Kornimate/medical-research-clean huggingface dataset:
a study to evaluate efficacy and safety of cs-3150 in japanese type 2 diabetic subjects with microalbuminuria

Conditions: Diabetic Nephropathy

Summary: this study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of cs-3150 compared to placebo in japanese type 2 diabetes mellitus and microalbuminuria. the primary endpoint is the change from baseline in urinary albumin to creatine ratio (uacr).


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * male or female subjects aged 20 years or older at informed consent * subjects with urinary albumin to creatine ratio (uacr) ≥ 45 mg/g cr and \< 300 mg/g cr * estimated glomerular filtration rate by creatinine (egfrcreat) ≥ 30 ml/min/1.73 m\^2 * subjects treated with angiotensin-converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) for at least 3 months prior to treatment period exclusion criteria: * type 1 diabetes * hba1c (ngsp) \>=8.4% * secondary glucose intolerance * subjects diagnosed with non-diabetic nephropathy * nephrotic syndrome * secondary hypertension or malignant hypertension * serum potassium level in any of the following categories: for subjects with egfrcreat of ≥ 45 ml/min/1.73 m\^2, serum potassium level of \< 3.5 meq/l or ≥ 5.1 meq/l; for subjects with egfrcreat of ≥ 30 ml/min/1.73 m\^2 and \< 45 ml/min/1.73 m\^2, serum potassium level of \< 3.5 meq/l or ≥ 4.8 meq/l

Keywords: diabetic nephropathy mineralocorticoid receptor antagonist cs-3150 japanese
use of pharmacotherapy to reduce cue-responsiveness in smokers

Conditions: Nicotine Dependence; Tobacco Dependence

Summary: in this study we, the investigators at the centre for addiction and mental health, intend to explore whether bupropion is able to reduce smokers' responses to cigarette-related environmental cues, and craving. previous studies have indicated that bupropion may be able to achieve these outcomes. therefore, we predict that smokers treated with bupropion for several weeks will show reduced reactivity to cigarette cues and craving.

current smoking cessation pharmacotherapy paradigms ignore the over-learned behaviour associated with smoking, thus contributing to the relatively poor absolute efficacy of pharmacotherapy. chronic nicotine use causes adaptive changes in the brain that differ from the acute effects leading to craving when smoking is stopped. this is a key element of relapse. thus, the development of more effective treatments involves a better understanding of craving and relapse by exploring the interaction between the psychology and neurobiology of nicotine addiction. bupropion, an amphetamine derivative, has demonstrated efficacy in smoking cessation in motivated smokers. its' mechanism of action is unclear but may be mediated by extinction processes. we hypothesize that bupropion will reduce cue-responsiveness and subsequent cravings in current smokers who are not consciously attempting to quit or cut down on smoking. fifty smokers (\>10 cigarettes/day) of either sex will be recruited to take either oral placebo or bupropion 150 mg twice daily for a total of 42 days. subjects will attend bi-weekly experimental sessions where cue-responsiveness will be measured using physiological and subjective responses to a variety of neutral and smoking-related cues. subjective effects will be measured using the questionnaire of smoking urges, the tobacco craving questionnaire and visual analog scales. subjects will record smoking behaviour and subjective experiences daily in a smoking diary. outcome variables include cue responsiveness, daily diary ratings, exhaled end tidal co levels, plasma cotinine levels, and subjective effects. gender effects will be assessed by using sex as a covariate in the analysis. this study will provide preliminary data on pharmacotherapy-assisted extinction as a novel approach to smoking cessation.

