Kornimate/medical-research-clean huggingface dataset:
community health worker diabetes prevention intervention

Conditions: Diabetes Prevention

Summary: the primary goal of this study is to develop, implement, and test a community health worker (chw) program designed to promote diabetes prevention among korean and south asian americans in new york city. in particular, the specific aims of this study are: 1. to utilize community based participatory research (cbpr) methods to expand upon an existing campus-community partnership to develop and implement a chw program among korean and south asian americans that promotes diabetes prevention; 2. to develop, implement, and assess the efficacy of a chw intervention to promote diabetes prevention and access to care among nyc koreans and south asians.


Eligibility criteria:
inclusion criteria: * is a south asian or korean american immigrant; * is identified as at-risk by a diabetes risk assessment * is between 18-75 years of age; and * is willing to be randomized to either treatment or control groups. exclusion criteria: * is a confirmed diabetic; * is on renal dialysis; * has an acute or terminal illness or serious mental illness; * has a history of recent coronary event within the last 12 months; * has a recent history of acute medical problem or admission to hospital; * has any other severe medical conditions that might make it difficult to attend educational sessions; * has poor short-term prognosis (expected death in \<2 years); * is planning to travel for longer than 6 weeks during the 6-month intervention period; or * is participating in another cvd study.

Keywords: diabetes prevention
duration of ureteral rest prior to ureteral reconstruction surgery

Conditions: Ureteral Stricture

Summary: our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.


Eligibility criteria:
inclusion criteria: * \>18 years of age * undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest * willing to sign informed consent form * able to read and understand informed consent form exclusion criteria: * \<18 years of age * inability to provide informed consent * members of vulnerable patient populations
diagnostic value of mri-targeted plus index-lesion-ipsilaterally systematic biopsy for biopsy-naive men at risk of prostate cancer

Conditions: Prostate Cancer

Summary: targeted and systematic biopsy stands as the prevalent diagnostic approach for prostate cancer. despite its widespread use, this method is characterized by a high volume of needle biopsies. a refined approach, termed targeted and index-lesion-ipsilateral systematic biopsy, as one of targeted and regional systematic biopsy methods, aim to reduce the number of biopsy cores while maintaining an adequate positive rate. however, the absence of robust evidence necessitates further investigation. this study employs a prospective, multicenter, paired, non-inferiority design to assess the diagnostic efficacy of targeted and index-lesion-ipsilateral systematic prostate biopsy in comparison with the conventional targeted and systematic biopsy for the detection of clinically significant prostate cancer (cspca). eligible participants were identified as those with target lesions on prostate mri, who subsequently underwent targeted and systematic prostate biopsies. the index lesion was defined as the one with the highest prostate imaging reporting and data system (pi-rads) score; in cases of multiple lesions with identical pi-rads scores, the lesion with the greatest diameter was prioritized. post-biopsy pathological data were collected and evaluated using the international society of urological pathology (isup) grading system, which classifies patients with a grade of 2 or higher as having cspca. the study's primary outcome was to calculate the confidence interval for the difference in cspca detection rates between the two biopsy methods under a paired design. this interval was then compared against a pre-specified non-inferiority margin to determine whether the targeted and index-lesion-ipsilateral systematic biopsy method is non-inferior to the standard targeted and systematic biopsy in detecting cspca.


Eligibility criteria:
inclusion criteria: * prostate specific antigen (psa) \>4 ng/ml; * prostate imaging-reporting and data system (pi-rads) score of any lesions on prostate magnetic resonance imaging ≥4 or pi-rads score of lesions on prostate magnetic resonance imaging = 3 and prostate specific antigen density ≥0.1ng/cm3; * accept prostate biopsy; exclusion criteria: * prostate specific antigen\>20ng/ml； * the location of index lesion on prostate mri is on the midline of the prostate and symmetrical on both sides; * any contraindication of prostate biopsy; * previous prostate biopsy； * previous history of androgen deprivation therapy (adt), pelvic radiotherapy, and other treatments； * previous history of transurethral prostatectomy (turp)；
the clinical performance of a moisture resistant, m-teg-p phosphate monomer based universal adhesive (yamakin tmr-aquabond0) compared to the conventional universal adhesive (3m espe single bond universal adhesive)

