Kornimate/medical-research-clean huggingface dataset:
therapeutic drug monitoring and continuous infusion of beta-lactam antibiotics in patients with bacteraemia

Conditions: Bacteremia

Summary: the study investigates whether therapeutic drug monitoring (tdm) and continuous infusion (ci) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.


Eligibility criteria:
inclusion criteria: * have a positive blood culture. * undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem. * hospitalised at hvidovre university hospital. * age ≥ 18. * able to understand and give informed consent. * included in the study within 24 hours after the final positive blood culture answer. exclusion criteria: * positive blood culture is interpreted as contamination. * the patient dies before the intervention.

Keywords: therapeutic drug monitoring continuous infusion beta-lactam antibiotics bacteraemia
study to assess adverse events when subcutaneous risankizumab injection is given to adult participants with psoriasis in real world setting

Conditions: Psoriasis

Summary: study is not recruiting and using secondary data sources only

study is not recruiting and using secondary data sources only

Eligibility criteria:
study is not recruiting and using secondary data sources only
implementation research on the intervention mode of " comorbidity-co-causes-joint-prevention" comprehensive demonstration district of depression and obesity among children and adolescents in beijing

Conditions: Depression; Obesity; High Risk of Depression; Overweight

Summary: depression and obesity have become the most prominent health problems among adolescents and have caused a heavy burden on the health and social economy of the whole population. there are high incidence, comorbidity and co-pathogenic factors of depression and obesity in adolescents, but there is still a lack of research on joint prevention strategies and multi-sectoral collaborative prevention and control network. this project plans to screen and integrate effective intervention measures based on multi-stage optimization strategy, developing an intervention mode of \[comorbidity-co-causes-joint-prevention\] for adolescents with depression or/and obesity, and then carry out with children or adolescents in beijing based on digital platform. the investigators will be considering the accessibility, sustainability and replicability of the implement based on the re-aim framework including the coverage of population and organizations as well as the effect, implement and sustainability of the interventions. the research will be promoted with the help of the national clinical research center for mental disorders and monitoring of student common diseases and health influencing factors. the results of the research will establish an intervention mode of \[comorbidity-co-causes-joint-prevention\] and a promotion model for adolescents' depression and obesity in beijing, providing support for the realization of healthy china 2030 and healthy beijing 2030 plans.


Eligibility criteria:
inclusion criteria: * stage i (screening stage): 1. middle school students in beijing economic-technological development area and other districts of beijing, both male and female; 2. students themselves and their guardians are willing to participate in this study and sign written informed consent file. stage ⅱ: middle school students who were identified as high risk of depression and/or obesity in stage i in beijing economic-technological development area and other districts of beijing, the screening criteria are as follows: ① ces-dc score ≥16 points; ② bmi ≥ws/t586-2018: screened as overweight and obesity among school-age children and adolescents, according to the recommendation by the national health commission; ③ students themselves and their guardians are willing to participate in this study and provide written informed consent. exclusion criteria: * stage i: 1. having serious physical or genetic disease that is not suitable for participation in the study; 2. have been evaluated that not suitable for this study by investigators. stage ⅱ: 1. having serious physical or genetic disease that is not suitable for participation in the study; 2. have been evaluated that not suitable for this study by investigators.

Keywords: children adolescents depression obesity effectiveness evaluation intervention mode
a study of ly2228820 in participants with advanced cancer

Conditions: Advanced Cancer

Summary: the objective of this study is to determine a safe dose of ly2228820 that may be given to participants with advanced cancer. part a of this study will consist of dose escalation, and part b will consist of dose confirmation.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of a diagnosis of cancer (including lymphoma) that is advanced or metastatic disease for which no therapy of higher priority (approved therapies or therapies with published substantial evidence of effectiveness) is available, or for whom no standard therapy exists * have the presence of measurable or nonmeasurable disease as defined by modified response evaluation criteria in solid tumors (mrecist) * have adequate hematologic, renal, and hepatic organ function * have a performance status of less than or equal to 2 on the eastern cooperative oncology group (ecog) scale * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 14 days (42 days for mitomycin-c or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy * males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug * females with child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug * have an estimated life expectancy of ≥ 12 weeks * are able to swallow capsules and/or tablets exclusion criteria: * have received treatment within 14 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication * have a history of major surgical resection involving the stomach or small bowel, or have serious preexisting medical conditions (based on judgment of the investigator) * have symptomatic central nervous system malignancy or metastasis (screening is not required) * have a diagnosis of inflammatory bowel disease (crohn's disease or ulcerative colitis) * have an active hematologic malignancy other than lymphoma * have known positive test results in human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcab). screening at baseline will not be required for enrollment * concurrent administration of any immunosuppressive therapy * females who are pregnant or lactating * have received, within 7 days of the initial dose of study drug, either grapefruit juice or treatment with a drug that is a known inhibitor or inducer of cytochrome p450 enzyme 3a4 (cyp3a4). in addition, participants should not receive grapefruit juice or treatment with a cyp3a4 inhibitor or inducer during the study
irrigation endoscopic decompression

