Kornimate/medical-research-clean huggingface dataset:
study of the use of niaspan for treatment of dyslipidemia in diabetic nephropathy

Conditions: Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia

Summary: the primary purpose of this study is to test the effectiveness and tolerability of niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. a secondary goal is to test whether niaspan® slows down further development of kidney damage.

diabetic nephropathy is the leading cause of end stage kidney disease in the united states. patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. here, we investigate whether niaspan, taken in addition to lipid-lowering drugs referred to as "statins", will decrease ldl cholesterol and increase ldl particle size, increase hdl, reduce proteinuria, and reduce the speed of loss of renal function.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * diagnosis of chronic kidney disease stage 2 or 3 with an estimated gfr of 30-89 ml/min using the four variable mdrd (modification of diet in renal disease study group) formula * presence of microalbuminuria or proteinuria less than 3.5 g/d * diagnosis of hyperlipidemia currently treated with a "statin" drug exclusion criteria: * not meeting inclusion criteria * hdl-c \> 40 mg/dl for men, \> 50 mg/dl for women * tg (triglycerides) \ 800 mg/dl * documented intolerance to niaspan or aspirin * treatment with other lipid-lowering agents (fibrates, bas \[bile acid sequestrants\], or ezetimibe) * elevated transaminases (ast or alt \>1.3 x uln) * unstable type 2 diabetes (fbg \>200 mg/dl or hba1c \>9.5%) * known seropositivity for hepatitis b, c, or hiv * documented history of malignancy * age \< 18 years * pregnant women or nursing mothers * inability to give informed consent * start or change in "statin" dose \< 2 months ago

Keywords: diabetes mellitus, type 2 kidney failure, chronic hyperlipidemia randomized controlled trials
human skin test model in colostomists

Conditions: Colostomy Stoma

Summary: the aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent. 2. be in the age of 45 to 75 years of age both extremes included. 3. have had a colostomy for at least 1 year. 4. has a colostomy with a diameter up to (≤) 40 mm. 5. have mental capacity to understand the study guidelines and questionnaires. 6. be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation. 7. are colostomists currently using a 1-piece and 2-piece flat ostomy appliance. 8. have a bmi between 20-30 kg/m2. 9. are willing to comply with investigation procedures. exclusion criteria: 1. currently suffering from peristomal skin problems (i.e. bleeding or broken skin). 2. received radio- and/or chemotherapy within the last two months. 3. currently using or have within the last 3 weeks used topical steroid products or other skin prep products. on peristomal skin (injections and oral treatment are accepted). 4. have dermatological problems. 5. participating in other clinical studies or have previously participated in this test. 6. be a daily user of a convex base-plate. 7. are pregnant or breastfeeding. 8. systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
human leukocyte antigen-a*02:01-restricted tumor vessel specific peptide vaccination for advanced pancreatic cancer

Conditions: Pancreatic Cancer; Pancreas Neoplasms

Summary: pancreatic cancer is the fourth leading cause of cancer death in the united states, and no combination therapy is far superior to gemcitabine alone. vascular endothelial growth factor receptor type 1 (vegfr1) is expressed on the tumor vessels and a candidate of tumor vessel-specific peptide vaccination strategy to induce t cell immune response. we conducted the study to confirm the safety and efficacy of combined modality intervention using conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific vegfr1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients. gemcitabine 1,000 mg/m\^2 (body surface area) will be administered on day 1, day 8, day 15, day 29, day 36, and day 43, respectively. vegfr1-derived hla-a\*02:01-restricted peptide (vegfr1-a02-770; tlfwllltl) emulsified with montanide isa51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).

hla-a\*02:01-restricted vegfr1-specific cytotoxic t lymphocyte (ctl) responses were obtained from hla-a2/kd transgenic murine model. hla-a\*02:01-restricted vegfr1-specific ctl clones were also obtained from peripheral blood mononuclear cells of healthy volunteer donors. these ctl clones showed potent anti-tumor ctl responses in hla class ⅰ-restricted manner in vitro. vaccination of hla-a\*02:01-restricted vegfr1-specific peptide to a2/kd transgenic mice markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.

