Kornimate/medical-research-clean huggingface dataset:
caregiver study dr. phillips

Conditions: Alzheimer Disease; Dementia

Summary: this study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia

this study used sample size analysis to determine the adequately sized intervention group and control group, well-defined statistical methodology, and a well-documented intervention that can be easily replicated. the intervention has been developed by dr. phillips center for the performing arts leadership with assistance from ams planning \& research.

Eligibility criteria:
inclusion criteria: * primary, unpaid caregiver of person with dementia or * person with dementia. * live independently in the community. * care recipient has a functional assessment staging test (fast) score of 4-6b. * caregiver does not display symptoms of emotional, cognitive, or mental impairment. * caregiver must be able to produce adequate saliva sample. * caregiver/care recipient can travel to program. * caregiver/care recipient agree to participate in all aspects of study intervention and assessments. * caregiver is 18 years of age or older. * care recipient is 65 years of age or older * access to home phone or mobile phone exclusion criteria: * unable to understand either spoken and/or written english. * caregiver is a paid employee of care recipient's legally appointed representative

Keywords: alzheimer disease dementia caregiver performing arts
contractubex treatment in scars after abdominal caesarean section

Conditions: Scars

Summary: the purpose of this study is to investigate the efficacy of contractubex® gel, containing extractum cepae, allantoin and heparin, in the treatment of scars after abdominal caesarean section compared to untreated scars after abdominal caesarean section.


Eligibility criteria:
inclusion criteria: * females having given birth via elective abdominal caesarean section for the first time within the last 5 to 10 days who had their suture removed (removed at screening). * age: 18 years or older. * the subject must be willing and must be able to complete the entire course of the trial and to comply with the trial instructions. * written informed consent has been obtained from the subject. * females using suitable contraceptions. exclusion criteria: * use of any inadmissible medication, e.g. systemic corticosteroids, systemic immunosuppressants (such as cytostatics, therapy with antibodies, biologics, interferone, mykophenolatmofetil, methotrexate, cyclosporine, azathioprine). any additional topical treatment in the area of the lower abdomen, regardless of the mode of action. * any other planned topical treatment in the lower part of the abdomen during the course of the trial. * any infection or wound in the area to treat. * history of keloids or hypertrophic scars. * any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of hiv infection. * any tumor diseases in the abdominal region independent of their dignity. * females having given birth via emergency abdominal caesarean section. * psychiatric problems which, in the investigator's opinion, are severe enough to interfere with the trial results. * participation in another clinical trial within 30 days prior to screening. * evidence or suspicion that the subject might not comply with the study directives and/or that she is not reliable or trustworthy. * evidence or suspicion that the subject is not willing or unable to understand the information given to her as part of the informed consent, in particular regarding the risks and discomfort to which she would agree to be exposed. * previous participation in this clinical study. * known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation. * subjects who are imprisoned or are lawfully kept in an institution. * employees or direct relatives of an employee of the cro, the study center or merz pharmaceuticals.

Keywords: scars after abdominal caesarean section
measurement of multiphysical fields at the subject-sitting interface

Conditions: Wheelchair Users

Summary: with the population ageing and the increase in disabilities prevalence, demand for wheelchairs is increasing. padding and shape of seat are important factors for comfort when sitting for long periods of time. sustained mechanical loads induced by the seated stance can cause pressure ulcers in the ischial prominences. temperature and humidity have also been shown to be important in the development of pressure ulcers.

the aim of this research is to measure the pressure, temperature and relative humidity fields at the user-seat interface of a wheelchair.

Eligibility criteria:
inclusion criteria: * healthy subjects * aged of 18 and more * agreeing to participate in the study exclusion criteria: * under 18 years old * pregnant women

Keywords: wheelchair pressure ulcers pressure measurement temperature measurement humidity measurement
pharmacokinetics study of ckd-11101 and nesp after sc administration in health male volunteers

Conditions: Anemia

Summary: the purpose of this study is to investigate the pharmacokinetics of ckd-11101 and nesp after sc administration in health male volunteers

healthy volunteers are administrated ckd-11101 60μg and nesp 60μg once subcutaneously. (crossover) every time before and after taking each medication, pk parameters and safety of ckd-11101 60μg and nesp 60μg are performed using a blood sample and conducting some tests(laboratory test, v/s and physical examination, etc) respectively.