Eligibility criteria:
inclusion criteria: * males or females * at least 19 years of age * smoking at least 10 cigarettes per day for at least 2 years * never treated with bupropion/zyban exclusion criteria: * co-morbid psychiatric disorder * history of psychotic disorder or eating disorder * current alcohol or substance abuse/dependence (excluding nicotine, caffeine) * brain injury * seizure disorder * pregnancy, lactation, or at risk of becoming pregnant * current regular use of psychotropic drugs * known allergy or sensitivity to bupropion

Keywords: tobacco nicotine bupropion cue-reactivity craving
intranasal capsaicin treatment for non-allergic irritant rhinitis

Conditions: Nonallergic Irritant Rhinitis

Summary: the proposed study seeks to investigate the effect of intranasal capsaicin treatment in patient with non-allergic irritant rhinitis (nair), as well as evaluate optical rhinometry (orm) as a means to quantify symptomatic improvement in nair patients during and after treatment.

a study by lambert et. al. (2012) was able to objectively identify patients with nair by intranasal capsaicin challenge followed by assessment with optical rhinometry. studies have shown that capsaicin therapy can improve symptoms of patients historically identified with nair via visual analog scale (vas) rating of symptoms and symptom surveys; however, there has been no study evaluating the capsaicin therapy on patients objectively identified as nair patients. multiple studies have demonstrated that intranasal capsaicin can improve nasal symptoms of nair patients. regarding the usage of capsaicin, there is a product on the market: sinus buster which has capsaicin as the active ingredient. numerous research papers have evaluated the efficacy and safety of sinus buster for the treatment of congestion in non-allergic rhinitis patients. however, the diagnosis of nair in these previous studies was based primarily on history. in addition, the primary outcome in these studies was symptomatic without any objective evaluation. the goal of this study will be two-fold: with patients objectively identified as nair patients via the optical rhinometer, we will re-evaluate the therapeutic action of intranasal capsaicin on the management of rhinitic symptoms. we expect that the patients will show significant improvement in their symptoms. we will then use optical rhinometry as a means to objectively monitor changes in symptoms in nair patients. we expect that post treatment, patients will no longer have the positive response previously seen on intranasal capsaicin challenge before receiving treatment. we hope to be able to establish optical rhinometry as an objective measurement of symptom improvement for nair symptoms, along with the subjective patient surveys.

Eligibility criteria:
inclusion criteria: * non-allergic irritant rhinitis (nair) patients as defined by history (symptoms of nasal congestion, rhinorrhea, nasal itching or sneezing upon exposure to nasal irritants) * patients with positive optical rhinometer (orm) response with intranasal challenge with 0.5 millimolar (mm) capsaicin as described by lambert et al 2012 * confirmed negative skin prick test to common allergens (which rules out allergic rhinitis) exclusion criteria: * history of sinonasal surgery * chronic rhinosinusitis * inflammatory or granulomatous diseases * asthma * allergic rhinitis * immunocompromised state * radiation to the head and neck * intranasal steroid use \>4 wks * intranasal or systemic antihistamine x 3 days * intranasal or systemic decongestants x 3 days

Keywords: nonallergic irritant rhinitis nasal congestion rhinorrhea
evaluation of the influence of radiofrequency-based toothbrush on the accumulation of calculus

Conditions: Oral Hygiene

Summary: to evaluate the influence of radiofrequency based toothbrush (silk'n toothwave)on the accumulation of the calculus

calculus is a white-brownish layer with various levels of stiffness, which accumulates on teeth and is formed by the mineralization of dental plaque. thus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque and calculus. the electromagnetic field is known for bone healing by lessening osteoclast activity, improving osteoid formation, and stimulating angiogenesis. furthermore, the electromagnetic field has an antimicrobial effect. electric toothbrushes have shown a statistical reduction in plaque accumulation and gingival inflammation. previous studies have shown that silk'n toothwave results in less plaque accumulation and calculus formation, in addition to stain removal and teeth whitening. study aim: to asses the effect of the electromagnetic field in a tooth brush (silk'n toothwave) on calculus accumulation and gingival parameters.

Eligibility criteria:
inclusion criteria: * male or female patient aged 20-85 years old * subject must have voluntarily signed the informed consent form before any study related action * presence of gingival inflammation (gingival index by silness and loe 1969) * presence of plaque on clinical crowns (calculation of area) * supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to t0 (baseline) * compliance with study schedules and arrival at study visits exclusion criteria: * a systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers * pregnant or lactating women (\*if male please write n/a). * heavy smokers (more than 10 cigarettes per day). * patients with a pacemaker that do not allow the use of an ultrasonic device. * patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study). * systemic condition requiring prophylactic antibiotics. * patients taking nsaids for prolonged period.

