Kornimate/medical-research-clean huggingface dataset:
evaluation of the effect of a shiitake extract on lipid profile in subjects with moderate hyperlipidemia

Conditions: Hypercholesterolemia; Hyperlipidemias; Dietary Supplements; Cardiovascular Risk Factor

Summary: effect of a dietary supplement with shiitake extracts (lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment.

prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of duration and 2 study groups (1) food supplement with extracts of the fungus shiitake; 2) placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived from the shiitake mushroom (lentinula edodes) on the lipid profile, other cardiovascular risk factors and the intestinal microbiota in subjects with hyperlipidemia moderate without pharmacological treatment.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * bmi ≥18.5 and \<30 kg/m2. * adequate cultural level and understanding for the clinical trial. * signed informed consent. * cardiovascular risk \<10% to 10 years measured by regicor. * total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list: * ≥ 45 years or women ≥ 55 years. * family history of cardiovascular disease (cvd) in first degree male relative less than 55 years of age and less than 65 years in women. * hdl cholesterol: men \<40 or women \<50. * triglycerides ≥ 150mg/dl and \<200 mg/dl * ldl cholesterol ≥ 130mg/dl and \< 160mg/dl * smoker * willingness to follow a healthy diet, hyperlipidemic control diet and a diet without stanols, sterols and yeast. * social or familiar environment that prevents from accomplishing the dietary treatment exclusion criteria: * individuals diagnosed with diabetes mellitus type 1. * individuals diagnosed with diabetes mellitus type 2 on pharmacological treatment (unless it is possible the suspension 30 days before the trials). * individuals with dyslipidemia on pharmacological treatment; * individuals with hypertension on pharmacological treatment; * individuals \> 60 years smokers with total cholesterol \> 200mg/dl or ldl \>130mg/dl. * individuals with hypertension on pharmacological treatment uncontrolled. * individuals with hyperthyroidism and hypothyroidism on pharmacological treatment uncontrolled. * individuals allergic to shiitake (lentinula edodes) * individuals with chronic diseases (hepatic, kidney, ...) * individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ados); * individuals who have participated in the last 6 months in a program or clinical trial to lose weight. * smokers wanting to stop to smoke during the period that clinical trial lasts. * individuals with mental illness. * consume drugs to lose weight during 30 days before starting the study * pregnant or breastfeeding women.
weekly tp-hdfl in the treatment of advanced tcc

Conditions: Transitional Cell Carcinoma

Summary: the purpose of this study is to evaluate the efficacy of weekly tp-hdfl in advanced transitional cell carcinoma in terms of response rate and overall survival.

transitional cell carcinoma(tcc)of urothelium,including bladder, ureter, and renal pelvis tccs, was the most lethal urology malignancy in taiwan. in 1995, approximately 1,300 new cases of tcc was diagnosed in taiwan and more than 600 patients died of this disease. advanced tcc is a moderately chemosensitive disease. a combination of methotrexate, vinblastine, and cisplatin with or without doxorubicin (m-vac or cmv) has been widely used since 1980s. despite the response rate was as high as 40-70%, the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy. one of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy.

Eligibility criteria:
inclusion criteria: 1. pathology proven tcc recurrent or metastatic tcc muscle-invasive tcc 2. measurable disease 3. age\>18 4. kps\>60﹪ 5. creatinine clearance\>35ml/min, 6. ast/alt \< or = 3.5times upper limits of normal reference values 7. bilirubin\< or = 2.0 mg/dl 8. wbc \> or = 4,000/mm3, plt \> or = 100,000/mm3 9. written informed consent exclusion criteria: 1. previous systemic chemo is not allowed 2. tg \<70mg/dl 3. cns metastasis 4. life expectancy less than 3 months

Keywords: combination, chemotherapy,transitional cell carcinoma
incidence and risk factor of post-ercp pancreatitis in chronic pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: the purpose of this study is to compare the incidence of post-ercp pancreatitis (pep) in chronic pancreatitis (cp) patients to that in biliary disease patients, to determine whether cp patients in early clinical stage have a higher pep incidence, and to identify the predictive and protective factors for pep in chronic pancreatitis patients.

analysis of patients with chronic pancreatitis (cp group) and biliary disease (bd group) in changhai hospital from january 2011 to may 2015 were conducted. difference of pep incidences between bd group and cp group, as well as between m-annheim subcategories were calculated by chi-square test or fisher's exact test. the predictive and protective factors for pep were investigated by univariate and multivariate analysis.

