Kornimate/medical-research-clean huggingface dataset:
molecular imaging of epidermal growth factor receptor in colorectal neoplasia using confocal laser endomicroscopy

Conditions: Colorectal Cancer; Colorectal Adenoma

Summary: the study aims to: 1. achieve molecular imaging of egfr in patients with colorectal neoplasia in vivo using confocal laser endomicroscopy. 2. compare the results of in vivo egfr-specific molecular imaging with cle and ex vivo immunohistochemistry .

various kinds of tumor markers have been shown to be over-expressed in colorectal cancer, including epidermal growth factor receptor(egfr). the conventional detection method of egfr expression in colorectal neoplasia is immunohistochemistry which is time-consuming, and the immunoreactivity can be affected by storage and fixation of tissues. confocal laser endomicrosopy is a newly developed device which could identify the cellular and subcellular structures clearly with the magnification at×1000, making it possible to explore the physiological and pathological molecular mechanism of the gastrointestinal tract. so the study aims to achieve molecular imaging of egfr in colorectal neoplasia in vivo using confocal laser endomicroscopy.

Eligibility criteria:
inclusion criteria： ●patients known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at qilu hospital were enrolled into the study exclusion criteria: * patients who are allergic to fluorescein sodium * patients with impaired cardiac, liver or renal function * patients who are unwilling to sign or give the informed consent form * patients with giant tumors or obvious gi tract bleeding which make it hard or impossible to observe the lesions * patients with coagulopathy * patients with pregnancy or breastfeeding

Keywords: molecular imaging epidermal growth factor receptor colorectal neoplasia confocal laser endomicroscopy
triclosan coated suture wound closure for peripheral vascular surgery: a prospective multicenter study

Conditions: Surgical Wound Infection

Summary: this is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.


Eligibility criteria:
inclusion criteria: * patient undergoing peripheral vascular surgery procedure exclusion criteria: * patients refusal

Keywords: surgical wound infection triclosan-coated suture
effect of caries conceptualizing and residential university life

Conditions: Caries, Dental

Summary: the study aims to detect the conceptualization of dental caries among dental student and compare the caries prevalence in residential and non residential dental student

a face-to-face meeting will be held with the target student group, illustrating the study set up and seeking the participation approval. the students who will accept to participate in the study will receive a questionnaire including the caries conceptualization assessment inquiry, the caries prevention practice as well as the residential habits. all the participating students will be scheduled for dental examination to record their dmft index. the digital responses will be coded, analyzed and correlated with the clinical findings.

Eligibility criteria:
inclusion criteria will be: * students already taught a dental cariology in 4th year of university. * students registered in the galala dental program science year one. * medically free students. * students having at least 1year clinical practice. exclusion criteria will be: * first, second-, and third-year students. * non dental students.

Keywords: caries prevalence residential students dental students
efficacy of postoperative adjuvant chemotherapy for stage ii colon cancer with high risk factors(epac1)

Conditions: Adjuvant Chemotherapy

Summary: the purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage ii colon cancer patients with high risk factors.therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage ii colon cancer.

the most controversial of adjuvant chemotherapy for colon cancer is whether stage ii colon cancer should receive adjuvant chemotherapy or not. because of the absolute little benefit of adjuvant chemotherapy after curative resection of stage ii colon cancer，nccn and esmo guidelines do not recommend routine adjuvant chemotherapy for patients with stage ii colon cancer unless combined with high risk factors. currently，most studies about stage ii colon cancer with high risk factors were retrospective. some suggested that patients with stage ii colon cancer can benefit from adjuvant chemotherapy, however, more got the negative conclusions. the study was designed as a multicenter, prospective, randomized, controlled trial.patients who agreed to participate in the study would be randomly assigned to a treatment group of adjuvant chemotherapy or observation with 50% chance by a central randomization system determined by the computer program. after a follow up of at least 3 years, the disease free survival of the two groups will be compared.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 75 years; 2. pathologically confirmed adenocarcinoma of the colon 3. after curative resection pathological stage was t3-4n0m0; 4. with at least one of the following factors: 1. t4 staging 2. lymph nodes number less than 12 3. poor differentiation (except msi-h) 4. lvi or pni 5. obstruction or perforation 6. elevated preoperative serum cea 5. ecog performance status 0-1 6. no evidence of distant metastases 7. no preoperative chemotherapy or chemoradiation therapy 8. anc \> 1.5 cells/mm3, hgb \> 10.0 g/dl, plt \> 100,000/mm3, total bilirubin ≤ 1.5 xuln, ast≤ 3 x uln, alt ≤ 3 x uln. 9. patients must read, agree to, and sign a statement of informed consent prior to participation in this study. exclusion criteria: 1. combined with other cancer 2. creatinine level greater than 1.5 times the upper limit of normal. 3. patients who have received preoperative chemotherapy or chemoradiotherapy. 4. patients with a history of a prior malignancy within the past 5 years. 5. women who are pregnant or breast-feeding. 6. patients may not complete the whole schedule of chemotherapy 7. patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Keywords: colon cancer adjuvant chemotherapy high risk
the effect of theobromine on blood lipid parameters in healthy subjects

