Kornimate/medical-research-clean huggingface dataset:
pain caregiver resource (paincare)

Conditions: Pediatric Cancer

Summary: pain is a problem for children with cancer, especially when they are outside of the hospital setting. younger children with cancer are particularly vulnerable to undermanaged pain because of their inability to self-report pain and their reliance on parents for treatment. one method to help these children to get the best care possible is through the use of smartphone-based mhealth solutions. smartphone apps can provide treatment advice to patients experiencing pain in real-time and in any environment. this research will use a phased and user-centered approach with family caregivers to co-design and co-evaluate the new cancer pain caregiver resource (paincare) app to achieve the following aims: (1) high-fidelity software development and usability refinement; (2) evaluation of trial feasibility and preliminary effectiveness in a pilot randomized controlled trial (rct); and (3) systematic analysis of caregiver app usage patterns to refine paincare for optimal engagement prior to a future rct.


Eligibility criteria:
1. be the primary caregiver, or person assuming the majority of care activities, for a child aged 2-11 years undergoing cancer treatment and experiencing above mild pain (≥3/10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale). 2. be able to speak and read english.
immune regulation in multiple sclerosis: microrna and antigen-presenting cells

Conditions: Multiple Sclerosis

Summary: micrornas regulate gene expression. the abnormal expression of micrornas has been reported in many human diseases. the purpose of this pilot study is to determine if microrna expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis.

micrornas regulate gene expression. the abnormal expression of micrornas has been reported in many human diseases. the purpose of this pilot study is to determine if microrna expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis. the expression of microrna will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Eligibility criteria:
inclusion criteria: * 18-60 year-old healthy subjects or patients with rrms/cis exclusion criteria: 1. any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or disease-modifying treatment (dmt) other than glatiramer acetate in the last 90 days 2. presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., hiv, lymphoma, lupus) or demyelinating disease other than ms (e.g., lyme, b12 deficiency) 3. pregnancy 4. intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (expanded disability status scale (edss) score greater than 5.5 )
factors influencing the positive outcome of bariatric surgery for morbidly obese patients

Conditions: Morbid Obesity; Diabetes; Hypertension

Summary: the purpose of this study is to report data with patients after bariatric surgery.

in the period 2006-2012 the icbs-israeli center for bariatric surgery in assuta hospital has performed about 1500 bariatric surgeries including laparoscopic adjustable gastric banding, laparoscopic sleeve gastrectomy, laparoscopic roux en y gastric bypass, and duodenal switch. in addition, pose and bpd procedures were performed.the icbs team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. during that period patients data were collected as part of the medical practice in the center and included bmi, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. during the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle. the purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.

Eligibility criteria:
inclusion criteria: * patients meeting established criteria set by the national institutes of health (nih) for candidacy for bariatric surgery * patients having a body mass index (bmi) of 35 with co-morbid conditions or bmi larger or equal 40 with or without co-morbid conditions, * patients having a comorbidity that should be improved by the surgery * patients that are able to comprehend the risks and benefits and the surgical procedure * patients having no glandular etiology for their obesity * patients that have attempted to lose weight by conventional means * patients that are willing to be observed over a long period of time exclusion criteria: * patients that can not obey one of the inclusion criteria

Keywords: laparoscopic sleeve gastrectomy bariatric surgery morbid obesity
a study of stellate ganglion block for prevention of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.

the investigator hypothesizes that stellate ganglion blockade with local anesthetic performed prior to cardiac surgery will reduce the incidence and duration of postoperative atrial fibrillation (poaf). specific aim 1: determine the incidence of poaf in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week. specific aim 2: determine the duration of poaf in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week. specific aim 3: determine the success rate of the block as evaluated by ipsilateral hand temperature change and skin sympathetic nerve activity (skna).

Eligibility criteria:
inclusion criteria: * patient presenting for cardiac surgery at the mayo clinic in rochester, minnesota. * patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting. exclusion criteria: * patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation. * patients with procedures not requiring cardiopulmonary bypass. * patients with procedures requiring deep hypothermic circulatory arrest. * patients with active infection or sepsis. * pre-operative immunosuppressive medication use (including steroid use). * pre-operative anti-arrhythmic medication use (aside from beta-blockers). * patients with immunodeficiency syndrome. * patients with known neurologic disorder. * patients requiring left internal jugular central line placement. * performance of maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the maze procedure forms.
a study to assess the efficacy, safety, and pharmacokinetics of abp-671 in patients with gout or hyperuricemia

Conditions: Gout; Hyperuricemia

Summary: this is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of abp-671 compared with placebo. the study will consist of three sequential groups with escalating total daily abp-671 doses. each group is further divided into two dose cohorts with either qd or bid dosing. each dose group will have 3 stages following screening: run-in, dose evaluation, and follow-up.


