Kornimate/medical-research-clean huggingface dataset:
role of ultrasound for evaluating rheumatoid arthritis in remission

Conditions: Rheumatoid Arthritis in Remission

Summary: the objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (us) remission in rheumatoid arthritis (ra). at a patient level, us-detected residual synovitis (evaluated both by us grey-scale signals and power doppler signals) is frequent in patients with ra in clinical remission. several longitudinal studies reveal an association of us-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years. however, the longitudinal relation between clinical remission and us remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. thus arise the question as to whether the presence of us-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care. the investigator propose to conduct a prospective, bi-center, non randomized study.

the study population will include all ra patient at least 18 years old in clinical remission for less than 6 month. the primary endpoint (ability of us-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up the total follow-up will be 12 months with a follow-up every 3 months. in addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * pr fulfilling arc / eular (european league against rheumatism) 2010 criteria * patient treated by dmards (disease-modifying antirheumatic drug) * patient in confirmed remission for less than 6 months exclusion criteria: * patient participating simultaneously in another clinical study with blind treatment * patient participating simultaneously in another clinical study involving decreasing of drug dose * patient in post clinical study exclusion period * patients subject to legal protection measures * patient unable to read french * pregnant or breast-feeding women * patient treated with rituximab

Keywords: rheumatoid arthritis articular ultrasound synovitis relapse risk
the effectiveness of covered stent viabahn and drug-coated balloon for complex femoropopliteal artery lesions

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to evaluate the effectiveness of the covered stent viabahn in treating long de novo femoropopliteal lesions (stenosis ≥ 25 cm, total occlusion ≥ 15 cm) or in-stent restenosis compared to drug-coated balloons (dcb) with or without a bailout bare nitinol stent.

this is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. approximately 200 subjects will be enrolled into a viabahn group (observe arm) or drug-coated balloons (dcb) group (contrast arm); each group will include 100 patients. all enrolled patients will be followed up for 12 and 24 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 3,6 and 9 months.

Eligibility criteria:
inclusion criteria: 1. the patient is ≥ 18 years old. 2. patient understands the nature of the procedure and provides written informed consent before enrolment in the study 3. the patient is willing to comply with specified follow-up evaluations at the specified times. 4. the patient presented a score from 2 to 5 following rutherford classification. 5. the patient has a projected life expectancy of at least 24 months 6. subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (cto) length ≥15cm. exclusion criteria: 1. patients with known hypersensitivity or contraindication to any of the following medications: contrast media, nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy 2. pregnant women or female patients with potential childbearing 3. patients who exhibit acute intraluminal thrombus at the target lesion vessel 4. significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy 5. the patient is currently participating in another investigational drug or device study that interferes with the study

Keywords: viabahn endoprosthesis drug-coated balloon
popq versus simulated apical support as a guideline for anterior or posterior repair during vaginal reconstruction

Conditions: Pelvic Organ Prolapse

Summary: the objective of the preoperative pelvic organ prolapse quantification (popq) versus simulated apical support as a guideline for anterior or posterior repair at the time of transvaginal apical suspension (prepare) trial is to compare surgical outcomes of popq-based surgery with simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.

the prepare trial is a prospective, randomized trial conducted with the aim to determine non-inferiority of the primary outcome between popq-based surgery and simulated apical support-based surgery for anterior or posterior vaginal wall prolapse. participants will undergo transvaginal surgery for prolapse, including the assigned procedure for anterior or posterior vaginal prolapse under general or spinal anesthesia. concomitant procedures will be performed as intended prior to surgery. women with a uterus in situ will undergo hysterectomy and all women will receive transvaginal vault suspension, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension with both delayed absorbable and permanent sutures, according to the preference of surgeon. incontinence surgery will also be performed for women with documented urodynamic stress incontinence. a standardized protocol for enrollment, treatment and data collection will be employed by all sites. the study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. however, it is our intent that when feasible and ethical, all outcomes assessors and the subjects will be blinded to the treatment assignment. postoperative follow-up will take place after 5 weeks and 6, 12, and 24 months. patients will undergo a standard gynecological examination including popq and fill in questionnaires.

