Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of athena car-t in subjects with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the goal of this clinical trial is to test athena car-t injection in adults with moderate to severe systemic lupus erythematosus. the main question it aims to answer is: • to evaluate the safety and tolerability of athena car-t. after screening, participants will be subjected to lymphodepletion regimen. after recovery, participants will be injected with athena car-t injection and followed up to 24 months.

this study is a single center, one-arm, open label, phase i study aimed at evaluate the safety and effectiveness of athena car-t treating moderate to severe sle patients. a traditional "3+3" design is used with two doses. dlt is monitored. safety and effectiveness are followed up until 24 months post infusion of athena car-t. besides safety monitoring, efficacy is evaluated via sledai-2000, bilag-2004, pga.

Eligibility criteria:
inclusion criteria: * male or female, between 18 and 56 years old; * diagnosed with sle according to 2019 eular/acr sle classifications; * anti-nuclear antigen ab positive (titer nlt 1:80) and/or dsdna ab positive and/or anti-sm ab positive at screening; * at screening, sledai-2000 scoring nlt 8 points, if low complement scoring and/or anti-dsdna ab scoring is available, the sledai-2000 scoring except low complement and anti-dsdna ab should be nlt 6 points; * should be subjected to at least 6 months of standard treatment for sle, and disease active at least two months before screening; * good organ functions; * trial participants whose partner is fertile agree to use effective contraceptives til 24 months post transfusion, fertile female participants should have negative urine/blood pregnancy test results (participants who were sterilized or menopause for mt 12 months is not considered fertile); * voluntary participates this trial and can comprehend and sign icf. exclusion criteria: * had or has active malignancy; * had been subjected to treatment by cd19 targeted therapy or car-t therapy or any gene therapy; * within 8 weeks before screening, had cns disease caused by sle or non-sle diseases; * within 8 weeks before screening, had lupus crisis; * has following kidney diseases: within 8 weeks before randomization, had sle with serious kidney involvement or need treatment using medications prohibited by protocol to treat active nephritis, or need hemodialysis or need treatment by prednisone mt 100mg/d for longer than 14d or equivalent therapy; * had serious allergy to any lymphodepletion medication or ingredients of athena car-t; * has uncontrolled fungi, bacterial or viral infection or other infections investigator deemed not suitable to participate in the study; * combined with other autoimmune disease that needs treatment; * pregnant or lactating women; * has other factors that deemed not suitable by investigator.

Keywords: adult moderate to serve sle
transvaginal versus transperineal repair of rectocele

Conditions: Rectocele

Summary: patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. the primary outcome of the study was improvement in constipation at 6 and 12 months


Eligibility criteria:
inclusion criteria: * adult female patients with anterior rectocele exclusion criteria: * male patients. * combined rectocele with internal rectal prolapse. * anismus. * associated anorectal condition such as hemorrhoids and anal fissure. * pregnancy. * unwilling to participate in the trial
d2 and d2+ radical surgery for the treatment of advanced distal gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the safety and the effect of d2 and d2+ radical surgery for the treatment of advanced distal gastric cancer.

to evaluate the safety and the disease-free survival time(dfs) and overall survival time(os) of d2 and d2+ radical surgery for the treatment of advanced distal gastric cancer.

Eligibility criteria:
inclusion criteria: * male and female aged 18 to 70 years old. * the preoperative evaluation: distal gastric cancer patients, ≥ t2 or n +; or staging ii, iiia, iiib. * karnofsky score ≥ 70, life expectancy \> 6 months. * endoscopic biopsy diagnosis of gastric cancer, excluding non-hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors. * the blood and biochemical indicators of the subjects must meet the following criteria: hb ≥ 9 g / dl; wbc ≥ 4,000 / mm3, ≤ 12000 / mm3; plt ≥ 100,000/mm3; * got, gpt within twice the institutional limit,serum total bilirubin \< 1.5 times the upper limit of normal, serum creatinine\< 1.25 times the upper limit of normal * have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent. * must accept the standard d2 or d2 + radical gastrectomy. * with good compliance. exclusion criteria: * pregnancy, breast-feeding women. * allergy with chemotherapy drugs or metabolic disorder. * the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation). * had long received systemic steroid treatment (note: short-term users of withdrawal \> 2 weeks can be selected.) * the existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders. * patients with severe infection requires treatment. * patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation. severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes. * with other malignancies which were not cured. * ekg abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or iii or iv grade myocardial infarction. coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or iii or iv grade myocardial infarction.

