Kornimate/medical-research-clean huggingface dataset:
stochastic resonance applied to amblyopia training and the plasticity of brain

Conditions: Amblyopia; Amblyopia, Anisometropic

Summary: the prevalence of taiwan's population with amblyopia is 2-5%. amblyopia affects the daily life and learning ability. the human visual system can be developed normally with exposure of clear images on the retina, which often drive the development and projection of optic nerves progressively. in general, the visual acuity progresses gradually with age. a normal vision is relatively mature until 8 years old. several types of amblyopia (strabismic amblyopia, refractive amblyopia, and deprivation amblyopia) are identified. the refractive amblyopia and deprivation amblyopia must be corrected by wearing glasses or surgeries. otherwise, amblyopia is often corrected by occlusion of the dominant eye or amblyopia training. the cambridge stimulator (cam) with rotating grating is commonly used in clinic in taiwan. the principle of the cam allows subjects to draw pictures on the plate in coincidence with occlusion of the dominant eye. the parents have to go with their children to a hospital weekly. the cam training is a stereotyped visuomotor behavior, which usually causes fatigue and uninteresting results for children. recently, some computer games have been incorporated with cam training. however, their clinical impact on amblyopia is largely unknown. moreover, most of studies don't have long-term tracking, and they only use limited assessments. in this project, a home-based training would be built for children with amblyopia. a cam training with a hierarchical structure with story-based organization would be implemented in the tablet. it will save time for children and parents for traffic between the home and hospital. the cam training with organized structure would increase acceptability and create subjects' motivation for long-term training. in addition, a stochastic resonance theory would be incorporated with the cam training to potentiate the learning curve of a visuomotor skill in young children. five systematic assessments, including visual acuity, grating acuity, contrast sensitivity, and 2 measurements of visual evoked potentials (veps), would be used. the investigators hypothesized that the rotating grating stimulation and stochastic resonance stimulation groups showed significant enhancement of the visual functions compared with the control group and performance of the veps toward better eye through the home-based training apparatus.


Eligibility criteria:
inclusion criteria: 1. participants were 4-8 years old. 2. participant had binocular or monocular best-corrected visual acuity (bcva) of ≤0.8, or they exhibited binocular bcva difference of ≥0.2. 3. participant had the wearing of optimal spectacle correction. exclusion criteria: 1. children with deprivation amblyopia were excluded. 2. children with ptosis were excluded.

Keywords: amblyopia amblyopic training contrast sensitivity grating acuity stochastic resonance visual acuity visual evoked potential
study of ixabepilone (bms-247550) in patients with solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to determine the dlt, mtd and recommended phase ii dose of ixabepilone in japanese patients with solid tumors.


Eligibility criteria:
inclusion criteria: * 20 years or older * histologically or cytologically confirmed diagnosis of adenocarcinoma solid tumors exclusion criteria: * patients with an eastern cooperative oncology group (ecog) performance status (ps) of ≥2
combining a caregiver intervention with aricept treatment for mild to moderate alzheimer's disease

Conditions: Alzheimer Disease; Caregivers

Summary: a unique multinational study was conducted simultaneously in the usa, england and australia. the goals of the study were to answer two questions: does psychosocial support for the family enhance the effectiveness of drug treatment for alzheimer's disease? is the added value of psychosocial support the same in all 3 countries?

this study is a single-blind prospective randomized trial with 150 patient/caregiver pairs (50 in each country). eligibility criteria at baseline require that the primary caregiver is the spouse of the patient; the patient must have a diagnosis of ad, be in the in mild to moderate stage of dementia, be living with the caregiver, and be willing to take donepezil (aricept). these participants were randomly assigned to one of two groups: in one group, the intervention consists of drug treatment for the patient plus psychosocial intervention for the caregiver; in the other group the intervention consists solely of drug treatment for the patient. the intervention for the caregiver consists of 5 scheduled individual and family counseling sessions within 3 months of baseline, and unlimited consultations on request. assessments were conducted every 3 months for the first year and every 6 months for a second year. there are 3 sources of data: an interview of the caregiver by an independent rater, an assessment of the patient, and a count of the amount of medication used. thus we will be able to assess the effect of adding counseling to medication for the caregiver, for the patient, and on compliance with medication use.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with mild to moderate stage alzheimer's disease and their spouse caregivers exclusion criteria: * severe psychological or physical illness * unwillingness by either spouse to participate in all aspects of the study

