Kornimate/medical-research-clean huggingface dataset:
periodization of exercise training in patients with coronary heart disease.

Conditions: Coronary Heart Disease; Healthy Control

Summary: the research project includes two components that assess exercise physiology parameters, cerebrovascular reserve, cognitive functions and cardiac function in coronary heart disease patients at rest, during an acute exercise, and after two different periodized training programs.


Eligibility criteria:
inclusion criteria for patients with coronary heart disease: * major * adequate physical and mental capacities * autonomy in daily activities * documented coronary artery disease * stable or recent coronary artery disease exclusion criteria for patients with coronary heart disease: * inability to complete the consent form * acute coronary syndrome \< 3 months * heart failure * ejection fraction of the left ventricle \<40% * coronary artery disease non revascularisable including left main coronary stenosis * waiting for a bridging of the coronary artery * chronic atrial fibrillation * malignant arrhythmias during exercise * restriction to non cardiopulmonary exercise * severe intolerance to exercise

Keywords: aerobic exercise training periodization cerebral oxygenation and perfusion cognition
massage therapy for cancer-related fatigue

Conditions: Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Summary: the purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.

the proposed project is a randomized pilot trial of a swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being. the proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. this study will determine efficacy, functioning, perceptions of fatigue, and quality of life. this study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying cam interventions for difficult-to-treat symptomatic conditions.

Eligibility criteria:
inclusion criteria: * confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum * have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session. * have a primary oncologist * currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months exclusion criteria: * active skin rash or open cutaneous lesions. * history of venous thrombosis (or symptomatic varicosity) * identification of a thrombosis using an ultrasound test of the legs. * long term (\> 3 months) steroid medications for other medical conditions in past 5 years * plans to move out of the study region within 6 months * thyroid-stimulating hormone (tsh) level above the upper limit of normal * hematocrit \<25% * platelet count of \< 50,000 * patients who have been receiving regular (i.e. at least twice a month) bodywork over the past 6 months.

Keywords: cancer-related fatigue alternative medicine cancer rehabilitation /care fatigue human therapy evaluation physical therapy neoplasm /cancer chemotherapy neoplasm /cancer palliative treatment
quantitative immunochemical fecal occult blood test in symptomatic patients

Conditions: Colorectal Neoplasms

Summary: the aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.

consecutive patients referred from primary care for colonoscopy due to symptoms are eligible. patients will receive written information of the study together with the time for colonoscopy. a specific research nurse will call them and for those accepting participation, history and current medication will be collected. kits will be sent to patients and they will provide three faecal samples before examination. these will be analysed at one certified laboratory. hemoglobin concentration will be notified in the range of 50 - \< 1000 ng/ml, or as a negative outcome. macroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.

Eligibility criteria:
inclusion criteria: * symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia) exclusion criteria: * screening investigations * high-risk patients

Keywords: fecal occult blood
evaluation of physiologic and standard sex steroid replacement regimens in women with premature ovarian failure

Conditions: Premature Ovarian Failure

Summary: the aim of the study is to determine whether physiological sex steroid replacement improves parameters of skeletal, cardiovascular and reproductive health of women treated with current sex steroid replacement regimens.

premature ovarian failure, defined as the onset of the menopause before the age of 40 years, is a relatively common problem that affects 1% of women. there are a variety of aetiologies underlying premature ovarian failure including turner syndrome and those with idiopathic onset, however with the increasing success of intensive treatment for childhood cancer, there are increasing numbers of young survivors, with a variety of late effects of treatment, including premature ovarian failure. evidence is required for the optimal management of young women with premature ovarian failure, either as a result of childhood cancer treatment or for other reasons. these women are currently offered combined sex steroid replacement in the convenient form of the oral contraceptive pill, or hormone replacement therapy, designed for older women after the menopause. these preparations are not designed to achieve physiological replacement of oestrogen or progesterone, either in dosage or in biochemical structure - many preparations using synthetic derivatives. these younger women who have differing metabolic and psychological requirements are looking to a future of 30 or more years of replacement. the optimal mode of ssr is not known for young women with premature ovarian failure, however there is concern that current regimens may be inadequate for optimal skeletal and cardiovascular health. current preliminary data demonstrates that use of physiological sex steroid replacement improves uterine parameters. evidence is required to determine whether optimising sex steroid replacement can also significantly improve parameters of skeletal and cardiovascular health. young women with ovarian failure face several decades of hormone replacement, so small improvements in management may make large differences to later morbidity and mortality. the aim of the study is to determine whether physiological sex steroid replacement improves parameters of skeletal, cardiovascular and reproductive health of women treated with current sex steroid replacement regimens.

