Kornimate/medical-research-clean huggingface dataset:
long-term efficacy and safety of gabapentin enacarbil in japanese restless legs syndrome patients

Conditions: Restless Legs Syndrome

Summary: the objective of this study is to evaluate the efficacy and safety of asp8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.


Eligibility criteria:
inclusion criteria: * patients who diagnosed with rls according to the diagnostic criteria established by the international rls study group * international restless legs syndrome scale (irls) score ≥15 presence of rls symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study exclusion criteria: * patients using dopamine agonists or gabapentin within 1 week before or any anti-rls treatment within 2 weeks before the start of the pretreatment observation period * patients with an estimated creatinine clearance \<60 ml/min determined using the cockcroft-gault formula * pregnant or lactating women * individuals with serum ferritin \<20 ng/ml were also excluded from the trial * individuals with movement disorders and/or abnormal neurological findings

Keywords: restless legs syndrome patients asp8825 xp13512
pharmacokinetics of micafungin in critically ill patients

Conditions: Critical Illness; Invasive Candidiasis

Summary: a study of micafungin in icu versus non-icu patients showed a significantly lower treatment success in icu patients compared with non-icu patients. it is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. the pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied. the pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.


Eligibility criteria:
inclusion criteria: * treatment with micafungin. * admission to an icu. * age ≥ 18 years. * invasive candidiasis. exclusion criteria: * blood sampling not possible.

Keywords: micafungin pharmacokinetics invasive candidiasis intensive care
non-ablative er:yag for recurrent candidiasis

Conditions: Candidiasis, Vulvovaginal; Candidiasis of Vagina; Candidiasis, Genital; Recurrent Candidiasis of Vagina; Infection, Candida; Vaginal Yeast Infections

Summary: the objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative er:yag laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (rvvc). eligible patients have received 4 laser therapies within four moths and will be assessed at baseline, 3 months and 9 months after last laser therapy. the effects of laser therapy have been assessed by following the vaginal microbial status, by assessing the five bothersome symptoms related to vaginal infection (burning, itching, dyspareunia, dysuria, and abnormal discharge), by assessing the overall patient satisfaction, and throughout the study the safety of the laser therapy has been monitored.

genital candidiasis is a common fungal infection that affects both men and women, though it is more frequently observed in women. it is estimated that up to 75% of women will experience at least one episode of vulvovaginal candidiasis (vvc) during their lifetime. the primary causative agents are candida albicans and other non-albicans pathogenic fungal species. the likelihood of developing genital candidiasis can be influenced by factors such as age and hormonal changes. women of reproductive age, especially those who are pregnant, using hormonal contraceptives, or experiencing hormonal fluctuations, are at higher risk. the highest prevalence rate, 9%, is reported among women aged 25 to 34 years. antibiotic use, which can disrupt the body's microbial balance, is a known risk factor for genital candidiasis, along with other factors like obesity, uncontrolled diabetes, corticosteroid use, chronic stress, and certain lifestyle choices. clinical guidelines recommend oral fluconazole or itraconazole as the first-line treatment for recurrent vulvovaginal candidiasis (rvvc). however, after stopping maintenance therapy, a recurrence rate of 40%-50% is expected. while clinical resistance to antifungal agents is rare, overexposure to azoles can lead to resistant strains of c. albicans. additionally, non-albicans candida species, such as c. glabrata, often show dose-dependent susceptibility or resistance to fluconazole and other azole agents, and their prevalence is increasing. given the limited therapeutic options, innovative treatment strategies are necessary.

Eligibility criteria:
inclusion criteria: * adult women (\> 18 years) * diagnosis of recurrent vaginal yeast infection (\> 4 infection per year) exclusion criteria: * patients having contraindications to laser therapy (epilepsy, pregnancy, acute systemic infection)

Keywords: non-ablative er:yag laser recurrent vaginal yeast infection recurrent vulvovaginal candidiasis candidiasis vaginal genital
determination of genetic susceptibility in severe recurrences of ocular toxoplasmosis

Conditions: Toxoplasmosis Infection; Genotype II; Ocular Toxoplasmosis With Recurrences

Summary: ocular toxoplasmosis (ot) is a major cause of visual impairment worldwide. ot is responsible for 30 to 50% of posterior uveitis. it is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. the overall recurrence rate of ot in europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of ot) in the most extreme cases. current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. these clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. the advanced analysis of the entire genome now possible to consider the project.


