Kornimate/medical-research-clean huggingface dataset:
statin/vitamin d & migraine study

Conditions: Migraine

Summary: the investigators are studying if taking simvastatin and vitamin d together will help prevent episodic migraines. simvastatin is an fda approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. vitamin d is a vitamin found in certain foods like some types of fish, and in nutritional supplements. this study is 9 months long. some people who participate will receive simvastatin and vitamin d, and some people will receive a placebo. a placebo is a "sugar pill" that looks like medication but does not have any active ingredients in it. the investigators hypothesize that taking vitamin d and simvastatin daily may reduce the number of migraines people who have episodic migraine get.


Eligibility criteria:
inclusion criteria: * age 18 years or older * have had migraines for at least 3 years * have between 4 and 15 migraines a month * able to speak and read the english language exclusion criteria: * women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months * individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes * individuals at high risk for cardiovascular disease

Keywords: migraine disorders headache simvastatin vitamin d
the effectiveness of high-flow nasal cannula after extubation in patients

Conditions: Post Extubation Respiratory Failure

Summary: observe the current status of prolonged mechanical ventilation (pmv) patients using high-flow nasal cannula oxygen therapy (experimental group) or traditional oxygen therapy (control group) after extubation, and compare the differences in ventilator weaning rates between the two groups. record the rox index (spo2/fio2/rr) at 2, 6, 12, and 24 hours after extubation in pmv patients and explore whether statistical methods can predict the weaning outcome within seven days. use statistical methods to analyze whether comorbidities in the pmv population affect ventilator weaning rates.


Eligibility criteria:
inclusion criteria: * patients over 20 years old and expected to undergo extubation. exclusion criteria: * patients with tracheostomy who will use non-invasive or invasive ventilators immediately after extubation.

Keywords: post extubation hfnc
a study to assess the effectiveness of aflibercept in routine clinical practice in patients with diabetic macular oedema

Conditions: Macular Edema

Summary: intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (dmo) in europe and the us in august 2014 and july 2014 respectively. the main objectives of this observational cohort field study are to evaluate effectiveness of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti vascular endothelial growth factor (anti-vegf) treatment naïve patients with dmo in routine clinical practice in the united kingdom.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * patients diagnosed with type 1 or 2 diabetes mellitus. * patients diagnosed with dmo with central involvement (defined as the area of the centre subfield of oct) treated with intravitreal aflibercept (in accordance with routine practice). * patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion. * patients must provide written informed consent. exclusion criteria: * patients under the age of 18. * patients with contraindications as listed in the smpc for intravitreal aflibercept. * patients with pre-planned cataract surgery during the observational period. * patients previously treated with intravitreal anti-vegf within 28 days. * patients currently or previously treated with systemic anti-vegf. * patients previously treated with intravitreal fluocinolone acetonide steroid. * patients participating in an investigational programme with interventions outside of routine clinical practice.

Keywords: diabetic retinopathy diabetic macular oedema diabetic macular edema aflibercept
carotid atorvastatin study in hyperlipidemic post-menopausal women

Conditions: Hypercholesterolaemia

Summary: to evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * postmenopausal women defined as having age =\< 70 years with documented menopause * fasting ldl cholesterol 130 mg/ dl (3.37 mmol/l)and =\< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet * triglycerides =\< 4 g/l(4.52 mmol/l) * informed, written consent exclusion criteria: * age \> 70 years * unconfirmed menopause * overall duration of treatment with any hmg-coa reductase inhibitor \> 3 months within the last year * patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization * history of myocardial infarction, coronary bypass surgery, angioplasty, stroke or tia * cpk levels \> 3 times upper limit of normal * body mass index \>= 30
focused ultrasound for the treatment of adhd symptoms

Conditions: ADHD

Summary: the purpose of this open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with attention deficit hyperactive disorder (adhd).

the primary cortical regions thought to be implicated in adhd include the prefrontal, orbitofrontal, and anterior cingulate cortices. a possible treatment approach for adhd would employ a process designed to promote healthier function of the anterior cingulate region. the anterior cingulate in particular appears to be implicated in the activation of cognitive control networks, and has been posited as an area of interest for therapeutic research on adhd. the subjects in this research study will be recruited through medical practice and enrolled in an 8-week protocol to undergo 8 consecutive weekly ultrasound sessions.

