Kornimate/medical-research-clean huggingface dataset:
predicting analgesic response to acupuncture: a practical approach

Conditions: Chronic Low Back Pain; Back Pain

Summary: in this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. the investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.


Eligibility criteria:
inclusion criteria: 1. age 21-65 2. english fluency 3. chronic lbp for ≥ 6 months 1. chronicity: clbp "defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months." 2. location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold 4. average pain over the last month ≥ 5/10 exclusion criteria: 1. radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. radicular back pain may also be accompanied by mri evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots. 2. pending litigation or worker's compensation related to the low back pain. 3. currently pregnant or planning to become pregnant (in next 6 months) 4. american society of anesthesiologist (asa) class iii or above physical status. asa class iii is defined as "a patient with severe systemic disease." examples would include poorly controlled diabetes, hypertension, copd or morbid obesity (bmi ≥ 40). 5. mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. for example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. these will be assessed by the mini. 6. medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids. 7. prohibited interventions: during the study period, the following are not permitted 1. back surgeries 2. injections with local anesthetics or steroids to the back 3. new chiropractic maneuvers 4. new physical therapy programs 5. new medications for back pain 8. bleeding disorders at the discretion of the study team. 9. previous acupuncture treatment in the past 10 years. 10. medical conditions that would interfere with study procedures (eg. heart disease or pacemaker, active infection), per discretion of the team

Keywords: acupuncture back pain chronic pain
optimizing sleep/wake related cognitive efficacy

Conditions: Laborist; Sleep; Cognition; Fatigue

Summary: this is a pilot study designed to elucidate sleep/wake patterns and associated cognitive efficacy of laborists involved in shift work at mayo clinic rochester.

each of the ten physicians working laborist shifts will be asked to wear an actigraphy watch (readiband- fatigue science, vancouver, bc) continually for three weeks in the winter 2014-2015 for initial data collection. a brief sleep education intervention based on aerospace and military fatigue countermeasure training will be given at a one hour departmental grand rounds presentation on april 20, 2015. this intervention will be based on acgme requirements for fatigue education for residents and will also address the latest data on sleep and health, as well as fatigue countermeasures of nap recommendations, sleep banking, and sleep hygiene. an additional two weeks of data will then be collected. data will be de-identified and entered into the fatigue science algorithm, which is validated to detect sleep quantity and quality. this algorithm allows labelling of data to reflect which type of shift, as well as its sequence in the schedule. for example, sleep/wake cycles of the fourth night shift of a series can be identified as such, so that wakefulness during a fourth night shift is not artificially compared to wakefulness during a first night of night shifts. average efficacy during each type of shift, as well as average efficacy during each shift in a series of one type of shift can then be calculated. efficacy is reported as a percentage, based on a nomogram established through military wakefulness task exercises and validated to correlate with blood alcohol level and with likelihood of human factor accident risk through the department of defense, us army, us navy, us marine corps, and federal railroad association. calculated data on shift efficacy will significantly contribute to the growing literature on the strengths of the laborist model, and will help with internal schedule structure to continue to maximize efficacy. as laborist programs develop and expand, the investigators may also be forerunners in describing optimal scheduling and staffing for programs of similar size and scope. ultimately, additional studies will use this innovative technology to elucidate the assumed but not scientifically established relationship between sleep/wake based cognitive efficacy and patient safety by superimposing the investigators' wakefulness data on the investigators' tracked adverse events. this would be landmark in the investigators' field and has the potential to effect groundbreaking safety measures in the investigators' training and staffing.

Eligibility criteria:
physicians working in laborist role, exclusion only by subject declining participation

Keywords: laborist efficacy sleep fatigue safte cognition
distinguishing healthy and keratoconic eyes using ultrahigh-resolution oct

Conditions: Keratoconus

Summary: the oct used in this trial offers the advantage of both a non-contact method and a very high axial resolution. determined parameters with the highest potential of diagnostic discrimination between eyes with keratoconus and healthy eyes are investigated. aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with keratoconus.