Conditions: Non-carious Cervical Lesions; Geriatric Patients

Summary: this trial is to test the clinical performance of a novel moisture resistant, m-teg-p phosphate monomer based universal adhesive (yamakin tmr-aquabond0) compared to the conventional universal adhesive (3m espe single bond universal adhesive) in geriatric patients with non-carious cervical lesions (nclls)

to evaluate the clinical performance of a novel moisture resistant, m-teg-p phosphate monomer based universal adhesive (yamakin tmr-aquabond0) compared to the conventional universal adhesive (3m espe single bond universal adhesive) in geriatric patients with non-carious cervical lesions (nclls) p: population: geriatric patients with non-carious cervical lesions (nccls) i: intervention: novel moisture resistant, m-teg-p phosphate monomer based universal adhesive (yamakin tmr-aquabond0) c: comparator : 3m espe single bond universal adhesive o: outcome:clinical performance using fdi criteria

Eligibility criteria:
inclusion criteria: 1. non-carious cervical lesions in anterior and posterior teeth. 2. geriatric patients from age 60 years and above. 3. patients willing to commit to the whole period of the study. 4. males \& females included. exclusion criteria: 1. lack of written informed consent to participate 2. cervical hypersensitivities 3. underage patients 4. allergies to components of the materials used 5. infectious diseases 6. mucosal diseases with unclear diagnosis 7. inadequate oral hygiene 8. bruxism 9. high caries activity 10. non-vital pulp 11. severe periodontal diseases 12. severe dysgnathia/traumatic occlusion 13. undergoing orthodontic treatments 14. undergoing bleaching procedures

Keywords: non-carious cervical lesions
a phase iii randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (pout)

Conditions: Transitional Cell Carcinoma of Ureter

Summary: pout is a multi-centred randomised controlled phase iii trial. 345 patients who have undergone nephro-ureterectomy, are surgically staged pt2-pt4, n0-3 or are pt1 and node positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of adjuvant platinum based chemotherapy (experimental group) or surveillance (control group). participants will be followed up according to routine practice. primary endpoint: disease-free survival (dfs) secondary endpoints: * overall survival * metastasis free survival * incidence of bladder second primary tumours * incidence of contralateral primary tumours * acute and late toxicity * treatment compliance * quality of life


Eligibility criteria:
inclusion criteria: * written informed consent * ≥18 years of age * post radical nephro-ureterectomy for upper tract tumour with predominant tcc component - squamoid differentiation or mixed tcc/scc is permitted. * histologically confirmed tcc staged pt2-pt4 pn0-3 m0 or ptany n1-3 m0 (providing all grossly abnormal nodes are resected). patients with microscopically positive margins on pathology may be entered (providing all grossly abnormal disease was resected). * satisfactory haematological profile (anc\> 1.5 x 109/l, platelet count ≥ 100 x 109/l) and liver function tests (bilirubin \< 1.5 x uln, ast and alkaline phosphatase \< 2.5 x uln), glomerular filtration rate ≥30 mls/min. * fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated * who performance status 0-1. * available for long-term follow-up exclusion criteria: * evidence of distant metastases * pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology * un-resected macroscopic nodal disease * concurrent muscle invasive bladder cancer (patients with concurrent non-muscle invasive bladder cancer (nmibc) will be eligible) * gfr \<30 ml/minute. nb gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin i.e. for gfr 30-49ml/min. patients with poor performance status or co-morbidities that would make them unfit for chemotherapy are ineligible for the trial * significant co-morbid conditions that would interfere with administration of protocol treatment * pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active); * previous malignancy in the last 5 years except for previous nmibc, adequately controlled non melanoma skin tumours, cis of cervix or lcis of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.

Keywords: adjuvant chemotherapy surveillance nephro-ureterectomy
effects of a mat pilates exercise program on elderly women with chronic nonspecific low back pain

Conditions: Low Back Pain

Summary: the technique of pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. however, its application in women over 65 years has not been adequately studied. objective: this assessor-blind randomized clinical trial aims to study the effect of a mat pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain. methods: 60 elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. participants will be divided into two groups of 30 people each; one being intervention and one control. the intervention group will follow a custom mat pilates program (twice per week) for 10 weeks, while the control group will not follow any treatment. pain, functionality, balance, the number of painkillers administered, and adherence to exercise will be assessed at the beginning and end of the study and will be re-examined six months later.

