Kornimate/medical-research-clean huggingface dataset:
hemocontrol's effectiveness on the reduction of cardiovascular long-term events

Conditions: Kidney Failure Chronic; Cardiovascular Diseases

Summary: it is hypothesized that a consistent use of the hemocontrol tm biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes


Eligibility criteria:
inclusion criteria: 1. age more than 65 years old 2. arterial hypertension: predialysis sbp \>140 mmhg and/or dbp \>90 mmhg in at least 50% over the previous month dialysis sessions or receiving at least one antihypertensive pharmacological drug including diuretics, disregarded blood pressure value 3. on a three times per week hemodialysis schedule 4. time on hemodialysis less than 6 months 5. able to measure their blood pressure at home (by themselves or with the aid of the care giver) 6. signed informed consent exclusion criteria: 1. active neoplastic disease 2. mental illness 3. pregnancy 4. single needle treatment 5. inability, as judged by the investigator, to follow or understand the protocol instructions 6. blood flow rate less than 200 ml/min 7. patients who at the time of recruitment need clinical indication for special renal replacement therapies and/or on treatment with one of the following modalities: hdf or similar diffusive-convective therapies, treatment time \>5h, blood temperature control, isolated uf profiling of na/ufr 8. patients with a life expectancy shorter than 6 months 9. patients in a list for transplant within the next 6 months 10. predialysis hemoglobin level greater than 13.5 g/dl 11. history of major cardiovascular events during run in period
wound etiology and healing study

Conditions: Wounds; Hidradenitis Suppurativa; Hidradenitis; Acne Inversa

Summary: the purpose of the we-heal study is to help researchers use human tissue samples and health records to study the reasons why some patients heal quickly and some have problems healing wounds. all patients seen with an open wound or hidradenitis suppurativa are invited to participate. information from this research may help to understand how to prevent and treat certain diseases.


Eligibility criteria:
inclusion criteria: 1. age \>18 2. open wound or hidradenitis suppurativa 3. english speaking 4. able to give informed consent exclusion criteria: 1. non-english speaking. 2. unable to give informed consent

Keywords: non healing ulcer wound hidradenitis suppurativa acne inversa hidradenitis
compare effect of surgical antiseptic preparations on incise drape adhesion to skin

Conditions: Healthy

Summary: the purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.

adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. this study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.

Eligibility criteria:
inclusion criteria: * subject is willing to sign the research consent form * healthy male or female subjects ages between 18 - 65 * subject has agreed to be and appears to be compliant with requirements of the study * subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples * subject is willing to have the back clipped or shaved if it has excessive hair exclusion criteria: * sensitivity/allergy to adhesive products (e.g. medical tapes) * sensitivity to the antimicrobial agent iodine, povidone iodine (pvpi), isopropyl alcohol (ipa), or chlorhexidine gluconate (chg) * allergy to seafood * history of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials * active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back * history of diabetes * subject is currently pregnant or thinks she may be pregnant or is nursing * subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy * subject is taking antihistamine medication * subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study * subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours
midvastus versus medial parapatellar approach for minimally invasive total knee arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare two different surgical approaches for total knee replacement surgery. the mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. both will have the same skin incision.


Eligibility criteria:
inclusion criteria: 1. patient is a male or non-pregnant female between the ages of 21-80. 2. patient requires cemented primary total knee replacement. 3. patient has a diagnosis of osteoarthritis (oa), traumatic arthritis (ta) or avascular necrosis (avn). 4. patient has intact collateral ligaments. 5. patient has signed and dated an irb approved study specific consent form. 6. patient is able and willing to participate in the study according to the protocol for the full length of the expected term of follow-up, and to follow their physician's directions. 7. patient has failed to respond to conservative treatment modalities. exclusion criteria: 1. patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee. 2. patient is morbidly obese, \>60% over ideal body weight for frame and height. 3. patient has a deformity at the involved knee greater than 45 degrees of flexion, 45 degrees of varus or 45 degrees of valgus. 4. patient has an active or suspected latent infection in or about the knee joint. 5. patient has a malignancy in the area of the involved knee joint. 6. patient has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, paget's disease) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 7. patient has a neurological deficit, which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. 8. female patient is or plans to become pregnant during the course of the study. 9. patient has a known sensitivity to device materials. 10. patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength 11. patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.

