Kornimate/medical-research-clean huggingface dataset:
metabolic effects of pioglitazone in type ii diabetic patients previously treated with insulin

Conditions: Type 2 Diabetes Mellitus; Insulin Resistance

Summary: the goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in hba1c by more than 0.5 %) within a 6 month observation period.

to demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control. primary aim is to maintain glycaemic control (hba1c) defined as an increase in hba1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline hba1c value (screening visit v1).

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * insulin therapy \> 1 year * residual ß-cell function (c-peptide increase in iv glucagon test) * written informed consent exclusion criteria: * type 1 diabetes * oral therapy * life-threatening disease * heart failure (nyha i-iv)

Keywords: type 2 diabetes insulin treatment ß-cell function
the trampoline vt study

Conditions: Ventricular Tachycardia

Summary: this non-randomised, prospective trial will examine the feasibility and efficacy of vt ablation guided by activation mapping using the octaray and optrell catheters. annotation algorithms within the carto3 electro-anatomical mapping system will be integrated with 3d scar segmentation data from cardiac mri (adas-vt), and extrastimulus voltage mapping will identify sites of interest for focussed activation mapping. the investigators hypothesise that the examination of these data will identify critical target sites for ablation. intra-procedural diagnostic performance of the octaray and optrell catheters will be assessed as the primary outcome, and will be compared with the standard of care. secondary, clinical outcomes - primarily the need for icd therapies at 12 months post ablation - will be compared with propensity-matched controls undergoing substrate-based ablation alone. follow-up mri scans will review the impact of ablation on the elimination of conduction channels.


Eligibility criteria:
inclusion criteria: * icd in situ * clinical indication for vt ablation; incessant vt or receiving appropriate icd therapies for vt despite anti-arrhythmic drugs * ischaemic or non-ischaemic heart disease exclusion criteria: * valvular heart disease precluding lv access * cardiotomy within previous 3 months * acute coronary syndrome within 6 weeks * dialysis patients * coagulopathy/thrombocytopaenia * pregnancy/breastfeeding women * cmr contraindicated * prognosis \<12 months * unable to provide informed consent

Keywords: octaray
effect of massage on chronic low back pain

Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)

Summary: this study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.

americans are increasingly seeking care from massage therapists for relief of chronic back pain. however, while initial studies suggest that massage is beneficial for back pain, we have no information about which of the many types of massage is most helpful. we will be conducting a study that compares two distinct therapeutic massage protocols with each other and with usual care for treating chronic back pain. this study is designed to determine which of these massage protocols will be most effective in reducing pain and increasing functionality in people with low back pain. 399 group health members with non-specific low back pain lasting at least 3 months will be randomized to one of the two massage groups or to a control group that receives no treatment beyond their usual care. massage therapists will provide each participant with 10 treatments over 10 weeks. the primary outcomes, function and bothersomeness of low back pain, will be assessed before treatment begins and 10, 26 and 52 weeks after randomization by interviewers who do not know which treatment the participant received. the results of this study will clarify the value of two different types of massage for treating one of the most common, challenging, and expensive health problems plaguing developed countries. the findings will help physicians make informed and confident referrals, consumers and insurers make safe and cost-effective choices, and massage schools make responsible curriculum decisions.

Eligibility criteria:
inclusion criteria: * 20 through 64 years of age * members of group health cooperative health plan * low back pain lasting at least 3 months exclusion criteria: * non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture) * inappropriate candidate for massage (active open skin lesions, conditions exacerbated by increased circulation, recent strokes or heart attacks, compromised immune system, systemic edema, hypersensitivity to touch or loss of sensation, recent surgery, active contagious infection) * characteristics complicating the interpretation of findings (e.g., involved with litigation or compensation claim, severe or progressive neurological deficit, back surgery within last 3 years, receiving other back treatment) * unable to speak or read english * had massage for any reason in prior 12 months

Keywords: massage back pain effectiveness
an open-label trial of donepezil in fragile x syndrome

Conditions: Fragile X Syndrome

Summary: fragile x syndrome is the most common known inherited cause of neurodevelopmental disability. functional magnetic resonance imaging (fmri) studies from our laboratory indicate that specific brain regions using the neurochemical, acetylcholine, show significantly reduced activation during learning. since donepezil is a medication that enhances acetylcholine function in the brain, the purpose of this study is to determine if donepezil has any beneficial effect on behavior or cognition in subjects with fragile x syndrome.

