Kornimate/medical-research-clean huggingface dataset:
atac - bone density sub-protocol

Conditions: Bone Density

Summary: to assess and quantify the changes in bone mineral density between the arimidex and arimidex plus nolvadex groups when compared to the nolvadex alone treatment group whilst receiving trial therapy.


Eligibility criteria:
inclusion criteria: * eligible for entry into the main atac trial 1033il/0029 * women defined as post-menopausal * patients with histologically proven operable invasive breast cancer * who following primary surgery have a good prognosis and would be ethically suitable to remain untreated exclusion criteria: * excluded from entry into the main atac trial (1033il/0029) * patients who have received hormone replacement therapy within the previous 12 months prior to randomisation * patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation * patients who have had a bone fracture within the previous 6 months prior to randomisation
bone microarchitecture in acromegaly

Conditions: Acromegaly; Osteoporosis Risk

Summary: the investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with pegvisomant, the growth hormone (gh) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (igf-1) levels. this study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease.

growth hormone (gh) and insulin-like growth factor-1 (igf-1) are important regulators of bone modeling and remodeling, fundamental to maintenance of normal skeletal integrity. in acromegaly, a disease characterized by longstanding exposure to excess gh and igf-1, these hormones induce marked skeletal changes. most dual energy x-ray absorptiometry (dxa) studies report that bone mineral density (bmd) is normal in acromegaly. despite this, however, there is mounting evidence that bone health is adversely affected in patients with both active and successfully treated acromegaly.

Eligibility criteria:
inclusion criteria: * individuals with acromegaly * on pegvisomant therapy with a normal igf-1 level for at least 1 year exclusion criteria: * malignancy (except cured basal, squamous cell skin carcinoma or other cured cancers free from recurrence \> 3 years) * pregnancy or lactation within last 12 months * untreated primary hyperparathyroidism, hyper- or hypothyroidism * cushing's syndrome * prolactin-secreting pituitary adenoma * gh deficiency * on current drug therapy for osteoporosis * diabetes mellitus * renal insufficiency * liver disease * current or past use of glucocorticoids (more than physiologic dose), anticonvulsants, anticoagulants, methotrexate, aromatase inhibitors

Keywords: acromegaly pegvisomant osteoporosis
care for post-concussive symptoms

Conditions: Concussion

Summary: the proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from seattle children's hospital departments of sports medicine and rehabilitation medicine. consent and assent will be obtained in-person. participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. the primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. exploratory analyses will examine mri findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.


Eligibility criteria:
inclusion criteria: * between ages 11 and 18 * have sustained a head impact during sports participation * have incurred an onset or increase of at least three post-concussive symptoms following head impact * have increased post-concussive symptoms following head impact have continued for at least 4 weeks * live with their parents or legal guardians * live within commuting distance of seattle children's hospital * willing to participate in assessment and treatment * have at least one parent/caregiver willing to participate in assessment and treatment exclusion criteria: * meet diagnostic and statistical manual of mental disorders (dsm - v) criteria for a psychotic disorder or bipolar disorder * active suicidality * substance dependence
proving utility of a new field-cycling mri prototype in acute stroke patients

Conditions: Stroke Acute

Summary: the goal of this study is to test if a new type of mri scanner, called field-cycling imaging (fci), can show changes in the brain within the first day of a stroke due to a blocked blood vessel or bleeding in the brain. the main question it aims to answer is: • can fci identify brain tissue that might recover within the first few hours after a stroke begins? participants will undergo a standard mri scan and an fci scan, as soon as possible after hospital admission. participants who have had a blocked blood vessel will also provide a blood sample and will have a follow up visit at 30 days for repeat of both scans and providing another blood sample.


Eligibility criteria:
inclusion criteria: * acute stroke (\<24 hours from symptom onset). * nihss ≥4 and \<25 with cortical involvement and/or large vessel occlusion on baseline imaging. * able to undergo 3t and fci mri \<24h of onset. * with or without thrombolysis. exclusion criteria: * contraindications to mri. * medically unstable. * unable to comprehend or comply with instructions regarding scanning * prior mrs of \>3. * identified for thrombectomy. * non-stroke pathology or previous cortical infarct on ct scan \> 1/3 of middle cerebral artery territory.

