Kornimate/medical-research-clean huggingface dataset:
archer1050: a study of dacomitinib vs. gefitinib in 1st-line treatment of advanced nsclc.

Conditions: Non-small Cell Lung Cancer With EGFR-Activating Mutations

Summary: this is a multinational, multicenter, randomized, open-label, phase 3 study comparing the efficacy and safety of treatment with dacomitinib (pf-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor egfr-activating mutation (s). analyses of primary objective (progression free survival) will be done as defined in the protocol.

452 patients were randomized in a 1:1 ratio between dacomitinib (pf-00299804 ) vs. gefitinib.

Eligibility criteria:
inclusion criteria: * evidence of histo or cytopathology confirmed, advanced nsclc (with known histology) with the presence of egfr-activating mutation (exon 19 deletion or the l858r mutation in exon 21). * it is acceptable for subjects with the presence of the exon 20 t790m mutation together with either egfr-activating mutation (exon 19 deletion or the l858r mutation in exon 21) to be included in this study * no prior treatment with systemic therapy for locally advanced or metastatic nsclc. minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant systemic therapy and recurrence of nsclc * adequate tissue sample must be available for central analyses. * adequate renal, hematologic, liver function. * ecog ps of 0-1. * radiologically measurable disease. exclusion criteria: * any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer. * any other mutation other than exon 19 deletion or l858r in exon 21, with or without the presence of the exon 20 t790m mutation. * any history of brain metastases or leptomeningeal metastases. * any previous anti-cancer systemic treatment of early, locally advanced, or metastatic nsclc. * any surgery(not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments * any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug. * current enrollment in another therapeutic clinical study. * history of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease * uncontrolled medical disorders. * prior malignancy and concurrent malignancy except for non melanoma skin cancer or in-situ cervical cancer with no evidence of active disease. * use of narrow therapeutic index drugs that are cyp2d6 substrates from screening to randomization.

Keywords: first-line locally advanced or metastatic non-small cell lung cancer epidermal growth factor receptor egfr archer mutation dacomitinib pf-00299804
impact of covid-19 in the emergency department

Conditions: COVID-19

Summary: to investigate the effects of lockdown in the emergency department in a tertiary health care hospital, nuremberg, germany.

to investigate the effect of the first lockdown caused by the pandemic of covid-19 in a tertiary health care hospital. klinikum nuremberg is one of the largest tertiary health care hospitals in germany with two locations in nuremberg. in the north department, around 150 outcome patients visit the emergency department every day. during the pandemic in 2020 the capacities of the hospitals were saved for the patients with covid-19. a decrease of patients presented in the ed was noticed. controlling system and patient management provided the number of cases and correlated with the same period of time one year ago, before the pandemic. for the classification of severity of diseases, different clinical diseases with severity scores were analyzed. following diseases and scores were evaluated: pancreatitis -- \> ranson score; acs (acute coronary syndrome) --\> grace-score; pulmonary embolism -- \> spesi (simplified pulmonary embolism severity index); diverticulitis --\> cdd (classification of diverticular disease); pneumonia -\> crb65 (confusion- respiratory rate- blood pressure- age ≥ 65 years);

Eligibility criteria:
inclusion criteria: only patients who presented in the ed. exclusion criteria: none
agaricus blazei murill in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: extract from the mushroom agaricus blazei murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. the investigators now want to investigate the effect of agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.

patients who are scheduled to undergo high dose chemotherapy for multiple myeloma will receive in addition in a double blinded manner 60 ml of agaricus extract or placebo once daily from the start of stem cell mobilizing therapy until one week after the end of aplasia after high dose melphalan. primary endpoints will be cytokine levels of degree of activation of tumor supressor genes before and after start of the investigational product. secondary endpoints will be treatment response and quality of life.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma exclusion criteria: * none
study of vilazodone to treat social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to determine whether vilazodone is effective in the treatment of symptoms of social anxiety disorder among adults.

the proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. the study will include 30 outpatients age 18-75 with sad, generalized subtype who return for at least one post randomization visit where efficacy evaluations are conducted.

