Kornimate/medical-research-clean huggingface dataset:
physical activity in patients after aortic valve replacement (valve-ex)

Conditions: Valvular Aortic Stenosis

Summary: a structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial function before, three and six months after operation; comparison with a non-intervention control group.


Eligibility criteria:
inclusion criteria: * patients with severe valvular aortic stenosis and indication for valve replacement exclusion criteria: * coronary heart disease with indication for additional bypass surgery leading insufficiency of the valve * age \ 75 * diseases or conditions leading to additional risks during physical activity (e.g. diabetes, arthrosis, obstructive pulmonary disease)
metabolic effects of vitamin d in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Vitamin D Insufficiency

Summary: the purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin d in patients with type 2 diabetes and vitamin d insufficiency.

there is increasing evidence that vitamin d affects the risk of diabetes. the role of vitamin d in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin d status and the development of type 2 diabetes has been found. moreover supplementation with calcium and vitamin d may attenuate increases in glycemia and insulin resistance in healthy older adults with ifg. however further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin d against diabetes. the aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin d insufficiency before and after a 12-week period of treatment with high doses of vitamin d.

Eligibility criteria:
inclusion criteria: * informed consent * type 2 diabetes * patients of danish extraction * vitamin d insufficiency (1,25ohvitd \< 50 nmol/l) exclusion criteria: * nephropathy (urea \> 12 mmol/l) * s-calcium \> 2,52 mmol/l * primary hyperparathyroidism * serious disease * malabsorption * sarcoidosis * pregnancy

Keywords: type 2 diabetes vitamin d insufficiency insulin secretion insulin sensitivity pulsatility
long-term follow-up after surgical treatment for gerd (gastroesophageal reflux disease)

Conditions: Patient Satisfaction; Relapse; Dysphagia; Bloating

Summary: 10 years of follow-up with sf-36 global (quality of life issues), gsrs (gastrointestinal symptom rating scale) and two reflux specific questionnaires.

long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease. quality of life sf-36; physical and mental component scores. gsrs, five dimensions of abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea. reflux specificquestionnaries on various issues of reflux disease and frequency issues about reflux disease problems.

Eligibility criteria:
inclusion criteria: gastroesophageal reflux 10 years follow-up after surgery informed consent exclusion criteria: deceased patients patients who declined participation
frailty score and postoperative morbidity in colorectal cancer surgery

Conditions: Postoperative Complications; Colorectal Cancer; Frailty

Summary: this prospective observational study aims to evaluate the independent predictive value of the edmonton frailty index (efi) in estimating postoperative morbidity among older patients undergoing elective colorectal cancer surgery. frailty, characterized by a decline in physiological reserves and increased vulnerability to stressors, has been recognized as a stronger predictor of adverse postoperative outcomes than chronological age alone. while the relationship between frailty and surgical outcomes has been extensively investigated in general surgical populations, data specifically focusing on patients with colorectal cancer remain limited. in this study, patients aged 65 years and older scheduled for elective colorectal cancer surgery will undergo preoperative frailty assessment using the validated edmonton frailty index (efi). postoperative complications, length of intensive care unit (icu) stay, total hospital stay, and 30-day adverse outcomes, including mortality, myocardial infarction, pulmonary embolism, sepsis, and the need for reoperation, will be recorded and analyzed. the primary objective is to determine whether frailty, as measured by the edmonton frailty index, serves as an independent predictor of postoperative morbidity in this specific patient population. secondary objectives include exploring associations between frailty and intraoperative variables such as blood loss, fluid administration, and vasopressor requirements. by addressing this gap, the study aims to contribute to the growing body of evidence supporting the routine incorporation of frailty assessment into preoperative risk stratification protocols for older patients with colorectal cancer. the ultimate goal is to enhance perioperative risk assessment, optimize perioperative care, and improve patient outcomes.


Eligibility criteria:
inclusion criteria: * patients aged 65 years and older * patients undergoing surgery for colorectal cancer * patients scheduled for elective (non-emergency) surgery * individuals eligible for preoperative frailty assessment using the edmonton frailty scale (efs) * patients who can be followed for at least 30 days postoperatively * patients able to provide informed consent exclusion criteria: * patients requiring emergency surgery * neurological or psychiatric disorders that prevent the assessment of consciousness level * severe comorbidities (patients with extremely high surgical risk due to severe cardiovascular, respiratory, or other systemic diseases) * patients who do not or cannot provide informed consent
defibrotide compassionate use for patients with life threatening veno-occlusive disease of the liver

Conditions: Liver Diseases

Summary: severe veno-occlusive disease (vod) of the liver is a life threatening complication of blood and marrow transplantation. treatment with currently available (food and drug administration \[fda\] approved) agents fails in most cases. recently conducted clinical studies indicate that patients benefit from defibrotide, a non-fda approved agent. this protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at children's healthcare of atlanta and at emory university in a safe, effective and ethical manner.

severe veno-occlusive disease (vod) of the liver is a life threatening complication of blood and marrow transplantation. treatment with currently available (fda approved) agents fails in most cases. recently conducted clinical studies indicate that patients benefit from defibrotide, a non-fda approved agent. this protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at children's healthcare of atlanta and at emory university in a safe, effective and ethical manner.