Eligibility criteria:
inclusion criteria: * premature ovarian failure exclusion criteria: * intercurrent illness

Keywords: premature ovarian failure sex hormone replacement hrt blood pressure bone mineral density bone metabolism uterine function
pharmacoeconomic evaluation of the cost/effectiveness ratio of physical exercise on non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: physical inactivity and poor dietary habits are associated with an increased risk of obesity and chronic disease (world health organization, 2019; glanz and bishop, 2010). conversely, higher levels of total physical activity result in a reduced risk of cardiovascular disease, breast and colon cancer, and diabetes (kyu et al., 2016). similarly, consumption of the minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower risk of cardiovascular disease and cancer (ezzati et al., 2004). however, despite these recognized benefits, unhealthy diet and physical inactivity are still major contributors to poor health and rising health care costs. worldwide, physical inactivity accounted for 13.4 million disability-adjusted life years (dalys) in 2013 and cost $53.8 billion to health systems and an additional $13.7 billion in productivity due to deaths attributable to physical inactivity (ding et al., 2016). pharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health of the population, is a set of evaluation models used to identify the value (convenience) and the overall economic impact of a possible treatment. the results of economic evaluations help decision makers inform their choice. their advantage is that the result is obtained by applying known and validated models, and everyone can know the basis of the decision (evidence-based decision making). the clinical-economic value and the overall financial impact must be compared with the willingness to pay the related costs. economic evaluations are a tool for defining the value of a medicine in terms of cost-opportunity, from the point of view of the patient, the nhs and society as a whole. the definition of "value" is very broad, multidimensional and includes concepts from many disciplines, beyond economics. specifically, economic evaluations that take into consideration new medicines, innovative or not, the value is given by the marginal utility that the patient, the nhs and/or society can obtain from its acquisition. in this regard, the measurement of years of life gained in full quality of life (qaly - quality-adjusted life years) is widely applied to medicines in various regulatory contexts, albeit with the awareness that it is not able to capture all the elements that contribute to value (carletto, a et al.; drummond, m. f)


Eligibility criteria:
inclusion criteria: * being affected by nafld in the observation period (2018-2020) * participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists exclusion criteria: * patient deceased * patient who does not agree to participate in the study

Keywords: non-alcoholic fatty liver desease cost/effectivness physical activity
effects of inhaled ciclesonide versus fluticasone propionate versus placebo on lower leg growth in prepubertal children with mild persistent asthma (6 to 12 y) (by9010/m1-208)

Conditions: Asthma

Summary: the aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. the study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable * prepubertal stage * good health with the exception of asthma * history of asthma for at least 6 months * currently using rescue medication only main exclusion criteria: * childbearing potential (beyond menarche) * concurrent diseases or conditions which may subsequently affect growth * copd or relevant lung diseases causing alternating impairment in lung function * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * history of life-threatening asthma * current smoking

Keywords: asthma ciclesonide child fluticasone propionate hpa-axis pediatric linear growth rate
medication errors and adverse drug events (ades) in ambulatory pediatrics

Conditions: Pediatric ALL

Summary: the purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. further, we wish to determine the effectiveness of a computerized physician order entry (cpoe) system in reducing errors.

this study has the following 2 goals: aim 1: to determine the rates, types, and predictors of medication errors and ades. aim 2: to perform a trial assessing the effectiveness of an intervention (cpoe) on reducing serious medication errors. we hypothesize that: 1. medication errors and ades are frequent in ambulatory pediatrics. 2. presence of the following predictors will be associated with higher error rates: cultural, racial, socioeconomic, educational, and linguistic barriers to communication, understanding, and successful completion of prescribed therapies; complex medical or chronic medical conditions; complex medication regimens; non-physician providers with limited clinical experience; high provider workloads; and complex prescription refill systems. 3. prevention strategies, including both technology-based and behavioral/ human factors-based interventions, will be effective and cost-effective in reducing rates of serious medication errors (defined as preventable ades and non-intercepted potential ades).

Eligibility criteria:
inclusion criteria: * pediatric providers at the participating office practices during the study period as well as the parents of the patients of these providers. exclusion criteria: * pediatric providers or patients at other office practices.
upper airway reeducation in moderate obstructive sleep apnea syndrome

Conditions: Moderate Obstructive Sleep Apnea Syndrome

Summary: the aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous positive anyway pressure (cpap) and the mandibular advancement device.

patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. they will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. only one of the 2 reeducations is expected to be effective. to limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. the initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the apnea-hypopnea index (ahi) and other outcomes.

Eligibility criteria:
inclusion criteria: * male or female, 18 years old minimum * diagnosis of moderate osas: ahi ≥ 15 events/h and \< 30 events/h at psg m0 * bmi \< 35 kg/m2 exclusion criteria: * moca \< 26 (montreal cognitive assessment) * craniofacial malformations * regular use of hypnotic medications * untreated hypothyroidism * stroke history * cardiac insufficiency * severe uncontrolled coronary heart disease * severe obstructive nasal disease * patients with indication for cpap in first intention * pregnant or breastfeeding woman * current participation in another interventional research in osa * no affiliation to a social security system or legal beneficiary (except ame,aide médicale d'état) * absence of free, informed, written consent * contraindications for tms: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism * protected adult under guardianship or curatorship
international multicenter patent foramen ovale & stroke (improve) registry

