Kornimate/medical-research-clean huggingface dataset:
targeted polymeric nanoparticles loaded with cetuximab and decorated with somatostatin analogue to colon cancer

Conditions: Colon Cancer; Colo-rectal Cancer

Summary: due to the great toxicity of chemotherapeutic drugs to both the healthy and cancerous area, the efficient targeting could be of great benefit for a patient with advanced or metastatic tumors. colorectal cells carry somatostatin receptors which make them a promising target for antitumor therapy since this would reduce side effects and increase drug delivery efficacy to the target site.

the investigator's aim is to deliver polymeric nanoparticles loaded with anti-cancer drug cetuximab and decorated with somatostatin analogue in the form of oral polymeric nanoparticles, which can release at only above ph 6.8 using ethylcellulose polymer. the polymeric nanoparticles were prepared using the solvent evaporation method, further will be characterized for its drug content, size, encapsulation efficiency and drug-loading using uv spectroscopy. moreover, the ethylcellulose nanoparticles loaded cetuximab will release the cetuximab at ph above 6.8, while can hold the cetuximab at ph 1.5 which protecting the stomach from the toxicity cetuximab. then, the nanoparticles will target the colorectal cancer cells using octreotide, the somatostatin receptor agonist which will lead it to sstrs overexpressed in colorectal cancer cells. the strategy of deposition of ligand will depend on using the advantage of the positive charge surface of nanoparticles which can absorb the negative charges of the targeting ligands. final outcomes: this project will present a novel formulation for the treatment of colorectal cancer which can be delivered safely to the patients in a high dose to the affected tumor cells with reduced side effects on the other healthy cells.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of colon cancer * follow up and collect data for a local and systemic activity of cetuximab * the systemic oral capsule of cetuximab be also given to enhance the activity as an anti-cancer activities exclusion criteria: * peptic ulcer * stomach disease * colon cancer
clinical trial to evaluate the efficacy and safety of ckd-397 in benign prostatic hyperplasia patients

Conditions: Benign Prostatic Hyperplasia

Summary: a multicenter, randomized, double-blind, active-controlled, parallel group, phase iii clinical trial to evaluate the efficacy and safety of ckd-397 in benign prostatic hyperplasia patients.


Eligibility criteria:
inclusion criteria: \[visit 1\] 1. male aged of 45 or above 2. patients must have a diagnosis of benign prostatic hyperplasia 3. ipss(international prostate symptom score) questionnaire total score ≥ 13 4. signed and dated informed consent document indicating that the patient \[visit 2\] 1. ipss(international prostate symptom score) questionnaire total score ≥ 13 2. 15ml/s ≥ qmax ≥ 4ml/s, if voided volume ≥ 120ml 3. pvr(post-void residual urine volume) ≤ 250ml exclusion criteria: 1. patients have ever taken finasteride in 3 months or dutasteride in 6 months 2. patients with prostate cancer or psa \> 10ng/ml 3. patients with other disease which could have influence on urine flow rate except bph(benign prostatic hyperplasia ) 4. patients with a history of operation on prostate which could have influence on the result and need to have surgery. 5. patients with acute urinary retention in 3months 6. patients with a history of drug or alcohol abuse within 6 months 7. patients have cardiovascular disease or associated disease which is not controlled. 8. patients who need to take nitrates, alpha blocker, nitric oxide donor 9. patients with orthostatic hypotension 10. patients with a history micturition syncope 11. patients with severe or malignant retinopathy 12. patients have a visual disturbance by non-arteritic anterior ischemic optic neuropathy 13. patients with a congestive disease like galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption 14. serum creatinine \> upper normal limit\*2, ast/alt \> upper normal limit\*3 15. patient with uncontrolled diabetes(hba1c\>9%) 16. patients have a history of malignant tumor within 5 years 17. patients have hypersensitivity reaction on this drug. 18. patients treated with other investigational product within 4 weeks at first time taking the investigational product 19. not eligible to participate for the study at the discretion of investigator
covid-19 serologic strategies for skilled nursing facilities

Conditions: COVID-19

Summary: the covid-19 pandemic ravaged united states skilled-nursing facilities (snfs). novel strategies that maximize the safety and quality of life for snf residents with adrd and staff who care for them are urgently needed. thus, the study's objectives are: 1. to rapidly plan and pilot test an intervention that leverages covid-19 antibody and pcr status to pair snf staff with residents in the safest way possible 2. to reduce reduced covid-19 incidence rate compared to snfs not using this novel staff-resident assignment strategy.


