Kornimate/medical-research-clean huggingface dataset:
ovarian response prediction in in vitro fertilization (ivf) patients

Conditions: Infertility, Subfertility

Summary: the aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian stimulation in a fixed gonadotropin dose gnrh-antagonist protocol by endocrine (amh, fsh), demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of gonadotropin receptors and secreted gonadotropins).

assisted reproduction by in-vitro fertilisation plays a pivotal role in the treatment of infertility, the understanding of reproductive biology, and future population dynamics. the success of assisted reproductive technologies (art) is critically dependent on optimizing protocols for controlled ovarian stimulation which aim at providing an adequate number of good quality oocytes for in-vitro laboratory procedures. interindividual variation in response to follicle-stimulating hormone (fsh) is a widespread problem with clinical and economical implications. a group of patients (9%-24%) tend to respond poorly to controlled ovarian stimulation (cos) whereas other patients tend to overrespond (2.5%) and thus run at risk of developing ovarian hyperstimulation syndrome, a potentially life-threatening disease. polymorphisms of gonadotropin receptors seem to have an influence on the outcome of controlled ovarian hyperstimulation treatment, e.g. contributing to the variation in ovarian response to exogenous fsh between individuals. other predictive factors include demographic (age), sonographic (follicular count in the ovaries, ovarian volume), endocrine (serum gonadotropin levels and anti-muellerian hormone) and life-style factors (smoking, obesity). such factors are routinely obtained prior to a treatment cycle, and are used to determine the optimal fsh starting dose or the best treatment regimen. the identification of gonadotropin receptor polymorphisms and variants in secreted gonadotropins prior to an ovarian stimulation treatment should allow the clinicians to tailor the starting dose of rfsh, especially for patients undergoing their first treatment cycle, as such ovarian response prediction will prevent cycle cancellations due to too low or too high ovarian response and reduce the risk of ohss. the aim of the present study is to identify the prevalence of fsh and lh receptor polymorphisms and hormonal variants of lh and to study the variation attributable to these genetics factors when controlling for already established predictors of ovarian response to exogenous fsh in a multi-variate analysis.

Eligibility criteria:
inclusion criteria: female patients for who the treating physician decides that treatment with long acting fsh 150µg in a gnrh-antagonist protocol is indicated. exclusion criteria: contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) use of hormonal preparations within one month prior to inclusion

Keywords: ovarian stimulation recombinant fsh gnrh-antagonist corifollitropin alfa
reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva ursi (uu)- a comparative effectiveness trial

Conditions: Urinary Tract Infections

Summary: it is well known that "over-treatment" of straightforward infections should be avoided as far as possible. evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. this randomised-controlled double blind trial examines whether initial herbal treatment with uva ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (uti) without a negative effect on symptom course and rate of recurrent utis. in total, 430 patients presenting with typical uti symptoms will be included by their gps and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.


Eligibility criteria:
inclusion criteria: * women (18-75 years) with suspected uti * at least two symptoms of uti (dysuria, urgency of micturition, frequency, lower abdominal pain) * written informed consent exclusion criteria: * signs of complicated uti (e. g. temperature \> 38°c, loin tenderness) * conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter) * pregnancy/ breastfeeding * current self-medication with uu preparations e.g. z.b. cystinol®, uvalysat®, arctuvan® * antibiotic use in the last 7 days * previous uti in the past 2 weeks * history of pyelonephritis * contraindications for trial drugs * serious diseases * inability to understand trial information * current participation in another clinical trial or participation in another clinical trial within the last 4 weeks

Keywords: uva ursi fosfomycin uncomplicated urinary tract infection of women
myocardial protection in minimally invasive mitral valve surgery

Conditions: Myocardial Protection; Minimally Invasive Surgery; Mitral Valve Prolapse

Summary: perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (mv) surgery have evolved over time and remarkable short- and long-term results have been re-ported. however, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest. aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (eac) versus the trans-thoracic aortic clamp (ttc) in patients undergoing right mini-thoracotomy mv repair. a single center, prospective observational study was performed between june 2014 to june 2018 on patients undergoing right mini-thoracotomy mv repair with retrograde arterial perfusion and eac or ttc. the selection of one setting in respect to the other was patient orientated. myocardial protection was assessed through creatinine kinase-myocardial band (ck-mb) and cardiac troponin t (ctn-t) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.


Eligibility criteria:
inclusion criteria: * surgical indication for mitral valve repair. * right mini-thoracotomy approach. * retrograde arterial perfusion. exclusion criteria: * age more than 75 years. * cardiac ejection fraction lower than 40%. * previous cardiac surgery procedures for coronary artery bypass graft. * any degree of coronary artery disease. * severe peripheral vascular disease. * concomitant procedures for atrial fibrillation ablation.
functional and quality of life outcomes following viscosupplementation for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study will compare changes in outcomes following viscosupplementation for knee osteoarthritis.

the specific aims of this study are to compare the changes in knee pain symptoms, physical function, gait parameters and quality of life in persons with knee oa following a standard viscosupplementation injection series of hyaluronic acid (ha) over a one year period.