Eligibility criteria:
inclusion criteria: * diagnosis of attention deficit hyperactive disorder (adhd) * failure to respond to traditional symptom management (e.g. stimulants, psychoeducation, cognitive-behavior therapy, etc.) * score of at least 8 (4 adhd-positive items) on the adult adhd self-report questionnaire (asrs-v1.1) * at least 18 years of age exclusion criteria: * • subjects unable to give informed consent * subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep * recent surgery or dental work within 3 months of the scheduled procedure. * pregnancy, women who may become pregnant or are breastfeeding * advanced terminal illness * any active cancer or chemotherapy * any other neoplastic illness or illness characterized by neovascularity * macular degeneration * subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) * advanced kidney, pulmonary, cardiac or liver failure
posse project: a community-level intervention for black ymsm

Conditions: HIV/AIDS and Infections

Summary: black young men who have sex with men (bymsm) are at high risk for contracting and transmitting hiv, and represent a priority population for developing effective interventions. within the house ball community (hbc), a clandestine subculture of the black gay community, hiv is highly stigmatized. this stigma, coupled with high hiv prevalence rates and elevated levels of undiagnosed/untreated hiv infection, places bymsm in hbcs at incredible risk for hiv infection. community-level interventions that target social norms, behavior, and stigma in the hbc are sorely needed in order to make a broader impact among bymsm. building on prior work in the community, this study proposes to launch an innovative effectiveness-implementation hybrid type 2 trial to examine the effectiveness and implementation of a community-level hiv prevention intervention (called posse) based on popular opinion leader (pol) models across two cities with similar hbcs, chicago and philadelphia. the proposed study has two specific aims: 1) to determine the effectiveness of a pol intervention, posse, to decrease sexual risk behavior (uai), stis and hiv stigma among bymsm in the hbc; and 2) to evaluate the processes, strategies, barriers and facilitators for the implementation of posse delivered across two distinct metropolitan areas with high hiv prevalence among bymsm and similar house ball communities. to examine these aims, the investigators will first use social network strategies to identify, screen, and recruit pols (n=75) from the philadelphia hbc. the investigators will then gather baseline behavioral and biological (hiv/sti testing) data in both chicago and philadelphia (n=100 bymsm per city) and train the philadelphia pols to implement the posse intervention. the investigators will conduct an implementation-focused process evaluation to assess fidelity to the posse intervention; number, content, spread, and acceptability of risk reduction messages; age appropriateness of the messages; acceptability of the overall intervention; and barriers/facilitators to implementation. next, the investigators will complete follow-up assessments every 6 months post- intervention in both cities (n=100 bymsm per city at each assessment point). the investigators will also assess behavior change in those delivering the intervention (pols) at each assessment point. the investigators will conduct implementation-focused qualitative interviews with pols (n=15) and community participants (n=30) from philadelphia. last, the investigators will implement posse in chicago by repeating the steps outlined above, continuing assessments in both cities, and conducting qualitative interviews in chicago.


Eligibility criteria:
inclusion criteria: * self-identified as black, * between the ages of 15 - 24 (inclusive), and * in attendance at a hbc event at the time of the assessment. exclusion criteria: * intoxicated or otherwise unable to consent at time of enrollment
comparison of the ability of the escco and the volume view to measure trends in cardiac output during cardiac surgery

Conditions: Cardiac Output, Low; Anesthesia

Summary: the purpose of this study was to compare co measured by two easy to use non-invasive monitors, the escco (nihon kohden, tokyo, japan) to the volume view (edwards lifesciences, irvine, usa) and to assess their trending ability in patients undergoing cardiac surgery.

cardiac output (co) is a major physiological variable that should be monitored closely during cardiac surgery in order to assess and guide therapeutic interventions so as to decrease postoperative morbidity. the purpose of this study was to compare co measured by two easy to use non-invasive monitors, the escco (nihon kohden, tokyo, japan) to the volume view (edwards lifesciences, irvine, usa) and to assess their trending ability in patients undergoing cardiac surgery. after internal review board approval and written informed consent, 19 patients were included in this study. before cardiopulmonary bypass (cpb), co was measured simultaneously using both the escco and the volume view device before and after 3 co-modifying maneuvers \[passive leg raise (plr), end expiratory occlusion test (eeot) and positive end expiratory pressure (peep) at 10 cm h2o. five co values for escco and three for volume view were averaged and compared during a one minute period of time before and after each maneuver. the precision error and its 95% confidence interval (ci) that corresponds to the least significant change (lsc) were calculated within this period of time. the bland-altman analysis was used to compare bias, precision and limits of agreement (loa) of both devices. trending ability of co changes was assessed by a modified 4 quadrant plot analysis, within angular limits of agreement considered as acceptable when the mean angle between both delta co was less than 30°.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective cardiac surgery exclusion criteria: * age less than 18 years * known or potential pregnancy * arrhythmias * known significant tricuspid or aortic valve insufficiency * left or right ventricular dysfunction * peripheral arteriopathy * low perfusion index.
effectiveness and safety study of solifenacin succinate and solifenacin succinate + estrogen to treat oab in postmenopausal women