Conditions: Lumbar Spinal Canal Stenosis

Summary: to evaluate a new endoscopic technique for lumbar spinal canal decompression.

104 consecutive patients suffering of neurogenic claudication were included in the study. patients were operated using the irrigation endoscopic decompression technique. mean follow up was 28 months primary outcome measures were assessed using the oswestry disability index \[19\] and the modified macnab criteria all statistical calculations were done using computer programs spss (statistical package for the social science; spss inc., chicago, il, usa) version 15 for microsoft windows

Eligibility criteria:
inclusion criteria: 1. neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit 2. symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on mri. (degenerative and congenital bony stenosis were included) 3. failure of 3 months conservative treatment 4. grade i degenerative spondylolisthesis and degenerative scoliosis exclusion criteria: 1. segmental instability 2. lytic spondylolisthesis 2- predominant low back pain

Keywords: iedl irrigation endoscopic decompressive laminotomy irrigation endoscopic decompression minimally invasive spine surgery endoscopic decompression spinal stenosis
the plasma serotonin and aortic stenosis: a pilot study.

Conditions: Aortic Stenosis

Summary: the goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine (5-ht) in patient with increased severity of aortic stenosis and increased weight cardiac muscle.

calcific aortic stenosis is the most frequent valve disease in adults. without therapeutic strategy, this disease leads to heart failure and death. surgical aortic valve replacement is now a well tolerated cardiac surgery leading to excellent outcomes. until recently, calcific aortic stenosis was considered to be histopathologically degenerative or passive in origin. it is now recognized, however, as a complex cellular process with features of atherosclerosis. it has been observed that drugs may slow dawn the progression of aortic stenosis in observational studies. it has been suggested that serotonin, a monoamine neurotransmitter and a peripheral signal mediator, may be involved in the progression of aortic stenosis and also in its consequences on myocardium hypertrophy. in the blood, serotonin in mainly stored in platelets, which release serotonin involved in post-injury vasoconstriction, thrombus formation, fibrosis and atherogenesis. this study hypothesized those patients with aortic stenosis exhibit higher circulating serotonin levels than their counterparts without heart disease. in addition to circulating serotonin, its metabolite 5-hiaa will be systematically measured on all patients. this study would allow to determine the potential of plasma serotonin as a prognosis marker and perhaps suggest the discovery of new targets for treatment of aortic stenosis.

Eligibility criteria:
inclusion criteria: * group 1 : non aortic stenosis * goup 2, 3 and 4 : aortic stenosis exclusion criteria: -
the role of apathy in glycemic control

Conditions: Apathy; Diabetes

Summary: in spite of several new medications and insulins for the control of blood sugars in patients with diabetes, a large number of patients do not have good control. this likely due to inability to carry out regular activities and self-care behaviors such as taking meds regularly, keeping a good diet, exercise etc. this inability to carry out self care lifestyle changes may be due to a condition called apathy. apathy is a lack of motivation and persistence. in this study we will attempt to treat apathy with a medication called methylphenidate for 6 months and see if blood sugar/diabetes control improves.

the incidence of diabetes in the us is at epidemic proportions. a large number of diabetes patients in the va system have uncontrolled diabetes with high hba1c. the inability to carry out important self-care behaviors such as measuring blood sugars regularly, following diet, exercise and medication programs may be due to apathy. apathy is the lack of motivation, persistence and novelty. we have found this to be very prevalent in the va diabetes population. we now do a randomized placebo controlled trial to see if treatment of apathy with methylphenidate will improve glycemic control in patients with a1c \>8. treatment will be for 6 months. the primary end point is hba1c.

