Kornimate/medical-research-clean huggingface dataset:
metformin as an add-on or monotherapy in treatment of aging people with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the goal of the study is to learn about treating older people with multiple sclerosis (ms) with metformin. metformin may be used as a single therapy or as an add-on therapy. the investigators want to learn: * the safety and tolerability of metformin extended release (1500 mg/day) as a single therapy or as an add-on therapy in older people with ms compared to placebo * how well metformin protects the nervous system against injury compared with placebo measured by brain mri over a 9 month treatment period * the effect of metformin to protect brain tissue from age and ms related injury when compared to the placebo group over a 9 month treatment period

specific aims and rationale: the main aim of this study is to determine the safety of metformin as monotherapy or as an add-on therapy to the disease modifying treatment in aging people with multiple sclerosis (pwms). while the tolerability of metformin has been studies in the general population, data specific to the ms population is not currently available. moreover, understanding the gastrointestinal tolerability of metformin when added on ms disease modifying treatment is needed. secondly, the study aims at understating the potential neuroprotective properties of metformin as measured through magnetic resonance spectroscopy and change in n-acetyl-aspartate (naa) levels over a 9-month study period. this pilot study will provide valuable insights into the efficacy and safety of add-on or monotherapy metformin therapy as a potential therapeutic approach to address the complex pathophysiology of ms and offer new avenues for promoting neuroprotection along with potential support for neural repair and remyelination in individuals with this debilitating condition. previous pre-clinical studies have shown that metformin can promote neuroprotection by reducing oxidative stress and inflammation and is able to enhance the reparative mechanisms within the central nervous system (cns). currently there are no neuroprotective interventions available for pwms that directly target the neurodegenerative component of ms, with particular emphasis for the aging ms population. the investigators hypothesize that older pwms that are treated with metformin will have a significantly lower decline in n-acetylaspartate levels when compared to pwms not treated with metformin.

Eligibility criteria:
inclusion criteria: 1. age between 55 and 75 years old 2. having a diagnosis of ms based on the latest mcdonald criteria 3. non-active disease course (no relapses and no mri activity) in the last 2 years as determined by the ms provider and based on the 2020 revised clinical course criteria 4. edss score \<7.0 exclusion criteria: 1. inability to undergo mri scans 2. inability to participate in the study during the study period 3. diabetes or uncontrolled cardiovascular disease 4. unable to consent

Keywords: metformin
nurses' knowledge and attitude about opioids

Conditions: Opioid Use, Unspecified; Nurse's Role; Knowledge, Attitudes, Practice

Summary: opioid analgesics used in moderate or severe pain have potential side effects and addiction. therefore, nurses have hesitations about opioid administration.this descriptive study aimed to evaluate the attitude and knowledge of nurses working in a university hospital about opioids. one hundred twenty-seven nurses were interviewed in the research population. the research data were obtained from the questionnaire, prepared by the researchers, between 01-05 june 2018. it consisted of three parts: descriptive characteristics, attitudes, and knowledge on opioid administration, and evaluation of basic nursing skills and pharmacology about opioids. statistical package for social sciences (spss) 24.0 package program was used for statistical analysis.

analgesics do not eliminate the cause of pain but reduce or eliminate that feeling. non-steroid analgesics are preferred in mild and moderate, and opioids are used to moderate or severe pain that does not respond to anti-inflammatory agents. however, nurses avoid the administration of opioids because of side effects and addiction risk.the first step in the effectiveness of pain management in the emergency department is evaluation and control. pain control should be included in the emergency management system from the stage of triage assessment of the patient and should be concluded with the correct analgesic use, if necessary. in emergency departments, waiting for analgesia can be prolonged unnecessarily, and mostly insufficient doses of analgesics administered.mainly the use of opioids in the emergency department is not preferred much because it reduces the symptoms and masks the examination findings. however, against this conventional idea, recent studies have shown that opioids use reduces pain-related anxiety.also, it increases the patients' participation in the examination, thus making it more effective. while patients feel better, symptoms such as tenderness and defense were generally not affected by analgesia.this descriptive study was conducted to evaluate the attitude and knowledge of nurses working in a university hospital about opioid analgesic administration, after the ethical committee approved.

