Kornimate/medical-research-clean huggingface dataset:
match: the mexican-american trial of community health workers

Conditions: Diabetes Mellitus, Type 2

Summary: the match study (mexican-american trial of community health workers) tests the hypothesis that the use of indigenous community health workers (chws), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling mexican-americans with type 2 diabetes mellitus. the study aims are to demonstrate that a chw, compared to an attention control, will: 1) result in improvement in short term physiologic outcomes (hemoglobin a1c levels and blood pressure), and 2) result in increased frequency of self-management behaviors (daily self blood-glucose monitoring, medication adherence, adherence to diet and physical activity recommendations). the study design is a single site, partially blinded, randomized controlled trial of 144 patients with type 2 diabetes mellitus. eligibility criteria include a diagnosis of type 2 diabetes, residence in target community areas in the chicago area, and mexican or mexican-american ethnic heritage. participants are randomized to either an experimental group receiving 36 home visits over a two year period in which a chw delivered diabetes education and self-management skills training, or to an attention control consisting of 36 bilingual diabetes education newsletters covering the same curriculum as the chws. the curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. chws also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. consistent delivery of the chw intervention is documented by audiotapes and documentation of intervention worksheets.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * taking at one oral medication daily to control diabetes * self-identified as mexican or mexican-american * resident in target community within chicago, berwyn, or cicero, illinois. exclusion criteria: * diabetes controlled with diet or insulin only * advanced end-organ complications, including: end-stage renal disease, stroke with paresis, congestive heart failure (nyha class 3 or 4), or other major end-organ complication of diabetes * receiving treatment for a major psychiatric disorder (i.e. schizophrenia) * are unable to understand and give informed consent in either english or spanish * live in a household with someone who is already a randomized study participant or know of family members who are already study participants. * have lived in mexico for more than four months in the past two years, or are anticipating extended travel to mexico in the next year. * are under the age of 18
the study of cik plus s-1 and bevacizumab as maintenance treatment for patients with advanced colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (cik) plus s-1 and bevacizumab vs s-1 and bevacizumab as maintenance treatment for patients with advanced colorectal cancer.

1200 patients with stage ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group a（receive cik plus s-1 and bevacizumab ) or group b（just receive s-1 and bevacizumab),and the randomize ratio will be 1:1. patients in group a will receive 3 cycles of cik treatment (every 1 year) and apatinib (continuous).patients in group b will receive only s-1 and bevacizumab (continuous) .

Eligibility criteria:
inclusion criteria: * patients who can accept curative operations 18-70 years old * histologically confirmed with colorectal cancer at stage ⅳ * patients who can accept oral drugs; * eastern cooperative oncology group (ecog) performance status was 0 - 1. exclusion criteria: * hemoglobin\<8.0 g/dl,white blood cell \<3 x 10\^9/l;platelet count \<75 x 10\^9/l; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times * known or suspected allergy to the investigational agent or any agent given in association with this trial * pregnant or lactating patients * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) or treponemapallidun (tp) infection * patients who are suffering from serious autoimmune disease * patients who had used long time or are using immunosuppressant * patients who had active infection * patients who are suffering from serious organ dysfunction * patients who are suffering from other cancer * other situations that the researchers considered unsuitable for this study.
safety study of rituximab (sc) administered in participants with cd20+ dlbcl or cd20+ follicular nhl grade 1 to 3a

Conditions: Non-Hodgkin Lymphoma

Summary: this open-label, single-arm study will evaluate the safety of rituximab subcutaneously (sc) administered during first line treatment for follicular non-hodgkin's lymphoma (nhl) (induction and/or maintenance treatment plus 24 months of follow up), or diffuse large b-cell lymphoma (dlbcl) (treatment plus 24 months of follow-up).


Eligibility criteria:
inclusion criteria: * histologically confirmed, cluster of differentiation (cd)20+ dlbcl or cd20+ follicular nhl grade 1 to 3a, according to the world health organization (who) classification system * currently being treated with rituximab iv in the induction or maintenance setting, having received at least one full dose of rituximab iv, defined as standard full dose of rituximab iv 375 milligrams per square meter (mg/m\^2) administered without interruption or early discontinuation because of tolerability issues * expectation and current ability for the participants to receive at least four additional cycles of treatment during the induction phase or six additional cycles of treatment during the maintenance phase (participants with follicular nhl) exclusion criteria: * transformed lymphoma or fl iiib * history of other malignancy that could affect compliance with the protocol or interpretation of results. this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (\>/=) 5 years prior to dosing
hemodynamic changes in connective tissue disease

Conditions: Systemic Sclerosis

Summary: the study serves the identification of early forms of pulmonary arterial hypertension (pah) in connective tissue disease and the hemodynamic follow-up of the investigated patients. the basic hypothesis is that pah may start with a remodeling of small pulmonary arteries, which leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a disproportional increase in pulmonary pressure during exercise. recent studies have shown that a proportion of such patients may develop manifest pah within a few years. the early identification of these patients and the understanding of the natural course of the disease may improve prognosis. the aim of the present study is to investigate hemodynamic and clinical changes in patients with connective tissue disease in a time interval of 3-5 years with a focus on the development of pulmonary hypertension.