Eligibility criteria:
inclusion criteria: * subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity. * subject meets the diagnosis of gout as per the american college of rheumatism/ european league against rheumatism (eular) gout classification criteria or diagnosis of hyperuricemia. * subject has an sua level ≥ 7.0 mg/dl at baseline. * subject must be willing to discontinue any other ua-lowering medication (e.g., allopurinol, febuxostat, and probenecid) and take gout prophylaxis medication during the study. * body mass index (bmi) ≤ 40 kg/m2. exclusion criteria: * subject with a documented history of rheumatoid arthritis or other autoimmune disease. * subject with any clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric illness, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder. * subject with a history of alcohol or drug abuse within the past 1 year prior to screening, or current evidence of substance dependence or abuse. * subject with a positive test for active hepatitis b, hepatitis c infection or human immunodeficiency virus (hiv) infection. * subject with active liver disease, or hepatic dysfunction. * subject with an inadequate renal function with estimated serum creatinine \> 1.5 mg/dl (\> 0.133 mmol/l) or creatinine clearance \< 60 ml/min (by cockcroft-gault formula). * subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ grade 1 cervical cancer. * subject with unstable angina, new york heart association class iii or iv heart failure, myocardial infarction, stroke, or deep venous thrombosis within the last 12 months; or subjects currently receiving anticoagulants. * subject with qt interval corrected for heart rate according to fridericia's formula \> 470 msec (females) and \> 450 msec (males) during the screening period, confirmed by a repeat assessment. * subject with uncontrolled hypertension * subject receiving chronic treatment with more than 325 mg aspirin per day. * subject that requires or may require systemic immunosuppressive or immunomodulatory treatment. * subject who received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to screening. * subject who is pregnant or breastfeeding.
bioresorbable intramedullary nailing of forearm fractures

Conditions: Forearm Fracture

Summary: the activa im-nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. the post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of activa im-nail™.

residual risk related to re-fracture rate will be addressed by this pmcf study. the research question is, if the re-fracture risk with activa im-nail is in line with the other treatment methods, namely esin. primary objective: will be to assess clinical outcome by determining re-fracture rate of all treated patients, difference of re-fracture rate depending on the fracture type determined by x-ray (e.g. greenstick vs. non-greenstick fracture), subject's age, bmi, surgical technique, immobilization time and bony union formation.

Eligibility criteria:
inclusion criteria: * diaphyseal forearm fractures (radius or ulna or both) * patients from 3 years to under 13 years, but the age limits depend on the biological development of the child and in addition exclusion criteria: * multifragmentary fractures, metaphyseal and epiphyseal fractures * situations where internal fixation is otherwise contraindicated, e.g., active or potential infection, or where a patient's cooperation cannot be guaranteed.
impact of black pepper on energy expenditure and substrate utilization

Conditions: Obesity

Summary: as obesity rates worldwide continue to increase, there is a focus on identifying active food ingredients which increase metabolic rate which can be used as a dietary supplement in the treatment of overweight and obesity. promising animal and cell studies have suggested a role for black pepper and an active component of black pepper, piperine, in energy expenditure. however, the effects of black pepper have not been determined in humans. the investigators hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one day) will result in an elevation in 24-h resting energy expenditure when contrasted to a control day (no black pepper, same diet intake).


Eligibility criteria:
inclusion criteria: * woman * postmenopausal * aged 50-65 years * bmi 25-35kg/m2 * not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results * thyroid hormone profile within the normal reference range * no medical condition which may impact the results (e.g. diabetes) * accustomed to eating regular meals including breakfast exclusion criteria: * smoker * heavy exerciser (defined as \>150 minutes/week for more than 3 months) * abuses alcohol or drugs * vegetarian

Keywords: black pepper metabolic chamber respiratory chamber
the effectiveness of health literacy intervention among middle eastern adolescents in malaysia

Conditions: Adolescents Obesity

Summary: in malaysia, middle eastern adolescents are going through changes in living status, yet few studies show that overweight and obesity are prevalent among arabic secondary school students. there have not been any intervention studies among middle eastern adolescents in malaysia. the current study aims to determine the effects of an intervention program on physical activity and healthy diet behavior among middle eastern adolescent students in arabic schools in malaysia

a cluster randomized controlled study will be conducted among 250 middle eastern adolescent students in arabic schools in malaysia. the intervention and control schools will be selected and allocated randomly. the intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. anthropometric questionnaires include knowledge, attitude, and practice of lifestyle, physical activity, adolescent sedentary activity, food assessment, and health belief model questionnaire. data will be collected from intervention and control groups at baseline, post-intervention, and tow month follow-up after the intervention. data will be analyzed by using the (spss) software version 25. descriptive statistics will be used to distribute and summarize the data. the normality of variables will be tested by the kolmogorov-smirnov test and the skewness \& kurtosis test. a p-value \< 0.05 will be considered statistically significant. one way anova will be used to determine whether any significant within group differences existed over time for the selected variables if the data is normally distributed, while friedman's test will be used if the data is not normally distributed. generalized estimating equation (gee) will be used to test the effect of the intervention program for the selected variables (outcomes) between \& within-group at baseline, six weeks, and one month after intervention which is adjusted for clustering

