Kornimate/medical-research-clean huggingface dataset:
comparing the effectiveness of two dietary interventions for fecal incontinence

Conditions: Fecal Incontinence

Summary: background: fecal incontinence (fi) is a common complaint, and is often associated with diarrhea and urgency. foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (fodmaps) cause symptoms of diarrhea and urgency. thus, assessing the impact of a low fodmap diet in fi patients is needed. aims: 1. compare the treatment response with a low fodmap vs. psyllium based on number of episodes in patients with fi. 2. compare the efficacy of a low fodmap diet vs. psyllium in patients with fi on pre-specified clinical and quality of life endpoints. methods: this is a prospective, randomized control trial of adults meeting the rome iii criteria for fi and at least 1 episode of fi due to loose stool per week. after a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to psyllium vs. low fodmap diet for 4 weeks. a total of 20 patients will be recruited for each arm. the primary endpoint will be treatment response based on number of incontinence episodes. a treatment response is defined as a reduction in the number of fi episodes/week.


Eligibility criteria:
inclusion criteria 1. experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (bristol stool scale of 5 or greater). 2. subjects aged 18 and older meeting the rome iii criteria for functional fecal incontinence diagnostic criteria: recurrent uncontrolled passage of fecal material in an individual and one or more of the following: 1. abnormal functioning of normally innervated and structurally intact muscles 2. minor abnormalities of sphincter structure and/or innervation 3. normal or disordered bowel habits, (i.e., diarrhea) criteria fulfilled for the last 3 months exclusion criteria 1. abnormal innervation caused by lesion(s) within the brain (e.g., dementia), spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple sclerosis), or as part of a generalized peripheral or autonomic neuropathy 2. anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma) 3. structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence 4. have cognitive dysfunction or unable to understand or provide written informed consent 5. pregnancy 6. fi with solid stool only 7. comorbid medical problems that may affect gastrointestinal transit or motility: inflammatory bowel disease, extraintestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.),severe renal or hepatic disease 8. previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery. 9. . previous treatment with low fodmap diet. 10. concurrent medications not permitted including probiotics, antibiotics, and narcotics. 11. active participation in another form of dietary therapy.

Keywords: fodmap diet
investigation of the relationship between executive functions and occupational performance of children with duchenne muscular dystrophy

Conditions: Executive Dysfunction; Occupational Problems; Duchenne Muscular Dystrophy

Summary: the effects of duchenne muscular dystrophy and its treatments on executive functions and occupational performance are under-mentioned in the literature. the researches believe that developmental and cognitive research is needed to identify interventions for children with dmd to identify and adapt to both individual and social environments, including self-care, productivity and leisure activities. therefore, the aim of this study was to examine executive functions and occupational performance in children with dmd and compare them with healthy controls.


Eligibility criteria:
inclusion criteria: * being diagnosed with dmd * volunteering to participate in the study by their parents and reading and signing the informed consent form exclusion criteria: * having a neuromuscular disease other than dmd and/or another diagnosed neuromuscular disease accompanying dmd * the family and/or the child has problems with cooperation in completing the assessments for any reason * difficulty understanding and speaking the turkish language
compare the different routes of administration of misoprostol during medicinal abortion between 7 and 9 weeks of amenorrhoea (sa)

Conditions: Misoprostol; Drug-induced Abortion

Summary: in france, drug-induced abortion is allowed up to 9sa, after which the surgical route is preferred. mifepristone 600mg is used 36-48 hours before the introduction of misoprostol. this is recommended orally at a dose of 400 μg. there are currently several studies on the subject, including a meta-analysis of the 2011 cochrane database, but doses, routes of administration and gestational age differ in all studies. currently, has recommends the vaginal route at the dose of 800μg for stopped pregnancies. it is therefore necessary to compare the different routes of administration of misoprostol at the same dose to allow to change our french recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.


