Kornimate/medical-research-clean huggingface dataset:
functional lung avoidance spect-guided radiation therapy of lung cancer

Conditions: Lung Cancer; Radiation-Induced Disorder; Radiation Pneumonitis; Pulmonary Disease; Lung Function Decreased

Summary: study aims to determine if functional lung avoidance based on perfusion single photon emission (spect)/ct scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

in this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. radiotherapy is usually based on a ct scan that does not account for functional variations in the lungs. therefore, i hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer. the objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial. to reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.

Eligibility criteria:
inclusion criteria: * histologically verified lung cancer (small-cell and non-small cell lung cancer) * referred for radiotherapy with curative intent * radiation dose of 60-66 gy given in 2-gy fractions, other dose levels and fractionation schedules accepted, as per site standard * concurrent chemotherapy is accepted * patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy * receiving (chemo)-radiotherapy to the thoracic disease with curative intent * adults over 18, that have given oral and written informed consent before patient registration. exclusion criteria: * concurrent immunotherapy * previous radiotherapy to the thorax * other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol

Keywords: radiation-induced lung toxicity functional avoidance methodology radiation therapy of lung cancer
addiction potential of very low nicotine filtered little cigars

Conditions: Smoking (Tobacco) Addiction

Summary: the goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. the main question\[s\] it aims to answer are: are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? participants will attend three study visits at osu. each visit would last up to 4 hours. during visits, they will * fill several surveys * provide blood samples * perform breathing tests * complete smoking sessions using either their own cigars or the study cigars.


Eligibility criteria:
inclusion criteria: * smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as \>=8 cigars smoked per month based on data showing median cigarillo use is 7.5 times per month and median flc use is 14 times per month 59. we will attempt to bring in heavier users if feasible during recruitment; or 2) dual-users: cigarette smokers (\>=20d/month for at least 3 months) with co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in the past 3 months) * willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions * willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit * capable of and willing to provide written informed consent * read and speak in english. exclusion criteria: * self-reported significant current lung disease (e.g. asthma, copd, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed * history of diagnosis or treatment for lung cancer * self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes) * history of cardiac event or distress within the past 3 months * unstable or significant psychiatric conditions (past and stable conditions will be allowed) * substance use disorders besides nicotine addiction * regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes \>10d per month * exclusive large or premium cigar users * zero use of filtered little cigars, cigarillos, little cigars, or small cigars in the past 3 months * use of blunts every time or most of the time * regular use of cannabis \>10d per month * planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days * pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant * inability to perform tests or follow instructions during testing
a study comparing tarlatamab, durvalumab, carboplatin, and etoposide versus durvalumab, carboplatin, and etoposide in first-line extensive stage small-cell lung cancer (es-sclc)

Conditions: Small-cell Lung Cancer; Extensive Stage Small-cell Lung Cancer

Summary: the main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (os).


Eligibility criteria:
inclusion criteria: * participant has provided informed consent before initiation of any study-specific activities/procedures. * age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * histologically or cytologically documented es-sclc (american joint committee on cancer, 2017, stage iv sclc \[t any, n any, m1 a/b/c\]), or t3 to t4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * measurable disease as defined per recist 1.1. * suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment. * minimum life expectancy ≥ 12 weeks. exclusion criteria: * participants can have no history of other malignancy in the last 2 years. * any previous diagnosis of transformed non-small-cell lung cancer (nsclc), epidermal growth factor receptor activating mutation positive nsclc that has transformed to sclc, or mixed sclc nsclc histology. * any symptomatic central nervous system (cns) metastases, or leptomeningeal disease. * they will have no history of severe or life-threatening events to immune-mediated therapy. * history of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment. * they will have no active autoimmune or inflammatory disorders. * presence of active human immunodeficiency virus (hiv) or active hepatitis (b/c) infection. * evidence or interstitial lung disease (ild) or active, non-infectious pneumonitis. * history of solid organ transplant. * they will not have had a myocardial infarction and/or symptomatic congestive heart failure (new york heart association \> class ii) within 6 months prior to first dose of study treatment.
evaluation of 2 oral doses of pg-760564 in rheumatoid arthritis (ra) patients receiving methotrexate

Conditions: Rheumatoid Arthritis

Summary: this will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and pk of oral administration of pg-760564 in adult patients with active ra receiving treatment with mtx. two oral doses of pg-760564 will be evaluated: 25 mg bid and 100 mg bid. the study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (dmards) and anti-cytokine therapies except mtx. after the washout period, patients determined to be eligible will be randomized to receive either 25 mg bid or 100 mg bid of oral pg-760564, or placebo for 12 weeks. there will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. the primary efficacy endpoint will be the proportion of patients meeting the acr 20 response criteria after 12 weeks of treatment.

