Kornimate/medical-research-clean huggingface dataset:
glutamine pet imaging colorectal cancer

Conditions: RAS Wild Type; Stage IV Colorectal Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer

Summary: the clinical trial studies how well 11c-glutamine and 18f-fspg positron emission tomography (pet) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (mri) or computed tomography (ct) scanning.

primary objectives: i. to establish and validate a 11c-glutamine (11c-gln) and fluorine f 18 l-glutamate derivative bay94-9392 (18f-fspg) pet image guided gene signature to predict response to egfr-targeted therapy in patients with advanced wild-type ras colorectal cancer (crc). outline: patients receive 11c-glutamine intravenously (iv) and undergo pet imaging over 120 minutes. beginning 2 hours to 7 days after 11c-glutamine pet, patients receive fluorine f 18 l-glutamate derivative bay94-9392 iv and also undergo pet imaging over 120 minutes. during each of the 11c-glutamine and 18f-fspg pet/ct scans, venous blood draws will be performed.

Eligibility criteria:
inclusion criteria: * ≥18 years of age; * pathologically or cytologically confirmed diagnosis of metastatic (stage iv) ras wildtype crc; * eligible for anti-egfr monoclonal antibody (mab) therapy as standard-of-care (soc), either as a single agent or in combination with approved soc therapies or investigational agents as part of irb-approved clinical trials; * archived tissue from the crc primary tumor in sufficient amounts to allow rna-seq gene analysis; specimen from metastatic sites are not required but highly preferred; * documented results from (or scheduled to undergo) ct or mri of the chest, abdomen and pelvis as a standard-of-care procedure within 28 days of baseline investigational 11c-gln pet/ct and 18f-fspg pet/ct; * measurable disease by response evaluation criteria in solid tumors (recist) v1.1; * at least one lesion \>2 cm in diameter and thus will be measurable according to pet response criteria in solid tumors (percist) v1.0 to avoid pet partial volume effects; * ability to provide written informed consent in accordance with institutional policies. exclusion criteria: * any other current or previous malignancy within the past 5 years * previous egfr-directed therapy * body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed * pregnant or lactating females
retrospective cohort study on post analysis on the link between the clinical heart rate and outcomes during pci

Conditions: Coronary Heart Disease

Summary: the trial is a single centre, retrospective cohort, non-interventional study to be conducted in the department of cardiology, chinese pla general hospital, beijing, china. to evaluate the link between mean perioperative clinical heart rate and short-term composite outcomes during pci among local chd patients.

the study requires those data including subjects aged from 20 to 80 year-old, diagnosed as coronary heart disease with records on mean clinical heart rate during pci from 2009.1 to 2014.5 in the database from the department of cardiology, chinese pla general hospital, beijing. all 15,000 subjects' related data from the database will be collected.once selected, 15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean clinical resting heart rate during pci. group 1 will be defined as subjects' mean clinical resting heart rate ≤70 bpm, which will be set as baseline. group 2 will be defined as subjects' mean clinical resting heart rate between 71 to 80 bpm. group 3 will be defined as subjects' mean clinical resting heart rate between 81 to 90 bpm. group 4 will be defined as subjects' mean clinical resting heart rate \>90 bpm. the primary endpoint is to determine the link between the mean perioperative heart rate and short-term outcomes during pci among local chd patients.

Eligibility criteria:
inclusion criteria: * all patients consecutive enrolled in chinese pla general hospital from january 2009 to may 2014 * diagnosed as coronary heart disease with records on mean clinical heart rate during pci . exclusion criteria: * inferior wall myocardial infarction (mi) history or/and acute inferior wall mi patients; * dead within 3 days after admit into wards; * lvef\<30%; * install a permanent pacemaker patients.

Keywords: heart rate percutaneous coronary intervention outcome
health-related quality of life in a cohort of spanish schoolchildren.

Conditions: Quality of Life; Physical Inactivity

Summary: background: health-related quality of life (hrqol) allows knowing the subject\&#39;s feelings in terms of distress and well-being, as well as her perception of her current and future health. objective: evaluate the associations between health-related quality of life, physical state, and adherence to the mediterranean diet in a cohort of spanish children and adolescents. methods: a cross-sectional study was carried out in a cohort of 305 (47.2% women) children and adolescents aged between 8 and 16 years, in the primary and secondary schools of the province of ávila (spain). for the analysis of the different variables, the subjects were classified according to their quality of life in three groups from highest to lowest (group 1 \&gt; group 2 \&gt; group 3).