Eligibility criteria:
inclusion criteria: * popq stage 2-4 prolapse * descent of vaginal apex or cervix at least ½ way into vaginal canal (i.e. popq point c ≥ -tvl/2) * correction of either anterior or posterior vaginal wall prolapse under simulated apical support (i.e. from stage 2 or greater to stage 0 or 1) * vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the pfdi-20) * vaginal reconstructive surgery is planned, including a vaginal apical suspension procedure exclusion criteria: * large pelvic mass * previous prolapse surgery * known malignancy * two or more inpatient hospitalizations for medical comorbidities in the previous year * subject wishes to retain her uterus * subject is unable and unwilling to participate in
lipid-lowering agents in patients with dermatomyositis and polymyositis

Conditions: Treatment Side Effects

Summary: the use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population.

impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.

Eligibility criteria:
inclusion criteria: * fullfill all criteria of bohan and peter (1975) * dyslipidemia * age\> 18 years * prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months * without changing nutritional habits in the last three months, and during the study period * no change of lifestyle in the last three months, and during the study period exclusion criteria: patients with: * disease relapsing * overlapping myositis * neoplasia associated myositis * diabetes mellitus * current and/or chronic infections * patients undergoing major surgery within six months prior to the study * pregnant patients * previous use of lipid-lowering agents in the last 6 months * in the use of cyclosporin, erythromycin, clarithromycin, fibrates, niacin, azole antifungals, cimetidine, diltiazem * active liver disease or persistent elevations of hepatic enzymes, with no apparent cause, exceeding three times the upper limit of normality
indigenous supported agriculture "go healthy"

Conditions: Diet, Healthy; Blood Pressure; Overweight or Obesity; Food Insecurity; Health Status

Summary: native americans (nas) have limited access to healthy food and a high prevalence of diet-related diseases. this study will implement an agricultural and health education program in which na residents of osage nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. the program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.

the study will implement a new community supported agriculture (csa) program, which the investigators refer to as the "go healthy" indigenous supported agriculture (isa) program, in which citizens in osage nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. the investigators will test the efficacy of the "go healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among na households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings. specific aims: 1. conduct a randomized controlled trial to test the newly developed isa program's effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (bmi), hemoglobin a1c (hba1c), food insecurity, health status, and skin carotenoid measurement by veggie meter (secondary outcomes) among 200 na households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as na with overweight/obesity; 2. perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and 3. document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other na communities to use to improve tribal food systems

Eligibility criteria:
adult participant inclusion criteria: * 18-75 years of age * identify as native american (index adult participant only) * reside in osage nation * plan to stay in osage nation in the next year * overweight ot obesity, defined as bmi \>= 25 kg/m2, measured by research staff (index adult participant only) * willing and able to follow study procedures child participant inclusion criteria: * 3-17 years of age * reside in osage nation * plan to stay in osage nation in the next year * willing and able to follow study procedures exclusion criteria: * those that are pregnant or planning to become pregnant during the study period

Keywords: blood pressure obesity cbpr american indian bmi food environment blood lipids
glycemic response to low sugar apple juice

Conditions: Impaired Fasting Glucose

Summary: primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (ifg) (5.6-6.9mmol/l resp. 100-125mg/dl) (kerner and brückel, 2012 (ddg recommendation)) secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response. exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.

objectives: investigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink. subjects/methods: in a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (ifg) received an oral drink of 500ml: 1. verum: apple juice, treated (low sugar content); 2. control: untreated apple juice (normal sugar content). capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.

Eligibility criteria:
inclusion criteria: 1. males aged ≥ 18y 2. diagnosed impaired fasting glucose (ifg) 3. written informed consent exclusion criteria: 1. subjects currently enrolled in another clinical study 2. subjects having finished another clinical study within the last 4 weeks before inclusion 3. hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food 4. acute or chronic infections 5. renal insufficiency 6. gastrointestinal illness 7. history of gastrointestinal surgery 8. known fructose intolerance 9. overt diabetes mellitus 10. endocrine disorders 11. any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria 12. history of hepatitis b and c 13. history of hiv infection 14. history of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid) 15. regular medical treatment including otc, which may have impact on the study aims (e.g. antidiabetic drugs, laxatives etc.) 16. major cognitive or psychiatric disorders 17. subjects who are scheduled to undergo hospitalization during the study period 18. eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian) 19. present drug abuse or alcoholism 20. legal incapacity

Keywords: postprandial glycemia; apple juice; sugar reduction
effects of manualized treatment in a seamless system

Conditions: Substance Abuse; Offenders; Criminal Thinking; HIV Risk Behaviors

Summary: the specific aims of this project are: 1. to conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders; 2. to understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level; 3. to understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and 4. to examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.