Eligibility criteria:
inclusion criteria: * 21 years of age or older * osteoarthritis degeneration, degenerative joint disease or degeneration * fully cognizant of study procedures * willing to carefully participate in all study processes and assessments exclusion criteria: * less that 21 years of age * allergic reactivity to hyaluronic acid * current knee infection, infection around injection site or any skin disease * pregnancy or lactation * non-ambulatory

Keywords: knee osteoarthritis hyaluronic acid viscosupplementation
biomarkers in inflammatory bowel diseases

Conditions: Inflammatory Bowel Disease; Colitis, Ulcerative; Crohn Disease

Summary: ulcerative colitis (uc) and crohn's disease (cd) are chronic relapsing inflammatory bowel diseases (ibd). at the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. there is a continuous need to improve diagnostic and prognostic tools. in chronic inflammation diseases there is an excessive turnover of the extracellular tissue. tissue is broken down to small fragments and released into the circulation. changes in the amount of these fragments in the blood may provide information on the damage and quality of the affected tissue and may therefore act as objective measure of disease burden and severity - a so called biomarker. the potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal survey including 300 patients with uc, cd, irritable bowel disease and healthy controls. the patients are followed for up to 1 year. changes in biomarker are correlated to standard markers of inflammation during active disease and remission. perspective the use of new biomarkers may offer a tool to evaluate early changes in the gut of patients with ibd, may be a supplement to the diagnosis, serve as markers for effect of treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.


Eligibility criteria:
inclusion criteria: * age ≥18 years * written informed consent * and one of: * for crohn's disease - active disease: verified cd diagnosis according to clinical, endoscopic and histological standard criteria and harvey bradshaw index \> 4. * for crohn's disease - disease in remission: verified cd diagnosis according to clinical, endoscopic and histological standard criteria and harvey bradshaw index ≤ 4. * ulcerative colitis - active disease: verified uc diagnosis according to clinical, endoscopic and histological standard criteria and sccai \> 3. * ulcerative colitis - in remission: verified uc diagnosis according to clinical, endoscopic and histological standard criteria and sccai ≤ 3. * irritable bowel syndrome: verified ibs according to standard criteria. * healthy control: no known chronic diseases which needs continuously medication. exclusion criteria: * common to all participants: * patient with ostomy or pouch. * the patient has had colon cancer, dysplasia or adenomatous polyps in the colon during the recent 5 year * the patient is in a poor general condition. * the patient is pregnant at the time of inclusion or has planned pregnancy during the period of study. * the patient cannot understand the information material. * healthy control: * the patient has a chronic disease. * ibs symptoms according to standard criteria. * the patient has had any type of illness within the last 14 days (for example diarrhea, a cold etc.). * the patient has any type of on-going medication or new medication within the last 14 days (except contraceptive pills and vitamins).

Keywords: biochemical markers
dallas heart study 2: return clinic visit for the dallas heart study cohort

Conditions: Atherosclerosis; Congestive Heart Failure; Left Ventricular Hypertrophy; Diabetes Mellitus; Hypertension; Obesity; Metabolic Syndrome X; Myocardial Infarction

Summary: the dallas heart study (dhs-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of atherosclerotic heart disease (ashd) in a representative united states (us) urban environment. this study completed enrollment in 2003. our objective is to pinpoint factors contributing to progression: 1. from health to ashd risk; 2. from ashd risk to subclinical ashd; and 3. from subclinical to clinical ashd. identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ashd develops.

early medical intervention in asymptomatic individuals at risk is the most effective strategy to combat atherosclerotic heart disease (ashd). the major roadblock to effective ashd prevention is that conventional tools to assess ashd risk are inadequate and new methods are needed to identify susceptible individuals before the disease process is established. other successful public-health screening programs have incorporated direct imaging procedures (e.g. mammography, colonoscopy); yet in ashd, direct imaging of the vasculature has not been incorporated into the risk stratification algorithms. the dallas heart study (dhs-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of ashd in a representative us urban environment. this study completed enrollment in 2003. in dhs-2 we will transform the dallas heart study from a cross-sectional health survey (dhs-1) into a longitudinal cohort study (dhs-2). we will perform state-of-the-art cardiovascular (cv) imaging coupled to biomarkers, genetic markers and classical ashd risk factors. we will repeat the detailed clinical phenotyping performed between 2000-2003 to capture interval changes in ashd risk and disease burden. our objective is to pinpoint factors contributing to progression: 1. from health to ashd risk; 2. from ashd risk to subclinical ashd; and 3. from subclinical to clinical ashd. identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ashd develops.