Eligibility criteria:
inclusion criteria for staff stakeholders: * must be employees of archcare * must be members of included unit staff or those that float on those designated units * willing to participate in focus groups or semi-structured interviews with study team inclusion criteria for family participants: * family members of residents who reside at either tcc or mmw (archcare facilities) * family member of resident who is on designated study unit or eligible to be transferred to such unit * willing to participate in focus groups or semi-structured interviews with study team inclusion criteria for resident participants: * resident has ability to communicate and follow simple commands * resident has ability to communicate and follow simple commands * english- or spanish-speaking * resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent. * must agree to have serologic testing for covid-19 * agrees to remain on one of the facility units of study or to be transferred to such unit exclusion criteria for staff stakeholders: * not employees of archcare * not members of included unit staff or those that float on those designated units * not willing to participate in focus groups or semi-structured interviews with study team exclusion criteria for family participants: * not family members of residents who reside at either tcc or mmw (archcare facilities) * not family member of resident who is on designated study unit or eligible to be transferred to such unit * not willing to participate in focus groups or semi-structured interviews with study team exclusion criteria for resident participants: * resident is not living in the unit of intervention * resident does not have ability to communicate and follow simple commands * not english- or spanish-speaking * resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent. * if resident lacks capacity, that resident does not assent with surrogate who provides assent * does not agree to have serologic testing for covid-19 * refuses to agree to remain on one of the facility units of study or to be transferred to such unit
modification of the "edmonton protocol" to allow for successful islet transplantation from a single pancreas and extension of the "edmonton protocol" to kidney transplant recipients

Conditions: Diabetes Mellitus

Summary: the experience of the edmonton group with islet transplantation and use of the "edmonton protocol" provides much promise for t1dm patients. however, the need to use 2 or more donor pancreases to achieve freedom from insulin shots limits the widespread use of this protocol. two classes of oral antidiabetic drugs improve insulin action and reduce the amount of insulin needed to have normal blood sugars. the first part of the proposed project (group 1) will use these drugs in conjunction with the edmonton protocol to allow for successful islet transplantation from islets isolated from a single pancreas. the edmonton protocol is a treatment, not a cure. it requires the long-term use of powerful immunosuppressive drugs that are expensive and increase the risk of infection and cancer. t1dm patients who have a functioning kidney transplant already have to use immunosuppressive drugs, and they are still at risk of recurrent diabetic kidney disease and other complications of diabetes. islet transplantation in these patients has only rarely been successful in the past in part because the usual immunosuppressive drugs used in kidney transplantation cause diabetes and actually harm the transplant kidney in other ways. the immunosuppressive drugs used in the edmonton protocol are less likely to cause diabetes and are also less harmful to the kidney. in the second part of this project (group 2), we will transplant islets into kidney transplant patients after they have switched to the immunosuppressive medications used in the edmonton protocol. even if some of the patients do not get islet transplants or still need insulin shots after islet transplantation, we expect to see improvement in kidney function and blood glucose control.

we anticipate that successful islet transplantation will establish a group of islet cell transplant patients who have normal blood sugars and do not need insulin injections. some of this group will have received a kidney transplant as well. all these patients will be studied in great detail along with other investigators in our islet cell program to understand better the mechanisms of efficacy and side effects of islet transplant and these new immunosuppressive drugs.

Eligibility criteria:
inclusion criteria: type 1 diabetes for \> 5 years and hypoglycemia unawareness, not felt adequately by patient (glucose \ 2 hospital \ 120mg/dl), disruption in lifestyle or danger to life, to self, to others or failure of intensive insulin management, as judged by an independent endocrinologist.
intraoperative brain shift calculation study

Conditions: Tumor, Brain; Cavernoma; Arteriovenous Malformations; Intracerebral Hematoma

Summary: the purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

brain shift is the main natural cause of major navigation imprecision. despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. some modern navigational features allow to partially resolve this problem. manual shift correction allows to displace brain structures but can only be used if brain shift is linear. intraoperative computed tomography (ct) and magnetic resonance imaging (mri) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve. the purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction. for each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Eligibility criteria:
inclusion criteria: * all intracranial tumors * cavernomas * arteriovenous malformations * spontaneous (non-traumatic) intracerebral hemorrhages * traumatic intracerebral hemorrhages * supratentorial localization * newly diagnosed * age 18-100 years * stable hemodynamics * error of patient registration in neuronavigation no more than 2 mm exclusion criteria: * rapid cerebral dislocation