Keywords: stroke field-cycling imaging fci
hip related functional limitations in individuals with idiopathic scoliosis

Conditions: Scoliosis Idiopathic

Summary: the aim of this study is to examine the functional parameters of hip and jaw in terms of scoliosis degree and scoliosis pattern in individuals with idiopathic scoliosis.

in this study investigators will examine the hip functional parameters and jaw functional parameters separately. in hip study hip functional parameters will be evaluated for determining the correlation between scoliosis degree/pattern and hip functions. in jaw study jaw functional parameters will be evaluated for determining the correlation between scoliosis degree/pattern and hip functions.

Eligibility criteria:
inclusion criteria: (for all hip and jaw evaluation) * having been diagnosed with adolescent idiopathic scoliosis by a specialist physician with existing anterior-posterior and lateral lateral radiographs, * primary curvature over 10 degrees in the coronal plane according to the cobb method, * being literate, * to cooperate in answering and implementing evaluation scales, * children with written consent from their parents and themselves will be included. exclusion criteria: (for hip evaluation) * having any systemic illness, * spinal surgery history, * presence of any acute or chronic disease other than scoliosis, * inadequate quality to examine the measurement parameters of the current vertebral radiography, * use of musical instruments, * long-term and professional sports. exclusion criteria: (for jaw evaluation) * having any systemic illness, * spinal surgery history, * presence of any acute or chronic disease other than scoliosis, * aesthetics or any injection intervention in the face and neck area, * spinal surgery history, * orthodontic treatment, * use of musical instruments, * long-term and professional sports.

Keywords: scoliosis hip jaw adolescent idiopathic scoliosis
influence of tobacco smoking on the development of obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea; Tobacco Use

Summary: the aim of this study was to retrospectively evaluate the influence of tobacco smoking on the development of obstructive sleep apnea (osa).

the aim of this study was to retrospectively evaluate the influence of tobacco smoking on the development of obstructive sleep apnea (osa). statistical analysis will be performed on this retrospective population to determine in tobacco smoking could influence the development of osa.

Eligibility criteria:
inclusion criteria: * all patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography exclusion criteria: * none
role of intraoperative beta blocker for morbid obese patients undergoing laparoscopic bariatric surgery

Conditions: Intraoperative Awareness; Postoperative Pain

Summary: using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, pnv and postoperative hypoxia.

postoperative pain, nausea, vomiting (pnv) and hypoxia are common in relation to laparoscopic bariatric surgery. sympatholytic drugs might decrease the need for intravenous or inhalation anesthetics and opioids. in this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, pnv and hypoxia. methods: sixty patients have been included. propofol, fentanyl and rocuronium were used for induction. study groups were as follows; group e esmolol infusion was added to maintenance anesthetics (sevoflurane and fentanyl), group n only sevoflurane and fentanyl was used during maintenance. they have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and pnv. visual analog scale (vas) scores for pain was also been assessed.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i - ii patients * age between 18-59 years * both genders * body mass index (bmi) \> 45 kg/m2 exclusion criteria: * patients with -hepatic * renal * cardiac * respiratory diseases * patients with a history of drug abuse or who were dependent on opioid drugs.

Keywords: role intraoperative beta blocker bariatric surgery morbid obese
project share (senior health and alcohol risk education)

Conditions: Alcohol Consumption

Summary: older adults become more sensitive to alcohol, and alcohol also interacts adversely with their common medical conditions and medications. the aim of project share (senior health and alcohol risk education) is to see whether patient and provider education can decrease risky alcohol use and reduce health care costs in persons 60 years of age and older.

alcohol use in the elderly is an increasingly important public health problem. alcohol-related risks and problems in older persons may come from the interaction between alcohol and diminished health or medication use. the proposed study is a randomized trial of the effectiveness and cost-effectiveness of an integrated patient-provider intervention to prevent risky alcohol use among older adults. the intervention will include a tested screening and education system that was developed especially for older adults and their providers, supplemented by a well-established intervention for physicians. the proposed research design involves randomization of 31 primary care physicians in seven clinics and their eligible patients aged 60+ to the intervention versus "usual care."