Eligibility criteria:
inclusion criteria: * school children aged 8 to 16 * present the informed consent signed by the parents or legal guardians exclusion criteria: * serious illness that may influence the nutritional or functional status of the child, mental limitation of the parents and / or children that may hinder the completion of the questionnaire.

Keywords: health-related quality of life physical state adherence to the mediterranean diet schoolchildren
computer-based brief intervention for perinatal substance abuse

Conditions: Substance Abuse

Summary: the purpose of the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use.

the purpose of this stage i/ii intervention study (that is, stage ii for drug use and stage i for alcohol use and smoking) is to test the efficacy of a brief, computerized motivational intervention for substance abuse among post-partum women. the study will randomly assign 350 post-partum women to either intervention or control conditions, with intervention itself taking approximately 30 minutes in the period before the participant leaves the hospital. inclusion criteria will include post-partum status, age between 18 and 45, ability to understand spoken english, and meeting criteria for one of the three substance use groups: any illicit drug use in month prior to pregnancy, meeting t-ace criteria for problem alcohol use, or smoking in past month. exclusion criteria will include receipt of narcotic pain medication in the past 3 hours, no sleep since giving birth, and inability to provide informed consent (e.g., due to psychosis or other clear cognitive impairment). lab-based follow-up will occur at 3- and 6-months postpartum. the primary outcomes will be participant report of frequency of substance use and toxicological analyses of substance use (urinalysis and expired breath co at 3 and 6 month follow-up, hair analysis at 6-month follow-up). secondary outcome measures include hiv risk behaviors, receipt of treatment services, motivation to change, self-efficacy, mental health functioning, violence exposure, and consequences related to substance use.

Eligibility criteria:
inclusion criteria: * hospitalized women in immediate post-partum period * self report of illicit drug use, problem alcohol use, or tobacco use in month prior to pregnancy exclusion criteria: * frank psychosis or other cognitive impairment * inability to communicate in english * no sleep since giving birth * recent receipt of narcotic pain medication * grieving over medically compromised infant

Keywords: motivational interview computer based intervention substance abuse post-partum
a study of telitacicept for the treatment of moderately to severely active systemic lupus erythematosus (remesle-1)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active sle.

systemic lupus erythematosus (sle) is a chronic autoimmune disease with heterogeneous manifestations and disease course. despite advances in medical care, there are still significant unmet needs in sle with diminished health-related quality of life (hrqol), persistent disease activity, disease flares, intolerance to standard of care (soc) therapies, and development of organ damage and co-morbidities. telitacicept is a fully human taci-fc fusion protein that targets b lymphocyte stimulator (blys) and a proliferating-inducing ligand (april). blocking the interaction of blys and april with their cell membrane receptors (taci, b-cell maturation antigen (bcma), and b-cell activating factor receptor (baff-r)) would inhibit b cell proliferation and maturation, suppresses immune responses, and may alleviate autoimmune symptoms. this phase 3 study is a 2-stage study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active sle while receiving soc treatment in a global patient population with active sle disease. * stage 1: a study to evaluate the efficacy, safety, pharmacokinetics (pk) and pd of two treatment arms of telitacicept compared to placebo in patients with moderately to severely active sle while receiving soc treatment. * stage 2: a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to soc compared to placebo with soc therapy in patients with moderately to severely active sle.

Eligibility criteria:
inclusion criteria: 1. age 12-70 years at screening. 2. has a diagnosis of sle for at least 6 months prior to the screening visit. 3. meets the 2019 eular/acr classification criteria for sle. 4. moderately to severely active sle defined by the following: 1. selena sledai total score ≥6 points with clinical sledai score ≥4 points at screening; 2. bilag organ system scores of at least 1a or 2b at screening. 5. clinical sledai score of ≥4 at day 0 prior to randomization. 6. at least one positive serologic parameter within the screening period. 7. currently receiving at least one of the soc sle medications: oral corticosteroid, antimalarial and/or immunosuppressive agent. exclusion criteria: 1. active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening. 2. active or unstable neuropsychiatric sle. 3. autoimmune or rheumatic disease other than sle

Keywords: systemic lupus erythematosus sle
cytomegalovirus (cmv) viremia and disease occurrence in pediatric allogeneic stem cell transplantation recipients

Conditions: Cytomegalovirus Infections

Summary: the primary objective is to determine the incidence of cmv viremia and disease in pediatric allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until day +100 by retrospective analysis.

this will be a single center, retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between june 29, 2011 and december 31, 2019 at westchester medical center (wmc). for this analysis, eligible patients will be identified through our transplantation database and clinical data collected through electronic medical record. this analysis will comprise of 100 pediatric allogeneic stem cell transplant recipients. cmv viremia will be defined as ≥2 cmv positive pcrs ≥500 copies and cmv disease will be defined as isolation of cmv in any body fluid or tissue specimen along with end-organ disease, as we have demonstrated.8 cmv viremia/disease will be evaluated through day +100 following allogeneic stem cell transplantation. review of clinical records and collection of data with de-identified information will be performed. the study team will not access medical records (paper or electronic) directly. medical records will be obtained through the hospital's health information management (him) department. him will query requested data / variables and provide a report / records of interest to investigator.

