Kornimate/medical-research-clean huggingface dataset:
a plan on investigation and collection of aricept safety information with a dose increase on alzheimer's disease patients

Conditions: Alzheimer's Disease

Summary: the purpose of the study is for investigation and collection of aricept safety information with a dose increase on alzheimer's disease patients.

this is an observational study to systematically investigate domestic patients with alzheimer's disease to figure out the safety under a situation of the use of donepezil hcl 23mg. additionally, if the dose of donepezil hcl increase, there is need to examine the safety of donepezil hcl 23mg in depth for patients with alzheimer's disease by comparing aspects of occurring adverse events by the type of donepezil hcl increase.

Eligibility criteria:
inclusion criteria 1. patients who admitted the reading and using of his/her biographical and medical data by word 2. patients who maintained aricept dosage for at least 3 months before involved in the study exclusion criteria 1. hypersensitivity to the active substance or to any of the excipients 2. breast feeding 3. pregnancy

Keywords: alzheimer's disease
a study to test combination treatments in people with advanced renal cell carcinoma

Conditions: Advanced Cancer

Summary: the purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer


Eligibility criteria:
inclusion criteria: * advanced renal cell carcinoma * must have at least 1 lesion with measurable disease * life expectancy of at least 3 months * karnofsky performance status (kps) must be =\>70% exclusion criteria: * patients/subjects with suspected or known central nervous system metastases unless adequately treated * patients/subjects with autoimmune disease * patients/subjects who need daily oxygen therapy other protocol defined inclusion/exclusion criteria apply
effects of a standardized treatment approach on kidney transplant recipients with antibody-mediated rejection

Conditions: Antibody-mediated Rejection; Kidney Transplant Rejection; Graft Loss

Summary: antibody-mediated rejection (abmr) is one of the leading causes of graft loss in kidney transplant recipients (ktrs). although it is a well characterized entity, there is limited data regarding effective treatment options for preserving graft functions. moreover, results from different studies have been contradictory. therefore, we conducted a study using our registry data to evaluate the effects of a standardized treatment approach consisting of therapeutic plasma exchange (regular plasmapheresis, double filtration plasmapheresis or immunoadsorption), intravenous immunoglobulin and rituximab on ktrs with acute or chronic abmr.


Eligibility criteria:
inclusion criteria: * being a kidney transplant recipient with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab. exclusion criteria: * not providing or withdrawing consent.

Keywords: antibody-mediated rejection kidney transplantation
the effect of coenzyme q10 on endothelial, vascular and myocardial function

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) is associated with increased cardiovascular risk. the aim of this study is to investigate the effects of coenzyme q10 (coq10) on endothelial, vascular and myocardial function in patients with nafld

non-alcoholic fatty liver disease (nafld) is associated with increased cardiovascular risk. the aim of this study is to investigate the effects of coenzyme q10 (coq10) on endothelial, vascular and myocardial function in patients with nafld. in this trial patients with nafld will receive 240mg q10 or placebo. at baseline and at 6 months, will be measured: a) perfused boundary region (pbr) of the sublingual vessels using the sideviewdarkfieldimaging technique (microscan, glycocheck), b) pulse wave velocity (pwv-complior, alam), c) flow-mediated dilation (fmd) of the brachial artery, d) left ventricular (lv) global longitudinal strain (gls), and e) controlled attenuation parameter (cap)for the quantification of liver steatosis by liver elastography (fibroscan, echosens).

Eligibility criteria:
inclusion criteria: * nafld and one of below : 1. dyslipidemia, as it is defined in the metabolic syndrome 2. increased waist circumference as defined in the metabolic syndrome 3. arterial hypertension, 4. overweight, (bmi\>25) 5. polycystic ovary syndrome, exclusion criteria: * chronic kidney disease * heart failure * liver failure * pregnancy/ breast feeding * active malignancy (receiving chemotherapy/immunotherapy)

Keywords: non-alcoholic fatty liver disease endothelial function vascular function myocardial function coronary flow reserve endothelial glycocalyx flow mediated dilation
bacterial decolonization to prevent radiation-induced oral mucositis

Conditions: Nasopharyngeal Carcinoma; Radiation-induced Oral Mucositis; Bacterial Colonization; Quality of Life

Summary: the purpose of this study is to determine whether bacterial decolonization of the nares prior to treatment with radiotherapy (rt) for patients with nasopharyngeal carcinoma, can prevent high-grade radiation-induced oral mucositis (riom) and improve quality of life. this study is being conducted because a randomized clinical trials form yana kost et al. have found bacterial decolonization in the nose prior to initiation of rt was effective for prevention of acute radiation dermatitis. patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares while patients in the control arm will receive standard of care treatment. bacterial cultures will be taken from the nares and mouth, and participants will also complete a quality of life questionnaire before and after rt.


