Kornimate/medical-research-clean huggingface dataset:
first-in-human phase i study of a selective c-met inhibitor plb1001

Conditions: Non-Small Cell Lung Cancer

Summary: this phase i, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (mtd), recommended phase ii dose (rp2d), dose-limiting toxicities (dlts), pharmacokinetics (pk) profile, and preliminary antitumor activity of plb1001.

this is a phase i, open-label, multicentre study of pb1001 administered orally to patients with met-positive (met+) advanced nsclc. the study includes a dose-escalation part (part a)and a dose expansion part(part b). the aim of the part a is to estimate the mtd and to identify the dose limited toxicity(dlt) and the recommended phase ii dose (rp2d) for plb1001 single agent as well as to determine the pk/pd profile .once response has been observed in certain dose level ,then followed by the expansion part to further assess the clinical efficacy and safety of plb1001 single agent. aprox. 40 patients will be enrolled in part a, while 20-30 patients for expansion cohort . plb1001 is a potent selective c-met inhibitor. plb1001 acts on cancer by blocking abnormal cmet-mediated signalling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (nsclc) tumours. preliminary data from a c-met inhibitor inc 280 has provided possibility on the safety and clinical activity of plb1001 monotherapy in this patient population.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age≥18 years * histologically or cytologically confirmed advanced non-small cell lung cancer * must have evidence of c-met positivity from the results of molecular pre-screening evaluations * at least one measurable lesion as per recist v1.1 * patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 * ecog performance status of 0-2 exclusion criteria: * previous or current treatment with a c-met inhibitor or hgf-targeting therapy * symptomatic central nervous system (cns) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any cns deficits. * clinically significant, uncontrolled heart diseases. unstable angina history of documented congestive heart failure (new york heart association functional classification \> ii) uncontrolled hypertension defined by a systolic blood pressure (sbp) ≥ 140 mm hg and/or diastolic blood pressure (dbp) ≥ 90 mm hg arrhythmias * active peptic ulcer disease or gastritis * adverse events from prior anti-cancer therapy that have not resolved to grade ≤ 1, except for alopecia * major surgery within 4 weeks prior to starting plb1001 * previous anti-cancer and investigational agents within 4 weeks before first dose of plb1001. if previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of plb1001. * pregnant or nursing women * involved in other clinical trials \< 30 days prior to day 1
spog 2015 fn definition. a multi-center non-inferiority trial on safety of a high versus low temperature limit defining fever in pediatric patients with cancer at risk for fever in chemotherapy-induced neutropenia

Conditions: Cancer; Pediatrics; Fever; Neutropenia; Fever in Neutropenia

Summary: in a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°c) versus low (38.5°c) temperature limit defining fever (tldf) for the diagnosis of fever in chemotherapy-induced neutropenia (fn) is studied. safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during fn. patients are repeatedly randomized (cluster: study site) to the high or the low tldf every month, resulting in possible multiple crossovers in one patient. the high tldf is declared not to be inferior regarding safety compared to the low tldf if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed poisson regression.


Eligibility criteria:
inclusion criteria: * chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation * age ≥12 months and \<18 years at time of recruitment * written informed consent from patients and/or parents exclusion criteria: * infants \<1 years old (reason: differences in temperature measurement method) * past allogeneic hematopoietic stem cell transplantation * denied written informed consent from patients and/or parents
immunogenicity and safety of dtap or dt vaccine in 6 year old children ( dtap/dt )

Conditions: Vaccine Reaction

Summary: this study is to evaluate the immunogenicity and safety of dtap or dt given in children aged 6 years.

a phase 4 trial was conducted in zhejiang province aimed to evaluate the immunogenicity and safety of dtap or dt in children aged 6 years. dtap and dt are produced by chengdu institute of biological products co., ltd. participants will be recruited and randomly divided into two groups to receive dtap or dt in 1:1 ratio. two blood samples were taken on day 0 (pre-vaccination) and day 28\~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.

