Kornimate/medical-research-clean huggingface dataset:
tear film sars-ncov-2 detection in symptomatic and pauci-symptomatic patients.

Conditions: Covid19; Eye Diseases

Summary: to investigate the presence of sars-ncov-2 in the tear film of symptomatic and pauci-symptomatic sars-ncov-2 positive patients.

the end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling. a sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. in addition, you must complete a questionnaire that assesses the symptoms present.

Eligibility criteria:
inclusion criteria: * subject needs to be above 18 years old. * the subject is willing to undergo sampling of the conjunctiva. * the subject is willing to fill in a questionnaire. * the subject is fluent in written and verbal dutch. * the subject is capable of giving informed consent. * applicable for part 1 only: the subject test positive for sars-ncov-2 on a nasopharyngeal swab. the time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days. exclusion criteria: * allergy to oxybuprocainehydrochloride * pregnancy or lactation
effectiveness of the suicidal crisis intervention (sci)

Conditions: Suicide; Suicidal Ideation; Suicide, Attempted

Summary: the main objective of this project is to be able to offer a new, specific evidence-based short-term treatment method, the suicidal crisis intervention (sci), to reduce suicidality. in addition, this study aims to investigate the influence of sci on other important aspects of suicidality (secondary goal) such as hopelessness, defeat, entrapment, and interpersonal needs.

research has extensively shown that a previous suicide attempt or a history of suicide attempts are important predictors of suicide death. it is therefore important to provide people with appropriate care after a suicide attempt to limit this risk. although this risk factor (previous attempts) is known, the number of interventions developed for this risk group is limited. based on these findings, a short-term treatment trajectory was developed for people after a suicide attempt or a suicidal crisis in flanders, called the suicidal crisis intervention (sci). this was inspired by the assip treatment trajectory and the safety plan was also given a significant place within the treatment. in addition, the importance of relatives and social support is emphasized by involving relatives in this treatment. throughout this treatment, further (treatment) goals are drawn up, in order to generate hope for improvement and to facilitate continuity of care. more information about the concrete content of sci will follow later in this protocol. a pilot study is currently being conducted to assess the feasibility of this treatment, as well as the experience of patients, relatives and care providers. based on this, the sci will be further updated for this effectiveness study. there are currently no specific evidence-based short-term treatment methods in flanders for people after a suicidal crisis or suicide attempt. the primary research question is therefore: 'is the suicidal crisis intervention (sci) in flanders an effective short-term treatment method for people after a suicidal crisis or suicide attempt?'. the main objective of this project is to be able to offer a new, specific short-term treatment method that has been scientifically proven to reduce suicidality. in addition, we want to investigate the influence of sci on other important aspects of suicidality (secondary goal) such as hopelessness, defeat, entrapment, and interpersonal needs.

Eligibility criteria:
inclusion criteria patient: * after a suicide attempt or suicidal crisis * ≥ 18 years * availability of a smartphone, tablet and/or computer with internet access, * dutch-speaking. exclusion criteria patient: * limited comprehension, cognitive impairment * psychotic disorder * unsuitable for individual therapy * receiving other forms of care is not an exclusion criterion. inclusion criteria close one: * close one of the patient * ≥ 18 years * dutch- speaking
a study to evaluate the efficacy of anti-emetic drug upon the combination chemotherapy for non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy of anti-emetic drug aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (nsclc).

the purpose of this study is to evaluate the efficacy of anti-emetic drug aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (nsclc). the incidence and grade of chemotherapy-induced nausea and vomit (cinv) will be assessed in patients receiving aprepitant for the prevention of cinv upon the combination chemotherapy of nedaplatin and docetaxel for nsclc. these data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except aprepitant.

