Kornimate/medical-research-clean huggingface dataset:
continuous positive airway pressure device or deep inspiration breath hold in reducing tumor motion in patients undergoing stereotactic body radiation therapy for lung cancer

Conditions: Lung Carcinoma; Malignant Respiratory Tract Neoplasm; Metastatic Malignant Neoplasm in the Lung

Summary: this pilot phase i/ii trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (sbrt) for lung cancer. the continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.

primary objectives: i. to compare the two methods of tumor motion management, continuous positive airway pressure (cpap) and deep inspiration breath hold (dibh) and to estimate the decrease in tumor motion from free breathing for cpap and dibh. secondary objectives: i. to determine if cpap is a more time-efficient option for tumor motion management than is dibh. ia. determine if cpap is better tolerated by patients than is dibh. ib. determine the reproducibility of lung expansion and tumor motion reduction by cpap. ic. determine if the dosimetric coverage of the tumor and the sparing of the normal tissues with cpap is comparable to that with dibh. id. measure treatment time differences between cpap and breath hold (dibh) treatments. outline: patients undergo free-breathing, dibh, and cpap ct simulation scans. if patient has difficulty exhaling on cpap, then patient undergo biphasic positive airway pressure (bipap) ct simulation. the attending physician then compares all 3 simulation treatment plans (free-breathing, dibh, and cpap/bipap) and determines which method to use during sbrt. if cpap/bipap is chosen as preferred method, patients wear cpap/bipap over 1 hour prior to sbrt, then again during sbrt over 30-60 minutes. all other patients complete free-breathing or dibh during sbrt over 30-60 minutes.

Eligibility criteria:
inclusion criteria: * the patient will receive stereotactic body radiotherapy in the thoracic radiation oncolcogy service at md anderson. exclusion criteria: * the patient has a contra-indication for using a cpap device. * the patient has not signed a study-specific informed consent for this study. * the patient is uncooperative. * the patient has reduced consciousness. * the patient has sustained trauma or burns to the face. * the patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months. * the patient has idiopathic pulmonary fibrosis (ipf) as documented in their medical history. * adults who are unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study.
do childhood measles and dtap vaccination decrease the mortality rate caused by covid-19 in oecd countries?

Conditions: Covid19; Measles Vaccine; Mortality

Summary: mortality rates caused by sars cov-2 differ between countries and this difference might be explained by several reasons. childhood vaccination rate is thought to be one of them. therefore present study aimed to examine the possible relationship between dtap (diphtheria, tetanus, pertussis) and measles vaccination rates of organization for economic co-operation and development (oecd) countries and case fatality rate (cfr) caused by sars cov-2.

the mortality rates caused by sars cov-2 differ between countries and this difference might be explained by several reasons. childhood vaccination rate is thought to be one of them. therefore present study aimed to examine the possible relationship between dtap (diphtheria, tetanus, pertussis) and measles vaccination rates of organization for economic co-operation and development (oecd) countries and case fatality rate (cfr) caused by sars cov-2.a total of 32 oecd countries, of northern hemisphere, have been included in this study. statistical analysis performed according to the cfr data of these countries based on sars cov-2. the cfr data calculated according to the total mortality count of a specific country for the 3-month period down from the date when first sars cov-2 case was observed.

Eligibility criteria:
inclusion criteria: * children vaccinated in oecd countries in northern hemisphere exclusion criteria: * non vaccinated children * southern hemisphere countries * non-oecd countries
lymphocyte immunophenotyping in common variable immunodeficiency

Conditions: Common Variable Immunodeficiency; Granulomatous Disease; Bronchiectasis; Immunoglobulin Treatment

Summary: the purpose of this study is to discover if differences in the surface markers of b-cells (antibody producing cells of the immune system) in common variable immune deficiency (cvid) are related to cvid or its complications/treatment (e.g. bronchiectasis, granulomatous disease, immunoglobulin treatment). the study hypothesis is that the altered b-cell surface markers are related to cvid, and not to the complications or treatment of cvid.

common variable immune deficiency (cvid) is a syndrome containing a spectrum of disorders which results in weakened immunity and recurrent infections. the esid (european society for immunodeficiencies) cvid definition includes patients with marked decrease of igg (at least 2 standard deviations below the mean for age). patients must also have disease onset at an age over 2 years, absent isohaemagglutinins and/or response to vaccines and other defined causes of hypogammaglobulinaemia must be excluded. the euroclass system of classifying cvid is the result of a european multicentre trial attempting to develop a consensus of two existing classification schemes of b-cell immunophenotyping. in this paper it was shown that b-cell immunophenotype correlated with coincidence of clinical sequelae and it suggested implementing this to further classify cvid to give prognostic and therapeutic information. however, it has not yet been shown that these alterations in b-cell immunophenotype are the result of cvid itself and not caused by the treatment or complications of cvid (e.g. immunoglobulin replacement therapy, granulomatous disease, bronchiectasis). the aim of this study is to show that alterations in b-cell immunophenotype are caused by cvid itself and not by its complications or treatment. the study will therefore compare cvid patients to suitable control patients with granulomatous disease, bronchiectasis and on long-term immunoglobulin therapy. a control group of normal people will also be included to ensure the assay can detect normality and to show differences between normal people and patients with cvid.

Eligibility criteria:
inclusion criteria: * 18 or over * competent to consent * have diagnosis of common variable immunodeficiency, granulomatous disease, on long term immunoglobulin or bronchiectasis. exclusion criteria: * under 18 * unable to consent. * medical problem that could alter b-cell immunophenotype (except for the diagnoses in the inclusion criteria)/

Keywords: common variable immunodeficiency granulomatous disease crohns disease bronchiectasis immunoglobulin replacement or treatment b-cell immunophenotyping
observational study of pediatric rheumatic and immunologic diseases in china: the caprid registry

Conditions: Autoimmune Diseases; Autoinflammatory Diseases

Summary: an observational, multi-center, longitudinal registry study for chinese pediatric patients with rheumatic and immunologic diseases.

pediatric rheumatic and immunologic diseases severely impact the health of children and adolescents. chinese alliance of pediatric rheumatic \& immunologic diseases (caprid) was founded in 2022 to form a national collaboration for high-quality data-driven multi-center pediatric rheumatology and immunology research in china. the caprid registry is an observational, multi-center, longitudinal registry for chinese pediatric patients with rheumatic and immunologic diseases to explore the clinical phenotypes, diagnoses, complications, real-world drug safety, therapeutic efficacy, adverse events, critical illness and outcomes of chinese pediatric patients with rheumatic and immunologic diseases. hospital-based databases are established and standardized with observational medical outcomes partnership (omop) common data model (cdm) for routine data collection. a web-based registry website is established with standardized electronic case report forms to register patients from caprid centers. a mobile application is created to allow long-term follow up and patient-reported outcome collection. the data captured in this registry reflects a "real world" situation with no intervention done outside the routine clinical practice. treatment plans are determined by the investigator.

Eligibility criteria:
inclusion criteria: * age \<= 18 years old * diagnosed with rheumatic and immunologic diseases (including diffuse connective tissue diseases, arthritis, vasculitis, inborn errors of immunity) * diagnosed and treated in china exclusion criteria: * disagreement of involving in this study by the patient or his/her family.

Keywords: systemic lupus erythematosus juvenile idiopathic arthritis vasculitis juvenile dermatomyositis sjogren's disease autoimmune autoinflammatory disease scleroderma
efficacy and safety of orelabrutinib plus lenalidomide and rituximab (r2) compared to placebo plus r2 in r/r marginal zone lymphoma

Conditions: Relapsed/Refractory Marginal Zone Lymphoma

Summary: evaluate the efficacy and safety of orelabrutinib plus lenalidomide and rituximab (r2) versus placebo plus r2 in relapsed/refractory marginal zone lymphoma.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤ 80 years, either sex. 2. histopathologically confirmed b-cell non-hodgkin lymphoma mzl (splenic, nodal, or extra-nodal). 3. at least one and no more than 3 prior lines of systemic therapy (cd20 targeted therapy included in at least one line). 4. relapsed or refractory disease. 5. at least 1 measurable lesion confirmed through enhanced computed tomography (ct) or enhanced magnetic resonance imaging (mri). 6. ecog performance status (ps) score of 0-2. exclusion criteria: 1. administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment. 2. administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial. 3. prior treatment with any types of btk inhibitor. 4. prior allogeneic hematopoietic stem cell transplantation (allo-hsct), or autologous hematopoietic stem cell transplantation (asct) within 6 months prior to the first dose of the study treatment; or prior car-t cell therapy. 5. central nervous system (cns) lymphoma, and lymphoma with cns or meningeal involvements.
evaluation of a novel microfluidic device to purify metastatic lung cancer patients ctc (circulating tumoral cells)

Conditions: Non Small Cell Lung Cancer

Summary: currents strategies for cancer diagnosis consist of the extraction of a solid tissue from the affected area. this sample enables the study of specific biomarkers and the genetic nature of the tumor. however, the tissue extraction is risky and painful for the patient and in some cases is unavailable in inaccessible tumors. in addition, cancer is a dynamic disease and during the course of disease, cancers generally become more heterogeneous. as a result of this heterogeneity, the bulk tumour might include a diverse collection of cells harbouring distinct molecular signatures with differential levels of sensitivity to treatment. this heterogeneity might result in a non-uniform distribution of genetically distinct tumour-cell subpopulations across and within disease sites (spatial heterogeneity) or temporal variations in the molecular makeup of cancer cells (temporal heterogeneity). to overcome these drawbacks, new alternatives are rising up, such as liquid biopsy. a liquid biopsy is the analysis of biomarkers in a non-solid biological tissue, mainly blood, which has remarkable advantages over the traditional method; it has no risk, it is non-invasive and painless, it does not require surgery and reduces cost and diagnosis time. of the various circulating biomarkers, circulating tumor cells (ctcs) have particularly opened new windows. circulating tumor cells (ctcs) are released into the bloodstream from primary cancer, metastasis, and even from a disseminated tumor cell reservoir. ctcs may ideally replace tissue biopsies in the prediction and monitoring of therapeutic responses and tumor recurrence. ctcs can be used to guide therapeutic cancer management and serve as drug targets. there are a wide range of instruments and methods for capturing, enriching, and enumerating ctcs. however, none of them is considered optimal. to improve the purity of ctcs, the study consortium has developed a cutting-edge microfluidic device (luton) to reduce leukocytes contamination while preserving ctcs viability. the added-value of the study innovation has been validated on clinical cell lines. the aim of this study is now to determine the performance of the device using patients' blood samples. for this purpose, ctcs from non-small cell lung metastatic cancer patients will be isolated using clearcellfx1 before injection into the luton workflow. collected cells will then be either growth in vitro or in ovo and the added value of this extra step of purification determined.


Eligibility criteria:
inclusion criteria: * adult patient (\>18 years) * stage iv non-small cell lung cancer (depending on classification) * first line treatment approved by multidisciplinary team meeting (mdtm) and referent physician * able to provide non-objection to participation exclusion criteria: * patient weight below 50kg at inclusion * suspected pregnancy

Keywords: metastatic non-small cell lung cancer
school inner-city asthma intervention study (sicas-2)

Conditions: Asthma

Summary: the investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.

our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. the investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. this will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.

Eligibility criteria:
inclusion criteria: * grades k-8 with asthma attending sampling/intervention schools exclusion criteria: * moving schools
easyer (epiaccess system registry) a post market observational registry

Conditions: Arrhythmias, Cardiac

Summary: the objective of the registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the epiaccess system.

the registry will be a prospective non-randomized single-arm trial of up to 150 patients enrolled in up to ten (10) centers in the united states. the overall duration of the registry is estimated to be 18 months per site. for the patients the registry duration will be from the time of procedure until discharge from the hospital, estimated to be approximately four (4) days. prior to enrollment, patients will be evaluated on the basis of the latest available data to establish eligibility. eligible patients will be considered enrolled in the registry after written informed consent is obtained. as epiaccess is only used for the access portion of the procedure, the safety performance and effectiveness endpoints are acute from the time of needle insertion until pericardial sac access is achieved. follow up clinical examinations will be performed according to institutional standard of care. no special tests are required for this device.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * pericardial access is clinically indicated * patient is willing and able to provide written informed consent exclusion criteria: * patients who have any condition which contraindicates pericardial access or who have any condition specified in the contraindications section of the instructions for use. this includes: * previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis * congenital absence of a pericardium * absence of a free epicardial space * patients with active infection * history of chronic pericarditis * patient requiring anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia * patient not in normal sinus rhythm * presence of thrombus in the left atrium * coagulopathy * known allergy to contrast media
a phase ii study on immunogenicity and safety of mva-bn® (imvamune™) smallpox vaccine in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.


Eligibility criteria:
inclusion criteria: group 1 (healthy participants): subjects without present or history of any kind of atopy. group 2 (atopic dermatitis participants): subjects with diagnosed atopic dermatitis. all study subjects: 1. male and female subjects between 18 and 40 years of age without history of smallpox vaccination. 2. women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination. 3. women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination. 4. lab values without clinically significant findings. 5. electrocardiogram (ecg) without clinically significant findings. exclusion criteria: 1. pregnant or breast-feeding women. 2. uncontrolled serious infection i.e. not responding to antimicrobial therapy. 3. history of or active autoimmune disease. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. 4. known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment. 5. history of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. subjects with history of skin cancer at the vaccination site are excluded. 6. history of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure. 7. history of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years. 8. ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the national cholesterol education program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) note: this criterion applies only to volunteers 20 years of age and older. 9. history of anaphylaxis or severe allergic reaction. 10. post organ transplant subjects whether or not receiving chronic immunosuppressive therapy. 11. administration of immunomodulatory substances.

Keywords: atopic dermatitis smallpox vaccination
expanded access to telisotuzumab vedotin

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to telisotuzumab vedotin prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: - the participant must not be eligible for a telisotuzumab vedotin clinical trial.

Keywords: non-small cell lung cancer (nsclc) telisotuzumab vedotin abbv-399 expanded access pre-approval access compassionate use special access program named patient basis special access scheme