Eligibility criteria:
inclusion criteria: * 1. participants aged ≥ 6 on the day of enrollment; 2. informed consent should be signed and dated by the participants; 3. the participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures; 4. the participants have received 4 doses of acellular tdap vaccine and have not received any immunization agents related to diphtheria, tetanus, and pertussis in the past 3 years; 5. the participant has no diease history of pertussis, diphtheria or tetanus; 6. ≥ 14 days interval between the last vaccination; 7. body temperature was ≤37.3℃. exclusion criteria: * 1、being allergic to any component of vaccines ； 2、a history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）； 3、having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases; 4、participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to hiv, or having congenital immune disorders in close family members; 5、injection of non-specific immunoglobulin within 1 month before enrollment; 6、participants are suffering from acute febrile diseases and infectious diseases; 7、a history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection; 8、participants with severe chronic diseases or acute episodes of chronic diseases; 9、participants with infectious, suppurative and allergic skin diseases; 10、other participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.

Keywords: immunogenicity，safety，dtap，dt
three dimensional versus two dimensional echocardiography in assessment of severity and scoring of rheumatic mitral stenosis.

Conditions: Mitral Valve Stenosis

Summary: although the prevalence of rheumatic fever is decreasing in developed countries, it still affects numerous areas in the non- industrialized world. untreated mitral stenosis (ms) contributes significantly to global morbidity and mortality. echocardiography is the main diagnostic imaging modality for evaluation of mitral valve (mv) obstruction and assessment of severity and hemodynamic consequences of ms as well as valve morphology. according to current guidelines and recommendations for clinical practice, the severity of ms should not be defined by a single value but assessed by valve areas, mean doppler gradients, and pulmonary pressures. transthoracic echocardiography is usually sufficient to grade ms severity and to define the morphology of the valve. transesophageal echocardiography is used when the valve cannot be adequately assessed with transthoracic echocardiography and to exclude intracardiac thrombi before a percutaneous or surgical intervention. three-dimensional transthoracic and transesophageal echocardiographic assessment provide more detailed physiological and morphological information. current definitive treatment for severe ms involves percutaneous balloon mitral valvuloplasty (pmbv) or surgery. the effectiveness of pmbv is related to the etiology of ms, and certain anatomic characteristics tend to predict a more successful outcome for pmbv, whereas other mv structural findings might suggest balloon valvuloplasty to be less likely successful or even contraindicated. does 3d echo can add more useful information over 2 d echo that could change treatment decision?


Eligibility criteria:
inclusion criteria: 1. patient age range from 18 years to 60 years. 2. patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for ptmc by 2d echo evaluation). 3. patient with normal left ventricular ef 4. patient both in sinus rhythm or atrial fibrillation exclusion criteria: 1. age below 18 years or above 60 years. 2. patient with another valve lesion or more than mild mitral regurgitation. 3. patient with impaired cardiac function. 4. mitral stenosis of other etiology than rheumatic origin
huaier granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy

Conditions: Hepatic Carcinoma

Summary: to evaluate the efficacy and safety of huaier granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

a multicenter, randomized, paralleled control clinical study investigating huaier granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy,to evaluate the efficacy and safety.

Eligibility criteria:
inclusion criteria: * age: ≥ 18 and ≤ 75 years, both male and female; * radical hepatectomy has been performed for hepatocellular carcinoma; * the hepatocellular carcinoma has been confirmed by pathological examination; * barcelona clinic liver cancer(bclc) stage a or b; * not receiving any preoperative anticancer drug; * the liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(ast), glutamic-oxalacetic transaminase(alt)\<3 upper limit of normal(uln), total bilirubin≤2uln, serum creatinine \<1.5 uln; * other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): hb≥9g/dl, platelet count≥60×109/l, absolute neutrophil count\>1.0×109/l; * the expected survival time ≥ 12 weeks; * the subjects volunteer to sign the informed consent. exclusion criteria: * hepatocellular carcinoma patients who received non-radical hepatectomy; * non-hepatocellular carcinoma patients; * those with child-pugh c; * pregnant or lactating women; * those with active bleeding due to various reasons; * those with hiv infection or aids-associated diseases; * those with severe acute and chronic diseases; * those with severe diabetes; * those with serious infectious diseases; * those who can not take drugs by oral route; * drug abusers or those with psychological or mental diseases that may interfere with study compliance; * conditions that are considered not suitable for this study investigators