Eligibility criteria:
inclusion criteria: * patients with an endoscope inserted to cannulate the pancreatic/biliary duct were included. exclusion criteria: * patients in whom the papilla of vater was not reached; * patients who underwent stent removal procedures without ductal cannulation; * patients in whom the intubation was failed.
a randomized clinical trial evaluating the effectiveness of carbon dioxide use in cardiac surgery

Conditions: Carbon Dioxide

Summary: study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive

prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)

Eligibility criteria:
inclusion criteria: * planned cardiac surgery on the left heart with limited deaeration: minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); re-intervention * signed informed voluntary consent exclusion criteria: * patient refusal to participate in any stage of the study * history of stroke, transient ischemic attack * hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%) * swelling or thrombosis of the heart * lv dysfunction (ef less than 30%) * atherosclerosis of the aorta (atheromatosis) * surgical access conversion

Keywords: carbon dioxide cardiac surgery delirium minimally invasive intervention redo cardiac surgery
safety study to evaluate the contact sensitizing potential of topically applied zuraprep™ and zuraprep™ without ipa

Conditions: Surgical Site Infection

Summary: this is a safety study to determine the skin sensitization potential of zuraprep™ and zuraprep™ without isopropyl alcohol (ipa) after repetitive patch applications to skin of human subjects. indications of both sensitization and skin irritation will be evaluated.

this study is designed to determine if the test product, zuraprep™ is a skin sensitizing agent when applied to human skin. the study, a modified draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. during the induction phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. the rest phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to zuraprep™, given any of its components serve as antigens. during the challenge phase, the subjects' skin is re-exposed to the test product (zuraprep™) to determine if it is likely to be immunosensitizing.

Eligibility criteria:
inclusion criteria: * subjects may be of either sex, at least 18 years of age and of any race * subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back. * subjects must be in good general health exclusion criteria: * known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate. * exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period. * use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period. * current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as aids or hiv positive. * pregnancy, plans to become pregnant, breast-feeding * any active skin rash or breaks in the skin of the back * any sunburn or tattoos on the skin of the back * current active skin disease or inflammatory skin condition including contact dermatitis * participation in a clinical study in the past 7 days or current participation in another clinical study * any medical condition or use of any medications that, in the opinion of the principal investigator, would preclude participation * unwillingness to fulfill the performance requirements of the study
economic evaluation of the use of plerixafor for autologous hsc transplantation for multiple myeloma

Conditions: Multiple Myeloma

Summary: this study aims to realize an economic evaluation of the introduction of plerixafor in addition to g-csf and alternative options, in patients with multiple myeloma (mm) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to g-csf alone.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with multiple myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (hsct) as part of their treatment plan * first mobilization attempt * "rhg-csf alone" mobilization regimen * failed mobilization as documented by an increase in cd34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µl), after the 4 first injections of rhg-csf that are administered in the evening exclusion criteria: * age \< 18 years; * primary diagnosis other than mm * 2nd or subsequent mobilization attempt * patients who previously received hdct + autologous hsct * chemotherapy-based mobilization regimen * efficient mobilization, allowing for apheresis and collection of the target cell number (5x106 cd34+ cells/kg for every planned autologous transplantation as per institutional sops).
cup versus bottle feeding for late preterm infants

Conditions: Breastfeeding

Summary: the purpose of the current study is to investigate the effect of using cup feeding for preterm infants during nicu stay on breastfeeding outcomes after discharge. the following hypotheses are being tested: 1. infants fed by cup during nicu stay will have higher breastfeeding proportions than infants fed by bottle 2. infants fed by cup during nicu stay will have higher breastfeeding behaviour score on the preterm infant breastfeeding behavior scale than infants fed by bottle

