Kornimate/medical-research-clean huggingface dataset:
effects of a comprehensive sexual rehabilitation programme in heart patients

Conditions: Ischaemic Heart Disease; Cardiac Arrhythmia; Sexual Dysfunction

Summary: the objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component. the primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual function.

sexual function is an important aspect of quality of life. there is a link between heart disease and sexual dysfunction. heart disease lowers the activity or the ability to perform the sexual activity. sexual problems have a negative impact on quality of life and well-being, and sexual dysfunction is associated with anxiety and depression. the causes of sexual dysfunction are physical changes (the disease), mental changes and adverse reactions from medication. despite the fact, that several international guidelines recommend that health professionals address sexual function in patients with heart disease, this is rarely done in practice. in denmark there is no consensus or practice on how or where patients with heart disease and sexual dysfunction should be treated. some patients are treated with phosphodiesterase type 5 inhibitors and a few referred to sexological clinics. non-pharmacological rehabilitation interventions such as physical exercise, pelvic floor exercise, and sexual therapy have shown potential beneficial effect on sexual function. however, the effects have not been tested sufficiently, have not been tested in combination, and have never been tested in a danish population. objective: the objective of this trial is to investigate the effect of a comprehensive sexual rehabilitation intervention program, consisting of a psycho-educative component and an exercise-training component plus treatment as usual versus treatment as usual in male patients with impaired sexual function and implantable cardioverter defibrillator or ischemic heart disease. design: copenheartsf is an investigator-initiated randomised clinical trial with blinded outcome assessment, including two university hospitals, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone.

Eligibility criteria:
inclusion criteria: * male patients above 18 years with sexual dysfunction associated with implantable cardioverter defibrillator or with ischemic heart disease verified by coronary angiography, which have a partner, speaks and understands danish and provides a written informed consent exclusion criteria: * patients at intermediate or high risk according to their cardiovascular status according to guidelines, with diseases in the urinary tract, who exercise intense more than 3 hours a week, patients with neurological or orthopedic deficits which prevent training, patients with cognitive deficits which prevents interviews, and patients who are included in ongoing research prohibiting additional research participation are excluded.

Keywords: heart disease sexual dysfunction exercise test comprehensive rehabilitation complex intervention
determining genetic biomarkers predictive of the development of prescription opioid addiction

Conditions: Usage of Prescription Opioids

Summary: this is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment. procedures include: an initial telephone prescreening, completion of a number of questionnaires, and a blood draw to determine genetic factors. participants will take part in a one-time clinic visit, during which all procedures will be completed. the investigators hypothesize that several classes of genes, including genes in opioid, pain, and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed nondependent subjects.


Eligibility criteria:
inclusion criteria: * subject is 18 years or older. * subject is willing and able to speak, read, and write in english and comply with all study procedures. * subject is willing and able to voluntarily sign and date an informed consent form (icf), approved by an institutional review board (irb), prior to the conduct of any study-specific procedures. * subject has been prescribed opioids for the treatment of pain for at least 6 months at the time of the study. cases: * subject has a diagnosis of current prescription opioid dependence (confirmed by the mini). * subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain. patients who have abused these substances but have not met criteria for dependence (confirmed by the mini and/or medical history) will be included. controls: * subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care. * subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening. * subject has no current or past substance abuse or dependence (confirmed by the mini and medical history). exclusion criteria: * subject has any condition that poses undo study-related risk, or that interferes with assessment. * subject is not willing to have blood drawn or has any condition that in the investigators' opinion precludes having blood drawn.

Keywords: opioid dependence opioids for the treatment of pain
peppermint oil as a treatment for children with bladder and bowel dysfunction

Conditions: Bladder and Bowel Dysfunction

Summary: the goal of this clinical trial is to study the effect of peppermint oil in in children with bladder and bowel dysfunction. the main question it aims to answer is: does peppermint oil improve symptoms of bladder and bowel dysfunction among children? participants will: * be provided peppermint oil capsules to be taken 3 times daily for 8 weeks. * at baseline and at a follow-up visit (8 weeks later), participants will be asked to complete the vancouver nonneurogenic lower urinary tract dysfunction/dysfunctional elimination syndrome questionnaire. researchers will compare baseline and follow-up questionnaire data for each participant to determine if there is improvement in symptoms of bladder and bowel dysfunction.


