Kornimate/medical-research-clean huggingface dataset:
combination chemotherapy followed by surgery in treating infants with newly diagnosed neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery. purpose: phase ii trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

objectives: * confirm that the management of infants with newly diagnosed stage iv neuroblastoma without mycn amplification treated with etoposide and carboplatin and cyclophosphamide, doxorubicin, and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation. * determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients. * determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients. outline: this is a multicenter study. patients receive vp-carbo chemotherapy comprising etoposide iv over 2 hours and carboplatin iv over 1 hour on days 1-3. treatment repeats every 21 days for 2 courses. patients without disease progression receive 2 additional courses of vp-carbo chemotherapy. patients with metastatic complete response (cr) undergo surgical resection of primary disease. patients with disease progression after 2 or 4 courses of vp-carbo chemotherapy receive cado chemotherapy comprising cyclophosphamide iv over 1 hour on days 1-5, doxorubicin iv over 6 hours on days 4 and 5, and vincristine iv on days 1 and 5. treatment repeats every 21 days for 2 courses. after 2 courses of cado chemotherapy, patients with metastatic cr undergo surgical resection of primary disease. patients with residual disease receive 2 additional courses of cado chemotherapy. patients with residual disease after 4 courses of cado chemotherapy are removed from the study. patients with metastatic cr after additional cado chemotherapy undergo surgical resection of primary disease. patients are followed within 6 months and then annually for 5 years. projected accrual: a total of 60 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: * histologically confirmed newly diagnosed stage iv neuroblastoma or ganglioneuroblastoma * metastases to bone, cns, or pleura/lung by x-ray or ct scan * no mycn amplification (i.e., fewer than 10 copies) patient characteristics: age: * under 12 months at diagnosis performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: disseminated neuroblastoma
twice (ezetimibe together with any statin cholesterol enhancement)(0653-060)

Conditions: Hypercholesterolaemia; Hyperlipidaemia

Summary: in patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl\>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).


Eligibility criteria:
inclusion criteria: * primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations). exclusion criteria: * pregnant or breast feeding women * lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (\>200 mg/day) and fibrates taken within the 3 months preceding visit 1.
treatment of acute myeloid leukemia with arsenic and all-trans retinoid acid

Conditions: Acute Myeloid Leukemia

Summary: the clinical trial was designed to prove that arsenic plus atra possibly had an effect on improving the symptoms, reducing the early mortality rate and prolonging the total survival time of patients with newly diagnosed or relapsed aml.

acute myeloid leukemia (aml) is a genetically heterogeneous disease with a highly variable prognosis and an overall high mortality rate. the 5-year overall survival of adult aml patients is less than 50%, and only 20% of elderly patients survive over 2 years. acute promyelocytic leukemia (apl) accounts for 10% - 15% of acute myeloid leukemia. arsenic and atra are very effective treatments for apl, a distinct aml subtype characterized by the expression of the pml/rara fusion protein. pml/rara expression disrupts pml nbs and blunts p53 signaling, which contributes to increased self-renewal of myeloid progenitors. the application of all-trans retinoic acid (atra) and arsenic modifies apl from highly fatal to highly curable. both ra and arsenic induce degradation of pml/rara through distinct pathways. nucleophosmin-1(npm1) is the most frequently mutated gene in acute myeloid leukemia (aml). according to el hajj's research, ra or arsenic trioxide synergistically induces proteasomal degradation of mutant npm1 in aml cell lines or primary samples, leading to differentiation and apoptosis. combined atra/arsenic treatment significantly reduced bone marrow blasts in 3 aml patients and restored the subnuclear localization of both npm1 and pml. overall, there is no consensus yet as to whether the addition of atra/arsenic improves the outcome of patients with npm1 mutant aml. however, it still needs clinical research to confirm. the investigators design a clinical trial to prove that arsenic plus atra is possibly improving the symptoms of aml patients, reduce early mortality, and extending overall survival time.