Keywords: gastric cancer surgery surgery safety effect
safety and tolerability of pro 140 in hiv uninfected male volunteers

Conditions: HIV Infections

Summary: the purpose of the study is to determine the safety and tolerability of pro 140, an investigational anti-hiv drug, administered via intravenous infusion. study hypothesis: single intravenous doses of pro 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

pro 140 is a man-made monoclonal antibody to the chemokine receptor ccr5, which serves as a co-receptor for hiv. in numerous preclinical models of hiv infection, pro 140 broadly and potently blocks ccr5-mediated hiv entry without blocking the natural activity of ccr5. pro 140 is being developed for therapy of hiv infected individuals. the purpose of this study is to evaluate the safety and tolerability of pro 140 in hiv uninfected male volunteers. the pharmacokinetics and pharmacodynamics of pro 140 will also be assessed in this study. participants in this study will be randomly assigned to receive a single dose of one of several possible doses of pro 140 or placebo. participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. physical exams, electrocardiograms (ecgs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.

Eligibility criteria:
inclusion criteria: * not more than 20% below or 20% above ideal weight for height and estimated frame size * good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests exclusion criteria: * history of clinically significant disease * history of clinically significant allergies, including drug allergy * participated in another clinical trial within the 3 months prior to study entry * hiv infected * hepatitis b or c virus infected * active significant infection * prior exposure, allergy, or known hypersensitivity to pro 140
impact of bread diet on intestinal dysbiosis and irritable bowel syndrome symptoms in quiescent ulcerative colitis

Conditions: Ulcerative Colitis in Remission

Summary: the present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on irritable bowel syndrome-like symptoms in patients with quiescent ulcerative colitis. the expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.


Eligibility criteria:
inclusion criteria: * patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice * remission of ulcerative colitis defined as a total mayo score ≤2 and faecal calprotectin values under 250 ng/g * subjects aged over 18 years * moderate-to-severe ibs-like symptomatology defined by rome iv criteria and ibs symptom severity score (ibs-sss) \> 175. exclusion criteria: * presence of flare-up of uc * coeliac disease, colectomy, or intestinal resection * antibiotic intake, prebiotic or probiotic treatment within 3 months before the study * any malignancy, pregnancy, or breastfeeding * intake of medication potentially influencing gastrointestinal function * disability to give informed consent
hypoproteic diet in acromegaly

Conditions: Acromegaly

Summary: since protein and aas are master regulator of gh and igf-i secretion, we hypothesized that a low protein diet could reduce gh and igf-i levels in acromegalic patients in addition to conventional therapy. furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of gh hypersecretion during conventional therapy and after a low protein diet