Eligibility criteria:
inclusion criteria: * heterozygote or homozygote of hla-a\*02:01 allele * inoperable or recurrent pancreatic cancer with or without any prior therapy * difficult to continue the prior therapy due to treatment-related toxicities * ecog performance status 0-2 * evaluable primary or metastatic lesion with recist v.1.0 criteria * clearance period from prior therapy more than 4 weeks * life expectancy more than 3 months * laboratory values as follows 2,000/μl\ 100,000/μl ast \<150 iu/l alt \<150 iu/l total bilirubin \<3.0 mg/dl serum creatinine \<3.0 mg/dl exclusion criteria: * pregnancy (refusal or inability to use effective contraceptives) * breastfeeding * active or uncontrolled infection * systemic use of corticosteroids or immunosuppressants * uncontrollable brain metastasis and/or meningeal infiltration * unhealed external wound * possibilities of complicated paralytic ileus or interstitial pneumonitis * decision of not eligible determined by principal investigator or attending doctor

Keywords: cancer pancreas advanced peptide vaccination vegfr1 hla gemcitabine ifa cancer of pancreas neoplasms, pancreas pancreas cancer
high-intensity laser therapy for eosinophilic fasciitis

Conditions: Eosinophilic Fasciitis

Summary: eosinophilic fasciitis (ef) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. this case report will describe use of high-intensity laser therapy (hilt) using the mectronic exand my high-intensity laser system in a patient with ef, highlighting its potential as an alternative or adjunct treatment option.


Eligibility criteria:
inclusion criteria: * patients diagnosed with eosinophilic fasciitis. exclusion criteria: * a diagnosis unrelated to eosinophilic fasciitis
lipid metabolism in obese subjects undergoing bariatric surgery

Conditions: Bariatric Surgery Candidate; Lipid Metabolism Disorders; Obesity

Summary: the aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (pufa) and biosynthesis of the lipid mediators n-acylethanolamines (nae), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (ppar)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. the study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.

the study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. the evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. for the study samples are stored identified by a code to be analyzed anonymously. study interruption criteria are: development of allergic reactions, ketonemia\> 1.5 mmol/l, acute gout

Eligibility criteria:
inclusion criteria: * subjects with pathological obesity suitable for bariatric surgery * body mass index (bmi) range 35-59 exclusion criteria: * established diagnoses of a major disease (e.g., diabetes or kidney disease) * pregnancy or breastfeeding, * food allergies, * use of drugs that could affect lipid metabolism

Keywords: fatty acids, nonesterified peroxisome proliferator-activated receptors endocannabinoids n-acylethanolamines
genes contributing to hereditary ovarian cancer in women and brca1/2 wildtype families

Conditions: Ovarian Cancer

Summary: the investigators propose to test for non-brca1/2 mutations in new and existing families with hereditary ovarian cancer in order to better define penetrance and associated malignancies of rare ovarian cancer susceptibility genes. the hypothesis is at least one third of hereditary ovarian carcinoma families wildtype for brca1/2 can be solved using an updated version of broca (broca-hr) that targets 47 genes, including all known ovarian cancer genes and additional candidate genes in related pathways. the objective is to identify families with mutations in rare ovarian cancer susceptibility genes and test both affected and unaffected family members, thereby generating a rough estimate of penetrance for each mutated gene as well as identify new ovarian cancer susceptibility genes. the investigators also plan to enroll self identified african america women, who have been drastically under-represented in clinical cancer genetic testing programs and in oc susceptibility research.

there is more to hereditary ovarian cancer than the breast and ovarian cancer susceptibility genes brca1 and brca2 (brca1/2). next generation sequencing techniques have made it possible to sequence multiple candidate ovarian carcinoma susceptibility genes simultaneously. the king laboratory has developed a targeted capture and massively parallel sequencing test called broca to evaluate mutations in known or suspected breast and ovarian cancer genes. in a prospective series of 360 unselected women with ovarian carcinoma, the investigators found that nearly one fourth of women carried mutations in one of 13 genes, and mutations in genes other than brca1 and brca2 accounted for 26% of all inherited mutations. while broca and similar gene panels are already in clinical use, little is known about the relative risks of carrying these non-brca1/2 mutations, making it difficult to counsel unaffected family members and develop optimum prevention protocols.

