Kornimate/medical-research-clean huggingface dataset:
analgesic ear drops for children with acute otitis media

Conditions: Acute Otitis Media; Pain

Summary: this trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with aom. children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. the primary outcome is the parent-reported ear pain score (0-10) over the first 3 days. note: at the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the netherlands trial register (ntr) (nl9500; date of registration: 28 may 2021). the addition of a data sharing plan was required to adhere to the international committee of medical journal editors (icmje) guidelines. the investigators therefore re-registered the trial in clinicaltrials.gov. this second registration is for modification purposes only and the ntr record (nl9500) should be regarded as the primary trial registration.


Eligibility criteria:
inclusion criteria: * age 1 to 6 years * parent-reported ear pain in 24 hours prior to enrolment * gp-diagnosis of (uni- or bilateral) aom exclusion criteria: * with (suspected) tympanic membrane perforation or ventilation tubes * with ear wax obscuring visualisation of the tympanic membrane * who are systemically very unwell or require hospital admission (e.g. child has signs and symptoms of serious illness and/or complications such as mastoiditis/meningitis) * who are at high risk of serious complications including children with known immunodeficiency other than partial iga or igg2 deficiencies, craniofacial malformation including cleft palate, down syndrome and previous ear surgery (with the exception of ventilation tubes in the past) * who have a known allergy or sensitivity to study medication or similar substances (e.g. other amide-type anaesthetics: bupivacaine, mepivacaine, prilocaine, etc) * who have taken part in any research involving medicines within the last 90 days, or any other aom-related research within the last 30 days * who suffer from chronic recurrent pain of another origin than the ear * who have participated in this trial during prior aom episode
dermal allograft augmentation of large and massive rotator cuff tears

Conditions: Full-thickness Rotator Cuff Tear

Summary: the purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative mri confirmed fatty infiltration stage ii and higher repaired with or without dermal allograft augmentation (daa).

the primary objective is to evaluate postoperative healing of rotator cuff repair with and without daa. primary: the primary outcome measure is healing evaluation in mri . mri post-operative assessment (goutallier stage and sugaya classification) secondary: the secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems, including: american shoulder and elbow surgeons score (ases) single assessment numeric evaluation score (sane) visual analog scale (vas) for pain veterans rand health survey (vr-12) population: males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears description of treatment: rotator cuff repair with or without augmentation using decellularized human dermal allograft.

Eligibility criteria:
inclusion criteria: * the subject is between the ages of 30 and 75 years. * subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (rct) * two complete rcts or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension * primary rotator cuff repair * stage ii fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative mri6. subject has a dual x-ray absorptiometry (dxa) or anterior posterior x-ray view of the target shoulder exclusion criteria: * the subject is unable or unwilling to sign the patient informed consent, approved by the institutional review board. * the subject objects to the use of allograft * stage i or lower fatty infiltration of the supraspinatus and infraspinatus muscle * complete full-thickness subscapularis tears of greater than the superior one third of the tendon (lafosse grade 3 and above) * less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph * recurrent shoulder instability * corticosteroid injection in the operative shoulder within one month of surgery * revision rotator cuff repair * subject preoperative mri obtained more than 12 months prior to surgery * pregnant or planning to become pregnant during the study period * workman's compensation case * subject has conditions or circumstances that would interfere with study requirements. intraoperative exclusion criteria: partial rotator cuff repairs lafosse grade 3 or higher subscapularis tears
blocking tumor necrosis factor in ankylosing spondylitis

Conditions: Spondylitis, Ankylosing

Summary: the division of rheumatology at university of california san francisco is conducting a research study on the treatment of ankylosing spondylitis (as) with a new therapy currently used for people with other forms of arthritis. the drug, called enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin. it blocks the action of tumor necrosis factor-alpha (tnf-alpha), a substance that may be involved in as, rheumatoid arthritis, and other inflammatory conditions. we will randomly assign patients to receive either the drug or a placebo (inactive treatment) for 4 months. the results we will monitor include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.

