Kornimate/medical-research-clean huggingface dataset:
accuracy and user performance evaluation of pixotest hba1c measurement system

Conditions: Diabetes; HbA1c

Summary: to evaluate the accuracy user performance of pixotest hbac1 measurement system and to collect feedback from subjects.

according to who report, the number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014. diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation. in 2012 alone diabetes caused 1.5 million death. tight glucose control is essential for prevention of complications in people with diabetes. the diabetes control and complications trial (dcct) provided direct evidence the relationship between hba1c level and risks for diabetic complications in diabetes. based on the results of the dcct, the american diabetes association (ada) has published recommendations for hba1c and plasma glucose levels that are widely used. hba1c testing can be performed at any time of day and without special patient preparation, it is more convenient for patients and even measuring fasting plasma glucose. the ada recommends measurement of hba1c (typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients, and 2 times per year for well-controlled type 2 diabetic patients) to determine whether a patient's metabolic control has remained continuously within the target range. .most diabetes patients will go to hospital to measurement hba1c, but should wait few days for test result. most diabetes patient maybe not measurement hba1c so many time per year. the pixotest hba1c measurement system can give result for a few minutes at home. the diabetes patient can measure hba1c at home don't need go to hospital. the pixotest hba1c measurement system is defined as the respective reagent system and the corresponding smartphone. it is intended for quantitative measurement of hba1c in capillary whole blood and use in the home by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. this study is designed to test the accuracy and user performance of the pixotest hba1c measurement system.

Eligibility criteria:
inclusion criteria: 1. 18 years or older. 2. willing to participate in the study, able to read and provide written informed consent form. 3. hct 25\~65%. 4. subjects including healthy subjects, outpatients and inpatients. exclusion criteria: 1. an individual who does not meet the inclusion criteria will be excluded from enrollment.taking prescription anticoagulants (such as warfarin or heparin) or have clotting problems that may prolong bleeding. taking plavix or aspirin daily is not excluded. 2. hemophilia or any other bleeding disorder 3. reports having an infection with a blood borne pathogen (e.g. hiv, hepatitis)

Keywords: hba1c
rct to compare orlistat and polyglucosamine for the management of overweight and obesity

Conditions: Overweight; Obesity

Summary: this trial compares two treatment methods: 1. orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. important is also that it is taken along with a reduced-calorie and low-fat diet. 2. polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.


Eligibility criteria:
inclusion criteria: * bmi ≥ 28 kg/m² and \< 45 kg/m² * waist circumference \> 80 cm (women) \> 94 cm (men) exclusion criteria: * energy intake lower than the standard value according to miffin st-jeor equation * pregnancy or breast-feeding * addiction to alcohol * inability to fulfil the requirement of the trial protocol * cancer ,malignant tumour * hypersensitivity reactions to crustaceans or ingredient of the study medication * chronic diseases not under control with adequate therapy * diabetes

Keywords: polyglucosamine l 112 overweight, obesity orlistat weight reduction
pre-hospital morphine titration : comparison of 0,05 versus 0,1 mg/kg

Conditions: Severe, Acute Pain in a Pre-hospital Setting

Summary: efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg

study objective : assess the efficacy of a morphine dose of 0.1 mg/kg versus a morphine dose of 0.05 mg/kg in pre-hospital pain methods : consecutive patients with severe, acute pain defined as a verbal rating scale (vrs) of 60/100 or higher may be included. 106 patients at all are required in the study. they will be randomised in two groups : group a will receive an initial intravenous injection of 0.05 mg/kg then injections of 0.025 mg/kg every 5 minutes and group b will receive an initial intravenous injection 0.1 mg/kg then injections of 0.05 mg/kg every 5 minutes. the pain scale will be checked every 5 minutes during 30 minutes. the titration will be stopped before, if the vrs is \< or = 30. the patient will be followed during the study until 60 minutes.

Eligibility criteria:
inclusion criteria: * severe, acute pain defined by a vrs of 60/100 or higher * male or female over 18 years * cared by a medical emergency care unit * written informed consent * affiliated to social security exclusion criteria: * a known opioid or paracetamol hypersensitivity * patient not agree ta participate at the study * pregnancy * uncontrolled epilepsia * incapacity to understand the vrs * renal, respiratory, or liver disease * patients who have received sedative drugs or alcohol (\< 6h) * acute respiratory, haemodynamic or neurologic failure * patients who have already received an analgesic (\< 6h) * drug addiction * patients under protection of justice

Keywords: acute pain morphine titration analgesia pre-hospital care
brave strategy - breast cancer risk assessment -achieving equity

Conditions: Breast Cancer

Summary: the central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in tennessee. the brave strategy (breast cancer risk assessment - achieving equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. the investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of tennessee. the primary outcome is the proportion of women age 25-49 having risk assessment. secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.