Eligibility criteria:
inclusion criteria: * diagnosis of social anxiety disorder, generalized subtype * lsas total score of 70 at visits 1 and 2 exclusion criteria: * lifetime history of bipolar disorder or schizophrenia * current suicidal risk * current unstable medical condition

Keywords: social anxiety disorder social anxiety social phobia sad
strong futures: a trial of two primary care based interventions to promote optimal health in latino infants and toddlers

Conditions: Childhood Obesity; Health-Related Quality of Life

Summary: latino children experience higher rates of obesity compared to non-hispanic white children, especially in low-income communities. optimal feeding strategies in early life, avoidance of screen time and longer sleep duration may lower the risk of obesity. family financial hardship is also associated with short- and long-term health risks, including behavioral and mental health problems, and toxic stress which contributes to elevated risk of common chronic conditions over the life course. this proposal aims to pilot test two interventions to promote optimal health outcomes in latino infants. study participants will meet with a health educator after well child visits at 2-weeks, 2-, 4-, 6-, 9- and 12-months. half of the parents will receive education on obesity prevention. the other half will receive financial education and case management using an established financial coaching approach. parents will also receive text messages that reinforce educational content. the objective of this study is to determine the acceptability and feasibility of offering these interventions in the well-child setting. study investigators also seek to determine the preliminary efficacy of these interventions on infant and parent health outcomes including dietary intake, screen time, sleep duration, health related quality of life and financial stress.


Eligibility criteria:
inclusion criteria: * study investigators will recruit parents who self-identify as latino and their newborn infants * infants must be born at zuckerberg san francisco general hospital (zsfg) * infants must be singletons * parents must intend to receive primary care for their infant at zuckerberg san francisco general hospital * parents must speak spanish (but may also speak english) exclusion criteria: * infants with birth weights less than 2500 grams * infants born prior to 37 weeks and 0 days gestation * infants with any medical condition that significantly affects feeding, such as infants who are unable to feed by mouth * infants with any medical condition that is known to be associated with failure to thrive or specialized nutritional needs * infants in foster care * infants for whom the primary caregiver is not the infant's mother or father
retrospective study of istatis syphilis ab test (poc)

Conditions: Syphilis; Syphilis Infection

Summary: the purpose of this retrospective clinical trial is to establish the clinical performance of the istatis syphilis abtest. the data will be used to demonstrate the product is safe and effective for its intended use. the data obtained will be used in the application for ce certification under in vitro diagnostic medical device regulation (ivdr) and world health organization (who) prequalification.

the objectives of this study are to establish the diagnostic sensitivity and diagnostic specificity of the istatis syphilis ab test. left-over samples stored at -80ᵒc from the previous trials conducted by epicentre will be used for this study. the samples are tested in a routine testing environment. serum samples were tested for evidence of syphilis infection using a non-treponemal rapid plasma reagin (rpr) assay. all reactive samples were further tested quantitatively.

Eligibility criteria:
inclusion criteria: 1. anti-tp negative samples: -stored at ≤ -80°c. 2. anti-tp negative samples - pregnant women: * samples from pregnant women, 1st and multipara * samples found negative or false reactive for anti-tp assay with the reference method. * stored at ≤ -80°c. 3. anti-tp positive samples: * samples screened with abbott architect syphilis tp and confirmed positive with bd macro-vue particle agglutination (rpr) and serodia particle agglutination (tppa). * stored at ≤ -80°c. 4. anti-tp positive samples - pregnant women: * samples from pregnant women * samples screened with abbott architect syphilis tp and confirmed positive with bd macro-vue particle agglutination (rpr) and serodia particle agglutination (tppa). * stored at ≤ -80°c. exclusion criteria: * n/a

Keywords: diagnostic kit diagnostic devices lateral flow device test syphilis rapid test syphilis point of care tests istatis syphilis antibody test
puerto rico covid-19 vaccine uptake study

Conditions: COVID-19

Summary: the purpose of this study is to recruit a total of 386 participants to evaluate the effectiveness of an educational program to increase the proportion of men and women aged 21 years and older who have received the covid-19 booster vaccine

this study will address vaccine hesitancy, evaluating the intervention's efficacy in a group of vulnerable and economically disadvantaged population in pr. randomized clinical trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. a total sample of 386 participants will be recruited. the duration of the study will consist of 1.5 hours for intervention group and 1 hour for control group. eligibility criteria for the study include the following: (1) age 21 years and older, (2) resident of puerto rico, (3) to be fully vaccinated (received the one-dose jansen/johnson \& johnson vaccine, -or- received both doses of the two-dose pfizer or moderna vaccine), have not received booster doses against covid-19, (4) no history of allergic reactions to any vaccine, (5) no history of mental health conditions that impede participation in the study, and (6) able to read, write, and understand spanish.