fragile x syndrome is the most common genetically inherited cause of neurodevelopmental disability in humans, affecting approximately 1:2000 to 4000 live births. affected individuals have significant, long-term problems with learning, and often with behavior as well. the disorder is caused by the presence of a greatly expanded cgg repeat within the fmr1 gene on the long arm of the x chromosome. abnormal methylation of this repeat, and adjacent areas within the fmr1 gene impedes transcription, ultimately resulting in reduced production of the fmr1 protein (fmrp). this protein is expressed in neurons, with particularly high levels of gene transcription occurring in the nucleus basalis (basal forebrain) and hippocampus. a recent functional imaging study from our group showed girls with fragile x to have greatly reduced levels of brain activation in the basal forebrain and hippocampal activation during a memory task. the nucleus basalis, is a cholinergic nucleus with widespread connections to the neocortex. it is critical to visuospatial attention in rodents and primates and is presumed to play a similar role in humans. the finding of decreased basal forebrain activation in girls with fragile x, considered in light of histological evidence showing high transcription levels of fmr1 in healthy nucleus basalis, suggests the possibility of a functional cholinergic deficit in fragile x syndrome. donepezil is an acetylcholinesterase inhibitor which slows the degradation of synaptic acetylcholine thereby increasing its availability. it is approved for the treatment of mild-moderate alzheimer's disease. it has been studied in several other neurologic disorders--including vascular dementia, lewy body dementia, and down's syndrome (with and without dementia)--where it has shown varying degrees of efficacy but consistently high degrees of safety and tolerability. the goal of the proposed study is to determine if enhancing cholinergic activity with donepezil has beneficial effects on behavior or cognition in subjects with fragile x syndrome.

Eligibility criteria:
inclusion criteria:1. confirmed genetic diagnosis of fragile x syndrome 2. age e 14 3. verbal iq e 60 exclusion criteria:1. currently taking any anticholinergic medications, tricyclic antidepressant medications, or diphenhydramine. 2. presence of cardiac disease or bradycardia (\< 60 beats/minute) at initial evaluation.
auricular stimulation vs. expressive writing for exam anxiety

Conditions: Anxiety

Summary: title of the study: auricular acupuncture (aa) vs. expressive writing for pre-exam anxiety - a randomised crossover study study period: 04 / 2014 - 07 / 2014 principal investigator: prof. dr. t. usichenko department of anaesthesiology and intensive care medicine university medicine of greifswald aim of the study: to investigate the anxiolytic effect of aa vs. expressive writing and vs. no intervention in students, passing the oral exams in anatomy at the university of greifswald design: prospective randomised crossover trial interventions: 1. aa using indwelling fixed needles, retained 24 h in situ 2. expressive writing number of volunteers: n = 40 healthy medical students at the university of greifswald participants of the anatomy exams in spring/summer 2014 without previous anxiolytic, sedative and analgesic medication no pregnancy or lactating informed consent outcome measures: anxiety level heart rate, blood pressure salivary α-amylase


Eligibility criteria:
inclusion criteria: 1. medical students at the university of greifswald 2. going to take part in oral exams of human anatomy 3. participants without previous anxiolytic medication 4. ability to express the thoughts and emotions ("expressive writing") 5. written informed consent exclusion criteria: 1. recidivist alcoholics 2. local auricular skin infection 3. pregnant or lactating women 4. participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of aha) 5. participants who are unable to understand the consent form 6. history of psychiatric disease
incretin effect in patients with psoriasis and controls

Conditions: Psoriasis Vulgaris

Summary: to investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis


Eligibility criteria:
inclusion criteria: no diabetes bmi \ 8) (case not controls) exclusion criteria: other chronic inflammtory skin disease other chronic inflammatory disease pregnancy psychiatric illness
virtually assisted home rehabilitation after acute stroke (vast-rehab)

Conditions: Stroke

Summary: the purpose of this study is to investigate the feasibility of a virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.