Keywords: dementia counseling
a study to assess the bioequivalence between brivaracetam tablet and dry syrup in healthy japanese male study participants

Conditions: Healthy Study Participants

Summary: the purpose of the study is to demonstrate the bioequivalence between the brv tablet and brv dry syrup after multiple oral doses in healthy male japanese participants.


Eligibility criteria:
inclusion criteria: * participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (icf) * participant is of japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 japanese grandparents born in japan) * participant is male exclusion criteria: * participant has a known hypersensitivity to any components of the investigational medicinal product (imp) formulations * participant has participated in another study of an imp (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of brv in this study or is currently participating in another study of an imp (and/or an investigational device) * participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the screening visit or on day-1 * participant has donated blood or plasma or has experienced blood loss ≥400 ml within 90 days, ≥200 ml within 30 days, or has donated any blood or plasma within 14 days before first administration of imp * participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of imp

Keywords: brivaracetam healthy study participants phase 1 brv
the efficacy and safety of topical valproic acid in preventing hair loss

Conditions: Androgenetic Alopecia; Male Pattern Baldness

Summary: beta-catenin, the transducer of wnt signaling, is critical in development, growth, and regeneration of hair. in the absence of wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by gsk-3, multifunctional serine/threonin kinase. after phosphorylation by gsk-3, β-catenin is ubiquitinated and degraded in cytoplasm. therefore, inhibition of gsk-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. valproic acid (vpa) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the gsk-3β. however, the effect of vpa on hairs has not been studied yet.


Eligibility criteria:
inclusion criteria: * age: 19 years \~ 45 years * subjects with aga (hamilton\&norwood grad iii\~iv) * subjects who are able to be followed for next 24 weeks. exclusion criteria: * subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease * subjects with aga treated with surgical methods (hair tpl) * subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months. * subjects who took medicine which can affect the hair growth * subjects with alopecia other than aga
nicotinamide and glaucoma

Conditions: Glaucoma

Summary: the investigators will include different subgroups of open-angle glaucoma and healthy controls. the participants will attend two visits with two weeks apart. at each visit the participants will have blood drawn and will undergo oct examination. in between the two visits, participants will receive a treatment of nicotinamide 1,5g/day for one week and 3.0g/day for the second week.

the investigators plan to recruit four groups, each containing 30 subjects: 1) pseudoexfoliative glaucoma, 2) high tension open-angle glaucoma, 3) normal tension glaucoma 4) age-matched controls. those enrolled will undergo two visits including an ophthalmic exam, blood sampling, and at the first visit, distribution of nicotinamide tablets. we plan to recruit participants amongst glaucoma patients already followed at the eye clinic at umeå university hospital. furthermore, age-matched controls will be recruited through lists from the population register at statistics sweden. before enrolling any subject, they will receive both oral and written information as well as sign a consent form. furthermore, they will be evaluated to make sure that they fulfill the inclusion- and exclusion criteria prior to inclusion. the ophthalmic exam includes measurement of iop, perimetry, and oct/a. between visits, the participants will receive 1,5 grams of nam per day the first week and 3 grams per day the second week. the blood drawn will initially be sent to biobanken norr for storage. samples will then be sent to the swedish metabolomics centre, umeå university and department of medical biochemistry and biophysics, karolinska university for analysis using high-resolution mass spectrometry.