Keywords: total knee arthroplasty
the effect of dairy fat and inulin on fasting induced adipose factor (fiaf) blood concentrations

Conditions: Obesity

Summary: the objective of this study is to investigate whether intake of a diet with a high content of butyrate (from dairy fat) can affect blood fiaf concentration compared to a control diet. further to examine whether high intake of inulin (a prebiotic) can increase the proportion of butyrate-producing bacteria in the gut and thereby affect blood fiaf concentration. in addition, the correlation between fiaf blood concentrations and resting energy expenditure, blood lipid profile and gut microbiota composition will be investigated. furthermore, this study will investigate whether the source of fiaf can be determined. to this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal water samples will be carried out. the study is a crossover randomized controlled trials with 3 arms. each arm has a duration of 3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the order of interventions. before and after each intervention period, blood samples will be collected and the participants will have their resting metabolic rate measured. at the end of each intervention period, the participants will collect feces for 5 consecutive days. in addition, adipose tissue biopsies will be taken after each intervention period.


Eligibility criteria:
inclusion criteria: * healthy males * age: 23-45 * bmi: 25-32 kg/m2 * body fat percentage (bfp) \> 25 exclusion criteria: * chronic diseases (known diabetes, cardiovascular disease (cvd), intestinal bowel disease and other chronic diseases likely to affect the results of the present study) * milk allergy/lactose intolerance * intolerance towards inulin * fasting glucose ≥7.0 mmol/l or non-fasting glucose ≥ 11 mmol/l\* * use of antibiotics 2 months before commencement of study * use of dietary supplements incl. multivitamins during run-in and the entire study period * smoking * elite athletes (\>10 hours of strenuous physical activity per week) * use of prescription medicine which could affect the results of the present study, including systemic glucocorticoids * use of lipid-lowering agents or medication with contraindications for a high fat diet * blood pressure \> 140/90 mmhg * blood donation \<1 month before study commencement and during study period * simultaneous participation in other clinical studies * inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
treatment of bulimia nervosa in a primary care setting

Conditions: Bulimia Nervosa

Summary: bulimia nervosa is a frequent problem for young women. it is widely assumed that this disorder cannot be treated effectively in a primary care setting. this assumption has never been tested empirically, and is probably incorrect. in the last 15 years, effective treatment interventions for bulimia nervosa have been developed and validated in specialized treatment centers. the broad aim of this proposal is to examine whether these treatments, suitably adapted, can be usefully transferred to general health care settings. specifically, the proposed study will determine the relative and combined effectiveness of the two leading treatments for bulimia nervosa in a primary care setting. the two major interventions are treatment with an antidepressant medication, fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for use in primary care.


Eligibility criteria:
inclusion criteria: * dsm-iv criteria for bulimia nervosa with a modified frequency criterion of at least once a week exclusion criteria: * physical disorder requiring hospitalization or ongoing treatment likely to affect eating and/or weight * significant suicidal ideation or behavior * subjects judged unable to tolerate four-month treatments available in the study because of comorbid psychiatric conditions * current drug or alcohol dependence * current anorexia nervosa * pregnancy or any physical condition or treatments known to influence eating and weight * current psychiatric treatment or medication known to affect eating or weight * previous course of fluoxetine at a dose of 60 mg. per day for at least four weeks * allergy to fluoxetine * previous course of cognitive behavioral therapy for bulimia nervosa at a qualified center

Keywords: primary care fluoxetine
bühlmann fpela in the diagnosis of exocrine pancreatic insufficiency

Conditions: Exocrine Pancreatic Insufficiency

Summary: the study shall determine the clinical performance of the bühlmann fecal pancreatic elastase (fpela) assays in the diagnosis of exocrine pancreatic insufficiency (pei). this is a observational and cross-sectional performance study. specimens and clinical data are collected by a single study site. included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.