nutrients are crucial modifiers of the gh/igf-i axis. in particular, a close cross-talk between proteins and amino acids (aas) and gh/igf-i secretion exists. both aas and proteins affect gh secretion. aas stimulate gh secretion upon oral administration, with different potency among studies, being the combination of arginine and lysine the most powerful. soy proteins also stimulate gh secretion when ingested either as hydrolysed proteins or free aas. furthermore, the acute gh response to aas ingestion may be influenced by the daily amount of dietary protein/aas consumption: diets high in proteins apparently increase basal gh levels. aas and proteins have a positive effect on igf-i secretion as well. in general, high levels of proteins, especially animal and dairy proteins, and consumption of branched chain amino acids (bcaas) increase serum igf-i levels. considering pathological gh conditions, metabolomic analysis of acromegalic patients suggests that the main metabolic fingerprint of gh hypersecretion is a reduction in bcaas, related to the disease activity. moreover, there is evidence that gh, rather than igf-i, is the main mediator of such metabolic fingerprint, which may be related to increased uptake of bcaas by the muscles, increased gluconeogenesis, and raised consumption of bcaas. thus, in acromegaly, a tailored diet is a further strategy that may contribute to blunt gh/igf-i secretion. indeed, some authors recently suggested that "personalized" or "precision" nutrition in some conditions and diseases could have an impact on their phenotype, combining dietary recommendations with individual's genetic makeup, metabolic and microbiome characteristics, and environment. however, studies on precision nutrition in acromegaly are still in a neonatal era.

Eligibility criteria:
inclusion criteria: * age 18/65 * diagnosis of acromegaly * in therapy with somatostatin analogues exclusion criteria: * pregnancy or lactation * alchool or drugs abuse * cancer * hematological diseases
mif- thyroxine interactions in the pathogenesis of pulmonary arterial hypertension

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension; Interstitial Lung Disease

Summary: the investigators will investigate the interrelationship of macrophage migration inhibitory factor (mif) and free t4 in patients with pah.

the investigators will test our hypothesis and accomplish our objectives by pursuing three specific aims: to investigate the interrelationship between macrophage migration inhibitory factor (mif) and free t4 in patients with pah with a working hypothesis that an increased release of mif into the pulmonary vasculature during cardiopulmonary exercise changes the normal balance between plasma mif and t4.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age and have confirmed pulmonary hypertension (ph) and interstitial lung disease (ild). * ild was identified on high resolution computed tomography along with a total lung capacity (tlc) \<70% of predicted value on pulmonary function tests (pfts) with no evidence of pulmonary hypertension on echocardiogram. * pah group patients were defined as patients with a mean pulmonary artery pressure \>25 mmhg at rest and a wedge pressure of \<15 mmhg (millimeters of mercury), measured by right heart catheterization (who group i pah). * ph+ild group, subjects with evidence of ild on high resolution ct scan and mean pulmonary artery pressure \>25 mmhg on right heart catheterization. * patient with evidence of chronic thromboembolic disease on ct angiogram and mean pulmonary artery pressure \>25mmhg on right heart catheterization. (who group iv) * patient with pulmonary hypertension due to other conditions, such as sarcoidosis, gauchers disease, hemolytic anemia and myeloproliferative disorders. * normal control group: subjects without cardiopulmonary disease, with a normal pft and ecg. exclusion criteria: * failure to obtain informed consent; * pregnancy * subjects with cardiopulmonary disease other than ph and ild; * unexplained abnormal pft, ecg, routine blood/chemistries test * history or existing other sever organ/system diseases * defined acute pulmonary embolism * age \< 18 years
prospective study on patients with obstructive sleep apnea in hong kong (prosa)

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea syndrome (osas) is a common disorder with prevalence rates of at least 4% among the middle-aged male caucasians and hong kong (hk) chinese populations. it is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. osas patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. however, there is no long term follow up of patients with osas on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. the study is aimed to carry out a prospective observational study assessing the role of osas as a possible cause of increased cardiovascular risk and cognitive decline.


Eligibility criteria:
inclusion criteria: * suspected obstructive sleep apnea syndrome * aged 18 or above * must be able to speak, read and understand chinese or english * possess the ability to respond to questions and follow instructions. exclusion criteria: * already treated sleep apnea, * a limited life expectancy due to illness unrelated to sleep apnea * human immunodeficiency virus (hiv), * advanced renal disease, * uncontrolled malignancies * documented alcohol or drug abuse up to 1 year prior to inclusion in the study.

