Kornimate/medical-research-clean huggingface dataset:
development of a decision-making aid for referring severe kidney injury patients for nephrology consultations

Conditions: Chronic Kidney Diseases; Acute Kidney Injury

Summary: acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease. recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization. risk factors of developing chronic kidney disease between hospital visits are understudied.


Eligibility criteria:
inclusion criteria: * age \>18 years * suffering from acute kidney injury treated with dialysis * hospitalized in a university center from august 2016 to december 2017 with severe aki defined according to 2 of the 3 criterion definitions of kdigo stage aki: an increase in scr above 354 μmol/lor renal replacement therapy (rrt) indication, but not the 3-fold increase in scr increase within 7 days with scr below 354 μmol/l. * the patient has been informed and does not oppose the study * the patient is insured or the beneficiary of a health insurance policy exclusion criteria: * the patients is under judicial protection or state guardianship * patient has chronic kidney disease(ckd) kdigo stage 5 * it proves impossible to give the patient clear information * patients living with kidney transplant * plan dialysis for bilateral surgery nephrectomy * patient refuse to participate and patients with no health insurance
analysis of ameliorative effects of oral probiotics on bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: the purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

to analyze the oral lactobacillus rhamnosus with lactobacillus acidophilus or lactobacillus rhamnosus with lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.

Eligibility criteria:
inclusion criteria: * informed consent form. * subjects with bacterial vaginosis and nugent score as 4-10 * subjects in age of 20-55 years old * regularly menstruating premenopausal women (normal menstrual function (eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days) * forbidden sexual behavior was required 72 hours before all visits exclusion criteria: * subjects are pregnant, lactating or planning to become pregnant. * allergy to test products (raw material components included: anhydrous glucose, magnesium stearate, fructooligosaccharides, microcrystalline cellulose, lactobacillus, etc.) * bleeding from genital tract of unknown aetiology. * congenital and acquired immunodeficiencies. * diabetes * mental illness * malignant tumor * application of nuvaring hormonal contraceptive vaginal ring * application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom * application of hormonal preparations, such as: vagifem, ovestin and vaginal estrogens in reproductive period. * mycotic vaginitis * antibiotic(unless indicated by pi) and steroids therapy during this trial. * use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before v1. * participation in another clinical study.
a phase 1/2 randomized, blinded, placebo controlled study of ipilimumab in combination with epacadostat or placebo in subjects with unresectable or metastatic melanoma

Conditions: Melanoma

Summary: the study design includes an open-label, dose escalation phase followed by a blinded, randomized phase, which combines epacadostat (an oral ido1 inhibitor) with an approved therapy and compares to approved therapy plus placebo in metastatic melanoma patients.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged 18 years or older with unresectable or metastatic melanoma. * a life expectancy of \>12 weeks. * laboratory ranges and medical criteria met, as defined within the protocol. * subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma. * for phase 2 period of the study only, subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy. exclusion criteria: * pregnant or nursing women. * current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-c or nitrosoureas.) * subjects receiving monoamine oxidase inhibitors (maoi)s; subjects who have ever had serotonin syndrome after receiving one or more serotonergic drugs. * subjects who have received prior immune checkpoint inhibitors (eg anti-ctla-4, anti-pd-1, anti- pd-l1 and others) who have had grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other grade 4 immune adverse events (aes) or ocular toxicity * subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis. * subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.

Keywords: melanoma, skin cancer, oncology
transhiatal/transabdominal approach compare with thoracoabdominal approach for siewert ii adenocarcinoma of esophagogastric junction

Conditions: Adenocarcinoma of Esophagogastric Junction

Summary: to compare transhiatal / transabdominal approach with thoracoabdominal approach for siewert ii adenocarcinoma of esophagogastric junction

objective: to compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for siewert ⅱ adenocarcinoma of esophagogastric junction. methods: a prospective, multi-center, randomized, controlled study will be performed. patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. the data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed. the primary endpoints :3-year disease-free survival. the secondary endpoints:(1) surgery and oncology indicators ;(2) the incidences of postoperative complications and mortality.