Eligibility criteria:
inclusion criteria: * suspected exocrine pancreatic insufficiency * at least 18 years of age. exclusion criteria: * diarrhea (stool water content ≥ 75%) at the time of sample collection
memantine augmentation of lamotrigine incomplete-response in bipolar depression

Conditions: Bipolar Depression

Summary: the purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (lamictal) which is frequently used to treat bipolar depression in the clinical setting. at present, memantine is approved for use in the treatment of alzheimer's disease or dementia, but not for use for the treatment of bipolar depression. subjects will be asked to participate because they are suffering from bipolar depression associated and have had an inadequate response to lamotrigine. subjects will have to be on at least 100 mg per day, for at least 4 weeks.

hypothesis/objectives: h1: lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement on the hamilton depression rating scale (hdrs) and clinical global improvement (cgi) scale compared to patients augmented with placebo. h2: lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement of scores on the selective reminding test (srt), the digit span test, the stroop test, and trail making test (tmt) than patients augmented with placebo. study population: we will study 40 bipolar disorder depressed (bdd) outpatients (20 in each arm) recruited from the outpatient mood disorders clinic and by advertisement.

Eligibility criteria:
inclusion criteria:: 1) age 18 - 65; 2) satisfy dsm-iv-tr criteria for bipolar disorder and major depressive episode; 3) lamotrigine inadequate-response: defined as already treated with at least 100 mg of lamotrigine for at least 4 weeks but 17 item hdrs rating \> 15; 4) give informed consent as approved by local irb; 5) if on other antidepressants or mood stabilizers on stable dose for the past 4 weeks. exclusion criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffective disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to be pregnant or not using adequate contraception; 6) satisfy criteria for substance dependence within 6 months prior to start of the study; and 7) on any medication with significant adverse interaction with either lamotrigine or memantine.

Keywords: bipolar depression incomplete response
optimizing social and communication outcomes for toddlers with autism

Conditions: Autism Spectrum Disorder

Summary: this project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.

the proposed research tests a theoretically and empirically derived treatment approach aimed at facilitating change in joint attention interactions between caregivers and their toddlers with autism. young children with autism show impairments in engaging in joint attention skills such as pointing and showing. the importance of joint attention is underscored by data showing that these skills are important to later development of language. yet these interaction and skills deficits have rarely been the focus of systematic intervention efforts, particularly with caregivers. moreover, current interventions for young children wiht autism are behavioral in approach, therapist driven, and often exclude the lowest functioning and developmentally youngest children. thus, targeting these deficits in developmentally young children using familiar caregivers may result in better language outcomes for these children. the overarching goal of the proposed project is to rigorously test an intervention program for caregivers and their toddlers with autism that is developmentally informed, child-centered and focused on joint attention intervention with their toddlers versus mothers who receive parent education about autism and child development. the primary aims of this research are as follows: * aim 1: to determine if caregiver mediated intervention on joint engagement is superior to caregiver education on social communication and language outcomes in children. * aim 2: to determine if skill development in the context of caregiver child interaction transfers to interactions with classroom teachers and peers. * aim 3: to examine characteristics of families and children that best predict social-communication outcome.

Eligibility criteria:
inclusion criteria: * child meets screening criteria for pdd * not currently enrolled in a pre-existing intervention program * parent is available for intervention * child must be ready to start in the early childhood partial hospitalization program (ecphp) at ucla exclusion criteria: * child does not have other sensory or genetic disorders * children already on medication on the outset, although we find few toddlers already on medication when they begin treatment. if children begin medication after treatment commences, then we will keep all informatin and data pertaining to possible medication effects and statistically convey medication use if necessary * co-morbidity, participant diagnosed with other diseases * family/participant unable to follow-up

Keywords: autism social and communication deficits in autism parent and caregiver interventions with children with autism autism spectrum disorder asd
retromaster - retrospective cohort mrc abpi stratification and extreme response mechanism in diabetes

Conditions: Diabetes

Summary: this study will examine extreme responders to second- and third-line type 2 diabetes (t2d) therapy using a retrospective approach and patients with slow or fast diabetes progression.