the technique of pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. however, its application in women over 65 years has not been adequately studied. objective: this assessor-blind randomized clinical trial aims to study the effect of a mat pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain. methods: 60 non-active elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. participants will be divided into two groups of 30 people each; one being intervention and one control. the intervention group will follow a custom mat pilates program (twice per week), while the control group will not follow any treatment. primary outcomes will include pain with the visual analog scale for pain and functionality with the roland-morris questionnaire (rmq). secondary outcomes will include the balance with the berg balance scale and the timed up and go test, the number of painkillers administered, and the adherence to the exercise that will be evaluated at the beginning and at the end of the study and re-evaluated six months after the end of the intervention. the treatment period will be 10 weeks.

Eligibility criteria:
inclusion criteria: * symptoms of chronic back pain lasting more than 12 weeks * score on the visual analog scale for pain less than 70mm * timed up and go test score less than 15sec exclusion criteria: * low back pain due to a serious pathology that refers to a red flag such as malignancy, vertebral fracture, osteomyelitis, rheumatoid arthritis, cauda equina syndrome (ces) * participation in another exercise program in the last six months * diagnosed with neurodegenerative disease (e.g., parkinson's disease) * recent stroke * senile dementia

Keywords: mat-pilates exercises elderly chronic low back pain physical therapy rehabilitation
the effect of pharmaceutical grade l-glutamine (endari) on glycemic control in patients with diabetes mellitus type ii

Conditions: Diabetes Mellitus, Type 2

Summary: the study is an initial non-blinded, non-placebo controlled trial to determine the efficacy of l-glutamine in lowering blood sugar in patients with diabetes mellitus type ii without sickle cell anemia.

the protocol will consist of starting patients on 15 g of l glutamine twice daily by mouth. this is the same dose that is used to treat patient with sickle cell anemia. they will be given this medication for a total of 3 months. their other medications will remain the same. at the conclusion of the 3 months, the patients will be taken off of the glutamine and will continue their other medications. the investigators will monitor the patients an additional 3 months (6 months after the initiation of the study) off the l-glutamine. in this manner, the investigators will have a washout period. the outcome will be a comparison of the results before the initiation of the l-glutamine, to the results after treatment, and after the washout. data analysis will consist of comparing the patient's fasting glucose and hemoglobin a1c values. the investigators will also check the levels of fructosamine. this is a standard test that is done in any clinical laboratory. to help determine the mechanism for the l-glutamine effect, the investigators will also measure the complete blood count, chemistry panel, hepatic function panel, urine micro-albumin, patients' weight, and waist circumference. the investigators will use the student t-test for statistical analysis. significance will be tested at the 0.05 level. the investigators will collect demographic information on the patients in the study. age, sex, duration of diabetes, smoking history, and race will be noted. the investigators will use regression analysis to determine whether these factors have any effects on the observed results.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of diabetes mellitus type ii * patient of straub medical center, internal medicine clinic exclusion criteria: * renal and liver impairment ( gfr less than 40) * transaminitis (elevation of ast of alt more than 2 fold) * patient with sickle cell anemia
pain perception in suicidal behavior vulnerability

Conditions: Major Depressive Episode

Summary: in france, almost 1 death on 50 is a suicide. the suicide occurs in unbearable psychic pain where mental trouble has a major influence. it is classified as preventable mortality. according to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. the social pain (or psychical pain on the broader sense) and physical pain are closely linked. the investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. it will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters. the aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts. after a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named cyberball).

242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters) first visit : clinical assessment second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).

Eligibility criteria:
inclusion criteria: * aged by 18 years old * came from west europe, excepted basque and sardinian (because of genetics analysis) * main diagnosis of major depressive episode (dsm v criteria) * not having take antalgics in the 24 hours before assessment * received a minimal psychotrope treatment (clinician evaluation) * able to understand nature, aims, methodology of the study * agree to cooperate in clinical and biological assessment * having signed informed consent specific inclusion criteria : 81 recent suicide attempters (being hospitalised for suicidal attempts and having realised a suicide attempts 8 days before inclusion) 81 former suicide attempters (having realised in his lifetime a suicide attempt, one month before inclusion) exclusion criteria: * current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime * current algic and chronic neurologic disease * current or actual treatment by tricyclic antidepressant and serotonin and norepinephrine reuptake inhibitors(snris) * pregnancy * patients on protective measure

