Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetics study of du-176b administered to non-valvular atrial fibrillation with severe renal impairment

Conditions: Non-valvular Atrial Fibrillation

Summary: to assess the safety and pharmacokinetics of du-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with du-176b administered to non-valvular atrial fibrillation (nvaf) patients with normal renal function or mild renal impairment (normal/miri).


Eligibility criteria:
inclusion criteria: * patients with nvaf and sri, or patients with nvaf and normal/miri. exclusion criteria: * patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment * patients who are at a significantly high risk for bleeding * patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran * patients who have evidence of hepatic function test abnormalities

Keywords: anticoagulant du-176b edoxaban factor xa oral atrial fibrillation severe renal impairment
evaluating increasing physical activity after acute coronary syndrome

Conditions: Physical Activity; Acute Coronary Syndrome

Summary: this study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. all participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.

cardiovascular disease is the leading cause of mortality in the united states. among patients that survive an acute myocardial infarction (ami), cardiac rehabilitation (cr) has been demonstrated to effectively reduce risk of re-infarction, cardiac mortality, and all-cause mortality. however, despite cardiac rehabilitation being a class i (standard of care) recommendation in multiple american heart association acute myocardial infarction guidelines, more than 80% of eligible patients do not receive appropriate cardiac rehabilitation and much of this is due to challenges in access to these programs. recent innovations in technology allow us to passively monitor an individual's physical activity using wearable devices. incentives designed using insights from behavioral economics have been demonstrated to motivate device engagement and behavior change. a remotely-monitored cardiac rehabilitation program could improve access for many individuals and potentially be more cost-effective because it is less resource- and personnel-intensive. the objective of this study is to use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. ability to read and provide informed consent to participate in the study; 3. history of a) acute coronary syndrome (unstable angina, non-st segment elevation myocardial infarction or st segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease. exclusion criteria: 1. inability to provide informed consent; 2. does not have daily access to a smartphone compatible with the wearable device; 3. unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks; 4. already enrolled in an exercise cardiac rehabilitation program prior to hospital admission; 5. hemodynamic instability or new york heart association iii-iv heart failure; 6. any other medical conditions that would prohibit participation in an 18-week physical activity program; 7. not being discharged to home if recently admitted.
real world patient-reported outcomes in chinese her2+ ebc patients receiving (neo) adjuvant anti-her2 based therapy

Conditions: HER2-positive Breast Cancer

Summary: this is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in chinese her2+ early breast cancer patients undergoing (neo) adjuvant anti-her2 based therapy and describe changes over time, from baseline to 12 months.

this is a non-interventional observational, multi-center cohort study with primary prospective data collection. this study will be conducted at approximately 10 sites in china. the study population is chinese her2+ early breast cancer patients receiving (neo) adjuvant anti-her2 based therapy. patients who are eligible for (neo) adjuvant anti-her2 based therapy will enroll in this study. treatment choice in this non-interventional study will be at the discretion of the treating physician as per caca-cbcs guidelines. participants are longitudinally assessed at baseline (t0, before treatment), during chemotherapy (t1, after 2 cycles), 1-month after completion of chemotherapy (t2) and at 12-month follow-up (t3). the pro instruments will be captured by electronic devices through wechat mini-program which are input by patients, before or after their clinic visit but before administration of anti-her2 therapy. paper questionnaires will be available only as a last option if the electronic devices cannot be used for any reason (such as issues with internet access or if the device is not working). oncology staff provided no assistance with filling in the questionnaires, but a prerecorded video will provide a detailed explanation of the questionnaires before the epro questionnaires. the pros data will be restored centrally at the server of the leading site. the usage of pros is considered non-interventional according to local regulation. pro measures include eortc qlq-c30, pdq-5 (cognitive), phq-9 (depression), gad-7 (anxiety) and insomnia severity index (isi). patient satisfaction for subcutaneous injection will be assessed using tasq-sc at t3.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years; 2. women; 3. have signed the informed consent form as per local regulations; 4. newly diagnosed with non-metastatic breast cancer (stage i-ii-iii, her2+) at the time of starting anti-her2 therapy; 5. be able to comply with the follow-up visits, assessments, answering questionnaires. exclusion criteria: 1. metastatic breast cancer; 2. prior systemic treatment for any malignancy; 3. active secondary cancer requiring anti-her2 therapy; 4. vulnerable populations \[e.g., decisional impaired (cognitive, psychiatric), terminally ill, prisoners\], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent; 5. men.
novocart®3d for treatment of articular cartilage of the knee

