Kornimate/medical-research-clean huggingface dataset:
vaginal uphold hysteropexy and laparoscopic sacral hysteropexy for the treatment of uterovaginal pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.

this will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (lshp) to a vaginal uphold hysteropexy (vuhp). symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.

Eligibility criteria:
inclusion criteria: * desires surgical treatment for uterovaginal prolapse. * symptomatic stage ii-iv pop including: * cystocele (aa or ba \> or = 0) by pop-q and * apical descent below the mid-vagina (point c \> -(tvl / 2)) by the pop-q and * a positive response to questions 3 of the pfdi 20: do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (appendix a) * eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (lshp) or vaginal uphold hysteropexy (vuhp) * female age 40 to 75. * completed childbearing confirmed by subject or practicing reliable form of birth control defined as permanent sterilization, hormonal contraception, abstinence, iud. * normal size uterus (length less than 10 cm) on bimanual exam or ultrasound within the past 6 months. exclusion criteria: * prior hysterectomy. * patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable). * current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). this includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft). * desires hysterectomy at the time of prolapse repair. * cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon. * history of cervical dysplasia (diagnosed within the past 5 years) or increased risk of cervical dysplasia (hiv, immunocompromise, des exposure), chronic pelvic pain, uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, cancer) or any uterine disease that would preclude prolapse repair with uterine preservation in the opinion of the surgeon. * any postmenopausal bleeding in the past 12 months (regardless of endometrial biopsy or ultrasound results) or any postmenopausal bleeding more than 12 months prior without adequate evaluation in the opinion of the investigator. * premenopausal women with menstrual issues including irregular bleeding, menorrhagia, dysmenorrhea, * pregnancy (confirmed before surgery with a pregnancy test).

Keywords: uterovaginal prolapse hysteropexy mesh
a predictive model for oropharyngeal dysphagia in non-hospitalized older patients

Conditions: Deglutition Disorders; Otorhinolaryngologic Diseases; Oropharyngeal Dysphagia

Summary: oropharyngeal dysphagia (od) is a highly prevalent and growing condition in the older population. it affects approximately one in three community-dwelling elderly, almost half of the geriatric patients, and even more than half of elderly nursing home residents. the main complications of od are respiratory infections such as aspiration pneumonia, malnutrition, and dehydration. it supposes substantial costs for the healthcare system, increases the risk for (re)admissions and length of stay, and has an important impact on the quality of life of people who suffer from it. the aim of this study is to develop a predictive model to identify non-hospitalized older patients at risk for oropharyngeal dysphagia, quantify that risk, and facilitate decision-making according to personal, clinical, and socio-emotional characteristics.

given the high prevalence of oropharyngeal dysphagia (od) in older people and the difficulty to detect it, the investigators purpose to develop a predictive model to identify non-hospitalized older patients at risk for od, quantify that risk, and facilitate decision-making. objectives: main objective: - develop a predictive model for oropharyngeal dysphagia in non-hospitalized older patients (≥ 65 years). secondary objectives: * identify predictive factors for od among the studied population. * contribute to the characterization of od in older people through a retrospective analysis of videofluoroscopic studies and clinical evaluations. * define different models of intervention from a multidimensional approach.

Eligibility criteria:
inclusion criteria: * older people between 65 and 99 years. * swallowing assessed with videofluoroscopy * non-hospitalized patients (swallowing assessed on an outpatient basis) exclusion criteria: * there are no exclusion criteria in relation to the gender or ethnicity of the participants. failure to meet one of the inclusion criteria will result in the participant's exclusion from the study sample.

Keywords: older people predictive models
chromoendoscopy for dysplasia detection in chronic inflammatory bowel disease

Conditions: Ulcerative Colitis; Crohn's Colitis

Summary: patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an increased risk of developing cancer. the purpose of this study is to determine if visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more abnormalities than conventional colonoscopy without dye spray.

background: patients with ulcerative colitis and crohn's colitis are at increased risk of colon cancer. the usefulness of chromoendoscopy is debated. previous studies are either based on magnifying endoscopy or on non-randomized trials. some guidelines recommend chromoendoscopy with targeted biopsies and some normal colonoscopy with up to 40 random biopsies. chromoendoscopy has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. whether chromoendoscopy with targeted biopsies can replace standard colonoscopy with random biopsies in the surveillance of patients with chronic colitis is unknown. aim: in a rct in surveillance colonoscopies in patients with ulcerative colitis or crohn's colitis, we will determine if chromoendoscopy using a dilute solution of indigo-carmine will improve dysplasia detection rate compared with colonoscopy without chromoendoscopy. methods: after informed consent patients undergoing surveillance colonoscopy will be randomized to be examined by the study or control method. the study method will employ a 0.2-0.5% indigo-carmine solution sprayed over the colonic and rectal mucosa. the control method will be colonoscopy without indigo-carmine chromoendoscopy. in both the study arm and the control arm all subjects will have 32 random biopsies taken (4 from each of 8 defined segments of the colon) and biopsies from suspicious mucosa.