Eligibility criteria:
inclusion criteria: 1. patients with newly histologically confirmed nasopharyngeal carcinoma 2. no evidence of distant metastasis (m0) 3. ecog (eastern cooperative oncologygroup) scale 0-1 4. 18-70 years old exclusion criteria: 1. previous or existing mental or cognitive impairment; 2. patients with other malignant tumors at the same time; 3. have received bacterial decolonization therapy; 4. oral mucositis or ulcers existed before radiotherapy. 5. prior rt to the region of interest
a new treatment option for mastalgia

Conditions: Mastalgia

Summary: the main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (tens) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus.

the main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (tens) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus. this randomized controlled clinical trial was completed with 20 women suffering from mastalgia. patients were randomly assigned to the tens treatment and sham application groups. pain intensity, pain patterns and quality of life were evaluated with breast pain and sf-36 questionnaires before and 10 days after treatment in all patients.

Eligibility criteria:
inclusion criteria: * patients with mastalgia between 18 and 70 yrs old exclusion criteria: * previous or new diagnosis of diseases that may cause extramammary mastalgia (history of previous breast surgery; inflammatory and/or tumoral breast or chest disorders such as mastitis, fibrocystic breasts, breast cancer or chest malignancies etc.) * having with conditions that might prevent tens application (pacemaker, metal prosthesis, epilepsy, etc.) * being unable or insufficient to fill the questionnaires.
effect of exercise intensity on vitamin d

Conditions: Down Syndrome; Vitamin D Deficiency

Summary: children with down's syndrome (ds) are more liable to vitamin d deficiency. treating this deficiency with supplements is associated with the risk of intoxication due to increased intestinal absorption or decreased vitamin d metabolism. the aim of the study was to compare the effect of two exercise intensities on the modulation of vitamin d and parathormone (pth) levels in children with ds.

forty-four ds male children aged from 8-12 years participated in the study. the subjects were assigned randomly into two equal groups. group i received high-intensity treadmill aerobic exercises (t-ae) and group ii received moderate-intensity t-ae, three times per week for three months. the blood samples were collected from both groups before the intervention, after one month of intervention, then after three months of intervention to assess serum 25(oh)d and pth levels.

Eligibility criteria:
inclusion criteria: * all subjects were trainable and able to walk freely without assistance. * had vitamin d deficiency, the serum level of 25-hydroxyvitamin d (25(oh) d) was ranged from 10-20ng/ml. * did not take calcium or vitamin d3 supplements, medications for osteoporosis, antiepileptic drugs, or any medications that may affect the vitamin d metabolism in the last 5 months. * the feeding method during the first two years of age for all children was bottle feeding. * mild to moderate mentally retarded, (iq ranged from 45-70) to be able to understand and obey simple orders. * free from any medical consequences for example cardiopulmonary disorders, auditory defects, and visual impairments. * had no previous history of strength training. * body mass index percentile ranged from the 50th percentile to less than the 75th percentile (healthy). * the feeding method was by mouth with no special diet, with an absence of signs of malnutrition exclusion criteria: * autoimmune disease. * renal diseases. * have taken any thyroid medications. * obesity. * epileptic fits.
hemodynamic monitoring carotid surgery

Conditions: Carotid Artery Diseases; Haemodynamic Monitoring

Summary: patients scheduled for carotid endoarterectomy will be randomly assigned to a group in which arterial hypotension will be avoided by a predictive haemodynamic approach or to a group in which arterial hypotension will be treated in a standard manner


Eligibility criteria:
inclusion criteria: - \>18 years old patients exclusion criteria: * body massindex \> 35 kg /m2; * atrial fibrillation * urgent surgery * pregnancy
tomosynthesis vs. contrast-enhanced mammography in women with personal history of breast cancer in western pennsylvania

Conditions: Breast Cancer Female; Breast Cancer; Breast Neoplasms; Neoplasms

Summary: this is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

the investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. the investigators expect a substantial increase in node-negative invasive cancers in particular. because dbt will be interpreted first by one reader, and cem will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or cem alone in this population. participants will be invited to three rounds of annual screening with cem. cem must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.

Eligibility criteria:
inclusion criteria: -asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment. exclusion criteria: * women with a history of prior iodinated contrast reaction * women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions) * women who have had bilateral mastectomy * women with a history of kidney failure or estimated glomerular filtration rate (egfr) \< 45 ml/min * pregnancy or lactation * women actively being treated for cancer of any type with chemotherapy * lump or other breast symptoms * abnormality on prior breast imaging that is being followed.

Keywords: breast cancer screening digital breast tomosynthesis contrast-enhanced mammogram
clinical equivalence of two butenafine hydrochloride 1% creams in patients with interdigital tinea pedis

Conditions: Tinea Pedis

Summary: to demonstrate comparable safety and efficacy of taro pharmaceuticals inc. butenafine hydrochloride cream 1% (test product) and lotrimin ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).


Eligibility criteria:
inclusion criteria: * microbiologically confirmed clinical diagnosis of interdigital tinea pedis * if female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (iud), oral, transdermal, injected or implanted hormonal contraceptives). * a confirmed clinical diagnosis of interdigital tinea pedis. lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic). * the presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (koh) wet mount examination (potassium hydroxide mount preparation). * identification of an appropriate dermatophyte by culture sent to the central laboratory. the appropriate dermatophytes are trichophyton rubrum, trichophyton mentagrophyte or epidermophyton floccosum. exclusion criteria: * use of any of the following within the indicated timeline: * oral or injectable steroids * any oral anti-fungals within 4 weeks of the study start * use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start. * any prescription or over-the-counter (otc) topical antifungals on the feet within two weeks prior to study entry * use of any antihistamines within 72 hours of the study start. * any known hypersensitivity to butenafine or other antifungal agents. * evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the investigator's evaluation of tinea pedis. * patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.