Conditions: Articular Cartilage of the Femoral Condyle Between 2-6cm2

Summary: this study is to compare novocart 3d relative to microfracture for the treatment of knee cartilage defects. efficacy will be evaluated by both pain and function. safety will also be evaluated.

subjects with articular knee defects will be randomized to receive either microfracture or novocart 3d. subjects will be followed for five years in total and will be evaluated for safety and efficacy.

Eligibility criteria:
inclusion criteria: * greater than 18 years old * isolated articular cartilage lesions on the femoral condyle 2-6 cm2 * minimum score on the koos questionnaire exclusion criteria: * instability of the knee joint * arthritis * autoimmune disease * immune suppression * prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline) * bone disease * any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
the combination of sperm selection by imsi and hyaluronic acid binding assay may improve icsi outcome.

Conditions: Fertility Issues

Summary: in this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve icsi outcomes. the methods include the selection of the optimal spermatozoa based on its morphology by imsi, together with its physiological function of binding to ha by spermslow (ss). the current study compared a group of et after sperm selection by imsi with ss to a group of et after sperm selection by imsi-only without ss, and to a mixed et group where two embryos were transferred, one after imsi-only and the other one after imsi with ss.


Eligibility criteria:
inclusion criteria: females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples exclusion criteria: frozen embryos surgically extracted sperm preparations embryo-biopsy cycles

Keywords: imsi spermslow sperm selection icsi outcome sibling-oocytes study
effectiveness of counseling interventions to modify risk behaviors in patients at the hospital san ignacio.

Conditions: Risk Behavior

Summary: randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the hospital universitario de san ignacio. bogotá-colombia

objective: to determine the effect in the behavioral change stage of an intervention to modify risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the hospital universitario de san ignacio. design: controlled clinical trial with random assignment population: patients candidates for scheduled surgery or diagnostic procedures in surgery rooms between 19 and 64 years attending the pre-anesthetic consultation of the hospital universitario de san ignacio. interventions: brief behavioral intervention to modify risk behaviors versus information material on healthy lifestyles. measurements: the characteristics of the study population will be described and the intervention and control groups will be compared in their basic conditions. the level of advance in the stage of change in the intervention and control arm, the proportion of people with the presence of the risk factor, as well as the decrease in the consumption of tobacco and alcohol will be compared. expected duration: 28 months. financing: hospital universitario de san ignacio and pontificia universidad javeriana. ethical aspects: the study is adjusted to international and national standards for research projects. under this norm, it is classified in the category of minimum risk because it is a clinical experiment with a common intervention in clinical practice.

Eligibility criteria:
inclusion criteria: * candidates for scheduled surgery with a hospital stay of 3 days or less (including ambulatory surgeries) or who attend outpatient diagnostic procedures performed in surgery rooms. * current smokers (any tobacco product in the last month and more than 100 cigarretes in life) or risky alcohol drinkers (more than 4 or 5 alcohol standard drinks during the last year and audit score between 8-15 points) * patients with contact information * patients that want to participate exclusion criteria: * people who are being treated for smoking cessation or decreased consumption of alcohol. * people with diseases that compromise their ability to understand information or their ability to verbal communication * patients with dependence or abuse of alcohol or other psychoactive substances other than tobacco * patients in action or maintenance stages of behavioral change against their risk factor

Keywords: counseling behavioral therapy tobacco alcohol drinking
effects of walkasins on gait speed of individuals with mild cognitive impairments

Conditions: Mild Cognitive Impairment; Cognitive Decline; Gait Disorders in Old Age

Summary: the primary aim of this pilot study is to investigate the effect of walkasins, a wearable lower-limb sensory prosthesis, on the gait speed and balance function of participants with mild cognitive impairment as measured by the saint louis university mental status (slums) examination.