Eligibility criteria:
inclusion criteria: * age 35-70 * participant in dhs-1 study completing visit 2 (blood sampling) and visit 3 (clinic visit) * provision of informed consent exclusion criteria: * none--population study

Keywords: atherosclerosis heart failure ventricular hypertrophy myocardial infarction screening hypertension diabetes obesity metabolic syndrome
prospective follow-up, marathon, long term, inflammation and cardiovascular system

Conditions: Participants of the Be-MaGIC-Study 2009

Summary: pro-magic is a prospective observational study and includes participants of the be-magic-study 2009 (n=277/nct00933218). we aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

physical activity is associated with health benefits. acute prolonged and strenuous exercise, i.e. marathon running, leads to hemodynamic, endothelial and myocardial functional changes. whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. in addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. the aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years. for this purpose, 277 male participants from the be-magic study (marathon 2009) are examined in this prospective observational study. a single examination with the following components will take place: anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations.

Eligibility criteria:
inclusion criteria: declaration of consent participants must have participated in the be-magic study in 2009 * current age: 30 - 70 years * sex: male exclusion criteria: -

Keywords: prolonged exercise, marathon, cardiovascular disease, long term
the impact of social media-delivered chemotherapy side effects education for breast cancer patients receiving chemotherapy

Conditions: Chemotherapy Side Effects; Social Media; Education of Patients

Summary: the goal of this clinical trial is to learn if a standardized pharmacists-provided education module by social media can improve patients' knowledge of chemotherapy-related side effects. the main questions it aims to answer is: • do patients who received a standardized pharmacists-provided education module by social media improve their knowledge of chemotherapy-related side effects? researchers will compare standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group). participants will: * received standardized chemotherapy education + video or chemotherapy handouts at the first and second chemotherapy section. * fill out a questionnaire for outcomes assessment.

the pharmacist-provided video education model for patients undergoing first time chemotherapy was developed. the content of the education video included the mechanism of side effects, its recognition, preventive measures, non-medical management, and further instructions when to visit hospital were included. patients were randomly assigned into two groups with different education strategies: standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group). every patient was asked to fill out a questionnaire prior to the implementation of the education model in both groups. the pre-test questionnaires consisted of baseline knowledge and personal information. patients in the experimental group would receive standardized chemotherapy education by pharmacists, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy on the first day of chemotherapy cycle. videos will be provided with patients and they will watch videos during the visit. the information regarding the prevention and management of side effects and further instructions when to visit hospital. patients will have access to videos and watch videos after leaving the hospital for the entire treatment course. the education time will be last around 15 to 20 minutes. in terms of control group, pharmacists will briefly explain and provide chemotherapy handouts, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy. the duration of visit will be around 5 to 10 minutes. after the education section, patients will be asked to do a post-test questionnaire of their knowledge and quality of life.

Eligibility criteria:
inclusion criteria: * breast cancer patients aged 18 or older undergoing their first chemotherapy. * possess a smartphone and are able to watch videos on it. exclusion criteria: * unable to read or complete questionnaires in chinese. * cognitive impairments. * pregnant women.

Keywords: pharmacist chemotherapy education social media
a trial investigating the exposure of nn5401 in young adults and elderly subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate the exposure of nn5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group) * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) * hba1c (glycosylated haemoglobin a1c) maximum 10.0% by central laboratory analysis exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
observational study of endothelial dysfunction in phenylketonuria

Conditions: Phenylketonuria; Endothelial Dysfunction

Summary: the purpose of this study is to determine whether adolescent and adult patients with phenylketonuria who are on long-term phenylalanine-restricted diet suffer from endothelial dysfunction.

the aim of the study is the examination of endothelial dysfunction and oxidative stress markers in adolescent and adult patients with phenylketonuria (pku), in correlation to phenylalanine values und phenylalanine-restricted diet. 25-50 patients with pku aged ≥16 years of age and a control group of 25 age- and sex-matched healthy volunteers will be included in the study. endothelial dysfunction will be measured by venous occlusion plethysmography on the lower legs in the pku patients and in the control group. wave velocity, aortic stiffness, and intima media thickness of the common carotid artery will be measured by vicorder and duplex ultrasound scanner in the pku patients and in the control group. analyses of phenylalanine metabolites and renal function will be performed only in the pku patients, analyses of oxidative stress markers in the pku patients and in the control group. dietary protocols of the patients with pku will be calculated for their daily phenylalanine, total protein, and calorie intake. results of the study will be kept in the medical records and paper case report forms. data will be analyzed only in pseudonymized form.

Eligibility criteria:
inclusion criteria: * phenylketonuria due to phenylalanine hydroxylase deficiency * age ≥16 years exclusion criteria: * age \<16 years * pregnancy or maternity * late-treated phenylketonuria * phenylketonuria due a defect in bh4 synthesis or bh4 regeneration

Keywords: phenylketonuria, endothelial dysfunction, ckd