Eligibility criteria:
inclusion criteria: * women \> 18 years hospitalized using abortions between 7 and 9 sa and after informed consent, * affiliation to a social security scheme. exclusion criteria: * minor or major women under guardianship or curatorship * bmi \<18.5 (thinness) * ambulatory * several abortions on the duration of the study * take mifepristone\> 48 hours before taking misoprostol * contraindications to misoprostol: prostaglandin allergy
using novel imaging to rethink diagnostic and treatment strategies for polymyalgia rheumatica

Conditions: Polymyalgia Rheumatica (PMR)

Summary: polymyalgia rheumatica (pmr) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. however, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (pet/ct) has low diagnostic accuracy, which decrease after start of prednisolone. the purpose is to evaluate a new method to diagnose pmr with pet/ct using magnetic resonance imaging (mri) for informing the interpretation of pet in 111 patients suspected of pmr at baseline and after 8 weeks prednisolone treatment. in addition, a treatment initiation strategy guided by clinical diagnosis combined with pet will be evaluated in 100 patients with newly diagnosed pmr.


Eligibility criteria:
inclusion criteria: 1. patients suspected of pmr seen at the department of rheumatology/internal medicine in aarhus, silkeborg, horsens, gødstrup, randers, and svendborg. 2. age above 50. 3. proximal extremity pain. exclusion criteria: 1. oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months. 2. previous prednisolone treatment for gca/pmr. 3. unable to give consent. 4. proximal extremity pain duration for more than one year. 5. symptoms of gca (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to gca, limb claudication). 6. active malignant cancers within the last 5 years (except basal cell carcinoma). 7. other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout). 8. uncontrolled diseases (e.g. severe active asthma, cardiac disease with nyha class iv) 9. for mri: implants contraindicating mri and bmi\>150 kg.

Keywords: polymyalgia rheumatica imaging diagnosis pet/ct pet/mri
rheumatism and dietetic: rhumadiet study (food practices and beliefs)

Conditions: Rheumatoid Arthritis; Axial Spondyloarthritis; Hand Osteoarthritis

Summary: cross sectional study assessing food practices and beliefs in ra, as and da (digital arthritis)

to investigate in patients having rheumatoid arthritis (ra), or axial spondyloarthritis (as) or digital osteoarthritis (da) practices and beliefs about influence of food and diet on their rheumatic disease. 200 patients of each disease will be included in this cross-sectional non interventional study factors associated with specific practices or specific beliefs will be determined. only questionnaires are used in this study.

Eligibility criteria:
inclusion criteria: * over 18 years of age * rheumatoid arthritis (ra) according to acr/eular criteria or axial spondyloarthritis (as) according to asas 2009 criteria or digital osteoarthritis (da) according to acr criteria. exclusion criteria: * severe upper functional or psychiatric disorders * patients under guardianship or trusteeship * patients unable to answer the questionnaire in french

Keywords: rheumatoid arthritis axial spondyloarthritis hand osteoarthritis diet beliefs
clinical trial of sound-based versus behavioral therapy for tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.

this study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, cbt) for bothersome tinnitus. all eligible participants will be randomly assigned to one of the two groups. depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.

Eligibility criteria:
inclusion criteria: * age ≥18 years * primary and persistent tinnitus (6 months or longer in duration) * tonal tinnitus * dominant tinnitus frequency measured between 0.2 and 10 khz * tinnitus questionnaire score * no current participation in other tinnitus therapy program * willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial * able to pass the tone audibility assessment with factor of 1.1 exclusion criteria: * secondary/somatic tinnitus due to a suspected underlying disease * atonal, pulsatile, intermittent, or occasional tinnitus * any hearing threshold \>70 db hl from .25-8khz, unless subject passes the tone audibility assessment screening with a factor of 1.1 * any health or other problems that may prevent the person from completing the study procedures as determined by investigator * participant reports current suicidal ideation and/or homicidal ideation * use of medication which may trigger tinnitus \[e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin\] * conductive hearing loss * visible congenital or traumatic deformity of the ear * history of active drainage from the ear within the past 90 days * history of sudden or rapidly progressive hearing loss within the past 90 days * inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures * previous use of desyncra for tinnitus therapy system
pain intensity after robotic assisted urological surgery