the walkasins system is one of a growing number of wearable devices that use various modalities of neuromodulation, defined as "the alteration of nerve activity through targeted delivery of a stimulus . . . to specific neurological sites in the body" (https://www.neuromodulation.com/). because these technologies are relatively new, innovative applications of their use in various patient populations may lead to improvements in the care and quality of life of individuals who suffer from these life-altering diagnoses. previous studies of walkasins have shown that individuals with peripheral neuropathy who have gait and balance problems walk faster with the walkasins device. this increase may be related to an improved automaticity of gait function, which decreases the need for cognitive attention to the walking task, which is known to slow down gait. individuals with mild cognitive impairment commonly show slow gait speeds, likely due to a decline in executive function. there is a reason to think that sensory stimuli from the walkasins device can improve the automaticity of gait in these individuals and thereby enhance gait speed.

Eligibility criteria:
inclusion criteria: * ambulatory person who is at least 65 years of age * ability to understand and provide informed consent * ability to perceive vibrations from the walkasins haptic module * ability to complete the functional outcome measures without the use of an assistive device * foot size that allows the walkasins to function appropriately * mild cognitive impairment (mci) as measured by the saint louis university mental status (slums) exam (scores between 20 and 24 + or -2 for those with less than a high school education and scores between 21-26 + or -2 for those who graduated from high school, which indicate mild cognitive impairment) and/or a diagnosis of mci (or related term) in the person's medical record * slow gait speed (\<1m/second or slightly faster, provided all other criteria are met) exclusion criteria: * use of ankle-foot orthosis for ambulation that prevents donning of walkasins * self-reported acute thrombophlebitis including deep vein thrombosis * untreated lymphedema * untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use * untreated fractures in the foot and ankle * self-reported severe peripheral vascular disease * other neurological conditions that impact walking (e.g., peripheral neuropathy) * weighs more than 300 pounds
qualitative study of long term cardiovascular risk prediction in the emergency department

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor; Emergencies

Summary: one of the most common presentations to ed is chest pain, with the rapid rule out of heart attacks in the emergency department being common place. this moves a new onus of responsibility to the ed; the care of long term heart disease. a study conducted locally demonstrated that patient's with a heart attack ruled out felt the 'what next' question is not answered sufficiently at present. the strength of this opportunity is re-enforced by studies suggesting that chest pain presents a teachable moment where patients are more accepting of advice. the study's overarching goal is to improve heart disease care (cardiovascular disease).the early warning signs for heart disease can be detected and treated enabling patients to live longer and healthier lives. this is where it is believed that the emergency department (ed) can improve, eds already collect the vast majority of data required to detect these early warning signs. in the united kingdom more than 23.8 million attendances were registered last year, and ed is currently underusing a large amount of patient data of potentially great value to the population. the study aims to explore the best way to use this long term heart disease prediction; how to communicate it to patients, who prescribes the necessary medication, who issues lifestyle advice, and who follows it up. the investigators intend to answer these questions with a series of semi-structured interviews. the study will comprise of initial semistructured interviews made up of emergency medicine consultants, general practitioners, nurses, and patients. then building on the knowledge gained from the initial interviews it is planned to build a prototype care pathway that will be explored in the second set of interviews. funded by the royal college of emergency medicine ethical approval by the uk's hra rec - 19/wa/0312


Eligibility criteria:
inclusion criteria: * genaral practitioner / emergency medicine consultant consultant /acute care nurse or * emergency department patients with low risk chest pain. these patients are deemed low risk by a predictive algorithm that was validated in more than 10,000 and has subsequently been used in clinical practice safely in over 7,000 patients. once deemed low risk they are then transferred to an ambulatory care unit where they receive further assessment. exclusion criteria: * the participants can not attend at least one of the semi-structured interviews * not fluent in english language * the ambulatory ward patient's clinical condition has deteriorated or is severe to the extent that participating in the research would (a) interfere in their clinical care, or (b) that participating would be too strenuous. this will be judged by the nursing staff on the ambulatory care unit, and the clinical academics interviewing the patients. * unwilling to take part
active surveillance or radical treatment for newly diagnosed patients with a localized, low risk, prostate cancer start