Eligibility criteria:
inclusion criteria: patients with ulcerative colitis or crohn's colitis satisfying criteria for surveillance colonoscopy: * ulcerative colitis, extensive \> 8 years or crohn's colitis involving ≥ 1/3 of colon/rectum * history of psc or * history of previous dysplasia on colon biopsies or * family history of colon cancer in first degree relative exclusion criteria: * patients who decline to participate * unable to give informed consent * increased risk of bleeding (i.e. warfarin, bleeding disorders, clopidogrel)

Keywords: ulcerative colitis crohn's disease chromoendoscopy dysplasia neoplasia inflammatory bowel disease
bypass pacu in knee and hip arthroplasty

Conditions: Surgery; Knee Osteoarthritis; Postoperative Complications; Hip Osteoarthritis; Arthroplasty Complications

Summary: a quality study in the use of post-anaesthesia care unit(pacu) in hip and knee arthroplasty, and the ability to bypass this unit. the investigators wish to investigate the amount of patients who is required to be secondary admitted to the pacu, after primary discharge from the operating room to the surgical ward, thereby bypassing the pacu.

the investigators wish to investigate the use of our standardized regimen for discharging patients directly to the surgical ward, thereby bypassing the pacu. the anaesthesiology dept. have a local standard operating procedure for doing this, and the patients will be treated according to this. this means that patients will be discharged directly to the surgical ward if the following criteria are met: * american society of anaesthesiologist-score (asa-score) \< 3 * anaesthesia and surgery without any complications, vital signs normal during the whole procedure and not demanding oxygen supplement on the end of the procedure. * bloodloss \< 500 ml. * postoperative evaluation, early warning score, and postoperative score documented in electronic patient journal(epj). the patients will upon arrival at the surgery start a registration containing preoperative data(baseline morbidity, sex, height, weight, type of anaesthesia and surgery), perioperative data containing surgery and anaesthesia data, and postoperative discharge-score(local operating procedure). after discharge to either the surgical ward or the pacu, the patient will be observed closely the first 2 hours while recording every intervention made by the nurse staff. after the initial 2 hours the recording goes on the next 24 hours recording every event and intervention which lead to a doctor consult, by telephone or physically examining the patient. also, the investigators wish to evaluate the use of the discharge score(danish society of anaesthesia and intensive care medicine(dasaim)-score), which is used as the discharge score after surgery in other hospitals in denmark, and the investigators therefore record this after surgery, and every 30 minutes after the surgery for the first 2 hours.

Eligibility criteria:
inclusion criteria: * planned elective unilateral primary hip- og knee-arthroplasty and unicompartmental knee-arthroplasty. * above 18 years. exclusion criteria: * none

Keywords: knee arthroplasty hip arthroplasty postoperative anaesthesia care unit
study of the microbiological profile of stool in patients with anorexia nervosa

Conditions: Anorexia Nervosa; Eating Disorder

Summary: anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. to date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. this intestinal dysbiosis could be involved in the maintenance of the disorders. bidirectional communication channels exist between the microbiota, the intestine and the brain. anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. this study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.


Eligibility criteria:
inclusion criteria common to all four groups * patient affiliated or entitled to a social security scheme * patient who received informed information about the study * patient does not object to participating in the study inclusion criteria specific to mental anorexia * bmi between 13 and 17.5 kg/m2 * diagnostic and statistical manual of mental disorders iv restrictive anorexia nervosa diagnostic criteria * evolution of the troubles since less than 1 year. * with feeling of hunger: "hunger" = total score on the 24-hour hunger scale \> 15 and presence of the three prandial peaks (score = 3) * having lost the feeling of hunger: "not hungry" = total score on the 24-hour hunger scale ≤ 5 and absence of the three prandial peaks (score ≤ 2) inclusion criteria specific to constitutionally thin patients * bmi between 13 and 17.5 kg/m2 * stable weight for at least 3 months * no eating disorder * no markers of undernutrition inclusion criteria specific to normal weight subjects * 20 kg/m2 ≤ bmi ≤ 25 kg/m2 * stable weight for at least 3 months * no eating disorder * no markers of undernutrition non-inclusion criteria for all subjects : * antibiotic treatment during the 2 months preceding the sampling. * history of immune system/autoimmune disease: immune deficiency, crohn's disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, psoriasis, behçet's disease, celiac disease, type i diabetes. * history of metabolic pathology: intestinal malabsorptive disease * medical or surgical history deemed by the investigator to be incompatible with this study. * severe progressive condition other * pregnant woman * majors under guardianship or subjects deprived of their liberty by judicial or administrative decision * ongoing psychotropic treatment * progressive diarrhea (bristol type v and vi)

Keywords: stool constitutional thinness
quality of life in greek hemodialysis patients receiving zemplar intravenous

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism

Summary: the purpose of this study is to assess health-related quality of life (qol) changes in participants with chronic kidney disease (ckd) and secondary hyperparathyroidism (shpt) undergoing hemodialysis and receiving paricalcitol intravenous (iv).

the scientific purpose of this study is to obtain data on the use of paricalcitol iv in real-life clinical practice and the effect it has on participant health-related qol. in this study, paricalcitol iv will be prescribed on an on-label basis in an everyday setting. the rand 36-item health survey results will be collected for a 6-month period (every 3 months) in order to assess the effect of paricalcitol iv on participant health-related qol.