Eligibility criteria:
inclusion criteria: * 1.18\~75 years old * 2.the tumor center located at the esophagogastric junction(egj) line from 1cm above to 2cm below(siewertⅱ) . * 3.histological diagnosis of adenocarcinoma * 4. american society of anesthesiologists(asa) physical status class is less than or equal to 3 * 5.informed consent of patients exclusion criteria: * 1.patients with distant metastasis (m1) or invasion of surrounding organs * 2.history of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer) * 3.history of other malignant tumors within 5 years * 4.the researcher believes that the patient is not suitable to participate in the clinical trial * 5.patients who persist in withdrawing from clinical trials
development and characterization of functional assays for the analysis of inflammation signaling pathways

Conditions: Autoinflammatory Disease

Summary: auto-inflammatory diseases are part of a heterogeneous group of illnesses manifested by an inflammatory reaction in its initial phase (innate immunity) that is activated inappropriately: either because the reaction is too strong, or because it is not justified (e.g. in the absence of infection). autoinflammatory diseases are often initially described as genetic in origin (i.e. hereditary or familial), and preferentially affect children or young adults. however, the preponderance of auto-inflammation as a cause of symptoms has led to the development of a number of other diseases. in some cases, autoinflammatory diseases may also remain "unclassified". generally speaking, autoinflammatory diseases manifest as recurrent attacks of fever, rash and joint pain. certain signs are more specific to certain diseases, such as urticaria, abdominal pain, mouth ulcers or cervical lymph nodes... it is above all the repetition of the attacks and their unprovoked nature that attract the attention of the patient and the doctor. these attacks are systematically associated with an increase in inflammation markers in the blood. at present, not all inflammation pathways have been identified. with this study, investigator aim to characterize rare autoinflammatory disease variants and develop relevant cellular models to study inflammation pathways.


Eligibility criteria:
for adults : inclusion criteria : * major patient * patient with a rare autoinflammatory disease * patient who has given his or her consent to participate in research exclusion criteria : * patient under legal protection or safeguard of justice or any other protective measure (guardianship, curatorship) * patient with known infection with hepatitis b or c virus or human immunodeficiency virus (hiv) for kids : inclusion criteria : * minor patients (between 4 and 17 years of age) * patient with a rare autoinflammatory disease. * no additional genetic research will be carried out as part of the project. * parents/legal guardians of the child who have given their non-objection to participate in the research. exclusion criteria : * patient under legal protection or safeguard of justice or any other protective measure (guardianship, curators) * patient with known infection with hepatitis b or c virus or human immunodeficiency virus (hiv)
internalized stress in relation to alcohol consumption

Conditions: Stress, Physiological; Ethanol Intoxication; Distress, Emotional

Summary: the proposed study uses an experimental design to establish causal support for the role of internalized stress, pertaining to uncertainty with regard to one's sexual orientation, in contributing to heavy drinking behavior. following exposure to internalized sexual stigma, physiological and psychological stress responses are expected to increase alcohol consumption in adults who are uncertain about their sexual orientation, especially among females, and following consumption, the physiological effects of ethanol and beliefs about the effects of alcohol are expected to alter relations between exposure to sexual stigma and the alleviation of psychological distress. showing that physiological stress responses, whether driven by the pharmacological effects of ethanol or expectancies regarding its effects, can account for known alcohol-use disparities, particularly in bisexual/bi+ communities, would contribute a great deal to knowledge on the biology of addiction and inform subsequent interventions that seek to regulate stress reactivity.


Eligibility criteria:
inclusion criteria: * cisgender * age 21-29 * sexual identity uncertainty (siu; non-zero scores on a published measure). among those with a zero level of siu, only those who report sexual attractions and/or behaviors to both female and male partners (i.e., bisexual/bi+) will be invited to lab sessions. * scores on the alcohol use disorders identification test (audit) that indicate mild or moderate risk for potential alcohol use disorder exclusion criteria: * alcohol naive persons (i.e., those without a history of alcohol use in their lifetime ). * female persons who are currently pregnant (established with urine pregnancy test) or actively trying to get pregnant (self-report in the screening survey). * persons who are currently in treatment or who have ever been in treatment for a substance use disorder. * persons who have essential medications that disallow the consumption of alcohol. * persons with scores on the alcohol use disorders identification test (audit) that indicate high risk for potential alcohol use disorder; national institute of alcohol abuse and alcoholism (niaaa) standard drink equivalencies will be provided in the survey,
secondary prevention after coronary bypass surgery