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters. hypothesis: theobromine has a positive effect on blood lipid parameters.


Eligibility criteria:
inclusion criteria: * apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician) * willing and able to participate in the study protocol * written informed consent * age 40-70 years * 10-year risk of developing chd \<10%, based on data from the framingham heart study * bmi \> 18 and \< 30 kg/m2 * blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician * willing to comply with the dietary restrictions of the study. * accessible veins on arm(s) as determined by examination at screening exclusion criteria: * previous cardiovascular event(s) (stroke, tia, angina, myocardial infarction, heart failure) * diabetes mellitus * reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male) * currently on a medically prescribed diet, or slimming diet * reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination * reported intense sporting activities \> 10 h/w * use of prescribed medication which may interfere with study measurements, as judged by the physician * use of antibiotics in the three months before screening or during the study. * currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself * reported intolerance to test products or other food products provided during the study * blood donation 1 month (males) or 2 months (females) prior to screening and during the study * reported participation in another nutritional or biomedical trial 3 months before screening or during the study. * extreme coffee consumption

Keywords: blood lipids risk factor for cardiovascular diseases
an investigator-initiated clinical study of lm303 injection for the treatment of advanced solid tumours

Conditions: Solid Tumor

Summary: this is a single-arm, open-label, exploratory study to evaluate safety and efficacy of lm303 injection in patients with advanced solid tumors. the purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.


Eligibility criteria:
inclusion criteria: 1. ajcc (v8) stage iii or iv melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment; 2. the patient has residual lesions that can be used for surgical resection (\>1.5cm3) or biopsy (\>1.5cm3) and measurable after resection for til collection and efficacy evaluation; 3. laboratory inspection index requirements: * blood routine: lymphocyte ratio \> 20%; neutrophil count \> 1.0 × 10\^9/l; white blood cells \> 3.0 × 10\^9/l; platelets \> 100 × 10\^9/l; hemoglobin \> 80 g/ l; * liver function: alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (alp) ≤ upper limit of normal x 2.5; total gallbladder red pigment (tbil)≤normal upper limit×1.5; * renal function: urea ≤ upper limit of normal × 1.5; creatinine (cr) ≤ upper limit of normal × 1.5; 4. left ventricular ejection fraction (lvef) ≥ 50%; 5. ecog physical condition is 0 or 1; 6. the expected survival time is more than 3 months; exclusion criteria: 1. suffering from active or previous autoimmune diseases ; 2. severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction; 3. combined with severe infection or persistent infection and cannot be effectively controlled; 4. central nervous system metastasis and/or cancerous meningitis; 5. with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. requires systemic steroid therapy; 7. positive for hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab); positive for hepatitis c virus (hcv) antibody; positive for human immunodeficiency virus (hiv) antibody; positive for syphilis;
clinical study on the treatment of pelvic pain with wearable dual-band led device

Conditions: Pelvic Pain

Summary: this study is a prospective clinical trial, which intends to prospective include female pelvic pain (dysmenorrhea and chronic pelvic pain), screen suitable cases, wear dual-band led devices in non-menstrual period, perform low-dose phototherapy on local pelvic area and acupoints, and observe the changes of pelvic pain and related serological indicators in clinical practice.