Eligibility criteria:
inclusion criteria for glaucoma patients: * manifest glaucoma (pexg, htg, ntg) in one or two eyes, * age \> 18 years, * replicable visual field defects that cannot be explained by any other disease or insult, * suspect/anomalous optic nerve head or abnormalities in the retinal nerve fiber layer. inclusion criteria for age-matched controls: -a normal visual field and optic nerve, age \> 18 years. exclusion criteria for all: * any disease affecting retinal function (such as more than mild macular degeneration or diabetic retinopathy), neurological or other non-glaucomatous conditions that may affect the visual field, * inability to perform a perimetric exam, * resistance in quitting intake of multivitamins or b-vitamins, * allergy to nam or niacin, previous eye surgery involving the central retina, * pregnant or breast-feeding women, * fertile women not using reliable contraception, * diagnosis of cancer in the last five years (not including treated squamous cell carcinoma), anamnesis of liver-disease or peptic ulcer, * not able to speak and understand either swedish or english.
agn-229666 for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: this study will evaluate the safety and efficacy of agn-229666 for the treatment of allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * japanese patients living in japan with a history of allergic conjunctivitis * willing to discontinue wearing contact lenses during the study period exclusion criteria: * use of nicotine products during the study period * presence of active eye infection (bacterial, viral, or fungal) * history of an ocular herpetic infection * eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
the tolerability and effects of azd8848 in allergic asthma subjects challenged with inhaled allergen

Conditions: Allergic Asthma

Summary: azd8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). this study will be in two parts and will include 59 asthmatic patients in total. the first part will investigate the tolerability and safety of azd8848 while the second part will investigate both the therapeutic effect of azd8848 and how well patients tolerate the drug.


Eligibility criteria:
inclusion criteria: * fev1 \> 70 % of predicted normal pre-bronchodilator * documented history of asthma * presence of allergic sensitivity exclusion criteria: * clinically relevant disease and/or abnormality (past or present), which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. * symptomatic allergic rhinitis * any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study
a study to evaluate the efficacy and safety of ksi-301, an anti-vegf antibody biopolymer conjugate, versus aflibercept in patients with neovascular (wet) age-related macular degeneration.

Conditions: Wet Macular Degeneration

Summary: this study will evaluate the efficacy, safety, durability, and pharmacokinetics of ksi-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (q8w), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (namd).

this study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. at baseline patients will be randomized 1:1 into two treatment arms: ksi-301 5 mg and aflibercept 2 mg.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to participation in the study. * active, treatment-naïve choroidal neovascularization (cnv) secondary to amd. * bcva etdrs score between 80 and 25 letters (snellen equivalent of 20/25 to 20/320), inclusive. * other protocol-specified inclusion criteria may apply exclusion criteria: * cnv secondary to other causes in the study eye. * any history of macular pathology unrelated to amd but affecting vision or contributing to subretinal or intraretinal fluid. * any history or evidence of a concurrent intraocular condition in the study eye that, in the judgment of the investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss. * active ocular or periocular infection or inflammation. * prior administration of any approved or investigational treatment for neovascular amd in the study eye. * uncontrolled glaucoma in the study eye. * women who are pregnant or lactating or intending to become pregnant during the study. * stroke or myocardial infarction in the 6-month period prior to day 1. * uncontrolled blood pressure defined as a systolic value \> 180 mmhg or diastolic value ≥100 mmhg while at rest. * history of a medical condition that, in the judgment of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. * other protocol-specified exclusion criteria may apply.

Keywords: amd wet amd choroidal neovascularization secondary to age-related macular degeneration ksi-301 aflibercept vascular endothelial growth factor vegf anti-vegf antibody biopolymer conjugate macular degeneration wet macular degeneration retinal degeneration retinal diseases eye diseases vision disorders vision, low kodiak
a group-based treatment of overweight and obesity in primary care

Conditions: Overweight and Obesity

Summary: overweight and obesity is a growing problem in the world. today more than 50 % of all people over 18 years in sweden are overweight or obese. main reasons for this are changes in lifestyle habits regarding diet and physical exercise. overweight and obesity increases risk of different diseases such as type 2 diabetes, arthrosis and cancer; it also affects quality of life. losing 5-10 % of your body weight improves metabolic health and quality of life. lifestyle changes are very important in order to lose weight but it can be challenging to carry through with these changes on your own without support. in the primary care in region orebro län a group treatment, "step by step", has been in use since 2010. it comprises of six group sessions over 6-8 months with different themes such as diet, physical exercise and stress. between the group sessions there are home assignments, such as writing a diet or exercise diary. this observational study will evaluate "step by step" and the effect the group treatment has on the participants' weight, dietary habits, physical activity, quality of life, eating habits and metabolic health.