Eligibility criteria:
inclusion criteria: * age\>18 * existence of keratoconus * written informed consent obtained exclusion criteria: * earlier surgery such as pk, cxl, relaxing incisions * systemic diseases

Keywords: keratoconus optical coherence tomography corneal epithelium thickness maps
safety and efficacy study of intramyocardial stem cell therapy in patients with dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy; Chronic Heart Failure

Summary: background. in patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell transplantation has been shown to improve exercise capacity, reduce ventricular remodelling and improve 1-year survival. pre-clinical data demonstrate that stem cell effects on the diseased heart can be further enhanced by direct intramyocardial delivery route. aims. 1. to evaluate safety and efficacy of intramyocardial stem cell therapy in patients with non-ischemic dilated cardiomyopathy. 2. to directly compare clinical effects of intracoronary and intramyocardial stem cell delivery. methods. of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial transplantation of cd34+ cells (study group), and 30 will receive intracoronary stem cell therapy (control group). in both groups peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; cd34+ cells will be collected via apheresis and labelled with technetium. in the study group electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with noga catheter. in the control group patients will undergo myocardial perfusion scintigraphy and cd34+ cells will be injected intracoronary in the artery supplying segments of reduced viability. patients will be followed for 1 year. primary endpoints will include changes in left ventricular ejection fraction and left ventricular dimensions (measured by echocardiography). secondary endpoints will include changes in exercise capacity and changes in nt-probnp values. hypotheses. 1. at 1 year, intramyocardial stem cell therapy will be associated with improved left ventricular ejection fraction, reduced left ventricular dimensions, improved exercise capacity and reduced levels of nt-probnp. 2. beneficial effects of intramyocardial stem cell therapy will be superior to those observed with intracoronary stem cell delivery.


Eligibility criteria:
inclusion criteria: * established dg. of dilated cmp (defined according to esc position statement - absence of any stenotic lesions on coronary angiography, no congenital heart disease, no primary valve disease on echocardiography, and no history of hypertension or alcohol abuse1) * left ventricular ejection fraction \< 30% * nyha functional class iii or iv for at least 3 months before referral * optimal medical management for at least 6 months exclusion criteria: * left ventricular aneurysm or thrombus * hematologic disease * multiorgan failure * active malignancy

Keywords: heart failure dilated cardiomyopathy stem cells
personalized smartphone-assisted coaching system to improve glucose homeostasis in adults with prediabetes

Conditions: Prediabetes; Hyperglycemia; Postprandial Hyperglycemia; Impaired Glucose Tolerance; Impaired Fasting Glucose

Summary: sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

the mobile phone app sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. the rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. compared to similar smartphone-assisted prevention apps, there are two novel features of the sweetch app that may increase its efficacy. first, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and gps (global positioning system) sensors on smartphones. in contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. for these reasons, the sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.

Eligibility criteria:
inclusion criteria: * adults aged 18 -75 years with prediabetes (fasting bg 100-125 mg/dl, a1c 5.7% - 6.4%, or 2 hour bg of 140-199 mg/dl following 75-gram oral glucose tolerance test) * body mass index 24 - 40 kg/m2 * english speaker * smartphone user (android or apple 5s and above) exclusion criteria: * currently doing more than 150 minutes/week of moderate/vigorous physical activity * presence of medical conditions that prevent adoption of moderate physical activity * use of any glucose-lowering or weight loss medications within the previous 3 months * current pregnancy (self-reported) or planning pregnancy during study period (self-reported) * presence of any condition that can result in spurious a1c readings (e.g. anemia \[hemoglobin level below lower limit of normal\] secondary to iron, vitamin b12, or folate deficiencies; hemoglobinopathies) * use of systemic glucocorticoids * use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed) * severe mental illness or learning disability * current participation in another clinical trial * liver enzymes \>3 x upper limit of normal * poor literacy (realm-r score of 6 or less)