Conditions: Overactive Bladder; Postmenopausal Disorder; Urination Disorders

Summary: this study is a multi-site, randomized, opened and parallel-controlled clinical study. the patients up to the inclusion criteria are randomly treated with solifenacin succinate tablets (5mg/d) or solifenacin succinate tablets (5mg/d) + local estrogen for 12 weeks. before the dosing and at week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.


Eligibility criteria:
inclusion criteria: * post-menopausal women aged ≤75. * signing of icf. * willing to and able to correctly complete the urination diary. * complications of oab for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence). * no dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary. exclusion criteria: * clinically-significant dysuria(at the investigators' viewpoints). * serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators. * at the ongoing intubatton or the intermittent self-intubatton. * evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors. * uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints. * non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study). * dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions * known or suspicious allergy to solifenacin succinate, other anti-cholinergic drugs or lactose. * clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints. * participation in other clinical studies within 30d before the random grouping. * no completion of urination diary according to relevant instructions. * potentially clinically significant abnormalities (pcsa) inapplicable for clinical study at the investigators' viewpoints.

Keywords: overactive bladder solifenacin succinate tablets estrogen
treatment of type 2 diabetes with immunonutrients

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this research study is to determine if the nutrients arginine and fish oil will reverse or improve diabetes and to find out what additional good or bad effects a combination of arginine and fish oil may have. both arginine and fish oil are common nutrients taken by normal people on a frequent basis. however, they have not been used in combination in the proposed doses to reverse diabetes once it is established. this study has been approved by the food and drug administration (fda investigational new drug \[ind\] 12191).

the hypothesis for the proposed studies is that selected immunonutrients will reduce glucose levels in type 2 diabetes and provide the basis for safe and effective treatment. this should result in an increased resistance to infection, decrease in cardiovascular disease and improve mortality as will be shown in subsequent studies. specific aim 1: to demonstrate proof of concept that supplementation of a normal (diabetic) diet with oral arginine and fish oil will reverse or at least improve glucose control, and improve hemoglobin a1c (hga1c) in patients with type 2 diabetes. specific aim 2: to determine the relationship of plasma amino acid profiles and concentration of selected fatty acids in cellular (rbc) membranes to the resolution of type 2 diabetes.

Eligibility criteria:
inclusion criteria: * adult onset diabetics, bmi under 35 with stable glycemic and hypertensive control. must be receiving medication for diabetes, be free of cardiac problems such as myocardial infarction, atrial fibrillation or flutter, severe hepatic or gastrointestinal disease, and have a glomerular filtration rate (gfr) of greater than 50 ml/minute. must have an ldl-c of less than 120 mg/ml with or without treatment. exclusion criteria: * chronic infection, past history of cancer except cured skin cancer. active inflammation processes will also be excluded. pregnant or nursing women will be excluded.

Keywords: diabetes fish oil arginine hyperglycemia
lifestyle intervention to treat diabetes in the marshall islands

Conditions: Type 2 Diabetes Mellitus

Summary: the republic of the marshall islands has the highest prevalence of type 2 diabetes (t2d) in the world. this clinical trial tested whether a community-based, intensive, plant-rich lifestyle intervention with exercise is more effective for treating and managing t2d in the republic of the marshall islands than the standard of diabetes care. the intensive lifestyle intervention consisted of a plant-rich diet and moderate exercise. it centered around a 12-week program of counseling and instruction on healthy eating, exercise, and stress management, as well as hands-on cooking classes and prepared meals. cardiometabolic outcomes were assessed throughout the intervention and at 24 weeks. the present study is the first randomized clinical trial ever conducted in the republic of the marshall islands and the first lifestyle intervention trial conducted in micronesia.