Conditions: Prostatic Neoplasm

Summary: the purpose of the start project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.

comparative effectiveness research project. all newly diagnosed prostate cancer patients fulfilling the low risk definition, resident in piedmont or in valle d'aosta regions, will be invited to participate. all enrolled patients will receive full and clear information about their prognosis together with a balanced synthesis of the benefits and risks of the available treatments (active surveillance or radical treatments). specific objectives are: * to estimate, at a population level, the proportion of newly diagnosed prostate cancer at low risk, eligible for active surveillance, the proportion of those accepting to be enrolled in a cohort of active surveillance and the risk of abandoning the program during follow-up. * to compare the patients' and physicians' characteristics of those accepting to be managed within the active surveillance program with those preferring a radical treatment (either surgery or radiotherapy). * to compare, at a population level, the clinical outcomes, quality of life and costs associated to different treatment choices.

Eligibility criteria:
iinclusion criteria: 1. newly diagnosed low risk prostate cancer patients, defined according to the presence of all the following criteria: * diagnosis of adenocarcinoma of the prostate * prostate cancer clinical stage t1c o t2a * psa \<=10ng/ml at diagnosis * adequate biopsy sampling according to prostate volume * maximum of two positive cores for random sampling and of maximum two lesions for target biopsies (even if the number of positive samples if \>2) * gleason grade 3+3 ( in patients age\>70 gleason 3+4) 2. residence in piemonte or valle d'aosta regions; 3. patients suitable for radical treatment (surgery or radiotherapy); 4. age at diagnosis \ 75 years if fragility assessment (measured with the g8 score)\> = 14; 5. patients suitability for expressing a valid consent to participate in the study. exclusion criteria: 1. patients previously treated for prostate cancer. 2. patients not willing to undergo radical treatments (surgery or radiotherapy).

Keywords: active surveillance low risk prostate cancer prostatic neoplasm/therapy (mesh) prostatic neoplasm/surgery (mesh) prostatic neoplasm/radiotherapy (mesh) prostatectomy (mesh) quality of life (mesh) costs and cost analysis (mesh)
nipper randomised trial - child follow up study

Conditions: Obesity, Childhood; Cognition; Neurobehavioral Manifestations; Metabolic Disturbance; Growth Disorders; Allergy; Atopic Dermatitis; Atopy; Nutrition, Healthy; Lifestyle; Microbial Colonization; Breastfeeding

Summary: there is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. this study is a follow up of children from the nipper trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. in this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms. the data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.


Eligibility criteria:
inclusion criteria: all children still participating in the nipper study at 6-8 years. exclusion criteria: known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.

Keywords: nutrition body composition neurodevelopment lifestyle endocrinology and metabolism preconception supplementation pregnancy infancy breast milk
trial to evaluate the efficacy of rotigotine on parkinson's disease-associated motor symptoms and apathy

Conditions: Idiopathic Parkinson's Disease

Summary: this trial is being conducted to assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic parkinson´s disease.


Eligibility criteria:
inclusion criteria: * patients with early or advanced idiopathic parkinson's disease * patients with advanced idiopathic parkinson's disease: intake of levodopa on a stable dose of at least 200 mg/day * unsatisfactory control of parkinson's disease motor symptoms under current treatment * patients experiencing apathy associated with parkinson's disease * hoehn and yahr stage score of i to iv * mini-mental state examination score ≥ 25 * if an antidepressant drug is taken, the dose must be stable exclusion criteria: * therapy with a dopamine agonist * discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy * any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation * patient has received neuroleptics, dopamine releasing substances, dopamine modulating substances, alpha-methyldopa, metoclopramide, mao-a inhibitors, budipine, or tolcapone * electroconvulsive therapy * patient has a * current/anticipated psychotherapy or behavior therapy * history of deep brain stimulation * history of suicide attempt or has suicidal ideation * impulse control disorder * severe depression

Keywords: parkinson's disease rotigotine apathy nonmotor motor neupro