pilot phase (march 2013 - dec 2014) patients will be recruited initially from 2 centres, plus exeter as a pre-pilot centre. patients with particularly good or poor response to second- and third-line type 2 diabetes treatments and patients progressing to insulin either particularly quickly or particularly slowly will be recruited from primary, secondary, or community settings. fasting blood and urine samples will be collected, along with standard biomeasures and information will be collected about medical history and prescribing history. all study documentation and sample materials will be sent out to sites from the coordinating centre. sites will be expected to process and freeze samples and send them to the central laboratory managed by the chief inspector's site where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response. post-pilot phase (jan 2015- oct 2017): subject to feasibility, interim analysis and continuation of funding from medical research council (mrc), this project will continue for another three years.

Eligibility criteria:
generic inclusion criteria: * demographics: age 18-90 inclusive * ethnicity: reflective of local demographic * medical history: clinical diagnosis of type 2 diabetes * mental capacity: capacity to consent responders cohort inclusion criteria: * on sulphonylurea, dpp-4 inhibitor, glp-1r agonist, sglt2 inhibitor or glitazone for \> 4 months. * pre-treatment hba1c≥ 58mmol/mol (7.5%). progressors cohort inclusion criteria: * type 2 diabetes (not on insulin treatment within 6 months of diagnosis) * either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or hba1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment \>10 years from diagnosis (defined as not on insulin treatment and hba1c \<69mmol/mol (8.5%). exclusion criteria: * age less than 18 years old and greater than 90 years old * incapacity to consent * type 1 diabetes.

Keywords: diabetes type 2 diabetes diabetes therapy response diabetes progression
efficacy and safety of fingolimod in patients with relapsing-remitting multiple sclerosis

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: this study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (rrms)


Eligibility criteria:
inclusion criteria: * male and female patients between ages 18-55 with a diagnosis of multiple sclerosis * patients with a relapsing-remitting disease course * patients with edss score of 0-5.5 exclusion criteria: * patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. * pregnant or nursing women other protocol-defined inclusion/exclusion criteria applied to this study.

Keywords: multiple sclerosis fty720 fingolimod
the menus of change health and heart benefits for university students

Conditions: Healthy Lifestyle

Summary: the goal of this cross-sectional study is to investigate the health benefits of the menus of change in undergraduate university students, by comparing 2 groups: students eating in the menus of change catered halls, versus students eating outside the menus of change meal plan. the main question it aims to answer is: what are the effects of the menus of change on other vascular outcomes, namely blood pressure? what are the effects of the menus of change on other health markers?

the menus of change (moc) is an example of behaviour change that was created by the culinary institute of america (cia) and harvard th chan school of public health. this initiative is based on a set of around 24 core principles, mainly promoting and serving 'healthy, sustainable, and delicious' food in restaurants and foodservice operations. the university of reading has successfully implemented the moc across the campus and in students' accommodations. however, moc is not implemented across all campus halls. to date, most of the studies performed in relation to the moc had explored techniques to encourage students towards healthier, more sustainable diets. very little research focuses on the associated health outcomes and hence the impact on health of the eating pattern laid out in the moc principles. therefore, this project aims to investigate the health impact of the menu of change on university students, by comparing 2 groups: students eating in moc catered halls, following the meal plan provided by the university food services, versus students who do not follow the menus of change meal plan. the primary aim will be to investigate the effect of the moc on vascular outcomes, namely arterial stiffness, a particularly important tool in younger adults with low-moderate cardiovascular disease risk. secondary aims will be to investigate other vascular outcomes, namely blood pressure changes, as well as looking at other health markers, such as full blood count, lipid profile, sugar levels, liver and kidney function, and cvd related inflammatory markers. in addition, the study aims to look at the impact of the moc on stress and anxiety levels and the differences in students' attainment between groups.

Eligibility criteria:
inclusion criteria: * adults * home students living in university halls * undergraduates * can understand participant information sheet and willing to comply with the study design exclusion criteria: * international students * postgraduates * living outside the university halls * participating in other studies

Keywords: menus of change arterial stiffness