Kornimate/medical-research-clean huggingface dataset:
medical assistant health coaching for diabetes in diverse primary care settings

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this study is a cluster (clinic level) randomized pragmatic trial to compare the effectiveness of ma health coaching (mac) delivered by non-clinician primary care staff (i.e., mas) versus usual care (uc) in improving diabetes clinical control among individuals with poorly controlled type 2 diabetes mellitus (t2dm).

the study will be conducted in the primary care environments of two distinct, yet representative healthcare systems in san diego county: neighborhood healthcare (a san diego county fqhc system and designated patient-centered medical home, serving predominantly ethnic minority, low income patients) and scripps (a large, non-profit, private insurance-based health system, serving predominantly caucasian, middle-to-higher income patients). six hundred patients at intervention (n=2; patient n=300) and control (n=2; patient n=300) clinics, aged 18 and older, with t2dm, and glycosylated hemoglobin (hba1c) ≥ 8.0%, and/or low-density lipoprotein cholesterol (ldl-c) ≥ 100 mg/dl, and/or systolic blood pressure (sbp) ≥ 140 within the last 60 days, will be identified and enrolled using electronic health records (ehrs). primary clinical outcomes of hba1c, ldl-c, and sbp assessed as part of quarterly (or annual, for ldl-c), standard-of-care medical visits will be extracted from ehrs over 12 months. changes in patient-reported behavioral (diabetes self-care) and psychosocial (quality of life, patient activation) outcomes will be evaluated via telephone assessment in a subset of intervention and control (n=300 total) participants at baseline, month 6, and month 12. a thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient, ma, and primary care provider perspectives. cost-effectiveness will also be examined from the health system perspective. principles of community engaged research were incorporated in intervention and study planning and will be sustained throughout the research period.

Eligibility criteria:
inclusion criteria: 1. must be a patient at selected scripps or neighborhood healthcare clinic, 2. must be age 18 years or older, 3. must have a t2dm diagnosis, 4. must show evidence of poor clinical control, defined as hba1c ≥ 8% and/or ldl-c ≥ 100 mg/dl, and/or sbp ≥ 140 mmhg. exclusion criteria: none as this is a pragmatic trial.

Keywords: diabetes medical assistant health coach glycemic control pragmatic trial
a validation study for detecting chlamydia and gonorrhea in rectal samples

Conditions: Gonorrhea; Chlamydia

Summary: our hypothesis is that nucleic acid amplification testing (naat) with the aptima combo2 (ac2) will have greater sensitivity than culture in detecting neisseria gonorrhoeae in rectal samples. we also hypothesize that ac2 will be equivalent to naat with the becton dickinson probetec in detecting chlamydia trachomatis and neisseria gonorrhoeae in rectal samples.

this research is being done to compare the results of tests for diagnosing sexually transmitted infections (sti) from rectal samples. specifically, this study will test for gonorrhea and chlamydia from rectal samples and compare the results between standard culture and newer technology (nucleic acid amplification testing otherwise know as "naat") used to detect these infections. gonorrhea and chlamydia are stis (infections you get from having sex with someone who is infected). infections in the rectum may cause symptoms such as rectal discharge, itching and/or pain or may be asymptomatic (no symptoms present). since these infections are sexually transmitted, it is important to have accurate tests to diagnose and treat these infections to prevent them from being passed onto a sexual partner. naat has not been food and drug administration (fda) approved for use in diagnosing these infections in the rectum. the tests are approved to detect these infections from other sites (cervix and urine) and investigators believe that these tests will be very accurate in detecting these infections in the rectum as well. this study will validate the use of naat in rectal samples so that this technology can be used in our research laboratory for future studies that involve testing for stis from the rectum. there are times when people have signs of inflammation in the rectum (known as proctitis) and an infection or cause is not able to be identified. investigators believe that this new technology (naat) may be able to find reasons (different bacteria) for infection that were not able to be identified with older testing methods. by participating in this study, one of the rectal swabs will also be tested for additional bacteria (called mycoplasma and trichomonas). both of these organisms are sexually transmitted and may be important organisms in the cause of proctitis.