Eligibility criteria:
inclusion criteria: * arabic citizen students * aged 13 to 14 years * who at least one of their parents consented to participate in the study. exclusion criteria: * students with diseases such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases. * students with any medical condition who are not allowed to do physical activity.
tear ferning test for dry eye diagnosis

Conditions: Dry Eye Syndromes

Summary: application of tear ferning test for clinical dry eye diagnosis

comparing dry eye patients' tear ferning structure with non-dry eye patients' to develop a protocol for easy and costless diagnosis in ophthalmology.

Eligibility criteria:
inclusion criteria: * aged between 20 and 65 years * for dry eye disease group: * schirmer's test results between 5 - 10 mm * tear film break up time less than 10 seconds * ocular surface disease index of more than 25 exclusion criteria: * those have diabetes, hypertension or other chronic diseases * no evident ocular diseases such as cornea disease, cataracts, vitreous degeneration, glaucoma, and retinopathy. * belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Keywords: dry eye diagnosis tear ferning
adas to alemtuzumab

Conditions: Multiple Sclerosis

Summary: the main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period

primary to quantify the longitudinal changes in alemtuzumab adas over a 24 month period. secondary 1. relative occurrence of infusion-related reactions based on high alemtuzumab ada levels prior to course 2. 2. relative change in lymphocyte counts after the second infusion of alemtuzumab in ada positive patients to assess the health economic impact of infusion-related reactions. 3. relative change in relapses or edss score based on alemtuzumab ada levels to assess the health economic impact of disease activity. 4. relative change in relapses or edss score based on alemtuzumab ada levels. 5. relative change in t2 lesion number or gd-enhancing lesions, and serum nfl based on alemtuzumab ada levels to assess the health economic impact of disease activity.

Eligibility criteria:
inclusion criteria: 1. patients with rrms who are being treated with alemtuzumab at barts health nhs trust will be approached to participate in the study. 2. patients must be willing and able to undergo blood tests. exclusion criteria: 1. ineligible for alemtuzumab under nhs england prescribing guidelines. 2. those unable to comply with study requirements, including frequency of visits. abnormal baseline investigations (wbc\ /3x upper limit of normal of site reference ranges, potassium \ 5.5 mmol/l, sodium /,125 mmol/l, creatinine \>130 umol/l).
effect of the release of the tongue muscles in the treatment of chronic non-specific neck pain

Conditions: Neck Pain

Summary: background the mechanisms behind non-specific neck pain (ns-np) have not yet been fully clarified. the anatomic relation between the tongue and structures that attach to the cervical spine suggests a possible clinical relation with a ns-np. this study protocol describes a randomized, double-blind, clinical trial, the aim of which is to determine the influence of the release of the tongue muscles on pain intensity, cervical range of motion and neck function in individuals with ns-np. methods/design forty patients with ns-np will be enrolled in a randomized, double-blind, clinical trial. the participants will be randomly allocated to two groups of 20 patients each. the experimental group (eg) will be submitted to a clinical method considered the gold standard for the treatment of neck pain together with a tongue muscle release protocol. the control group (cg) will only receive the gold standard method for the treatment of neck pain. all patients will receive six sessions of treatment at a frequency of twice per week and will be evaluated before and one week after the end of treatment. the primary outcome will be pain intensity measured using a numerical pain rating scale (range: 0 \[no pain\] to 10 \[maximum pain\]). the secondary outcomes will be the pain catastrophizing scale, patient-specific functional scale, neck disability index and cervical range of motion. comparisons between groups before and after treatment will demonstrate whether the tongue muscle release technique exerts an effect on pain intensity, cervical range of motion and neck function in individuals with ns-np. discussion the purpose of this randomized clinical trial is to evaluate the effect of a tongue muscle release technique on pain intensity, cervical range of motion and neck function in patients with ns-np. the data will be published after the study is completed. the study will support the practice of evidence-based physical therapy for individuals with nonspecific neck pain.


Eligibility criteria:
inclusion criteria: * history of neck pain for a period of more than three months; score of 10 to 24 on the neck disability index (adapted and validated for the brazilian population); score of 3 to 6 points on numerical rating scale (nrs) for perceived pain intensity. exclusion criteria: * history of neurological disorders (irradiated pain) or neck surgery; chronic neck pain resulting from a traumatic incident (whiplash); chronic musculoskeletal condition (such as muscular disorder or polyarthritis); fibromyalgia; systemic disease; current pregnancy; having undergone physical therapy, massage or acupuncture in the previous two weeks; or use of analgesic, muscle relaxant, psychotropic agent or anti-inflammatory agent in the previous three days.