Eligibility criteria:
inclusion criteria: * 60 and over * at-risk drinkers * patient of participating physician exclusion criteria: * severe cognitive impairment * terminally ill or deceased * expected to move out of area or into nursing home within following year * could not fill out written surveys in english * likely dependent drinker

Keywords: at-risk drinking alcohol education effectiveness cost-effectiveness
a 7-year assessment on subject understanding of zyban/ wellbutrin associated risks

Conditions: Depressive Disorder, Major

Summary: branded bupropion hydrochloride products including zyban and wellbutrin range are approved for the treatment of smoking cessation and depressive disorders respectively. the risk evaluation and mitigation strategy (rems) for zyban was initially approved in 2010 and consists of a medication guide and a timetable for rems assessments submission at 18 months, 3 years and 7 years from the date of initial approval of rems. the present study is a 7-year rems assessment to evaluate subjects' understanding of the potential serious risk of neuropsychiatric adverse events associated with the use of zyban, wellbutrin, wellbutrin sr, and wellbutrin xl. the assessment will be a 20-minutes knowledge, attitudes and behavior (kab) survey and will be conducted among approximately 125 subjects currently using or who have filled a prescription for a branded bupropion product for smoking cessation within the 6 months prior to survey administration. zyban, wellbutrin, wellbutrin sr, and wellbutrin xl are registered trade marks of the gsk group of companies.


Eligibility criteria:
inclusion criteria: * subjects who currently use or who have filled a prescription for zyban, wellbutrin, wellbutrin sr, or wellbutrin xl for smoking cessation within the previous 6 months. (note: branded bupropion hydrochloride product use will be confirmed through a series of questions within the screener concerning manufacturer information detailed on the product label \[label on medication container\] and following a review of photographs of generic bupropion, zyban, wellbutrin, wellbutrin sr or wellbutrin xl tablet types online or via a paper copy sent with the invitation letter for those who choose to participate via phone) * 18 years of age or older * fluent english speaker (for telephone) * consent to take the online survey or have the survey administered via a telephone interview exclusion criteria: * subjects taking generic bupropion * subjects who currently use or who have filled a prescription for a branded bupropion product for depression alone * under 18 years of age * previous participation in a branded bupropion hydrochloride survey, which will be determined via self-report in the survey

Keywords: rems smoking cessation wellbutrin zyban neuropsychiatric adverse events
open trial of escitalopram treatment for male subjects with posttraumatic stress disorder

Conditions: Chronic Posttraumatic Stress Disorder

Summary: the primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, escitalopram, in the treatment of posttraumatic stress disorder (ptsd) in an open clinical trial. a secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with ptsd and if increases in allopregnanolone levels are correlated with treatment efficacy.


Eligibility criteria:
inclusion criteria: * current dsm-iv tr ptsd and a score \> 40 on the caps, as a result of a traumatic event that occurred at least 6 months prior to evaluation. exclusion criteria: * lifetime history of bipolar or any psychiatric disorder with psychotic features. * prominent suicidal or homicidal ideation. * history of alcohol abuse/dependence within the past 3 months. * history of drug abuse/dependence within the past 6 months. * subjects who plan to start a new form of psychotherapy during the protocol. * history of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function. * history of myocardial infarction in the past year. * subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks. * use of citalopram or escitalopram within the past 6 months.

Keywords: posttraumatic stress disorder escitalopram efficacy
evolution of lymphocyte populations under biotherapy in inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: this is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (ibd).


Eligibility criteria:
inclusion criteria: * patients aged 18 or more. * crohn's disease diagnosis (cd) or ulcerative colitis (uc) according to defined criteria (ecco recommendations). * active disease as defined by clinical biological and/or morphological assessment. * initiation of an anti-tumor necrosis factor (tnf) therapy (infliximab, adalimumab, golimumab) or new biotherapy (vedolizumab, ustekinumab) provided in connection with the management of digestive disease. * patient (e) have signed and dated consent of the study before undertaking procedures related to the study. exclusion criteria: * patients under guardianship / curators * following situations * persons unable to understand, read and / or sign an informed consent * patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study * uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year. * no affiliation to a social security scheme, a universal medical coverage or any similar plan. * pregnant or lactating women.
effect of tdcs combined with intraoral electrical stimulation

Conditions: Pontine Infarction

Summary: objective: to investigate the clinical efficacy of transcranial direct current stimulation (tdcs) combined with intraoral electrical stimulation in patients with dysphagia after pontine infarction. methods: this prospective study enrolled a total of 90 patients with dysphagia due to pontine infarction from october 2022 to november 2024, and they were divided into three groups according to the treatment method: control group a, control group b, and experimental group c. control group a was given intraoral induction electrical stimulation, control group b was given transcranial direct current stimulation (tdcs), and experimental group c was given tdcs combined with intraoral induction electrical stimulation. the three groups were compared in terms of efficacy, modified waffield drinking water test score (mwst), penetration-aspiration scale (pas), functional oral intake scale (fois), hyoid-larynx complex mobility, maximum amplitude of surface electromyography, and swallowing time.


