Kornimate/medical-research-clean huggingface dataset:
tear based sample collection breast cancer detection

Conditions: Breast Cancer; Tear; Breast Cancer Female

Summary: this study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

namida lab, inc. is a biotechnology company located in fayetteville, ar, with a certified, high-complexity clia lab. in january of 2021, namida lab, inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. the validation process was carried out manually and now needs to be conducted on the hamilton starplus automated elisa system. to complete the robot validation, namida lab, inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.

Eligibility criteria:
inclusion criteria: * individual is an adult woman and has recently been diagnosed with breast cancer. exclusion criteria: * individual is excluded if they have already started treatment for the breast cancer diagnosis. * age less than 18 or more than 100 years.

Keywords: preventative screening protein biomarkers lacrimal tear fluid mammography elisa assay clia laboratory lab developed test high complexity tear collection mammogram improved patient outcomes reduce gap in access health equity total cost of care trust from patient increased compliance affordable low cost non-invasive women's health and wellness breast health breast cancer screening test
study of teduglutide effectiveness in parenteral nutrition (pn)-dependent short bowel syndrome (sbs) subjects

Conditions: Short Bowel Syndrome

Summary: teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (pn) dependent short bowel syndrome (sbs). teduglutide is similar to a protein the body makes. when people have sbs, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. this study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in sbs subjects.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent prior to any study-related procedures are performed * men and women 18 years of age or older at the time of informed consent signing * intestinal failure resulting in short bowel syndrome * at least 12 months of continuous pn dependency * 12 weeks of clinical remission of crohn's disease (cd) prior to dosing * pn required at least 3 times weekly * a stable pn volume for four weeks prior to dosing exclusion criteria: * history of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state * participation in clinical study within 30 days for drug or 90 days for antibody * use of native glp-2 or human growth hormone (hgh) within 6 months of screening * use of iv glutamine within 30 days prior to screening * use of teduglutide * cd patients who have been treated with biological therapy within 6 months of screening * ibd patients who require chronic systemic immunosuppressant therapy * more than 4 sbs- or pn-related hospitalizations within 12 months of screening * unplanned hospitalization within one month of screening * pregnant or lactating women * body weight \> 88kg * body mass index (bmi) \< 15 kg/m2 * severe hepatic impairment or disturbed renal function * female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period * not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements * any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results * significant active, uncontrolled, untreated systemic diseases

Keywords: sbs short bowel syndrome tpn parenteral nutrition pn
vaccine responses in patient with multiple myeloma and non-hodgkin lymphoma after car-t treatment

Conditions: Chronic Lymphocytic Leukemia; Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Multiple Myeloma; Primary Mediastinal Large B-Cell Lymphoma; Small Lymphocytic Lymphoma

Summary: this study evaluates immune responses after car-t therapy to find out if car-t therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-hodgkin lymphoma.

primary objectives: i. to assess positive vpd antibody (ab) titers prior to and at 6 months after car-t therapy to evaluate the impact of car-t on immune responses in patients undergoing car-t therapy. ii. to assess the change in ab titer to s. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination cd4+ count and igg level. outline: this is an observational study. patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. patients undergo blood sample collection and have medical records reviewed throughout the study.

Eligibility criteria:
inclusion criteria: * \* willingness to provide written informed consent before any study-specific procedures or activities are performed * age ≥ 18 years of age, at the time of consent * documented, histologically or cytologically confirmed diagnosis of multiple myeloma (mm), diffuse large b cell lymphoma (dlbcl),follicular lymphoma (fl), mantle cell lymphoma (mcl), chronic lymphocytic leukemia (cll), or small lymphocytic lymphoma (sll), or primary mediastinal b cell lymphoma (pmbl). all number of prior lines of therapy are allowed * history of prior vaccination against common vpd * approved by managing physician for car-t therapy, with preparative conditioning planned within the next 90 days * approved by managing physician for revaccination against streptococcus pneumoniae or tetanus exclusion criteria: * \* ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints * uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable
surgical prevention of anastomotic recurrence by excluding mesentery in crohn's disease

Conditions: Crohn Disease

Summary: kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for crohn's disease (cd). this tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis. in a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery. aim of this trial is to compare the outcomes of the kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.


Eligibility criteria:
inclusion criteria: * patients with crohn's disease requiring ileocecal resection exclusion criteria: * age \> 75 years * age \< 18 years * inability to give the consent to the participation in the trial * refusal to participate in the trial after receiving accurate information

Keywords: crohn disease ileocecal resection anastomosis kono
impact of emergency department probiotic (lgg) treatment of pediatric gastroenteritis

Conditions: Gastroenteritis

Summary: the investigators will study the efficacy and side effect profile of lgg, a probiotic, in pediatric patients with acute gastroenteritis.

multicenter randomized controlled trial of lgg in patients 3-48 months of age presenting to the emergency department with acute gastroenteritis.