Eligibility criteria:
inclusion criteria: 1. patients with chronic kidney disease stage 5 undergoing hemodialysis and receiving paricalcitol iv for more than 1 month. 2. patients with a rand 36-item health survey completed 10 to 35 days before paricalcitol iv initiation 3. patients with baseline parathormone ≥ 300 pg/ml 4. patients willing to give their informed consent to participate in the study. 5. patients should not receive vitamin d-related compounds or cinacalcet for 3 months prior to entering the study 6. patients must be on steady regimen for anemia, hypertension and diabetes for the past 30 days exclusion criteria: 1. patients with a history of clinically significant intolerance or sensitivity to vitamin d or any ingredients of the product. 2. patients with persistent hypercalcemia or evidence of vitamin d toxicity. 3. patients with a continuous increase in serum (calcium x phosphorus) product greater than 65. 4. pregnant or lactating female patients. 5. patients who have previously undergone parathyroidectomy

Keywords: quality of life changes secondary hyperparathyroidism chronic kidney disease hemodialysis paricalcitol intravenous treatment
bioequivalence study of montelukast 10 mg tablets

Conditions: Asthma

Summary: the objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. test product was montelukast (10 mg tablets; glaxosmithkline) and reference product singulair (10 mg tablets; merck sharp \& dohme). the single dosage was one tablet. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 32 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. healthy, between 18 and 50 years. body mass index between 19 and 27 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) - exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. hospitalization for any cause in the seven months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any antibiotics or non-steroidal anti-inflammatory analgesics. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of drug or alcohol abuse. special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. non-cooperative attitude during the study. positive anti-doping or pregnancy test. breast-feeding. females on contraceptive hormonal treatment. -

Keywords: mexico montelukast pharmacokinetics bioequivalence
haemocomplettan® p during aortic replacement

Conditions: Aortic Aneurysm

Summary: the primary purpose is to show that administration of haemocomplettan® p significantly reduces the amount of blood products needed during aortic surgery.


Eligibility criteria:
inclusion criteria: * eighteen years of age or older * undergoing elective thoracoabdominal aortic replacement surgery (taaa) or thoracic aortic replacement surgery (taa) * understood and willingly given written informed consent (german language) to participate following an explanation of study background, restrictions, and procedures * experience clinically relevant bleeding of the microvasculature following removal of cpb during surgery exclusion criteria: * positive pregnancy test, pregnancy or lactation * women of child bearing age not using a medically approved method of contraception during the study * previous aortic replacement at the same aortic site (redo surgeries) * undergoing an emergency operation * proof or suspicion of a congenital or acquired coagulation disorder (e.g. vwd or via severe liver disease) * myocardial infarction (mi) or apoplexy in the 2 months preceding study surgery * asa administration in the 3 days preceding study surgery, and a pathological (\<74.5 u) aspi multiplate® test immediately preceding surgery begin * clopidogrel administration in the 5 days preceding study surgery, and a pathological (\<31.1 u) adp/pg multiplate® test immediately preceding surgery begin * tirofiban administration in the 2 days preceding study surgery, and a pathological (\<94.1 u) trap multiplate® test immediately preceding surgery begin * phenprocoumon administration in the 5 days preceding study surgery, and an inr \> 1.28 immediately preceding surgery begin * participation in another clinical study in the 4 weeks preceding aortic replacement * sensitivity to any of the components of study medication, or to mps with a similar chemical structure to any of the components of study medication * any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude) * any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given * multiple morbidities, with a notably constrained remaining length of life
fovea erm after fovea-sparing ilm peeling

Conditions: Epiretinal Membrane; Internal Limiting Membrane Wrinkling

Summary: to report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction

purpose: to report the rare complication of foveal epiretinal membrane (erm) formation on residual internal limiting membrane (ilm) with severe contraction after previous fovea-sparing internal limiting membrane (ilm) peeling. study design: retrospective case series methods: we report patients who previously received fovea-sparing ilm peeling and complicated with foveal erm formation and contraction.

Eligibility criteria:
inclusion criteria: * patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery exclusion criteria: * patients who did not receive previous fovea-sparing internal limiting membrane surgery

Keywords: fovea-sparing internal limiting membrane peeling epiretinal membrane.