Kornimate/medical-research-clean huggingface dataset:
denosumab in metabolic bone disease in chronic intestinal failure patients

Conditions: Metabolic Bone Disease

Summary: low bone mineral density (bmd) is commonly reported in patients receiving home parenteral nutrition (hpn). denosumab represent a new drug, which helped to prevent osteoclast. the aim of the study was to assess its value in chronic intestinal failure patients.

low bone mineral density (bmd) is commonly reported in patients receiving home parenteral nutrition (hpn). oral and intravenous calcium, vitamin d and bisphosphonates have been commonly used to treat bmd, but their efficiency is may be inadequate due to limited absorption and compliance. denosumab represent a new drug, which helped to prevent osteoclast development and activation, hence decreased bone resorption in some studies. the aim of the study was to assess its value in chronic intestinal failure patients receiving hpn. between november 2011 and march 2013 denosumab was administered to 16 hpn patients (9 f, 7 m mean age 55.4) with intestinal failure. regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated, and after 12 months. bmd, t-score and z-score were measured.

Eligibility criteria:
inclusion criteria: * intestinal failure requiring home parental nutrition * bone disease measurement exclusion criteria: * intestinal failure not requiring hpn * diagnostic modalities impossible
screening of malignant hyperthermia susceptible individuals

Conditions: Malignant Hyperthermia

Summary: this study intends to target patients who underwent surgery under general anesthesia during the study period and developed malignant hyperthermia during or after surgery. therefore, the total sample size was estimated to be about 50 people based on the past incidence of this rare disease. every year, about 20 patients and their families who developed malignant hyperthermia during or after surgery will participate in this nationwide study (estimated by the current incidence of malignant hyperthermia), and about 1-5 patients will be admitted to peking university third hospital participate in this research. relevant specimens were collected from malignant hyperthermia (mh) patients and their family members for genetic analysis to determine the mutation of mh-related pathogenic gene loci.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery under general anesthesia during the study period developed malignant hyperthermia during or after surgery. exclusion criteria: * malignant hyperthermia was ruled out by later treatment and diagnosis; * the patient or family member refuses to be recruited.
the effect of motivational interviewing on self-efficacy and quality of life in gestational diabetes mellitus

Conditions: Motivational Interviewing; Self Efficacy; Quality of Life; Gestational Diabetes Mellitus

Summary: this study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus.

this study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus. 24-26 weeks for pregnant women diagnosed with gestational diabetes mellitus. a total of motivational interviews will be held for 4 weeks with the pregnant women. personal information form, health management self-efficacy scale and quality of life scale will be administered before the motivational interview, and the health management self-efficacy scale and quality of life scale will be administered at the end of the motivational interview.

Eligibility criteria:
inclusion criteria: being pregnant for the first time * being diagnosed with gestational diabetes mellitus * 24-28. being in the pregnancy week * being able to speak and understand turkish * being 18 years or older * having a single and viable fetus * volunteering to participate in research * having and being able to use a mobile phone * having all check-ups at the same hospital and regularly throughout pregnancy, exclusion criteria: * being diagnosed with diabetes mellitus (type 1, type 2 diabetes) before pregnancy * having a psychiatric diagnosis, * having a chronic disease * having risk factors such as threat of premature birth, placenta previa, premature rupture of membranes * having any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than turkish), * pregnant women who do not want to continue the study and give birth before the 37th week of pregnancy will be excluded from the study.

