Kornimate/medical-research-clean huggingface dataset:
study of at-527 in subjects with normal and impaired renal function

Conditions: Healthy Volunteer; Renal Impairment

Summary: study of at-527 in subjects with normal and impaired renal function


Eligibility criteria:
inclusion criteria: * must agree to use two methods of birth control from screening through 90 days after administration of the last dose of study drug * females must have a negative pregnancy test at screening and prior to dosing * bmi of 18.5 to 42.0 kg/m2 * willing to comply with the study requirements and to provide written informed consent subjects with normal renal function (group e): * medically healthy, in the opinion of an investigator * normal renal function with egfr ≥ 90 ml/min/1.73m2 at screening renal impaired subjects (groups a, b, and c): * considered stable in the judgement of an investigator * presence of severe renal impairment (egfr ≥ 15 and \< 30 ml/min/1.73m2), moderate renal impairment (egfr ≥ 30 and \< 60 ml/min/1.73m2) or mild renal impairment (egfr ≥ 60 and \< 90 ml/min/1.73m2) at screening: renal impairment should have been stable for at least 1 month prior to screening. subjects with end-stage renal disease -esrd (group d) * considered clinically stable in the opinion of the investigator * presence of esrd (egfr \<15 ml/min/1.73m2 and being on intermittent hemodialysis) at screening and have been stable for at least 1 month prior to screening exclusion criteria: * pregnant or breastfeeding * infected with hiv or covid-19 * abuse of alcohol or drugs * use of other investigational drugs within 28 days of dosing * other clinically significant medical conditions or laboratory abnormalities subjects with normal renal function (group e): • any clinically significant illness in the opinion of the investigator subjects with impaired renal function (group a, b, c and d): * history of renal transplant * presence of poorly controlled type 1 or type 2 diabetes as defined by hemoglobin a1c (hba1c) \> 10% * subjects requiring treatment for renal impairment or other chronic disease must be on a stable treatment plan
clinical trials of vitalplant and helichrysum infusions in adults ( vitalplant_smilj )

Conditions: Overweight; Metabolic Syndrome

Summary: the study evaluates the effects of vitalplant and helichrysum italicum on different components of the metabolic syndrome. the components of metabolic syndrome will be measured at baseline and one week after daily consumption of either vitalplant alone or either vitalplant+helichrysum italicum after one week of washout.

"vitalplant" medicinal plant mixture, aimed at body weight regulation and metabolism enhancement was formulated in order to be incorporated as an ingredient in functional food formulations on the basis of known biological activity of the alder buckthorn bark, peppermint, caraway and parsley. medicinal plants have long been known as sources of biologically active substances.oil component apiole - a proven kidney stimulant and parsley (petroselinum crispum (mill.) a.w. nym. ex hill) are known for their diuretic action. peppermint (mentha x piperita l.) and caraway (carum carvi l.) essential oils are frequently used in herbal drugs for treatment of abdominal discomfort and pain, while the alder buckthorn bark (rhamnus frangula l.) contains anthraquinone glycosides with purgative effects. "vitalplant" mixture was found to be beneficial for the reduction of body weight and improvement of antioxidant status of the erythrocytes, and its antihyperlipidemic property was highly active for enhancing the profile of plasma lipids in rats. similarly, helichrysum italicum (hi) is also widely used in traditional medicine. lately, it has been shown that hi infusion consumption had a beneficial effect on anthropometric traits. indeed, significant reductions in body weight, body mass index, and visceral and total body fat were observed in adults. moreover, after four weeks of intervention, ldl decreased and serum antioxidant properties were improved. therefore, consuming infusion could thus be recommended as a simple, profitable habit for individuals with traits of metabolic syndrome. therefore, the aim of our study is to evaluate the effects of vitalplant alone and vitalplant+helichrysum italicum on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. the components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and one week after daily consumptions of either vitalplant alone or vitalplant+smilj. in between there will be one week of washout period.

Eligibility criteria:
inclusion criteria: * stable weight in the last 3 months * bmi more than 25 * clinical diagnosis of at least two components of metabolic syndrome exclusion criteria: * consumption of dietary supplements * medications for any component of metabolic syndrome

Keywords: functional food tea infusion overweight metabolic syndrome
changes in tissue microcirculation during ischemic conditioning: pilot study

Conditions: Microcirculation

Summary: changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. in previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. moreover, the occlusion slope, which reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease during repeated ischemia-reperfusion cycle by its protecting effect, however there has not been well-conducted study. the purpose of the study is to evaluate the changes in microcirculation measured by tissue oxygen saturation during ischemic conditioning between healthy volunteers and cardiac surgery patients.

subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min ischemia with pressure of 200 mmhg on upper extremity followed by 5-min reperfusion with no pressure. during ischemic conditioning, changes in tissue microcirculation (baseline tissue saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. for cardiac surgery patients, the study will be conducted before anesthesia induction on the surgery day to exclude any potential effect of anesthetics.