the provision of breast milk is essential for preterm infants as it provides unique health benefits that are unmatched by other types of feeding \[1-3\]. however, breastfeeding presents unique challenges for preterm infants that include establishing and maintaining the mothers' milk supply and transitioning the infant from gavage feeding to breastfeeding \[4\]. one of the issues that presents during the transition to breastfeeding is that mothers of preterm infants are rarely available for all oral feedings during hospitalization; this makes it necessary for infants to receive oral feedings by other method, usually bottle feeding. however, exposure of newborn infants to artificial nipples has been strongly associated with breastfeeding problems \[5-9\]. frequently these problems have been explained by phenomena called nipple confusion. nipple confusion occurs when infants are exposed to two different feeding methods, bottle and breast, resulting in the infant refusing to breastfeed. consequently, it has been recommended that bottle feeding be avoided and that cup feeding be used for the supplementation of term as well as preterm infants. cup feeding is known as an alternative method of feeding breast milk to an infant using a small cup without a lip. cup feeding is also recommended by the baby friendly hospital initiative.the use of cup was originally based on the goal of avoiding propping of bottles and also to increase bodily contact with the mother during feeding. although cup feeding receives little mention in medical literature, and may seem to be a new technique for some, it has been used in several developing as well as developed countries. lang, who observed cup feeding in south nepal, implemented cup feeding in england and the practice expanded to other developed countries. consequently cup feeding was established as a method for feeding infants who could not be breastfed from birth.

Eligibility criteria:
inclusion criteria: * singleton birth * 34 to 37 weeks of gestation at birth * maternal intention to breastfeed * fed only by tube feeding exclusion criteria: * infants who had any condition interfering with oral feeding * infants with craniofacial anomalies * infants with intracranial hemorrhage

Keywords: cup feeding late preterm
an exploratory investigation of dietary supplementation and the effect on common symptoms of perimenopause and menopause

Conditions: Menopause; Menopause Related Conditions; Perimenopausal Disorder

Summary: a combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.


Eligibility criteria:
inclusion criteria: * ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day) * moderate self-reported discomfort related to perimenopause or menopause. participants will complete the menopause well-being survey and must answer an average of "moderate" or higher. exclusion criteria: * current use of medication for high blood pressure or for blood thinning * currently undergoing chemotherapy or has previously been treated for cancer * pregnancy, breastfeeding, or attempting to become pregnant during the study * known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )

Keywords: menopause perimenopause
vitamin d regulates the expression of glucocorticoid receptors in blood of severe asthmatic patients

Conditions: Effect of Drug

Summary: vitamin d (vitd) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. severe asthma has been linked with a decreased glucocorticoid receptors (gr) ratio (gr-α/ gr-β ratio), indicating steroid hyporesponsiveness. using combined in silico and in vivo approaches, aimed to explore the immunomodulatory effect of vitd on asthmatic patients diagnosed with hypovitaminosis d.

vitamin d (vitd) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. severe asthma has been linked with a decreased glucocorticoid receptors (gr) ratio (gr-α/ gr-β ratio), indicating steroid hyporesponsiveness. using combined in silico and in vivo approaches, the investigators aimed to explore the immunomodulatory effect of vitd on asthmatic patients diagnosed with hypovitaminosis d. methods: in silico tools were used to identify the regulatory effect of vitd supplementation on gr genes. the investigators measured the expression levels of gr-α and the inactive isoform, gr-β, in the blood of adult asthmatics diagnosed with hypovitaminosis d before and after vitd supplementation. moreover, the blood levels of inflammatory cytokines associated with asthma severity were determined.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma * age group between 18 and 65 years * low level of 25-hydroxyvitamin d3 (25 d3) level less than 20ng/ml exclusion criteria: * smoker patients * less than 18 years old * patient on vitamin d supplementation already
a clinical study of children with status epilepticus in china

Conditions: Status Epilepticus

Summary: phase 1: the first part of study is a multi-center, retrospect study involving 38 hospitals. the program is a national epidemiological study on status epilepticus in chinese children.the aims of the epidemiological study include: 1. to obtain national epidemiological data on the etiology, diagnosis,treatment,evaluation, risk factors , outcome and analyze the burden of disease. 2. to build a collaborative network in pediatric status epilepticus research. 3. to establish a national clinical database of pediatric status epilepticus. 4. to lay the foundation for the further prospective study. phase 2: the second part of study is a multi-center, prospective study involving 38 hospitals. the aim of the study is to set up guideline of children with se in china.