Keywords: pregnancy gestational diabetes mellitus health management self-efficacy quality of life motivational interview
simultaneous integrated boost radiotherapy and concurrent chemotherapy for locally advanced esophageal carcinoma

Conditions: Esophageal Neoplasms

Summary: this phase ⅰ/ⅱ trial is designed to explore a higher radiation dose by using imrt simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.

despite the application of imrt and the studies of concurrent chemoradiation in esophageal carcinoma, which improves 5-year survival rate from 10% to 20%-40% and decrease recurrence rate from 80% to 50%-60%, local recurrence remains to be the most common failure pattern. therefore, enhancing local control is the key to obtain a better survival. a phase ⅱ study of radical radiotherapy with imrt simultaneous integrated boost technique and concurrent chemotherapy for esophageal carcinoma use the same radiation dose as the high dose arm in rtog 94-05, which reveals an significantly improved median survival time of 23 months and 3-year overall survival rate of 44.4%. this study implies the simultaneous integrated boost technique may be effective to some extent. but the question is how to identify patients who may gain potential benefits, and whether this therapeutic model can be copied in the specific situation in china? few adverse effects such as perforation, hemorrhage and stenosis was reported, mainly owing to the lack of cases. for widely application of this new technique in the clinic, more studies need to be conducted in the future to obtain sufficient evidence. the current imrt can simultaneously achieve prophylactic dose (dt 50gy) and radical dose (dt 60-64gy) in respective target volume by using inverse intensity-modulated planning system. however, it is still controversial on whether esophageal carcinoma can receive prescription dose more than 2.0gy each time. that is to say, it is challengeable to find an optimal fraction dose and total dose between tumor and adverse effects. for this reason, the dose escalation trial is to be conducted to explore the clinical value and optimal dose to esophageal carcinoma with different radiosensitivity, and also provide data support for phase ⅲ clinical trials.

Eligibility criteria:
inclusion criteria: * diagnosis of clinical stage t2-4n0-1m1a untreated squamous esophageal carcinoma * kps≥70 * adequate organ function * no known history of drug allergy exclusion criteria: * known drug allergy * insufficient hepatorenal function * severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
objective measurement of ossicular chain mobility using a palpating instrument intraoperatively

Conditions: Disorder of Middle Ear; Otosclerosis of Middle Ear; Cholesteatoma, Middle Ear

Summary: feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (palpear).

the aim of this study was to develop and test a palpating instrument, which enables the experienced and occasional otologic surgeon to record force in three dimensions during his standard palpation of each ossicle at surgery and al-lows correlation of his subjective impression with objective measurement results. the first task was to incorporate force sensing capability into a standard 45° angulated 2.5 mm hook, which is commonly used to palpate, disconnect and luxate ossicles during middle ear surgery.

Eligibility criteria:
inclusion criteria: * adult subjects * normally scheduled for middle-ear or internal-ear surgery as a result of an ear disease and for whom a routine assessment of the mobility of the ossicle chain is in order. the targeted subject population consists of patients undergoing stapedotomy for otosclerosis and subjects with a normal ossicular chain who are subject to the placement of a cochlear implant to treat hearing loss. exclusion criteria: * children * subjects in whom the ossicle chain is missing or incomplete * missing informed consent form * incapacitated subjects or subjects with impaired judgment capability.
impact of pandemic of presentation to emergency department and admissions

Conditions: Emergencies

Summary: observational study assessing the impact of the covid-19 pandemic on presentations and admission to hospital in children and young adults.

the covid-19 pandemic has had a major impact on healthcare utilisation and delivery for children and young adults. this is despite these groups experiencing minimal morbidity and almost no mortality as a direct result of the pandemic. the immediate impact of the first lockdown in april 2020 has been well documented. a number of studies show a marked reduction in presentations of children and young adults to the emergency department. the question is now, are these trends continuing and are they particularly impacting on specific groups and on specific presentations? with these data, services can be modified to minimise any potential for deleterious effects. it may also be possible to target groups who are not utilising health services as the investigators would expect. the investigators will use fully anonymised routine data on presentations and admission of 0 to 24 years olds to university hospital southampton nhs foundation trust. data will be graphed to show trends in activity before and after the start of the pandemic. an interrupted time series regression analysis will be used to assess the significance of any changes in trends.