Eligibility criteria:
inclusion criteria: * newly diagnosed or relapsed aml.diagnosis based on chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia(not apl)(2018) * older than 18 years old * patients or their families signed written informed consent exclusion criteria: * be allergic to the drug ingredient, the supplementary material or the allergic constitution person * cardiac insufficiency, renal insufficiency, significant arrhythmias, ekg abnormalities or other important organ dysfunction * combined with other malignant tumors * pregnant and lactating women * participants in other drug trials in the last 3 months * suffering from mental illness or other circumstances which unable to carry out the plan * other patients who were not suitable for the study

Keywords: acute myeloid leukemia all-trans retinoic acid arsenic
a study of tqb3616 capsules combined with fulvestrant injection in subjects with advanced breast cancer

Conditions: HR-positive, HER2-negative Advanced Breast Cancer

Summary: this study is a multicenter, open-label, multi-cohort phase ii clinical trials to evaluate the efficacy and safety of tqb3616 capsules combined with fulvestrant injection in subjects with hr-positive and her2-negative advanced and/or metastatic breast cancer, including cohort 1 and cohort 2. each cohort will enroll 30-60 cases.


Eligibility criteria:
inclusion criteria: * 1.understood and signed an informed consent form. 2.eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 3. histopathologically confirmed hr positive and her2 negative advanced or metastatic breast cancer. 4.cohort 1: patients had received ≤1 line of treatment. 5.cohort 2: patients had not previously received systemic antitumor therapy. 6.has at least one measurable lesion according to recist1.1 criteria. 7.adequate laboratory indicators. exclusion criteria: * 1. concomitant disease and medical history: 1. has other malignant tumors within 3 years; 2. has multiple factors affecting oral medication; 3. unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 4. has active or uncontrolled severe infections before the first dose; 5. cirrhosis, active hepatitis# 6. have a history of immunodeficiency; 2. tumor-related symptoms and treatment: 1. has central nervous system metastases (cns) and/or cancerous meningitis or leptomeningeal carcinomatosis; 2. had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose; 3. has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 3. has known to be allergic to fulvestrant injection , tqb3616 or any excipient. 4. has participated in other clinical trials within 4 weeks before first dose. 5. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
vegf and sflt-1 levels in the pathogenesis and severity of covid-19 disease

Conditions: COVID-19 Disease

Summary: to assess blood levels of vasoactive mediators that may regulate pulmonary endothelial permeability and contribute to multi-organ injury in patients with covid-19 disease and to correlate the levels of these mediators with disease outcomes such as icu admission, length of ventilatory support, respiratory failure, kidney failure, heart failure, and death.

when patients are sick with other lung infections (pneumonias) caused by viruses or bacteria there are changes in a pathway that regulates the "leakiness" the tiny airspaces inside the lungs. even bigger changes in this pathway are seen when patients develop severe breathing difficulties (acute respiratory distress syndrome) similar to what is seen in patients who get really sick with covid-19 disease. there are important changes in this pathway that occur in patients who have preexisting cardiovascular (heart) disease who do not have lung infections. the investigator will evaluate these levels in patients with covid-19 because the investigator believes that this baseline difference in pathway regulation may be one reason patients with heart disease who contract covid-19 get sicker than patients without heart or vascular disease. the investigator will also assess the levels of components of this pathway in patients who are less sick with those who became sick enough to require a tube to help them breathe because this is important to determine if covid-19 lung disease has a similar effect on this pathway as other lung infections like flu and bacterial pneumonias.

Eligibility criteria:
inclusion criteria: * positive test for covid-19 (sars-cov-2 infection) * \>=18 years * blood (plasma) specimen(s) available in the ccts biorepository exclusion criteria: * \<18 years * lack of blood specimen

Keywords: covid-19 sars-cov-2 viral infection vegf and sflt-1 levels
prediction model for response to biologics and small molecular agent for uc

Conditions: Ulcerative Colitis

Summary: this prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for korean patients with ulcerative colitis.

in this prospective observational study, patients with confirmed ulcerative colitis, who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled after an informed consent. in the screening period, inclusion/exclusion criteria will be checked and if eligible and consented, demographic data, medical history, disease characteristics and disease activity data will be collected. before drug administration (week 0), baseline lower gi endoscopy will be performed and colon tissues will be collected. blood sample and fecal sample will also be collected. after induction therapy with each drug, clinical and endoscopic response will be evaluated at week 14 to week 16 and patients will be classified into responders non-responders. combing clinical data, blood laboratory data, fecal inflammatory biomarker, genetic data, and colonic transcriptomic data, a prediction model for response to induction therapy will be developed and it will be validated in another patient group. similarly, based on evaluation at week 52, a prediction model for maintenance response will also be developed and validated.

Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of ulcerative colitis based on clinical symptoms, endoscopic features and histopathologic features * patients who are going to receive vedolizumab, ustekinumab, or tofacitinib treatment exclusion criteria: * not korean ethnicity by family history * inflammatory bowel disease unclassified * patients who already received colectomy due to ulcerative colitis

Keywords: response, vedolizumab, ustekinumab, tofacitinib, multiomics
a phase 2a study of iv bcv in subjects with adenovirus infection

Conditions: Adenovirus Infections; Cytomegalovirus Infection

Summary: the purpose of this study is to determine the safety and tolerability of intravenous (iv) brincidofovir (bcv; syb v-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (biw) or 0.4 mg/kg dosed once weekly (qw) for 4 weeks in subjects with adv, and iv bcv in subjects with cmv

this is a phase iia, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous brincidofovir (bcv, syb v-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed biw or 0.4 mg/kg dosed qw (cohorts 1 to 4) in adult and pediatric subjects with adv viremia, and iv bcv in subjects with cmv.

Eligibility criteria:
inclusion criteria: * male or female, aged 2 months and older at the time of informed consent. * adv dna viremia \>10,000 copies/ml from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies/ml, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to day 1 (adv dna viremia results collected within the 7 day window, but prior to consent may be used if the informed consent form (icf) signed by the subject provides approval) . cmv viremia with or without evidence of tissue invasive cmv disease. for laboratory results that are generated in units other than copies/ml or iu/ml, please refer to the testing laboratory for guidance on the appropriate conversion calculation. * either (a) have disseminated adv disease or (b) have an underlying immunocompromised state, and have asymptomatic adv infection or localized adv disease. * in the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for adv. exclusion criteria: * subjects who weigh ≥120 kg. * nih/nci ctcae (united states \[us\] national institutes of health \[nih\]/national cancer institute) grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per day over usual pre-transplant stool output) within 7 days prior to day 1. * nih stage 4 acute gvhd of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to day 1. * nih stage 2 or higher acute gvhd of the liver function (i.e., bilirubin \>3 mg/dl \[si: \>51 μmol/l\]) within 7 days prior to day 1. * nih stage 2 or higher acute gvhd of the gut (i.e., diarrhea \>556 ml/m2/day for pediatric subjects \[or \>1000 ml/day for young adults as applicable, at centers in the united states only\], or severe abdominal pain with or without ileus) within 7 days prior to day 1.
carg, ves13, g8 scales in predicting drug toxicity in patients receiving nivolumab

Conditions: Nivolumab Related Toxicity

Summary: the geriatric 8 (g8), vulnerable elders survey (ves-13), and cancer and aging research group (carg) questionnaires are among the main tests whose purpose is to predict the risk of chemotherapy-induced toxicity (crt) and allow treatment. investigators aimed to investigate the effect of using the g8, ves13, and carg scales in the geriatric age group in cancer patients receiving nivolumab treatment in predicting side effects.

investigator aimed to examine whether the g8, ves13, and carg scales can shed light on clinicians in predicting side effects during the use of nivolumab in geriatric cancer patients. in the chemotherapy unit, demographic information, diagnosis date of the disease, previous treatments, comorbidities, and carg, ves13, and g8 questionnaires will be recorded face-to-face to the patients who meet the study criteria. in addition, routine hemogram and biochemistry tests, which were requested by the patient's follow-up physician before nivolumab treatment and which will be requested by the patient's own physician during follow-up visits, will be recorded prospectively. side effects that may occur during nivolumab treatment will be pursued at each visit. ctca v.6. will be used for grading. inclusion criteria 1-advanced cancer patients whose nivolumab treatment was started by the physician followed up (independent of diagnosis) 2-60 years and over, 3-ecog performance score 0-1 4-patients who signed the informed consent form exclusion criteria 1. under 60 years old 2. ecog score \>1

Eligibility criteria:
inclusion criteria: * advanced stage cancer patients who have been treated with nivolumab * be over 60 years old exclusion criteria: * be under the age of 60
effects of beer (alcohol) on social cognition