Eligibility criteria:
inclusion criteria: * informed consent * patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) sle or overlap syndrome * existing exercise doppler echocardiography or/and right heart catheterization 3-5 years before inclusion exclusion criteria: * - severe lung or bronchial disease (fev1 \<60%) * systolic lv dysfunction (lvef \ grade i * valvular defect \> grade i (except for tricuspid- or pulmonary insufficiency) * uncontrolled systemic arterial hypertension (at rest \>150 mmhg systolic or 95 mmhg diastolic) * uncontrolled ventricular arrhythmias * uncontrolled bradycardia or tachycardia supraventricular arrhythmias * myocardial infarction within the last 12 months * pulmonary embolism within the last 12 months * relevant changes in hemodynamic therapy or major surgery within the last 12 weeks * musculoskeletal or peripheral vessel disorders which complicates an ergometry

Keywords: systemic sclerosis pulmonary arterial hypertension
multi-centre randomised controlled trial of pelvic floor muscle training for prolapse

Conditions: Pelvic Organ Prolapse

Summary: the aim of this study is to determine the effectiveness and cost-effectiveness of pelvic floor muscle training in the management of pelvic organ prolapse in women.

pelvic organ prolapse is a common problem that adversely affects the daily activities and quality of life of many women. pelvic floor muscle training interventions are commonly used by physiotherapists to manage prolapse. however, a cochrane review found limited evidence to support the effectiveness of such interventions. based on the findings of a successful feasibility study, this multi-centre randomised controlled trial will address the paucity of evidence. 556 symptomatic women with diagnosed prolapse will be enrolled in 16 uk centres and 1 new zealand centre over 16 months and randomised to pelvic floor muscle training plus lifestyle advice, or to receive a lifestyle leaflet only. principal measures of outcome are: prolapse symptoms, prolapse severity, and subsequent further treatment up to 12 months after trial entry.

Eligibility criteria:
inclusion criteria: * new attendee at outpatient gynaecology clinic * any type of prolapse exclusion criteria: * stage 0 or iv prolapse * women reporting no symptoms of prolapse * previous treatment for prolapse (surgery or formal instruction in pelvic floor muscle training \[pmft,\]unless completed more than 5 years ago, pessary, unless pessary removed more than 12 months ago) * unable to comply with pfmt * women who have urogenital atrophy requiring treatment with local oestrogens (after an 8 week course of local oestrogen such women can be included); * pregnant or less than 6 months post-natal * unable to give informed consent

Keywords: pelvic organ prolapse pelvic floor muscle training prolapse symptoms urinary symptoms sexual function randomised controlled trial
study of impacts of food supplementation on malnourished hiv-infected adults in kenya

Conditions: HIV; Malnutrition; HIV Infections

Summary: the purpose of the study is to test whether food supplementation of malnourished hiv-infected adults (both pre-art and art) in resource constrained settings improves their nutritional status, clinical status, effectiveness of treatment, quality of life, functioning, and survival.

malnutrition remains a significant problem among hiv-infected populations, even among those with access to art. in patients with hiv infection, poor nutritional status is associated with significant reduction in survival rates, accelerated disease progression, diminished response to therapies including art, increased susceptibility to opportunistic infections, and reduced work capacity and quality of life. however, there is not evidence whether delay or reversal of weight loss improves life expectancy, nor is there evidence about the specific benefits food supplementation has on people with hiv infection. as antiretroviral therapy (art) services continue to scale up in sub-saharan africa, there is a critical need for information about the impacts of appropriate food supplementation on the effectiveness of art, on the health status of clients, and on the progression of the disease. malnourished adult art and pre-art clients at six clinical sites in kenya are randomly allocated either to a group that receives nutrition counseling only or a group that receives nutrition counseling and supplementary feeding for six months. all patients continue to receive medical treatment (art and other medicine) according to their condition. baseline measures of socioeconomic and demographic status are collected. measures of both nutritional and non-nutritional clinical outcomes are collected at baseline, 3, 6, 9, and 12 months. clients beginning art are treated as one arm and randomized between food and non-food, and clients not yet eligible for art (pre-art) are treated as a second arm and randomized between food and non-food. within each arm, outcomes of subjects receiving supplemental food will be compared with outcomes of those who are not.

