolomic analysis
electroacupuncture vs sham electrocupuncture for mixed urinary incontinence

Conditions: Mixed Urinary Incontinence

Summary: the investigators plan to conduct this randomized sham-controlled clinical trial to evaluate the efficacy and safety of electroacupuncture (ea), compared with sham electroacupuncture (sa) on women with mixed urinary incontinence (mui).

mui tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. current european association of urology (eau) guideline on incontinence recommends to initiate treatment targeted at predominant component of mui. electroacupuncture has been proved not inferior to pelvic floor muscle training plus solifenacin in decreasing the 72-hour ief and shows promise as an effective alternative for the treatment of mui. the purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

Eligibility criteria:
inclusion criteria: * female, 35 to 75 years old * diagnosed as mixed urinary incontinence * positive in cough stress test * experiencing persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in baseline screening * sign the informed consent form exclusion criteria: * diagnosed as simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence or neurogenic bladder, etc. * uncontrolled urinary tract infection with urinary pain and urge * urogenital system tumours and/or pelvic organ tumours * patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month * history of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy; patients have pelvic organ prolapse ≥ ii degree * residual urine ≥ 100ml * uncontrolled diabetes mellitus and severe hypertension * diseases affecting lower urinary tract function * severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction * constrained or unable to complete movements like walking, going stairs up and down and running, etc. * at pregnancy, breastfeeding or postpartum period for less than 12 months * cardiac pacemaker, metal allergy or strong fear of needle * patients have received acupuncture in the past 3 months
the effect of milnacipran on fatigue and quality of life in lupus patients

Conditions: Systemic Lupus Erythematosus; Widespread Pain; Fibromyalgia

Summary: systemic lupus erythematosus (sle) is a chronic multi-system autoimmune disease impacting the physical, social, psychological health and quality of life of patients. fatigue and pain are aspects of sle patients which affect their health related quality of life (hrqol). the purpose of this study is to determine the effect of milnacipran on fatigue in sle patients with widespread pain (wsp) or fibromyalgia syndrome (fms). a secondary objective will be to determine the effect of milnacipran on pain and quality of life measurements. fifty sle male and female patients, 18 years and older, will be recruited for a 15-week study, in which patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo. measurements of fatigue, pain, and hrqol will be compared between the milnacipran and placebo groups at the screening visit, baseline visit, week number 6, and week number 14. milnacipran has been shown to be an effective treatment for pain, fatigue and physical function in fms patients. to date, no clinical trials have demonstrated efficacy for the treatment of fatigue in sle patients with concomitant wsp or fms. the investigators hypothesize, based on fms studies, that the milnacipran treated patients will have less fatigue than those in the placebo group. in addition, compared to control arm, those treated with the study drug will have less pain and improved quality of life.


Eligibility criteria:
inclusion criteria: * female or male age 18 or older. * has fulfilled the 1997 classification criteria for sle. * has chronic wsp or fms. * score a 40 or more on the visual analog score (vas) for fatigue. exclusion criteria: * has a chronic inflammatory autoimmune condition other than sle. * has an acute or uncontrolled co-morbid medical condition. * uncontrolled narrow angle glaucoma. * has been hospitalized in the last four months for a lupus flare. * pregnant or breast feeding. * has a current or prior major depressive disorder or other dsm iv diagnosis within 2 years of the screening visit. * the use of antidepressants, mao inhibitors, antipsychotics or lithium * the use of pregabalin or milnacipran within 2-4 weeks. * has received cyclophosphamide and or rituximab within 4 and 6 months. * unable to speak, read, and understand english.

Keywords: systemic lupus erythematosus widespread pain fibromyalgia fatigue pain quality of life
safety and efficacy of emergency on-call respiratory physiotherapy services in the paediatric intensive care unit

Conditions: Pediatrics; Critical Care; Respiration, Artificial

Summary: emergency on-call respiratory physiotherapy cover for children in intensive care is frequently provided by physiotherapists who ordinarily work in non-respiratory areas. this has produced concerns about the safety and efficacy of on-call treatments and is widely recognised as an important clinical governance issue affecting services throughout the national health service (nhs). the aim of this study is to investigate whether emergency on-call respiratory physiotherapy services provided in the paediatric intensive care unit (icu) are safe and effective. further it will explore whether there are any quantifiable differences between specialist and on-call physiotherapy treatments. the study is a randomised, cross-over study design. infants and children who are likely to require at least 2 physiotherapy treatments in one day are recruited to the study. both physiotherapy airway clearance treatments are administered during a 12 hour period, with at least 2 hours between treatments. one is administered by a respiratory physiotherapist who works regularly in the icu and one by a physiotherapist on the on-call rota, who normally practises in a non-respiratory clinical area. treatments are performed in a randomised order and outcomes measured before, during and after treatments. physiotherapy staff who consent to participate in the study include: specialist respiratory physiotherapists who regularly work in the icu non-respiratory physiotherapists on the on-call rota who normally work in a non-respiratory areas but cover the icu overnight and at weekends. patients include: the study aims to recruit 80 infants and children (ages 0 to 16 years), who are in the paediatric intensive care unit and 1. require full mechanical ventilation and are well sedated 2. are likely to require at least two physiotherapy treatments within the day of the study (assessed by an independent senior respiratory physiotherapist) and 3. whose parents or carers consent for them to participate in the study. respiratory mechanics, arterial blood gases, oxygen saturation and peak pressures are recorded before and after each intervention forces applied during manual techniques, flow, pressure and volume during manual lung inflations, volume of saline and selection and order of treatment components are recorded during treatments adverse events occurring during or up to 30 minutes after physiotherapy are also recorded.


