Kornimate/medical-research-clean huggingface dataset:
contrast-enhanced multispectral optoacoustic tomography for non-invasive assessment of diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: the objective of the proposed study is to assess gastric emptying time (get) based on contrast-enhanced multispectral optoacoustic imaging (ce-msot) in a collective of patients with type 1 diabetes mellitus (t1dm). the results will be correlated with disease duration and severity.

t1dm is a chronic autoimmune disease in which autoantibodies destroy the pancreas's insulin-producing cells. in germany, it is estimated that 32,000 children and adolescents and approximately 335,000 adults suffer from t1dm. the trend has been increasing in recent years. a complication of t1dm is diabetic gastroparesis (dgp), in which gastric emptying is delayed without mechanical obstruction. symptoms of dgp include nausea, vomiting, and abdominal pain. many patients\* are asymptomatic. dgp is associated with higher hba1c, autonomic neuropathy, nephropathy, retinopathy, and increased gastrointestinal symptoms. in this study, gastric emptying will be imaged noninvasively and without radiation based on msot. msot, in addition to imaging endogenous chromophores, allows visualization of exogenous chromophores. if the dye indocyanine green (icg) is ingested orally, the signal of the dye in the lumen of the gastrointestinal tract can be visualized noninvasively by msot over different intestinal segments. if food is labeled with icg and ingested by subjects\*, the passage of chyme through the gastrointestinal tract can be tracked by measuring the signal with msot, and transit times can be measured. this study will investigate gastric emptying times of patients\* with t1dm.

Eligibility criteria:
nclusion criteria group 1 * written informed consent * t1dm diagnosis * duration of disease at least 5, preferably 10 years with diagnosed neuropathy group 2 * written informed consent * t1dm diagnosis * duration of disease at least 5, preferably 10 years without diagnosed neuropathy group 3 * written informed consent from parent or guardian * t1dm diagnosis * duration of disease at least 5, preferably 10 years with inadequate medication control (hba1c value \> 8.5 mmol/l) group 4 * written informed consent of parent or guardian * t1dm diagnosis * duration of disease at least 5, preferably 10 years with good medication control (hba1c value \< 7.5 mmol/l) exclusion criteria generality: * pregnancy * breastfeeding mothers * tattoo in the area of the examination * subcutaneous fat tissue over 3 cm * known hypersensitivity to icg, sodium iodide or iodine * hyperthyroidism, focal or diffuse thyroid autonomy * timely close treatment to check thyroid function with ingestion of radioactive iodine (within two weeks before or after the study) * impaired renal function * taking the following medications: beta blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite

Keywords: diabetic gastroparesis msot
digital interventions to treat hazardous drinking

Conditions: Hazardous Drinking; Stress

Summary: there has been a significant increase in the prevalence of stress- and alcohol- related disorders during the covid-19 pandemic. this project aims to conduct a feasibility study to evaluate the preliminary efficacy of a digital intervention designed to reduce stress and alcohol use. additionally, this study will examine the impact of stress, including covid-19 related stress, on the risk of alcohol misuse and the outcomes of the intervention in risky social drinkers.

this project proposes a feasibility study to evaluate the preliminary efficacy of a digital intervention aimed at addressing stress-related drinking in risky drinkers with emotional stress. this digital intervention combines telehealth- and smartphone app- based approaches, allowing concurrent intervention and participant-initiated daily exercise in a real-life setting. this program integrates alcohol intervention with breathing-based stress reduction and focuses on developing emotion regulation skills to manage stress, craving, and alcohol misuse. after the 4-week intervention, all participants will be prospectively followed for 30 days to monitor stress, alcohol use, and other health-related behaviors.

Eligibility criteria:
inclusion criteria: * heavy or binge drinkers * either high or low covid-19 related stress exclusion criteria: * current or past substance use disorder other than mild alcohol, tobacco, marijuana use disorder * psychiatric disorders except for mood and anxiety disorders * any significant current medical conditions

Keywords: hazardous drinking covid-19 stress digital intervention
awareness to osteopenia's treatment by bisphosphonate in male suffering from prostate cancer

Conditions: Osteoporosis; Prostate Cancer

Summary: patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician. primary objective: to evaluate the compliance in male patients with prostate cancer treated with bisphosphonate and that suffered from osteopenia/osteoporosis. secondary objectives: to evaluate the compliance of family physicians to prescribe bisphosphonate for patients upon recommendation by urologists. to evaluate the overall number of patients treated by bisphosphonate in the out-patient clinics, to evaluate incidence of osteopenia/osteoporosis in this study population.


