Kornimate/medical-research-clean huggingface dataset:
metformin in asthma for overweight and obese individuals (mina)

Conditions: Asthma; Asthma Chronic; Overweight and Obesity

Summary: this is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

this is a randomized, placebo-controlled, parallel-arm pilot clinical trial. adult participants who are overweight or obese and have not well-controlled asthma despite use of an inhaled corticosteroid will be randomized to metformin, an fda-approved medication for the treatment of type 2 diabetes mellitus, or to placebo, to be taken daily for a total duration of six months. recruitment will occur at two sites in the united states. randomized participants will have regular telemedicine visits to assess side effects and adherence. additionally, participants will have a measurement of asthma outcomes at randomization and at 3 and 6 months after randomization. the purpose of this study is to determine feasibility to inform a future multi-center clinical trial of metformin in this population.

Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma on maintenance therapy * not well-controlled asthma (act score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months) * overweight or obesity: body mass index ≥25kg/m2 * adult: age ≥18 exclusion criteria: * currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding * major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months * other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis * active smoking or former smoker with ≥20 pack-year smoking history * chronic kidney disease: estimated glomerular filtration rate ≤60 ml/min/1.73 m2 * heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man * liver disease: elevation in aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2x the upper limit of normal or prior diagnosis of liver disease * anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females * taking glucagon like peptide 1(glp-1) medications for weight loss * diabetes (hemoglobin a1c ≥ 6.5% or taking metformin or other medications used to treat diabetes) * participation in any other clinical trial (observational studies are permitted)
the influence of a cognitive behavioral approach on changing patient expectations in shoulder pain

Conditions: Rotator Cuff Impingement Syndrome; Rotator Cuff Injury; Shoulder Pain

Summary: background: despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (rtc) related shoulder pain has increased. with the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. the investigators propose a comprehensive intervention that involves patient engagement education, and restructuring of cognitions (peerc) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. the cognitive behavioral therapy (cbt) approaches that form the core of our peerc protocol are patient-centered and are designed to empower the patient in their own recovery process. purpose/aims: to examine the effect of the peerc protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).


Eligibility criteria:
inclusion criteria: * age 18 to 70 * a rotator cuff related shoulder pain diagnosis * a mobile or land-line telephone * ability to read and write english for completion of the self-report forms. exclusion criteria: * the investigators will exclude patients who have received or are scheduled for a surgical intervention for their shoulder condition * demonstrate any evidence of cervicogenic pain and/or radiculopathy from cervical origin * who demonstrate symptoms consistent with thoracic outlet syndrome * the investigators will also exclude individuals who are undergoing treatment for a serious psychological disorder (e.g., severe depression, psychosis).
a comparative analysis of myopia prevalence among madarsa students vs. non-madarsa students in sukkur

Conditions: Myopia

Summary: myopia (nearsightedness) has become a major global health concern, particularly among students, due to factors such as prolonged screen time, close-up work, and limited outdoor activities. in regions like sukkur, pakistan, the educational environments and lifestyles of students in madarsas (religious schools) differ significantly from those in non-madarsa (regular) schools, potentially influencing the prevalence of myopia. this comparative cross-sectional study aims to assess and compare the prevalence of myopia among madarsa and non-madarsa students in sukkur.

the study will be conducted at al shifa trust eye hospital over six months, involving students aged 5-20 years. informed consent will be obtained from parents or guardians, and a structured questionnaire will collect data on lifestyle factors such as time spent on near work, outdoor activities, family history of refractive errors, and the use of corrective eyewear. visual acuity and refractive errors will be assessed using standard eye charts, cycloplegic refraction, and measurements of keratometry, biometry, and axial length. the data will be analyzed using descriptive statistics, including frequencies, means, and standard deviations, with normality tests applied to continuous variables. chi-square tests and independent t-tests will be used for comparative analysis, while logistic regression will assess risk factors associated with myopia. the study will help determine the prevalence of myopia and its contributing factors in these student populations, informing potential interventions.

