Kornimate/medical-research-clean huggingface dataset:
orthotic use for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain. the hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period. specific aims: 1. to determine the changes in perceived pain levels (numeric pain rating scale) and dysfunction (oswestry disability index) in patients with chronic low back pain after six weeks of custom-made shoe orthotic use with or without chiropractic care as compared to no care. 2. to determine the changes in perceived pain levels and dysfunction in patients with chronic low back pain after twelve weeks of custom-made shoe orthotic use. 3. to determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. subjects must be symptomatic with current pain between t12 and the si joints with or without radiating pain at an average score of 4 or higher on the nprs scale 3. symptoms must have been present for at least three months exclusion criteria: 1. use of custom-made orthotics in the past 6 months 2. ongoing active conservative care (such as physical therapy or chiropractic care) for the low back, leg, or foot received in the past 6 months (excluding the use of oral medications or daily at-home exercises for general well-being). 3. current or future litigation for any healthcare concern 4. not fluent or literate in the english language. we will not be able to provide multiple translators within this study 5. brain disorders (e.g., dementia, alzheimers disease , etc.) that would lead to difficulty in questionnaire completion 6. chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis 7. clinically significant chronic inflammatory spinal arthritis 8. spinal pathology or fracture 9. progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome 10. history of bleeding disorder 11. known arterial aneurysm 12. previous lumbar spine surgery 13. severe skeletal deformity of the foot 14. peripheral neuropathy due to disorders such as diabetes 15. low back pain that is not reproducible 16. current pregnancy 17. other conditions that may affect the subjects' ability to participate throughout the duration of the study or exclude patients from participation in the study, including contraindications to orthotic use or chiropractic spinal manipulations

Keywords: low back pain chiropractic shoe orthotics
pelvic floor exercise before surgery in women with pelvic organ prolapse

Conditions: Pelvic Organ Prolapse; Pelvic Floor Disorders

Summary: the lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. there are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery. the aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. this study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.


Eligibility criteria:
inclusion criteria: * referred to surgery for urogenital prolapse * informed consent exclusion criteria: * not able to communicate in norwegian or english * not able or willing to sign informed consent

Keywords: exercise therapy pelvic floor preoperative care
pharmacokinetics of ifx and tnf concentrations in serum, stool, and colonic mucosa in acute severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with acute severe ulcerative colitis.

in acute severe ulcerative colitis (asuc), drug exposure may be affected by intestinal protein loss leading to hypoalbuminemia and rapid clearance of infliximab (ifx). importantly, 2 studies have associated the loss of ifx in stool with poor outcomes. multiple observational studies have identified that patients with faster ifx clearance have worse clinical outcomes and higher rates of antidrug antibody formation. to better understand optimal dosing of ifx in asuc, the pharmacokinetics of ifx in association with outcomes must be better defined in this setting.

Eligibility criteria:
inclusion criteria: * present to hospital with asuc based on truelove and witts criteria,33 defined as the presence of more than 6 bloody stools per day along with any 1 of the following: tachycardia \> 90 beats per minute, fever \> 37.8 °c, hemoglobin \ 30 mm/h (or crp \> 30 mg/l \[high-sensitivity crp \> 300 mg/l\]) is a suitable surrogate if esr is not available1). * have a partial mcs \> 7. * have a mayo clinic es ≥ 2 with disease extending 15 cm or more beyond the anal verge. * require rescue inpatient ifx infusion as part of routine care. note, the ifx treatment regimen is not defined by this protocol and any dosage regimen is acceptable for the purposes of this study, such as standard or accelerated induction regimens. * be able to speak english and participate fully in all aspects of this clinical trial. * provide written informed consent. exclusion criteria: * a known history of being positive for anti-ifx antibodies. * have a serious active infection, active malignancy, or any other known condition contraindicated with infliximab therapy, according to current prescribing information. * serious underlying disease other than asuc, or other physical or psychosocial condition that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study. * prior enrollment in the current study.