Eligibility criteria:
inclusion criteria: 1. male and female subjects aged 18 and older 2. women or men who have a history of engaging in receptive anal intercourse 3. willing to provide written informed consent for participation in this study exclusion criteria: 1. use of oral antibiotics in the past 7 days 2. use of rectal douche or other rectal product in the past 24 hours

Keywords: gonorrhea chlamydia rectal
comparison of postoperative analgesic effect of intrathecal magnesium and fentanyl added to bupivacaine in patients undergoing lower limb orthopedic surgery

Conditions: Post Operative Pain

Summary: magnesium has been suggested that nmda (n-methyl d-aspartate)receptor antagonists induce preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent sensation of pain. following ethics committee approval and informed patients consent, ninety patients 20-60 yr old asa physical status i or ii, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. the patients were randomly allocated to one of three groups of 30 each. the magnesium group (groupm) received bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group f) received bupivacaine 15mg combined with0.5 ml fentanyl\[25microgram\] and the placebo group (group p) received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . time to first requirement of analgesic supplement, sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[saturation of peripheral oxygen (spo2)\<90\], postoperative analgesic requirements and adverse events, such as sedation, dizziness , pruritus and postoperative nausea and vomiting were recorded. patients were instructed preoperatively in the use of the verbal rating scale (vrs) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. if the vrs exceeded four and the patient requested a supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain relief as needed .


Eligibility criteria:
inclusion criteria: .patients with american society of anesthesiologists(asa) physical status i and ii, undergoing elective femur surgery - exclusion criteria: * significant coexisting disease such as hepato-renal and cardiovascular disease * any contraindication to regional anesthesia such as local infection or ''''bleeding disorders * allergy to opioids * long-term opioid use * history of chronic pain.

Keywords: magnesium fentanyl intrathecal pain
study of chemokine coreceptor 5 (ccr5) antagonist gw873140 in r5/x4-tropic treatment-experienced hiv-infected subjects

Conditions: HIV Infection

Summary: the purpose of this study is to evaluate the safety and efficacy of the ccr5 antagonist gw873140 or placebo in combination with an optimized background regimen in treatment-experienced hiv-infected subjects with r5/x4-tropic virus


Eligibility criteria:
inclusion criteria: * hiv-infected. * screening viral load at least 5000copies/ml. * r5/x4-tropic virus at screening. * total prior antiretroviral experience of at least 3 months. * documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (nrti), non-nucleoside reverse transcriptase inhibitors (nnrti), and protease inhibitors (pi), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening. * able to receive a ritonavir-boosted protease inhibitor during treatment studies. * women of childbearing potential must use specific forms of contraception. exclusion criteria: * acute laboratory abnormalities. * history of pancreatitis or hepatitis, hepatitis b or hepatitis c coinfection, or any chronic liver disease. screening liver function tests will be used to determine eligibility. * r5-tropic only. * x4-tropic only. * non-phenotypeable virus at screening. * changes to antiretroviral therapy from 4 weeks prior to screening until day 1 of treatment study. * pregnancy or breastfeeding women. * recent participation in an experimental drug trial. * prior use of a ccr5 or cxcr4 antagonist. * significant ecg abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness. * current use of certain medications may exclude participation in this study. * additional qualifying criteria and laboratory test requirements to be assessed by study physician.

Keywords: hiv-1 gw873140 ccr5 antagonist treatment experienced
frailty as an instrument for evaluation of elderly patients with non st elevation myocardial infarction (nstemi)

Conditions: Non ST Elevation Myocardial Infarction (NSTEMI); Frailty

Summary: the purpose of this study is to describe patients, 75 years old or older, with non st elevation myocardial infarction (nstemi) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. the investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.

the term frailty denotes a multi-dimensional syndrome characterized by increased vulnerability and decreased physiologic reserves. frailty stratification predicts a patient's risk of death and need for institutional care. the construct is well validated, but there is not one single accepted operational definition. the csha clinical frailty scale (cfs) is a 7-point scale relying on clinical judgement. it is a global clinical measure of biological age, and it mixes co-morbidity, disability and cognitive impairment.though frailty instruments so far mainly have been used in a geriatric context, it has been pointed out as relevant for cardiologic patients as well, e.g. regarding risk stratification for elderly patients with nstemi. the purpose of this study is to describe patients, 75 years old or older, with non st elevation myocardial infarction (nstemi) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. the investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.