Eligibility criteria:
inclusion criteria: 1. patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer. 2. ecog performance status 0-1. 3. aged 20-79 years old. 4. laboratory values as follows 4000/mm3 \ 2000/mm3, platelet count \> 100000/mm3, hemoglobin \> 9.5g/dl, asparate transaminase \ 60 torr. 5. able and willing to give valid written informed consent. exclusion criteria: 1. allergy against polysorbert 80 or platinum-containing drugs. 2. severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency). 3. active and uncontrolled infectious disease. 4. massive pleural or pericardial effusion. 5. other malignancy requiring treatment. 6. active interstitial pneumonitis or its past historybreastfeeding and pregnancy (woman of child bearing potential) 7. peripheral nerve disorder. 8. pregnant or lactating women. 9. concurrent administration of pimozide. 10. decision of unsuitableness by principal investigator or physician-in-charge
impact: safety and feasibility of a single-stage procedure for focal cartilage lesions of the knee.

Conditions: Foreign-Body Reaction; Inflammation; Effusion (L) Knee; Knee Pain Swelling

Summary: articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. cartilage cell therapy using autologous chondrocyte implantation (aci) has been established as the first advanced treatment therapy medicinal product. although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase. therefore, there is a need for improvement. a new cartilage repair technique should aim at decreasing surgical trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or improving clinical outcome. direct contact between mesenchymal stromal cells (mscs) and dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic phenotype of dedifferentiated articular chondrocytes. in addition, preserving the pericellular matrix of chondrocytes improves cartilage formation. these chondrons (chondrocytes with their pericellular matrix) have shown improved cartilage formation when combined with allogeneic mscs in extensive preclinical studies. the cells are mixed with fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. this will reduce patient morbidity and improve patient care through immediate transplantation of a potent cell-based cartilage product. this is a phase i/ii prospective monocenter study to evaluate the safety and feasibility of the impact for treatment of focal articular cartilage lesions of the knee.


Eligibility criteria:
inclusion criteria: * age \>18 and \<45 years old * symptomatic isolated full-thickness articular cartilage lesion on the femoral condyle or trochlea. * size 2 - 8 cm2 * intact anterior cruciate ligament exclusion criteria: * (history of) osteoarthritis, defined as kellgren-lawrence grade \>3 as determined from appropriate x-ray. * concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis) * (history of) septic arthritis. * malalignment requiring an osteotomy. * (history of) total menisectomy in the target knee joint. * any surgery in the knee joint 6 months prior to study inclusion. * risk groups for mri scanning due to the magnetic field like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding. * patients with severe anxiety for mri scans and/or needles

Keywords: impact chondrons mesenchymal stem cells allogeneic mscs single-stage cartilage repair safety efficacy
usefulness of balanced high protein supplementation on recovery and clinical outcomes after chemotherapy

Conditions: Colorectal Neoplasms

Summary: the goal of this clinical trial is to find usefulness of balanced high protein supplementation on muscle function recovery and clinical outcomes after chemotherapy. participants will intake test or placebo oral nutritional supplements. researchers will compare test groups and placebo groups to see if test oral supplements are more useful in muscle function recovery and clinical outcomes.


Eligibility criteria:
inclusion criteria: * a person aged 19 or older * a person who is diagnosed with direct colorectal cancer and begins chemotherapy * a person who voluntarily agreed to participate in this trial and signed a informed consent form exclusion criteria: * a person who has previously been diagnosed with cancer * a person with a bmi of 30.0 kg/m2 or more * a person who is diabetes mellitus with whose blood sugar is not controlled even when taking medication * more than 126mg/dl of fasting blood sugar even on diabetes medication * a person diagnosed with hypertension whose blood pressure is not controlled even when taking medication * systolic blood pressure 160mmhg or diastolic blood pressure 100mmhg or higher even when taking hypertension medication * a person with renal dysfunction (up 1.5 times the upper limit of creatinine normal) and liver dysfunction (up 2.5 times the upper limit of ast and alt normal) * a person with a serious musculoskeletal problem * a person who has been diagnosed with acute or serious diseases (e.g., liver, kidney, heart, thyroid disease, etc.) or is on medication * a person who has continuously taken health functional foods related to the ability to perform exercise within three months before visiting (hormones, muscle enhancers, protein supplementation and muscle function improvement) * a person who is allergic or overreacting to the ingredients of a test product * all ingredients of the test product shall be specified in the consent form, and all ingredients that may cause allergies, such as sodium casein, shall be checked during screening * a person who has participated in another clinical trial or a drug clinical trial within one month of the commencement of this test * a person who is illiterate or whose ability is limited * a person who is pregnant or lactating * a person judged inappropriate by a researcher to participate in this study for other reasons
video analysis of vaginal deliveries

Conditions: Birth Trauma

Summary: video documentation of vaginal deliveries to evaluate the impact of the support of the perineum

documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.