Eligibility criteria:
inclusion criteria: * seropositive for toxoplasma gondii (for patient and parents) * infection with genotype ii (for patient and parents) * ocular toxoplasmosis recurrences \>5 (patients only) exclusion criteria: * parents seronegative for t. gondii infection * infection with others genotypes than type ii
gastrointestinal and metabolic effects from a prebiotic, lifting, and aerobic intervention

Conditions: Overweight and Obesity

Summary: this study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.


Eligibility criteria:
inclusion criteria: * bmi 18.5-45 kg/m2 * without physician diagnosed gastrointestinal or metabolic diseases * sedentary (\< 30 minutes of moderate or high intensity exercise per week or \< 20 aggregate godin-shepard leisure time physical activity questionnaire (gsltq; godinleisure) score) * fully vaccinated against covid-19 exclusion criteria: * fasting blood glucose \>126 mg/dl * blood pressure \>160/100 mm hg * physician diagnosed metabolic or gastrointestinal diseases or constipation * heart conditions that may pose risk during exercise * taking oral hypoglycemic agents or insulin * pregnant, breastfeeding or postmenopausal * smoke or consume \> 2 alcoholic beverages/day, abuse drugs * have had \> 5% weight change in the past month or \> 10% change in the past year * have had any form of bariatric surgery or gallbladder removal * have taken antibiotics during the previous 3 months * unable to consume the experimental fiber

Keywords: gastrointestinal microbiota fructooligosaccharides exercise fiber prebiotic short-chain fatty acids glucose homeostasis body composition cognition
assessment of pcr multiplex tests as a tool to obtain a quicker diagnosis of bacteria responsible for foot osteomyelitis than usual cultures

Conditions: Diabetes Mellitus; Foot Osteomyelitis

Summary: bone samples from infected diabetic feet will be collected and tests will be performed for the diagnosis of causative bacteria. samples will be processed by pcr multiplex tests and usual cultures for identification of causative bacteria and sensitivity to antibiotics. results obtained by the two methods will be compared in terms of quickness and similarity of germ identification. usual care strategy will not be modified since results of pcr multiplex tests will not be transmitted to the physicians before the results of usual cultures.

this study will investigate the quickness of identification of bacteria causing bone infection in the feet of patients with diabetes from bone samples obtained by biopsies performed in usaual care practice. bone biopsies will be performed in patients diagnosed for osteomyelitis from clinical, biological and mri signs. bone samples will be collected in ultra-turrax® tubes in the operating theater before being transferred to the department of bacteriology. time of registration at the bacteriology lab will be considered as time 0 (t0). samples will be processed simultaneously using the usual culture method and by pcr multiplex tests. the time of identification of causative bacteria for bone infection (time 1, t1) and the time of identification of sensitivity/resistance to antibiotics (time 2, t2) by the two different methods will be recorded. identified germs and their sensitivity/resistance to antibiotics according to the two methods will be compared. if the results are similar, the time that could be gained for the prescription of specific antibiotics from pcr multiplex tests' results will be computed in comparison to the prescription performed from the results of usual cultures.

Eligibility criteria:
inclusion criteria: * biological and mri signs of foot osteomyelitis * indication of bone biopsy * no antibiotics since 2 weeks exclusion criteria: * antibiotic therapy * previous cultures for the same infectious event

Keywords: diabetes diabetic foot osteomyelitis
why still in neurosurgical ward after tumor craniotomy?

Conditions: Surgery--Complications; Brain Tumor

Summary: the aim of this prospective observational study is to identify the specific reasons that prolong a hospital stay after elective tumor craniotomy. optimal postoperative in-hospital stay is considered to be two days from surgery to discharge from the neurosurgical ward. however, a variable length of stay at a neurological department for follow-up of late recognized deficits of neurological consequences of the surgical procedure are common.