Keywords: mobile health
a study of circulating endothelial cell as marker for avastin (bevacizumab) in combination with docetaxel plus xeloda (capecitabine) as first line treatment for patients with locally recurrent and metastatic breast cancer

Conditions: Breast Cancer

Summary: this single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with avastin in combination with docetaxel + xeloda.patients will be treated with docetaxel 60mg/m2 iv on day 1, and xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. the anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * female patients, 18-65 years of age; * locally recurrent and metastatic breast cancer; * measurable or evaluable disease; * ecog performance status of 0-2; * lvef \>=50% without clinical symptoms or signs of heart failure. exclusion criteria: * unknown her2 status, or known her2-positive status; * prior chemotherapy for locally recurrent or metastatic disease; * prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment; * clinical or radiological evidence of cns metastases; * clinically significant cardiovascular disease.
outcomes of perforation after colorectal endoscopic submucosal dissection

Conditions: Colorectal Neoplasms; Perforation of Rectum; Perforation Colon

Summary: endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. en bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. endoscopic submucosal dissection (esd) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. however, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. the aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing esd and analyse the need for surgical intervention.


Eligibility criteria:
inclusion criteria: * patients from the fecco (nct04592003) cohort experiencing perprocedural or delayed perforation * age over 18 years old exclusion criteria: * patients refusing exploitations of health datas * patient treated with endoscopic mucosal resection

Keywords: endoscopic submucosal dissection laterally spreading tumors perforation
individually timed stair climbing and descending to lower postprandial glucose

Conditions: Postprandial Hyperglycemia; Postprandial Insulin

Summary: effect of individually timed exercise to attenuate postprandial glucose excursions

participants will perform 1 and 3 minutes stair climbing and descending at a self-selected pace after a mixed meal on separate visits. the timing of these exercise bouts will be determined from an initial control condition where the participant remains seated. timing of exercise will coincide with the peak glucose from the control condition. glucose will be measured every 10 minutes.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years exclusion criteria: * high-risk from par-q
app-based mindfulness training for individuals with anorexia nervosa and bulimia nervosa

Conditions: Anorexia Nervosa; Bulimia Nervosa; Anorexia Nervosa, Atypical; Bulimia; Atypical

Summary: we will evaluate the acceptability and feasibility of a 8-week long digital mindfulness-based intervention for anorexia nervosa and bulimia nervosa. this study is a prospective single-arm trial during the intervention development phase. following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

procedures include completing: (1) pre-intervention screening assessment; (2) brief daily assessments for the first and last weeks of the study (4 times per day); (3) an initial baseline visit; (4) 8-week web-based intervention (3) a post-intervention assessment (8-weeks after baseline); and (4) a brief 8-week follow-up assessment.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * can read and write in english * meet diagnostic dsm 5 diagnostic criteria for anorexia nervosa, bulimia nervosa, or atypical anorexia nervosa/bulimia nervosa * owns a smartphone * willing and able to participate in an eight-week long research study * have a private quiet space at home or headphones to complete modules * completed one month or more of eating disorder treatment * currently enrolled in eating disorder treatment exclusion criteria: * fail to meet above-listed inclusion criteria * current alcohol or drug dependence * current untreated psychotic or bipolar disorder * current suicidal intent * significant cognitive impairment that would impair the ability to use mindful courage effectively * bmi \<15 or medically unstable * currently receiving residential/inpatient treatment

Keywords: anorexia nervosa bulimia nervosa mindfulness training digital intervention
genetic markers of patients with history of pulmonary embolism post total joint arthroplasty