Eligibility criteria:
inclusion criteria: * substance abusers * men and women * treatment exclusion criteria: * parolees * low threshold substance abuse * violent offenders

Keywords: drug treatment substance abuse offenders high risk
modified pivotal response treatment for insistence on sameness in autistic youth

Conditions: Autism Spectrum Disorder; Restricted Behavior; Autism

Summary: the purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (asd). treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.


Eligibility criteria:
participants will include children with: 1. parent/guardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent; 2. diagnosed with asd (based on history, review of available medical records including diagnostic testing, e.g., ados) or suspicion of asd diagnosis and confirmed with autism diagnostic interview-revised (adi-r); 3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility; 4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes; 5. english-speaking parent and youth able to consistently participate in study procedures; 6. family resides in united states.

Keywords: intervention pivotal response treatment
diabetic retinopathy candesartan trials

Conditions: Type 1 Diabetes

Summary: the primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy. the secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (uaer). this study is part of the direct programme also including secondary prevention studies of diabetic retinopathy in both type 1 and type 2 diabetes. the primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included. * duration of diabetes for \> 1 year and \< 15 years with stable diabetic therapy within last 6 months. * patients with untreated resting mean sitting sbp \< 130 mmhg, mean sitting dbp \< 85 mmhg and with retinal photograph grading level 10/10 (on etdrs severity scale). exclusion criteria: * patients with the following conditions are excluded from participation in the study: * cataract or media opacity of a degree which precludes taking gradable retinal photographs * angle closure glaucoma, which precludes pharmacological dilatation of the pupil * history of retinopathy * history or presence of clinical significant macular oedema (csme) * history or evidence of photocoagulation of the retina other retinal conditions which may mask assessment, eg, retinal vein occlusion * positive micral dipstick test * presence of secondary diabetes * pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception * need of treatment with ace-inhibitor * haemodynamically significant aortic or mitral valve stenosis * known renal artery stenosis or kidney transplantation * hypersensitivity to study drug * severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator

Keywords: diabetes mellitus, insulin-dependent
gene expression profiles in generalized aggressive periodontitis: a gene network-based microarray analysis

Conditions: Generalized Aggressive Periodontitis

Summary: in this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (gagp) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls.

aggressive periodontitis (agp) is an inflammatory periodontal disease which is complex, multifactorial, and destructive. progression and severity of the disease depend on interacting risk factors such as: immunological, microbiological, environmental, and genetic factors, as well as age, sex, and race.some patients are genetically predisposed to agp; they have immunological abnormalities, which are thought to be under genetic control. however, high susceptibility for periodontal destruction and the relationship between inflammatory changes, and genetic factors remain unclear. gene expression profiling is a powerful means of generating comprehensive genome-level data sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides significant insight information for these diseases. gene expression profiling may provide an evidence for involving genes in the pathogenesis of agp and generate further information other than clinical signs and symptoms of agp. the aim of this study was to identify gene-expression patterns of patients with generalized aggressive periodontitis by whole-transcriptome gene-expression analyses.

Eligibility criteria:
inclusion criteria: * the periodontal diagnosis of subjects with gagp was established on the basis of clinical and radiographic criteria and was defined by the 1999 international world workshop for a classification of periodontal diseases and conditions.(lang et al., 1999) patients were included if they were between 18 and 35 years of age and otherwise healthy. the bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss. exclusion criteria: * subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases), any history of hepatitis and/or hiv infection, immunosuppressive chemotherapy, current pregnancy, planning a pregnancy or lactation, requirement for antibiotic prophylaxis, oral diseases other than gagp, ongoing orthodontic therapy, a history of antibiotic therapy, or periodontal treatment within the preceding six months.

Keywords: generalized aggressive periodontitis microarray analysis