Keywords: tinea pedis
long-term follow-up study of advm-022 in dme (infinity-ext)

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Summary: this is a prospective, observational study designed to evaluate the long-term safety and tolerability of advm-022 in participants with diabetic macular edema (dme). participants who previously participated in the infinity parent study and received a single unilateral intravitreal dose of advm-022 are eligible for enrollment upon completion of the end of study visit in the parent study.

this is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (ivt) injection of advm-022 in a preceding "parent" study, advm-022-04 \[infinity\]. participants will be followed for a total of 5 years post- advm-022 administration (inclusive of the parent study). there is no investigational treatment administered in this study.

Eligibility criteria:
inclusion criteria: * must have participated in the advm-022-04 \[infinity\] (parent) study and received advm-022 * must provide signed informed consent * must be willing and able to comply with all study procedures exclusion criteria: - none

Keywords: advm-022 advm-022-04 advm-022-10 aav.7m8 anti-vegf therapy blindness infinity gene therapy aflibercept (eylea) retinal diseases eye diseases aav vector adverum dme dr infinity-ext infinity-extension diabetic eye disease long-term extension, long-term follow-up, aav vector
fish oil-derived omega-3 fatty acids on gut microbiota and lipid metabolome in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Lipid Metabolism Disorder; Fatty Acid Metabolism Disorder

Summary: the objective of this research was to investigate the impact of omega-3 pufas on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.

the pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. nevertheless, the precise impact of omega-3 polyunsaturated fatty acids (omega-3 pufas) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. the objective of this research was to investigate the impact of omega-3 pufas on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. the investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. bacterial 16s rdna, fungal diversity analysis of internally transcribed spacer sequences (its) and untargeted lipidomics were used to investigate the effects of omega-3 pufas on intestinal microbiota and serum lipid metabolites.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes have been diagnosed; * male or female aged 18-70 years; * after listening to the project presentation, voluntarily participate in the study and sign an informed consent form. exclusion criteria: * pregnant or lactating women; * poorly controlled diabetes, i.e. hba1c\>9%； * have taken omega-3 pufas-related supplements in the past six months； * taking lipid-lowering drugs or other drugs that affect blood lipid metabolism； * patients with severe diabetic complications, severe hypertension, combined with * diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis； * patients with severe immune system disorders； * have special diets: vegetarians, weight managers, ketogenic test takers, etc； * the attending physician deems the participant unsuitable

Keywords: omega-3 fatty acids gut microbiota lipid metabolome glycerophospholipid type 2 diabetes mellitus
antibiotics in patients with acute respiratory tract infection with procalcitonin as parameter

Conditions: Respiratory Tract Infection

Summary: antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter. the purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.


Eligibility criteria:
inclusion criteria: * 18 years or older * informed consent * respiratory tract infection based on the clinical judgement of the primary care physician exclusion criteria: * antibiotic pretreatment in previous 14 days * portal hypertension * major surgeries or multiple trauma which require hospitalization, in previous 4 weeks * autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease) * peritoneal dialysis * acute treated or recently operated medullary c-cell-carcinoma, sclc, carcinoid * other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis

Keywords: primary care procalcitonin antibiotic prescription
long term study of canakinumab (acz885) in patients with gout

Conditions: Gouty Arthritis

Summary: this 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. patients will be treated on demand with canakinumab (acz885) in this extension study.


Eligibility criteria:
inclusion criteria: * patients who completed the core study cacz885h2251. a patient is defined as completing the core study if he/she completed the study up to and including the last visit (visit 9). * patients who have signed a written informed consent before any trial procedure is performed. exclusion criteria: * patients for whom continuation in the extension 1 is not considered appropriate by the treating physician. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine). * female patients who were physiologically capable of becoming pregnant, unless they were: * female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner. * female patients whose partners had been sterilized by vasectomy or other means. * using an acceptable method of contraception with a failure rate (pearl index (pi)) \< 1. * reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation. other protocol defined inclusion/exclusion criteria may apply

Keywords: gouty gouty arthritis gout flares anti-interleukin-1β monoclonal antibody
celebrex short versus long therapy in osteoarthritis of the knee

Conditions: Osteoarthritis,Knee

Summary: this is a phase iii, multicentre, randomized, double blind, parallel-group, pilot study designed to compare a long term (12 weeks) versus a short term (2 weeks) treatment with celecoxib 200 mg/die in treatment and prevention of new flare in patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * diagnosis of oa of the knee according to the acr classification criteria for osteoarthritis; * patients in flare exclusion criteria: * any concomitant inflammatory rheumatic condition which may interfere with the assessment of oa * clinical or radiological evidence of chondrocalcinosis