methods: 1. case retrieval: the investigators query cases with a diagnostic code of se via usage of the international classification of diseases, 10th revision (icd-10) code g41. 2. data collection:the subjects will be recruited from all hospitals.the investigators collect detailed information by a standardized questionnaire ,which contains each patient's age, gender, the date of occurrence of se, past history of se and seizures, etiology of se, developmental history, underlying diseases, family history of seizures, duration of se, seizure types of se, laboratory data,eeg findings during se and/or after se, cranial ct and/or mri findings after se, medical treatment during the acute period and the outcome.the outcome include neurological sequelae, recurrence and death following se. 3. the establishment of the database and data entry :the investigators established a database according the standardized questionnaire. then the information will be put in the database by the responsible person of each hospital. 4. the standardized management of the database and quality control:there is a special person administrating the database and controlling the quality of data.

Eligibility criteria:
inclusion criteria: 1. patients who meet the diagnosis of status epilepticus(se),which is defined as more than 30 minutes of either1).continuous seizure activity or 2).two or more sequential seizures without full recovery of consciousness between seizures, including status epilepticus (cse) and nonconvulsive status epilepticus(ncse). 2. the age range: 29 days to \<18years 3. cases with complete clinical information. 4. inpatient. all cases those meet full of the above 4 criterias are included in our study. exclusion criteria: 1. a seizure less than 30 minutes 2. the newborn and more than 18 years old.

Keywords: status epilepticus children multi-center etiology treatment outcome risk factor
prime-boost dose scheduling trial for human gm-csf gene transduced irradiated prostate allogeneic cancer cell vaccines (allogeneic prostate gvax®)

Conditions: Prostate Cancer

Summary: the objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with human gm-csf gene transduced irradiated prostate allogeneic cancer cell vaccines (allogeneic prostate gvax®). clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. additionally, the antitumor effects of allogeneic prostate gvax® on serum psa levels will be evaluated and antitumor responses will be quantitated.


Eligibility criteria:
inclusion criteria: * diagnosis of adenocarcinoma prostate cancer * no evidence of measurable metastatic disease * an ecog performance status of 0 or 1 exclusion criteria: * previous hormonal therapy of any type for prostate cancer * any previous chemotherapy, or prior investigational therapy for prostate cancer * prior immunotherapy * prior treatment with gene therapy

Keywords: prostate cancer gvax metastatic vaccine allogeneic cells
assessment of health related quality of life in patients treated for rectal cancer

Conditions: Rectal Cancer; Colon Cancer; Anal Cancer

Summary: treatment of rectal cancer often consists of surgical resection of the tumor. chemotherapy and/or radiotherapy are frequently given before or after surgery. in this study, we wish to learn if there are differences in the treatment effectiveness or in the quality of life of patients based on their type of treatment (e.g. radiotherapy and chemotherapy before or after surgery). information from this questionnaire collected from you and other patients may help improve the quality of life of rectal cancer patients in the future. medical information on your tumor, treatment received, and side effects will be compiled and maintained in a database to learn more about outcomes of treatment for rectal cancer.

there exists little published data studying the health related quality of life (hrqol) of patients treated for the rectal cancer. patients are commonly treated with surgery preceded or followed by chemo radiotherapy. patients chart review and questionnaires administered during follow-up exam or by mailing will be use to compile data comparing the hrqol of the two study groups(preoperative versus post operative chemotherapy). our radiation oncologist will also informed all the new pts. under going radiotherapy regarding this study and will encourage them in become part of our study population. the prospective study will help us in increasing the number of participants and also it give us an opportunity following the patients as they go through their treatment. through the use of department databases, a cohort or rectal cancer patients treated at stanford will be identified. patients demographics, treatment received ,disease outcomes, and treatment associated complications will be compiled from available data. hrqol questionnaires will be answered through a mailing or during clinic visits. treatment outcomes, toxicities and overall quality of life of preoperative and postoperative chemo radiotherapy treatment group will be compared in relation to the lesion location.

Eligibility criteria:
inclusion criteria:history of histologically-confirmed rectal cancer with treatment or undergoing treatment at stanford university hospital.