Conditions: Robot-assisted Urological Surgery

Summary: postoperative pain remains a widespread but still underestimated problem. studies have shown that despite improvements in pain management, many patients still suffer from moderate to severe postoperative pain. severe pain is associated with decreased patient satisfaction, delayed postoperative ambulation, prolonged length of stay, risk of developing chronic postoperative pain, and increased morbidity and mortality. therefore, it is of great importance that surgical procedures that result in severe pain and the optimal analgesic strategies for these procedures can be identified. most recommendations on postoperative pain management (prevention and treatment) are not procedure-specific. however, risk factors for postoperative pain depend on the patient and the procedure. in order to develop procedure-specific postoperative pain management guidelines, pain must be assessed in a procedure-specific manner. additionally, data is sparse on relatively new procedures like robotic surgery. a study, harel et al. compared pain intensities after ureteral reimplantation with robotic or open surgery in children and reported lower pain scores after robotic surgery. this single study reinforces the clinical findings that robotic surgery is associated with less pain. however, pain assessment after robotic urologic surgery has not been evaluated before. in order to add to the evaluation of postoperative pain in different surgical groups, we wish to evaluate pain intensities after robot-assisted urological surgery. in this cohort study, we seek to provide an estimate of the pain intensities that can be expected after most types of robot-assisted urological surgery in relation to analgesic treatment.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years old * programmed robot-assisted urological surgery * patient who did not declare any opposition to participating in the study exclusion criteria: * urgent surgery * impossibility of communicating in french * cognitive deficit * adults legally protected or deprived of liberty
microbiome and host susceptibility in severe pneumonia, a prospective, multicenter, cohort study

Conditions: Severe Pneumonia

Summary: this study was a prospective multicenter cohort of severe pneumonia. and by collecting clinical samples to clarify the correlation between lung microbiome, intestinal microbiome, host susceptibility, and prognosis of severe pneumonia patients.

the human lung and intestinal microbiota play an important role in human health. at present, the correlation between lung and intestinal microbiota in severe pneumonia patients and host susceptibility is limited to small sample, single center studies. due to sample size limitations, the pathogenesis of severe pneumonia caused by many pathogens remains unclear. this study plans to construct sputum, alveolar lavage fluid, feces, and whole blood samples of severe pneumonia patients admitted to the icu from 2023 to 2025, and collect clinical data from patients to identify changes in lung and intestinal microbiome, host susceptibility, and disease progression risk in different groups of patients.

Eligibility criteria:
inclusion criteria: 1. new lung infection that meets one of the following definitions: the patient receives mechanical ventilation (invasive or non-invasive) due to acute respiratory failure, with a peep level of 5cm or above; patients receiving high flow oxygen therapy with a fio2 of 50% or more and a pao2: fio2 ratio below 300 exclusion criteria: 1. expected length of stay in icu is less than 1 day 2. pregnant
cost-effectiveness analysis between biosynthetic and biological parietal prostheses

Conditions: Ventral Hernia

Summary: eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. it is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. at present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. but in the case of contaminated surgery (modified ventral hernia working group grade 3), there is no consensus. since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. they are very numerous, and their prices vary between 3 000 € and 12 000 €. the choice is therefore difficult for the surgeon. in 2016 the strasbourg university hospital general surgery team made the choice to use biosynthetic prostheses. this attitude does not seem consensual and is not based on any recommendations at present, either in france or internationally. the homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses. the main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mvhwg grade 3 incisional hernias in terms of cost and serious complications at 6 months. the secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.