Eligibility criteria:
inclusion criteria: * ovarian cancer diagnosis with secondary criteria as noted above exclusion criteria: * age less than 18 yrs

Keywords: ovarian cancer brca1 brca2 broca
ultrasonography guided pleural biopsy versus computed tomography guided pleural biopsy

Conditions: Pleural Diseases

Summary: this study aims to compare the diagnostic efficiency and reliability of abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

background. in cases with pleural effusion, tissue samples can be obtained through abrams' needle pleural biopsy, thoracoscopy, or cutting-needle pleural biopsy under the guidance of computerized tomography or ultrasonography for histopathological analysis. this study aims to compare the diagnostic efficiency and reliability of abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion. methods. patients with exudative pleural effusion, who could not be diagnosed by cytological analysis, will be included in the study. all patients were randomized following the thoracic computerized tomography with contrast enhancement. patients either underwent abrams' needle pleural biopsy under computerized tomography guidance or the cutting-needle pleural biopsy under ultrasonography. the two groups will be compared in terms of diagnostic efficiency and in terms of complications associated with the methods used.

Eligibility criteria:
inclusion criteria: * patients with exudative pleural effusion who require invasive procedure for diagnosis exclusion criteria: * patients without pleural effusion

Keywords: pleura biopsy diagnosis ct ultrasonography
bronx transthyretin amyloid cardiomyopathy database

Conditions: Transthyretin Cardiac Amyloidosis; Transthyretin Amyloid Cardiomyopathy

Summary: transthyretin amyloid cardiomyopathy (attr-cm) is a commonly undiagnosed and potentially fatal disease. contemporary studies on this condition often underrepresent the female gender and diverse patient populations. this registry retrospectively evaluated patients referred for 99mtc-pyrophosphate (pyp) single photon emission computed tomography (spect) between 2014 and 2023 at montefiore-einstein in the bronx. the patient population is racially and ethnically diverse and with a high proportion of females. demographic, clinical (e.g. comorbidities), laboratory, echocardiographic, hospitalization, and mortality data were collected for each patient.


Eligibility criteria:
inclusion criteria: * all adult patients referred for pyp spect at montefiore medical center between 2014 and 2023 exclusion criteria: * did not have a transthoracic echocardiogram in our medical records

Keywords: transthyretin cardiac amyloidosis transthyretin amyloid cardiomyopathy
99mtc-my6349 spect/ct imaging in trop2-positive triple-negative breast cancer

Conditions: Breast Cancer

Summary: human trophoblast cell-surface glycoprotein antigen 2 (trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. studies have shown that trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. according to statistics, more than 80% of breast cancer patients highly express trop2, and high expression of trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. in this study, a single-domain antibody targeting trop2 was selected to prepare a new nuclear medicine molecular probe 99mtc-my6349, so as to monitor the expression level of trop2 in patients' systemic tumors through spect/ct imaging. breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mtc-my6349 spect/ct imaging to detect trop2 expression levels in systemic tumors. subsequently, 18f-fdg pet/ct imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. this study analyzes the heterogeneity of trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.


Eligibility criteria:
inclusion criteria: * female, aged between 18 and 80 years old. * patients with suspected or definite diagnosis of triple-negative breast cancer. * patients with suspected or confirmed triple-negative recurrent or metastatic breast cancer. * female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, isolation contraceptive measures must be taken during this study period. exclusion criteria: * suffering from severe gastrointestinal, cardiovascular, liver, kidney, blood system, endocrine, respiratory system, immune deficiency and other serious diseases. * claustrophobia. * in the past year, due to other clinical medical treatment or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50msv. * pregnant or lactating women. * received experimental drug or device treatment (with unclear efficacy or safety) within 1 month. * there is any situation in which the conductor of this study believes that any aspect related to this experiment may cause harm or be potentially harmful.
fnirs neurofeedback training using virtual reality in children with adhd

Conditions: ADHD

Summary: the study aims to explore the effectiveness of neurofeedback training on improving attention and inhibitory control of children with attention-deficit/hyperactivity disorder (adhd) in hong kong. this study will contribute to the current understanding of the alternative treatments for adhd, and hopefully help to mobilize more resources to support children with adhd. the programme includes the following components: participants will be randomly assigned to the neurofeedback training group (with virtual reality \[vr\] technology applied), the computerized cognitive training group, or the waitlist control group. all participants will complete a total of 16 training sessions in 8 weeks (twice a week), and each session will last around 35 to 60 mins. to investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to the intervention (i.e., time 1), immediately after the 8-week training (i.e., time 2), and 2 months after the training (i.e., time 3, a 2-month follow up). the assessment will take around 1 hour and it will be conducted at the laboratory at the university of hong kong. also, parents and teachers will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 timepoints.