Eligibility criteria:
inclusion criteria: * man with prostate cancer * men ≥70 years old or ≥60 years old treated by lh-rh agonist for at least 2 years or man who was diagnosed in the past with osteopenia/osteoporosis * osteopenia/osteoporosis proven by bone density test. exclusion criteria: * creatinine clearance \< 30ml/min * hypercalcemia * actual treatment by bisphosphonate or steroids * hypersensibility to bisphosphonate or any contraindication to its use. * metastatic prostate cancer * patients not suitable for compliance. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: osteoporosis prostate cancer osteoporosis in male with prostate cancer
study of mirogabalin for central neuropathic pain

Conditions: Central Neuropathic Pain

Summary: investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

\[double blind phase\] the primary objective is to compare change in the average daily pain score (adps) from baseline to week 14 in asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo. \[open extension phase\] the objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in parkinson's disease).

Eligibility criteria:
inclusion criteria: * spinal cord injury (sci) due to trauma * american spinal injury association impairment scale a, b, c, or d exclusion criteria: * other severe pain at screening or randomization, unrelated to central neuropathic pain after sci, that may confound the assessment of central neuropathic pain after sci * neurologic disorders at screening or randomization, unrelated to central neuropathic pain after sci, that may confound the assessment of central neuropathic pain after sci * major psychiatric disorders within 1 year prior to screening

Keywords: central neuropathic pain developmental phase iii
a comparison of learning method (cam-icu) between e-learning and conventional face-to-face lecture and demonstration

Conditions: Delirium

Summary: delirium is an acute and fluctuating disturbance of consciousness characterized by reduced attention, impaired cognition and perception, usually resulting from general physical conditions. delirium contributes to longer hospital length of stay, increased mortality, increased healthcare costs, and long-term cognitive and functional impairment. however, it is often underdiagnosed and undertreated. e-learning (electronic learning) proves to be a time-efficient, flexible and convenient training method, making it suitable for a large organization like siriraj hospital where there is a large employee turnover rate. so the investigators want to compare the passing rate between the e-learning group and the traditional learning group.

primary objective: compare the passing rate between the e-learning group and the traditional learning group secondary objectives: assess the trainees' satisfaction and problems associated with e-learning implementation, investigate the causes of inaccurate cam-icu assessment for improvement in future training sessions

Eligibility criteria:
inclusion criteria: * icu nurse * general ward nurse * private ward nurses * nurse anesthetists exclusion criteria: * previous exposure to cam-icu * inability to complete the training courses * inability to complete the required 3 simulated patient scenarios
efficacy/safety of dp-r207 tablet versus crestor tablet in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: the purpose of this study is to evaluate efficacy and safety of dp-r207 in patients with primary hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * aged over 19 years * signed informed consent form * at visit 1 and visit 2, ldl-cholesterol ≤ 250mg/dl and triglyderide ≤ 350mg/dl exclusion criteria: * has a history of hypersensitivity to hmg-coa reductase inhibitor and component of ezeimibe * liver transaminases \> 2 x upper limit of normal
the risk assessment scale for peripherally inserted central venous catheter (picc) related thrombosis in cancer patients

Conditions: Thrombosis; Catheter

Summary: the aim of this study is to compare the accuracy and clinical predictive value of the michigan risk score, caprini risk assessment model , and maneval scale （chinese version）in predicting picc-related thrombosis.

the aim of this study is to compare the accuracy and clinical predictive value of the michigan risk score, caprini risk assessment model , and maneval scale（chinese version） in predicting picc-related thrombosis. patients who will receive picc placement will be evaluated by using the michigan risk score, caprini risk assessment model , and maneval scale the day during picc placement, 24-48h after picc placement and every time patients receive picc maintenance.

Eligibility criteria:
inclusion criteria: * cancer patients * older than 18 years * being able to complete the questionnaire independently * patients who need picc for treatment * being able to perform catheter maintenance in the hospital of admission until catheter removal * patients who agree to participate and sign the consent form exclusion criteria: * patients who were or suspected to be allergic to the ingredients contained in picc * picc placed in the lower extremity
development and validation of a multi-mineral fluoride mouthrinse

Conditions: Dental Caries

Summary: the primary goals of this project are to determine the anticaries benefits of a prototype multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a ca through the remineralization of enamel white-spots (non-cavitated lesions). the selection of patients with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel white-spot lesions.


