Kornimate/medical-research-clean huggingface dataset:
as-oct study in diabetic retinopathy

Conditions: Diabetes Mellitus

Summary: this study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus

to investigate the potential role of anterior segment-optical coherence tomography (as-oct) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination. the as-oct could represents a valid early biomarker in these patients.

Eligibility criteria:
inclusion criteria: * age older than 50 years * diagnosis of previous type 2 diabetes mellitus * absence of signs of diabetic retinopathy * absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * absence of significant lens opacities, low-quality oct and oct-a images exclusion criteria: * age younger than 50 years * absence of previous diagnosis of type 2 diabetes mellitus * presence of signs of diabetic retinopathy * presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * presence of significant lens opacities, low-quality oct and oct-a images.
weaning of immunosuppression in nephritis of lupus

Conditions: Nephritis of Lupus

Summary: the investigators wish to evaluate the discontinuation of maintenance immunosuppressive treatment after 2 years in patients with stable remission after a proliferative lupus nephritis. the patients will be continuing their treatment with hydroxychloroquine, possibly associated with low dose corticosteroids.

open multicenter randomized non-inferiority study, comparing 2 types of therapeutic strategies after 2 years of maintenance treatment: * group i: continuation of immunosuppressive therapy with mmf or aza, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids. * group ii: immunosuppressive treatment discontinuation, continuation of hydroxychloroquine, and possibly low-dose corticosteroids (15 mg / day).

Eligibility criteria:
inclusion criteria: * at least 18-years-old patient, woman or man, * patient having a lupus according to the criteria of the acr, * patient having presented a glomérulonéphrite lupique proliférative (class iii or iv has +/-c, +/-list(classify) v) - first push or relapse - proved by renal biopsy, * patient having received for this push a treatment of attack by steroids with strong doses and cyclophosphamide or mycophénolate mofétil, * patient in the course of treatment of interview(maintenance) by azathioprine or mycophénolate mofétil for at least 2 years, and at most for 3 years, with at the time of the inclusion, mycophénolate mofétil? 1 gram / day or azathioprine? 50 in the daytime, * patient in reply renal complete or partial (criteria of the european, secondary consensus 2) since? 12 months, * patient under plaquenil ® since? 6 months with a hydroxychloroquinémie = 750 µg / l, * patient having accepted of participated in the study and having signed a lit(enlightened) consent. exclusion criteria: * patient presenting a severe chronic renal insufficiency (dfg estimated(esteemed) by mdrd \< 30 ml / min / 1.73m ²), * patient having presented an extra-renal push having required an increase of corticoids à\> 20 in the daytime during at least 7 days less than 6 months ago, * patient presenting a contraindication to the hydroxychloroquine, * unaffiliated patient in a national social security, * minor patient.
a safety and efficacy study of nac in patients with ta-tma

Conditions: Thrombotic Microangiopathies; Hematologic Diseases

Summary: hsct associated thrombotic microangiopathy(ta-tma) is a heterogeneous, fatal disorder seen within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal failure, mental status changes and involvement of other organs. n-acetylcysteine (nac) is a small, simple molecule that began as a generic drug almost 40 years ago. it has since been approved by the fda for many indications. the investigators conducted an prospective clinical trial to evaluate the safety and efficiency of nac in patients with ta-tma.

hematopoietic stem cell transplantation (hsct) has been commonly used as a potentially curative option in the treatment of various hematological malignancies. however, it may end up with serious complications in various systems, including the hemostatic system. hsct associated thrombotic microangiopathy(ta-tma) is a heterogeneous, fatal disorder seen within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal failure, mental status changes and involvement of other organs. since the pathophysiology has not been clarified, there are no established treatments for ta-tma several agents seem to have successful results. n-acetylcysteine (nac) is a small, simple molecule that began as a generic drug almost 40 years ago. it has since been approved by the fda for many indications. studies showed nac reduce plasma vwf multimers and vwf multimeric size without an effect on the bleeding time in vitro and in vivo, thus proposed as a possible supplementary treatment for ttp. the investigators conducted an prospective clinical trial to evaluate the safety and efficiency of nac in patients with ta-tma.