Eligibility criteria:
inclusion criteria: nurses, working university hospital, accepted to join to study - exclusion criteria: * other health care personnel, did not accept to join to study, long term leaving from job

Keywords: opioid knowledge attitude nursing
determination of the glycemic index values of 10 cereal-based products

Conditions: Low Glycemic Index (GI) Food; Pre Diabetes; Diabetes

Summary: to determine the glycemic index values for 10 cereal-based products

to determine the glycemic index values for 10 cereal-based products per international standard (iso26642:2010) for glycemic index determination.

Eligibility criteria:
inclusion criteria: * 10 healthy participants, male and female (non-pregnant, non-lactating) of mixed ethnicity, aged between 18 - 65 y * bmi: 18 - 25.0 kg/m2 (bounds included) * non smokers * normal glucose tolerance (assessed by 50 gram oral glucose tolerance test performed within the last 30 days: fasting \<6 mm, 2 hr glucose \<7.8 mm) * stable weight and dietary habits. normal eating patterns and no history of eating disorders or recent dieting * normal sleep patterns (ie. at least 6 hours of sleep per night) * the participants are required to avoid alcohol and unusual levels of food intake and physical activity for the 24 hours before each test session. * absence of health conditions that would prevent fulfillment of study requirements as judged by the investigator on the basis of medical history. understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. exclusion criteria: * food allergy or intolerance to the study ingredients (eg. gluten, etc.) * regularly taking prescription medication other than standard contraceptive medication * taking any medications known to affect glucose tolerance (eg. acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis) * suffering from any illness or disease * following a restricted diet * smokers * eating disorders * abnormal glucose tolerance or known history of diabetes mellitus. * individuals currently participating in other acute metabolic studies * failure to meet any one of the inclusion criteria

Keywords: low gi food glycemic index cereal carbohydrate glucose
a study of yoga for treating geriatric insomnia

Conditions: Primary Geriatric Insomnia; Sleep Initiation and Maintenance Disorders

Summary: insomnia is common in the elderly population and is associated with increased health problems, reduced quality of life and greater use of sleep inducing drugs. this research aims to examine the effectiveness of yoga practice to treat insomnia in elderly people, determine the ability to enhance their quality of life and determine if it is suitable to western culture and conditions.

introduction: geriatric insomnia is prevalent, reducing life quality, diminishing cognition and increasing risk of accidents and mortality. treatment with sedative-hypnotic drugs has limited effectiveness and further increases the risk of accidents and falls. yoga has been shown to increase well-being in the elderly. hypotheses 1. integrated yoga style practice can improve sleep quality/quantity 2. integrated yoga style practice can improve quality of life. objectives: 1. examine effectiveness of yoga for insomnia and reduction in use of hypnotics/relaxants in the elderly; 2. determine whether yoga enhances quality of life in the elderly; and 3. determine whether yoga is suitable for elderly in western culture(s). methods: a mixed design crossover controlled trial (n =74, age range 60-87, m = 74.4, sd = 7.1) with 2 weekly classes incorporating physical and meditative yoga, and daily home practice of meditative yoga for 12 weeks. measures included self-reported assessment of sleep quality (sleep logs, kss, ess, psqi, maps), mood states (dass, poms), general health (sf-36) and mobile objective home sleep studies.

Eligibility criteria:
inclusion criteria: * age 60 years or older * independent, self mobile * suffering from light to severe primary insomnia exclusion criteria: * age less than 60 years * currently or in the past engaged in regular yoga practice * suffering from any physical or mental health condition or disability which may affect sleep, or for which yoga practice is counter indicated or may lead to health risks or complications. * suffering from co-morbid insomnia in conjunction with another condition clearly salient to sleep disturbance.

Keywords: insomnia geriatric yoga sleep electrocardiogram
efficacy & safety of td-1473 in ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: a phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with td-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