Keywords: asuc infliximab optimal dose optimal frequency theraputic drug monitoring
a bioequivalence study of capecitabine tablets

Conditions: Metastatic Breast Cancer or Metastatic Colorectal Cancer

Summary: 1. purpose: to conduct the relative bioavalability study of capecitabine tablets 500 mg (jiangsu chia-tai tianqing pharmacy co. ltd.) versus xeloda® 500 mg tablets (manufactured by roche pharma ag) 2. experimental design： two-period crossover design 3. test drug: capecitabine tablets reference drug: xeloda 4. sample size：24


Eligibility criteria:
inclusion criteria: * patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer，without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients; * age: 18-70 years, gender: both，bmi≥17，eastern cooperative oncology group (ecog) performance status：0-2，life expectancy greater than 3 months; * patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: anc≥1.5×109/l，plt≥80×109/l, total bilirubin≤1.5×the upper limit of normal, alt,ast≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal. * patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy. * patients must volunteer to participate and sign informed consent form. exclusion criteria: * suffering from heart, liver, kidney disease or severe acute and organ invasion disease; * prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known dpd (dihydropyrimidine dehydrogenase) deficiency. * pregnant or breast-feeding female * only bone metastasis lesions, no other measurable lesions * known brain metastasis or history of organ transplantation * have long-term systemic steroid therapy * serious diseases of vital organs; other malignancies which is not cure * use of chemotherapy in the last 4 weeks * history of drug/alcohol addiction or a positive hepatitis screen including hepatitis b surface antigen, hcv or hav (igm) antibodies * patient having abnormal serum calcium level at screening visit which as judged by investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial. * pre-existing motor or sensory neurotoxicity of a severity grade 2 by nci ctcae criteria or known, existing uncontrolled coagulopathy. * subjects are thought unsuitable for the study by investigators; * inability to comply with protocol or study procedures in the opinion of the investigator;
study on the effect of eye-covering pretreatment on acute delirium after general anesthesia in pre-school aged children

Conditions: Ophthalmology

Summary: participants (preschool children), because their cognitive ability and anti pressure ability are obviously weaker than adults, most of the children who have this kind of operation and anesthesia stressors will have perioperative anxiety. after eye surgery, they need to bandage their eyes with gauze (single or double), so that the participants are in a state of complete or partial darkness for a certain period of time, which is easy to produce dark phobia. in clinical practice, investigators found that more than 80% of children with advanced ophthalmology were prone to leprosy, resistance, crying and other symptoms after general anesthesia, which brought greater difficulties to nursing. how to improve the cognitive ability of preschool children, reduce the anxiety level of children during the perioperative period, the incidence of postoperative detention and the difficulty of nursing are new topics worthy of exploration.


Eligibility criteria:
inclusion criteria: 1. ages 3-7; 2. selective ophthalmological general anesthesia (static inhalation compound: propofol + fentanil intravenous administration; heptaflurane inhalation); 3. no mental disorders, stunting and low intelligence; 4. there is no other history of surgical hospitalization. exclusion criteria: 1. those who have completed the operation under local anesthesia; 2. people with visual impairment of both eyes; 3. eyeball removal and/or eye socket implanter; 4. hearing and language impairment cannot communicate normally; 5. have a history of taking psychotropic drugs; 6. people with severe organs such as the heart, lungs, brains and kidneys.

Keywords: pre-school aged children acute delirium eye-covering pretreatment
impact of the use of zinc in the prevention of oral mucositis in pediatric patients with lymphoblastic acute leukemia.

