Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of exenatide in patients with type 2 diabetes using thiazolidinediones or thiazolidinediones and metformin

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (oad) agents and twice-daily placebo plus oad with respect to glycemic control, as measured by hemoglobin a1c (hba1c), in patients with type 2 diabetes who experience inadequate glycemic control with oad alone.


Eligibility criteria:
inclusion criteria: * treated with thiazolidinedione (tzd) alone or in combination with metformin. tzd dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening. * hba1c between 7.1% and 10.0%, inclusive. * body mass index (bmi) between 25 kg/m\^2 and 45 kg/m\^2. exclusion criteria: * patient previously in a study using exenatide or glp-1 analogs. * treated with oral anti-diabetic medications other than tzd and metformin within 3 months of screening. * treated with oral insulin within 3 months of screening.

Keywords: exenatide exendin-4 diabetes amylin lilly
comparison of two pre-prosthetic surgical techniques for augmentation of mandibular vertical ridge defects

Conditions: Alveolar Ridge Enlargement

Summary: the aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).

background: expansion of the periosteum and soft tissue matrix by tenting has been described as a method of guided bone regeneration (gbr) for reconstruction of atrophic alveolar ridges. materials and methods: the current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. they are divided into 2 equal groups, each consisting of 7 patients. the first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).

Eligibility criteria:
inclusion criteria: * patients of both genders * with age range from 40 to 60 years, * having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and * requiring prosthetic rehabilitation with dental implants. exclusion criteria: * heavy smokers, * patients undergoing radiotherapy or chemotherapy, * those having infection or local lesions in the area of surgery, and * patients with bone diseases which may compromise the results
vns during rehabilitation for improved upper limb motor function after stroke

Conditions: Stroke; Upper Limb Deficits

Summary: the primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.


Eligibility criteria:
inclusion criteria: 1. history of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior 2. age \>30 years and \<80 years 3. right or left sided weakness of upper extremity 4. uefm score within designated range. 5. at least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits exclusion criteria: 1. history of hemorrhagic stroke 2. any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands. 3. significant sensory loss. 4. presence of ongoing dysphagia or aspiration difficulties. 5. active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy. 6. subject receiving any therapy (medication or otherwise) at study entry that would interfere with vns (e.g. drugs that interfere with neurotransmitter mechanisms). additionally, no psychoactive medications - including nicotine - may be used during the acute study. 7. prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy) 8. severe depression 9. not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.) 10. any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug 11. medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) 12. pregnant or plan on becoming pregnant or breastfeeding during the study period 13. currently require, or likely to require, diathermy during the study duration 14. any health problem requiring surveillance with mri imaging 15. active rehabilitation within 4-weeks prior to therapy 16. botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy 17. severe spasticity of the upper limb
a long-term study of tenapanor alone or in combination with sevelamer in patients with ckd on dialysis and hp

Conditions: Hyperphosphatemia; End Stage Renal Disease

Summary: the study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sp) within the population reference range (sp \>2.5 and ≤4.5 mg/dl) in patients with end-stage renal disease (esrd) on dialysis with hyperphosphatemia (\>4.5 mg/dl).

patients who complete the ten-02-301 study (phreedom) may be eligible to enroll into ten-02-401 (normalize). patients from the ten-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sp. patients from the ten-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sp following a protocol-specified dose titration schedule. patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months. laboratory assessments will be measured at every visit (weeks 1, 2, 3, 4, 6 and 8 and months 3, 6, 9, 12, 15 and 18) using a central laboratory. safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ecgs), and adverse event (ae) monitoring.

Eligibility criteria:
inclusion criteria: * must complete ten-02-301 (phreedom) exclusion criteria: 1. schedlued for kidney transplant 2. life expectancy \<12 months
eus examination using endosound vision system vs. standard echoendoscope

Conditions: Pancreatic Disease; Pancreatic Cancer; Pancreatic Cyst; Gastrointestinal Tumor; Bile Duct Diseases; Bile Duct Cancer; Lymph Node Disease; Submucosal Tumor of Gastrointestinal Tract; Gastrointestinal Cancer

Summary: this is a randomized trial to compare the standard echoendoscope with the newly developed endosound visual system in the evaluation of lesions in the gastrointestinal tract.

endoscopic ultrasound (eus) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. a new endoscopic ultrasound system - the endosound visual system has now been developed for endoscopic ultrasound examination. the endosound visual system is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an eus examination. the aim of this randomized trial is to compare the standard echoendoscope with the newly developed endosound visual system in the evaluation of lesions in the gastrointestinal tract.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * any patient undergoing eus examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon. exclusion criteria: * age \< 18 years. * unable to obtain consent for the procedure from either the patient or lar. * intrauterine pregnancy.