Eligibility criteria:
inclusion criteria: * signed the informed consent form prior to study participation. * a healthy male volunteer between 20 and 55 years old. * body weight between 55kg and 90kg, bmi between 18 and 27. * appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.) exclusion criteria: * have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases * clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor * have abnormal laboratory result. * hemoglobin \ 17g/dl * vitamin b12 \< 200pg/ml * ferritin \< 21.8ng/ml * transferrin \< 190mg/dl * reticulocyte over the normal limit * positive for the triage tox drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids) * positive for hiv antibody, hbsag, hcv antibody test * a heavy smoker (cigarette \> 10 cigarettes per day) * administer epo, darbepoetin, immunoglobulin or iv iron within 3 months prior to the first ip administration * have hypersensitivity reactions history for epo, darbepoetin, excipient of ip or iron tablets * sit sbp \ 140mmhg or sit dbp \ 90mmhg or pulse rate \> 100 per/min * history of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening * subject takes ethical drug or herbal medicine within 14 days, otc or vitamin supplements within 7 days before the first ip administration * participated in the other clinical trials and administrated ip within 8 weeks prior to the first ip administration * a heavy alcohol consumer (alcohol \> 21 units/week) or cannot stop drinking * bleed or donate blood (\> 400ml) within 8 weeks before the first ip administration * participated in this clinical trials and administrated ip * have a diet within 2 days before the first ip administration or cannot stop having * food containing grapefruit * food containing caffeine * disagree to avoid getting pregnant during clinical trial * an impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason

Keywords: ckd-11101 nesp darbepoetin alfa anemia subcutaneous pharmacokinetics phase 1
controlled internal convection in low flow hemodialysis of dialysate: removal of beta-2-microglobulin

Conditions: Daily Home Hemodialysis

Summary: since 2013 daily home hemodialysis allows low volumes of convection. this study is a prospective cross-over trial testing the efficiency of internal convection on beta2-microglobulin in daily home hemodialysis.

daily home hemodialysis with low dialysate volume system does not normally allow convection. middle molecular weight toxins clearance is therefore lower. beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state. since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9l per session. this technology is called "push pulls" and uses internal convection. this study is a prospective cross-over trial testing the efficiency of internal convection on beta2-microglobulin in daily home hemodialysis. intradialytic fall of b2m levels is compared in 16 patients treated by one session of dialysis with 9l internal convection and one usual session with free internal convection. the kt/v of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.

Eligibility criteria:
inclusion criteria: * home hemodialysis since at least 2 weeks * hemodialysis since at least 3 months

Keywords: daily dialysis home hemodialysis middle-molecular weight toxins beta2-microglobulin push-pull
evaluation of artificial intelligence system (gi-genius) for adenoma detection in lynch syndrome.

Conditions: Lynch Syndrome

Summary: the purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with lynch syndrome.

to compare the performance of white-light colonoscopy (hd-wle) versus white-light + cad (cad) for detection of adenomas (1:1 ratio). the cad system will include an artificial intelligence-based medical device (gi genius, medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display as a green box over suspected lesion. an adequate bowel preparation and minimum withdrawal time of 6 min will be required. colonoscopies will be performed by experienced endoscopists and with high-definition scopes. lesions will be collected, and histopathology findings used as the reference standard. the primary outcome of this trial will be the mean number of adenomas per colonoscopy (apc).