Conditions: Coronary Artery Disease

Summary: despite immediate symptomatic success after coronary bypass surgery in patients with coronary artery disease, this effect is not sustained over time since risk factors for coronary artery disease are still in place. the role of secondary prevention becomes increasingly important as it can potentially decrease or eliminate the need for another intervention in these high risk subjects. this project seeks to evaluate the effect of emphasizing secondary prevention measures in this patient population during hospital admission and through six months post-discharge.


Eligibility criteria:
inclusion criteria: * subjects over the age of 18 who will undergo a cabg procedure and who have given written informed consent exclusion criteria: * subjects under the age of 18 or who are unable to give consent on their own behald

Keywords: coronary artery disease cabg
clinical study of cd38 car-t cells in the treatment of hematological malignancies

Conditions: AML

Summary: clinical study on the safety and effectiveness of cd38 car-t cells in the treatment of cd38-positive hematological malignancies

the car-t cell injection uses immune cells from healthy donors, and is the final product obtained after car genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. cd38 is highly expressed in myeloid leukemia, and it has been confirmed that the treatment of targeting cd38 has great potential in the treatment of cd38-positive hematological malignancies. the center intends to apply for a clinical trial of cd38 car-t cells to treat cd38-positive hematological malignancies on the basis of preliminary research.

Eligibility criteria:
inclusion criteria: * 1. patients is histologically diagnosed with cd38-positive aml according to the nccn clinical practice guidelines in oncology：acute myeloid leukemia（version 2.2021）; * 2. the diagnosis is consistent with r/r cd38 + aml, and includes any of the following conditions: 1. no cr was obtained after 2 courses of standard chemotherapy 2. the first induction was cr, but the duration of cr was less than 12 months 3. no cr was obtained after the first or multiple remedial treatment 4. relapse twice or more * 3. the number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry); * 4. no active lung infection, inhaled air oxygen saturation ≥92%; * 5. the estimated survival time is more than 3 months; * 6. ecog score was 0-2; * 7. the patients or their legal guardians voluntarily participated in the trial and signed the informed consent. exclusion criteria: * 1. patients with history of epilepsy or other central nervous system diseases; * 2. patients with prolonged qt or severe heart disease; * 3. pregnant or lactating women (the safety of this therapy for unborn children is unknown); * 4. the patients with uncontrolled active infection; * 5. active hepatitis b or hepatitis c virus infection; * 6. previous application of gene therapy; * 7. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 8. serum creatinine \> 2.5mg/dl or alt / ast \> 3 times uln or bilirubin \> 2.0mg/dl; * 9. those who suffer from other uncontrolled diseases are not suitable to join the study; * 10. hiv infection; * 11. any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Keywords: aml cd38 car t-cell therapy
efficacy of artificial intelligence-assisted colonic polyp detection system

Conditions: Adenoma Colon

Summary: this is a randomized controlled multicenter clinical trial of computer-aided detection (cade) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a chinese population. in addition, this study will evaluate the effect of cade system on adenoma detection of endoscopists under fatigue.


Eligibility criteria:
inclusion criteria:patients who need to undergo colonoscopy. - exclusion criteria:patients with crc, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded. -
a 6 months nis to evaluate the use of rescue medication and quality of life in adult asthmatic subjects treated with symbicort® smart®

Conditions: Asthma

Summary: the purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with symbicort smart® (regular dose according to physician's prescription and the current summary of product characteristics - spc) or treated with a free combination of ics plus laba plus as needed saba prescribed by the physician.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1. * patients being prescribed either symbicort smart or a free combination of ics and laba with saba as rescue inhaler and being on that treatment for at least 3 month. * a history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to visit 1. * a severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following: * oral/systemic gcs treatment due to asthma for at least 3 days * unscheduled health-care visit due to asthmahospitalization or emergency room visit because of asthma requiring treatment with oral/systemic gcs exclusion criteria: * intake of oral, rectal, or parenteral gcs within 30 days prior to visit * use of ß-blocking agents * respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.