Eligibility criteria:
inclusion criteria: * infants and children who are well sedated and mechanically ventilated and likely to require at least 2 physiotherapy interventions over the course of a single day exclusion criteria: * patients in whom the application of manual techniques is contra-indicated

Keywords: physical therapy modalities pediatrics critical care respiration, artificial
ischemia-reperfusion exercise study

Conditions: Insulin Sensitivity

Summary: the study investigates the relationship between activation of amp-activated protein kinase (ampk) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake. this will be investigated in young healthy lean male subjects.

this study aims to demonstrate the association between ampk activation and increased insulin sensitivity in human skeletal muscle. the investigators intend to examine insulin sensitivity after various levels of ampk activation in skeletal muscle that includes exercise at different intensities as well as exercise combined with leg blood flow restriction (ischemia). the hypothesis is that exercise combined with ischemia will result in an increased activation of ampk compared to exercise alone, and therefore it is expected that exercise combined with ischemia will result in the greatest improvement in muscle insulin sensitivity. methods: the main experiment consists of 3 experimental days (a, b and c), separated by a minimum of 14 days and carried out in a randomised order. on all the study days, the participants will arrive in the laboratory after an overnight fast. catheters will be placed in both femoral veins and in one femoral artery. a muscle biopsy will be obtained from vastus lateralis of one leg (resting leg). experiment a consists of one-legged muscle work for 1 hour at 70% of the leg maximum aerobic work capacity with the other leg serving as a resting control. in experiment b, the same work are performed, but with periodic at the same constricting the blood supply to the working leg (25 seconds every 2 min). experiment c consists of one-legged muscle work for 1 hour at 70% and 95% of the leg maximum aerobic work capacity (alternately every 5 min). immediately after each type of exercise a biopsy will be obtained from the exercising leg and the participants will rest in the fasted state for 3 hours before a third set of muscle biopsies (from both legs) will be obtained. subsequently, insulin sensitivity will be evaluated in the participants during a 2-hour physiological hyperinsulinemic euglycemic clamp. by the end of the clamp, a final set of biopsies (both legs) will be obtained. throughout the study day sampling of artery and venous blood/plasma samples allows for the estimation of substrate extraction by the two legs. further, measures of artery blood flow by ultrasound doppler technique allow for the final calculation of substrate uptake/release across the two legs before exercise, during exercise and in recovery from exercise. importantly, the ability for insulin to stimulate these processes can be evaluated in both a rested and in a prior exercised leg.

Eligibility criteria:
inclusion criteria: * normal weight (bmi: below or equal to 27) * physical active on a regular basis * cardiorespiratory fitness between 40-60 ml/kg/min * no history or sign of type 2 diabetes, hypertension, insulin resistance or dyslipidemia exclusion criteria: * smoker * bmi: above 27 * using any kind of medication

Keywords: exercise glucose uptake ischemia insulin sensitivity
a study to explore the effect on inflammatory markers after nasal allergen challenge in subjects with seasonal allergic rhinitis and the effect of a single dose of ibuprofen or fluticasone propionate on the allergen response.

Conditions: Allergic Rhinitis

Summary: after a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. if these markers are reproducible and impacted by the study drugs they could be useful for future drug development.


Eligibility criteria:
inclusion criteria: * male or female subjects with seasonal allergic rhinitis (out of season). * sensitive to ragweed skin prick test and screening nasal allergen challenge. exclusion criteria: * subjects with significant concomitant diseases. * subjects with symptoms of allergic rhinitis in 2 weeks prior to screening. * female subjects that are pregnant or nursing. subjects with hypersensitivity to study drugs or allergen challenge.

