Kornimate/medical-research-clean huggingface dataset:
respiratory muscle endurance training in obese patients

Conditions: Obesity

Summary: obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. the investigators hypothesized that respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.


Eligibility criteria:
inclusion criteria: * obese patients (bmi \> 30 kg/m2), without respiratory pathology (vems \> 80% predicted, vems/cv \> 80%) * men or women * age between 18 and 60 years old exclusion criteria: * respiratory, cardiovascular, musculoskeletal diseases * alcoholism

Keywords: obese patients (bmi > 30 kg / m²)
effects of intermittent fasting and exercise on inflammation, metabolism, and the microbiome in metabolic syndrome

Conditions: Metabolic Syndrome; Obesity and Obesity-related Medical Conditions

Summary: the goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. the main question it aims to answer is: does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome? participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. in addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. the study includes a 3-month intervention phase followed by a 3-month follow-up phase. during the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.


Eligibility criteria:
inclusion criteria: * written consent to participate in the study. * persons aged 18 years and older. * diagnosis of metabolic syndrome (mets) with elevated hscrp. exclusion criteria: * pregnant or nursing individuals. * cardiovascular diseases or orthopedic restrictions that prevent exercise. * use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks). * body weight greater than 200 kg (maximum capacity of training equipment). * individuals with mental illnesses that may impair their ability to understand or participate in the study.

Keywords: obesity metabolic syndrome high-intensity interval training inflammation intermittent fasting
aot and ict for hemiplegia

Conditions: Hemiplegia; Hemiplegic Cerebral Palsy

Summary: a new rehabilitative approach, called aot, based on the recent discovery of mirror neuron system (mns), has been used with promising results on the upper limb (ul) function in some studies in children with cerebral palsy (cp).the purpose of the present trial is to provide evidence by a rct that aot is an effective rehabilitation tool in children with unilateral cp (ucp) and that its effects are greater than standard care. assisting hand assessment is chosen as primary outcome measure and a sample size of 10 per group is required. the rehabilitation lasting 3 weeks will be provided at home by an ict platform able to deliver, manage, monitor and measure a personalized aot.

a waitlist control, evaluator-blinded, randomized trial (rct) will be conducted according to consort guidelines. each participant will be randomized to either: 1. immediate intervention group (experimental group). children will receive immediately the system for 3 weeks. 2. waitlist delayed intervention (control group). children will continue standard care for 3 weeks and then will receive the system as the experimental group. as such, all participants will receive the aot training. the system will provide an in-home, individualized, intensive treatment based on the aot. the system will be delivered at home and the children will perform a 60-minute training session 5 days a week for 3 consecutive weeks. for the immediate intervention group, follow-up assessment (outcome measures) will be conducted before (t0) and post-intervention at 3 weeks (t1), and then 8 and 24 weeks after t1(t2 and t3). for the waitlist group, the assessments will be conducted before t0 and 3 weeks after (t1) the standard care, then they will follow the same timeline of the first group (t1 plus, after the aot intervention) and 8 and 24 weeks after t1 puls (t2 and t3). the primary endpoint will be t1. clinical assessments will be administered by a therapist blind to group assignment in each center. scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of spastic ucp * age between 15 and 20 years * predominant spasticity at upper limb upper limb * minimal ability to grasp and hold objects, also passively, with affected hand (house functional classification score 2 or more) * sufficient cooperation, cognitive and communicative understanding to perform assessments and participate in the intervention * subjects and parents able to commit to the intensive therapy program for a period of 3 weeks exclusion criteria: * children who had sustained previous orthopedic surgery or botulinum toxin a injection in the ul within 6 months prior to study entry were excluded.