Eligibility criteria:
inclusion criteria: * pregnant women, * at least 18 years of age (yoa), * term deliveries (at least 37+0 weeks of gestation), * vaginal delivery, * fetal vertex presentation, * single pregnancy exclusion criteria: * younger than 18 yoa, * preterm deliveries, * cesarean sections, * fetal malformations, * maternal disease in form of collagenosis, * multiples pregnancy, * vaginal/vulvar/perineal pre-operations (excluding birth trauma), * perineal birth trauma grade iii+iv

Keywords: perineum videoanalysis
thiamine supplementation in heart failure patients receiving full medical therapy

Conditions: Chronic Heart Failure

Summary: the study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.

the study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle. heart failure patients (left ventricular ejection fraction (lvef ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. all subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. at randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.

Eligibility criteria:
inclusion criteria: * heart failure patients (left ventricular ejection fraction (lvef ≤ 40%) * optimal medical therapy according to the present guidelines for at least 3 months before enrollment. exclusion criteria: * decompensated heart failure * renal failure * copd * asthma * uncontrolled hypertension * bradycardia or tachycardia which needs increase or decrease in medications

Keywords: thiamine heart failure
safety evaluation of biatain ibu in painful chronic venous leg ulcers

Conditions: Leg Ulcers

Summary: the objective of this open label extension study (extension to study dk143ws) is to evaluate the safety of biatain ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.


Eligibility criteria:
inclusion criteria: * the patient has participated in study dk143ws * the patient is able to understand the treatment and is willing to comply with the treat-ment regimen. * the patient is willing and able to give written informed consent exclusion criteria: * pregnant or lactating women * concomitant participation in other studies
the align-ar efs trial: jenavalve pericardial tavr aortic regurgitation study

Conditions: Aortic Regurgitation

Summary: to collect information about treatment for severe aortic regurgitation (ar), which affects the aortic valve in the heart. aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. symptoms of aortic regurgitation may include fatigue and shortness of breath. the preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

this study will examine the use of tavr (transcatheter aortic valve replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. in this study, tavr will be performed using the jenavalve pericardial tavr system, which is intended to help treat severe aortic regurgitation.

Eligibility criteria:
inclusion criteria: * patient with severe aortic regurgitation (ar). * patient at high risk for open surgical valve replacement * patient symptomatic according to nyha functional class ii or higher * the study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board (irb)/ ethics committee (ec) of the respective clinical site. exclusion criteria: * congenital uni or bicuspid aortic valve morphology * previous prosthetic aortic valve (bioprosthesis or mechanical) implant * endocarditis or other active infection * need for urgent or emergent tavr procedure for any reason * cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device * severe mitral regurgitation

Keywords: aortic valve disease aortic regurgitation aortic insufficiency
milk oriented microbiota

Conditions: Microbial Colonization

Summary: the purpose of this study is to determine if supplementing healthy term infants delivered vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.

the purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of decreasing levels of human milk oligosaccharides on fecal b.infantis during and after 21 days of supplementation with evolve activated b.infantis using exclusively breastfed, mixed-fed and exclusively formula-fed infants; 2) determine the effect of evolve activated b.infantis on fecal b.infantis levels in exclusively breastfed infants compared to pre-supplementation levels.