Eligibility criteria:
inclusion criteria: * poor glycemic control hba1c\>8 * presence of apathy, a score of \>30 on aes * subjects should be on stable dose of metformin, thiozolidinediones, and sulfonylureas, statins and ace inhibitors for at least two months * subjects should have a negative cardiac stress test within the previous year exclusion criteria: * presence of major depressive disorder, psychosis, suicidal ideations, and history of stimulant dependence as evaluated by mini. * patient currently being treated or a history hypersensitivity to methylphenidate * hypertension with bp\>140/90 * history of renal disease with gfr\<60 * history of hepatic failure with ast/alt \> three times the normal range * history of seizure disorder, or tourette's syndrome or presence of motor tics * patients with glaucoma * patients being treated with monoamine oxidase inhibitors (maois) or clonidine * patients with active cancer. * patients with acute illness needing hospitalization * patients with cardiovascular events such as myocardial infarction, stroke, amputation, unstable angina within the last six months. * hba1c\> 12 * planned elective surgery in next 6 months * pregnancy

Keywords: apathy diabetes self-care behaviors
high definition white-light colonoscopy vs. chromoendoscopy for surveillance of lynch syndrome.

Conditions: Lynch Syndrome

Summary: adenomas in lynch syndrome have an accelerated progression to colorectal cancer (crc) which might occur despite a regular follow-up. despite low evidence, high-definition technology (hd) and indigo-carmine chromoendoscopy (ce) are recommended for surveillance in lynch syndrome.the investigators will conduct a prospective multicenter randomized non-inferiority study. the principal aim is to compare the adenoma detection rate with wle vs ce. our hypothesis is that hd-white-light endoscopy (wle) is not inferior to ce. therefore - under expert hands - hd-ce does not add any significant advantage over hd-wle on adenoma detection rate in patients with lynch syndrome.

the investigators will conduct a prospective multicenter randomized non-inferiority study. eligible patients will be those with lynch syndrome (known germline mutation in mismatch repair genes) who undergo surveillance colonoscopies. patients will be sequentially assigned in a 1:1 ratio to hd-wle or hd-ce. the method of stratified randomization based on partial colectomy history will be used to avoid proportion imbalance between groups. participant centers must have an organized high-risk of crc clinic and endoscopic unit provided with hd technology. endoscopists must have a documented high adenoma detection rate and experience in performing ce in patients with high-risk conditions of crc. the principal aim is to compare the adenoma detection rate with wle vs ce. principal outcome measures will be: 1) adenoma detection rate, defined as the proportion of patients with at least one adenoma in each arm; 2) number of adenomas per patient, defined as the total number of detected adenomas in each arm (hd-wle or hd-ce) divided by the number of colonoscopies in each arm. the sample size calculation was determined for a non-inferiority study. assuming an adr of 28% with conventional chromoendoscopy in patients with lynch syndrome, a 15% non-inferiority margin, a one-sided significance level of 0.05 powered at 80% and a 10% of drop-off. based on these assumptions, it was determined that 122 patients were required for each arm (a total of 244).

Eligibility criteria:
inclusion criteria: * patients with proven pathologic germline mutation in one of the mismatch-repair (mmr) gene (mlh1, msh2, msh6, pms2 or epcam) who will undergo surveillance colonoscopy exclusion criteria: * patients with total colectomy * concomitant inflammatory bowel disease * inadequate bowel preparation (boston scale \<2 in any colonic segment) * incomplete procedure (without intubation of cecum or ileo-colonic anastomosis) * previous colonoscopy in less than one year * inability to sign informed consent

Keywords: surveillance colorectal cancer colonoscopy adenoma chromoendoscopy
a non-interventional study evaluating the clinical benefit and effectiveness of quetiapine fumarate extended

Conditions: Schizophrenia

Summary: the primary objective of this nis is to assess the clinical benefit subjects derive from taking seroquel xr, using the cgi-cb. the secondary objective is to assess the effectiveness,safety and tolerability of seroquel xr tablets.