Eligibility criteria:
inclusion criteria: to participate in this study, panelists will be required to meet the following criteria: 1. subjects must be 13 - 65 years of age; 2. subjects must read and sign the informed consent prior to initiation of study procedures. all subjects will receive a copy of the signed informed consent; 3. subjects must have a reasonable functional dentition, without a large number of missing teeth, and teeth #'s 22-27 present; 4. have normal salivary gland function (unstimulated whole salivary flow rate equal to or greater than 0.25 ml/min and paraffin stimulated whole salivary flow rate equal to or at least 1.0 ml/min); 5. subjects must be willing to participate in the study, be able to follow the study directions, be willing to return for all specified visits at their appointed time, and to use the product as per instructions; 6. subjects must be in good general health based on medical history and oral soft and hard tissue examination. exclusion criteria: criteria that will not permit participation in this study will be as follows: 1. any subject who is pregnant or lactating - based on oral interview only - as pregnancy may interfere with the outcome of the study; 2. any subject who has a systemic health condition such as diabetes that could affect the outcome of the study at the discretion of the examiner; 3. any subject who has an oral condition, such as excessive, untreated dental caries, periodontal disease, chronic dental neglect, or any oral pathology including xerostomia determined by oral examination and subject history that in the opinion of the dental examiner could affect the outcome of the study; 4. any subject who has full dentures, or full orthodontic appliances. no use of nightguards will be permitted during the study period; 5. any subject who uses oral care products (other than those permitted) during the treatment or wash-out periods; 6. any subject with an immunological disorders such as hiv positive, aids, and systemic lupus erythematosis; 7. any subject concurrently participating in another clinical study; 8. any subject currently taking antibiotics or other medications, which in the opinion of the investigator/examiner might influence the study outcome; 9. any subject with a history of sensitivity to oral products or allergies to ingredients in the products; 10. any subject who fails to keep any of their scheduled appointments.

Keywords: remineraliation pre-existing white-spot (non-cavitated) enamel lesions
hybrid imaging modalities for the evaluation of infection

Conditions: Infectious Diseases

Summary: the synergistic value of the fusion of physiologic and anatomical data has been described using several co-registration techniques for various nuclear medicine procedures and morphologic imaging modalities (single photon emission computed tomography-computed tomography \[spect-ct\], spect-magnetic resonance imaging \[mri\], camera-based positron emission tomography \[pet\]-ct and pet-ct). the researchers hypothesize that fusion of nuclear medicine (nm) and ct data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. they hypothesize that more accurate localization of increased radiotracer activity on nm procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management. the purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.

the researchers hypothesize that fusion of nuclear medicine (nm) and ct data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. they hypothesize that more accurate localization of increased radiotracer activity on nm procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management. the purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.

Eligibility criteria:
inclusion criteria: * patients referred for nm imaging procedures to assess the presence of infectious processes. * patients signed informed consent exclusion criteria: * the study will not be performed in pregnant or lactating women. * patients unable or unwilling to tolerate the scan until its completion
a safety study of ly2886721 multiple doses in healthy subjects

Conditions: Alzheimer's Disease

Summary: this is a phase 1 study in healthy subjects to evaluate the safety and tolerability of ly2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.


Eligibility criteria:
inclusion criteria: * healthy men and non-childbearing potential women * body mass index between 18.0-32.0 kilograms per square meter (kg/m\^2) * are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies exclusion criteria: * taking over-the-counter or prescription medication with the exception of vitamins or minerals * smoke more than 10 cigarettes per day * drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
effect of hydrocortisone iontophoresis versus hydrocortisone phonophoresis on post surgical scar

Conditions: Scar; Hydrocortisone; Iontophoresis; Phonophoresis

Summary: the purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.

scar contractures develop and extend to the underlying connective tissue and then muscles, leading to reduction in joint range of motion and affecting the day-to-day activities. most patients (irrespective of age, gender and ethnicity) believe that even a small improvement in scarring is worthwhile , any research that may help improve scar outcome is meaningful. the need of this study has developed from the rarity of information about the difference between the effectiveness of iontophoresis and phonophoresis in enhancing the overall appearance of surgical scar.