Keywords: allergic rhinitis nasal allergen challenge inflammatory markers
juvenile justice girls randomized control trial: young adult follow-up

Conditions: Delinquency; Drug Use

Summary: this study is a young adult follow-up of 166 females who originally participated in an rct during adolescence due to their involvement in the juvenile justice system.

females under age 18 years old are the fastest-growing segment of the juvenile justice population and are at risk for negative co-occurring outcomes including drug abuse, hiv/sti risk, criminal behavior, and educational failure. as they enter young adulthood, this constellation of behaviors puts them at heightened risk for early parenthood and subsequent involvement in the child welfare system (for their parenting behaviors) and the adult corrections system (for criminal behaviors). such system involvement is costly, and its prevention would be of great significance to public health; however, very little is known about factors leading to females' success/failure in young adulthood and factors that might prevent involvement in these two public systems. this study aims to further our understanding of the pathways to and the prevention of hiv/sti risk, drug use, and child welfare and adult corrections involvement by following-up 166 women who participated in two randomized intervention trials aimed at reducing delinquency during adolescence. in the original studies, juvenile justice girls who had been referred for out-of-home placement due to chronic delinquency were randomly assigned to services as usual or to treatment foster care oregon (tfco, formerly known as mtfc). efficacy of the intervention with this sample has been shown at 12- and 24-month follow-ups on criminal referral rates, days spent in locked settings, deviant peer associations, educational engagement, and pregnancy prevention. the investigators propose to examine the developmental pathways for these juvenile justice girls into young adulthood (ages 21-28 years) using innovative data collection and data analytic techniques, with foci on the long-term effects of tfco, the mediators of young adult adjustment and child welfare/corrections involvement, and the cost effectiveness and cost avoidance of tfco on these outcomes. the overarching aim is to identify potential targets for subsequent intervention. one in-person assessment is proposed with each female and her current romantic partner (if she has one); in addition, telephone interviews will be conducted every 6 months for the duration of the study, and system data from child welfare and adult corrections will be collected.

Eligibility criteria:
inclusion criteria: * female * 13-17 years old * at least one criminal referral in the prior year * court-mandated placement in out-of-home care exclusion criteria: * currently pregnant

Keywords: delinquency drug use hiv risk behavior economic costs
comparative effects of virtual reality and vestibular exercises on balance gait in older adults

Conditions: Old Age; Vestibular Disorder; Balance; Exercise

Summary: to compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.

it will be a randomized clinical trial where non-probability convenience sampling technique will be used. total 44 participants will be taken aged 60 to 85 years. all participants will be randomized through lottery method and allocated into two groups. group a (n=22) participants will receive virtual reality intervention with conventional treatment, while group b (n=22) will receive vestibular exercises with conventional treatment. the berg balance scale for balance assessment, dynamic gait index for gait while time up and go test, and modified barthel index for activities of daily living will be outcome measure tools.

Eligibility criteria:
inclusion criteria: * older adults with or without any assistive device. * participants with a mini-mental state examination score greater than 24. * participants with a value greater than 10 secs on the time up and go test. exclusion criteria: * severe visual or vestibular impairments (e.g., meniere's disease, labyrinthitis). * significant musculoskeletal impairments (e.g., arthritis, joint contractures). * unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease). * history of epilepsy or seizures.

Keywords: old age vestibular disorder balance exercise
study of ana773 in healthy volunteers and patients with hepatitis c virus (hcv) to assess safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd)

Conditions: HCV Infection

Summary: the overall study design includes two parts, part a and part b. part a evaluated ana773 following oral administration to healthy volunteers. a total of 40 evaluable healthy volunteers were enrolled in part a of the study. part b evaluated ana773 following oral administration to patients with chronic hcv infection. a total of 34 evaluable patients were enrolled in part b of this study in 2 study centers.

study design: part a evaluated ana773 following oral administration to healthy volunteers. a total of 40 evaluable healthy volunteers were enrolled in part a of the study. part b evaluated ana773 following oral administration to patients with chronic hcv infection. a total of 34 evaluable patients were enrolled in part b of this study in 2 study centers.

Eligibility criteria:
part a inclusion: * male or female, ages 18 to 65 years * no clinically significant abnormalities * no serious or severe chronic conditions * non-smokers part a exclusion: * female subjects who are pregnant or breast-feeding * history of significant medical condition that could interfere with study medication or associated study assessments * history of or current drug or alcohol abuse part b inclusion criteria: * male or female, ages 18 to 65 years * diagnosed with chronic liver disease consistent with chronic hepatitis c infection for at least 6 months * screening hcv rna ≥ 375,000 copies/ml or ≥ 75,000 iu/ml * naïve to or have relapsed from prior ifn-alpha based therapy part b exclusion criteria: * female subjects who are pregnant or breast-feeding * received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication * use of an investigational drug or participation in an investigational study with a licensed drug within 30 days * history of significant medical condition that could interfere with study medication or associated study assessments * history of or current drug or alcohol abuse
paediatric oximetry algorithms - normative data collection

Conditions: Sleep Apnea Syndromes in Children

Summary: to undertake normative data collection of existing clinical algorithms using existing oximetry technology.

paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached to also wear an additional oximeter at the same time so that comparisons between two oximeters and their clinical algorithms can be compared.

Eligibility criteria:
inclusion criteria: * all children who have been referred for a clinical overnight pulse oximetry test exclusion criteria: * families who do not understand written english if an interpreter is not present for clinical reasons * times when the kit is already being used for another recruit * if children do not attend with the legal guardian and so informed consent cannot be signed * patient is deemed too unwell by clinical team to be approached about the research