Eligibility criteria:
inclusion criteria: * retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between june 29, 2011 and december 31, 2019 at westchester medical center (wmc). * ages 0-≤26 years * received an allogeneic stem cell transplantation on the pediatric bone marrow transplant service including matched unrelated donor, matched sibling donor, haploidentical donor, umbilical cord donor * received ganciclovir prophylaxis for ≥14 days exclusion criteria: * none listed
virology follow up study in subjects previously treated with telaprevir

Conditions: Hepatitis C

Summary: observational follow-up study to assess long-term response to telaprevir and to evaluate changes in hepatitis c virus over time.


Eligibility criteria:
inclusion criteria: * received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: vx05-950-104, vx05-950-104eu, vx06-950-106, vx06-950-107, vx07-950-108, vx08-950-111, or vx-950-tidp24-c216 * have baseline hcv viral sequencing data available from previous telaprevir study exclusion criteria: * may not be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (note: subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient-reported outcomes data for their previous telaprevir study may be eligible.) * for subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and day 1 in this study
diagnostic value and safety of flecainide infusion test in brugada syndrome

Conditions: Brugada Syndrome; Arrhythmogenic Right Ventricular Cardiomyopathy

Summary: the study aims to use flecainide infusion test as diagnostic test to unmask concealed brugada syndrome cases. it proposes to assess the safety profile of this test in us patients and its higher sensitivity when compared to procainamide infusion (the conventional drug used in the usa). as a substudy it proposes to apply this test to early arvc cases in order to evaluate if ecg changes similar to those seen in brugada syndrome could be unmasked by flecainide iv.

brugada syndrome is an inherited arrhythmogenic disease responsible for life-threatening arrhythmias and sudden cardiac death in young individuals with structural normal heart. it is characterized by a peculiar ecg pattern, but this pattern could be intermittent. the infusion of sodium channel blockers (flecainide, ajmaline, procainamide) is used to unmask a concealed ecg pattern, thus providing an essential contribution to the diagnosis of this condition. in the current clinical practice in usa, only procainamide is used for diagnostic purposes; however in europe only ajmaline and flecainide, available as iv formulations, are widely used. european and japanese studies have demonstrated that the use of flecainide harbors less risks of adverse events in patients and may have a higher accuracy in unraveling the presence of the disease. in the present study the investigators propose to use flecainide infusion test in the cardiovascular genetics program at nyumc, in order to assess its sensitivity and specificity in diagnosing the disease and compare the incidence of adverse events to that observed during procainamide use. additionally, the investigators propose to extend the study protocol to patients with a suspect diagnosis of arrhythmogenic right ventricular tachycardia (arvc), due to the possible overlap between the two conditions. the study has the following aims: 1. to demonstrate the higher sensitivity and specificity of flecainide iv infusion compared to procainamide infusion for the diagnosis of brugada syndrome. 2. to demonstrate that flecainide is equally safe or safer than procainamide to use for diagnosing brugada syndrome. 3. to demonstrate that flecainide has high sensitivity and specificity in diagnosing also some patients with early stage arrhythmogenic right ventricular cardiomyopathy (arvc).

Eligibility criteria:
inclusion criteria: * suspect diagnosis of brugada syndrome or arvc * idiopathic ventricular fibrillation and suspect concealed brugada syndrome * family history of brugada syndrome * family history of unexpected cardiac sudden death exclusion criteria: * type 1 brugada syndrome ecg * pregnancy * history and/or evidence of ischemic cardiomyopathy * recent myocardial infarction * allergy or known adverse reaction to flecainide

Keywords: brugada syndrome arvc flecainide st elevation
post-authorization safety study of allogeneic hematopoietic stem cell transplantation in patients treated with mogamulizumab

Conditions: Leukemia/Lymphoma; Cutaneous T Cell Lymphoma; ATLL

Summary: this is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with ctcl or atll treated with mogamulizumab pre- or post- allohct for patients transplanted beginning january 1, 2012 until accrual is complete.

this is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. data will be collected at baseline (retrospectively), 100 days post allohct, 6-months, 1 year and at 2 years post allohct (retrospectively and prospectively). a cut-off time limit of 18 months post allohct exposure will allow at least 6 months of follow-up within the 2 years post-allohct follow-up period.