Keywords: tele-rehabilitation action observation mirror neurons ict
lowering the risk of operative complications using atorvastatin loading dose

Conditions: Myocardial Infarction; Peripheral Vascular Disease; Aortic Aneurism

Summary: patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular complications. statins have shown to lower cholesterol levels and reduce cardiovascular events in other scenarios. the objective of this study is to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal myocardial injury after noncardiac surgery (mins), or stroke among patients who undergo noncardiac surgery.

cardiovascular complications, such as myocardial infarction (mi) and stroke are common in the perioperative period of noncardiac surgeries. to the moment there are no safe and effective interventions to reduce vascular events in this scenario. data from observational studies and small-sized randomized controlled trials (rcts) have shown promising results in terms of risk reduction. in addition, experimental data have indicated that statins have acute anti-inflammatory properties, which promote the stabilization of atherosclerotic lesions and, therefore, might reduce the risk of mi, even in the short term. this study was designed to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal myocardial injury after noncardiac surgery (mins), or stroke among patients who undergo noncardiac surgery. the study was conducted in accordance with the prespecified protocol and reached successful enrollment rates when, by the end of 2014 the steering committee was invited to join an international initiative and participate in a much larger clinical trial to investigate this relevant question. due to this outstanding possibility, the steering committee decided to redesign the study which is now formatted as an exploratory trial. as described, the study was completed with the inclusion of 648 participants in june, 2015.

Eligibility criteria:
inclusion criteria: patients older than 40 years-old undergoing non-cardiac surgery with an expected hospital stay of at least 24hs and that fulfills any one of the following criteria: a) established vascular disease: i) major vascular surgery ii) all types of surgery in patients with overt atherosclerosis (any significant or symptomatic coronary, cerebral or peripheral artery disease) b) without established vascular disease: at least 3 risk factors for cardiovascular complications: 1. major surgery; 2. emergency surgery; 3. previous history of heart failure; 4. diabetes; 5. arterial hypertension; 6. smoking habit along the last two years; 7. chronic kidney disease (creatinine greater than 2mg/dl); 8. patients older than 70 years. exclusion criteria: * previous intolerance to statins * current rhabdomyolysis * current use of statins * severe liver failure (child-pugh score c) * breast-feeding or pregnancy * low-risk surgeries

Keywords: myocardial infarction statin perioperative care peripheral vascular diseases anesthesiology
obstetric pain management for women with opioid use disorder (quest)

Conditions: Opioid-use Disorder

Summary: this is a mixed methods longitudinal observational study to assess patient and provider perspectives on pain and pain management among pregnant women with opiate use disorder (oud). the findings from this study will inform patient-centered approaches to pain management. themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesia endpoints will be identified. findings will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with oud.

a fine understanding of the attitudes and beliefs about pain and its management for patients with opioid use disorder is currently lacking. these psychological aspects of pain and analgesia are expected to have significant effects on nociception, pain experience, analgesic efficacy, and opioid requirements and its subsequent risks for relapse/treatment noncompliance. there is also have little understanding of provider-held attitudes and beliefs which can influence pain and its treatment for this population. the findings from this study will inform patient-centered approaches to pain management for obstetric patients with oud. they will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with oud. this work will find new patient-centered endpoints for this special population that may be currently overlooked with existing standard pain assessments.

Eligibility criteria:
inclusion criteria: * pregnant women who are 18 years of age or older * history of opioid use disorder, on medication assisted therapy * currently in their third trimester exclusion criteria: * unable to participate in informed consent discussions * unable to give informed consent for any reason * not fluent in english (surveys are validated in english language) * unable to participate fully in all study procedures for any reason
study of tisporin eye drops group and restasis eye drops group after treatment, each treatment group comparisons for evaluation of efficacy and safety in moderate to severe dry eye disease

Conditions: Dry Eye Syndromes

Summary: the purpose of this clinical study is tisporin eye drops 0.05%(cyclosporine ophthalmic solution) group and restasis eye drops 0.05%(cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in moderate to severe dry eye disease. - corneal staining test, ocular surface disease index (osdi), tear break up time (tbut), non-anesthetic schirmer test