Conditions: Pulmonary Embolism

Summary: this study seeks to uncover potential genetic determinants of pulmonary embolism (pe). our translational goal is to ultimately identify certain genetic markers that will allow us to stratify patients in terms of their pe risk post total knee or total hip arthroplasty. the clinical implications for this study would allow for better patient care by lowering the risk of post-operative bleeding while still preventing symptomatic pes and deep vein thromboses (dvts). we look to sample patients who have a history of pe after undergoing total knee or total hip arthroplasty. we will sample these patients' blood dna for a set of dna genetic markers. to do so, we will utilize the taqman assay, which is a pcr-based 5'-nuclease allelic discrimination assay to determine single nucleotide polymorphism (snp) genotypes at specified loci. the region flanking the snp is amplified using two allele-specific fluorescent probes, allowing for the detection of each allele in a single tube. using this assay, there is no post-pcr processing because the probes are included in the pcr reaction (hui). using this approach, we will measure the frequency of genetic mutations in patients who have developed a pe after a total joint arthroplasty. this data would then be used to perform a prospective study to determine a subset of genetic markers that can definitively be used to risk stratify patients.


Eligibility criteria:
inclusion criteria: * patients with a history of pulmonary embolism and total hip arthroplasty or total knee arthroplasty, between the ages of 18 and 70 years exclusion criteria:
osteoarthritis in terms of icf components

Conditions: Osteoarthritis; Quality of Life; OUTCOME MEASURES

Summary: osteoarthritis (oa) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. therefore, the comprehensive assessment is important to determine how complex problems affect patients with oa. the first aim of this study was to link and allocate items of the western ontario and mcmaster universities (womac) oa index with icf comprehensive core set for osteoarthritis. the second aim was to examine the relationship between the quality of life and each icf component's scores determined based on clinical data of womac in oa.


Eligibility criteria:
inclusion criteria: * diagnosed with oa according to american college of rheumatology clinical criteria for oa of the knee or hip;\[14,15\] * being in the age range 18-65; and * absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology). exclusion criteria: * comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus); * previous lower extremity surgery; * intra-articular steroid or hyaluronic acid injection in the last three months * cognitive impairments; * pregnancy; and * illiteracy.
omega-3 supplementation to adhd medication in children

Conditions: Attention Deficit Hyperactivity Disorder; Deficient Emotional Self-Regulation

Summary: this study is a 12-week open-label trial to assess the effectiveness of omega-3 fatty acids for deficient emotional self-regulation (desr) as a supplement to attention deficit/hyperactivity disorder (adhd) treatment in children and adolescents with attention deficit/hyperactivity disorder. subjects will be between the ages of 6-17 and will currently be on medication for their attention deficit/hyperactivity disorder but still experience desr traits.


Eligibility criteria:
inclusion criteria: * male or female children ages 6-17 years * living at home * a diagnosis of adhd (inattentive, hyperactive/impulsive, or combined type) according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) based on clinical assessment * having a score outside the normal (a t-score of 60 or greater) on the emotional control subscale of the behavior rating inventory of executive function (parent-report version) or a score outside the normal range (cumulative of 180 or greater) on the anxious/depressed, attention problems, and aggressive behavior subscales of the child behavior checklist for ages (6-18) * currently on fda approved traditional stimulant medication (such as concerta of adderall xr) or non-stimulant medication (such as strattera or tenex) for their adhd for at least one month * beings able to come to weekly/monthly study visits for 12 weeks * having a parent or guardian with a level of understanding of the study exclusion criteria: * having unstable medical illness as determined by the clinician investigator * having a current diagnosis of schizophrenia or bipolar disorder * having delusions or hallucinations * having a bleeding disorder * taking any other ongoing non-adhd psychotropic medications other than stable, effective serotonin reuptake inhibitors such as fluoxetine (prozac), citalopram (celexa) or medications used on an as-needed basis * pregnant or nursing females * iq \< 70 by previous testing or as judged by the clinician investigator * illegal substance use * investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild * presence of suicidal risk, or homicidality * unwilling/unable to comply with study procedures * allergies to fish or shellfish or omega 3 fish oils; multiple adverse drug reactions * poor command of the english language

Keywords: adhd attention deficit hyperactivity disorder desr deficient emotional self-regulation emotional dysregulation omega-3 fatty acids fish oil