Conditions: Oral Mucositis

Summary: oral mucositis (om) is a secondary complication of chemo/radiotherapy, which causes pain, dysphagia and predisposition to infections, being a frequent reason for hospitalization that may have an impact on the prognosis of cancer patients. various interventions for the prevention of om have been studied, including the use of zinc, which is a micronutrient that participates in various cellular functions and in wound repair, while showing a reduction in the incidence and severity of mo, so the purpose of the present study is to evaluate the impact of the use of zinc in the prevention of oropharyngeal mucositis in pediatric patients with acute lymphoblastic leukemia in chemotherapy, comparing it with the use of placebo. hypothesis: the use of zinc reduces the incidence and severity of om in pediatric patients with all in chemotherapy compared to the control group.

objective: to evaluate the impact of the use of zinc in the prevention, incidence and severity of oral mucositis in patients with acute lymphoblastic leukemia in chemotherapy (induction and consolidation phase) of the national institute of pediatrics and the federico gómez children's hospital of mexico during the period from 2019 to 2020. methodology: double-blind randomized clinical trial conducted in pediatric patients with newly diagnosed or relapsed acute lymphoblastic leukemia. the subjects will be randomized to designate them in the control group (group1 placebo) or intervention group (group 2 zinc). the zinc / placebo intervention will be administered orally in tablets of 50-100 mg / day, from day 1 of chemotherapy until the end of the consolidation phase (2 to 2.5 months). for the detection of om the mucositis scale of the world health organization will be used and the observation times will correspond to day 1, 4, 7, 14 and 21 of each chemotherapy cycle. patients of both groups with om will receive the same treatment (mouthwash of gelclair) and will be observed daily until healing to determine the days of recovery. statistical analysis: independent t-test and chi-square test for the difference between the two study groups, anova to compare the groups with respect to the severity of om.

Eligibility criteria:
inclusion criteria: * patients aged 3 to 18 years * patients with recent diagnosis of all or relapse * pacientes who accept by informed consent to participate in the study. exclusion criteria: * patients with another disease or systemic condition in addition to all. * patients with down syndrome * patients allergic to zinc or mannitol.

Keywords: zinc leukemia, acute lymphoblastic
optical imaging for assessment of foot perfusion

Conditions: Ulcer Foot; Diabetes

Summary: this study is designed to evaluate the ability of spatial frequency domain imaging (sfdi) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.

this study is designed to evaluate the ability of spatial frequency domain imaging (sfdi) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. sfdi is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. our hypothesis is that sfdi parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. this phase of the study is designed to correlate sfdi outputs to current clinical risk categories

Eligibility criteria:
inclusion criteria: - exclusion criteria: * pregnant/lactating women * rheumatoid arthritis
concentration of plant sterols in serum and aortic valve cusps

Conditions: Aortic Valve Stenosis

Summary: this study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols. we assume that consumption of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue concentrations of plant sterols (sitosterol; campesterol).

the role of plant sterols in cardiovascular diseases is controversially debated. there is an increasing body of evidence that indicates that increased plant sterol serum concentrations are correlated with an increased cardiovascular risk. functional foods such as margarines supplemented with plant sterol esters are advertised to patients with hypercholesterolemia. numerous studies show that margarines supplemented with plant sterol esters reduce serum cholesterol concentrations significantly. however, there are no studies available investigating relevant clinical endpoints. nor are there any studies availabe investigating the effect of the consumption of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. this study is done to investigate the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations.

Eligibility criteria:
inclusion criteria: aortic valve stenosis - exclusion criteria:familial hypercholesterolemia. -

Keywords: plant sterols, serum, aortic valve cusps
comparison of in 10 003 to placebo in subjects with insomnia suffering from difficulty in falling asleep and staying asleep

Conditions: Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Summary: this study aims to assess the efficacy of in 10 003 in improving sleep parameters in patients with insomnia exhibiting both difficulty in falling asleep and staying asleep. the study will compare 2 formulations of the in 10 003 to placebo