Eligibility criteria:
inclusion criteria: * children aged 8-17 years and weighing 30kg or more with non-neurogenic bladder and bowel dysfunction who have failed behavioral therapy. behavioral therapy, or also termed standard urotherapy, is defined as encompassing the following components \[15\]: information and demystification; instruction on avoidance of holding maneuvers, regular bowel habits, proper voiding posture; lifestyle advice encompassing balanced fluid intake and diet, diminished caffeine, regular bladder and bowel emptying patterns; registration of symptoms and voiding habits with bladder diaries or frequency-volume charts; support and encouragement via regular follow up with caregiver. failure of behavioral therapy is defined as no symptomatology improvement after adherence to behavioral therapy after 6 weeks. * participants must be able to swallow pills exclusion criteria: * patients with neurogenic bladder, tethered cord, society of fetal urology grade 3-4 hydronephrosis, vesicoureteral reflux, learning disabilities, or those who have undergone surgical therapy for bladder and bowel dysfunction will be excluded. * patients on medical therapy with oxybutynin within the last 30 days. * patients with hiatal hernia, severe gastrointestinal reflux or gallbladder disorders or on medications for these conditions will be excluded. * patient weighing less than 30 kg.
a long-term trial of opa-15406 in infants with atopic dermatitis

Conditions: Atopic Dermatitis (AD)

Summary: to investigate the efficacy of 0.3% opa-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with atopic dermatitis


Eligibility criteria:
inclusion criteria: * subjects who are diagnosed with ad in accordance with the criteria of the japanese dermatological association * subjects whose ad affects 5% to 40% of bsa (excluding scalp) at the screening and baseline examinations * subjects who have an iga score of 2 or 3 at the screening and baseline examinations exclusion criteria: -subjects who have an ad or contact dermatitis flare-up defined as a rapid intensification of ad, within 28 days prior to the baseline examination
testing p2y12 platelet inhibitors generics beyond bioequivalence

Conditions: Cardiovascular Diseases; Acute Coronary Syndrome

Summary: this is a pilot study that was conducted to prove the efficacy and safety of ticagrelor generically named ticaloguard® compared to its brand brilique® in healthy volunteers. we advocate comparing the clinical efficacy rather than simple bioequivalence comparison.

cardiovascular diseases are the leading cause of death worldwide. ticagrelor, is an oral antiplatelet drug used in acute coronary syndrome. although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. this study was conducted to prove the efficacy and safety of ticagrelor generically named ticaloguard® compared to its brand brilique® in healthy volunteers. a loading dose of 180 mg ticagrelor named brilique® or ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in ticaloguard and brilique groups, respectively. the platelet aggregation on adenosine diphosphate (adp) agonist was assessed at different time intervals .

Eligibility criteria:
inclusion criteria: volunteers of both sexes, aged between 18-64 years old exclusion criteria: * volunteers with any abnormalities in the complete blood count (cbc) at entry time * those with any medical conditions contraindicated with antiplatelet therapy * those taking aspirin, non-steroidal anti-inflammatory drugs (nsaids), or any over the counter medications (otc) that contain medication such as, antihistamines, antibiotics in the previous month * volunteers with history of blood disorders or bleeding diathesis.
comparative effects of exergaming versus task oriented training among sub-acute post-stroke patients

Conditions: Subacute Stroke

Summary: this study is a randomized control trail and the purpose of this study is to determine the effects of exergaming versus task oriented training among sub-acute post-stroke patients.

effects of exergaming training will be assessed for trunk control which includes the parameters of balance and posture. sub-acute post stroke patients aged 40-85 years the participants will be assessed through trunk impairment scale (tis), berg blanace scale (bbs) and biodex (clinical test for sensory integration in balance). informed consent will be taken after which the participants will be recruited into the two groups, where one group will receive intervention through exergaming and other group will receive task oriented trainig. baseline and post-treatment measurements will be taken for analysis.