Eligibility criteria:
inclusion criteria: 1. age 3-48 months (have not yet reached their fourth birthday); and 2. presence of 3 or more watery stools within 24 hours of screening; and 3. duration of vomiting or diarrhea less than 7 days; and 4. symptoms consistent with acute intestinal infectious process. exclusion criteria: 1. presence of an indwelling vascular access line; or 2. presence of structural heart disease excluding non-pathological heart murmurs; or 3. receiving immunosuppressive therapy or history of immunodeficiency; or 4. hematochezia in the preceding 48 hours; or 5. chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); or 6. patients with known pancreatitis; or 7. history of abdominal surgery; or 8. critically ill patients; or 9. family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; or 10. bilious emesis; or 11. probiotic use (supplement) in the preceding 2 weeks; or 12. oral or intravenous steroid use in the preceding six months; or 13. previously enrolled in this trial; or 14. allergy to lactobacillus or microcrystalline cellulose (mcc); or 15. allergy to erythromycin, clindamycin, and betalactam antibiotics (all); or 16. not available for daily follow-up while symptomatic; or 17. parent/guardian not speaking english or spanish; or 18. under 6 months old and premature (\<37 weeks).

Keywords: lactobacillus rhamnosus gg lgg probiotic gastroenteritis acute gastroenteritis child pediatric rct
probiotic supplementation reduces gastrointestinal symptoms during the therapy and improves therapeutic response in al amyloidosis

Conditions: Immunoglobulin Light-chain Amyloidosis

Summary: the purpose of this clinical trial is to evaluate whether specific probiotic can reduce gastrointestinal symptoms and improves therapeutic response, on a background of bortezomib+dexamethasone or bortezomib+dexamethasone combined with daratumumab therapy, for naive al amyloidosis patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * biopsy-proven naive al amyloidosis * receive at least 1 course of treatment based on bortezomib+dexamethasone or bortezomib+dexamethasone+daratumumab therapy * at least 1 organ (heart, kidney, liver, etc) involved * agree to participate in the project and sign the informed consent. exclusion criteria: * received antibiotics for 3 consecutive days and on in the past 2 months prior to the enrollment * had history of probiotics, prebiotics, immunosuppressants, hormones, and other medications use in the past 3 months that influence the gastrointestinal microbiome * had other underlying diseases（malignancy or immune system diseases, etc.） * had history of clearly diagnosed chronic gastrointestinal disease * secondary al amyloidosis or local al amyloidosis * other conditions the researcher judged unsuitable for enrollment
belgian infective endocarditis registry

Conditions: Infective Endocarditis

Summary: the objective of this prospective observational registry is to study patients di-agnosed with infective endocarditis (ie) and to gather comprehensive long-term outcome data, including mortality rates and ie-related complications (e.g., thromboembolic events, (hospitalization for) heart failure, valve surgery and ie recurrence) at one, three-, and five-years post-enrollment. additionally, the registry will document epidemiological characteristics, clinical presentation at baseline, biochemical and microbiological profiles, relevant comorbidities and risk factors, diagnostic strategies, and therapeutic interventions, including an-timicrobial therapy and surgical procedures.


Eligibility criteria:
\> 18 yo
immunonutrition and colorectal adenocarcinoma surgery - incas study

Conditions: Colorectal Adenocarcinoma

Summary: compared to upper gastrointestinal (gi) malignancies, crc patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of crc. therefore, in the latter surgery may not be offered with curative intent. based on the current evidence, the role of oin appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. regarding not malnourished patients, there is still no clear correlation between oin and decrease in post-operative complications. furthermore, whether oin increases immune response within the tumour microenvironment is based on studies with poor number of patients.

randomized, controlled, open-label, single-centre study in patients candidate for elective curative surgery for colon-rectal cancer. the study intervention consists of the oral nutritional supplementation enriched with immune-nutrients delivered before and after surgery in addition to standard dietary advice according to e.r.a.s. protocol. all patients will follow low-fiber diet according to eras protocol during the study period. patients assigned to the experimental arm will assume also impact oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by nestlé health science s.p.a. it is a liquid drink packaged in a brick of 237 ml. patients will assume impact oral® for 5 days before surgery and 5 day after surgery.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years or older; * histologically confirmed adenocarcinoma of colon or rectum; * eligible for elective curative surgery with indication of colon and/or rectal resection in laparoscopy with mini-invasive technique; * eligible for eras protocol; * written informed consent to the study participation according to the local ethic committee requirements before any study procedure; exclusion criteria: * colon or rectal resection for benign disease; * tnm stage ≥4; * neoadjuvant radio and/or chemotherapy * asa score \> 3; * contraindications to oral nutrition (e.g. dysphagia, pyloric stenosis) or hypersensitivity to any ingredient of study product; * albuminemia \< 3.0 g/l; * weight loss \> 10% in the last 3-6 months; * bmi \< 18.5 kg/m2; * pregnant or breastfeeding; * not self-sufficient or with poor family compliance; * congenital or acquired immunodeficiency; * active uncontrolled pre-operative infections or other clinically relevant concomitant illness that preclude laparoscopic procedure; * bowel obstruction or parenteral nutrition or gastric tube;
the comparison of xelox and eox in the first-line treatment of advanced gastric cancer

Conditions: Gastric Cancer

Summary: this study is designed to compare the efficacy and safety of xelox regimen with eox regimen in the first-line treatment of advanced gastric cancer patients.

this study is designed to compare the efficacy and safety of xelox regimen with eox regimen in the first-line treatment of advanced gastric cancer patients.