Eligibility criteria:
inclusion criteria: 1. patients be scheduled to undergo hsct; 2. not received decitabine 6 month ago; 3. without severe organ damage; 4. ecog 0-2; 5. informed consent were obtained. exclusion criteria: 1. be sensitive to nac; 2. bronchial asthma； 3. peptic ulcer； 4. severe organ damage； 5. pregnancy and breastfeeding women；

Keywords: n-acetylcysteine complement thrombotic microangiopathies
evaluation of graft material in coronary artery bypass grafting (cabg)

Conditions: Angina Pectoris

Summary: the aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting. the hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.

patients undergoing coronary artery bypass grafting are included in the study. each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. the left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion. the evaluation is made with angiography up to 5 years after surgery.

Eligibility criteria:
inclusion criteria: * isolated coronary artery disease embracing all three main branches of the coronary artery tree. exclusion criteria: * kidney insufficiency (creatinine \> 120 µmol/l) * war-farin anticoagulation therapy * ejection fraction \< 40% * repeat operation * other concurrent sur-gery * signs of reduced circulation in non-dominant hand * other severe illness, or if the patient declines to participate.

Keywords: cabg lima saphenous vein radial artery
omitting biopsy of sentinel lymph node with radiation after neoadjuvant chemotherapy in breast cancer (obserb) trial

Conditions: Breast Neoplasm Female; Lymphatic Metastasis

Summary: the obserb study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with ct1-3n1 and ycn0 breast cancer.

the obserb study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cn1 was conversed as ycn0 after neoadjuvant chemotherapy. to verify whether, the radiotherapy without sln can be applied, when the cn1 was conversed as ycn0 after neoadjuvant chemotherapy. to verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes to verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cn1 was conversed as ycn0 after neoadjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: 1. women aged \> 20 years 2. ct1-3n1m0, primary invasive 3. initially confirmed aln by fine needle aspiration cytology before neoadjuvant chemotherapy 4. completion of neoadjuvant chemotherapy 5. tumors negative for ln metastasis confirmed by imaging after neoadjuvant chemotherapy exclusion criteria: 1. synchronous distant metastases 2. previous other malignancy 3. bilateral breast cancer 4. previous primary systemic therapy 5. pregnancy or breastfeeding 6. pre-operative radiological evidence of multiple involved or suspicious axillary nodes 7. patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

Keywords: breast cancer cn1, ycn0 neoadjuvant cheotherapy sentinel lymph node radiotherapy
endothelial microparticles in systemic sclerosis pulmonary hypertension

Conditions: Systemic Sclerosis; Pulmonary Hypertension; Scleroderma

Summary: systemic sclerosis (ssc, also known as scleroderma) is a disease characterized by fibrosis of the skin and organs, inflammation, and an abnormal endothelial cell lining inside of vessels. a common and deadly complication of ssc is pulmonary hypertension (ph), which is an abnormal elevation in the blood pressure within the lung blood vessels. early identification and treatment of ph is important in ssc, and no clinical factors can predict which patients will develop ph with acceptable accuracy. a potential marker of ph in ssc is the presence of increased amounts of endothelial microparticles (emps), which are substances circulating in the blood that were released from damaged vessel wall endothelial lining. a main goal of this study is to investigate if there is a difference in emp levels between ssc patients with and without ph. the investigators will also use human endothelial cells in a lab environment to test whether these emps isolated from ssc patients are actually causing damage to the vessel lining. lastly, the investigators will investigate the potential benefit of a medication used after transplant, mycophenolate mofetil (mmf). this will be done by causing damage to isolated human endothelial cells and treating them with mmf. the main goal of this portion of our study is to see if emp levels are reduced when cells are treated with mmf. overall, the investigators anticipate the following outcomes of this study: 1) use emp levels to differentiation patients with ssc who have ph from those without ph, 2) use emps to understand how endothelial damage occurs in ssc, and 3) use emps to help us develop new treatments for patients with vascular diseases.