Eligibility criteria:
inclusion criteria: * veno-occlusive disease of the liver

Keywords: venous occlusive disease vod
ct-guided lung biopsy risk optimization method

Conditions: Pneumothorax; Biopsy, Needle; Risk Factors; Radiology, Interventional

Summary: the purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.

study participants with written consent and the percutaneous, ct-guided lung biopsy already regularly indicated by the referring doctors (e.g., oncology) will be part of this study and will be randomized directly before the intervention. after randomization, the intervention is performed by interventional radiology, either with or without prior fluid administration into the pleural space. three samples are taken using either an 18g or 20g coaxial needle, and any complications are treated according to the clinical standard. the lung biopsy will be only performed if clinically indicated and is not a study-specific intervention; data about the lung biopsy, like internal dicom images of them retrieved from inselspital's picture archiving and communication system (pacs), laboratory results, and clinical information are retrieved from ris (radiological information system) and ipdos® and kiss by epic® (electronic medical record) and the associated histopathological findings from the institute of pathology, university of bern, will be analyzed.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent (knowledge of project languages), \>18 years. * indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or status after unsuccessful transbronchial biopsy * indication for biopsy given by referring specialist (in patients). exclusion criteria: * preintervention bleeding into the pleural cavity * more than 1 lesion should be biopsied at the same time * infiltration of the thoracic wall * pregnancy

Keywords: image-guided biopsy risk factors tomography biopsy pneumothorax
assessment of food practices by residents in nursing homes

Conditions: Malnutrition

Summary: nutrition is an essential component of health and a key determinant of aging and quality of life of individuals. malnutrition in the elderly is now recognized as a public health problem affecting nearly half of residents in nursing homes. the fight against malnutrition requires to rethink the meal in all its dimensions, beyond the nutritional needs. in order to improve practices of care at the elderly, the impact of environmental and social aspects of food in nursing homes has been assessed. the social environment and interactions during the meals are now identified as effective ways to stimulate food intake and increase feelings of well-being in the elderly. the objectives of the study are to characterize the appreciation of food and social interactions during the meals and to study the relationships between the quality of food practices and nutritional status of the residents in nursing homes to improve their quality of life.


Eligibility criteria:
inclusion criteria: * men or women living in nursing homes * person able to consent and understand the study * person able to converse in french, answer to a questionnaire * person feeding orally with or without assistance * person having lunch in community * availability of assessment criteria in the medical file exclusion criteria: * person with cachexia syndrome * person with severe dementia (mms \<20) * dependent person (gir score 1 and 2) * person with severe disorders of neurological origin swallowing * person under artificial nutrition (enteral, parenteral) * person with acute infectious disease * person with unstable medical or psychological conditions that could lead to be non receptive or uncooperative during the study or could compromise the security or the participation of the subject in the study * person under trusteeship or deprived of their liberty by judicial or administrative decision * at the end of life

Keywords: malnutrition food practices elderly nursing home aging nutritional status quality of life
obesity and weight loss on reproductive function

Conditions: Obesity

Summary: the purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. the study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. specifically, we, the researchers at penn state university, propose to characterize reproductive abnormalities in morbidly obese men and women. we hypothesize that morbid obesity leads to reproductive abnormalities in men and women. we plan to examine the short-term effects of alteration in gi hormones after bariatric surgery on reproductive function. we hypothesize that bariatric surgery radically alters gi hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. we hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. we also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men.

obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implantation. in males, obesity may impair reproductive function by several mechanisms including: decreasing libido, causing erectile dysfunction, influencing semen composition, or sperm function. therefore the long term goal of the current project is to understand the impact of severe obesity on reproductive function and how this is influenced by dramatic weight loss.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of greater than 40 or a bmi between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure. * failed medical weight loss * ages of 18-40 * not using hormonal contraception or sex steroids * subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy * subject's obesity has no medical explanation (hypothyroidism, cushing's syndrome, genetic) exclusion criteria: * not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery * subject is pregnant or lactating * not willing to use barrier contraceptives or intrauterine device (iud) to prevent pregnancy for one year following bariatric surgery * post-menopausal, either surgical or natural * subject has had a vasectomy * subject is a smoker

Keywords: obesity reproduction weight loss reproductive system
clinical prognosis and progression of myasthenia gravis patients

Conditions: Myasthenia Gravis

Summary: this study collects the clinical data of myasthenia gravis (mg) patients, assesses outcomes and adverse effects of different treatment regimens, and searches for risk factors of conversion to generalized mg.

this is a multicenter, observational cohort trial in the real-world clinical setting recruiting mg patients from neurology departments of 6 hospitals in different regions of china. clinical manifestations, laboratory test results, chest imaging and history of thymectomy are recorded. patients will be classified by clinical manifestation as well as antibody status, and treatment regimens are determined according to the physician's judgment and preferences of the patients. patients are followed up prospectively on regular to assess the outcomes of treatments and monitor any side effects. peripheral blood samples are collected annually. patients' clinical records are uploaded to an online database. the investigators plan to recruit a final sample of 2000 patients for analysis.