Keywords: symbicort smart free combination gcs/laba treatment
technology-assisted case management in adults with type 2 diabetes

Conditions: Diabetes

Summary: the purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. patients must be served at a federally qualified health center (fqhc) in coastal south carolina.

the long-term goal is to develop a practical and sustainable system of diabetes management that will help low income patients achieve and maintain goals within established treatment guidelines regardless of geographic location. this randomized clinical trial will employ the innovative fora system, an inexpensive, off-the-shelf, state-of-the-art technology comprised of a 2-in-1 blood glucose and blood pressure monitor, coupled with nurse case management (tacm) to optimize diabetes care for low income, rural adults with type 2 diabetes (t2dm). the target population will be low income patients served in federally qualified health care centers (fqhcs) with poorly controlled t2dm residing in coastal south carolina. two hundred patients will be randomly assigned to two groups of 100 patients each; group a (usual care) and group b (technology-assisted case management, tacm). each patient will be followed for 6 months, with study visits at baseline, 3, and 6 months. the primary outcome will be hemoglobin a1c (hba1c) at 6 months post-randomization while the secondary outcomes will be blood pressure control and quality of life (qol) at 6 months post-randomization.

Eligibility criteria:
inclusion criteria: * age ≥18 years and receiving care within the franklin c. fetter family health center * clinical diagnosis of t2dm and hba1c ≥8% at the screening visit * subject must be willing to use the fora 2-in-1 system * subject must have a working land-line for the duration of the study in order to be able to upload the readings from the fora 2-in-1 machine * subjects must be able to communicate in english exclusion criteria: * mental confusion on interview suggesting significant dementia * participation in other diabetes clinical trials * alcohol or drug abuse/dependency using a screening questionnaire * active psychosis or acute mental disorder * life expectancy \<6 months * pregnant and/or lactating females

Keywords: type 2 diabetes nurse case management telemedicine
using 3d imaging to optimize bifurcation stenting

Conditions: Coronary Artery Disease; Bifurcation Lesion

Summary: the primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3d-ofdi) is superior to that with angiographic guidance by measuring incomplete stent apposition (isa) in the bifurcation segment.

the recently developed optical frequency domain imaging (ofdi) can provide high quality resolution images of the coronary arteries. this new imaging system enhances the understanding of complex coronary lesions and the complex interaction between coronary devices and vessels by assembling/compiling 2-dimensional cross sections. this 3-dimensional reconstruction with strut segmentation becomes possible on-line in the terumo ofdi console with 3-dimensional imaging software, which enables stent enhancement and 3d reconstruction within one minute. this "real time" 3d ofdi will promote the utilisation of 3-dimensional assessment in the treatment of bifurcation lesions.

Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years of age and signed informed consent 2. subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and non-st segment elevation acute coronary syndrome (nste-acs) 3. subject is appropriate to be treated by pci according to the local practice (operator's judgment or heart team decision) 4. patients' residence is in the area covered by the hospital 5. patients with angiographically significant stenosis (\>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in operator's opinion appropriate to be treated by pci with a single stent strategy 6. the size of main vessel matches available ultimaster stent sizes (\<4.0 mm, and 2.0 mm by visual assessment) 7. the size of side branch is \>2.0mm in diameter by visual assessment 8. the sidebranch is treatable with a sidebranch fenestration and/or kissing balloon exclusion criteria: 1. pregnancy 2. patients with st elevation myocardial infarction 3. known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material 4. known thrombocytopenia (platelet count\< 100,000/mm3) 5. cardiogenic shock 6. significant comorbidities precluding clinical follow-up (as judged by investigators) 7. major planned surgery that requires discontinuation of dual antiplatelet therapy 8. history of stenting in the target bifurcation lesion 9. renal insufficiency (gfr/mdrd \<45 ml/min), which precludes in operator's opinion contrast injection during repeat ofdi pullback 10. severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (ofdi) or excessive risk of complication to place an ofdi catheter 11. target lesion reference vessel diameter (rvd) \ 4 mm 12. other: patient is judged inappropriate by the attending physician