Eligibility criteria:
inclusion criteria: * ages 25-49 exclusion criteria: * personal history of breast cancer

Keywords: breast cancer mammogram screening risk assessment
the outcome of percutaneous balloon pulmonary valvuloplasty in pediatrics

Conditions: Balloon Pulmonary Valvuloplasty in Pulmonary Valvular Stenosis

Summary: evaluation the outcome of percutaneous balloon pulmonary valvuloplasty in children with valvular pulmonary stenosis at the pediatric cardiology unit.

pulmonary valve stenosis (ps) is a heart valve disorder in which outflow of blood from the right ventricle of the heart is obstructed at the level of the pulmonic valve. although most commonly diagnosed and treated in the pediatric population, individuals with more severe forms of ps are surviving into adulthood and require ongoing assessment and cardiovascular care. the prevalence of valvular pulmonary stenosis has been reported at 0.6 to 0.8 cases per 1000 live births. when associated with other congenital heart disorder, it occurs in approximately 50% of all born with some kind of congenital heart disease . pulmonary stenosis can be due to isolated valvular (90%), subvalvular, or peripheral (supravalvular) obstruction, or it may be found in association with congenital heart disorders of some other kind . critical pulmonary stenosis (ps) is a life-threatening congenital heart disease which requires immediate treatment . unlike older children with isolated ps, neonates with critical ps presents with severe cyanosis and the suprasystemic right ventricle (rv) pressure may result in rv dilatation and failure with severe tricuspid regurgitation (tr). since the discovery of balloon pulmonary valvuloplasty (bpv), it has replaced surgical approach for relieving ps . femoral vein is the most common venous access for bpv; however, crossing the pulmonary valve using this approach can be difficult, especially in the presence of severe tr and right chambers dilatation . this problem can be overcome by using transjugular approach, yet many operators are reluctant to use this method because of potential complications and lack of data reporting transjugular approach. balloon pulmonary valvuloplasty (bpv) is a safe and effective treatment for isolated pulmonary valve stenosis . the optimal age or body size for elective bpv depends on an individual's pulmonary valve diameter, transpulmonary pressure gradient, and femoral vessel size. selecting a balloon with an appropriate profile also affects outcomes. an ideal balloon catheter for bpv in younger, smaller patients would have a low profile with a short, round shoulder to lessen the risk of valvular or vascular injury . balloon pulmonary valvuloplasty provides long-term relief of stenosis of the pulmonary valve in the majority of patients with moderate to severe pulmonary valve stenosis.

Eligibility criteria:
inclusion criteria: * children with valvular pulmonary stenosis confirmed by echocardiography, and managed with percutaneous balloon pulmonary valvuloplasty exclusion criteria: * cases with pulmonary stenosis not candidate for balloon valvuloplasty cases with pulmonary stenosis associated with other congenital heart diseases
development of fecal scoring for the management of fecal impaction with regards to lower urinary tract dysfunction

Conditions: Fecal Impaction; Lower Urinary Tract Disorder; Bladder Dysfunction; Bowel Dysfunction

Summary: the role of bowel bladder disorder, or bbd, has been highlighted as a major player in vesicoureteral reflux and urinary tract infection (uti). however, the diagnosis of bbd are still conceptual and subjective, because of the diagnosis of constipation, main pathophysiology in bbd has not been established well.