Eligibility criteria:
inclusion criteria: 1. age \>14. 2. clinical diagnosis of mg with supporting evidence: 1. unequivocal clinical response to pyridostigmine 2. positive antibody testing 3. decrement \>10% in repetitive nerve stimulations study (rns) . 3. willingness to sample collection, imaging study and other disease-related examinations and assessments. 4. patients with informed consent. exclusion criteria: 1. history of chronic degenerative, psychiatric, or neurologic disorder other than mg that can produce weakness or fatigue. 2. age ≤14 years. 3. severe anxiety, depression or schizophrenia. 4. cognitive impairment or mini-mental state examination (mmse) score ≤24. 5. severe systemic illness with life-expectancy less than 4 years. 6. unwillingness to consent for collection of biological samples. 7. inability to provide informed consent.
umbilical cord derived mesenchymal stem cells therapy in aplastic anemia

Conditions: Aplastic Anemia

Summary: this study is to evaluate the safety and efficacy of umbilical cord derived mesenchymal stem cells transplantation in aplastic anemia.

aplastic anemia (aa) is a disorder thought to be caused by an immune-mediated bone marrow failure. not all people with aa are eligible for today's standard treatments. one new treatment approach uses umbilical cord derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to provide the basis for clinical application. the aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with aa .

Eligibility criteria:
inclusion criteria: 1. diagnosis of aa according to established criteria in 2010 2. age from 14 to 60 years 3. suffering from aa within six months 4. no serious infection or acute hemorrhage. 5. left ventricular ejection fraction (lvef) ≥ 50% 6. no acute infectious diseases. 7. understanding and willingness to sign a written informed consent document. 8. eastern cooperative oncology group(ecog) score of 0-2pionts. exclusion criteria: - patients with aa have to be disqualified from this study if any of the following is applicable. 1. severe aplastic anemia(saa) with severe infection. 2. severe aplastic anemia(saa) with active hemorrhage. 3. severe heart attack, liver and kidney disease following serious complications 4. patients with allergic constitution. 5. pregnancy and lactation. 6. accompanied by malignant tumors and other clonal disease. 7. patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.
efficacy and safety of mycograb as adjunctive therapy for cryptococcal meningitis in patients with aids

Conditions: Cryptococcal Meningitis

Summary: this is a multicenter, randomized, efficacy and safety trial to evaluate mycograb®. subjects will be randomized to one of the 3 arms: 1/ amphotericin b (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ amphotericin b plus mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ amphotericin b plus 5-flucytosine plus mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). after 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. the total duration of the study will be approximately 24 months


Eligibility criteria:
inclusion criteria: * male or non-pregnant female who is \> 18 years old. * hiv-positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis. * currently on no treatment, or receiving treatment (\< 3 days) with either amphotericin b plus 5-flucytosine, or amphotericin b alone. * positive csf culture for cryptococcus neoforman. * physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings. exclusion criteria: * excluded for coma, or significant other medical conditions. * subject has other opportunistic fungal infections that requires other systemic antifungal therapies. other protocol-defined inclusion/exclusion criteria may apply

Keywords: cryptococcal meningitis
comorbid esophageal disorders in ibs patients

Conditions: GERD; Non-erosive Reflux Disease; Functional Esophageal Disorders; Irritable Bowel Syndrome

Summary: assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in ibs patients using different diagnostic modalities.

in the practice of a gastroenterologist, irritable bowel syndrome (ibs) is the most frequent functional disorder. its prevalence in the population is 9.8%-12.8%. its frequency in women is more than men. in some studies, it has been shown that a patient may have an overlap of symptoms of different functional diseases of the gastrointestinal tract. different researchers have ambiguously assessed the frequency of occurrence of esophageal disorders in patients with ibs. so, based on the publications of different authors, they are found in 15-80% of cases. in a study by n. de bortoli et al. (2016) noted the association of ibs with functional heartburn in 77% of cases, and with gerd and hypersensitive esophagus (called heartburn associated with reflux) - in 33% of cases. traditionally, diagnostics of a combination of functional disorders of the esophagus and intestines were based on data x-ray and endoscopic methods. however modern research has shown the importance of using in this group of patients with daily combined ph impedance measurement. thus, many authors have noted the undoubted advantages of this method in the diagnosis of esophageal disorders. unfortunately, works devoted to this topic, extremely few in number, and the information obtained in them is quite contradictory, which indicates the need to continue research in this direction.

Eligibility criteria:
inclusion criteria: * established diagnosis of ibs (according to the rome criteria of the iii revision). * upper git symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain. exclusion criteria: * history of thoracic, esophageal, or gastric surgery. * presence of duodenal or gastric ulcer on upper endoscopy. * presence of duodenal or gastric cancer on upper endoscopy. * conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma). * mental disorders state and disability. * pregnancy and breastfeeding.