Eligibility criteria:
inclusion criteria: \[patients with moderate-to-severe ocular dry eye\] 1. the one eye of corneal fluorescein staining score of 2 or higher (oxford grading) 2. non-anesthetic schirmer test value ≤ 10mm/5min patients at least one eye score (non-anesthetic schirmer test value = 0/5min, nasal stimulation in the same eye, schirmer test value ≥ 3mm/5min) 3. tear break-up time is 10 seconds or less 4. screening both eyes, the corrected visual acuity is 0.2 or more 5. despite conventional treatment, the symptoms of dry eye signs (artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.) exclusion criteria: 1. screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions. 2. the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) 1. abnormal eyelid function : disoders of the eyelids or eyelashes 2. ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.) 3. cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, steven-johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation 3. current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status 4. the use in clinical trials of drug hypersensitivity reactions in patients

Keywords: dry eye syndromes
oxygen therapy for headache

Conditions: Primary Headache Disorder

Summary: headache is one of the common causes of emergency department admissions and constitutes approximately 2%. although the exact mechanism is not clear, it is known that high-flow oxygen therapy is effective in headache treatment. there are limited studies related to the use of oxygen therapy in headaches and its derivatives in the literature. in this study, the investigators aimed to compare the high and medium flow oxygen therapies with placebo in primary headache disorders.

four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2) medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air), 4) medium-flow room air as placebo (8 lt/min room air). all four treatment methods will be applied to all patients included in the study. one of the four treatments will be randomly applied at each separate ed admission with a gap of 1 week or more in between. this randomization will be performed by a computer at the time of admission. a study nurse will administer the patient's therapy according to the computer's current decision for 15 minutes. patients and treating physicians will be blinded to the selected therapy. after 15 minutes of the end of treatment (at the 30th minute of the start of treatment), the treating physician will ask patients if they need rescue analgesia and analgesia will be administered if necessary. additional analgesia is at the discretion of the treating physician. patient data, including demographics, medical history, and findings of a physical examination performed before and after therapy will be recorded by the treating physician.

Eligibility criteria:
inclusion criteria: * age 18-55 years * frequent attacks of primary headache disorders according to international headache society (ihs) criteria exclusion criteria: * secondary headache disorders * oxygen-dependent chronic illnesses such as chronic obstructive pulmonary disease * a history of cerebrovascular disease * pregnancy * active smokers or living with a smoker.

Keywords: oxygen therapy migraine emergency department cluster type headache
study evaluating pantoprazole in children with gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux

Summary: to evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic gerd.


Eligibility criteria:
inclusion criteria: * ability to undergo endoscopy with required biopsy * ages 1 through 5 years * endoscopically confirmed gerd by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with gerd other inclusions apply. exclusion criteria: * history or presence of upper gastrointestinal anatomic or motor disorders * known current or active cow's milk allergy * malignancy * other exclusions apply.

Keywords: gerd children child child, preschool
a study to assess the effects of mk0812 on disease activity in patients with relapsing-remitting multiple sclerosis as measured by magnetic resonance imaging (mri)(0812-003)(completed)

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the purpose of this study is to test mk0812 on disease activity in patients with relapsing-remitting ms. disease modifying activity will be assessed by measurement of brain lesions via mri brain scans and an open label extension is offered.


Eligibility criteria:
inclusion criteria: * patients must have clinically definite relapsing-remitting ms onset within last 10 years and have had at least 1 objective clinical exacerbation in the last year or a recent clinically isolated syndrome suggestive of ms occurring 3-12 months before screening * patients must be relatively healthy exclusion criteria: * patient has primary progressive ms
addressing origins of the opioid epidemic by improving prescribing for opioid-naive patients

Conditions: Opioid Use; Opioid-Related Disorders; Opioid Abuse; Prescription Drug Abuse and Dependency

Summary: risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent centers for disease control and prevention (cdc)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. in this quality improvement project, primary care departments at weill cornell and the institute for family health (federally qualified health center in new york city) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the cdc-endorsed low doses for all opioids. in the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. the analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.