Keywords: electromagnetic fields oral hygiene
determination of glycemic index of six greek honey grades

Conditions: Potential Abnormality of Glucose Tolerance; Appetitive Behavior

Summary: this study determined the glycemic index and glycemic load of six greek honey varieties

this randomized, double-blind, cross-over study investigated the glycemic response to six greek honey grades differing in floral source and carbohydrate composition. isoglucidic test meals (50g available carbohydrate) and 50g glucose reference were given to 11 clinically and metabolically healthy, fasting individuals (27±7 years; 9 women; bmi 24±4kg/m2), in random order. gi was calculated using the fao/who method. capillary blood glucose samples were collected at 0,15,30,45,60,90-and-120min. salivary insulin samples were collected at 0,60-and-120min. subjective appetite ratings (hunger, fullness and desire to eat) were assessed by visual analogue scales (vas, 100mm) at baseline and 120min.

Eligibility criteria:
inclusion criteria: * healthy * non-smoking * individuals with normal body mass index (between 18.5 and 24.9 kg/m2) exclusion criteria: * coronary heart disease * diabetes mellitus * kidney disease * liver conditions * endocrine conditions * gastrointestinal disorders * pregnancy * lactation, * competitive sports * alcohol * drug dependency
perceive and calculated cv risk

Conditions: Patient-Perceived Versus

Summary: cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ascvd) risk to guide treatment decisions and engage patients in shared decision-making. research has focused on refining the accuracy of these cv risk calculators for different populations, relatively little has been done to understand how patients perceive their own ascvd risk. accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. patients often show optimistic bias when considering their own cv risk and consistently underestimate it. we aim to determine patient perceived versus actual risk of ascvd in a chinese population. we aim to better understand the degree to which patients underestimate or overestimate their ascvd risk and whether patients are better or worse at estimating their ascvd risk relative to their peers of the same age and sex. finally, we aim to evaluate patients willingness to follow guideline recommended cv prevention and specifically lipid-lowering therapy.

cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ascvd) risk to guide treatment decisions and engage patients in shared decision-making. research has focused on refining the accuracy of these cv risk calculators for different populations, relatively little has been done to understand how patients perceive their own ascvd risk. accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. patients often show optimistic bias when considering their own cv risk and consistently underestimate it. we aim to determine patient perceived versus actual risk of ascvd in a chinese population. we aim to better understand the degree to which patients underestimate or overestimate their ascvd risk and whether patients are better or worse at estimating their ascvd risk relative to their peers of the same age and sex. finally, we aim to evaluate patients willingness to follow guideline recommended cv prevention and specifically lipid-lowering therapy.

Eligibility criteria:
inclusion criteria: 1. aged 40 years and above 2. consent to complete questionnaire 3. lipid profile within 12 months exclusion criteria: 1. known ascvd defined as history of coronary heart disease (i.e. obstructive coronary disease, prior myocardial infarction, or prior coronary revascularization); cerebrovascular disease (i.e. stroke or transient ischemic attack); and peripheral arterial disease (i.e. obstructive peripheral disease, prior vascular amputation or prior revascularization) 2. other chronic illness with life-expectancy \<12 months

Keywords: cardiovascular disease lipid-lowering therapy
comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity

Conditions: Retinopathy of Prematurity (ROP)

Summary: this study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-vegf agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. furthermore it shall help to improve safety in the treatment of rop and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates. the primary objective is to assess clinical efficacy of ranibizumab in children with rop