Eligibility criteria:
inclusion criteria: * students aged 5-20 years.\[18\] * students of sukkur enrolled in either madarsa or schools. * parents or guardians who understand and sign the informed consent form. * students who are willing to undergo an eye examination and complete the research exclusion criteria: * students with known systemic diseases or eye conditions (e.g., cataracts, retinal diseases) that could influence the assessment of myopia. * students who have had corrective eye surgery (e.g., lasik) or those who have worn contact lenses or glasses for less than 3 months. * students unable to participate due to language barriers or other communincation difficulties * students with neurological conditions affecting vision * students unable to cooperate with visual acuity testing due to cognitive impairments"
treating chronic insomnia in breast cancer patients

Conditions: Chronic Insomnia

Summary: this study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

phase iv, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

Eligibility criteria:
inclusion criteria: * female patients aged 21-60 years old * have a negative serum or urine pregnancy test for women of child-bearing potential * have a three-month or longer history of insomnia * self-report \< 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening * a score of less than 60 on the zung self-rating depression scale * self-report bedtimes that do not vary by more than two hours on five nights per week * have completed chemotherapy for breast cancer less than two years prior to study drug administration * have completed chemotherapy for breast cancer for at least two months prior to screening visit * patients that are receiving herceptin are eligible for study enrollment * have completed radiation therapy for breast cancer for at least two months prior to screening visit * ecog (eastern cooperative oncology group)score of 0-1 * be able to read, understand, and provide written informed consent before enrolling in the study * must be willing to comply with all study visits and comply with daily phone calls to the ivrs throughout the study * agree to participate for the entire study period (about two months) exclusion criteria: * metastatic disease * pregnant or lactating female * self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly * self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods * current use of any of the following medications, and cannot discontinue these medications for the duration of the study: hypnotic medication, anti-convulsants, anxiolytics, narcotic analgesics, medications or supplements containing melatonin, ketaconazole and fluconazole * currently taking fluvoxamine, brand name luvox * have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome) * currently on night or rotating shift work * self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week * has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder) * a score of 60 or greater on the zung self-rating depression scale * has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the investigator

Keywords: chronic insomnia
kinespring® system patient preference study

Conditions: Osteoarthritis of the Knee

Summary: the primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the kinespring system.

well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.

Eligibility criteria:
inclusion criteria: * males and females aged 25 - 80 years * diagnosed with osteoarthritis in the knee * experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful * experience knee pain at least once a week * previously failed non-surgical treatments for knee oa pain * pass a security screen exclusion criteria: * do not suffer or has not been diagnosed with knee osteoarthritis * has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)
bariatric surgery and pharmacokinetics of quetiapine

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on quetiapine are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics quetiapine fumarate
observational study to characterize real-world clinical outcomes with relapsing-remitting multiple sclerosis (rrms)

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (dmf). secondary objectives of the study are: to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dmf, glatiramer acetate (ga), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (dmt) and were diagnosed with multiple sclerosis (ms) within 3 years of starting the index therapy; to compare relapse activity, defined as annualized relapse rate (arr), among participants treated with dmf, ga, teriflunomide, or fingolimod; to compare ms-related hospitalizations among participants treated with dmf, ga, teriflunomide, or fingolimod; to compare intravenous corticosteroid use among participants treated with dmf, ga, teriflunomide, or fingolimod.


Eligibility criteria:
key inclusion criteria: * diagnosis of rrms per mcdonald criteria * initiated treatment with dmf, ga, teriflunomide, or fingolimod (defined as index therapy) no earlier than january 2011 and no later than 12 months prior to the date of medical record abstraction (i.e., patient has at least 12 months of data available in the medical record following initiation of index treatment). note: patients who have initiated the index therapy but subsequently discontinued or switched to other therapies are allowed in this study as long as there is at least 12 months of follow-up following the initiation of the index therapy. * have sufficient available medical records for data abstraction to meet the objectives of the study, i.e., the patient was either under the medical care of the investigating site during the entire period of the index treatment or the patient's complete ms disease and treatment history is otherwise available at the investigating site key exclusion criteria: * diagnosis of a progressive form of ms (progressive relapsing, primary progressive, secondary progressive) at any time before or during the period for which data will be collected * have received disease-modifying therapies other than one platform therapy (ifn or ga) prior to initiation of index therapy. in patients for whom ga is index therapy, only one prior ifn therapy is allowed. * have received any formulations of dmf, fumaderm®, or compounded fumarates (e.g., psorinovo) at any time prior to initiation of treatment with tecfidera® * concurrent enrollment in any interventional clinical trial of an investigational product during time evaluated for medical record abstraction note: other protocol defined inclusion/exclusion criteria may apply

Keywords: tecfidera, dmf, dimethyl fumarate, fingolimod, glatiramer acetate, teriflunomide, gilenya, copaxone, aubagio
effects of exercise-intensity on physiological adaptations in overweight and obese

Conditions: Overweight; Obesity

Summary: the main purpose of our study is to examine the physiological adaptations in oxygen transport chain for high-intensity exercise and moderate exercise in overweight and obese humans. the main goals are: 1. to investigate the most effective short-and long-interval training in terms of vo2max, pulmonary diffusion, cardiac output, endothelial function and mitochondrial function. 2. how these physiological adaptations affect the aerobic endurance and performance, and how this training can reduce the risk of cardiovascular diseases related to overweight and obesity.