functional constipation is a common disorder among children, accounting for 3-5% of visits to pediatric clinics and even 10% to 25% of consultation for pediatric gastroenterologists. it could cause recurrent abdominal pain, stool retention as well as fecal incontinence. in the urologic field, this is known to develop urinary symptoms. constipation has been associated with voiding dysfunction and urinary tract infection in children. it is assumed that impacted stool in distal rectum mechanically affect the bladder leading to detrusor overactivity. additionally, impacted stool would elevate the uretheral sphincter tone, having patients void with incomplete sphincter relaxation and eliciting dysfunctional voiding. stool impaction may be the source of bacteria causing urinary tract infection and led to recurrent bacteriuria. treatment of constipation by itself is quite effective alleviating urologic symptoms in as much as two-third of the patients. the role of constipation has been highlighted as a major player in vesicoureteral reflux and urinary tract infection (uti). the presence of bowel bladder disorder (bbd) was associated with higher risk of breakthrough infection and a lack of spontaneous resolution. although constipation is the major player in bbc, there is any objective standard regarding the diagnosis and treatment of constipation. given the high prevalence and morbidity of children affected by uti or vur in relations to bbd, it is imperative that diagnostic and treatment methods are developed. despite the known implication of constipation, the diagnosis of constipation may be problematic due to a lack of standard definition for this condition. this may be due to different views between clinicians about which aspect are most crucial for diagnosing constipation. some underline the subjective nature such as infrequent or difficult defecation, other stress the quality of stool, still others were in search of objective criteria of constipation, like the amount of impacted stool or colonic transit time. consequently, various criteria have been reported. the lack of standard criteria for constipation causes trouble sometimes in making a proper decision for diagnosis, intervention, follow-up, and discharge of treatment.

Eligibility criteria:
inclusion criteria: * patients with having both significant lowery urinary tract dysfunction history suggestive of constipation (more than two positive criteria in rome 4). * parental recalling of hard stool (bristol stool scale of 6 or 7). * parental impression of constipation. exclusion criteria: - those without lower urinary tract dysfunction or constipation.
characterizing myositis with 68ga-fapi pet/ct

Conditions: Myositis; Idiopathic Inflammatory Myopathies

Summary: to evaluate the potential usefulness of 68ga-fapi pet/ct for the diagnosis and evaluation of systemic involvement in idiopathic inflammatory myopathies (iim)/myositis, and compared the results with those of 18f-fdg pet/ct.

inflammatory myopathies (iim), collectively known as myositis, are heterogeneous systemic autoimmune disorders characterized by muscle inflammation, and frequently accompanied by extra-muscular manifestations that affect the skin, lung, and joints. prevalence of underlying malignancy is high in patients with iim. 68ga-fapi has been developed as tracers specific for fibroblast-activation protein (fap), which is overexpressed in activated fibroblasts in various type of cancers and autoimmune diseases, such as rheumatoid arthritis, igg4-related diseases and interstitial lung diseases. recently the investigators have published articles of the application of 68ga-fapi in igg4-related disease and rheumatoid arthritis, which showed it was more sensitive than fdg in detecting a certain type of inflammation, and the potential utility of fap-targeted pet/ct imaging for disease assessment in myositis have been reported in a case recently. thus, this prospective study is going to investigate utility of 68ga-fapi pet/ct in diagnosis, disease assessment including skeletal muscle involvement, cardiac involvement, interstitial lung diseases and potential underlying cancer screening, response to treatment and prognosis, compared with 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of myositis according to american college of rheumatology/european league against rheumatism 2017 (acr/eular 2017) criteria 2. adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (icf). 3. participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the clinical research ethics committee. 4. 68ga-fapi and 18f-fdg pet/ct were performed within two weeks. exclusion criteria: 1. pregnancy; 2. breastfeeding; 3. known allergy against fapi; 4. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
probiotic supplementation among adults with recurrent gastrointestinal symptoms

Conditions: Gastrointestinal Symptoms; Bloating; Gas; Indigestion; Abdominal Pain; Defecation Irregularity

Summary: participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. the investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.


Eligibility criteria:
inclusion criteria: 1. self-reported response of "moderate discomfort" or worse (3 or greater on 1-5 likert scale) and "frequent discomfort" or more often (3 or greater on 1-5 likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks 2. agree to continue with typical diet and exercise habits during study 3. agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only) 4. able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects exclusion criteria: 1. current and documented diagnosis of inflammatory bowel disease (crohn's disease or ulcerative colitis), celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety. 2. current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health. 3. daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.) 4. usage of systemic steroids during the past 2 months 5. usage of antipsychotic medications during the past 2 months 6. usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months 7. uncontrolled anxiety or current medication for anxiety disorder 8. pregnant or breastfeeding females 9. history of alcohol, drug, or medication abuse 10. known allergies to any substance in the study product 11. previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.) 12. participation in another clinical trial within 30 days of screening
genetic testing in african americans