Eligibility criteria:
inclusion criteria: * both genders * same approach of medications * scar size varies from 5-15 cm exclusion criteria: * have cardiac / pacemakers * have significant health problems * obese patients (bmi more than 30) * uncooperative patients
german validation study of the subjective cognitive decline questionnaire (scd-q)

Conditions: Alzheimer Disease; Subjective Cognitive Decline

Summary: the scd-q (subjective cognitive decline-questionnaire) is an established instrument to quantify self-perceived cognitive decline. both self- and informant-rated versions of the scd-q are available. however, the scd-q has not been validated in the german language yet. hence, the investigators aim to validate the self-reported scd-q in a clinical sample in germany.

the scd-q is a well-established screening instrument to quantify perceived subjective cognitive decline. in addition to self-perceived cognitive complaints, a 24-item questionnaire for informants is part of the scd-q. it demonstrates high sensitivity and lower specificity for detecting dementia and early cognitive changes associated with dementia. however, the questionnaire has not been translated into german or validated. plasma biomarkers for amyloid and tau pathology, as well as for neurodegeneration and astrocytic activation, have been developed and show promising sensitivity and specificity for detecting alzheimer's disease (ad). a relevant proportion of biomarker-positive patients does not convert to mild cognitive impairment or alzheimer's disease dementia during the disease course. currently, the predictive value of blood biomarkers remains to be clarified, particularly in conjunction with scd. this study aims to validate the scd-q in german and analyze possible connections with biomarkers and (digital) cognitive tests. follow-up visits are planned.

Eligibility criteria:
inclusion criteria: * medical appointment for dementia diagnostics at the alzheimer therapie- und forschungszentrum * provision of signed, written and dated informed consent * capacity to give informed consent exclusion criteria: * dementia in a very advance stage * illiteracy

Keywords: alzheimer's disease subjective cognitive decline german validation
minimizing the effects of covid-19 hospitalization with the covid rehabilitation program for the elderly

Conditions: Covid19

Summary: although evidence from the management of other viral respiratory infections suggest that early multidisciplinary rehabilitation could mitigate the adverse effects of the severe form of the illness, and reduce the length of hospital stays (los), specific data for covid-19 are lacking. hence, in response to the current pandemic, we propose to implement and assess the impact of an early standardized multidisciplinary rehabilitation program tailored to frail older adults on 1) los, 2) post-discharge destination, 3) prognostic index and 4) functional capacity. with a pragmatic multicenter controlled study, the covid rehabilitation program for the elderly (core) trial will allow to measure the effectiveness of a multidisciplinary program to minimize the effects of hospitalization and provide the required tools to rapidly implement an innovative strategy of care for older adults. indeed, based on the results of this study, and with the support of scientific and professional organizations, a standardized program tailored to older adults with covid-19 will be disseminated in canada for all medical units dedicated to the management of the disease. because of its pragmatic approach, this study will provide a sustainable multidisciplinary intervention that can be quickly implemented in any canadian (or abroad) covid-19 medical unit. finally, given that covid-19 is the third coronavirus infection in the last 20 years, the expected results will provide guidelines, with decision tree algorithms, for implementation should another coronavirus or for that matter, any other such type of infection that surface in the future.


Eligibility criteria:
inclusion criteria: * patients with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula \ 92%; resting respiratory rate \< 24; and heart rate between 50 and 120 beats per minute). controls were paired with those of the core program according to age, sex and pre-admission origin exclusion criteria: * none
ptns on urinary and global quality of life in ms patients

Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms; Neurogenic Bladder; Overactive Bladder; Urinary Incontinence; Urinary Urge Incontinence

Summary: this is a single-centered, prospective, longitudinal, observational cohort study of patients with ms who suffer from lower urinary tract symptoms (luts) and are refractory to two prior treatment modalities who have elected to pursue ptns therapy for luts.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * lower urinary tract symptoms (urinary frequency, urgency and/or incontinence) * failed prior first and second line therapy (behavioral and pharmacotherapy) * electing for posterior tibial nerve stimulation therapy for urinary symptoms * patients performing intermittent catheterization are eligible exclusion criteria: * indwelling catheters (urethral or suprapubic) * currently pregnant or planning pregnancy * unable to attend weekly office visits for ptns * urodynamic findings of bladder outlet obstruction history of: bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 months