Keywords: huaier granule; after radical hepatectomy; prevention of recurrence and metastasis; safety.
medial enhancement technique for the treatment of old femoral neck fractures

Conditions: Fracture of Neck of Femur

Summary: a prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years, gender not specified; 2. patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures; 3. have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery; 4. participants or their legal representatives are informed about the nature of this study and agree to participate. exclusion criteria: 1. participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment; 2. known history of hypersensitivity to one or more implanted materials by the patient; 3. judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases; 4. active infectious foci in the hip joint or other parts of the body, as judged by the investigator; 5. diagnosed with metabolic bone disease, radiation-induced bone disease, etc.; 6. severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless; 7. suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.; 8. patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with; 9. other situations where the investigator deems the participant unsuitable for inclusion.

Keywords: cannulated compression screws with iliac bone graft medial enhancement technique with iliac bone graft
the role of novel organisms in acute endometritis

Conditions: Pelvic Inflammatory Disease

Summary: the goal of this project is to identify the microorganisms present in the endometrial samples obtained from women with or without evidence of endometritis using a combination of culture methods, rrna sequencing and whole genomic sequencing. the overarching aim of these studies is to identify the etiology of endometritis. the investigators will define the role of fastidious anaerobic microorganisms in the etiology of pid, and assess whether antibiotic treatment regimens used for the treatment of pid have activity against the novel organisms linked with pelvic infections.


Eligibility criteria:
inclusion criteria: * this is a laboratory research study involving the use of biologic specimens only. * specimens (endometrial biopsy samples) collected from subjects who meet the inclusion criteria for pro10010159 and pro10010112 will be utilized for this study. exclusion criteria: * specimens (endometrial biopsy samples) that are collected from subjects enrolled in pro10010159 and pro10010112 that are insufficient will not be included in this study.
indicators and evaluation of efficacy of yin-nourishing and fire-reducing chinese medicine for girls with rapid progression of early puberty

Conditions: Puberty Changes

Summary: 1. evaluate whether amh and shbg have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type. 2. assess the therapeutic effect of nourishing yin and purging fire traditional chinese medicine on girls with rapid progression type of early puberty providing a standardized clinical basis for the formulation of diagnostic and treatment guidelines (or protocols) for the rapid progression type of early puberty using traditional chinese medicine


Eligibility criteria:
inclusion criteria: * girls with an onset age \>8 years and ≤9 years; * breast bud tanner stage ii breast bud diameter \<3 cm; * ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm; * bone age does not exceed actual age by more than 1 year; * lhrh stimulation test: lh/fsh ≥0.6 lh peak ≥5.0 iu/l. * good compliance; * patients and their parents are willing to actively cooperate with the clinical trial; * legal guardian signs the informed consent form. exclusion criteria: * disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.; * use of treatments that affect gonadal function such as chemotherapy radiotherapy; * diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.

Keywords: tcm puberty
value of triglyceride glucose index in prediction of cardiac outcomes in patients with acute coronary syndrome

Conditions: Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose Index

Summary: triglyceride glucose index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (maces), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure. we hypothesis that there is a relation between prediction of mace in acute coronary syndrome patients and between triglyceride glucose index.