Conditions: Stroke; Patent Foramen Ovale; Atrial Fibrillation; Atrial Flutter

Summary: patent foramen ovale (pfo) is a prevalent cause of ischemic stroke and transient ischemic attack (tia) in young patients. its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. recent randomized controlled trials (rcts) have shown that pfo closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. as such, the number of pfo closure procedures are expected to increase substantially in the upcoming years. real world data (rwd) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with pfo, with and without pfo closure, will become crucial for understanding how results from rcts are translated into clinical practice globally. the improve (international multicenter patent foramen ovale \& stroke) registry is an observational, multicenter, international registry of men and women with an ischemic stroke or tia. the aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. the improve registry will provide important information about the management and related outcomes of patients with ischemic stroke or tia and pfo throughout different regions of the world and across a wide spectrum of healthcare systems.


Eligibility criteria:
inclusion criteria (all of the following criteria should be fulfilled) * age ≥18 years * ischemic stroke or tia within 5 years and 1 year before inclusion in the registry. patients with cerebrovascular events occurred within one year before the inclusion in the registry should be part of the prospective cohort. * ischemic stroke is defined as: * focal neurological deficit of central origin lasting ≥24 hours -except for death within 24hrs- with or without imaging confirmation of cerebral infarction; or * focal neurological deficit of central origin lasting \<24 hours with corresponding imaging evidence of cerebral infarction; or * focal neurological deficit of central origin lasting \<24 hours in patients receiving iv thrombolysis or endovascular thrombectomy with or without imaging confirmation of cerebral infarction; or * non-focal encephalopathy lasting more than 24 hours -except for death within 24hrs- with imaging evidence of cerebral infarction; or * acute and permanent retinal ischemia of arterial origin. * tia is defined as: * focal neurological deficit of central origin lasting \<24 hours without corresponding imaging evidence of cerebral infarction in patients not receiving iv thrombolysis or endovascular thrombectomy. * confirmed patent foramen ovale. exclusion criteria: exclusion criteria * age \<18 years * venous stroke * stroke mimics * patients with incomplete data at 12 months after the index ischemic stroke or tia.
assessment of left and right ventricular function in patients with ebstein anomaly with different echocardiographic methods

Conditions: Ebstein Anomaly

Summary: ebstein anomaly is a rare congenital heart disease. it encompasses abnormalities of the tricuspid valve, the right atrium and the right ventricle (rv). currently, cardiac magnetic resonance imaging (mri) is considered the method of choice for the assessment of rv volume and function. to evaluate the right heart function ventripoint method was designed to assess the rv in a fraction of the time, resulting in better efficacy and lower costs. ventripoint is approved for tetralogy of fallot patients as well as patients with systemic rv in d-transposition of the great arteries. this method uses 2 dimensional standard ultrasound views linked to a ventripoint medical systems unit. after acquisition, the physician identifies anatomical landmarks with dots on a number of the 2d ultrasound views through the heart. with a sensor (magnetic tracking system: gps) on the ultrasound probe we know where the 2d plane is in 3d space. in this way the precise anatomical landmark is located in 3d space. the aim of the present study is to assess the feasibility, reliability and accuracy of the echocardiographic knowledge-based 3d reconstruction method to measure rv volume and function in patients with ebstein anomaly. the accuracy of the method will be assessed by comparison with measurements obtained by cardiac mri. in addition to the right ventricle the investigators want to assess the left ventricular function in patients with ebstein anomaly in this study. by using speckle tracking echocardiography the investigators would like to investigate on the left ventricular contractility, rotation and synchrony of the left ventricle together with the rv. not seldom the left ventricle is neglected in a patient with ebstein anomaly by impressive findings of the right ventricle. changes in the myocardial left ventricular structure (non compaction) are also described and may have negative impact on the function. the investigators want to analyze 25-30 patients with ebstein anomaly including children starting at 11 years of age.


Eligibility criteria:
inclusion criteria: * ebstein anomaly * male and female 11 years to 80 years of age * unoperated or operated on the heart, including 1 1/2 chamber palliation * wolff-parkinson-white syndrome exclusion criteria: * moderate or severe mitral valve insufficiency, moderate or severe aortic insufficiency, moderate or severe aortic stenosis * univentricular palliation (fontan) * st.n. myectomy of the left ventricle * concomitant l-transposition of the great arteries
the significance of the mesh thickness in the operation of inguinal hernia

Conditions: Inguinal Hernia

Summary: the trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes. hypothesis: there is less postoperative pain after the implantation of a light-weight mesh.

the implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. the experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). chronic pain is defined as pain that remains 3 months after the operation. recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery. in the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. in an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.

Eligibility criteria:
inclusion criteria: * male, age 25 years or older * reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before exclusion criteria: * the patient is not able or do not want to give written informed consent * the patient is not suitable for an operation in local anesthesia * anticoagulant medication or a known coagulation disorder

Keywords: inguinal hernia polypropylene mesh heavy-weight mesh light-weight mesh