Keywords: endoscopic ultrasound endosound vision system randomized trial
function definition and clinical validation of digital health app: using weight management as an example

Conditions: Weight Loss; Body Fat Rate Loss; Body Composition Change

Summary: this project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. the investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. this study proposes on using cognitive behavior therapy (cbt) in decreasing individual's food craving, which is administered through ai (assistive intelligence) tracking. as with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. researchers have also reported on 85% of people re-gaining premedication weight after 5 years. there is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. therefore, the investigators propose on the research and development of self-managing digital health app (application) for 12 months over two phases, with three months to design app and nine months to confirm the clinical validation. during the first phase, the investigators propose on design of an "ai mindful eating" app, to enhance individual's healthy lifestyle with subsequent weight-loss. based on "gut-brain-axis", this is anticipated to be achieved by using cbt and ai is used to recognize nutrition and mood within mobile images. this facilitates fulfilling lifestyle and long-term weight-loss. finally, the study proposes to complete function definition and clinical validation for our ai humanity app. by scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. the investigators intend to disclose the effect of the ai assistant app in weight management and metabolic disease prevention.


Eligibility criteria:
inclusion criteria: * obese subjects (bmi\>= \>= 27 kg/m2) with age 18 year-old and less than 65 y/o over will be considered (m/f= 1:1) exclusion criteria: * any history of cancer * unstable mental status * uncooperative subject * complex clinical comorbidities, such as heart failure, end-stage renal disease, etc. * severe physical disability

Keywords: obesity assistive intelligence app weight control cognitive behavior therapy
myopic optic neuropathy in chinese high myopia population

Conditions: Eye Diseases

Summary: this study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in chinese adult population.

global prevalence of high myopia brings about markedly increasing of blinding complications as myopic optic neuropathy (mon) and glaucoma. it was estimated that there were 163 million people who have high myopia in 2000, and the population with high myopia would increase to almost one billion (9.8% of the world population) worldwide by 2050. glaucoma is the leading cause of irreversible blindness worldwide while it is difficult to distinguish glaucoma among mon in high myopia eyes. however, there lack longitudinal study to illustrate the natural course interpreting the distribution and natural history of mon. in view of the above problems, this is a longitudinal registry cohort study to observe the long-term changes of structural and functional parameters of mon in high myopia, and to investigate the natural course and associted risk factors that influence the progression in a chinese adult population.

Eligibility criteria:
inclusion criteria * age ≥18 years * equivalent spherical ≤-6d or axial length ≥26.5mm * best corrected visual acuity ≥ 6/12 exclusion criteria * unwilling or unable to give consent, or unable to return for scheduled protocol visits. * glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease. * obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, vf test or monophthalmia. * need for ocular surgery/laser or anticipated need for cataract surgery during the study period. * other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases); * pregnant or nursing women

Keywords: myopic optic neuropathy high myopia glaucoma
evaluation of health related quality of life and patient adherence in case of hungarian patients affected by osteoarthritis

Conditions: Osteoarthritis

Summary: translation and cross-cultural adaptation process of the osteoarthritis knee and hip quality of life questionnaire. according to granted guidelines, shared by the developer of the questionnaire, the study was conducted among hungarian patients affected by osteoarthrosis.

this prospective study was performed among patients diagnosed - by the doctors acting as the expert panel of this study - with oa of the lower limb. the recruitment period was: june 2017 and november 2017, in six hospitals situated in six different geographical regions of hungary. the participating hospitals were selected in a way to represent different geographic and cultural areas of the country; the patients were selected randomly by the doctors of the given sites. the process was conducted with the contribution of: (1) translation committee (4 members), (2) our research team, as moderator (4 members), (3) expert panel (6 doctors professors of the study sites: orthopaedists, rheumatologists, musculoskeletal rehabilitation doctors). the used instruments were for the validation process: short version of world health organization quality of life questionnaire (whoqol-bref), euroquality of life - 5-dimension questionnaire as generic quality of life measurement tools (eq-5d - vas). in addiction 99 patients filled the questionnaires in an appropriate way. the results were evaluated by 23.0 version of spss program.

Eligibility criteria:
inclusion criteria: * age over 18 years * clinically/doctor diagnosed knee and/or hip osteoarthritis * native hungarian language * ability of self-filling and completely filled patient data sheet. exclusion criteria: * age under 18 years * other type of oa osteoarthritis * psychiatric disorders * surgeries within 1 month * incapable of filling out the forms/tools
an observational study to describe evusheld™ (tixagevimab/cilgavimab) pre-exposure prophylaxis in real-world setting in japan

Conditions: COVID-19

Summary: this is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received evusheld as prep against sars-cov-2 infection/covid-19 in japan. all patients who have a record of administration of evusheld in the database will be included in the study. the index date will be defined as the date of first evusheld administration in the database (day 0) and the patients will be followed up to 6 months after the index date (day 1 to 180). the look back period is defined as the 12-month period prior to index date (day -360 to -1). the exposure of interest will be defined as the administration of evusheld for use as prep against covid-19. as the result of feasibility assessment, sample size of the study expected to be approximately 280.

this is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received evusheld as prep against sars-cov-2 infection/covid-19 in japan. all patients who have a record of administration of evusheld in the database will be included in the study. the index date will be defined as the date of first evusheld administration in the database (day 0) and the patients will be followed up to 6 months after the index date (day 1 to 180). the look back period is defined as the 12-month period prior to index date (day -360 to -1). the exposure of interest will be defined as the administration of evusheld for use as prep against covid-19. as the result of feasibility assessment, sample size of the study expected to be approximately 280.