Eligibility criteria:
inclusion criteria: * women with infants age 8 to 12 weeks * term infants born \>37 weeks gestation * mother-infant pairs who live within a 20-mile radius from uc davis campus in davis, ca or within a 20-mile ucdmc * women and infants who live in one location * infants born vaginally * infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed * women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (earth's best organic infant formula with iron, earth's best) throughout the first two months of the study * women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (earth's best organic infant formula with iron, earth's best) for the first two months of the study exclusion criteria: * women who have lived in the united states or other developed nation for less than 10 consecutive years * multiple infants born to one mother * plan to feed infants solid foods before infants turn 5 months of age * family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy * infants born by c-section * infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection * infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth * infants who have taken probiotics since birth * plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study * mothers who have a chronic metabolic disease or obesity * mothers who currently smoke or plan to resume smoking during the study period * infants who consume solid foods or other liquids other than breastmilk, infant formula or water

Keywords: infants probiotic b. infantis
neoadjuvant trastuzumab and letrozole for postmenopausal women

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and her2-positive breast cancer.

eligibility criteria * ages eligible for study: ≥ 20 years * invasive cancer (clinical stage ib-iiib) * measurable tumor larger than 1cm * ecog status 0 or 1 * postmenopausal women * age ≥55 years and amenorrhea * age \ 30 miu/ml * her2 positive tumor * 3 positive on ihc * 2 positive on ihc with her2 gene amplification on fish or sish using a single-probe or dual-probe * estrogen receptor positive tumor * positive er expression with allred score more than ps3/ts8 or modified allred score more than ps4/ts7 * eligible cardiac function * normal heard evaluated by ecg * consider clinically non-significant arrythmia and ischemic change as normal * lvef ≥ 55% measured by echo or muga scan outcome measures * primary end-point * the rate of pathologic complete response (pcr) * no residual invasive cancer in breast * secondary end-point * clinical response rate * safety profiles for the preoperative use of concurrent trastuzumab and letrozole * the rate of breast conservative surgery * total pathologic complete response (tpcr) * no residual invasive cancer in breast and ipsilateral axilla * analysis of biomarkers based on baseline specimen and residual tumor * ki67 expression * cdna microarray: gene expression profiling * association between clinical response rate and circulating tumor cells (ctcs) * ctcs are measured by cytogen (seoul, korea)"

Eligibility criteria:
inclusion criteria: * invasive cancer (clinical stage ib-iiic) * measurable tumor larger than 1cm * ecog status 0 or 1 * postmenopausal women * age ≥55 years and amenorrhea * age \ 30 miu/ml * her2 positive tumor * 3 positive on ihc * 2 positive on ihc with her2 gene amplification on fish or sish using a single-probe or dual-probe * estrogen receptor positive tumor * positive er expression with allred score more than ps3/ts8 or modified allred score more than ps4/ts7 * eligible cardiac function * normal heard evaluated by ecg * consider clinically non-significant arrythmia and ischemic change as normal * lvef ≥ 55% measured by echo or muga scan exclusion criteria: * inflammatory breast cancer * bilateral breast cancer * patients with previous breast cancer history * patients with previous breast cancer treatment: generally include hormone therapy, chemotherapy, and radiotherapy) * patients having uncontrolled heart problems * ischemic heart disease within 6 months * congestive heart failure more than nyha class ii * unstable angina * clinically significant pericarditis * amyloid heart disease

Keywords: breast cancer her2 er postmenopausal trastuzumab letrozole neoadjuvant endocrine treatment
feasibility study of family teamwork peer-delivery

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to 1) convene african american and latino community coalitions to adapt family teamwork (ft) for school-age youth, and integrate ft with the smart and secure children (ssc) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for african american and latino parents of children (5-9 years) with t1d to refine, with community coalitions the adapted and integrated family teamwork- peer delivery (ft-p), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the ft-p program among african american and latino parents of school-aged children (5-9 years) witht1d. a randomized pilot trials will be conducted with african american and latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of ft-p. families will be stratified by race/ethnicity, age, and hba1c strata, and randomized to ft-p plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through baylor college of medicine's institute for clinical training and research data management specialists.


Eligibility criteria:
inclusion criteria: * primary caregiver of a child ages 5-10 years with type 1 diabetes as defined by the american diabetes association criteria * having a child with diabetes duration of \>1 year * self-identified african american or latino race/ethnicity * fluent in english * not planning to leave the geographic area during the study exclusion criterion: • not fluent in english

Keywords: health disparities family teamwork peer-delivered intervention facilitators to diabetes management barriers to diabetes management community-based intervention