the study will be conducted in north america and europe at approximately 50 to 60 sites. approximately 270 patients will be randomized, of which 189 are expected to complete the study. the study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (dmards) and anti-cytokine therapies except mtx. the washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, d-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept. after the washout period, the patients determined to be eligible will be randomized to receive either 25 mg bid or 100 mg bid of oral pg-760564, or placebo for 12 weeks. there will be 6 treatment visits (weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (week 16). patients will not initiate new therapies until after the 4-week follow-up is completed. liver function tests will be evaluated at every visit. the primary efficacy endpoint will be the proportion of patients meeting the acr 20 response criteria after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * meet american college of rheumatology (acr) criteria for rheumatoid arthritis * disease duration of at least 6 months * must be treated with methotrexate for at least 24 weeks * at least 6 swollen joints and 6 tender joints * washout required for other disease modifying anti-rheumatic drugs (dmards) * women of childbearing age and all males must use acceptable method of birth control exclusion criteria: * tuberculosis * malignancies * abnormal electrocardiograms as described in the protocol * current infection or recurrent infections or immunodeficiency * liver diseases and abnormalities in liver function tests as described in the protocol * autoimmune diseases other than ra except sjogren's syndrome secondary to ra; * history of demyelization diseases * any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
effects of flywheel exercise on muscle and walking function in teenagers and young adults with cerebral palsy

Conditions: Cerebral Palsy

Summary: the main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (cp) by using an eccentric-overload resistance exercise model specific aims 1. to compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with cp. 2. to increase force, power and muscle mass in the lower limbs of patients with cerebral palsy. 3. to improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy. we hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with cp, when compared with conventional weight-stack technology. importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance. forty teenagers and young adults (age range 16-23 yr) with spastic cp will be recruited. they will be randomly assigned to flywheel (fl; n=20) or weight-stack (ws; n=20) resistance exercise. during 8 weeks, all the teenagers will follow a standard resistance exercise training program within the stockholm habilitation center system. in addition, patients will perform either flywheel (fl group) or conventional (ws group) leg press resistance exercise twice per week. muscle force, power and activity (electromyography; emg), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (fig. 1).


Eligibility criteria:
inclusion criteria: * teenagers and young adults between 16-25 years of age * unilateral or bilateral spastic cerebral palsy * gross motor function classification system (gmfcs) of level i, ii or iii. exclusion criteria * surgical treatments of the knee extensor apparatus within the last 12 months * botulinum toxin treatment within the last six months * ongoing intrathecal baclofen treatment
the role of matrix metalloproteinase 2 and 9 enzymes in developing chronic thromboembolic pulmonary hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery.matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. the clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.in this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension

chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery. only 4% of patients with acute pulmonary embolism develop chronic thromboembolic pulmonary hypertension and acute pulmonary embolism or deep vein thrombosis is reported in the anamnesis of 75% of those with chronic thromboembolic disease. therefore, the etiology of the disease is not clear. altought many studies are done, especially the role of inflamation is emhasised underlie the disease. matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. the clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.in this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension. matrix metalloprotinase enzymes are known to play a role in atherosclerosis. this research will investigate whether there is atherosclerosis together with inflamattion in the background of chronic thromboembolic hypertension.

Eligibility criteria:
inclusion criteria: * despite 3 months of anticoagulation therapy * mean pulmonary arterial pressure \> 20 mmhg * pulmonary vasculary resistance \> 3 wood * pulmonary capillary wedge pressure \< 15 mmhg * perfusion defect in ventilation perfusion scintigraphy * pulmonary angiography or computed tomography angiography showing pulmonary artery occlusive lesions exclusion criteria: * patients undergoing pulmonary thromboendarterectomy concomitant coronary bypass, carotid endarterectomy, aortic valve, ascending aorta, mitral valve, tricuspid valve, pulmonary valve surgery * patients who have undergone surgical or percutaneous procedures due to atherosclerotic disease
hpv dna testing through mobile mammography unit

Conditions: Cervical Cancer

Summary: invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. many low-income women in virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. self-collection of specimens for hpv testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. innovative delivery models are needed to reach at-risk populations. this study seeks to explore the acceptability and feasibility of pairing self-collection of hpv samples for dna testing with mobile mammography in women living in rural virginia.

the proposed study aims to determine whether offering self-collection for hpv testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in rural virginia. the procedures will be recruitment of under-screened women in rural virginia to complete hpv testing using self-collection kits distributed through the mobile mammography unit. regardless of hpv positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete pap screening by a clinician.