Eligibility criteria:
inclusion criteria: * bmi \> 25 exclusion criteria: * exclusion criteria will be cardiovascular disease or another disease that is not consistent with high physical activity. subjects should not have exercised regularly before the study.

Keywords: exercise high-intensity interval training
phase iii randomized, double-blind, placebo-controlled study of intravenous immune globulin for chronic inflammatory demyelinating polyneuropathy

Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Summary: objectives: i. compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.

protocol outline: this is a randomized, double-blind study. the first group receives intravenous immune globulin (ivig) on days 1, 2, and 21; the second group receives an intravenous placebo on the same schedule. patients in either group may receive ivig (same dosage as first group) after day 42. concurrent steroids and other immune globulin preparations are prohibited.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- chronic inflammatory demyelinating polyneuropathy (cidp), i.e.: progressive or relapsing motor and sensory dysfunction of more than 1 limb over at least 2 months hypo- or areflexia of at least 2 limbs no myelopathy no central demyelination no drug or toxic exposure known to cause peripheral neuropathy --prior/concurrent therapy-- no prior corticosteroids or other immunomodulators for cidp no prior plasmapheresis at least 30 days since participation in other investigational study at least 6 months since the following: cyclophosphamide intravenous immune globulin cyclosporine interferon alfa azathioprine corticosteroids orthoclone tacrolimus --patient characteristics-- hepatic: no hepatitis renal: not specified neurologic: cerebrospinal fluid (csf) protein greater than 50 mg/dl csf cell count less than 10 csf vdrl negative 3 of the following motor abnormalities by electrophysiology: reduced conduction velocity in 2 or more motor nerves less than 80% of normal if amplitude greater than 80% of normal less than 70% of normal if amplitude less than 80% of normal conduction block or abnormal temporal dispersion in 1 motor nerve no ulnar or peroneal nerve entrapment prolonged distal latency in 2 or more nerves greater than 125% of normal if amplitude greater than 80% of normal greater than 150% of normal if amplitude less than 80% of normal absent f-waves or h response (patients aged under 60) or prolonged shortest f-wave latency in 10 to 15 trials in 2 or more motor nerves other: no hypersensitivity to immune globulin no iga deficiency no mutilation of hands or feet no retinitis pigmentosa no ichthyosis no disease that would limit neuromuscular assessment no endocrinopathy no connective tissue disease or vasculitis no lyme disease no malignancy no castleman's disease no hyper- or hypothyroidism no hiv infection no alcohol or drug abuse no pregnant or nursing women

Keywords: demyelinating neuropathy neurologic and psychiatric disorders rare disease
how well do primary care doctors in region örebro county, sweden follow diagnostic guidelines of ibs?

Conditions: Irritable Bowel Syndrome

Summary: the aim of this project is to investigate the implementation of the rome criteria in daily primary care clinical practice and adherence of general practitioners (gps) to recommended diagnostic approaches for ibs.

irritable bowel syndrome (ibs) is a common functional gastrointestinal disorder. to diagnose ibs, the so-called rome criteria combined with limited laboratory tests should be used. however, within the primary care, too much unnecessary diagnostics, for example radiology and endoscopy, are used. this is meaningless, stressful for the patient and they also cost a lot of money. in örebro region there are 29 public general health centers. approximately 300.000 inhabitants are listed within these health centers. approximately 150 doctors are currently working within the primary health care of örebro region. the software program medrave and the electronic patient register in örebro region allows to search for the international statistical classification of diseases (icd-10) for ibs (k58.9 and k58.0) this allows retrospective research regarding diagnosing ibs, the used diagnostic tools, comorbidities, as well as the different treatments that were used. patients diagnosed with ibs will be identified by icd-code k.58. by evaluating their patient register it will be determined how the gp has made the ibs diagnosis. patients will fall into three categories: those who received a positive ibs diagnosis using the rome criteria, those who received a negative ibs diagnosis and those whose patient record is lacking sufficient information. data will also include demographics, number of gp contacts and referrals to specialists, diagnostic procedures, treatments, and relevant somatic, psychological and psychiatric comorbidities. data regarding substance abuse will be collected as well.

Eligibility criteria:
inclusion criteria: • all adult patients (both sexes) who were diagnosed with ibs according to icd-10 in region örebro county 2015-2019. exclusion criteria: • patients \ 65 years

Keywords: irritable bowel syndrome rome iv functional gastrointestinal disorders