Eligibility criteria:
inclusion criteria: * patients with dysphagia (able to cooperate with swallowing assessment) and consistent with the criteria of the "chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018"\[9\] or pontine infarction by clinical imaging examination; * age≥18 years or ≤80 years; * the modified water swallow test (mwst) score is 3-5\[10\] or the functional oral intake scale score \<4 exclusion criteria: * those who are intolerant to electrical stimulation or allergic to auxiliary electrodes; * patients with implanted pacemakers, metal stents in the neck, or other reasons that cannot be treated with electrical stimulation; * patients who are critically ill or unable to cooperate with the assessment and treatment of patients with dysphagia due to other reasons.

Keywords: pontine infarction dysphagia transcranial direct current stimulation inductive electrical stimulation in the mouth
a study of the efficacy and safety of cp-601,927 augmentation of antidepressant therapy in major depression

Conditions: Major Depressive Disorder

Summary: the primary objectives of this study are to: 1) evaluate the efficacy of cp 601,927 compared to placebo in the augmentation of antidepressant therapy (adt) in patients with major depressive disorder (mdd) using the montgomery asberg depression rating scale (madrs). 2) evaluate the safety and tolerability of cp 601,927 in patients with mdd on adt.

the study was stopped at interim analysis in august 2011, as stopping criteria for futility were met. there was no statistically significant change on the primary efficacy scale in favor of the drug. there was a very small chance that any additional data could change the study overall outcome. there were no concerns regarding subject safety.

Eligibility criteria:
inclusion criteria: * medically healthy males or females aged 18-65 (inclusive). * patients must have a primary current diagnosis of mdd without psychotic features. * patients must be receiving ongoing antidepressant therapy at the time of screening. duration of the current episode of mdd must be at least 8 weeks prior to enrollment without adequate response to treatment. exclusion criteria: * patients with other psychiatric disorders. * patients who use tobacco products. * alcohol or substance abuse or dependence. * treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment. * pregnancy or breastfeeding. * clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination.

Keywords: antidepressant augmentation
lifestyle intervention feasibility for arrhythmia and symptoms with intermittent fasting (life as if)

Conditions: Obesity; Morbid Obesity; Diabetes Mellitus, Type 2; Atrial Fibrillation

Summary: background and rationale two out of three americans are overweight and obesity is associated with hypertension, sleep apnea, atrial fibrillation. metabolic syndrome with centripetal obesity is also a precursor to insulin resistance and the development of type ii diabetes mellitus. while multiple strategies for weight reduction are often recommended in physician visits, calculating calories and energy expenditure is often inconvenient and does not promote compliance. intermittent fasting, or time-restricted eating, is a methods to limit caloric intake by fasting for 16 hours to promote ketosis and suppress insulin secretion. weight loss and reduction in body fat has been observed with brief periods of intervention as time-restricted eating results in reduction in overall caloric intake. prospective feasibility studies and randomized comparative trials with intermittent fasting are lacking. the investigators recommend caloric restriction in all of our patients that suffer from arrhythmias and bmi \>30. however, they have not systematically measured compliance and the efficacy of lifestyle interventions. lifestyle counseling and weight loss has been shown to decrease the progression and burden of symptomatic atrial fibrillation. intermittent fasting can result in consistent reductions in body fat and weight without specific lifestyle counseling. the aim of the present observation cohort study is to assess the feasibility of recommending intermittent fasting in an arrhythmia clinic with regard to compliance and efficacy. the investigators hypothesize that compliance and adherence to a 16/8 intermittent fasting regimen will be \>25% and result in weight loss, compared to the 6 month trend prior to the intervention. this pilot study will serve as the basis to power the first randomized trial comparing intermittent fasting with other types of dietary counseling for arrhythmia outcomes. objectives to prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.


Eligibility criteria:
inclusion criteria: * age ≥18 * bmi≥ 30 * ongoing evaluation and management of cardiac arrhythmias exclusion criteria: * pregnant or nursing * eating disorder or history of eating disorders (self-report) * diabetic mellitus type 1 or insulin requiring type 2 diabetes

Keywords: obesity fasting diet