Eligibility criteria:
inclusion criteria: * hiv-infected * bmi \< 18.5 * resident of area for past 6 months exclusion criteria: * pregnant or lactating (child \< 6 months) * bmi \> 18.5, bmi \< 14 * already receiving other food supplements

Keywords: food supplementation hiv malnutrition
use of a test that evaluates how the body handles insulin and glucose

Conditions: HIV Infections

Summary: the purpose of this study is to find out if testosterone gel affects how the body handles insulin and glucose. specific anti-hiv treatments may increase a patient's risk of certain diseases by causing metabolic problems such as reduced sensitivity to insulin. this substudy will examine how testosterone affects insulin sensitivity. if testosterone increases insulin sensitivity in the patients, then giving testosterone to hiv-infected patients may allow the continuation of anti-hiv treatments without increasing the patients' risk of disease. the test used to determine insulin sensitivity will be a modified frequently sampled intravenous glucose tolerance test (fsivgtt), which can accurately measure insulin sensitivity.

assessment of insulin sensitivity is an important objective of this substudy. extrapolation from earlier studies suggests that insulin resistance will be associated with low testosterone levels at baseline in hiv-infected men with visceral obesity and that physiologic testosterone replacement in these individuals is likely to increase insulin sensitivity. however, direct assessment of insulin sensitivity under carefully controlled conditions is crucial to understanding the full metabolic impact of physiologic testosterone replacement in the context of a5079. the fsivgtt, using the bergman minimal model, has become a widely used method for the assessment of insulin sensitivity in epidemiological and intervention studies. based on these considerations, the modified fsivgtt was chosen as the optimal modality to assess insulin sensitivity in a5112s. this study is a substudy of a5079. patients enrolled in a5079 are eligible for this substudy but receive no study treatment other than that which they receive on a5079. insulin sensitivity is measured by fsivgtt performed at entry and at weeks 24 and 48. in the modified fsivgtt, 15 serial blood specimens for glucose are drawn over a 245-minute interval. the fsivgtt assesses whether patients given testosterone supplements have more sensitivity to insulin than patients given a placebo.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are enrolled in a5079.

Keywords: infusions, intravenous testosterone insulin resistance hormone replacement therapy glucose tolerance test
a study to investigate the genetic variation of dopamine pathway in patients with chronic pain

Conditions: Peripheral Neuropathy; Osteoarthritis

Summary: patients having completed former trials t1001-01 or t1001-02 will undergo one blood sampling for genotyping purposes. in addition they will compete the personality questionnaires they had completed in the former trial.


Eligibility criteria:
inclusion criteria: * have completed t1001-01 or t1001-02 study (visit 5 completed) * are men or women of at least 18 years of age * have given written informed consent approved by the relevant ethics committee governing the study sites exclusion criteria: * have any close relationship with the investigators or the sponsor * are under legal protection, according to the national law

Keywords: pain
acellular dermal matrix graft in root coverage of gingival recessions with previously restored cervical lesions

Conditions: Gingival Recession

Summary: patients with high standards of oral hygiene frequently search for buccal gingival recession (gr) treatment due to cervical wear, root sensitivity and compromising aesthetics. the cervical lesion (nccl) is commonly produced by improper toothbrushing techniques, sharing the same etiology of gr. many different surgical approaches have been described. the association of a graft to the coronally advanced flap had demonstrated the best long-term outcome for root coverage. but, substitutes for the autogenous graft must be studied. therefore, the aim of this clinical trial was to investigate the effectiveness of the acellular dermal matrix graft (admg) in root coverage associated with a previous restored cervical lesion or not. material and methods: seventeen individuals with bilateral gr were included in the study. at one side, the gr must present a previously restored cervical lesion, as the test group (tg). the contralateral arch, must present gr with an intact root surface (cg). all patients were treated with the extended flap technique associated with the admg. all clinical parameters were assessed at baseline and 6-months postoperative.