Eligibility criteria:
inclusion criteria: * informed consent provided by the subject or legally authorized representative. * occurrence of a hemorrhagic or ischemic stroke * pre-stroke mrs less than 3 * qualifying stroke event must be confirmed by ct or mri * recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist * must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments * able to access the internet via a personal device exclusion criteria: * . history of neurological or other disease resulting in significant functional impairment (e.g.parkinson's disease, motor neuron disease, moderate dementia, arthritis,contractures or fixed anatomical abnormality). * subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months. * any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.

Keywords: rehabilitation
intraventricular transplantation of mesenchymal stem cell in patients with als

Conditions: Amyotrophic Lateral Sclerosis

Summary: als is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). als is the most common of the five motor neuron diseases.riluzole (rilutek) is the only treatment that has been found to improve survival but only to a modest extent. it lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. it also extends the time before a person needs ventilation support.stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

in this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in icu to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:als-frs,emg-ncv,fvc,side effect check list.

Eligibility criteria:
inclusion criteria: * age:18-65 * both gender * duration of disease\<2 years * fvc\>40% als-frs\>26 exclusion criteria: * neurological and psychiatric concomitant disease * concomitant systemic disease * treatment with corticosteroid,ig,immunosuppressive during 12 months.

Keywords: mesenchymal stem cell intraventricular injection als
diazoxide-mediated insulin suppression in hyperinsulinemic obese men

Conditions: Obesity; Hyperinsulinism

Summary: the purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia. obesity is associated with markedly elevated plasma insulin levels throughout the day. the concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. according to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.

the purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia. study design: this study is an open-labelled, non-randomized, phase iia study. treatment: during a 6 month period, the dosage of diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels. endpoints, monthly determined: * body weight * abdominal circumference * body composition measured by dual energy x-ray absorptiometry * glucose tolerance

Eligibility criteria:
inclusion criteria: * fasting glucose \< 7.0 mmol/l * fasting c-peptide plasma level \> 1.0 nmol/l * hba1c of 6.0% or lower * absence of comorbidity * absence of medication use exclusion criteria: * plasma creatinine \> 120 micromol/l * liverenzymes \> 2 times the upper normal limit * gout * alcohol use \> 2 units/day * illicit drug use * quit smoking less than 6 months ago

Keywords: obesity hyperinsulinism diazoxide
evaluation of the strong hearts urban program

Conditions: Cardiovascular Diseases

Summary: the aim of this study is to assess the feasibility and preliminary effectiveness of the adapted strong hearts (sh) intervention to improve weight status, american heart association's life's essential 8 (aha essential 8), and health behaviors among black/african american and/or hispanic/latinx urban residents with overweight or obesity.

cultural adaptation of effective health behavior interventions holds the potential to improve health behaviors and ultimately health outcomes among underserved populations. the strong hearts (sh) urban intervention will adapt the existing sh curriculum for delivery in urban dallas communities to improve weight status and life's essential 8 score for ideal cardiovascular health. despite declines in heart disease mortality in the united states since 2000, it remains the leading cause of mortality in both men and women-accounting for about one-third of all deaths in the u.s. costs related to cardiovascular disease (cvd) place a substantial financial burden on the health care system, accounting for an estimated $320 billion in 2016. although most obesity or cvd prevention programs target only the individual level, the us centers for disease control and prevention recognizes that health is affected by factors at multiple levels: individual (e.g., behaviors, knowledge, attitudes, skills, psychological factors), social (e.g., influences from one's social network on health-related behaviors), and environmental (e.g., safe places to walk, food choices at workplaces, availability of affordable fruits and vegetables), and recommends integrating approaches to make changes beyond the individual level to support long-term, sustainable behavior change. providing individuals with the motivation, skills, and opportunity to change behaviors may be less effective if their social or community environment makes it difficult to adopt or maintain these behaviors sh is a multilevel, multicomponent community-based program, in which an experiential learning focus is combined with social and environmental components, including civic engagement activities related to local resource awareness and enhancement. there is limited knowledge about how programs and services can move beyond commonly used individual-level approaches, which have limitations in terms of cost, impact, reach, and sustainability, to effectively reduce cvd health disparities using an integrated, multi-level, community-engaged approach. this pilot study will provide needed data on the feasibility and preliminary effectiveness of such approaches in urban and underserved communities.