Conditions: Healthy

Summary: the present study aims to evaluate effects of beer (alcohol) on social cognition.

alcohol is one of the most widely used recreational drugs and it is often used in social settings to enhance sociability. there are few data showing that acute alcohol consumption affects facial emotion recognition. however the acute effects of alcohol in social drinkers on different aspects of social cognition are largely unknown. in the present study, we will therefore evaluate effects of beer (alcohol) on social cognition. the study will include 60 subjects (30 male, 30 female) and use a placebo-controlled, crossover design with the two experimental conditions alcoholic beer (individually calculated amount aiming to achieve a blood-alcohol concentration of 0.4g/kg), and non-alcoholic beer (placebo). we primarily aim to evaluate whether beer (alcohol) affects the ability to correctly decode emotions in facial expressions using different facial emotion recognition tasks. additionally, appraisal of visual erotic stimuli following alcohol consumption will be evaluated. subjective social and mood effects will be assessed using validated questionnaires. blood samples will be collected to assess plasma levels of the "social hormone" oxytocin as well as blood alcohol levels to test possible associations with effects on emotional processing.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 50 years 2. sufficient understanding of the german language 3. subjects understand the procedures and the risks associated with the study 4. participants must be willing to adhere to the protocol and sign the consent form 5. participants must be willing to refrain from drinking alcohol in the evening preceding the study session 6. participants must be willing to abstain from excessive drinking and from taking illicit psychoactive drugs during the study. 7. participants must be willing not to eat or drink xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) 3 h prior to the study session 8. participants must be willing not to drive a traffic vehicle or to operate machines for 3h after the sessions 9. women must have a negative pregnancy test at the beginning of each session. exclusion criteria: 1. chronic or acute medical condition. 2. current or previous personal history of psychotic or major affective disorder. 3. prior or current alcohol abuse, dangerous drinking behavior (\>15 points in the audit questionnaire). 4. family history of alcoholism (first-degree relative). 5. alcohol hypersensitivity 6. prior illicit drug use (except tetrahydrocannabinol (thc)-containing products) more than 15 times or any time within the previous week. 7. use of medications that are contraindicated or interfere otherwise with the effects of the study (monoamine oxidase inhibitors, antidepressants, sedatives etc.) 8. pregnant or nursing women. 9. participation in another clinical trial (currently or within the last 30 days).

Keywords: social neuroscience emotion face recognition empathy beer alcohol social cognition
diabetes multicenter observational study (diamond-1-)

Conditions: Diabetes

Summary: the purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.

in this study, 100 subjects, users of paradigm 522/722 infusion pump and self- monitoring blood glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate. moreover the subjects won't have achieved the best blood glucose control, with an average hba1c above 7% and should meet all the inclusion and none of the exclusion criteria. the hba1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for hba1c measurement will be analyzed centrally by hplc, in a lab in germany. in all enrolled patients a continuous glucose monitoring system will be provided. since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement. all subjects will be followed for 3 months according to the current medical practice of each investigational center. all other visits, e.g. patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits. these visits are usually linked to adverse events.

Eligibility criteria:
inclusion criteria: * subjects and/or their legal representative must sign the patient data release form (pdrf). * subjects must be aged between 12 and 45 years old. * subjects must be pump and self- monitoring blood glucose fingersticks users for at least 3 months and no more than 9 months. * hba1c \>7.0% with a measurement no older than three months prior to enrollment. * diagnosed t1d at least 1 year before study entry. * subjects must be able to understand how to use the paradigm real-time system and how to adjust and administer corrective treatment. * subjects should not have used the sensor in the past. exclusion criteria: * hearing or vision impairment so that alarms can not be recognized. * alcohol or drug abuse other than nicotine. * subjects suffering from severe chronic disease or genetic disorder other than t1d. (i.e. down syndrome etc.) * subjects suffering from allergy. * subjects in pregnancy or with desire to conceive during study. * subjects participating in other device or drug studies.

Keywords: hba1c paradigm 522/722 infusion pump transmitter (mmt-7703ww) sensor mmt-7002 (i.e. glucose sensor) levels of hba1c at enrollment higher than 7