Eligibility criteria:
for systemic sclerosis subjects: inclusion criteria: * age \>18 years * meet american college of rheumatology criteria for systemic sclerosis exclusion criteria: * chronic kidney disease (estimated creatinine clearance \<50ml/min) * uncontrolled hypertension (diastolic blood pressure\>120mmhg) * acute coronary syndrome within the past 6 months * chronic obstructive pulmonary disease * diabetes mellitus * hemolytic anemia * active tobacco abuse for healthy control subjects: inclusion criteria: * age\>18 years * age- and sex-matched to ssc patients exclusion criteria: * coronary artery disease * uncontrolled hypertension (diastolic blood pressure\>120mmhg) * chronic obstructive pulmonary disease * chronic kidney disease * diabetes mellitus * hemolytic anemia * active tobacco abuse
phase i single-dose escalation clinical trial of salvianolic acid a tablets

Conditions: Neuropathy of Diabetes

Summary: salvianolic acid a has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. professor du guanhua, at institue of materia medica, chinese academy of medical sciences, first discovered that salvianolic acid a can alleviate diabetic complications and improve patients' quality of life. with the support of major national science and technology projects, the preclinical research work of salvianolic acid a was completed, and the application was approved by the state food and drug administration (clinical approval no.: 2016l06293). peking university first hospital was used as the research unit. this study is the first human clinical trial of the drug. the project leader of this study is professor cui yimin from peking university first hospital. the sponsor of this project is shandong huizhi pharmaceutical technology co., ltd.


Eligibility criteria:
inclusion criteria: * 1) gender: male or female, healthy volunteers; 2) age: 18\~45 years old; 3) weight: male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass index \[bmi = weight (kg) / height 2 (m2)\] in the range of 19 \~ 25 kg / m2; 4) subjects must give informed consent to the trial prior to the trial and voluntarily sign a written informed consent form; 5) the subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol. exclusion criteria: * (1) hepatitis b surface antigen, hepatitis c virus, human immunodeficiency virus and syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of drugs within 2 weeks before screening (4) blood donors within 3 months prior to the trial; (5) participated in any drug clinical trial within 3 months prior to screening; (6) had a clear history of allergic disease; (7) had central nervous system, cardiovascular systematic, kidney, liver, digestive tract, lung disease, metabolic and skeletal muscle system with a clear history or other significant disease; (8) pregnant, lactating women; (9) other factors not suitable for participation in the study.
radiation therapy and docetaxel followed by standard therapy in treating women with breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. purpose: this phase i trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.

objectives: primary * evaluate the tolerance to concurrent neoadjuvant docetaxel and cyberknife hypofractionated radiotherapy followed by standard treatment in women with breast cancer in order to find the maximum-tolerated dose of radiotherapy. secondary * evaluate the efficacy of the combination chemoradiotherapy. * evaluate breast-conserving surgery. * evaluate the quality of life. outline: this is a dose-escalation study of cyberknife hypofractionated radiotherapy. patients receive neoadjuvant docetaxel iv on day 1. treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. beginning during the first or second course of neoadjuvant chemotherapy, patients undergo hypofractionated radiotherapy. patients then receive standard chemotherapy comprising epirubicin hydrochloride iv, cyclophosphamide iv, and fluorouracil iv on day 1. treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. patients undergo surgery 4-8 weeks after the last course of chemotherapy, and then undergo standard radiotherapy.

Eligibility criteria:
disease characteristics: * histologically confirmed diagnosis of breast cancer * unifocal disease * non-metastatic disease * not a candidate for breast-conserving surgery * no superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm) * undergone mri of the breast to define the macroscopic tumor volume * undergone scanning of the breast to mark the location for radiotherapy patient characteristics: * who performance status 0-2 * not pregnant or nursing * fertile patients must use effective contraception during and for 6 months after completion of study treatment * no counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of an implantable venous device * no patient for whom clinical follow up is impossible for psychological, familial, social, or geographical reasons * no patients deprived of liberty or under trusteeship prior concurrent therapy: * no prior ipsilateral breast irradiation

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer recurrent breast cancer
safety study of mm-121 in combination with multiple anticancer therapies in patients with advanced solid tumors

Conditions: Solid Tumors

Summary: to evaluate the safety and tolerability of escalating doses of mm-121 + certain anticancer therapies

this study was a phase 1 and pharmacologic dose-escalation trial of mm-121 in combination with certain anticancer therapies. the dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of mm-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. doses of mm-121 and/or the anticancer therapy were escalated until either the mtd is identified or the combination was shown to be tolerable at the highest planned doses.