in this phase ii clinical trial we will use tumor necrosis factor receptor p75 fusion protein (tnfr:fc, or etanercept) to treat patients with ankylosing spondylitis (as). tnfr:fc is an antagonist of tumor necrosis factor (tnf), a cytokine that researchers have shown to play a possible role in disease pathogenesis of ankylosing spondylitis, rheumatoid arthritis, and vasculitis, as well as other inflammatory conditions. tnfr:fc consists of two molecules of the extracellular portion of the p75 receptor, each consisting of 235 amino acids. the two receptors are fused to the fc portion of human igg1, which consists of 232 amino acids. the gene fragments encoding the truncated tnfr and the fc portion of human igg1 are expressed in a chinese hamster ovary cell line. recent observations from animal and human studies suggest that tumor necrosis factor-alpha (tnf-alpha) may play a role in disease activity in as and other seronegative spondyloarthropathies. this study aims to test the efficacy of tnfr:fc used in conjunction with standard medications in the treatment of as. we will give patients either 25mg of tnfr:fc or placebo subcutaneously twice a week for 4 months. outcome measures will include measures of function, pain, morning stiffness, patient global assessment, and swollen joint count, as well as safety measures.

Eligibility criteria:
inclusion criteria: * diagnosis of ankylosing spondylitis * acceptable stable treatments during study: oral glucocorticoids (less than or equal to 10 mg/d) and/or nsaids at recommended doses and/or one of the following options: methotrexate (less than or equal to 20.0 mg/week); sulfasalazine (less than or equal to 3 grams/d); azathioprine (less than or equal to 2 mg/kg/d); methotrexate and sulfasalazine combination at doses listed above; 6-mercaptopurine (less than or equal to 1.5 mg/kg/d) exclusion criteria: * diagnosis of psoriatic arthritis, inflammatory bowel disease, reactive arthritis, or behýet disease * significant medical problems, such as diabetes mellitus * history of active or recurrent infections * complete ankylosis of the entire spine

Keywords: spondylitis etanercept enbrel tumor necrosis factor-alpha
the effect of an exercise program in reducing the severity of postpartum depression in women

Conditions: Depression, Postpartum

Summary: aim: this study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery. methods: this randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern turkey. in the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. the participating women were administered the edinburgh postpartum depression scale.

postpartum depression is characterized by irritability, guilt, burnout, anxiety, sleep disorders, and somatic symptoms that could have negative effects on the mother, baby, and family. in a meta-analysis study including 219 prevalence studies from 56 countries that investigated different phases of postpartum using various data collection tools, hahn-holbrook et al. (2018) found the depression prevalence at the global level as 17.7% (hahn-holbrook, 2018). in turkey, 23.8% of women in the postpartum period were reported to be suffering from postpartum depression, which underlines the need for health professionals to be concerned about the health of the women in the postpartum period. exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss caused by lactation, and less stress incontinence. studies have generally indicated the importance of regular exercise in the postpartum period. studies have generally indicated the importance of regular exercise in the postpartum period.

Eligibility criteria:
inclusion criteria: 1. must be score of 13 and over in the edinburgh postpartum depression scale (epds), 2. must being between 19 and 40 years old, 3. must had a spontaneous vaginal delivery between the 38th and 42nd weeks of pregnancy, 4. must had a healthy newborn baby with 2500 gr and over exclusion criteria: 1. postpartum obstetric complications 2. psychiatric disease history before or during pregnancy
recovery after emergency laparotomy: a prospective observational feasibility study

Conditions: Quality of Life; Postoperative Complications

Summary: observational feasibility study using patient reported outcomes (pro) to assess quality of life and 'return to normal life' up to 1 year following emergency laparotomy

regaining baseline health related quality of life (hrqol) and returning to 'normal life' after surgery are of vital importance for patients. knowledge of the trajectory and degree of long-term functional recovery following emergency laparotomy, including the regaining of optimal hrqol is limited as most research relating to this field has been done in patients undergoing planned surgery. furthermore, a comprehensive understanding of the pattern of recovery and restoration of baseline hrqol is also important to researchers wishing to assess the full impact of interventions in order to improve outcomes following emergency laparotomy. assessing hrqol in this surgical population remains a challenge in the absence of a validated instrument. the investigators plan to undertake a feasibility study to assess utilisation of four patient questionnaires, well established within other surgical populations, to describe the quality of early and long-term recovery following emergency laparotomy. the investigators will utilise the qor-15 to describe short-term (in - hospital) recovery metrics and versions of the who-das and the whoqol-bref to describe longer term disability free survival and return towards baseline hrqol. the post-operative morbidity survey (poms) will help capture the onset of complications at different points during recovery. the study also aims to test the feasibility of assessing the impact of pre-operative co-morbidities, age, quality of peri-operative and intra-operative care, surgical indication and findings as well as post-operative complications on long-term hrqol.

