Kornimate/medical-research-clean huggingface dataset:
perfect project - part 2 - study 3

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the objectives are to test the acute effects of different bagels containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. we hypothesize that consumption of bagels containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. we also hypothesize that consumption of bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.


Eligibility criteria:
* normoglycemic (\<5.6 mmol/l) and normotensive (systolic blood pressure \<140 mm hg and diastolic blood pressure below \< 90 mm hg) * bmi of 18.5-29.9 kg/m2 exclusion criteria: * restrained eaters * regularly skip breakfast * smokers * those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity) * those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year * those unable to walk for an hour continuously
pilot community clinical study of hypothermia in cardiac arrest

Conditions: Cardiac Arrest

Summary: the overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. in this pilot study we will randomize 125 patients after return of spontaneous circulation (rosc) to hypothermia with rapid infusion of 2 liters of 4oc normal saline iv solution over 20 to 30 minutes, iv sedation and muscle paralysis or to standard of care following rosc. the primary objectives of this study will be to determine whether temperature of 33-34oc can be achieved and maintained using this strategy. the primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. if this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.


Eligibility criteria:
inclusion criteria: * resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose iv access intubated exclusion criteria: * age less than 18 traumatic cause of cardiac arrest

Keywords: cardiac arrest hypothermia
pooled analysis of single-arm studies of budesonide/glycopyrronium/formoterol (bgf) in routine care setting

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the choros pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by astrazeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: united kingdom, germany, italy, greece, japan, canada and romania.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe copd and initiating bgf treatment according to the local prescribing guidance and as per their treating physician's recommendation * enrolled in on-going single-arm studies * provided consent for secondary use of data exclusion criteria: * did not provide consent for secondary use of data
virtual reality pain control orthopedic trauma

Conditions: Trauma/Injury Problem

Summary: the treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. the proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored delivery system that uses audio recordings. the goal will be to reduce postoperative pain in a sample of patients hospitalized for the care of severe orthopedic trauma and other types trauma. this proposal will test innovative and low-risk approaches to reducing postoperative trauma pain that are designed to reduce pain, anxiety and other complications after surgery. the findings have the potential not only to reduce pain and suffering in patients who have suffered severe trauma but could be applicable to the millions of people who have surgery every year. reducing addictive opiate-based medication and health care costs are both potential outcomes from this project.


Eligibility criteria:
inclusion criteria: * compliant and able to complete questionnaires * english speaking * hospitalization for trauma orthopedic injuries * no history of psychiatric disorder * not demonstrating delirium, psychosis or any form of organic brain disorder * able to communicate verbally * 18 years of age or older exclusion criteria: * not capable of filling out study measures * evidence of a traumatic brain injury or any other * cognitive deficits that would impact decisional capacity to consent for the * study or complete measures * history of psychiatric disorder as evidenced in the rn and md admission notes * unable to communicate verbally * extreme susceptibility to motion sickness * seizure history * non-english speaking * in isolation for infections such as clostridium difficile

Keywords: ortho trauma. virtual reality. pain. anxiety
a safety and pharmacokinetics study of idp-122 lotion in pediatric participants with plaque psoriasis

Conditions: Psoriasis

Summary: this study is to evaluate the safety, the systemic exposure of halobetasol propionate (hp), and the hypothalamic-pituitary-adrenal (hpa) axis suppression potential for topically applied idp-122 lotion in pediatric participants with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * is 6 to 16 years 11 months of age at time of informed consent/assent obtained. * verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian. * has a clinical diagnosis of psoriasis at screening and baseline with an investigator's global assessment (iga) score of 3 or 4. the face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present. * has an area of plaque psoriasis appropriate for topical treatment that involves a bsa of at least 10% at screening and baseline. the face, scalp, axillae, and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is \>18 μg/dl at the screening visit. * females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study. exclusion criteria: * has a history of adrenal disease. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device. * received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening hpa axis stimulation test. * has a history of hypersensitivity or allergic reaction to any of the study drug constituents. * is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Keywords: plaque psoriasis
comparison of scheimpflug photos of the crystalline lens in patients who have undergone vitrectomy surgery and controls

Conditions: Nuclear Sclerotic Cataract

Summary: progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years the mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. the objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.

approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.