the two participating institutions, wcmc (weill cornell medical college) and ifh (institute for family health), intend to redesign the e-prescribing interface to create a minor "nudge" to encourage prescribers to prescribe the minimum dose set by the 2016 cdc guideline for opioid-naive patients in 2018. the change to the e-prescribing system is that after a prescriber chooses the drug they wish to prescribe, the minimum recommended dosage from the cdc guidelines will be displayed. the prescriber can choose to change the dosage by overwriting in the field box. the changes to the prescriber system will be implemented at two weill cornell clinical organizations: weill cornell internal medicine associates (wcima) and weill cornell medical associates (cma), and at all locations at our collaborating institution ifh (institute for family health). weill cornell and ifh will provide data for the analysis, which will be conducted by the co-investigators on this protocol. the project will assess data pre- and post- implementation to study prescribing patterns.

Eligibility criteria:
inclusion criteria: * prescriber - practices internal medicine at wcmc or family practice at ifh and has prescribed opioids since 11/1/2015 exclusion criteria: * prescriber - has not written any opioid prescriptions during the study period
feasibility and acceptability of laughter yoga in children with autism spectrum disorder and their parents

Conditions: Autism Spectrum Disorder; Parenting Stress; Depression; Anxiety

Summary: this is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with asd and parenting stress reduction for their parents. hypotheses of this study include: 1. laughter yoga is acceptable to children with asd and their parents. 2. laughter yoga is feasible for anxiety and depression reduction in children with asd and parenting stress reduction in their parents. 3. participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group.

the intervention is a laughter yoga programme consisting of twelve sessions (biweekly). sixty-six children with asd and their father or mother from local autism support groups will join this study. participants will be given an information sheet. participants will be fully informed about laughter yoga's details, benefits and risks. all participants voluntarily take part in this study. if the family agrees to participate in this study, the parent will sign the consent form. families will be randomized into an experimental group or a wait-list-control group. before the laughter yoga programme, baseline data (t0) will be collected. the experimental group (n=33) will attend the twelve classes led by a certified laughter yoga trainer in an activity room that is suitable for indoor exercise. a research assistant will assist the laughter yoga teacher and provide first aid if needed. parents will complete the questionnaire again immediately at the programme end (t1) and at a 3-month follow-up (t2). the wait-list-control group (n=33) will receive the same laughter yoga programme after 3-month follow-up (t2).

Eligibility criteria:
inclusion criteria: the child should: * aged 8 to 12 * be diagnosed with autism spectrum disorder (according to either the diagnostic and statistical manual of mental disorders, fifth edition, text revision (dsm-5-tr) or international classification of diseases 11th), and * able to read and understand chinese and cantonese, and * have a parent (father or mother) participating in this study together. the parent should: * be able to read and understand chinese and cantonese, and * willing to attend the laughter yoga classes with their child, and * willing to complete the required post-test. exclusion criteria: the child: * has recently undergone surgery, or * has a primary diagnosis not asd, or * has an intelligence quotient lower than 70, or * has been diagnosed low functioning asd, or * has severe behavioral problems, or * is receiving medical treatment for anxiety or depression at the start of the laughter yoga program. the parent has: * recently undergone surgery, or * been diagnosed with a psychiatric disorder, or * no child with asd is willing to participate in this study.
an efficacy and safety study of cnto 148 subcutaneous injection compared with placebo in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of golimumab (cnto 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active ra despite mtx therapy.

this is an experimental medical research study. the purpose of this study is to determine if golimumab is safe and effective in the treatment of rheumatoid arthritis. subjects will receive subcutaneous injections of either 50 or 100 mg golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Eligibility criteria:
inclusion criteria: * diagnosis of ra according to the american college of rheumatology criteria for at least 3 months prior to screening * have active rheumatoid arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria exclusion criteria: * have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, lyme disease * received disease-modifying antirheumatic drugs (\[dmards\] eg, d penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin \[il\]-1 receptor antagonist \[anakinra\], azathioprine, sulphasalazine, agents other than mtx) within 4 weeks prior to the first study dose

Keywords: rheumatoid arthritis cnto 148 methotrexate joint pain arthritis