Keywords: suicidal behavior psychological and social pain physical pain pain perception
study of high-dose-rate endorectal brachytherapy (hdrbt) in the treatment of locally advanced low rectal cancer

Conditions: Rectal Cancer

Summary: this research is being done to see how effective high-dose rate endorectal brachytherapy (hdrbt) is in treating cancer of the lowest part of the bowel (rectum). in this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (hdrbt). this is a different form of radiation than what is normally given (crt). with hdrbt, the radiation is given through an applicator placed into the bowel next to the tumor. the radiation is directed at the tumor and a small area around it.

this study is a pilot study open to patients with clinical stage t2n1 or t3n0-1 resectable rectal cancer. the investigational tool being evaluated is high-dose endorectal brachytherapy (hdrbt) which is an fda approved method to administer endoluminal radiation for low rectal cancer. this study assumes that the rate of pathological response to hdrbt will be similar to historical controls (conventional neoadjuvant chemoradiation). all patients will receive postoperative standard 5-fluorouracil (fu) based chemotherapy (at the discretion of the medical oncologist). the clinical response will be assessed with endoscopic/ultrasound, pelvic mri and fluorodeoxyglucose (fdg)-positron emission tomography (pet)/ct. in addition, tissue and serum will be collected to evaluate for biological predictors of response to therapy. the endpoints of this study include adverse events (gastrointestinal toxicity), quality of life as measured by the quality of life questionnaire (qlq)-c30, and tumor regression/response.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed adenocarcinoma of the rectum * able to undergo local staging of the rectal tumor performed by mri and/or endoscopic ultrasonography (eus) demonstrating a t2n1 or t3n0-1 tumor * eastern cooperative oncology group (ecog) performance status of 0 or 1 * participants are willing to undergo initial therapy and if needed subsequent therapy prior to resection at johns hopkins medical institutions * english as a primary language in order to complete the quality of life questionnaires exclusion criteria: * patients with tumors \>12 cm from the anal verge. * near obstructing or bulky tumors which will not allow application of the endorectal probe * patients with distant metastatic disease * any pelvic lymph nodes outside of the mesorectum (iliac or inguinal) * prior history of radiation therapy to the pelvis * prior history of chemotherapy for rectal cancer * active connective tissue disease such as scleroderma or crohn's disease

Keywords: rectal cancer high dose endorectal brachytherapy
study to determine appropriate nurse: patient ratios in peritoneal dialysis programs

Conditions: Chronic Renal Failure

Summary: as the resolution of the brazilian federal council of nursing (cofen) sizing the framework of nursing professionals is essential to ensure the safety and quality of patient care. to achieve such goals actions are needed to evaluate the variety of tasks and performance specific to each area in nursing profession. the national agency for health surveillance (anvisa), through board resolution (rdc-154) determines that the nurse to patient ratio is 1 to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not based on any evidence, and same apply to other latin-american countries. objective: to determine the appropriate nurse: patient ratio for peritoneal dialysis unit. method: this research will be developed in two phases. the first with an observational design with descriptive and qualitative approach. there will be a focus group with experts in the field, to defined the activities and responsibilities of the peritoneal dialysis nurse, and produce a tool with a list of activities. a time-orientated score will be created. in the second stage a cross-sectional quantitative approach will be used. to apply the instrument from by direct observation of activities performed by nurses during their workday. with the instrument activities will be timed and the overall time of each nursing activity will be determined by multiplying the time spent by the total number of patients. it is expected tat this strategy will increase time on treatment and/or decrease dropout rates, by developing an easy test/ formula application to determine the correct ratio according to the peritoneal dialysis program. this tool will provide better outcomes for patients as well as allow for growth of peritoneal dialysis programs with qualified assistance and patient safety.

research question: can a time-oriented score system and expert consensus be applied to pd to develop an easy and repeatable system to evaluate work load for peritoneal dialysis nurses to achieve the best outcomes and allow for planned growth of the unit?

Eligibility criteria:
inclusion criteria: * to have at least one year of experience with peritoneal dialysis exclusion criteria: * not applicable * consent withdraw

Keywords: peritoneal dialysis nursing staff nursing activities personnel downsizing