Keywords: brain shift tumor cavernoma arteriovenous malformation intracerebral hematoma
artificial intelligence in predicting progression in multiple sclerosis study

Conditions: Multiple Sclerosis; Multiple Sclerosis Lesion; Multiple Sclerosis Brain Lesion

Summary: the study proposal focuses on multiple sclerosis (ms), a chronic incurable disease of the central nervous system (cns). the ms disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (edss), and subsequent remission (disappearance of symptoms and reduced edss score) or, alternatively, a gradual edss disability progression and exacerbation of associated symptoms. at the same time, the ms is characterised by multifocal inflammatory lesions disseminated throughout the white and grey matter of the cns, which can be observed and quantified in the magnetic resonance (mr) scans. the proposed study will address the critical unmet need of computer-assisted extraction and assessment of prognostic factors based from an individual patient's brain mr scan, such as lesion count, volume, whole-brain and regional brain atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized future disability progression prediction.


Eligibility criteria:
inclusion criteria: * persons diagnosed with ms (any phenotype; according to the 2010 mcdonald criteria) and cis patients * availability of at least two mri exams with both flair and t1-weighted scans of the same participant over a period of at least 6 months at the most recent examination * availability of demographic, clinical data and treatment information for the same participant over a period of at least 6 months at the most recent examination * availability of edss score and at least one previous edss scores for the same participant over a period of at least 6 months at the most recent examination exclusion criteria: * other clinically relevant systemic diseases if the researcher considers them to be significant

Keywords: artificial intelligence prediction model magnetic resonance imaging computer-assisted image analysis
post stemi echo registry

Conditions: ST Elevation Myocardial Infarction

Summary: this is a prospective observational study of consecutive patients presenting with stemi to the prince of wales hospital over a 12-month period. all patients will receive standard of care including reperfusion and gdmt irrespective of study enrolment. patient will be followed for 9 months after enrolled in this study. point-of-care ultrasound (pocus) using a hand-held ultrasound (vscan, ge healthcare) will be performed to assess baseline lvef within 48 hours of admission. patients with baseline moderate-to-severe lv dysfunction by visual pocus assessment (i.e. lvef \<40%) will be recruited for follow-up lvef assessment at 3 months. patients with persistent lvef \<40% by pocus will undergo formal echocardiography to confirm lvef by either 2d area (simpson's rule) and 3d volumetric measurements. in 9 month visit, patient's clinical data will be collected and no echo is needed during this visit.

this is a prospective observational study of consecutive patients presenting with stemi to the prince of wales hospital over a 12-month period. all patients will receive standard of care including reperfusion and gdmt irrespective of study enrolment. patient will be followed for 9 months after enrolled in this study. point-of-care ultrasound (pocus) using a hand-held ultrasound (vscan, ge healthcare) will be performed to assess baseline lvef within 48 hours of admission. patients with baseline moderate-to-severe lv dysfunction by visual pocus assessment (i.e. lvef \<40%) will be recruited for follow-up lvef assessment at 3 months. patients with persistent lvef \<40% by pocus will undergo formal echocardiography to confirm lvef by either 2d area (simpson's rule) and 3d volumetric measurements. in 9 month visit, patient's clinical data will be collected and no echo is needed during this visit. categorical variables were presented in frequency tables and were compared using the pearson chi square test if all cell sizes were more than 5, or fisher exact test if otherwise. parametric and nonparametric continuous variables were expressed as mean ± sd and median (interquartile range) and were compared using the student t test and mann-whitney u test, respectively. p\<0.05 was considered statistically significant. all statistical analyses were performed using spss version 24.0

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. stemi (defined by symptoms of myocardial ischemia accompanied by persistent elevation of the st segment on ecg and the subsequent rise of biomarkers of myocardial necrosis) 3. ability to provide informed consent and to complete the study and required follow-up exclusion criteria: 1. pregnancy 2. pre-existing icd or crt-d implantation

Keywords: st elevation myocardial infarction low left ventricular ejection fraction
transcend auto vs commercially available device clinical evaluation for treatment of obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to determine whether the transcend auto is as effective in treating obstructive sleep apnea as another device that is already on the market.

this is a prospective, randomized, crossover trial. patients will be randomized 1:1 to undergo two full night sleep studies with the transcend auto and a commercially available device.