Eligibility criteria:
inclusion criteria: 1. women aged 18 or older 2. overweight or obese (bmi≥25) 3. less than 150 minutes of moderate physical activity per week 4. black/african american race and/or hispanic/latinx ethnicity exclusion criteria: 1. pregnancy, or intent to become pregnant during the study duration 2. unable to read and communicate in english 3. planning to participate in another health behavior change program in the next three months 4. unable/unwilling to provide informed consent
is vitamin d2 treatment-associated decrease in 25(oh)d3 level a reciprocal phenomena?

Conditions: Vitamin D Deficiency; 25-Hydroxyvitamin D Concentration

Summary: several studies have demonstrated that d2 treatment is associated with a decrease in 25(oh)d3 level and therefore have proposed that d3 would be preferable in term of raising total 25(oh)d level. the investigators postulate that the d2 treatment-associated decrease in 25(oh)d3 level may be related to an increase in total 25(oh)d level rather than being specific to d2 treatment, and thus there would be a d3 treatment-associated decrease in 25(oh)d2 level. the investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of d3 treatment on 25(oh)d2 level and the effect of d2 treatment on 25(oh)d3 leve


Eligibility criteria:
inclusion criteria: * non-pregnant adults (age ≥18 years) * healthy * total 25(oh)d level between 20 to 65 nmol/l. * living in riyadh area exclusion criteria: * consumption of more than one serving of milk daily * taking vitamin d supplements * habitual weekly sun exposure of 10 hours or more * history of granulomatous, liver, or kidney disease * taking anticonvulsants, barbiturates, or steroids
role of roflumilast in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study aims to investigate possible efficacy and safety of roflumilast in adult patients with ulcerative colitis disease .

* study design and study population this study will be randomized, controlled, parallel study. * it will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. group 1 (n=26): patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months. 2. group 2 (n=26): patients will receive previous conventional treatment and roflumilast (500 mcg ) orally once daily for 3 months * patient will be selected from gastroenterology and endoscopy unit, internal medicine department, tanta university hospital. * a written informed consent will be obtained from all patients * this study will be approved by the research ethics committee of tanta university. * any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form . * randomization will be carried out based on days of hospital admission

Eligibility criteria:
inclusion criteria: * patients referred to endoscopy units in tanta university hospitals during the period of the study. patient with mild to moderate uc diagnosed as: 1. clinical signs: patients with moderate clinical disease have frequent loose, bloody stools (\>4per day), mild anemia, and abdominal pain that is not severe. patients have minimal signs of systemic toxicity, including a low-grade fever. adequate nutrition is usually maintained, and weight loss. 2. endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis. exclusion criteria: * other inflammatory bowel disease (crohn's disease) . * patients \ 80 years * patients who didn't give consent to participate in the study * patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded * history of allergic reaction to roflumilast or any component of the formulation like rash , hives ,itching and redness . * depression , thoughts of suicide , anxiety and emotional instability . * excessive weight loss . * moderate to severe hepatic impairment (child pugh class b or c) . * strong (cyp3a4) inducers : barbiturates (phenobarbital) , carbamazepine , phenytoin , rifampicin ( risk , x interaction ) * loxapine ( risk , x interaction )
12-week pilates program on community-dwelling middle-aged women

Conditions: Functional Fitness; Health Promotion; Exercise; Frail Elderly Syndrome

Summary: the purpose of this study was to investigate the effects of a pilates exercise intervention program on functional physical fitness in community-dwelling middle-aged women.

based on quasi-experimental design with a parallel control group, subjects were allocated into to intervention group and control group with convenience sampling method. the primary outcome included body composition, basal metabolic rate, and functional physical fitness-comprising cardiovascular capacity (3-minute step test), flexibility (sit-and-reach test), muscular strength of upper limbs (grip-strength test), muscular strength of lower limbs (30 s chair stand test), core strength (bent-knee sit-up test), agility (8-foot timed up-and-go test), static balance (single-leg stance with eyes closed test), and dynamic balance (functional reach test), assessed in both groups before and after the 12-week intervention.

Eligibility criteria:
inclusion criteria: * female 45-64 years old in age exclusion criteria: * cognitive-function impairment * spinal disease * unsuitability for engaging in physical activity (e.g., because of severe cardiovascular disease) * muscular strength affected by medication for nervous system diseases.

Keywords: pilates middle-aged women