the concept of fast-track surgery and later enhanced recovery after surgery (eras) was first imputed in 1990s. since then, eras protocols have been successfully adopted in many surgical fields, often with dramatic benefits for the patients. length of hospital stay is one of the main questions addressed in many eras studies, as it by a simple approach address many of the complications encountered by the patients or the case flow in the perioperative period. why patients have prolonged hospital stay after surgery has been investigated by husted et al. in 2011 after hip and knee arthroplasty and p. munk-madsen et al. in 2019 after laparoscopic colorectal surgery. both studies could isolate dominating factors prolonging hospital stay, some of them preventable. existing length of stay studies on tumor craniotomy patients have focused on specific variables affecting hospital duration, but never explored the true cause of prolonged hospitalization.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective brain tumor craniotomy exclusion criteria: * stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (litt)
gastroparesis outcome longitudinal database enrolled numerically

Conditions: Gastroparesis

Summary: golden is a longitudinal database of patients with the symptoms (sx) of gastroparesis (gp) who were seen and recorded at the university of louisville from 2012 and is ongoing. patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. outcome relate to patients sx, survival, quality of life and other measures as detailed below, over time, regardless of whether any treatment was given or not. if treatments were administered golden allows for examination and stratification of outcome by groups both at baseline and at follow up.

1. all patients seen with the sx of gp and who were evaluated for diagnosis and/or treatment 2. including legacy patients who were seen and treated at previous locations (mississippi, arkansas, tennessee) before kentucky if they were part of a clinical research series. 3. numbers of patients referred or consulted for gp sx who were drug refractory. 4. interventions: gi neuromodulation with gastric electrical stimulation (ges); immunotherapy with intravenous immunoglobulin; pyloric therapies such as pyloroplasty, surgical or endoscopic. 5. data for evaluation by: sx assessments by whatever scales used; measures of health related quality of life; psychological and pain assessments; gastric emptying texts; electrical measures; autonomic measure; serologic measures; full thickness biopsies; measures of outpatient \& emergency room visits; measures of hospitalization; placement of endoscopic or surgical tubes; radiological and surgical procedures; nutritional assessments; if enrolled in any research protocols for data; stool biome measures; metabolic measures; other morbidity measures; mortality

Eligibility criteria:
inclusion: * patients with the symptoms (sx) of drug refractory gastroparesis * disordered nutrition by standardized assessment * ability to assess current symptom status * ability to measure other medical conditions exclusion: * anatomic obstruction of the gi tract * pregnancy * inability of patient or guardian to sign informed consent, if needed * psychiatric disorders precluding assessment and treatment of the patient's gi condition
effect of an exercise program designed for orchestral musicians

Conditions: Musculoskeletal Disorder

Summary: this study is a randomized clinical trial evaluating the effect of an exercise program designed specifically for orchestral musicians on performance-related musculoskeletal problems (prmps). professional and conservatory-level orchestral musicians will be recruited. half of the subjects will participate in an 11-week home exercise program and attend three group exercise sessions and an educational presentation on injury prevention, while the other half of the subjects will receive no intervention, and continue their usual activities.


Eligibility criteria:
inclusion criteria: * professional or freelance orchestral musician, or tertiary-level full-time music student majoring in an orchestral instrument * able to commit to performing exercises 2 times per week over an 11-week period * medical condition permitting participation in an exercise program (ie. no serious heart or lung condition that may be exacerbated by physical exertion) exclusion criteria: * presence of musculoskeletal injuries definitively non-related to musical practice or performance * fewer than 15 hours per week playing their instrument * corticosteroid infiltration in the 6 weeks preceding recruitment * prescribed anti-inflammatory drugs or neurontin in the 3 weeks preceding recruitment
proof of concept - digital electro-optical surgical platform as replacement for operational microscopes

Conditions: Retinal Detachment

Summary: evaluate the use of elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.


Eligibility criteria:
inclusion criteria: * patients older than 18. * pseudophakia patients with silicone oil in the vitreous cavity. * silicone oil density of 1500 centistoke or 5500 cs. * good corrected visual acuity (\> 6/10) in the second eye. * lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, posterior capsular opacity, low transmission in the implantable lens, non-expanded pupil). exclusion criteria: * additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, posterior capsular opacity, low transmission in the implantable lens, non-expanded pupil). * the presence of heavy silicone oil (oxane) in the vitreous cavity. * posterior segment pathology in the second eye. * special populations (children under the age of 18, pregnant women)
fecal microbiota transplantation and analysis of fecal microbiome in ibd patients

Conditions: Inflammatory Bowel Diseases

Summary: fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in ibd patients.

fecal microbiota transplantation will be performed to the ibd patients, and microbial analysis will be done for donor and recipient feces. fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. during the early stage of fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently. clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation. relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.