Eligibility criteria:
\ inclusion criteria: * age 20-45 * no underlying chronic disease * male volunteer exclusion criteria: * under taking prescription drugs * taking herbal medicines within 2 weeks * baseline systolic blood pressure \> 150 mmhg or diastolic pressure \> 100 mmhg * body mass index \ 30 kg/m\^2 * vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours * any abnormalities on upper extremities * do not consent to participate \ inclusion criteria: * age 20-80 * scheduled for cardiac surgery exclusion criteria: * baseline systolic blood pressure \> 150 mmhg or diastolic pressure \> 100 mmhg * body mass index \ 30 kg/m\^2 * uncontrolled diabetes * under taking beta-blockers * severe renal dysfunction, chronic kidney disease, on hemodialysis * any abnormalities on upper extremities (i.e, av fistula on arms) * peripheral vascular disease, peripheral neuropathy, coagulopathy * vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours * pregnant * emergency surgery * do not consent to participate

Keywords: tissue oxygen saturation, ischemic conditioning
rheumatoid arthritis (dmard) intervention and utilizationstudy

Conditions: Rheumatoid Arthritis

Summary: the rheumatoid arthritis dmard intervention and utilization study (radius 1) is designed to systematically collect and document use patterns, effectiveness, and safety of dmard treatments currently used in the management of rheumatoid arthritis (ra). it is anticipated that study data may help improve the quality of information upon which clinical decisions are based.


Eligibility criteria:
inclusion criteria: * fulfillment of the 1987 american rheumatism association criteria for ra * currently requiring a new dmard (change or addition) exclusion criteria: * currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol * nursing or pregnant women * patients with active infection

Keywords: rheumatoid arthritis ra dmard
prospective double-blinded randomized controlled trial of 12-weeks high dose rabeprazole (pariet) in the treatment of reflux laryngitis in chinese patients

Conditions: Gastroesophageal Reflux; Laryngitis

Summary: the purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in chinese patients. patients who attend the voice clinic of department of ent, queen mary hospital with suspected reflux laryngitis will be recruited. a questionnaire will be administered by the research assistant of the department of medicine and ent, queen mary hospital. a 12-week course of ppi versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. the study will finish after a 12-week course of rabeprazole.


Eligibility criteria:
inclusion criteria: * ambulatory patients with age between 18-80 years old * patients with newly presented laryngitis. exclusion criteria: * they were under 18 or over 80 years of age * has significant concomitant medical disease * pregnancy or lactating women * chronic cough attributable to known chronic pulmonary or tracheobronchial disease * previous glottal surgery, radiotherapy or malignancy * acid suppressive therapy within 4 wk prior to recruitment * pharyngo-laryngeal infection in the previous 3 months * tracheal intubation in previous 12 months * immunosuppression and use of inhaled corticosteroid

Keywords: reflux laryngitis
sensory support care for elderly patients suffering from alzheimer's-type neurodegenerative disease

Conditions: Alzheimer Disease

Summary: the main objective of this study is to evaluate the effect of 3 months of "snoezelen-type" multi-sensory care sessions on neuropsychiatric inventory questionnaire (npi-q) scores for patients with alzheimer's-type neurodegenerative disease.

the secondary objectives of this study are to study the following elements in relationship to the implementation of a "snoezelen-type" multi-sensory care strategy for patients with alzheimer's-type neurodegenerative disease: a. to evaluate the effects on npi-q scores at 1 month, 6 months and 12 months . b. evaluate the effects on quality of life (questionnaire qol-ad) at 0 and 12 months. c. assess changes in the "aggressive behavior" subsection of the cohen-mansfield agitation inventory (cmai) questionnaire over 0, 1, 3, 6 and 12 months. d. assess changes in drug consumption (anxiolytics, antidepressants, hypnotics, neuroleptics)over the study period

Eligibility criteria:
inclusion criteria: * the patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent) * the patient must be insured or beneficiary of a health insurance plan * alzheimer's-type neurodegenerative pathology * the patient has been living in the participating center for \> 2 months exclusion criteria: * the patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent) * it is impossible to correctly inform the patient's legal representative * the patient has already has snoezelen-therapy