Eligibility criteria:
inclusion criteria: - \>=18 years nela inclusion criteria exclusion criteria: - not willing to participate nela exclusion criteria
switch from metformin monotherapy to a bitherapy with metformin and repaglinide

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice


Eligibility criteria:
inclusion criteria: * type 2 diabetes * metformin monotreatment * hba1c greater than 7% * treatment according to spc * informed consent obtained exclusion criteria: * any contraindication to the use of repaglinide (according to the spc)
dietary intake and eating habits during the covid-19 pandemic

Conditions: COVID-19

Summary: the covid-19 pandemic affects eating habits, diet quality and physical activity differently among individuals; it is unclear how these behaviours will evolve as the pandemic continues. in this observational study, dietary intake will be frequently collected using an artificial intelligence (ai)-enhanced mobile application combined with real-time analysis, and lifestyle behaviours from online questionnaires, to provide timely, relevant data for public health decision making.

a thousand nine hundred and twenty adult men and women aged 18 years and older, living in the community and owning a smartphone or tablet, will be recruited all over canada. rapid recruitment will be achieved using social media and professional networks. all data will be collected online to allow a broad reach even in remote regions. self-reported eating habits, physical activity, sleep, alcohol consumption, anxiety and depression data will be collected using validated questionnaires on an online survey platform, and dietary intake data using the mobile application keenoa. with the application, participants take pictures of their meals, which are analyzed and accessible to researchers in real-time, providing comprehensive data on nutrient and food intake, and hence patterns and diet quality. diet will be tracked for a full week at study entrance and repeated 6 times during a year, and once one year later, along with follow-up questionnaires on lifestyle behaviours. the main study objectives are 1) to evaluate how eating habits, diet quality and related lifestyle behaviours of canadian adults are impacted by confinement phases of the pandemic over one year; and 2) determine the association between eating behaviours and diet quality with contextual socio-demographic, education, emotional and health factors, and identify emerging explanatory factors as clusters.

Eligibility criteria:
inclusion criteria: * men and women aged 18 years and over, living in canada * owning a smartphone and having access to internet * able to read and understand english or french exclusion criteria: * any active and uncontrolled acute disease that interferes with usual food intake * being hospitalized * pregnancy or lactation

Keywords: nutrition dietary intake eating habits lifestyle behaviours physical activity sleep artificial intelligence mobile application
work-related stress among recently graduated midwives practicing in the delivery room

Conditions: Recently Graduated Midwives Practicing in the Delivery Room

Summary: work stress results from an imbalance between the worker's hopes and work's conditions. midwifes are exposed to emergency situations (newborn distress, neonatal resuscitation, foetal abnormal heart rythm, delivery hemorrhage, ...), which can cause stress and sometimes lead to burnout.

the aim of the study is to describe work-related stress among recently graduated midwives practicing in the delivery room

Eligibility criteria:
inclusion criteria: * midwives graduated for less than three years in france * practicing in the delivery room * whatever the duration of exercise in the delivery room * agreeing to participate in the study exclusion criteria: * no agreeing to participate in the study

Keywords: midwives work-related stress delivery room
the geolynch cohort study

Conditions: Lynch Syndrome; Neoplasms; Hereditary Nonpolyposis Colorectal Cancer; Colorectal Neoplasms

Summary: the geolynch cohort study has been established to investigate the influence of genetic, environmental and other factors on tumour risk in persons with lynch syndrome.