Keywords: cognitive function
researching coronary reduction by appropriately targeting euglycemia (recreate pilot study)

Conditions: Hyperglycemia; Cardiovascular Diseases; Myocardial Infarction

Summary: insulin will safely reduce glucose levels in patients with acute st-elevation myocardial infarction and admission hyperglycemia.

patients will be randomly assigned to either the control arm and will receive usual ami care or the experimental arm, which will include routine ami care as well as intensive therapy intervention. in addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.

Eligibility criteria:
inclusion criteria: both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected ami are eligible if they meet the following criteria: * signs or symptoms of ami with definite ecg changes, defined as persistent st-segment elevation (\> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block * onset of symptoms within 24 hours before hospital presentation * capillary blood glucose level on presentation \> or = 8.0 mmol/l (144 mg/dl) exclusion criteria: * patient with conditions that require the administration of insulin, including: * type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30 * type 2 diabetes mellitus that was treated with insulin prior to ami presentation * type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose \> 16.0 mmol/l (288 mg/dl)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy) * a history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years * known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis) * cardiogenic shock on admission (due to the inaccuracy of glucose meter readings) * documented pregnancy * any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days * anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.) * prior enrollment in this trial or current enrollment in another trial of st-segment elevation myocardial infarction

Keywords: clinical trial insulin
ax-003/arimidex (anastrozole) in the adjuvant therapy of early breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is the initial/followed by 5 year adjuvant therapy with anastrozole.


Eligibility criteria:
inclusion criteria: * postmenopausal women with early hormone receptor positive breast cancer/no metastasis exclusion criteria: * none

Keywords: primary early mca arimidex
renoprotective effects of dulaglutide in patients with type 2 diabetic nephropathy

Conditions: Type 2 Diabetic Nephropathy

Summary: the purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with type 2 diabetic nephropathy.

related studies have found that glucagon-like peptide-1 (glp-1) receptors are localized on a variety of tissues and cell types in addition to pancreatic β-cells, and glp-1 and glp-1 receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic potential physiological, pathophysiological as well as pharmacological implications. multiple clinical trials suggest that glp-1 receptor agonists can exert renoprotective effects and persuasively inhibit the progression of kidney disease in type 2 diabetic patients. the beneficial effects of glp-1 receptor agonists on type 2 diabetic nephropathy, independent of their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory and natriuresis properties. however, it is not clear whether the above-mentioned properties are involved in the emt process of renal tubular epithelial cells. all participants meeting all eligibility criteria received routine medical consultations. during routine medical visits, patients were randomized into two groups (1.07:1) to receive a total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic agents not including glp-1 receptor agonists (intervention group), and other hypoglycemic agents not including glp-1 receptor agonists (control group). a random number method was applied for grouping in this study. dulaglutide and other hypoglycemic agents were administered according to the drug package insert. of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.

Eligibility criteria:
inclusion criteria: * all adults aged 18 and above * no minors involved in the study * diabetic nephropathy defined as a urinary albumin-to-creatinine ratio ≥30 mg/g at least twice in three measurements within a period of 3-6 months exclusion criteria: * patients with other types of kidney disease * urinary tract infection * type 1 diabetes

Keywords: dulaglutide diabetic nephropathy renoprotective effects
lipid, glycemic, and insulin responses to meals rich in different fatty acids

Conditions: Type 2 Diabetes Mellitus

Summary: a meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. a meal rich in very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to other fatty acids.

research design and methods: test meals rich in palmitic acid, linoleic acid, oleic acid, and eicosapentaenoic acid (epa) and docosahexaenoic acid (dha) and containing 1,000 kcal each were administered in a randomized cross-over design every 3 to 4 days to 11 patients with t2dm. serum insulin, glucose, and triglycerides concentrations were measured for 360 minutes. all subjects received an isoenergic diet of constant composition throughout the study.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus not on insulin therapy exclusion criteria: * thyroid, renal, or hepatic disease, uncontrolled hypertension, anemia, history of ketosis

Keywords: type 2 diabetes mellitus fatty acids postprandial response insulin glucose triglycerides