Eligibility criteria:
inclusion criteria: * subjects between the ages of 18 and 65 years of age * subjects that meet dsm iv diagnostic criteria for insomnia * subjects that report a time in bed nlt 6.5 and nmt 9 hours * subjects that report on a one week sleep diary (on at least 3 of 7 nights) tst nmt 6.5 hours * subjects that report on a one week sleep diary (on at least 3 of 7 nights) wake time after sleep \>1.0 hour * subjects that report on a one week sleep diary (on at least 3 of 7 nights) nlt 30 minutes time to sleep onset * on two nights of psg screening a mean waso of ≥60 minutes with neither night less than 45 minutes * on two nights of psg screening a mean lps of ≥20 minutes with neither night less than 15 minutes * on two nights of psg screening a tst of nmt 6.5 hours on each of the two nights exclusion criteria: * subject has a circadian rhythm disorder including shift work or the need to travel nlt 3 time zones during the course of the study * use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first. * subject with a history (past year) of alcohol or substance abuse * subject that needs to smoke during the sleep period time * subject that reports habitual napping (more than 3 times per week)
safety of overestimation of a meal insulin bolus in the context of dual-hormone closed-loop operation - part 2

Conditions: Type 1 Diabetes

Summary: in previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. with this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). it is however important to establish the safety of this simplified meal bolus approach. the safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. for ethical reasons, only dual-hormone closed-loop will be tested. investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/l compared to dual-hormone closed-loop with an adequately estimated meal size bolus.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. the subject will have been on insulin pump therapy for at least 3 months and currently using a fast acting insulin analog (lispro, aspart or glulisine). 4. last (less than 3 months) hba1c ≤ 10%. 5. currently using carbohydrate counting as the meal insulin dose strategy. exclusion criteria: 1. clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. 2. recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 3. pregnancy. 4. severe hypoglycemic episode within 1 month of screening. 5. agents affecting gastric emptying (motilium®, prandase®, victoza®, byetta® and symlin®) as well as oral anti-diabetic agents (metformin, sglt-2 inhibitors and dpp-4 inhibitors) if not at a stable dose for 3 months. otherwise, these medications are acceptable and will be kept stable during the entire protocol. 6. oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone cortef®). inhale steroids at stable dose in the last month are acceptable. 7. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition). 8. failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).

Keywords: type 1 diabetes artificial pancreas closed-loop system postprandial glucose control hypoglycemia insulin glucagon
renal replacement anticoagulant management

Conditions: Critical Illness

Summary: observational comparative effectiveness study of individual patient data using interrupted time series analysis techniques of linked data sources to establish clinical and health economic effects of moving from systemic heparin anticoagulation to regional citrate anticoagulation during continuous renal replacement therapy (crrt) for patients treated on non-specialist intensive care units (icus) in england and wales.

rram is an observational comparative effectiveness and cost-effectiveness study of individual patient data using interrupted time series analysis techniques and linked data sources. this study will use existing high quality clinical data collected for the case mix programme (cmp) - the national clinical audit for adult critical care - linked with hospital episodes statistics, office for national statistics, and uk renal registry national data sets to establish the clinical and health economic effects of moving from systemic heparin anticoagulation (sha) to regional citrate anticoagulation (rca) during crrt for patients treated on non-specialist icus in england and wales. this will include data from approximately 85,000 patients treated with crrt between 1 april 2009 and 31 march 2017 in 184 english non-specialist intensive care units within the icnarc cmp. specific objectives of the rram are to: 1. investigate the short-term benefits, risks, and costs of citrate anticoagulation. 2. provide information on the subsequent development of end-stage renal disease (esrd). 3. trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in icus in england and wales over a reasonably short time scale.

Eligibility criteria:
inclusion criteria: * age 16 years or greater * admitted to an icu participating in the icnarc case mix programme (cmp) in england between 1 april 2009 and 31st march 2017 exclusion criteria: * pre-existing end-stage renal disease (esrd) * admitted to an icu after kidney or kidney-pancreas transplantation * primary admission with acute hepatic failure

Keywords: acute kidney injury continuous renal replacement therapy citrate heparin