Eligibility criteria:
major inclusion criteria * had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic * measurable disease, according to the response evaluation criteria in solid tumors (recist)1.1 * an eastern cooperative oncology group performance status of 0 to 2 * adequate renal, hepatic, and hematologic function major exclusion criteria * previous chemotherapy or radiotherapy (unless in the adjuvant setting) * uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer * accumulated dose of epirubicin exceeds 300mg/m2 * her2 positive and willing to use trastuzumab
exploration of mesocorticolimbic pathway in impulse control disorders in parkinson's disease: study using tensor diffusion imaging and tractography.

Conditions: Parkinson's Disease; Impulse Control Disorders

Summary: impulse control disorders (icd) are frequent in parkinson's disease. neurobiological substrates of these symptoms are largely unknown. the investigators aim to explore mesocorticolimbic pathway in parkinson's disease patients with impulse control disorders (icd) using an mri technique called tensor diffusion imaging (dti). more precisely, the main purpose is to demonstrate that fractional anisotropy (fa) (data obtained with dti) in the ventral tegmental area (vta) is different between patients with icd and patients without icd. secondary objectives are to demonstrate a difference in volume of vta, in fa in others structures included in reward system (prefrontal cortex, nucleus accumbens, amygdala), and in number of fibers between vta and the other structures of reward system between this two groups. other objective is to measure and compare these same variables between parkinson's patients and healthy controls. we hypothesized that a denervation of mesocorticolimbic pathway predisposes parkinson's patients to icd.

type of study: prospective, case control study. number of centers: 1 (clermont-ferrand) patients : inclusion of 25 patients with parkinson's disease and impulse control disorders (inclusion's criteria detailed later), 25 matched parkinson's disease patients without impulse control disorders and 25 healthy volunteers. study performance : j0 (inclusion; 3 hours) : each subject will perform a clinical and neurological examination (updrs) and a neuropsychological evaluation for diagnostic and quantification of impulse control disorders and to ensure of the absence of exclusion criteria. j0+1week (mri; 1hour) each subject will then have an mri acquisition including anatomical sequences (t1 and t2 weighted sequences) and a diffusion tensor imaging sequence (60 directions). analysis analysis (pre-processing and processing) will be realized with the oxford centre for functional mri of the brain (fmrib) software (fsl).

Eligibility criteria:
inclusion criteria: * parkinson's disease (uk parkinson's disease society brain bank criteria) * from 18 to 85 years old * impulse control disorder (one item icd ≥2 at the scale ecmp : evaluation comportementale de la maladie de parkinson) exclusion criteria: * dementia (mini mental state \< 26 or mattis \< 130) * apathy (lars (lille apathy rating scale) \> 7) * depression (madrs (montgomery and alsberg depression scale) ≥16 * contra indication to mri (claustrophobia, deep brain stimulation, pace maker...)

Keywords: parkinson's disease impulse control disorders diffusion tensor imaging mri mesocorticolimbic pathway
asimadoline for the treatment of post-operative ileus

Conditions: Post-Operative Ileus

Summary: the purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

this randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon resections. subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. one hundred and fourteen subjects were planned, and in the event that a subject was converted from a laparoscopic surgery to an open surgery (laparotomy), that subject would be discontinued from the trial and followed for safety only. the protocol allowed subjects converted to open procedures to be replaced. the first dose was administered approximately 90 minutes pre-operatively, and subsequent dosing was b.i.d. for up to 10 post-operative doses. subjects were dosed with study drug only while in the hospital. after discharge, they were followed for an additional 28 days. total study duration for each patient was approximately 5 to 6 weeks.

Eligibility criteria:
inclusion criteria: * males and females aged 18-80 * must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy * must sign an icf * females of childbearing potential must have a negative pregnancy test at screening exclusion criteria: * subjects with evidence of a biochemical or structural abnormality of the gi tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data * pregnant or breastfeeding females * use of investigational drugs in previous 30 days * refusal to discontinue prohibited concomitant medications * chronic use of prescription narcotics over the previous 6 months
active management for low back pain for 6 to 8 year old schoolchildren

Conditions: Low Back Pain

Summary: the objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. subjects will be taken from a random sample of schools in majorca, spain: private, public and concerted. a 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. schools will be randomly assigned to the study and control groups. in the study group the students will get a back comic-book (promotes active management) after the first assessment. the control group will have no other intervention than the questionnaire.


Eligibility criteria:
inclusion criteria: * students in randomly selected private, public and concerted majorca schools * must be present in class on day of intervention and assessments exclusion criteria: * absent from class on day of intervention and assessments

Keywords: low back pain prevention schoolchildren education campaign