Eligibility criteria:
inclusion criteria: 1. age 21 years and older 2. resident of puerto rico 3. to be fully vaccinated (received the one-dose jansen/johnson \& johnson vaccine, -or- received both doses of the two-dose pfizer or moderna vaccine) 4. have not received booster doses against covid-19 5. no history of allergic reactions to any vaccine, 6. no history of mental health conditions that impede participation in the study 7. able to read, write, and understand spanish. exclusion criteria: 1. age 20 years and younger 2. not a resident of puerto rico 3. not to be fully vaccinated (have not received the one-dose jansen/johnson \& johnson vaccine, -or- have not received both doses of the two-dose pfizer or moderna vaccine) 4. have received booster doses against covid-19 5. history of allergic reactions to any vaccine, 6. history of mental health conditions that impede participation in the study 7. not be able to read, write, and understand spanish.

Keywords: covid-19 booster vaccine hesitancy educational intervention covid-19
endoscopic band ligation (ebl) versus endoscopic band ligation and propranolol for the prevention of variceal rebleeding

Conditions: Cirrhosis; Variceal Bleeding

Summary: both propranolol and endoscopic band ligation (ebl) are effective for prevention of variceal rebleeding. recently several studies compared the efficacy of ebl alone and with a combination of propranolol and ebl. however, the results of recent studies showed discrepancy. this study is performed to compare the efficacy and safety of ebl alone and ebl combined with propranolol in patients without previous history of endoscopic variceal treatment.


Eligibility criteria:
inclusion criteria: * liver cirrhosis * age between 18 and 70 years * successful control of esophageal variceal bleeding within 6 weeks before enrollment exclusion criteria: * gastric variceal bleeding * patients with systolic blood pressure \<100 mmhg or basal heart rate \<60/min * portal vein thrombosis * prominent hepatic encephalopathy * coexisting untreated malignancy * severe cerebrovascular or cardiovascular disease, renal failure * previous history of endoscopic, radiologic, or surgical treatment for varices or ascites * contraindication to beta-blocker * pregnancy * refusal to give consent to participate in the trial

Keywords: cirrhosis esophagus disorders varicose veins
study on hrqol and cost-effectiveness analysis in management of patients with <2cm thyroid nodules

Conditions: Thyroid Nodules

Summary: ideally randomized controlled trials should be carried out to compare the cost-effectiveness between fnac and watchful waiting but such studies are very difficult to conduct in practice because they require following up very large number of subjects for a long period of time. the aims are to determine the health-related quality of life (hrqol) and hrqol preference (utility) of patients undergoing watchful observation (no fnac) and routine fnac, and to determine the cost-effectiveness of two strategies in managing small incidental thyroid nodules for the chinese population in hong kong.


Eligibility criteria:
inclusion criteria: * aged 18 or above * have life expectancy of at least 6 months * have an incidental nodule which measures between 1.0 to 2.0cm in the largest dimension on ultrasound guidance (usg) and has benign ultrasonographic features such as spongiform or honeycomb appearance, purely-cystic, egg shell type calcification, iso-echoic or hyper-echoic in relation to the rest of the thyroid tissue and peripheral vascularity on doppler usg. for subjects with more than one nodule on usg, provided that the other nodules are not \>2.0cm or have suspicious features (see below), they will still be eligible. * normal thyroid function (both serum thyroid-stimulating hormone (tsh) and free t4 levels within normal range) * given consent to take part in the study exclusion criteria: * have suspicious ultrasonographic features such as microcalcifications, marked hypoechogenicity, irregular margins and / or taller than wide and intranodular vascularity on transverse view on doppler usg that warrant a fnac * nodule size \> 2.0cm * insisting or refusing fnac or surgical intervention despite medical reassurance * inability to understand or communicate in cantonese or chinese * significant cognitive impairment judged by the doctor to be unable to answer the questionnaire * too ill to carry out interview * refusal to give consent

Keywords: fnac small incidental thyroid nodules
low-frequency electrical muscle stimulation vs cycle training during haemodialysis

Conditions: Kidney Failure, Chronic

Summary: the purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise training.

end stage renal disease is associated with reduced functional capacity. dynamic exercise training i.e. cycling, performed between dialysis sessions or during dialysis (intra-dialytic) can be effective in improving functional capacity and quality of life. however, many patients are unable to engage in intra-dialytic cycling due to limiting comorbidities. other exercise modalities should be considered. low-frequency electrical muscle stimulation of the quadriceps is well tolerated and may improve functional capacity in clinical populations. the trial is a longitudinal, randomised controlled trial. participants will be randomly allocated to 10 weeks of 1) intra-dialytic low-frequency electrical muscle stimulation, 2) intra-dialytic cycling, or 3) usual care haemodialysis without exercise training. outcomes will be assessed at baseline and 10 weeks by assessors blinded to group allocation.