Eligibility criteria:
inclusion criteria: * children aged 7- 12 * clinical diagnosis of adhd * significant teacher- or parent-reported attention problems during screening exclusion criteria: * iq under 70, as measured on raven's progressive matrices * hearing, visual, or physical impairments that might hinder participation in the training and assessment activities * clinical diagnosis and suspected cases of autism spectrum disorder (asd) * prior or current participation in nft * current participation in a psychotherapeutic treatment

Keywords: fnirs neurofeedback training virtual reality children with adhd
mechanisms of uterine fluid absorption during early pregnancy ( elf study)

Conditions: Endometriosis; Endometrioma

Summary: the researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy


Eligibility criteria:
inclusion criteria: 1. subject must be a healthy woman between the ages of 18 and 45 years. 2. women with diagnosed endometriosis or infertility (cases). 3. women without a diagnosis of endometriosis or infertility (controls). 4. subject must have regular menstrual cycles. 5. subject must have a body mass index (bmi) between 18 and 40. 6. subject must be or have been sexually active or have had a previous vaginal exam that used a speculum. 7. subject must be able to understand and provide consent to procedures and use/disclosure of protected health information. 8. no history of chlamydia trachomatis, mycoplasma genitalium, neisseria gonorrhoeae, hepatitis b, and hiv. 9. for ivf study subjects, a minimum endometrial thickness of 7mm at the time of sample collection. exclusion criteria: 1. pregnant women. 2. study subjects with endometrial cancer. 3. study subjects with a history of endometrial ablation. 4. study subjects with undiagnosed uterine bleeding. 5. women with reproductive diseases that affect the endometrium (such as fibroids or uterine polyps that distort endometrial cavity). 6. study subjects with an intrauterine device (iud).

Keywords: endometriosis endometrial biopsy
evaluation on the effectiveness and safety of ruixin-coronaryai for diagnosis of coronary artery stenosis

Conditions: Coronary Artery Disease; Artificial Intelligence; Coronary Artery Stenosis; CT Angiography

Summary: with the emergence of advanced technology to date in the artificial intelligence (ai), computer aided diagnosis has gradually gained its popularity in the field of healthcare. particularly, in the clinical practice of coronary artery disease diagnosis, the application of ai could be of great implication in alleviating the shortage of medical sources. to evaluate the effectiveness and safety of the ai-based coronary ct angiographic analysis software (ruixin-coronaryai) for diagnosis of coronary artery stenosis, a retrospective, multi-center, cross-over designed, blinded, sensitivity superiority and specificity non-inferiority clinical trial will be conducted.

patients ≥18 years old with suspected or known coronary artery disease who underwent ccta will be included. ccta images of subjects should be of good quality up to the dicom 3.0 standards, obtained by ct scan with ≥64-slices. the subjects with unqualified cta will be excluded. ccta images will be analyzed in three methods (3 groups). control group: ccta images will be visually evaluated by physicians. experiment group: ccta images will be evaluated by physicians using ruixin-coronaryai. reference group: ccta images will be visually evaluated by cardiologists with at least 10 years experiences, and the conclusions they offer will be used as golden standard. primary outcomes are diagnostic sensitivity and specificity of ruixin-coronaryai and coronary cta for diagnosis of ischemia on a per-vessel basis. the effectiveness of ruixin-coronaryai for diagnosis of coronary artery stenosis will be conducted by testing superiority of diagnostic sensitivity and non-inferiority of specificity.

Eligibility criteria:
inclusion criteria: 1. layer thickness of ccta images should be less than 1mm, image quality should be up to dicom 3.0 standards; 2. vessels should be clearly developed, contrast medium ought to be well filled, the average of ct value of aortic root cavity should be between 325-600hu in ccta image; 3. remodeling of vessels should be intact, including coronary artery and branches, without missed or inaccurate slices; 4. ccta image should be obtained from single- or dual-source computed tomography (ct) scanners with a minimum of 64 detector rows. exclusion criteria: 1. ccta image is of poor quality due to motion artifact, severe calcification, metal coverage, noise, poor contrast medium injection and other variables influencing the diagnosis of stenosis; 2. previous percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg); 3. anomalous origin of coronary artery; 4. other non-atherosclerosis-related coronary diseases like coronary artery fistula, aneurysm, coronary artery ectasia, arteritis coronaria, etc.; 5. repeated enrollment; 6. other conditions not suitable for enrollment.