Eligibility criteria:
inclusion criteria: * children and young adults aged 0 to 24 years * presented +/- admitted to the emergency department at university hospital southampton nhs foundation trust between the 1st of april 2016 and 31st of march 2021 exclusion criteria: none

Keywords: emergencies children adolescents young adult
assessment of poles' attitudes towards living kidney donation

Conditions: End Stage Renal Disease

Summary: the main goal of the project is to examine the public opinion on living kidney donation and to assess the knowledge of poles in this field.

researchers also want to estimate how large percentage of the respondents will declare their willingness to donate a kidney to a stranger and what percentage of respondents would support a possible extension of the existing law on the collection, storage and transplantation of cells, tissues and organs of july 1, 2005 to include donation to a stranger.

Eligibility criteria:
inclusion criteria: * 18 years or older * polish citizenship exclusion criteria: * below 18 yers of age * not polish citizen
role of tmem219 marker in type 1 diabetes

Conditions: Diabetes Mellitus

Summary: type 1 diabetes (t1d) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. the different immunological approaches implemented to date to treat t1d have obtained a negligible number of insulin-independent individuals. the initial stages of diabetic disease are characterized by the massive and progressive infiltration of t cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. the onset of t1d has been mainly associated to a dysregulation of the immune response. however, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. the investigators have recently shown that the expression of the tmem219 death factor is an essential factor in controlling the fate of stem cells in diabetes. the aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as tmem219.

methods of recruiting the subjects healthy subjects, individuals with type 1 and type 2 diabetes and those who are at risk of developing diabetes will be enrolled. enrollment was approved by the university of florida ethics committee within the npod project, network for the pancreatic organ donors with diabetes. duration of the study: 5 years. experimental procedure: the following analyses will be performed on the collected and received samples: * study of tmem219 expression and of other tmem219-related markers by immunohistochemistry and immunofluorescence and western blot * study of tmem219 expression and of other tmem219-related markers by molecular biology analysis * analysis of the proteomic profile on collected biological liquids the above analyses will be performed at the pediatric clinical research center romeo ed enrica invernizzi at the sacco hospital - university of milan. previous experiences the investigatore expertise in manipulating / studying the signaling involved in the pathogenesis of type 1 diabetes has been widely recognized in several publications in recent years (diabetes 2013, diabetes 2014, diabetes 2015, science translational medicine 2017) as well as the characterization of marker expression including tmem219 (cell stem cell 2015). relevance of the study the study offers the possibility to acquire new information on the pathogenesis of diabetes and to identify new target mechanisms for designing innovative therapeutic strategies in the treatment of diabetes.

Eligibility criteria:
inclusion criteria: * reported in the npod protocol exclusion criteria: * reported in the npod protocol

Keywords: diabetes mellitus beta cell loss beta cell apoptosis
dia:conn p8(smart insulin pen) study in diabetes patients

Conditions: Diabetes Mellitus

Summary: a multicenter, open label, randomized, comparative study to evaluate the efficacy and safety of electric smart insulin pen dia:conn p8 in patients with type 1, type 2 or pancreatogenic diabetes mellitus under multiple dose insulin therapy

\[blind cgm period\] all eligible participants who voluntarily provide informed consent to participate in this clinical trial and are determined suitable for trial inclusion/exclusion criteria undergo a blind cgm before the baseline visit (randomization). during this period, every subjects is provided with two dia:conn p8 devices for continuous glucose monitoring (cgm), basal insulin, and bolus insulin administration. throughout this period, subjects receive training on fundamental insulin pen usage and cgm operation. they use the dia:conn p8 specifically for insulin dosage entry and administration, functioning similarly to a conventional insulin pen, only utilizing the injection and injection recording function. insulin injection dosages and timing (time stamps) recorded on the dia:conn p8 and the participant's blood glucose data logged in the cgm app are collected. \[application period\] the subject allocated to the intervention or control group through randomization will visit hospital maximun 5 times during the 12-week application period, including the baseline visit, in the following process. 1. treatment group: for the treatment group, education sessions will be conducted during the baseline visit on carb counting and bolus calculator methods, installation, and usage instructions for dia:conn p8 and dia:conn app, as well as cgm and cgm app. 2. control group: the control group will receive education on insulin pen and cgm usage, maintaining their conventional multiple dose insulin therapy while implementing cgm.