Eligibility criteria:
inclusion criteria: * resident of the republic of marshall islands * aged 18 - 75 years * hba1c ≥ 8.0% or diagnosed with t2d and taking diabetes medication * medical clearance to participate from diabetes wellness center (dwc) physicians. exclusion criteria: * recent (≤3 months) change in a diabetes-related medication dosage * a physical or medical condition that would impede participation in the lifestyle intervention (e.g., wheel-chair bound, unstable angina) * evidence of significant coronary heart disease * previous participation in an intensive lifestyle intervention
assessment of safety and performances of hype scs stem associated to novae sunfit th acetabular cup in hip arthroplasty

Conditions: Hip Arthropathy

Summary: total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. hype scs stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip. clinical data for hype scs available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. thus, in order to maintain compliance with the eu regulation (2017/745) relating to medical devices and following meddev 2.7.1.guidelines, serf has set up post-market clinical follow-ups (pmcf). this pmcf study aims to generate clinical data in order to confirm these performance of hype scs stem associated to novae sunfit th acetabular cup. in the meantime, through complications faced over the entire period of the study, risks related to the implantation of hype scs stems will be assessed at medium term (5 years). it should be noted that this patient cohort reflects the usual medical care of hospital center "j. monod" of flers.


Eligibility criteria:
inclusion criteria: * patients over 18 years old. * patients covered by health insurance system * patients requiring a total hip arthroplasty, implanted swith a femoral stem scs associated to novae sunfit th acetabular cup exclusion criteria: * patient who expressed opposition to participation in the study and to the use of his personal data * patient unable to understand surgeon's instructions and meet follow-ups requirements * patient presenting a contraindication indicated in the ifu of both implantsw * patient presenting a contraindication to have an x-ray * patients implanted with a femoral stem scs associated to novae sunfit th acetabular cup, in context of off-label use

Keywords: total hip prosthesis
investigating the effects of different incision types on aesthetic outcomes and incision-related complications after breast reconstruction surgery

Conditions: Breast Neoplasm Female

Summary: 1. data collection: about 300 cases of female patients who underwent breast reconstruction at hubei cancer hospital(hbch) between february 2013 and june 2023 were retrospectively collected. the incision was defined as the mastectomy incision and was grouped by the commonly used inframammary fold incision, lateral chest wall incision, circumareolar incision, and radial incision. the incidence of postoperative incision-related complications was recorded for different incision types; 2. data organization: patients were divided into subgroups based on history of previous breast surgery, location and size of the lump, retention of the nipple-areola complex, timing of reconstruction, and type of the implant. the correlation of each subgroup with incision design is discussed; 3. follow-up: collected cases were followed up by telephone to complete the breast-q questionnaire (aesthetic score); 4. data analysis: the incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.


Eligibility criteria:
inclusion criteria: 1. total mastectomy 2. implant and/or autologous breast reconstruction. exclusion criteria: 1. no total mastectomy 2. loss of data or loss of follow-up 3. fatal cases
influence of ipv on gor in infants from 0 to 12 months.

Conditions: Gastro-oesophageal Reflux

Summary: the purpose of this study is to determine whether intrapulmonary percussive ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.


Eligibility criteria:
inclusion criteria: * infants from 0 to 12 months * impedance monitoring exclusion criteria: * gestational age \< 24w * anti-reflux medication * nissen fundoplication * no parental consent
upper airway training for treatment of snoring

Conditions: Snoring

Summary: the objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.


Eligibility criteria:
inclusion criteria: 1. fluent in english. 2. age is between 20 and 65. 3. bmi less than 32 4. less than 5% variance in weight since sleep study. 5. snoring without health risk related to sleep apnea and not currently receiving treatment. 1. mild osa or negative hsat or psg within past year with ahi 0-14 2. has refused oral appliances, cpap, weight loss, surgery or positional therapy. 6. owns an iphone 4 or newer and is comfortable downloading and using apps. 7. complaint of habitual snoring 3 or more nights per week 8. rated by polysomnograph technologist as moderate or loud snoring. exclusion criteria: 1. non-fluent in english. 2. persistent rhinitis diagnosis or nasal obstruction. 3. bmi \> 32 4. greater than 5% variance in weight since sleep study. 5. diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, rls) 6. insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report. 7. spouse/partner is also a habitual snorer. 8. lacking ability to consent for themselves. 9. heavy drinker (self reported average more than 2 drinks per day). 10. regular narcotics (greater than 3 times/week) 11. epworth sleepiness scale score \> 11 or one near miss accident in the past 6 months. 12. medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.

Keywords: upper airway exercises smart phone application