Eligibility criteria:
inclusion criteria: * phakic eyes of patients that are scheduled to undergo pars plana vitrectomy, * controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery, * age 18 and older exclusion criteria: * any eye that is pseudophakic, * has had previous vitreoretinal surgery, * has had previous intravitreal injection, * previous intraocular inflammatory condition such as uveitis, * previous irradiation, * any patient with a history of ocular malignancy, * history of infectious intraocular condition

Keywords: nuclear sclerotic cataract cataract
awareness on cancer in persons with intellectual disabilities

Conditions: Cancer

Summary: context people with intellectual disability (pwids), nearly 1,300,000 adults and children in france, develop as many cancers as persons in the general population. however, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. these cancers are not well known from physicians, carers and families, and often discovered late. a recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. currently, no population study on clinical features and stage at diagnosis of cancer in pwids is available. no interventional research study has been conducted on this subject. hypothesis investigators hypothesize that inequalities in cancer care of pwids do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.

the study will first evaluate characteristics of all cancers diagnosed in pwids in the department of hérault (20,000 pwids) during the four-year period preceding the intervention. investigators will cross the data of social network of pwids (creai languedoc roussillon) which covers nearly 90% of pwids living in this area, and the hérault cancer registry. second, during a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in pwids by the mean of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in pwids. third, characteristics of tumors observed during the three years after the beginning of the intervention will be statistically compared to the corresponding tumors before the intervention. this will be done especially for colon cancer and breast cancer using the tnm stage and the used therapeutic means. on the basis of the first part of the study, if a significant difference on stage at diagnosis and treatment is observed compared to the general population, other tumors will also be included in the comparison, if relevant.

Eligibility criteria:
inclusion criteria: * persons with intellectual disabilities according to the world health organization definition * residing in the hérault department of france * diagnosis of a malign invasive or in-situ tumor exclusion criteria: * refusal of study participation following provision of information (refusal by the patient, or his/her guardian, or principal caregiver)

Keywords: care of disabled population mental retardation cancer screening cancer prevention
effect of preemptive analgesia with flurbiprofen axetil on perioperative sleep quality and postoperative pain in patients undergoing sevoflurane inhalation.

Conditions: Flurbiprofen Axetil; Preemptive Analgesia; Postoperative Pain; Perioperative Sleep Quality; Postoperative Inflammatory Markers

Summary: in humans and animals, circadian rhythm sleep cycle is an important function to maintain and regulate basic physiological homeostasis, such as cognitive function, glucose metabolism, memory consolidation, immune function and growth hormone secretion. the induction of general anesthesia leads to a state of reduced responsiveness, which is often described by anesthesiologists and patients as "sleep". however, previous studies have shown that in the case of patients under general anesthesia, besides surgery trauma and general anesthetics may change sleep function and sleep cycle perioperatively, the postoperative complications such as pain, nausea and vomitting etc after general anesthesia may also reduce postoperative sleep quality.meanwhile, there is a mixed literature linking sleep and markers of systemic inflammation that greater sleep disturbances were associated with higher levels of circulating il-6 and crp but not tnf-α. and the effects of inflammatory cytokines may also cause changes in sleep patterns. flurbiprofen axetil is a new non-steroidal anti infection analgesic(nsaids), which is widely used for analgesia to reduce the dose of opioids. it not only has a high affnity for infammatory tissues to achieve targeted drug therapy and prolonged duration of action, but causes analgesia effect through decreasing the biological production of prostaglandins, reducing the reactivity of peripheral nerves to endogenous infammatory factors, and inhibiting the sensitization of central as well as peripheral nervous systems.furthermore, it could also inhibite the occurrence of adverse reactions, such as declined sleep quality, respiratory depression, nausea and vomiting. preemptive analgesia is an analgesic intervention that begins before surgery to prevent the nervous system from becoming sensitive to subsequent stimuli that may aggravate pain. a large number of experimental studies have shown that the use of local anesthetics and/or analgesics in advance can prevent central nervous system hyperplasia, thereby reducing postoperative pain. the aim of our study was to investigate the effect of preemptive analgesic with flurbiprofen axetil on postoperative pain, inflammatory markers and sleep quality among patients under general anesthesia. we hypothesized that use flurbiprofen axetil preoperatively would effectively relieve postoperative pain, inhibite inflammtory reaction and improve postoperative sleep quality.