Eligibility criteria:
inclusion criteria: * immunocompromised patients who were administrated evusheld as prep and have administration date of evusheld * patients aged ≥ 12 years at the index date exclusion criteria: * patients who have no medical visit records at any time in the 12 months preceding the index date

Keywords: covid-19 sars-cov-2 prep
validation of a french version of the confusion assessment method (cam)

Conditions: Confusion; Delirium

Summary: to validate the french version of the cam, a multicenter diagnostic study will be conducted. the principle of this study is identical to the study of inouye which initially validated the cam in 1990. this is to verify the diagnostic properties of the cam (french version) compared to the gold standard represented by the confused state of psychiatric diagnosis using the dsm. a representative sample of geriatric patients for whom a delirium is suspected, will be recruited in the various participating centers, patients will undergo two consecutive visits: * a visit by a geriatrician, during which the confused state of the patient will be evaluated using the french version of the cam. * a visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the dsm iv. these two evaluations will be conducted on the same day and blinded from each other. the order of these two procedures will be balanced within each center. this process will allow the calculation of diagnostic parameters of the cam french version (validation competitive): sensitivity, specificity, positive and negative predictive values .


Eligibility criteria:
inclusion criteria: * a family member of the patient, or his/her "trusted person" must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * hospitalization in geriatric short stay or patient consulting at a geriatric assessment center / memory clinic or geriatric day hospitalization * patients for whom a state of confusion is suspected during the pre-inclusion visit run-in based on the following criteria: * presence of a cognitive function disorder as defined by a score greater than or equal to 3 on the short portable mental status questionnaire (spmsq) (pfeiffer e, 1975) and / or * presence of a mood disorder and / or behavior disorder (regardless of duration) according to the patient's family or caregivers * presence of a caregiver who can answer questionnaires concerning activities of everyday life exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient's family or "trusted-person" refuses to sign the consent * the patient does not understand french * severe aphasia * stay is \< = 3 days

Keywords: french language validation the confusion assessment method (cam)
pencil beam proton therapy for pelvic recurrences in rectal cancer patients previously treated with radiotherapy

Conditions: Rectal Cancer Recurrent

Summary: study design: a prospective phase ii, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.


Eligibility criteria:
inclusion criteria: * • locally recurrent rectal cancer. * bioptically verified (adenocarcinoma ) * available dose plan from primary radiotherapy * previous pelvic rt (\>30gy eqd2) * evaluated in mdt-conferences (herlev, aarhus) * age\>18 years * ps 0-2 * adequate organ function * informed consent exclusion criteria: * non-resectable distant metastases (pet-ct) * unable to undergo mri, pet-ct * inability to attend full course radiotherapy and follow up in the out patient clinic.
er:yag laser effects on microbial population in conservative dentistry

Conditions: Dental Caries; Microbial Colonization

Summary: the aim of this study is to verify the quantitative and qualitative effect of erbium dental laser therapy on microbial populations in carious lesions and to compare the laser therapy with traditional conservative therapies.

patients will be assessed and selected at the university odontostomatology clinic (cou) in perugia; patients are considered eligible for enrolment if they are at least 18 years old and have a carious lesion on permanent teeth, cavitated and non-destructive, deepening to the middle third of the dentine and no further. the patients will be randomly assigned to two groups as follows: group a, control group, which includes treatment with traditional therapy; group b, intervention group, which includes treatment with er:yag laser therapy. for each patient, two salivary swabs will be taken on the cavity dentine of the carious lesion: one before and one after the treatments.

Eligibility criteria:
inclusion criteria: - adult patients of both sexes with at least 18 years of age and one cavitated non-destructive carious occlusal lesion of a permanent teeth, that deepens up to the middle third of the dentin and not beyond, confirmed by radiographic exam and without pulp involvement. exclusion criteria: * patients that refused to sign the informed consent document; * children or individuals with less than 18 years; * pregnant subjects; * patients with syndromes or chronic systemic diseases; * patients who had used antibiotics within the previous three months or under pharmacological treatments; * patients with painful symptoms consistent with irreversible pulpitis or mobility and destructive carious lesions extending beyond the middle third of the dentin; * teeth with exposure of the dental pulp or periodontitis; * patients with caries on deciduous teeth; * patients with no cooperation during the radiographical exam and/or treatments.

Keywords: er:yag laser oral microbiota conservative dentistry