Eligibility criteria:
inclusion criteria: 1. on haemodialysis for at least 3months 2. on 3 times 4 hours of dialysis per week 3. urea reduction rate of at least 65% during the three months before enrolment 4. age 18 years or older 5. able to complete the exercise test and exercise training 6. able to provide informed consent 7. life expectancy of more than 6 months according to clinical assessment exclusion criteria: 1. clinically significant valvular insufficiency 2. clinically significant dysrythmia 3. uncontrolled blood pressure: systolic \> 160, diastolic \>95 during the months before enrolment 4. excessive fluid accumulation between dialysis sessions (\>3 liters), more than twice pulmonary edema over 3 months before enrolment deemed to be due to excess fluid intake 5. haemoglobin unstable and below 9.0 6. ischemic cardiac event or intervention in the last 3 months 7. clinically significant, still active inflammatory or malignant process 8. pacemaker or cardiac device (contraindicated for bioelectrical impedance) 9. planned kidney transplant during study period.
respiratory muscle function and neural respiratory drive in interstitial lung disease

Conditions: State Key Laboratory of Respiratory Disease

Summary: the purpose of this study is to assess the respiratory muscle function and neural respiratory drive in interstitial lung disease patients.

in total, 50 patients with interstitial lung disease (ild) are going to recruited.the patients are studied at the afternoon in a semirecumbent position. after the application of topical anaesthesia (2% xylocaine), the patient will be asked to swallow two balloon-tipped catheters and the multi-pair esophageal electrode catheter through the nose into the their right position. at the first period, the stable signals of unassisted spontaneous breathing (about 10min) were chosen to be recorded. the esophageal and gastric balloon-catheters are used to detect the intra-thoracic and abdominal pressure.the diaphragm electromyogram (emgdi) will be recorded from a multipair esophageal electrode.the baseline data of the respiratory muscle activity will be detected by these catheters and electrode.p0.1 (the negative airway pressure generated during the first 100 ms of an occluded inspiration) will be also meassured. after the first period, the nonvolitional tests on respiratory muscle function and strength (twitch mouth and transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (twpmo and twpdi) will be done. after the second period,the patients will be ask to perform different maneuvers, including maximal inspiration against a closed valve ,maximal inspiration to total lung capacity (tlc),maximalexpiration at the total lung capacity (tlc) against a closed valve and maximal sniff from functional residual capacity(frc).each maneuver will repeated more than three times with an interval of 30 s or more. inspiratory capacity(ic),global maximal inspiratory pressure (pimax), maximal sniff nasal pressure (snpna) and maximalexpiratory pressure will be meassured with the balloon-catheters.the maximal value of the diaphragm electromyogram (emgdi) will be recorded during these maneuvers.

Eligibility criteria:
inclusion criteria: * interstitial lung disease patient meet the diagnose criteria of interstitial lung disease exclusion criteria: 1. severe cardiovascular disease 2. pneumonia 3. neuromuscular and chest wall deformity 4. respiratory arrest 5. cardiovascular instability (hypotension, arrhythmias, myocardial infarction) 6. change in mental status; uncooperative patient

Keywords: interstitial lung disease respiratory muscle function neural respiratory drive
the relationship between health literacy, physical activity, back pain and posture habits in university students

Conditions: University Students

Summary: this study aims to investigate the relationship between health literacy, physical activity, back pain, and posture habits among university students. the health literacy scale, the international physical activity questionnaire, and the posture habits questionnaire for back health in daily activities will be used to collect data from participants. health literacy will be assessed in terms of individuals' ability to access, understand, and apply health-related information, while physical activity levels and posture habits will be examined for their influence on back pain. the findings are expected to shed light on the role of health literacy in promoting healthier physical activity and posture habits, providing insights for strategies to improve back health in this population.


Eligibility criteria:
inclusion criteria: * being a university student exclusion criteria: * having any diagnosed physical or psychological illness

Keywords: university students physical activity back pain posture habits
study examining the effect of hepatic impairment on safety, toleration and how the body processes an experimental drug

Conditions: Obesity; Hepatic Insufficiency

Summary: cp-945,598 is eliminated following extensive metabolism. decrease hepatic function can affect its elimination from the body via metabolism. this study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of cp-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.


Eligibility criteria:
inclusion criteria: * healthy:matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender) * subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment. exclusion criteria: * all subjects: non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ecg and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits * normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits * subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;undergone porta-caval shunt surgery; history of gi hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; positive blood alcohol test/alcohol breathalyzer at screening or on day 0.