Eligibility criteria:
inclusion criteria: * over 18 years old * patient who has consented to the use of her medical data for research purposes. * emergency or planned surgery for an abdominal wall reconstruction, in the context of a contaminated surgery (mvhwg grade 3) at the chu strasbourg hautepierre * use of biological type (cellis®, xenmatrix®, strattice®) or biosynthetic (phasix®) parietal prostheses exclusion criteria: * refusal of the patient to participate in the study * prosthesis placed prophylactically, subcutaneously, endoscopically, for bridge

Keywords: abdominal wall repair infection biologic mesh biosynthetic mesh cost-effectiveness
survey of inhibitors in plasma-product exposed toddlers

Conditions: Hemophilia A

Summary: the primary objective of the study is to assess the immunogenicity of vwf/fviii and of rfviii concentrates by determining the frequency of inhibitor development in previously untreated patients (pups) or minimally blood component-treated (mbctps) in the first 50 eds or in the first 3 years from enrollment, whichever occurs first. .

patients meeting the enrollment criteria will be consecutively enrolled at each participating centre, randomized to be treated exclusively with a single fviii product either plasma-derived or recombinant, and followed up until inhibitor development or until 50 exposure days (eds) or 3 years from enrolment have elapsed, whichever comes first. study products, belonging to the class of rfviii concentrates and to the class of plasma-derived vwf/fviii concentrates, will be provided for free to the patients for all the duration of the study

Eligibility criteria:
inclusion criteria: * male subjects * any ethnicity * age \<6 years * severe haemophilia a (fviii:c \<1%), as confirmed at enrolment by the central laboratory. o those patients diagnosed locally as severe but subsequently found to have fviii levels \>= 1% on testing at the central laboratory will be separately recorded in the screening list. * previously untreated (0 eds to any fviii concentrates or blood products) or minimally treated (\<5 eds) with blood components, namely whole blood, fresh frozen plasma, packed red blood cells, platelets or cryoprecipitate. o patients not meeting these criteria will be separately recorded in the screening list. * negative inhibitor measurement at both local and central laboratory at screening * ability to comply with study requirements * signed informed consent of legal tutors o patients who will not accept to enter into the study or to be randomized will be separately recorded. exclusion criteria: * previous history of fviii inhibitor * other congenital or acquired bleeding defects * plasma fviii level \>= 1%, as assayed at the central laboratory o those patients originally diagnosed locally as severe but subsequently found to have fviii levels ranging from 1% to 2% on testing at the central laboratory will be separately recorded in the screening list. * concomitant congenital or acquired immunodeficiency * concomitant treatment with systemic immunosuppressive drugs * concomitant treatment with any investigational drug

Keywords: hemophilia a factor viii inhibitors vwf/fviii rfviii
finding a safe and effective dose of linagliptin in pediatric patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main objective of this study is to identify the dose of linagliptin in paediatric patients. other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (fpg) observed after 12 wk of treatment. furthermore, the study will investigate the pharmacokinetics (pk), the pharmacodynamics (pd) and the pk/pd relationship of linagliptin in the paediatric population.


Eligibility criteria:
inclusion criteria: 1. paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus 2. insufficient glycaemic control (i.e. an hba1c \> 6.5% and \ = 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be \<= 0.5u/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation) 3. negative for islet cell antigen (ica) auto-antibodies and glutamic acid decarboxylase (gad) auto-antibodies 4. c-peptide levels (serum) \>= 1.5 ng/ml (at 90 min following a boost challenge) exclusion criteria: 1. history of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months 2. current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation 3. treatment with weight reduction medications (including anti-obesity treatments)
lymph node ratio as a predictor for outcome in rectal cancer

Conditions: Recurrence

Summary: this study aims to evaluate the value of the lnr as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.

patients and methods study design and setting this is a retrospective review of prospectively collected and maintained database of patients with crc admitted in the oncology center of mansoura university (ocmu), the colorectal surgery unit of mansoura university hospitals, and the department of general surgery of alexandria university. selection criteria patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. we will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up. study endpoints the primary endpoint of the study is to assess the value of lymph node ratio (lnr) on the oncological outcomes.

Eligibility criteria:
inclusion criteria: * rectal cancer of tnm stage i-iii * underwent radical resection with curative intent exclusion criteria: * synchronous colon cancer * synchronous gastrointestinal cancer * underwent palliative resection * presented with intestinal obstruction * those lost to follow-up.