Eligibility criteria:
inclusion criteria: * diagnosed as schizophrenia according to dsm-iv-tr criteria * patients who are taking seroquel xr no longer than 1 month * patients who get antipsychotics monotherapy at least 1 week before enroll in this study exclusion criteria: * first episode, drug naive schizophrenic subjects. * meeting the criteria for any other (than schizophrenia) dsm-iv axis i diagnosis,concomitant organic mental disorder or mental retardation that in the opinion of the principal investigator may interfere with study conduct or interpretation. * known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment.

Keywords: schizophrenia seroquel xr cgi-cb swn-k
tislelizumab with anlotinib and chemotherapy for second-line treatment of pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: this is a prospective, one-arm, phase ii clinical study of tislelizumab combined with anlotinib and chemotherapy for second-line treatment of advanced or metastatic pancreatic cancer

this is a single-arm, open-label, clinical trial of tislelizumab in combination with anlotinib and investigator-selected chemotherapy for second-line treatment of patients with advanced or metastatic pancreatic cancer. patients with histopathologically or cytologically confirmed unresectable, recurrent or metastatic pancreatic cancer are planned to be recruited. systemic medical antineoplastic therapy previously treated with first-line chemotherapy, meeting the inclusion and exclusion criteria of this study, and giving tislelizumab and anlotinib in combination with investigator 's choice of second-line chemotherapy regimen

Eligibility criteria:
inclusion criteria: * advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology; * previously received a standard first-line chemotherapy regimen of pancreatic cancer * age ≥ 18 and≤ 75 years old; * expected survival ≥ 3 months; * ecog score 0-1; * child-pugh score \< 8; * there is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the short diameter of lymph nodes is ≥15 mm; * the results of liver and kidney function and blood routine examination within 1 week before enrollment meet the following conditions: neutrophils (anc) ≥ 1.5×109/l, platelets (plt) ≥ 80×109/l, hemoglobin (hgb) ≥ 80g/l; serum creatinine (cr) ≤ 1.5 × upper limit of normal value; total bilirubin (tbil) ≤ 2.5 × upper limit of normal value, alanine aminotransferase (alt), aspartate aminotransferase (ast) and alkaline phosphatase (alp) ≤2.5× upper limit of normal value; - the patient voluntarily participated in this study and signed the informed consent form. exclusion criteria: * received other immunotherapy previously(including immune checkpoint inhibitor pd-1/pdl1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs (including anti-vegfr monoclonal antibody and anti-angiogenic small molecule kinase inhibitors) ; known to be severely allergic to the drugs used in the study of tislelizumab and anlotinib; * patients with obstructive jaundice who cannot reach tbil ≤ 2.5 times the upper limit of normal value after surgical intervention; * patients with biliary obstruction that may occur or worsen within 4 to 6 weeks; * obvious blood coagulation disorder, active bleeding and bleeding tendency; * there is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ); * interstitial pneumonia or pulmonary fibrosis; * uncontrollable pleural effusion or ascites; * severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months); * during pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during the test; * patients judged by the investigator to be inappropriate to participate in this study.

Keywords: advanced second-line treatment
pyrotinib or trastuzumab plus nab-paclitaxel as neoadjuvant therapy in her2-positive breast cancer

Conditions: Breast Cancer

Summary: this study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced her2-positive breast cancer.

the study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced her2-positive breast cancer. patients will receive 4 cycles of pyrotinib in combination with nab-paclitaxel or 4 cycles of trastuzumab with nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive 4 cycles of epirubicin in combination with cyclophosphamide, then complete 1 year of trastuzumab.

Eligibility criteria:
inclusion criteria: * with signed consent * histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique * breast cancer stage at presentation: stage i-iii * her2-positive breast cancer defined as 3+ score by immunohistochemistry in \> 10 percent (%) of immunoreactive cells or her2 gene amplification by in situ hybridization * known hormone receptor status (estrogen receptor and/or progesterone receptor) * eastern cooperative oncology group performance status equal to or less than (\<=) 1 * baseline left ventricular ejection fracture \>= 50% measured by echocardiography * willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male * negative serum pregnancy test for women with fertility * willing to obey the study protocol exclusion criteria: * stage iv disease * previous anti-cancer therapy or radiotherapy for any malignancy * history of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage i uterine cancer * concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy * major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered * serious cardiac illness or medical condition * other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness * any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization * sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol * not able to swallow the drug * pregnant or lactating

Keywords: her2-positive neoadjuvant