this protocol consists of 3 separate studies: an 8-week phase 2b dose-finding induction study, an 8-week dose-confirming phase 3 induction study, and a 44-week phase 3 maintenance study. subjects who respond to induction will enter the maintenance study; those who do not will receive td-1473 during extended induction. the safety and efficacy data of the phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory phase 3 studies. participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies. 240 subjects are planned for the phase 2b and the planned primary completion date for this portion of the study is july 2021. 640 subjects are planned for the phase 3 portion of the study.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age at screening * has a history of uc for at least 3 months prior to screening * has moderately-to-severely active uc, as defined by a mayo endoscopic subscore of ≥2 points and an adapted mayo score between 4 - 9 points inclusive * is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics * willing to use highly-effective methods of contraception during the study and for 7 days after the last dose * additional inclusion criteria apply exclusion criteria: * has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation * likely to require surgery for uc or other major surgeries * has previously received / is currently receiving prohibited medications within specified timeframe * is refractory to 3 biologics with ≥2 mechanisms of action * has a current bacterial, parasitic, fungal, or viral infection * has clinically significant abnormalities in laboratory evaluations * has had any prior exposure to an approved janus kinase (jak) inhibitor or potential exposure to an investigational jak inhibitor that was stopped due to intolerance or lack of efficacy * additional exclusion criteria apply

Keywords: td-1473 janus kinase inhibitor jak inhibitor inflammatory bowel disease ibd ulcerative colitis uc gut selective
support strategies for parents during the first year following their child's diagnosis of sickle cell disorder

Conditions: Sickle Cell Disease

Summary: background: sickle cell disorder (scd), the commonest genetic (faulty gene inherited from both parents) condition in the uk, affects mainly underserved groups. babies with scd must start treatments soon after birth to prevent them becoming unwell. stigma, fear and inequalities can make it difficult for parents to accept their child's diagnosis and access appropriate treatment and support. aim: develop strategies to improve support for parents during their child's first year of life following a scd diagnosis to encourage early engagement with health services. method: comprises two stages: (i) determine why parents choose to engage with support or not (ii) use this information to co-design strategies to ensure greater accessibility of support for parents during their child's first year of life. patient and public involvement: we are working with sickle cell society and parents of children with scd. dissemination: findings will be shared with support groups, charities, health professionals and academics.


Eligibility criteria:
inclusion criteria: * parents whose children have been diagnosed with scd via screening in the last 36 months * health professionals involved in the care of children with sickle cell disorder exclusion criteria: * parents whose inclusion may be contradicted on psychosocial grounds or who are unable to give informed consent. * health professionals who do not have experience of caring for children with sickle cell disorder.

Keywords: sickle cell disease, scd, sickle cell anaemia
renal denervation therapy in hypertensive patients undergoing a-fib ablation

Conditions: Atrial Fibrillation; Hypertension

Summary: we propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

symptomatic atrial fibrillation (af) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. after af ablation hypertension (htn) is a strong predictor for recurrence of atrial fibrillation. drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. our primary hypothesis is concomitant renal denervation therapy along with af ablation is associated with improvement in success rates of af ablation along with adequate control of blood pressure. the specific objectives of this study are to prospectively compare success rates, time to af recurrence, af burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with af ablation alone.

Eligibility criteria:
inclusion criteria: 1. paroxysmal and persistent atrial fibrillation refractory eligible for af ablation as per hrs/ecas/ehra consensus statement.\[23\] paroxysmal af is defined as two or more episodes of af lasting less than 7 days in duration during the last 6 months before enrollment. persistent af is defined as af lasting more than 7 days or requiring cardioversion for termination. 2. hypertension (\>140/80 mm hg) on treatment with at least 1 hypertensive medication. 3. gfr \>60ml/dl using cockcroft- gault equation exclusion criteria: 1. secondary causes of hypertension 2. severe renal artery stenosis or dual renal arteries 3. congestive heart failure with nyha class iii or iv status 4. ef\< 35% 5. la diameter \>6 cm 6. previous af ablation 7. previous renal artery stent or angioplasty 8. severe contrast allergy 9. inability to give informed consent 10. solitary kidney

Keywords: atrial fibrillation hypertension renal denervation
auditory-somatosensory stimulation to alleviate tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.

this study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. this project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation. the device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.