Eligibility criteria:
inclusion criteria: * cej without significant damage; * localized bilateral rt112 gingival recession ≥3 mm in the same arch, in which one had a non-carious cervical lesion (nccl) restored with composite and the opposite one was intact exclusion criteria: * previous periodontal surgical treatment on the involved sites; * smokers * pregnants or lactating * compromised systemic health and contraindications for periodontal surgery

Keywords: acellular dermal matrix graft clinical trial root coverage noncarious cervical lesion
evaluation of corneal irregular astigmatism and visual quality following bilateral sequential small incision lenticule extraction (smile) and laser subepithelial keratomileusis (lasek): a six-year comparative study

Conditions: Myopia

Summary: to compare the corneal spherical component (sc), regular astigmatism (ra), irregular astigmatism (ia, including asymmetry and irregularity) and visual quality six years after small incision lenticule extraction (smile) and laser subepithelial keratomileusis (lasek) for mild to moderate myopia.


Eligibility criteria:
inclusion criteria: * (1) patients aged over 18 years; (2) absence of corneal, ocular, or systemic diseases; (3) stable refractive diopter maintained for the past 2 years with a change of ± 0.50 diopter; (4) discontinuation of soft contact lens wear for at least 2 weeks and rigid contact lenses for at least 4 weeks prior to surgery; (5) preoperative manifest refraction spherical equivalent (mrse) less than -6.00 diopter (d) exclusion criteria: a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery
influence of hemodialysis on endothel-depending dilatation of peripheral arteries

Conditions: Hemodialysis

Summary: an impairment of nitric oxide (no) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (hd) patients. it is not known whether cell-free hemoglobin limits nitric oxide bioavailability during hd.

cardiovascular complications are the major cause of death in end-stage renal disease (esrd) patients undergoing chronic haemodialysis (hd).1 during haemodialysis (hd) the endothelium is the first organ to sense and to be impaired by mechanical and immunological stimuli.2 adequate endothelial function and integrity reduce thromboembolic events, while endothelial dysfunction is an early key step in the development of atherosclerosis3-5, is involved in plaque progression6 and has been attributed to impaired nitric oxide (no) bioactivity and enhanced formation of oxygen-derived free radicals.7 given that endothelial dysfunction is at least in part reversible, the assessment of altered no availability is of important diagnostic and prognostic significance and may deepen the understanding of cardiovascular disease in hd.8 nitric oxide bioavailability has been shown to be limited by cell-free hemoglobin.9 the rates of no consumption by cell-free and intraerythrocytic hemoglobin suggest that only when hemoglobin is physically compartmentalized within erythrocytes will no produced by endothelial cells reach concentrations within smooth muscle necessary to activate guanylyl cyclase and cause vasodilation.10;11 however, the rate of no scavenging is reduced 1,000-fold by sequestering hemoglobin within the red cell membrane.12;13 this mechanism is believed to be important in various conditions of health and disease.14-16 in esrd intravascular hemolysis during hd has been described.17-19

Eligibility criteria:
inclusion criteria: * patients older 21 years dependent on hd for more than 6 months exclusion criteria: * known hd associated hypotension intake of nitrate

Keywords: hemodialysis flow-mediated dilation nictric oxide endothelial function
theeffect of ph on misoprostol in induction of labor

Conditions: Labor Pain

Summary: misoprostol is a synthetic analogue of the naturally occurring prostaglandin e1. it was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .

although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium

Eligibility criteria:
inclusion criteria: * singleton pregnancies. gestational age 38-41 weeks. cephalic presentation exclusion criteria: * 1. multi-fetal pregnancy. 2. pregnant women less than 38 weeks gestation.
therapeutic approach to diastolic dysfunction in chronic liver disease patients and its impact on morbidity and mortality

Conditions: Diastolic Dysfunction; Chronic Liver Disease

Summary: cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. it is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. the purpose of this prospective, randomized controlled trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction, worsening cardiac function, and mortality).


Eligibility criteria:
inclusion criteria: patients with cirrhosis who have been diagnosed by clinical, biochemical,or histological (when available) criteria plus ultrasound imaging. * age range of 18-60 years * cirrhosis as diagnosed by histology or clinical, laboratory and usg (ultrasonography) findings, * upper gi bleed who are undergoing secondary endoscopic variceal ligation for eradication of varices exclusion criteria: * age \>60 years * chronic renal disease * pregnancy and peripartum cardiomyopathy * hypertension * coronary artery disease * valvular heart disease * sick sinus syndrome/ pacemaker * cardiac rhythm disorder * hypothyroidism * hyperthyroidism * portal vein thrombosis * transjugular intrahepatic porto systemic shunt (tips) insertion * hepatocellular carcinoma * anemia hb \< 8gm/dl in females, and \< 9 gm/dl in males