Eligibility criteria:
inclusion criteria: * 18 years and older * bmi 30 or over * bmi over 28 and under 30 with one or more of following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnoea or polycystic ovary syndrome. exclusion criteria: * severe mental illness * previous or present eating disorder * pregnancy * breast feeding * serious cancer under treatment * use of weight-loss drugs * misuse of alcohol or drugs * type 1 diabetes * not being able to speak/read/write swedish.

Keywords: overweight obesity group treatment primary care
assessment of the effectiveness of olmetec® and olmetec plus® for treatment of hypertension in stage i and ii patients (study p05254)(completed)

Conditions: Hypertension

Summary: the purpose of this study is to determine the efficiency of olmesartan medoxomile (olmetec®) alone or in combination with hydrochlorothiazide (olmetec plus®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.

α= 0.05. α's z=1.96 β= 80%. β's z=0.84 estimated proportion of subjects to achieve optimal control of arterial hypertension= 83.2% 450 subjects are expected to be enrolled in the study of which 40 subjects will be enrolled in venezuela.

Eligibility criteria:
inclusion criteria: * men or women 18 years of age or older * essential arterial hypertension stade i and ii according to jnc vii * signature of informed consent exclusion criteria: * secondary arterial hypertension * pregnant woman or during lactancy * recent cardiovascular disease, as heart attack, unstable angina, or procedures of coronary revascularization on the previous six months. * acute coronary failure syndrome on the previous six months. * chronic ischemic cardiopathy treatment. * cerebral vascular disease on the previous six months. * alcoholism story or use of drugs on the two previous years. * hepatic disease story * chronic renal failure defined by a serumal creatinine higher than 2mg/dl * albuminuria higher than 1gr. * known allergy to blockers of angiotensine ii receptors. * neoplasmic malignant disease included leukemia and the lymphoma (skin basocellular cancer is not included) * auto immune disorders as systemic erythematosus lupus. * non attachment to medical treatments history. * patients sharing some clinical investigation essay on the last 3 months. * congestive heart failure under previous treatment with eca inhibitors. * allergy to thiazidic diuretics. * angioedema history * use of drugs that affect potassium secretion, as diuretic savers of potassium, angiotensine enzyme inhibitor, betablockers, non-steroid anti-inflammatory drugs. * potassium consumption orally

Keywords: hypertension stage i hypertension stage ii
study in asthma control

Conditions: Asthma

Summary: this study will compare patients treated with a marketed medication and those who continue with their usual care to assess the proportion of patients achieving well controlled asthma after 24 weeks.


Eligibility criteria:
inclusion criteria: * documented clinical history of asthma and receiving regular maintenance therapy. exclusion criteria: * using oral/parenteral or depot corticosteroids within 12 weeks of visit 1. * history of heavy smoking or substance abuse. * females who are pregnant or lactating. * required emergency room treatment for their asthma 12 weeks prior to visit 1. * serious, uncontrolled, systemic disease that may make study participation unsafe or inappropriate in the opinion of the physician. * other medical criteria will be evaluated at the screening visit.

Keywords: asthma advair
treatment of "low anterior resection syndrome" by percutaneous nerve evaluation and transanal irrigation

Conditions: Rectal Cancer

Summary: a randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.

patients will undergo anal physiological assessment and will then be randomized to either treatment arm. the first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with tai or pne. after 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm. detailed records of bowel, micturition and sexual function and qol will be obtained at regular intervals during the entire trial fase.

Eligibility criteria:
inclusion criteria: * low anterior resection for rectal cancer between may 2001 and may 2011 exclusion criteria: * non-radical resection * metastatic disease * chemotherapy * radiotherapy * previously treated for another cancer * dementia or other mental retardation/severe mental disease * inability to read and understand the danish language * recurrent disease

Keywords: percutaneous nerve evaluation transanal irrigation low anterior resection syndrome