Eligibility criteria:
inclusion criteria: * not pregnant exclusion criteria: * history of hysterectomy or pelvic rt non english speaking
top down versus step up in pediatric ulcerative colitis

Conditions: Ulcerative Colitis; Infliximab; Children

Summary: pediatric ulcerative colitis (uc) patients with moderate to severe disease activity at high risk of colectomy. early use of biologic agents will likely be more effective. but there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. in our study, newly diagnosed moderate to severe pediatric uc patients (6-18 years old) will be randomly divided into infliximab (ifx) treatment group (top down group, td) and corticosteroids (cs) treatment group (step-up group, su). mucosal healing rate at week 12 will be compared between the two groups. the relapse rates and sustained durations of remission within one year will also be evaluated.

pediatric ulcerative colitis (uc) is typically more extensive and has a more active disease course than adult uc. pediatric uc patients with moderate to severe disease activity at high risk of colectomy. rapid disease control may improve the prognosis of the disease and reduce the rate of surgery. early use of biologic agents will likely be more effective. but there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. in our study, newly diagnosed moderate to severe pediatric uc patients (6-18 years old) will be randomly divided into infliximab (ifx) treatment group (top down group, td) and corticosteroids (cs) treatment group (step-up group, su). a decrease of pediatric ulcerative colitis activity index (pucai) at least 20 points were defined as clinical response. clinical response will be evaluated at week 2 in su group and week 6 in td group. for no-responder, treatment plan will be changed. clinical remission rate at week 10 and mucosal healing rate at week 12 will be compared between the two groups. the relapse rates and sustained durations of remission within one year will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed uc; 2. moderate to severe disease activity 3. age: 6 to 18 years old exclusion criteria: 1. with mild disease activity 2. have been treated with corticosteroid or biological agents for uc
chronic and acute effects of smoking on the left and right ventricular relaxation in young healthy smokers

Conditions: Cardiovascular Diseases

Summary: impairment of relaxation, the early phase of ventricular diastole is the first stage of heart diastolic dysfunction. left ventricular diastolic function can be determined noninvasively by echo- doppler - derived mitral valve flow velocities. the addition of pulmonary venous flow pattern enables more accurate assessment of left ventricle diastolic function. the role of the right ventricle in haemodynamic function of the heart is now emphasized. the right ventricle diastolic function can be assess by recording the doppler tricuspid valve flow pattern. impaired lv diastolic function usually precedes systolic dysfunction and may cause clinical signs of congestive heart failure. cigarette smoking is one of the major risk factors for cardiovascular diseases. the aim of the study was to assess left and right ventricular diastolic function in healthy, young and slim smokers before and after smoking one cigarette. echocardiographic examination: before and after smoking one cigarette echocardiographic evaluation of mitral valve flow, pulmonary venous flow, tricuspid valve flow and hepatic vein flow to assess diastolic function of ventricles.

echocardiographic examination: in left lateral position after 10 minutes rest. the first examination: after a 2-hour non-smoking period, the second: immediately after smoking one cigarette containing 0.9 mg of nicotine. the duration of the second examination: no more than 15 minutes. echocardiography equipment: hewlett-packard sonos 2000 (andover, massachusetts) imaging system. the transducer's frequency: 2 mhz. from the apical four chamber view the visualisation of transmitral flow, pulmonary venous flow and transtricuspid flow. from subcostal view the visualisation of right superior hepatic vein and the hepatic vein flow.

Eligibility criteria:
inclusion criteria: * smokers smoking over 10 cigarettes per day over the last 5 years * body mass index \< 25 kg/m2 * normal blood pressure and normal parameters of echocardiographic examination (wall thickness, left- and right- chamber size, valvular function and left and right ventricular systolic function) * normal results of routine physical examination, chest x-ray, standard rest electrocardiogram and routine laboratory tests. exclusion criteria: * body mass index \> 25 kg/m2 * abnormal blood pressure * abnormal parameters of echocardiographic examination (wall thickness, left- and right- chamber size, valvular function and left and right ventricular systolic function) * abnormal results of routine physical examination, chest x-ray, standard rest electrocardiogram and routine laboratory tests.

Keywords: heart echocardiography diastolic function left ventricle right ventricle cigarette smoking smoking heart ventricles diastole doppler echocardiography