Eligibility criteria:
inclusion criteria: * 7 years old to 80 years old at start of trial * inflammatory bowel disease such as ulcerative colitis, crohn's disease, and behcet's colitis * patients who do not respond to the conventional treatments or who do not wish/not able to use one. * patients who agree to participate in the trial after thorough explanation * evidence of active disease exclusion criteria: * patients whose crp\<8, calprotectin\<200, and mucosal healing endoscopically (who are in stable state) * patients whose symptom is due to other disease than ibd _patients with immunosuppressive disease * patients who are clinically unstable such as massive hemorrhage or perforation * patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction * absolute neutrophil count (anc) \<1.5 \*10\^9/l (1500/mm3) * pregnant or under breast feeding * patients enrolled in other clinical trials

Keywords: inflammatory bowel diseases, fecal microbiota transplantation, microbiome
baroreflex activation therapy in heart failure

Conditions: Heart Failure

Summary: the purpose of this clinical investigation is to evaluate the efficacy and safety of the cvrx barostim neo system in the treatment of patients with heart failure.


Eligibility criteria:
inclusion criteria: * age at least 21 years * symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks exclusion criteria: * significant carotid plaque or stenosis * known or suspected baroreflex failure or autonomic neuropathy * myocardial infarction, unstable angina, syncope, cerebral vascular accident, scd, or received defibrillation therapy within the past 3 months * heart failure secondary to a reversible condition
fiber-enriched buckwheat pasta and glucose variability in patients with type 1 diabetes and celiac disease

Conditions: Type 2 Diabetes Mellitus; Celiac Disease

Summary: the intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (cgm) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. the study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (fbp) or corn pasta (cp), used as control. over the experimental period, participants underwent cgm, wearing their sensors 7 days/week.


Eligibility criteria:
inclusion criteria: * age: 20-50 years * documented history of celiac disease and type 1 diabetes. exclusion criteria: * pregnancy/breast feeding * serious microvascular and macrovascular diabetes complications * any other chronic or acute disease apart from diabetes seriously affecting health status
assessment of effects of museum prescription of a montreal museum of fine arts visit tour in primary care patients

Conditions: Museum; Mental Health; Quality of Life; Health, Subjective

Summary: the objective of this study is to examine effects on mental and physical health and quality of life in primary care patients visiting the montreal museum of fine arts (mmfa), this visit being prescribed by their physician. to visit the mmfa and to complete after this visit a series of self-administered questionnaires within the two days after their visit at the museum

during the past decade, museums have become involved in the care of patients by using art to improve their quality of life and well-being. museums have, thus, emerged as new partners in public health. very few programs developed by museums have focused on primary care patients who are a target audience for museum health program preventions. for the development of appropriate museum programs based on visit tour, there is a need to improve knowledge the effects of a museum visit prescribed by a primary care physician in patients. the objective of this study is to examine effects on mental and physical health and quality of life in primary care patients visiting the montreal museum of fine arts (mmfa), this visit being prescribed by their physician. based on a cross-sectional study it will be prescribed to all patients consulting their primary care physician to visit the mmfa and to complete after this visit a series of self-administered questionnaires within the two days after their visit at the museum. the period of recruitment will be one year. the outcomes are the scores of the different questionnaires.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old 2. home internet access with an electronic device (computer, pad or cellular phone) 3. patient without dementia 4. speak the language of the recruitment centre (french or english) exclusion criteria: 1. dementia 2. participation refusal

Keywords: museum art
serious game for fibromyalgia patients

Conditions: Fibromyalgia

Summary: aim: to check the applicability of litemotion© in people with fibromyalgia. design: randomized clinical trial, with pre, post and follow-up evaluation. researchers and outcome evaluator blinded. method: the experimental group will play during three weeks to litemotion© videogame. the control group will not play.

the study will be a longitudinal-transversal research work with two groups. findings will us prove the correlation between a right management of emotions and the perception of pain, daily life activities and quality of sleeping. sample will be selected by following strict rules; people with no requirements will be dismissed.

Eligibility criteria:
inclusion criteria: * fibromyalgia diagnosed * referred pain during the last month exclusion criteria: -

Keywords: serious game videogame