Conditions: Ovarian Cancer; Endometrial Cancer; Peritoneal Cancer

Summary: this is a pilot/feasibility study to conduct genetic testing using tumor/blood samples of african american and caucasian patients with ovarian and endometrial cancer following surgery at au health medical center. the aim of the pilot/feasibility study is to sequence a panel of cancer genes on paired tumor/blood (germline) samples of patients with ovarian and endometrial tumors at a two-week time point following surgery at au medical center. while paired testing of tumor and blood (germline) provides direct clinical value to patients, investigators propose to study whether investigators can define and overcome such minority barriers among the georgia cancer center (gcc)/au health medical center (aumc) patient population.

the purpose of this study is to identify genetic mutations using a sequence a panel to detect cancer genes on paired tumor/blood (germline) samples particularly (aa) patients with ovarian, endometrial, fallopian or primary peritoneal carcinoma as aa individuals with cancer are less prone to accept a recommendation to undergo genetic testing. approximately 30 subjects will participate in this study at georgia cancer center/au health medical center. primary objective: to test the feasibility of this approach designed to provide a preliminary statistical analysis among the number of patients to overcome minority barriers among the gcc/aumc patient population. secondary objectives: 1. measure attitudes toward early testing. 2. compare rates of participation based on messaging of benefits between caucasians and aa subjects must meet all inclusion criteria of the study. there are no exclusion criteria. patients will be identified by an au health gynecologic oncologist (sg, br, rh). a research coordinator will be deployed to the clinic at the 2-week post-biopsy visit. all subjects who consent to participate a clinical research coordinator will ask for their permission to provide a matched tumor and blood sample for genetic testing. if consented the subjects will be given a questionnaire regarding their knowledge of genetic testing for germline mutations. tumor and blood samples will be collected for testing and sent to the georgia esoteric and molecular laboratory. it is estimated that it will take approximately one year to fully accrue and complete assessments on all participants entered on this study.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years of age. 2. new diagnosis of ovarian, endometrial, fallopian, or primary peritoneal carcinoma. 3. diagnostic procedure performed at au health medical center. 4. adequate tissue is available for the tumor testing component (e.g., cytology and fna samples are typically not adequate, whereas core biopsies and open biopsies usually are adequate. 5. consent at first post-biopsy outpatient clinic visit (typically about 2 weeks). 6. ability to provide informed consent in english. exclusion criteria: there are no exclusion criteria -

Keywords: black and african american health genetic testing ovarian cancer endometrial cancer peritoneal cancer
speedx ciprofloxacin gyra assay for n. gonorrhoeae gonococcal infection

Conditions: Neisseria Gonorrhoeae Infection

Summary: this study aims to test the effectiveness of using of speedx resistance plus assay to guide treatment of neisseria gonorrhoeae (ng) in a sexual health clinic setting.

patients entering the sexual health clinic will be offered participation in the study if they have; 1) no infectious genitourinary symptoms that require immediate treatment, 2) who seek routine sti screening, 3) if they report sexual contact with a partner who reports having ng or 4) men who have sex with men (msm) with contact to chlamydia trachomatis (ct). all participants will have specimen collected from anatomical sites of exposure for naat and culture. naat specimen positive for ng will be flagged and further tested with speedx resistance plus assay. this will delay results reporting on average by 1 day. the assay detects ciprofloxacin resistance based on a point mutation of the gyra gene (gyra s91). participants without this mutation or wild-type (gyra wt) infection should be sensitive to ciprofloxacin. participants who are n. gonorrhoeae (ng) positive and gyra wt, will receive ciprofloxacin 500 mg po x 1. participants with gyra s91 mutation will be asked to return to clinic for the standard of care (i.e. ceftriaxone-based therapy).

Eligibility criteria:
inclusion criteria: * english speaking * have access to the internet (via computer or phone) on at least a weekly basis * asymptomatic (as defined below) exclusion criteria: * urogenital symptoms consistent with a sexual transmitted infection (other than vaginitis associated with trichomonas vaginalis, bacterial vaginosis or yeast). symptoms consistent with cervicitis, urethritis, or pid will not be offered enrollment. * antibiotic use within the last 2 weeks * contact to syphilis * contact to an sti and are unwilling to defer empiric treatment until diagnostic test results return * anyone receiving a gonococcal-active drug (such as doxycycline, penicillin, ceftriaxone) during the visit. those receiving metronidazole, fluconazole, or clotrimazole will not be excluded. * known allergy to ciprofloxacin and/or ceftriaxone

Keywords: antimicrobial resistance ciprofloxacin molecular diagnostics