Keywords: snoezelen multi-sensorial care session alzheimer's-type neurodegenerative disease dementia
repetitive transcranial magnetic stimulation for lower limb spasticity in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: leg spasticity is common problem encountered with a large proportion of patients suffering with multiple sclerosis (ms) with an increasing severity as the disease progresses. it mostly affects the antigravity muscles that significantly complicates transfer, increases fatigue and makes walking more difficult. hence, leg spasticity often interferes with patients' mobility and significantly influences their quality of life. a great number of multidisciplinary rehabilitation studies has shown a significant effect of numerous specific functional changes in patients with secondary (sp) and primary progressive (pp) ms but there are no reviews related to spasticity. the positive therapeutic effect of modulating transcranial magnetic stimulation ( tms) methods on spasticity is shown in only two studies, in patients with relapse remitting clinical form in the remission phase of the disease. the effect of tms on clinical measures of lower limb spasticity, functional inability and the quality of life in patients with spms and ppms will be examined in this study. the objective to this study are to to explore whether rtms boosted exercise therapy (et) treatment can bring more improvement in lower limb spasticity than et treatment alone in these patients.


Eligibility criteria:
inclusion criteria: * confirmed clinical form of spms and ppms (established on the basis of the revised mcdonald criteria) * edds score 2-6.5 * lower limb spasticity caused by ms * 18 years ≥age of the patient ≤ 65. years exclusion criteria: * clinical worsening of the disease over the past 30 days, * the presence of pregnancy, dementia, alcoholism, history of loss of consciousness, epilepsy, metal objects in the head, pacemakers and other electronic devices in the body at a distance of 20cm from the top of the patients head, serious associate diseases (malignancy, heart disease).
cteph in patients with prior pulmonary embolism and risk score validation

Conditions: Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Embolism

Summary: cteph-solution aims to create a risk score for the early detection of chronic thrombo-embolic pulmonary hypertension (cteph) among patients with previous pulmonary embolism. the risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients.

cteph-solution is a multicenter observational cross-sectional and prospective study in patients with a prior and new diagnosis of pulmonary embolism. patients with prior pulmonary embolism will be screened at baseline with doppler echocardiography: an estimated spap ≥ 40 mmhg will be the indication for pulmonary hypertension detection. after 24 months from baseline, patients will be followed-up for cteph detection. cteph diagnosis will be carried out according to the current esc/ers guidelines. incident (pulmonary embolism episode at least three months before the baseline) and prevalent (pulmonary embolism episode) patients will be enrolled.

Eligibility criteria:
inclusion criteria: * age ≥ 18 at baseline evaluation * diagnosis of prior (\> 30 days from pulmonary embolism onset) or new-onset pulmonary embolism, according to the esc guidelines on the diagnosis and management of acute pulmonary embolism exclusion criteria: * patients without pulmonary embolism diagnosis
safety and efficacy of chlorthalidone in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Hypercalciuria

Summary: this open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes

type 1 diabetes (t1d) is associated with increased urinary calcium loss, which may contribute to the low bone mineral density and increased fracture risk observed in patients with this condition. chlorthalidone is a thiazide-like diuretic that is commonly used to reduce urinary calcium excretion in other conditions such as idiopathic hypercalciuria. its safety and efficacy has not been specifically tested in an adolescent type 1 diabetes population. t1d subjects with hypercalciuria and who meet inclusion/exclusion criteria will be given chlorthalidone daily. blood and urine tests, blood pressure, and glycemic control will be assessed at weekly study visits for 4 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of t1d * age 12-21 years * tanner stage 2 or greater pubertal development * urine calcium excretion ≥ 4 mg/kg/day * able to swallow pills exclusion criteria: * bmi \> 99th percentile for age (\ 35 kg/m2 (≥ 18 years) * coexistent conditions that may affect calcium metabolism including: * celiac disease * graves' disease * addison's disease * hypo- or hyperparathyroidism * history of diabetes related complications including: * neuropathy * retinopathy * nephropathy * gastroparesis * history of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month * history of any diuretic use within the past month * laboratory abnormalities on screening bloodwork including: * estimated glomerular filtration rate \<90 ml/min per 1.73 m2 of body surface area * serum calcium \>10.5 mg/dl * serum potassium \<3.5 mmol/l * systolic or diastolic blood pressure \<5th percentile for age and sex50 for age \<18 years or systolic \<90 mmhg or diastolic blood pressure \<60 mmhg for age ≥18 years

Keywords: type 1 diabetes hypercalciuria
impact of transcranial direct current stimulation on fatigability and fatigue induced by a selective attention task