the geolynch cohort study includes persons with lynch syndrome (ls) only. persons with ls carry an inherited mutation in one of the dna mismatch repair genes mlh1, msh2, msh6 or pms2 which increases their risk of several types of cancer, especially colorectal and endometrial cancer. additionally, mutations in the epcam gene that result in epigenetic silencing of the msh2 gene cause ls. since 2006, persons with ls are invited to participate in the geolynch cohort study via the netherlands foundation for the detection of hereditary tumours, the radboud university medical center nijmegen or the university medical centre groningen. moreover, persons with ls can participate in the study after contacting the researcher themselves. participants are asked to complete a food frequency questionnaire and questionnaires about dietary supplement use, physical activity, weight, height and medication use. a buccal swab was asked of every participant recruited between 2006 and 2008. from 2012 on, newly recruited participants are asked to donate a blood sample instead of a buccal swab. furthermore, participants who had been recruited between 2006 and 2008 were asked to complete the questionnaires again and to donate a blood sample too. hence, follow-up measurements are available for a subset of participants. dna has been subtracted from the buccal swabs to genotype snps of the igf gene axis and polymorphisms of mthfr c377t. blood samples are biobanked to facilitate future analyses of biomarkers, nutrients, dna etc. clinical characteristics regarding performed colonoscopies and tumour diagnoses of all participants is gathered from medical records and a linkage to the nationwide network and registry of histo- and cytopathology in the netherlands (palga foundation ). hazard ratios will be calculated to investigate the influence of genetic, environmental and other factor on tumour risk. repeated measures analyses will be used if follow-up measurements are taken into account.

Eligibility criteria:
inclusion criteria: * persons with a known mutation in a gene that causes lynch syndrome, i.e. with an inherited monoallelic pathogenic germline mutation in either the mlh1, msh2, msh6, pms2 or epcam gene. * aged between 18 and 80 years at inclusion. exclusion criteria: * additional carrier of another hereditary colon cancer predisposition syndrome (e.g. fap) * (chronic) inflammatory bowel disease * non-dutch speaking * dementia or another mental condition that makes it impossible to fill out questionnaires * terminally ill persons

Keywords: lifestyle nutrition
evaluation of the effectiveness of surgical treatment of villo-nodular synovitis of the hip in children

Conditions: Synovitis

Summary: villo-nodular synovitis can affect the joints, bursae or tendon sheaths. this condition is rare, with 1.8 cases per million inhabitants. the hip is affected in 3.6 to 18.1% of cases. the age of predilection is between 30 and 50 years old and this condition is rarely described in children. two articles report a case of villous-nodular synovitis of the child's hip. surgical treatment by resection seems to be consensus but various adjuvant treatments are also proposed. a case of villous-nodular synovitis of the hip in children was treated without surgical intervention. the main objective of this study was to evaluate the efficacy of surgical treatment of villous nodular synovitis of the hip in children.

french multicentric cases serie

Eligibility criteria:
inclusion criteria: * children with histologically villo-nodular synovitis of the hip * surgical procedures performed for the treatment of this synovitis exclusion criteria: * degree of bone maturation and risser test greater than 4 at the time of diagnosis * parents opposing the use of their child's data / patient opposing the use of his/her data

Keywords: villo-nodular synovitis hip surgery
clinical research of s-1 versus pemetrexed in the maintenance treatment of advanced nsnsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to compare the curative effect of oral s-1 with pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (nsclc), and initial to explore a new treatment strategy for advanced non-squamous nsclc.

s-1 consists of tegafur,gimeracil and oteracil potassium. tegafur is metabolize to gimeracil，and slows down the metabolism of 5-fu in high dpd enzyme expression tumor cell, so that 5-fu could bring the antimetabolic fiction more efficiently. plenty of studies support that s-1 shows a desirable effect on advanced non-squamous nsclc, and s-1 is more convenient compare with pemetrexed. the curative effect of pemetrexed in the maintenance treatment of advanced non-squamous nsclc has been proved to be valid. the purpose of our study is to explore whether s-1 could replace pemetrexed in the maintenance treatment of advanced non-squamous nsclc.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. histological or cytological documented 3. nsclc of stage iiib (surgery is unacceptable) or iv confirmed by mediastinoscopy or pet based on recist1.1. 4. candidates have been accepted 4-6 cycles of gemcitabine/carboplatin naive chemotherapy, and evaluated as cr,pr or sd. 5. candidates's expected survival time should be greater than or equal to 3 months with ecog performance status 0-1, adequate haematological and hepatic- renal function, and cardiac function. 6. at least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by ct or mri) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy. 7. no any other following malignancy or any serious complication caused by metastatic encephaloma. 8. no any gastrointestinal diseases that could reduce the drug absorption. 9. female: candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. pregnancy tests results must be negative.lactation female are not included. 10. male: be sterilized or take contraceptives during therapy or in 3 mouths after therapy. exclusion criteria: 1. any unstable systemic disease 2. patients with exposure to any recent anticancer therapy outside of this trial. 3. pregnant or breast-feeding women

Keywords: carcinoma, non-small-cell lung s-1 pemetrexed maintenance therapy