Eligibility criteria:
inclusion criteria: * patients registered to the center for international blood and marrow transplant research (cibmtr) * adults ≥18 years of age with either ctcl or atll; * allohct performed from january 2012 onward. exclusion criteria: • patients without consent for research.
saliva profiles in children with congenital heart disease

Conditions: Cardiac Disease; Dental Caries

Summary: the purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with chd directly dental caries including gender, age, salivary flow rate, salivary ph, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ace) inhibitors. if such relationships exist, they might be employed to patient caries -prevention treatment.

using heart failure medications may cause low salivary ph and buffering capacity.as improved oral health is a priority for cardiac patients, it is necessary that they attend dental clinics for regular follow up. this cross sectional study was carried out with 42 chd and 42 healthy children who applied to istanbul university, faculty of dentistry, department of pedodontics. gender, age, general health and medications, and caries scores (dfs/dmfs) were recorded. unstimulated saliva was collected from the participants and were assessed for the salivary secretion rate, salivary buffering capacity, ph, protein levels, superoxide dismutase (sod), ferric reducing antioxidant power (frap), the thiobarbituric acid reactive substances (tbars), protein carbonyl, protein thiols, total sialic acid.

Eligibility criteria:
inclusion criteria: * 3-12 years * caridac problems exclusion criteria: * other ages * syndromes * other systemic diseases

Keywords: saliva composition antioxidant activity caries risk factors congenital cardiac disease
effect of prehabilitation on surgical outcomes of abdominally-based plastic surgery procedures

Conditions: Ventral Hernia; Panniculus; Abdominoplasty; Flap Reconstruction

Summary: the purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the abdomen improves surgical outcomes. the investigators hope to determine how a multimodal peri-operative prehabilitation program can be most effective in engaging and motivating patients to physically and mentally get ready for an abdominally-based plastic surgery operation. the overall goal is to determine if this program will improve post-operative recovery after abdominally-based plastic surgery. the importance of this new knowledge is better understanding of ways that plastic surgeons can improve outcomes, engagement, and experience of patients undergoing abdominally-based plastic surgery operations. this would translate to increased healthcare value and better long-term outcomes.


Eligibility criteria:
inclusion criteria: - adult patients (\>18 years) who are undergoing elective abdominally-based plastic surgery operations in 3+ weeks by one of the following plastic surgeons: nazerali, lee, murphy, nguyen, lorenz. exclusion criteria: * patients who do not speak english * patients who do not have access to a smartphone or internet/cell service. * patients who are undergoing another intervention study that consists of a nutrition and/or exercise behavior change.
a study atg-101 in patients with metastatic/advanced solid tumors and mature b-cell non-hodgkin lymphomas

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Mature B-cell Non-Hodgkin Lymphoma

Summary: this is a first-in-human phase i trial of atg-101 in patients with metastatic/advanced solid tumors and mature b-cell non-hodgkin lymphomas.

this is a first-in-human phase i trial of atg-101 in patients with metastatic/advanced solid tumors and mature b-cell non-hodgkin lymphomas. dose escalation phase: approximately 40-50 subjects with a maximum number of 62; dose expansion phase: estimated 100-400 subjects depending on the number of cohorts to be expanded.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. aged at least 18 years as of the date of consent. 3. histological or cytological confirmation of a solid tumor, and has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. estimated life expectancy of a minimum of 12 weeks. 4. eastern cooperative oncology group (ecog) performance status 0 or 1. 5. female and male subjects should be using adequate contraceptive measures as requested. exclusion criteria: 1. subjects with cns tumors or known cns metastases will be excluded. 2. prior atg-101 administration or a 4-1bb agonist. 3. prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment. 4. radiotherapy with a wide field of radiation within 28 days. 5. with the exception of alopecia, any unresolved toxicities from prior therapy greater than grade 1 (ctcae v5.0) at the time of icf signature. 6. active infection, including hepatitis b and/or hepatitis c. 7. have uncontrolled intercurrent illness, including but not limited to: 8. inadequate bone marrow reserve or organ function. 9. history of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to atg-101. 10. prior organ allograft transplantations. 11. pregnant or nursing females. 12. have a history of another primary malignancy within 3 years prior to starting study treatment. exceptions are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc. 13. in the opinion of the investigator, subject's complications or other conditions may affect protocol compliance or may be unsuitable for participation in the study.

Keywords: solid tumor, lymphoma, bispecific, antibody