Conditions: Fatigue

Summary: this research project is focusing on changes in mental fatigue due to transcranial direct current stimulation (tdcs) in healthy individuals. the study aim is to see if mental fatigue can be rescued by administering a safe dose of tdcs. tdcs has been shown to decrease fatigue in healthy individuals experiencing extended wakefulness, and the investigators aim to investigate if similar results can be found in a fatigue inducing task. this is a single-blind randomized control trial that will compare mental fatigue between tdcs treatment and sham treatment groups through both subjective and objective measures. objective fatigue will be measured by reaction time with the stroop test and subjective fatigue will be measured by the multidimensional fatigue inventory questionnaire.

right handed healthy individuals aged 18-40 will be eligible to participate. participants will be randomized in a 1:1:1 ratio to receive real or placebo 2ma tdcs delivered for 20 minutes while performing a 3 hour computerized cued stroop task. groups will receive real or sham stimulation during the first 20 minutes or 90-110 minutes into the task. groups will be: 1) sham (sham given at both time points); 2) prevent (real will be given during first 20 minutes to try to prevent or delay fatigue and sham given at second time point); or 3) rescue (sham will be given initially and real given at 90-110 minutes to see if performance can be rescued after fatigue has set in). the primary outcome measure will be the slope of change for intra-individual variability of response time for correct items and regression models will be used to determine whether real preventative or rescue tdcs alters the rate of performance change relative to sham stimulation. accuracy and mean response time will also be examined as secondary outcomes.

Eligibility criteria:
inclusion criteria: * right-handed * normal or corrected-normal vision, exclusion criteria: * pregnant women, * history of medical conditions associated with fatigue, including, but not limited to: * parkinson's disease, * alzheimer's disease, * diabetes mellitus, * hypothyroidism, * chronic fatigue syndrome, * anemia, * infectious mononucleosis, * irritable bowel syndrome
novel classification of adult-onset diabetes and its association with common microvascular complications in upper egypt

Conditions: Diabetes Mellitus, Type 2

Summary: aim of our work: first aim: classify patients with adult-onset diabetes according to the novel classification into new subgroups, depending on multiple variables related clinically to those patients. second aim: to identify the association between the new classification subgroups and the presence of common microvascular complications (retinopathy, nephropathy, and neuropathy), which can help in the early prediction of these complications and their early management.

we will conduct an observational cross-sectional study and cluster analysis for patients from different diabetes clinics and tertiary centres located in different governorates in upper egypt. our participants in this study will be divided into two groups: 1. the first group will be as a prospective group, all necessary examinations and investigations will be performed for every patient of this group during their clinic visit at the time of registration to this study. 2. the second group will be the retrospective group. data for those patients will be collected from electronic records and/or paper records in collaboration with different diabetes centres and clinics scattered in upper egypt governorates. we will collect clinical and lab data as much as we can. all available data for this group at end of this study will be used in the clustering of this group. then we will use the above data from both groups to classify diabetic patients to the new clusters and to find the association between those clusters and the incidence of microvascular complications.

Eligibility criteria:
inclusion criteria: * adult-onset dm type 2 diagnosed patients according to current ada recommendations, aged \<18 years old and within 3 years from the time of diagnosis. exclusion criteria: * 1- patients diagnosed with gestational dm or rare types of diabetes like monogenic diabetes types, such as maturity-onset diabetes of the young (mody), diabetes secondary to steroid use, cystic fibrosis, hemochromatosis, and pancreatic diabetes according to ada criteria. 2- patients diagnosed with non-diabetic kidney diseases, such as chronic glomerulonephritis, vasculitis, polycystic kidney disease, and renal cancer or patients with a transplanted kidney were excluded from the analysis for diabetic kidney disease. 3- patients diagnosed with retinopathy due to non-diabetic causes or diagnosed with neuropathy due to non-diabetic causes will be excluded from the analysis for diabetic retinopathy and neuropathy, respectively.
application of knee measurements on 3d ct in tkr

Conditions: Knee Osteoarthritis; Knee Disease

Summary: a 3d computed tomographic study of vietnamese knee morphology for total knee replacement

there were controversies and inconsistent results regarding the effectiveness of psi. however, most authors used psi from commercial manufacturers. from our view, the surgeon's involvement in psi planning and design can affect the psi's accuracy. some other benefits of in-hospital psi included the use of any type of implant without depending on the manufacturer's software system, faster and cheaper. therefore, we conducted this study to evaluate the effect of in-hospital psi in which the surgeons take part in the manufacturing job.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis, grade iii, iv * underwent total knee replacement using patient-specific intrumentation * with pre and post-operative whole limb ct-scanners exclusion criteria: * paticipants with valgus knee deformity, * a history of hip arthroplasty, * large bone defect that required augments.