Eligibility criteria:
inclusion criteria: * pelvic pain exclusion criteria: * irregular menstrual cycles; * inflammatory disease; * pregnant; * light allergy;

Keywords: led pelvic pain
s-adenosylmethionine therapy for non-alcoholic steatohepatitis

Conditions: Hepatitis

Summary: the purpose of this study is to examine the effect of s-adenosylmethionine therapy in those patients with non-alcoholic liver disease in the form of steatohepatitis (nash). this will be accomplished by development of a database of these patients, all of whom will have biopsy documented nash. a placebo controlled trial will then examine the effect of s-adenosylmethionine over time on clinical outcome in these patients. it is expected that this agent will slow or halt the progression of this disease.


Eligibility criteria:
inclusion criteria: * men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the vamc-louisville.

Keywords: s-adenosylmethionine fatty liver obesity non-alcoholic steatohepatitis
development of 'emma'--a pediatric ibd quiz

Conditions: Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Disease

Summary: we would like to collaborate and further develop an ipad-based, interactive quiz game 'emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. these gaps can be used to improve patient education.


Eligibility criteria:
inclusion criteria: * children 10-18 years of age * diagnosis of crohn's disease or ulcerative colitis * english-speaking * established patient of participating institution exclusion criteria * inability to understand and read english at a grade 5-12 year level, as commensurate to their chronological age * research denial by patient or guardian
study of agn-190584 eye drops to assess safety and efficacy in participants aged 40-80 years with pseudophakic presbyopia

Conditions: Presbyopia

Summary: presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. this study will assess the safety and exploratory efficacy of agn-190584 is in treating participants with pseudophakic presbyopia. agn-190584 is approved (in the united states) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. this study is double-masked meaning that neither the participants nor the study doctors will know who will be given agn-190584 and who will be given vehicle (does not contain treatment drug). study doctors put the participants in 1 of the 2 groups, called treatment arms. each group receives a different treatment. there is a 1 in 3 chance that participants will be assigned to vehicle. approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the us. participants will receive eye drops of agn-190584 or vehicle once daily in the morning in each eye for 14 days. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study. the effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * history of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition. * if a participant has had neodymium-doped yttrium aluminum garnet (nd:yag) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline. * subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score \>= 3) on at least 1 question on 25-item national eye institute visual function questionnaire (nei vfq-25) questions 5 to 7 in the main questionnaire or near vision subscale, questions a3 to a5 in the appendix of optional additional questions at the screening visit. * best distance correction at screening in the range of spherical -1.50 d to +1.00 d inclusively and cylinder \<= ±2.00 d with photopic high contrast binocular corrected distance visual acuity (cdva) of 20/25 or better at the screening and baseline visits. * mesopic, high contrast binocular distance-corrected near visual acuity (dcnva) no better than 20/40 (j3) at screening and baseline visits. exclusion criteria: - presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).

Keywords: presbyopia pseudophakic presbyopia agn-190584 aries pilocarpine hcl
the effect of obesity on growth hormone response to anaerobic exercise

Conditions: Obesity

Summary: the aim of the present study is to asses the effect of obesity on anaerobic exercise's growth hormone (gh) response.

exercise is a potent physiological stimulator of growth hormone (gh) release. gh is an important factor in the distribution of fat and lean tissue in the body. previous studies suggested that the gh response to aerobic exercise may be attenuated by obesity. the effect of obesity on gh response to anaerobic effort is unclear. the aim of the present study is to asses the effect of obesity on anaerobic exercise's gh response. we will recruit 12 obese (bmi \> 30) healthy adults and 12 age and gender matched normal weight (bmi \< 25) controls. all the participants will conduct a "wingate" anaerobic test (30 seconds of intense effort against resistance calculated by the individual's body weight). blood sample for gh level will be collected at 5 different time (0, 20, 30, 40 and 60 minutes after the test). we will compare the gh response in the two groups.