Eligibility criteria:
inclusion criteria: * adult 18 years of age or older * diagnosis of obstructive sleep apnea * presently using cpap or apap therapy exclusion criteria: * central or mixed apnea

Keywords: obstructive sleep apnea osa autopap pap sleep disordered breathing cpap apnea hypopnea index ahi
technical optimization of detection of kras, braf and nras mutations on tumor dna circulating in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the objective of this study is to optimize the search by next-generation sequencing (ngs) mutations in the kras, braf and nras on circulating tumor dna and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility criteria:
inclusion criteria: * patients with metastatic or locally advanced colorectal carcinoma with a kras, braf or nras mutation * age ≥ 18 years * patient information and written informed consent form signed * patient must be affiliated to a social security system exclusion criteria: * patients whose health-cons indicates a blood sample 10ml * age \< 18 years * pregnant or breast feeding females * persons deprived of liberty or under supervision

Keywords: colorectal cancer kras mutation nras mutation braf mutation
a primary care educational intervention for families of overweight children

Conditions: Obesity

Summary: the purpose of the research is to find out if an educational booklet is helpful to families with overweight children. the educational booklet contains information for parents about nutritious eating, physical activity, and strategies for healthy living.

the prevalence of overweight among children has at least doubled in the past 25 years. in the year 2004, 18.8% of children ages 6-11 were overweight. being overweight as a child is clearly associated with adulthood obesity. in addition, complications once prevalent only in adults are now being seen in overweight children and adolescents. these include hypertension, hypercholesterolemia, and type ii diabetes which are well known risk factors for cardiovascular disease. obesity is also associated with low self-esteem among some groups of overweight adolescents. primary care providers are in a unique position to combat this epidemic. however, a recent survey found that only 12% of pediatricians felt highly effective in their ability to treat obesity. furthermore, physicians reported that low self-efficacy in treating obesity was associated with a lack of patient educational materials. few written resources for families of overweight children have been tested in the primary care setting. much of the research on childhood overweight has been conducted in specialty obesity clinics where the resources and patient population may differ from those of primary care offices. kid stride is an educational booklet designed for parents of overweight children. it includes information about nutrition, physical activity, and strategies for healthy living. it is hypothesized that the booklet will be distributed to and used by parents of children who are overweight or at risk for overweight. this study will analyze parents' perceptions of this booklet in order to improve its potential value. information obtained from this pilot study will be used to prepare for a future study to determine the effectiveness of this intervention. the purpose of this study is: aim 1 is to determine the distribution rate and uptake rate of an educational booklet for parents of children between the ages of 8 and 12 who are overweight. aim 2 is to describe parents' perceptions of the educational booklet. aim 3 is to assess the impact of the intervention on bmi as measured by change in bmi z-score.

Eligibility criteria:
inclusion criteria: * body mass index greater than or equal to the 95th percentile for age and gender * presenting to pediatrician for a health maintenance visit exclusion criteria: * genetic conditions known to predispose to overweight * endocrine conditions associated with overweight * chronic steroid therapy * current enrollment in a professional weight management program

Keywords: obesity overweight
assessing the efficacy of clomiphene citrate in patients with azoospermia and hypoandrogenism

Conditions: Non Obstructive Azoospermia; Hypogonadism

Summary: hypothesis: prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. however, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microtese improve.

Eligibility criteria:
inclusion criteria: * patients over 18 years old. * man seeking fertility treatment. * azoospermia confirmed in at least 2 semen analyses with centrifugation. * testosterone \<300 ng/dl and bioavailable testosterone\<156 ng/dl. exclusion criteria: * presence of genetic disorders: y chromosome deletions or abnormal karyotypes. * luteinizing hormone (lh) \>25 iu/ml. * estradiol \> 40 ng/dl. * hypogonadotropic hypogonadism (lh \<2 iu/ml and follicle stimulating hormone (fsh) \<1 iu/ml). * obstructive azoospermia (fsh \ 4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy). * clinical varicocele (palpable or visible in physical exam) * previous history of cryptorchidism. * use of chemotherapy, testosterone, or anti-androgen in the last two years. partner \>40 years or female factor infertility associated. * contraindications to clomiphene use: depression, heart and liver impairment, uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.

Keywords: azoospermia hypogonadism clomiphene