Eligibility criteria:
inclusion criteria: 1. age between 19 and 75 years old. 2. confirmed diagnosis of type 1 or type 2 diabetes or post-pancreatectomy(total or partial) diabetes at least 1 year prior to screening. 3. currently using multiple dose insulin therapy at least 3 months prior to screening, regardless of continuous glucose monitoring(cgm) usage. 4. hba1c levels between 7.5% and 12.0% at screening. exclusion criteria: 1. who have administered medications affecting glucose metabolism within 3 months before screening(e.g., corticosteroids, immunosuppressants) (candidate with stable, ongoing dosage for over 6 months before screening are exempted from this criterion). 2. diagnosed with clinically significant cardiovascular disease within 6 months prior to screening. 3. exhibiting an estimated glomerular filtration rate(egfr)\<15 ml/min at the screening. 4. unable to engage in study education due to severe systemic disorders(e.g., end-stage renal failure requiring dialysis, liver cirrhosis of child-pugh class c or higher, etc) 5. participants with severe diabetic complications(e.g., diabetic foot, diabetic retinopathy, etc) 6. pregnant or lactating women
oral functions and malocclusions

Conditions: Malocclusion

Summary: the aim of our research is to establish a link between malocclusions and oral dysfunctions. the clinical examination includes: caries screening (dmft and dft scores), a quantification of dental plaque (silness and loë's plaque index) and orthodontic treatment need (haute autorité de santé has). the functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.


Eligibility criteria:
inclusion criteria: * all the pupils benefit from the clinical examination exclusion criteria: * none
duration of androgen receptor pathway inhibitor and adt with metastasis directed therapy in oligometastatic cancer of the prostate (direct)

Conditions: Metastatic Prostate Cancer

Summary: this is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor to standard of care radiation and hormone therapy improve quality of life. participants will either receive standard of care radiation and hormone (adt) therapy (arm 1) or standard of care radiation and hormone (adt) therapy plus oral abiraterone for 8-9 months (arm 3). participants will be routinely follow-up in clinic or remotely for up to 5 years.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. able to provide informed consent 3. histologic diagnosis of prostate adenocarcinoma 4. ecog performance status 0-2 5. stage iv castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases 1. maximum one metastatic deposit on conventional imaging (ct or bone scan or mr) 2. additional metastases can be detectable by psma pet only 6. all sites of disease are amenable to and can be safely treated with radiotherapy 7. patients decline continuous use of adt exclusion criteria: 1. significant comorbidities rendering patient not suitable for adt, enzalutamide and sbrt 2. history of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively 3. prior use of salvage systemic therapy 4. evidence of spinal cord compression
educating women about pelvic floor disorders during pregnancy

Conditions: Pelvic Floor Disorders; Stress Urinary Incontinence; Pelvic Organ Prolapse

Summary: the purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.

pelvic floor disorders (pfds) are common and significantly affect the quality of life of many women as they age. pregnancy has been identified as a major risk factor for developing pfds later in life. educating women about pfds is essential to ensuring that they present to care in a timely manner. no study has investigated different education tools during pregnancy. the proposed study is a randomized controlled trial in pregnant patients comparing two educational tools: written materials about pfds versus an educational workshops led by pelvic floor physical therapists (pfpts). pregnant patients will be recruited in the first and second trimester and randomized at that time. knowledge will be assessed at baseline and again 6 weeks postpartum using the validated prolapse and incontinence knowledge questionnaire. secondary outcomes will be evaluating referral patterns to urogynecology and to pfpts from general obgyns and assessing any pelvic floor symptoms with the pelvic floor disability index (pfdi-20) at baseline and at 6 weeks postpartum.

Eligibility criteria:
inclusion criteria: * pregnant (prior to 27 weeks gestation) * english speaking * greater than 18 years old exclusion criteria: * non-english speaking * unable to provide informed consent

Keywords: pregnancy education prolapse incontinence