Eligibility criteria:
inclusion criteria: * patients, 75 years old or older, with diagnosed nstemi, and cared for at one of the following hospital care units: cardiology, acute medicine, geriatrics, other internal medicine unit. exclusion criteria: * not willing to participate. * non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (cfs).

Keywords: non st elevation myocardial infarction (nstemi) elderly frailty
micra atrial tracking using a ventricular accelerometer study

Conditions: Atrioventricular Conduction Block

Summary: the purpose of this study is to characterize performance of the marvel algorithm downloaded into the micratm tps to provide atrial synchronous ventricular pacing in subjects with av block. a sub-study will be conducted within the marvel study, the purpose of this study is to characterize the marvel algorithm in patients who were enrolled in the marvel study, and to collect and compare the accelerometer signals and av synchrony at a second point in time.


Eligibility criteria:
inclusion criteria: * subject has been implanted with, or is expected to be implanted with a micratm tps (model mc1vr01), with remaining device longevity of 6 years or more. * subject is ≥ 18 years old and as per required local law. * subject has atrioventricular (av) block. * subject (and/or witness, as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements. * subject is willing and able to comply with the protocol. exclusion criteria: * subject is in atrial arrhythmia at the time of enrollment. * subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the medtronic study manager. * subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to marvel study procedures). * subject meets any exclusion criteria required by local law (age or other). additional criteria for the marvel evolve sub-study: inclusion criteria: • subjects in the marvel sub-study have previously been enrolled in the marvel main study
erwinase study in patients with acute lymphoblastic leukemia

Conditions: Leukemia

Summary: the goal of this clinical research study is to allow doctors to use erwinia l-asparaginase (erwinase®) as a replacement for patients who are allergic to e.coli l-asparaginase or pegylated e.coli l-asparaginase as part of the treatment for acute lymphoblastic leukemia (all) or t or b cell lymphoma. this trial was part of a multi institutional effort by the drug company to make erwinase available for use.

the study drug: erwinia l-asparaginase helps stop the growth of cancer cells by blocking the nutrients that cancer cells needed to survive. study visits: erwinia l-asparaginase will be given either outpatient or inpatient, depending upon your condition. if you are allergic to e. coli asparaginase or pegylated asparaginase, you will be given 6 doses every other day. you will receive erwinia l-asparaginase as an injection through a needle in your vein, under the skin, or in your muscle, as directed by your study doctor. you will be monitored closely by your nurse and your doctor before, during, and after receiving the drug for any side effects. if you develop a severe allergy to erwinia l-asparaginase, you may not receive any more asparaginase therapy. the length of study will be based upon on the all treatment you are currently receiving. your doctor will discuss the details of your treatment schedule with you. this is an investigational study. erwinia l-asparaginase is not fda approved. the fda allows patients with acute lymphoblastic leukemia who have an allergic reaction to the u.s.-approved l-asparaginases to receive erwinia l-asparaginase. up to 35 patients will take part in this study at the university of texas (ut) md anderson cancer center.

Eligibility criteria:
inclusion criteria: 1. age: no restrictions 2. patient must give written informed consent to receive erwinase® under investigational new drug (ind) 290. 3. patient must be treated for acute lymphoblastic leukemia 4. patient with either t or b cell lymphoma being treated with asparaginase. 5. patient must have either systemic hypersensitivity reactions to native (elspar®) or pegylated (oncaspar®) e. coli l-asparaginase. this includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection. 6. patient with previously documented local or systemic reactions to e. coli derived l-asparaginase. 7. patients who are on elspar® (including those enrolled in a clinical trial randomized to elspar®) and where elspar® is not available. exclusion criteria: 1. previous allergic reaction to erwinia l-asparaginase (erwinase ®) 2. previous acute pancreatitis 3. pregnant or lactating woman

Keywords: acute lymphoblastic leukemia leukemia erwinia l-asparaginase erwinase
university of washington reading & dyslexia research program

Conditions: Reading Disability

Summary: subjects are recruited for a pre-kindergarten education program focusing on early literacy skills. primary outcomes are improvement in letter knowledge and changes in brain response to text.