Eligibility criteria:
inclusion criteria: * healthy female * age 18-40 exclusion criteria: * male * age \ 40 * heart, liver, kidney or hypophyseal disease * medications that may alter gh secretion (eg steroids, eltroxin)

Keywords: obesity growth hormone secretion anaerobic exercise
use of a selected mixture of probiotic strains for degrading gluten during digestion

Conditions: Probiotics

Summary: gluten intake spreads worldwide, being the major food protein consumed in the western diets (up to 20 g gluten/d). but gluten has unique and unusual features. it resists the complete luminal digestion by gastric, pancreatic and intestinal brush border enzymes, and is susceptible to post-translational modification (deamidation) by mucosal transglutaminases. apart from partial digestion, gluten per se has a negative impact on a consistent part of the worldwide population, which mainly results in the manifestations of celiac disease (cd) or other gluten-related disorders. this study will enable to test in vivo a novel multi-species probiotic that in vitro has proven to degrade gluten to non-immunotoxic peptides.

hypothesis and significance: the project intends to confirm whether the novel multi-species probiotic preparation has the ability to degrade gluten upon digestion at increasing dosages (from 50mg/d up to 10g/d). further we aim to evaluate the efficiency of the probiotic to persist and colonize the human gut as well as its ability to modulate the human gut microbiome. since this is a phase 1 trial, healthy participants will be recruited to avoid any triggers of cd symptoms. participants will undergo gluten free diet for 10 days to eliminate any traces of gluten from their feces and will be provided probiotic/placebo capsules as long as specific amounts of gluten to be ingested with their meal. faecal samples will be collected at the end of each period that increasing gluten amounts were ingested. residual gluten amounts in feces will be evaluated and the fecal microbiome will be studied by 16s metabarcoding analysis. fecal metabolome will be also assessed as long as the persistence and colonisation ability of the probiotic preparation by qpcr. specific aim 1: evaluate the gluten depredating efficiency of the probiotic by elisa specific aim 2: investigate the gut microbiome alterations between the intervention groups and possible modulation specific aim 2: investigate the fecal metabolome (volatiles and short chain fatty acids) between intervention groups specific aim 2: monitor the persistence and colonization ability of the probiotic preparation by qpcr

Eligibility criteria:
inclusion criteria: * healthy individuals; * adherent to mediterranean diet exclusion criteria: * known medical disease; * known digestive disease symptoms; * known family history of celiac disease (cd); * wheat allergy; * and use of prescription medications (including antibiotics or probiotics in the previous 2 months)

Keywords: gluten gut microbiome celiac disease
nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer

Conditions: Breast Cancer; Lung Cancer; Nausea and Vomiting

Summary: rationale: understanding how nausea or vomiting caused by chemotherapy effects a patient's treatment decisions may help doctors plan better cancer treatment and may help patients live more comfortably. purpose: this clinical trial is studying nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer.

objectives: * determine the contribution of nausea or vomiting to the overall importance for a current state of health in patients with breast or lung cancer undergoing chemotherapy. * determine the average importance for various emetic scenarios in these patients. * compare the importance of a specific level of chemotherapy-induced nausea or vomiting, defined by the standard gamble vs morrow assessment of nausea and emesis. * determine the feasibility of using a standard gamble technique in patients currently undergoing chemotherapy. outline: this is a multicenter study. patients are stratified according to history of chemotherapy-induced nausea or vomiting (yes vs no). patients undergo a structured interview over 1 hour by a trained interviewer at least 2½ weeks after initiation of the most recent course of chemotherapy and before the new course is administered. patients complete a functional assessment of cancer therapy-general questionnaire and morrow assessment of nausea and emesis questionnaire during the interview. the trained interviewer also administers a standard gamble exercise during the interview, in which patients are instructed to imagine various amounts of nausea or vomiting as their current state of nausea and vomiting, and rank their importance to them. they are being asked to answer the question of whether they would choose to accept their current (imagined or real) state of nausea or vomiting or receive a medication that would result (with various probabilities) in either perfect health for 2 years or immediate death.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer or lung cancer * must be undergoing chemotherapy with each course lasting 3-6 weeks and meets all of the following criteria: * completed ≥ 1 course with ≥ 1 additional course planned * at least 2½ weeks since initiation of the most recent course of chemotherapy patient characteristics: * common toxicity criteria performance status 0-2 * must have command of written and/or spoken english prior concurrent therapy: * see disease characteristics

Keywords: nausea and vomiting pulmonary carcinoid tumor recurrent breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer recurrent non-small cell lung cancer stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer