Kornimate/medical-research-clean huggingface dataset:
osimertinib in subjects with advanced non-small cell lung cancer egfr-t790m mutation-positive

Conditions: Non Small Cell Lung Cancer

Summary: this is a retrospective, multicenter and observational study of osimertinib monotherapy treatment in subjects with advanced or metastatic non-small cell lung cancer (nsclc) egfr-t790m mutation-positive who have received the treatment within the special use medication program (sump) in spain.

the study is based on the collection of data about the patients treated with osimertinib within the special use medication program. the patienes participating in this non-interventional study will not receive treatment in relation to the study. approximately a total of 270 patients will be included in this project from several spanish sites. around 52 hospitals will participate in the study. the observation period is from august 2016 to december 2018 and will include patients who started the treatment with osimertininb from august 2016 to april 2018. the primary objective is to estimate the progression free survival of the osimertinib treatment.

Eligibility criteria:
inclusion criteria: * squamous or non-squamous, non-small cell lung cancer (nsclc), stage iiib/iv (histologically or cytologically confirmed), egfrm/t790m, who received osimertinib treatment within the spanish special use medication program of osimertinib (sump). * alive patients must have signed, dated and irb/ec-approved written informed consent form in accordance with regulatory and institutional guidelines. this must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. exclusion criteria: * alive patients who do not want to sign and date an irb/iec-approved written informed consent form. * patients who were accepted in the sump, but did not receive treatment.

Keywords: lung cancer, egfr positive, nsclc, osimertinib
blood pressure measuring practice of hong kong primary care doctors

Conditions: Hypertension

Summary: background: while office bp measurements were traditionally used to detect, diagnose and manage hypertension(ht), studies had convincingly showed that out-of-office blood pressure, including home blood pressure monitoring (hbpm) and ambulatory blood pressure monitoring (abpm), was superior in predicting cardiovascular outcomes and death. furthermore, some countries' guidelines suggested the use of validated automatic blood pressure machines (called automated office blood pressure monitoring (aobp)) to screen for ht and record bp in routine ht clinical management. with difference between guidelines and various available bp measurement methods, it is not known how primary care doctors, who play the key role to detect and treat ht, are measuring bp in their daily practice. method: all doctors registered in the primary care directory will be mailed a questionnaire. those who do not respond would be mailing for maximally 3 times, 2 weeks apart to enhance response rate. it is estimated that around 1500-2000 doctors will be eligible.


Eligibility criteria:
inclusion criteria: * all doctors registered in the primary care directory in hong kong exclusion criteria: * nil
reducing eye strain and anxiety using a digital intervention during online learning class recess among children at home: a randomized controlled trial

Conditions: Anxiety; Digital Eye Strain

Summary: the primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention in reducing anxiety and digital eye strain compared to usual care among chinese children during the period of home confinement.

in response to the coronavirus disease 2019 (covid-19), many countries have taken the decision of school closure after the confirmation of coronavirus cases in the general population. in china, the burden of covid-19 is among the highest in the world, with more than 80,000 cases confirmed by 11th march 2020. an estimate of 220 million children and adolescents are confined at home for weeks with inadequate level of physical activity and more susceptible to anxiety. there is also a concern of digital eye strain for many children who spend hours daily in front of a computer screen for recreation or learning purposes. recess represents an essential scheduled period in a school day for psychological and physical relaxation. during the unusual period of home confinement, many schools have already issued physical activity requirement and policy recommending recess and physical activity breaks. however, recess could be easily skipped by students during online learning at home. mobile health intervention offers a potential opportunity for capitalizing on digital technology as a feasible modality to encourage recess activities, especially in regions where social distancing is implemented as an emergency measure. the primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention during recess in reducing anxiety and digital eye strain compared to usual care among chinese children during the period of home confinement.

Eligibility criteria:
inclusion criteria: * grade 7 (12-13 years old) students in duanzhou district, zhaoqing city * students under home confinement and enrolled in online learning courses, during the covid-19 outbreak exclusion criteria: * autism spectrum disorders and pervasive developmental delay or disorder * mental retardation * psychotic disorders and schizophrenia * mania or hypomania disorders * suicidal behavior and/or acute plan that require higher level of care * participation in psychotherapy
use of blood ketone meters to improve ambulance hyperglycaemia care

Conditions: Diabetic Ketoacidosis

Summary: in this karma2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of diabetic ketoacidosis using blood ketone meters and start fluid (saline) therapy before arriving at hospital. the investigators aim to include 800 patients in this stepped wedge control study and the results will help decide if a larger study is warranted.

diabetic ketoacidosis (dka) is a potentially life-threatening condition which requires immediate treatment. national health service (nhs) hospital guidelines recommend immediate fluid (saline) therapy. delays in diagnosis and treatment are known to be associated with health complications and death. there is an opportunity to involve ambulance crews to improve dka identification and treatment times; however, currently ambulance staff do not have access to ketone testing, and fluids are recommended only when it is thought a patient is critically unwell. in this karma2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of dka using blood ketone meters and start fluid (saline) therapy before arriving at hospital. during an 8-month period (4-month control followed by 4-month intervention), 120 ambulance clinicians from the east of england ambulance service nhs trust will receive training to consent 400 patients with hyperglycaemia and unwell patients with diabetes to the control group receiving usual care, followed by determining the presence of ketones using capillary blood testing from a further 400 consenting patients with hyperglycaemia and unwell patients with diabetes. subsequent patient care will depend on the ketone value obtained: high-risk dka patients will receive fluid therapy. twenty ambulance and hospital clinicians will be invited to an online interview to share views of dka care and the impact of ambulance blood ketone meters. the results will help the investigators decide if a larger study would be a good idea.

Eligibility criteria:
inclusion criteria: * aged 18 years or more * attended by study clinician * informed or proxy consent to participate * blood glucose level greater than 11mmol/l or unwell with history of diabetes * if required will be transported to partner hospital exclusion criteria: * failure to meet inclusion criteria * previously recruited to study
a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis c virus infection who have not had treatment before

Conditions: Chronic Hepatitis C Infection

Summary: this is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis c virus infection who have not had treatment before.

the primary purpose of this study is to demonstrate that treatment with abt-450/ritonavir (r)/abt-267 and abt-333 administered with or without ribavirin (rbv) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegifn) and rbv and to compare the safety of these regimens in treatment-naive hepatitis c virus (hcv) genotype (gt) 1a- and 1b-infected adults.

Eligibility criteria:
inclusion criteria: * males or females between 18 and 65 years, inclusive, at time of screening * females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control * subject has never received antiviral treatment for hepatitis c infection * chronic hcv genotype-1 infection prior to study enrollment exclusion criteria: * positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) * females who are pregnant or plan to become pregnant, or breastfeeding * any current or past clinical evidence of cirrhosis * screening laboratory analyses that showing abnormal laboratory results * use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegifn and rbv * recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol * positive screen for drugs or alcohol

Keywords: chronic hepatitis c interferon free hepatitis c treatment naive hepatitis c virus hepatitis c genotype 1
study of stapokibart injection in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: this study is a randomized, double-blind, placebo-controlled phase ii clinical study evaluating the efficacy and safety of stapokibart injection in patients with allergic rhinitis.

allergic rhinitis (ar) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin e (ige) in atopic individuals exposed to allergens.

Eligibility criteria:
inclusion criteria: * able to understand the study and voluntarily sign the informed consent form. * diagnosed allergic rhinitis according to the criteria stated in the chinese guidelines for the diagnosis and treatment of allergic rhinitis (2022, revised edition). * subjects with asthma must be evaluated by the researcher as having a stable condition. * has a positive skin prick test (spt) or positive antigen-specific serum immunoglobulin e (ige). exclusion criteria: * use of anti-interleukin 4 receptor alpha subunit (il-4rα) monoclonal antibody, thymic stromal lymphopoietin (tslp) monoclonal antibody, anti-ige monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit. * use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study. * forced expiratory volume in 1 second (fev1) ≤ 50% of the predicted value during the screening/run-in period. * have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening. * have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.
ucmscs combined with standard therapy for the treatment of newly diagnosed type 1 diabetes

Conditions: Newly Diagnosed Type 1 Diabetes Mellitus

Summary: the aim is to investigate the safety and tolerability of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells in pediatric patients diagnosed with newly onset type 1 diabetes

this is an iit study, where the first part is an open, dose escalating study consisting of 9 patients, 8-18 years of age. the second part is a randomized, double-blinded, placebo-controlled, iit study in parallel design comparing allogeneic ucmscs treatment to placebo in pediatric patients diagnosed with newly onset type 1 diabetes. besides safety, preservation of endogenous insulin production (measured as c-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed. a total number of 24 patients will be enrolled in the study and followed for one year after ucmscs/placebo treatment. patients 8-18 years of age, both male and female, diagnosed for type 1 diabetes will be eligible. providing informed consent and fulfillment of inclusion criteria and no exclusion criteria, they will within 6 months of diagnosis be randomized.

Eligibility criteria:
inclusion criteria: 1. meets the diagnostic criteria for diabetes according to the world health organization (who) guidelines from 1999. 2. presence of at least one pancreatic autoantibody, or idiopathic type 1 diabetes mellitus (t1dm) with negative autoantibody testing. 3. ages 8 to 18 years, regardless of gender. 4. newly diagnosed t1dm within the past 6 months. 5. fasting c-peptide ≥0.1 nmol/l and postprandial 2-hour c-peptide \>0.2 nmol/l. 6. voluntary acceptance of stem cell transplantation therapy by the individual, their family members, or legal guardians, and signing of an informed consent form. exclusion criteria: 1. diabetic ketoacidosis is not under control. 2. severe allergic constitution. 3. bmi \ 35. 4. history of other autoimmune diseases, hematologic disorders. 5. hiv positive, carrier of viral hepatitis, active phase of viral hepatitis, or other uncontrolled infectious diseases. 6. history of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe diseases of the heart, liver, kidneys, respiratory system, nervous system, etc. 7. suffering from gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as cushing's syndrome, thyroid dysfunction, or acromegaly-induced diabetes); 8. pregnancy or planning pregnancy within 3 months before or after treatment, as well as breastfeeding women. 9. mental illness, alcohol or drug abuse, inability to comply with treatment. 10. known or suspected tumors. 11. according to the investigator's judgment, there are other clinical conditions that may endanger the safety of the subjects.
a study of samuraciclib and elacestrant in participants with metastatic or locally advanced hr+/her2-negative breast cancer

Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer; Breast Cancer

Summary: this is an international, multisite, open-label, phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced hormone receptor (hr) positive and human epidermal growth factor receptor (her)2-negative breast cancer.

this is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. a safety review committee (src) will monitor the safety, tolerability, and pk data during this phase. once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of er-positive, her2-negative locally advanced or metastatic breast cancer. * documented objective disease progression while on or within 6 months after the end of the most recent therapy. * received prior ai in combination with a cdk4/6i as the last therapy * known tp53 and esr1 mutation status. * participants must have measurable disease or bone only disease as defined by response evaluation criteria in solid tumors (recist) version 1.1. * pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (lhrh) agonist at least 4 weeks prior to first dose of study intervention. * eastern cooperative oncology group (ecog) performance status ≤1 with no deterioration over the past 2 weeks. * expected life expectancy of \>12 weeks in the judgement of the treating investigator. exclusion criteria: * inflammatory breast cancer. * participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. * more than 1 line of endocrine treatment for locally advanced or metastatic disease treatment. * inadequate hepatic, renal, and bone marrow function. * clinically significant cardiovascular disease. * any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. * pregnant or breastfeeding women.

Keywords: metastatic breast cancer advanced breast cancer breast cancer hr positive her2-negative
ai-ecg screening for left ventricular systolic dysfunction

Conditions: Left Ventricular Systolic Dysfunction

Summary: the purpose of the current study is to verify the effectiveness of the artificial intelligence algorithm applied to the electrocardiogram as a potential screening tool for left ventricular systolic dysfunction.

the current investigators have developed an artificial intelligence (ai) algorithm based on 12-lead electrocardiogram (ecg) detecting left ventricular systolic dysfunction, through 364,845 ecgs from 148,547 patients. then, when the model was tested retrospectively on 59,805 ecgs of 24,376 patients, the model performance expressed as an area under the receiver operating characteristic curve was 0.889 (95% ci 0.887-0.891). the investigators are planning to prospectively validate the model's effectiveness as a potential screening tool for left ventricular systolic dysfunction.

Eligibility criteria:
inclusion criteria: * individuals or those whose legal representative agree to participate in the study, and sign the consent form * can complete both 12-lead electrocardiogram and transthoracic echocardiography exclusion criteria: * individuals whose age is less than 18 year-old. * individuals who do not agree to participate in the study * patients who are unable to participate in clinical trials at the discretion of the investigator
phase iia study of copanlisib in relapsed or refractory mantle cell lymphoma (mcl)

Conditions: Lymphoma, Mantle-Cell

Summary: the primary objective of this study is to assess objective response rate (orr) in patients with relapsed or refractory mcl who failed ibrutinib treatment or were unable to tolerate ibrutinib.


Eligibility criteria:
inclusion criteria: * histologically confirmed mcl * patients who have previously received treatment with ibrutinib (modified by amendment 1), including: * completion of at least 1 cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or * discontinuation of ibrutinib treatment at an earlier time due to toxicity * measurable disease according to the lugano classification * at least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1) * availability of fresh tumor tissue at screening * male or female patients ≥ 18 years old * ecog (eastern cooperative oncology group) performance status of ≤ 2 * left ventricular ejection fraction (lvef) by echocardiogram or multiple gated acquisition (muga) scan ≥ the lower limit of normal (lln) for the institution * adequate bone marrow, liver and renal function exclusion criteria: * any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only * current central nervous system (cns) involvement by lymphoma * new york heart association (nyha) class iii or iv heart disease * unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). myocardial infarction less than 6 months before start of study treatment * uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1) * type i or ii diabetes mellitus with hba1c \> 8.5% at screening (modified by amendment 1) * arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. however, if a patient has recovered to ecog performance status of ≤ 2 he/she may be enrolled provided that other eligibility criteria are met * ongoing or active infection of common terminology criteria for adverse events (ctcae) grade ≥ 3 * known history of human immunodeficiency virus (hiv) infection * acute or chronic hepatitis b (hbv) or hepatitis c (hcv) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy) * history or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator) * prior treatment with pi3k inhibitor(s) * cytomegalovirus (cmv) pcr positive at baseline
vih-1 colo-rectal transmission by infected semen cells and effects of seminal plasma ex vivo (cellspermvih)

Conditions: HIV-1-infection

Summary: the objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in hiv cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from hiv-infected donors and tissue explants

this project relies on: * our expertise of hiv in semen and male genital tract and our experience in organotypic cultures; * a network of infectious diseases and reproductive biology clinicians to collect, analyze and process seminal cells and seminal plasma from hiv+ donors; * the expertise in confocal microscopy and ex vivo colo-rectal model. state of the art culture of colo-rectal tissues, primary cell culture and infection, confocal microscopy, flow cytometry, polymerase chain reaction and luminex assays for cytokine measurements will be the methodologies primarily used in this project.

Eligibility criteria:
inclusion criteria: * hiv-1 infected patients who have never been treated by antiretroviral therapy * signature of informed consent * affiliation to social service exclusion criteria: * patients' general condition not allowing protocol follow-up * patients with an ejaculation disorder * patients unable to perform semen sampling * patients with chemotherapy or radiotherapy antecedents * patients with very severe oligospermia (≤1million/ml of spermatozoa) * patients with active genital infection * protected subjects

Keywords: hiv-1 colo-rectal transmission seminal plasma