Eligibility criteria:
inclusion criteria: * bilateral rop in zone i (stage 1+, 2+, 3+/-, ap-rop) or rop in central (=posterior) zone ii (stage 3+, ap-rop). zone i is defined as twice the distance from the optic disc to the fovea measured temporally, posterior zone ii is defined as three times the distance from the optic disc to the fovea measured temporally. * legal representatives or their designates willing and able to attend regular study visits with the study infant. * written informed consent to participate in the study (signed by all patient's legal representatives). exclusion criteria: * pediatric conditions rendering the infant ineligible to anti-vegf treatment or to repeated blood draws as evaluated by a neonatal icu specialist and a study ophthalmologist. * congenital brain lesions significantly impairing optic nerve function. * severe hydrocephalus with significantly increased intracranial pressure. * advanced stages of rop with partial or complete retinal detachment (rop stage 4 and 5). * rop involving only the peripheral retina (i.e. peripheral zone ii or zone iii). * known hypersensitivity to the study drug or to drugs with similar chemical structures. * contraindications for an intravitreal injection as listed in ranibizumab smpc. * systemic use of anti-vegf therapeutics. * use of other investigational drugs - excluding vitamins and minerals - at the time of enrollment, or within 30 days or 5 half-lives prior to enrollment, whichever is longer.
nepal elimination of trachoma study

Conditions: Trachoma

Summary: the main purpose of this study is to determine if ocular chlamydia trachomatis infection can be eliminated in communities in nepal following mass antibiotic distributions with azithromycin. the investigators will study both clinical trachoma and ocular c. trachomatis infection. the overall objective is to determine if the current world health organization (who) treatment strategy results in elimination of trachoma and infection. 1. the investigators hypothesize that 24 communities in kanchanpur, kailali, and achham districts of nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments. 2. the investigators hypothesize that infection with c. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. the investigators hypothesize that 24 communities in kanchanpur, kailali, and achham districts of nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments. 2. the investigators hypothesize that infection with c. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mrna-based aptima and dna-based amplicor pcr).ve nucleic acid amplification testing available (mrna-based aptima and dna-based amplicor pcr).

here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western nepal following a mass antibiotic distribution program. it is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. the investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).

Eligibility criteria:
inclusion criteria: * children aged 1-9 years * children who live in kailai, kanchanpur, or achham districts of nepal exclusion criteria: * all individuals who are allergic to macrolides * all pregnant woman * all neonates

Keywords: trachoma
carrying out of focus group to improve cervical screening proposal by vaginal self-sampling (apache-4/fg).

Conditions: Cancer Cervix

Summary: despite the existence of an effective screening test (pap smear), cervical cancer is, every year in france, the cause of more than 3,000 new cases and 1,100 deaths. but, in france, 4 in 10 women are not screened or not often enough (nearly 7 millions women). it is therefore necessary to develop new strategies to reach these women. the etiological factor of this cancer is persistent infection with oncogenic high-risk human papillomavirus (hr-hpv). thereby, hpv-based tests could be alternative screening tests. vaginal self-sampling with hr-hpv test is simpler and less intrusive than the pap smear. it has been shown that vaginal self-sampling with hpv test is a powerful means to increase the participation rate in cervical cancer screening. the investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. this is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the focus group method. the objective is to identify improvement ideas of these two communication media.


Eligibility criteria:
inclusion criteria: * women from 30 to 65 years old * women living in french territorial division 37 ("indre-et-loire") * no pap smear made in the three last years (ideally) exclusion criteria: * follow-up in progress for positive screening

Keywords: cervical cancer screening vaginal self-sampling focus group communication
buprenorphine to improve hiv care engagement and outcomes

Conditions: HIV; Substance Related Disorders

Summary: the purpose of this study is to compare two models of substance abuse treatment in vietnam, and how they each affect hiv care. in vietnam, the current model for treating people with hiv who are also dependent on opioids is to refer them to methadone maintenance treatment centers. the new model the protocol will study is treatment of hiv and opioid dependence with buprenorphine/naloxone and counseling in the hiv clinic.


Eligibility criteria:
inclusion criteria: * hiv positive * current moderate or severe diagnostic and statistical manual (dsm-v) opioid use disorder * urine drug screen positive for opioids * interested in receiving treatment for opioid dependence * age at least 18 years old * willing to practice an effective method of birth control, if female exclusion criteria: * known hypersensitivity to buprenorphine or naloxone * aspartate aminotransferase (ast) \& alanine aminotransferase (alt) \> 5x upper limit * currently pregnant or breastfeeding * serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician * methadone maintenance treatment within 30 days of consent