Eligibility criteria:
inclusion criteria: 1. constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology. 2. hearing thresholds better than 50db hl at peak tinnitus frequencies. 3. able to modulate their tinnitus with a somatic maneuver 4. bothersometinnitus. exclusion criteria: * no participation in a tinnitus treatment regimen within the past four weeks * retrocochlear pathology/ viiith nerve lesion

Keywords: tinnitus
preoperative corticosteroid therapy in neonates undergoing cardiopulmonary bypass

Conditions: Congenital Heart Disease; Disorder of Fetus or Newborn

Summary: randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (cpb).

this study proposes a randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (cpb). the study will focus on neonates for a few reasons. although their post-cpb clinical course is typically more severe and intensive care unit (icu) care more prolonged than older children, their modes of morbidity are also well characterized. further, the high level of severity itself provides a substrate for identifying the positive effects of a particular therapy. finally, a therapy identified as beneficial has the greatest potential for benefit in this vulnerable population. the well characterized scenario of low cardiac output syndrome (lcos) will be used as the primary endpoint, while a variety of secondary endpoints will be related to the biochemical anti-inflammatory effects of therapy, icu care and late neurological outcome.

Eligibility criteria:
inclusion criteria: * neonates age \</= 1 month * scheduled to undergo cardiac surgery involving cardiopulmonary bypass (cpb) (reparative or palliative procedures) * inpatient status at musc a minimum of 8 hours prior to planned surgery exclusion criteria: * prematurity: \</= 36 weeks post gestational age at time of surgery * treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery * participation in research studies involving the evaluation of investigational drugs within 30 days of randomization * suspected infection that would contraindicate steroid use (eg - herpes) * known hypersensitivity to ivmp or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding) * preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization * inability to begin the pre-operative study drug at least 8 hours prior to surgery

Keywords: cardiopulmonary bypass (cpb) system inflammatory response low cardiac output syndrome (lcos) in neonates methylprednisolone cardiopulmonary bypass (cpb) in neonates glucocorticoid use in neonatal cardiac surgery steroid
serum neuroglobin and nogo-a concentrations in acute traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: neuroglobin has been described as a marker of traumatic brain injury. nogo-a plays an important role in mediating neuroanatomical plasticity and functional recovery following traumatic brain injury. the investigators sought to examine the changes in serum neuroglobin and nogo-a concentrations in patients with traumatic brain injury during the initial 96-h posttraumatic period and assessed the relation of neuroglobin and nogo-a to glasgow coma score and prognosis of such patients with traumatic brain injury.


Eligibility criteria:
inclusion criteria: * patients who suffered head trauma and whose highest abbreviated injury score (ais) was 3 or less (other than head injury) * patients who delivered to hospital within 4 h exclusion criteria: * patients who suffered open injuries * patients who had existing prior neurological disease * patients whose serial serum samples could not be obtained * patients less than 18 years of age * patients who suffered severe life-threatening injury to organs other than the brain

Keywords: traumatic brain injury neuroglobin nogo-a prognosis
improving nicotine patch adherence among latino hiv-positive smokers

Conditions: Smoking

Summary: the goal of this study is to evaluate a smoking cessation program for latino hiv-positive smokers focused on improving adherence to using the nicotine skin patch.


Eligibility criteria:
inclusion criteria: * 18 years or older * latino * hiv positive * current, daily smoker * ready to set quit date in next 30 days * willing to try the nicotine patch exclusion criteria: * suffering from any medical condition which would prevent using the nicotine patch * currently using other tobacco products or e-cigarettes * currently receiving counseling or medication to quit or reduce smoking

Keywords: smoking hiv latino cessation nicotine patch
5 year follow-up of adolescents with knee pain

Conditions: Patellofemoral Pain Syndrome; Knee Pain

Summary: the prevalence of adolescent knee pain is 33%, and patellofemoral pain (pfp) is the most common diagnosis with a nontraumatic onset. the 5-year prognosis of adolescent pfp compared with other types of knee pain is unknown. in 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on musculoskeletal pain. of these, 504 reported knee pain, and 153 of these were clinically diagnosed with pfp. now, after 5 years, the 504 adolescents, as well as 252 randomly selected adolescents who did not report knee pain in 2011, will be contacted again to gain insights into their prognosis.


Eligibility criteria:
from the 504, 153 were diagnosed with pfp, the criteria for which included: - insidious onset of anterior knee or retropatellar pain for longer than 6 weeks that was provoked by at least 2 of the following: prolonged sitting or kneeling, squatting, running, hopping, or stair climbing; tenderness on palpation of the patella; pain when stepping down; or double-leg squatting. exclusion criteria were: * concomitant injury or pain from the hip, lumbar spine, or other knee structures * self-reported patellofemoral instability * knee joint effusion.