Eligibility criteria:
inclusion criteria: * patients diagnosed with sub-acute post-stroke. * aged 40 years-85 years. * mini-mental status examination \>24 * motor assessment scale (1-5 scoring) exclusion criteria: * post-stroke patients with major cognitive deficits. * acute infections. * patients with any fracture/ msk disorders. * neurological deficits other than stroke

Keywords: exergaming task-oriented training trunk control sub-acute stroke tis bbs
study of the inflammatory microenvironment in atypical meningiomas

Conditions: Atypical Meningioma

Summary: atypical meningiomas represent 15% of meningiomas. they present a high rate of recurrence, and therapeutic strategies are limited. there is a need for novel treatment strategies, such as immuotherapy. this is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. the presence of t cells (cd4, cd8, treg and memory t cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (cd4, cd8, foxp3, cd45ro and cd208). this could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.


Eligibility criteria:
inclusion criteria: * primary diagnosis of atypical meningioma * surgery
safety, tolerability, and immunogenicity of 3 frozen proquad consistency lots in healthy children (v221-012)(completed)

Conditions: Measles; Mumps; Rubella; Varicella

Summary: this study will compare three consistency lots of proquad to each other as well as to m-m-r ii and varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.


Eligibility criteria:
inclusion criteria: * in good health * negative clinical history of measles, mumps, rubella, varicella, and zoster exclusion criteria: * previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination * any immune impairment or deficiency * exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination * vaccination with an inactive vaccine with in the past 14 days * vaccination with a live vaccine within the past 30 days
oxygenation changes after 2-month exercise in sedentary older adults with diabetes

Conditions: Diabetes Mellitus, Type 2; Oxygen Deficiency

Summary: the aim of the study is to determine the physiological evidence of how muscular and cerebral oxygenation changes link to fatigue, physical, and cognitive performance after moderate-intensity exercise in sedentary older adults with type 2 diabetes.

this is an experimental design. one intervention group will do exercise for 2 months and be measured twice, at baseline, and after 2 months. the other 2 control groups will be assessed just once without exercise intervention. our primary objective is to clarify physiological evidence of how muscular and cerebral oxygenation changes in sedentary older adults with diabetes after low-to-moderate intensity exercise. the secondary objective is to determine fatigue, physical, cognitive performance changes, blood glucose level among sedentary older adults with diabetes after low-to-moderate intensity exercise.

Eligibility criteria:
inclusion criteria: * for the intervention group, the inclusion criteria are * sedentary older adults 60 years or older who are living in their homes in the community * diagnosed type 2 diabetes * ambulatory with or without mobility devices such as a cane and/or walker * be able to follow simple exercise instructions without assistance. * for the comparison group, the inclusion criteria are * individuals aged 60 years or older who are living in their homes, in the community; * ambulatory with or without devices; * able to follow simple exercise instructions without assistance * able to walk six minutes as quickly as possible without any adverse symptoms including extreme pain on feet or joints, dizziness, vertigo, or nausea. exclusion criteria: * for the intervention group, the exclusion criteria are * foot deformities, cuts, blisters, or amputation, achilles tendonitis, joint replacements within the past three months, parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders * current smoking or smoking within the last 12 months * current cardiopulmonary diseases, vascular disease, or stroke * dementia indicating the inability to follow exercise instructions independently * those who are currently or plan to receive physical therapy in the following three months * individuals without english proficiency will be excluded * if the individuals with blood glucose level are over 400 mg/dl or hba1c \> 8.0%, and * type 1 diabetes. for the comparison group, the exclusion criteria are * individuals who have prediabetes, diabetes, or current cardiopulmonary diseases and stroke * current smoking or smoking within the last 12 months * individuals with foot deformities, cuts, blisters, or amputation, achilles tendonitis, joint replacements within the past three months, parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders, and dementia.
testing multiple behavioral science strategies to increase flu-shot rates