Eligibility criteria:
inclusion criteria: * advanced-stage solid tumors * ≥ 18 years of age * adequate liver and kidney function exclusion criteria: * any other active malignancy * no known hiv, hepatitis c or b

Keywords: advanced-stage solid tumors mm-121 carboplatin pemetrexed gemcitabine cabazitaxel erbb3 phase i cancer
comparison of transfers of fresh and thawed embryos in normal responder patients

Conditions: Infertility

Summary: this study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.

the purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (ptec) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation. multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation. ptec cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. once thawed, the embryos are cultured to the blastocyst stage before transfer. in typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. ptec ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw). the viability of a blastocyst in a ptec cycle has been shown to be on par with that of a fresh blastocyst. therefore, comparing outcomes of blastocyst transfers in ptec cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.

Eligibility criteria:
inclusion criteria: * female patient 18 to 40 years of age seeking their first ivf treatment. * cycle day 3 fsh less than 10.0 iu/l. * 8 to 15 antral follicles observed on ultrasound. exclusion criteria: * failure to follow the protocol. * embryo biopsy. * any prior ivf cycle(s).

Keywords: blastocyst transfer endometrial receptivity ivf in vitro fertilization embryo cryopreservation
evaluation of mild tbi in collegiate athletes

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.


Eligibility criteria:
inclusion criteria: 1. university of florida student athlete involved in men's football, men and women's basketball, men and women's swimming, men and women's diving, women's soccer, or women's lacrosse or university of florida student athlete not participating in those sports who is being treated for a sports-related head injury. 2. age greater than or equal to 18 years of age. 3. willing to undergo the informed consent process and provide informed consent prior to enrollment into the study. exclusion criteria: * subject is otherwise determined by the investigator to be medically unsuitable for participation in the study

Keywords: traumatic brain injury sports head injury sports concussion
cross-sectional survey of zhejiang ecmo application

Conditions: Extracorporeal Membrane Oxygenation; Cardiopulmonary Resuscitation; Epidemiology

Summary: extracorporeal lung oxygenation (ecmo) was first used in neonates in the 1970s and is now widely used to treat adult patients with intractable shock and respiratory failure who have failed various types of conventional life support. according to the extracorporeal life support organization (elso), a total of 61,193 adult patients worldwide received ecmo in 2019. according to the extracorporeal life support organization (elso), a total of 61,193 adult patients were treated with ecmo worldwide in 2019, including 25,631 vv-ecom, 12,836 va, and 5086 ecpr. the number of ecmo cases and hospitals in zhejiang province are increasing year by year, and they play an irreplaceable role in various critical care resuscitation, especially in response to public emergencies, but there is a lack of precise data on the current status of ecmo implementation. this study aims to investigate the implementation of ecmo, problems and needs of hospitals at all levels in zhejiang province, and provide reference for further improving the capacity and quality of ecmo application in the province.

this is a multicenter cross-sectional survey study ,was conducted jointly by the zhejiang emergency medicine quality control center, the zhejiang medical emergency medicine branch and the zhejiang physicians association emergency physicians branch. the survey covers the general situation and ecmo implementation in general public hospitals at the county and district level in zhejiang province, including people's hospitals, chinese medicine hospitals and above.

Eligibility criteria:
inclusion criteria: * all general hospitals at the first people's hospital and above at the county and district level in zhejiang province exclusion criteria: * hospitals that explicitly do not wish to participate

Keywords: extracorporeal membrane oxygenation epidemiology