cardiovascular diseases, particularly coronary artery disease (cad), is considered as a main cause of death and disability in the developed countries as its responsible for about 1 in every 5 deaths in the last few years. acute coronary syndrome (acs), which is the most severe ischemic heart disease including non-st-elevation myocardial infarction (nstemi), st-elevation mi (stemi), and unstable angina has been one of the leading causes of death worldwide which leads to a large social and economic burden. it has been well recognized that the development of (cad) is driven by multiple factors including glycemic abnormality and lipid disorders. insulin resistance (ir) is a key metabolic abnormality leading to the development of t2dm, and recent studies have also found that it could independently predict the development of cardiovascular disease (cvd). hyperinsulinemic-euglycemic clamp (hiec), as the gold standard for the diagnosis of insulin resistance, is very difficult to be carried out in clinical work due to its difficulty of operation and equipment requirements. triglyceride and glucose index (tyg index) was one of the alternative methods for evaluating insulin resistance and is a novel marker unlike the homeostasis model assessment and quantitative insulin sensitivity check index, insulin is not included in the tyg index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (maces), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure. the tyg index was calculated as the ln (fasting triglyceride level \[mg/dl\] × fasting glucose level \[mg/dl\]/2) normal cut-off values reported for the tyg in the literature are roughly around 4 and 8. aim of the work to study the value of triglyceride glucose index as a short term predictor of mace in diabetic and non diabetic patients presented by acute coronary syndrome.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome patients exclusion criteria: * with acute infectious disease, rheumatic disease, hematological disease, or neoplastic disease. * with severe valvulopathy or cardiomyopathy * lacking clinical or follow-up data. * suspected familial hypertriglyceridemia
a controlled study of potential therapeutic effect of oral zinc in manifesting carriers of wilson disease

Conditions: Wilson Disease

Summary: the assumption is that in some of the carriers, the increase in enzymes reflects tissue damage due to excess copper. the reduction of the amount of copper absorbed will decrease excess copper in the liver, which will result in a decrease in the level of liver enzymes. zinc causes the induction of metalothionines in the intestine, which in turn prevents absorption of copper from the digestive system. zinc administration in wilson's patients causes the depletion of copper deposits and constitutes one of the cornerstones in the treatment of this disease.

the research group is composed of patients over the age of 18 referred for unexplained elevation of liver enzymes and carry a single mutation in the atp7b gene. after a washout period of 3 months these patients will be re-checked for liver enzymes and if high will receive zinc therapy at a dose of 300 mg / day for 6 months, after which the liver enzymes will be checked again.

Eligibility criteria:
inclusion criteria: patients over the age of 18 unexplained elevation of liver enzymes patients that carry a single mutation in the atp7b gene. - exclusion criteria: na
optimal management of antithrombotic agents: optima-5

Conditions: Acute Coronary Syndrome (ACS)

Summary: this is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (acs) patients after percutaneous transluminal coronary intervention (pci) in china. patients on maintenance dosing (md) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (ld)/ 75 mg md according to their bleeding risk. then each group will randomly switch at different times(24 hours/ 12 hours after the last md of ticagrelor). pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by light transmittance aggregometry method (lta). all patients are followed-up for 30 days.

the primary endpoint of the study was platelet inhibition measured by light transmittance aggregometry method(lta). secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (mace) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the mace. safety endpoints of 30-day timi major and minor bleed were also evaluated.

Eligibility criteria:
inclusion criteria: * ≥ 18 years. * acs patients. * patients who are treated with ticagrelor and do not tolerate it. * volunteer to participate and sign informed consent. * approved by national regulatory authorities ethics committees. exclusion criteria: * patients who are contraindicated, intolerant or resistant to clopidogrel. * history of hematological disease or bleeding tendency; platelet count \ 600 × 10\^9 cells/l, hemoglobin \< 100 g/l. * abnormal liver or kidney function (alt \> 3 uln; estimated crcl \< 30 ml/min calculated by cockcroft-gault equation); diagnosed severe pulmonary disease. * patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole. * malignancies or other comorbid conditions with life expectancy less than 1 year. * pregnant or lactating woman.

Keywords: dual antiplatelet therapy (dapt) platelet function clopidogrel ticagrelor switch