Conditions: Influenza, Human

Summary: this research aims to identify which behavioral science strategies are most effective at increasing flu vaccination rates overall and based on patients' individual characteristics. past behavioral science interventions have shown promise in increasing flu vaccinations. for example, successful interventions have encouraged people to make concrete plans for when they will get a flu vaccination (milkman et al. 2011), sent automated calls or text messages reminding patients to get a flu vaccination (cutrona et al. 2018; regan et al. 2017), or provided financial incentives for getting vaccinated (nowalk et al. 2010). although these results are promising, these studies have been conducted in isolation on different populations, which makes it difficult to compare their interventions' effectiveness or to have enough power to reliably detect differing responses to interventions based on individual characteristics. this research will simultaneously test 19 different sms interventions to increase flu vaccinations in a "mega-study" and apply machine learning to identify which interventions work best for whom. the interventions are designed by behavioral science experts from the behavior change for good initiative (bcfg), penn medicine nudge unit (pmnu), and geisinger behavioral insights team (bit). we expect to include at least 80,000 participants. the specific aims of this research are to identify (1) which behavioral science strategies effectively increase flu vaccination rates overall, and (2) which strategies are most effective for different subgroups (e.g., based on age, gender, race).


Eligibility criteria:
penn medicine and geisinger patients will be included if they: inclusion criteria: * have a cell phone number recorded in a penn medicine or geisinger database * have a new or routine primary care appointment during the study recruitment period (not a sick visit) exclusion criteria: * have documentation of allergy or adverse event to influenza vaccination in medical records * have documentation of already receiving their 2020 influenza vaccination prior to randomization in medical records * have opted out of receiving text message appointment reminders * have asked not to be contacted for research purposes * have an appointment with someone other than their primary care physician * have an appointment with someone other than a physician, resident, nurse practitioner, or physician assistant we will recruit as many patients as possible starting in september 2020. we will stop enrolling participants with appointments scheduled to occur after december 31, 2020 if we have reached 4,000 participants per condition. if we do not have 4,000 participants per condition by december 31, 2020, we will continue enrolling participants until we have reached 4,000 per condition, or until march 31, 2021 (discontinuing enrollment at whichever milestone arrives sooner - 4,000 people enrolled or 3/31/21).

Keywords: influenza vaccination behavioral science interventions vaccination promotion
the use of ranolazine for atrial fibrillation and diastolic heart failure

Conditions: Atrial Fibrillation; Heart Failure

Summary: the purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female \> 18 years of age; * documentation of heart failure and who are in nyha class ii or iii; * documented history of symptomatic af \< 6 months in duration at the time of presentation, currently in af at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm; * percutaneous coronary intervention (pci) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran); * demonstration of preserved ejection fraction (ef) by echocardiography; * echocardiographic evidence of impaired diastolic filling. exclusion criteria: * known history of permanent or long-standing af (\> 6 months); * other acutely reversible causes of af, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism; * known history of cirrhosis; * nyha class iv; * myocardial infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening; * percutaneous coronary intervention (pci) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion; * clinically significant valvular disease; * clinically significant pulmonary disease; * stroke within 3 months prior to screening; * creatinine clearance \< 30 ml/min as calculated by cockcroft-gault formula; * use of anti-arrhythmic drugs (class ia or iiic) within 3 months prior to screening; * concurrent use of drugs considered strong inhibitors of cyp3a; * concurrent use of drugs considered as cyp3a inducers; * prior treatment with ranolazine.

Keywords: atrial fibrillation heart failure ranolazine cardioversion persistent af paroxysmal af
angeliq regulatory post marketing surveillance

Conditions: Postmenopausal Period; Osteoporosis, Postmenopausal

Summary: angeliq regulatory post-marketing surveillance (pms) is to get data about safety and efficacy in real practice for the indication approved by korea food and drug administration (kfda). this is non-interventional , prospective, multi-center study.target number of patients is 4500.


Eligibility criteria:
inclusion criteria: * hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause * prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis exclusion criteria: * undiagnosed genital bleeding * known, past or suspected cancer of the breast * known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer) * untreated endometrial hyperplasia * previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism) * active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) * acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal * porphyria * severe renal insufficiency or acute renal failure * known hypersensitivity to the active substances or to any of the excipients

Keywords: menopause menopausal symptoms prevention of osteoporosis in menopausal women estrogen deficiency symptoms hormone replacement therapy