Eligibility criteria:
inclusion criteria: typically developing children enrolled before kindergarten. * typically developing child between 60 and 72 months of age * has not yet begun kindergarten exclusion criteria: * reported neurological or psychiatric condition. * claustrophobia. adhd
eze/simva switch study in diabetics (0653a-807)

Conditions: Diabetes Mellitus, Type 2

Summary: a study to assess the effectiveness and tolerability of mk0653a and mk0653a versus atorvastatin in lowering ldl-c levels.


Eligibility criteria:
inclusion criteria: * currently being treated with atorvastatin 10 mg for at least 6 weeks * have type 2 diabetes * weight must be stable for more than 6 weeks before entering the study exclusion criteria: * consume more than 14 alcoholic drinks per week. * pregnant or lactating * have taken another investigation drug within 3 months of starting this study * history of congestive heart failure, heart attack, coronary artery bypass surgery * uncontrolled high blood pressure * hiv positive * history of cancer in the last 5 years
selective thromboembolism prophylaxis after arthroplasty

Conditions: Venous Thrombosis, Deep; Arthroplasty Complications

Summary: asian populations have a lower rate of high-risk gene mutations of venous thrombosis, which means a reasonable perioperative anticoagulant management after hip or knee arthroplasty for caucasian populations may be too excessive for asians. so, individual patient risk assessment, rather than a "blanket policy", is considered the best thromboembolism prophylaxis for asians.the purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (teg) after joint arthroplasty for asian populations.

asian patients who underwent hip or knee arthroplasty in guangdong general hospital from august 2016 to august 2017 were randomly divided into selective anticoagulation group (sag) and conventional anticoagulation group (cag). sag used anticoagulant when teg indicated hypercoagulability while cap used anticoagulant until one month after surgery regularly. data including patients' basic information, postoperative complications, perioperative clotting index, intraoperative blood loss, perioperative teg, volume of drainage, and blood transfusion were evaluated.

Eligibility criteria:
inclusion criteria: * over 18 years of age, * asa ⅰ-ⅱ grade, * bmi \<40kg / m \^ 2 * underwent total knee arthroplasty/ total hip arthroplasty in guangdong general hospital * consent to enroll in this study exclusion criteria: * history of vte, preoperative infection, preoperative coagulation * liver and kidney function existed clinically abnormalities * history of tumor * history of vascular surgery * heart infarction or cerebral infarction within 6 months * history of lower extremity surgery within 3 months
cognitive behavioral therapy for adolescent binge eating and loss of control eating

Conditions: Binge Eating; Eating Disorders in Adolescence; Overweight and Obesity

Summary: this study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.

youth who engage in binge eating or loss-of-control eating are at high risk for physical and mental health impairment, as well as excess weight gain. as there are few evidence-based treatments for adolescents with binge/loss-of-control eating, assessment and treatment have received minimal attention for adolescent patients. among adults, cognitive-behavioral therapy (cbt) has a strong evidence base for binge-eating disorder. adolescents have unique social, cognitive and emotional needs because of their developmental stage; unique treatment approaches are essential to meet these unique needs. this study will develop a new cbt treatment for adolescents with binge eating or loss-of-control eating (modifying adult cbt for binge-eating disorder, conducting interviews with adolescents about aspects of treatment that need to be modified, conducting an open series of patients who receive the active treatment). this study will also test the efficacy of the newly-developed cbt for adolescents with binge/loss-of-control eating versus a control group in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: to be included, adolescents must: 1. be in the age range ≥12 years old and ≤17 years old; 2. have a bmi that places them above the 85th percentile based on their age and sex; 3. report 2 episodes of binge/loc eating (feeling a loss of control while eating) per month for the past 3 months; 4. be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions); 5. read, comprehend, and write english at a sufficient level to complete study-related materials; 6. be available for participation in the study for 7 months. exclusion criteria: prospective participants will be excluded if the adolescent: 1. has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality); 2. has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems); 3. has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension); 4. is pregnant or breastfeeding; 5. is taking medication(s) or participating in treatment(s) that could influence weight or appetite; 6. began taking hormonal contraceptives less than 3 months prior; 7. has a developmental or cognitive disorder (e.g., autism spectrum disorder); 8. has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or 9. is participating in another clinical research study.

Keywords: adolescent cognitive-behavioral therapy loss of control eating