Eligibility criteria:
inclusion criteria: age: 18-75 asa: i-ii receive operation under general anesthesia exclusion criteria: * ①patients with mental illness; * severe sleep disorders in the past; * a history of taking opioids; * patients who are allergic to the drug * patients who have difficulty communicating and refuse to participate in the trial.
analyzing clinical research participation of patients with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the percentages of participants in clinical studies haven't always been perfectly representative of a particular group. this research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for spinal cord injury. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future spinal cord injury research.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old * ability to understand and the willingness to sign a written informed consent document. * diagnosis of spinal cord injury exclusion criteria: * is pregnant, breastfeeding or expecting to conceive within the projected duration of the study * has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. * inability to provide written informed consent

Keywords: spinal cord injuries spinal cord injury
shared decision for drug interactions in oral anticoagulation

Conditions: Anticoagulants; Drug Interactions

Summary: the purpose of this project is to implement and evaluate a shared-decision making (sdm) tool called ddinteract that was developed to support decision making for drug-drugs interactions while on oral anticoagulants. ddinteract will be implemented in clinics at the university of utah, university of colorado and university of vanderbilt. ddinteract will be launched from within the electronic health record (ehr) retrieving patient-specific risk factors, will calculate the risk of harm, and will allow providers and patients to dynamically explore "what if" scenarios to optimize treatment and minimize risk. ddinteract will enable shared-decision making using individually-tailored information on the potential benefits and harms of drug interactions in anticoagulated patients.

the purpose of this project are: 1) examine contextual factors and define relevant implementation strategies to facilitate integration of ddinteract within 3 university-based healthcare systems; 2) evaluate ddinteract in production/real-world situations to identify barriers and facilitators to adoption and use of ddinteract and to develop solutions to overcome those barriers; 3) conduct a cluster randomized, multi-system trial to evaluate the effectiveness of ddinteract to mitigate exposure to drug interactions involving oral anticoagulants this project will implement a sdm tool designed to inform clinicians and patients about the risk of harm from drug interactions in patients receiving oral anticoagulants. an initial version of the ddinteract will be ehr-integrated and will be accessed directly in the ehr and auto-populate relevant patient-specific data including other medications that might interact with oral anticoagulants. this study will use a multi-center randomized cluster design using clinics from the above-mentioned institutions. each organization will implement ddinteract in their electronic health record system and the study will evaluate the degree to which the tool is utilized within each organization. the implementation period will last 18 months. this project is supported by a r18 award from agency for healthcare research and quality (ahrq).

Eligibility criteria:
inclusion criteria: * be at least 21 years of age or older * receive more than one prescription of an oral anticoagulant (i.e. warfarin, apixaban, edoxaban, dabigatran, rivaroxaban) exclusion criteria: * individuals not able to speak english or spanish

Keywords: oral anticoagulants drug interactions gastrointestinal hemorrhage shared decision making
prevalence of subclinical atherosclerosis and its associated factors in hyperlipidemic korean adults with diabetes

Conditions: Diabetes Mellitus; Dyslipidemia

Summary: this study is to investigate correlation between carotid intima media thickness (cimt) and several factors such as; hs c-reactive protein (crp), hba1c, lipid profile in korean diabetic patients with atherosclerosis. total 360 patients will be enrolled through 6 sites.

mc md

Eligibility criteria:
inclusion criteria: * patients with diabetic mellitus * patients with dyslipidemia exclusion criteria: * patients who have established cardiovascular disease * patient using nsaid

Keywords: cimt hs crp (c-reactive protein) dm (diabetic mellitus) korea corelation between cimt (carotid intima media thickness) cardio vascular risk in diabetic mellitus
effects of repeated botulinum toxin injections in children with cerebral palsy

Conditions: Cerebral Palsy; Muscle Spasticity; Vascularization

Summary: one of the disorders observed in children with cerebral palsy (cp) is abnormal muscle tone, and the most common tone problem is spasticity. botulinum toxin a (bont-a) injections are frequently used to reduce spasticity in cp rehabilitation. bont-a injections can be administered as a single dose, and some patients require repeated injections. the aim of this study was to examine the effects of repeated bont-a applications applied to the gastrocnemius muscle of children with cp on muscle morphology and functionality.

the study will be planned to include 50 children with cp. the children will be divided into two groups.children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by superb microvascular imaging method by an experienced radiologist. functionality of children with cp was evaluated with gross motor function measure (gmfm), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.

Eligibility criteria:
inclusion criteria: * children with unilateral and bilateral, ambulatory, spastic cp, aged 5-18 years * children who had previously been injected with bont-a into the gastrocnemius muscle exclusion criteria: * children with dyskinetic, ataxic, and hypotonic type cp * children with a history of any surgical operation or botulinum toxin injection treatment in the previous 6 months

Keywords: repeated botulinum toxin injections muscle morphology functionality