Eligibility criteria:
inclusion criteria: * age ≥18 years with a proven pathogenic germline variant in one of the mmr genes (mlh1, msh2, msh6) or epcam deletion who are under surveillance colonoscopy. exclusion criteria: * previous history of total colectomy, * concomitant inflammatory bowel disease, * inability or refuse to sign the informed consent, * previous colonoscopy \< 12 months. * inadequate bowel preparation. * incomplete procedure. * pms2 mutation carriers
neuropsychological profiles of children with duchenne muscular dystrophy and its effects on motor functions

Conditions: Duchenne Muscular Dystrophy

Summary: this study was planned to determine neuropsychological profiles of children with duchenne muscular dystrophy and investigation of its effects on motor functions \& compare to typically developed peers.

in this thesis, it is aimed to determine the neuropsychological profiles of children with duchenne muscular dystrophy (dmd) and to investigate its effects on motor functions. the study will be carried out with children between the ages of 7 and 16 who have been diagnosed with dmd as a result of genetic testing and who applied to hacettepe university, faculty of physical therapy and rehabilitation, pediatric neuromuscular diseases unit for physiotherapy and rehabilitation evaluation. in addition, considering the primary purpose of the study, typically developed boys between the ages of 7 and 16 with similar physical characteristics will be included in the study and compared with children with dmd. typically developed boys included in the study will be evaluated only with neuropsychological tests. evaluating cognitive function from neuropsychological tests; modified mini mental test, the controlled oral word association test,computer-based the central nervous system vital signs will be applied. to evaluate neurodevelopmental status from neuropsychological tests; conners' parent rating scale, child behavior checklist, strengths and difficulties questionnaire (sdq) will be applied. to evaluate the motor functions of individuals with dmd; brooke lower extremity functional classification, motor function measurement, four square step test, six minutes walk test, timed performance tests (10 meters walk/run test, gower's (from a supine to a standing position), right/left leg standing, ascent/descent of 4 steps) will be used. in the study, in which the effect of the mutation region of dystrophin protein isoforms causing dmd on the neuropsychological profile of children will be investigated by comparing them with typically developed boys and the effect of this on motor function will be examined, the statistical significance level will be considered as p\<0.05

Eligibility criteria:
inclusion criteria: * having been diagnosed with dmd by a pediatric neurologist, * being between the ages of 7-16, * not to have any diagnosed chronic disease, * not having lost yet the ability to write and draw as required by neuropsychological assessments, * cooperate with the physiotherapist and be able to comply with their instructions. exclusion criteria: * inability to cooperate adequately with the physiotherapist who made the evaluations, * have had any injury and/or surgery to the lower/upper extremities in the last 6 months, which may prevent the performance of motor function tests.

Keywords: duchenne muscular dystrophy (dmd) neuropsychological profile cognitive status neurodevelopmental status motor function balance
learn-6™: a prospective, observational nursing home study

Conditions: Anemia; Chronic Kidney Disease

Summary: this is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, quality of life and other physical performance measures among older, long-term stay nursing home residents with ckd, with versus without anemia. enrolled patients will participate in the study up to a total of 26 weeks and be assessed at weeks 1, 2, 14 and 26/end of study. based upon week 1 hemoglobin and serum creatinine lab results, participants will be categorized into 1 of 4 groups.

study design: multicenter, non-interventional, 26-week, prospective, observational study of older, long-term stay residents with ckd, with and without anemia, in us nursing homes.

Eligibility criteria:
inclusion criteria: * age \> 65 years * long-term resident of nh as documented in medical record by director of nursing (don) or medical director or as indicated in minimum data set (mds) section q * able to walk at least 1 step or propel wheelchair 1 revolution of wheel * able to follow a one-step instruction * written informed consent exclusion criteria: * admitted to nh for short stay rehabilitation (anticipated stay less than 3 months) * receiving renal replacement therapy (rrt) * major surgery within the past 3 months * life expectancy \< 6 months or receiving palliative care * currently enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or is receiving investigational agent(s) * currently is enrolled in an interventional trial * previously withdrawn from this study

Keywords: anemia chronic kidney disease quality of life ckd chronic renal insufficiency
oxidative stress and endothelial dysfunction in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea Syndrome; Endothelial Dysfunction; Oxidative Stress; Intermittent Hypoxia; Cardiovascular Risk

Summary: patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. this exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. the major aim of our study is to examine the effect of cpap treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.

subjects will undergo overnight polysomnography in the sleep laboratory (psg1, d0), which will be immediately preceded and followed by measurements of oxidative stress in exhaled gas and vascular relaxation. patients included in the osas group will be randomly assigned to treatment by either cpap or placebo (sham cpap) for 4 weeks. measurements of oxidative stress in exhaled gas and vascular reactivity will be repeated immediately before and after psg2 and psg3 at d7 and d30, respectively.

Eligibility criteria:
inclusion criteria: * no smoking * 30-70 years old subjects * being referred for daytime hyper- somnolence and snoring * apnea hypopnea index \>=30/hour and desaturation index\>=30/hour exclusion criteria: * chronic lung diseases. * exposure to occupational contaminants. * active smoking within last 2 years. * alcoholism. * chronic systemic disease other than osas. * treatment with vasoactive drugs or antioxidants * respiratory infection or vaccination during the 6 weeks preceding the psg1.

Keywords: isoprostane alkane exhaled condensate peripheral arterial tonometry polysomnography obstructive sleep apnea hypoxia
tandem predictive low glucose suspend inpatient feasibility study

Conditions: Diabetes Mellitus; Type 1 Diabetes; Insulin Pump

Summary: the goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.

this protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. the study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a premarket approval (pma) application.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months * insulin pump therapy for at least 6 months * age ≥18.0 years * subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months exclusion criteria: * pregnant (female subjects must have negative urine or serum pregnancy screening test) * severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment * diabetic ketoacidosis in the month prior to enrollment * a current condition that would prevent the use of a cgm sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation * use of acetaminophen during study participation * current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications
sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis .

Conditions: Allergic Fungal Rhinosinusitis

Summary: this study aims to assess sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding:: 1. anatomical variations and correlate radiological finding with intraoperative finding. 2. other associated factors like demographic ,environmental, immunological and climatic risk factors .

introduction allergic fungal rhinosinusitis (afrs) is a subtype of crs with nasal polyposis (crswnp) that is characterized by eosinophilic mucin within expanded sinus cavities and immunoglobulin e (ige)-mediated type 1 hypersensitivity to fungal elements. this noninvasive disease process typically affects immunocompetent, younger patients in geographic regions with warm temperatures and high humidity, which facilitate fungal proliferation. afrs has a worldwide distribution pattern with varying prevalence. afrs is presented in variable rates in different climatic, socioeconomic, and geographic factors. the disease prevalence showed predilection toward climatic factors

Eligibility criteria:
inclusion criteria: denovo cases . any age any sex. patients diagnosed with unilateral or bilateral allergic fungal rhino sinusitis, meeting classic bent and kuhn criteria for afrs:(10). nasal polyposis. fungi on staining. eosinophilic mucin without fungal invasion into sinus tissue., type i hypersensitivity to fungi. characteristic radiologic findings with soft-tissue differential densities on computed tomographic (ct) scanning exclusion criteria: diagnosis of benign or malignant neoplasm of the sinonasal cavity. prior radiation therapy to the head or neck. significant prior facial trauma. autoimmune disorder. craniofacial anomaly. fungus ball. immunodeficiency. cystic fibrosis. patients unfit for surgery. previous nasal surgery or recurrent cases .
clinical performance of a new esthetic, self-ligating orthodontic bracket

Conditions: Malocclusion

Summary: a cohort of 15 patients starting orthodontic treatment with fixed appliances will receive exd-952 ceramic self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. tooth movement will be initiated using 0.014" or 0.016" nickel-titanium archwires. a second cohort of 15 patients will receive exd-952 ceramic self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. the mandibular incisor brackets will be removed and exd-952 ceramic self-ligating brackets placed instead. other mandibular brackets will remain in place. tooth movement will be performed using 0.019x0.025" stainless steel archwires. in both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed. the evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2). after the evaluation period, exd-952 ceramic self-ligating brackets will remain in place until the orthodontic treatment is completed.


Eligibility criteria:
inclusion criteria: * permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars) * mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide exclusion criteria: * mental/emotional/developmental disability * inability to give informed consent * cleft lip and/or palate, craniofacial anomaly, or syndrome * obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions * prosthodontic or restored substrate extending on the labial surface of mandibular incisors * deep bite * known allergies to any study materials