Kornimate/medical-research-clean huggingface dataset:
a study of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (egfr). participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the egfr * measurable disease according to recist * eastern cooperative oncology group (ecog) performance status 0-2 * life expectancy greater than or equal to (\>/=) 12 weeks * adequate hematological, liver and renal function * participants with asymptomatic and stable cerebral metastases receiving medical treatment exclusion criteria: * previous chemotherapy or treatment against egfr for metastatic disease * treatment with an investigational agent less than 3 weeks before enrollment * history of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma) * participants with symptomatic cerebral metastases * any significant ophthalmologic abnormality * unstable systemic disease * coumarins use * evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug * participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis * participants with known infection with human immunodeficiency virus (hiv), hepatitis b (hbv), hepatitis c (hcv)
cardiac resynchronization therapy delivery guided non-invasive electrical and venous anatomy assessment

Conditions: Cardiac Resynchronization Therapy; Chronic Heart Failure; Left Bundle-Branch Block

Summary: the objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality crt-roadmap by integration of 3d images from 3d activation sequence from ecg, and coronary venous anatomy from cardiac computed tomography. this crt-roadmap will be used to guide lv lead placement to a coronary vein in an electrically late-activated region. study hypothesis: at least 75% of patients undergoing a crt implantation guided by non-invasive electrical and venous anatomy assessment (xspline technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.


Eligibility criteria:
eligible subjects shall meet all following criteria: * appropriately signed and dated informed consent. * age ≥18 years at time of consent. * crt indication according to the 2021 esc guidelines on cardiac pacing and crt (class i and iia indication in patients with lbbb qrs morphology) or to 2017 aha/acc/hfsa guidelines (cor i). * sinus rhythm * qrs duration ≥130 ms * left bundle branch block * left ventricular ejection fraction ≤35% * symptomatic heart failure nyha class ≥ ii * documented stable medical treatment for at least 6 months * no cardiovascular intervention during the last 6 month exclusion criteria are: * history of persistent or permanent atrial fibrillation * previous pacemaker or icd implantation * indication to pacing due to bradycardia * patients considered for his bundle pacing or cardiac conduction pacing * patients with unstable angina * subject experienced a recent myocardial infarction, within 40 days prior to enrollment * subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment * subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year * subject is implanted with a left ventricular assist device * subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure * subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period) * subject has congenital heart disease * subject has a mechanical right-sided heart valve * subject has a life expectancy of less than one year in the opinion of the investigator * pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control * subject is enrolled in one or more concurrent studies that would confound the results of this study * patients who have contraindications to ct scanning. * patients with chronic kidney diseases and estimated glomerular filtration rate (egmr) calculated based on ckd-epi 2009 \< 40 ml/min/1.73m2

Keywords: non-invasive activation mapping coronary sinus
sexual behavior in head and neck cancer patients

Conditions: Oropharyngeal Cancer; Head and Neck Cancer; Squamous Cell Carcinoma

Summary: the goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (hpv-16). knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.

scchn is believed to be caused by different types of viruses being exposed to the mucous membrane on the inside of the mouth, throat, and voice box, over a long period of time. this exposure results in changes in the cells of the mouth, throat, and voice box, which can lead to the development of cancer. hpv-16 has been linked to scchn. half of all cancers of the oropharynx (the middle part of the throat, the base of the tongue, and tonsils) may be caused by hpv-16. hpv-16 is normally spread sexually, and is one of the main causes of cervical cancer in women. by finding out if the virus is also spread sexually to the throat, doctors may be able to teach patients about risk factors for developing cancer in this area. study procedures: if you agree to take part in this study, you will be asked to complete a questionnaire about your sexual history, such as specific sexual practices, number of partners, exposure to hpv and other viruses, and any medical history related to hpv-16. the questionnaire will take 10-15 minutes to complete. none of your personal identifying information will be attached to your questionnaire, and the questionnaire will be assigned a one-of-a-kind study code number. to check your cancer diagnosis, your medical records will be reviewed. length of study: once you have completed the questionnaire, your participation in this study is over. this is an investigational study. up to 1,500 patients will be enrolled in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (scchn) who are candidates for the molecular epidemiology study lab00-062 of head and neck cancer. 2. must have the ability to understand and provide informed consent. 3. patients must be 18 years and older. 4. ability to read, write, and speak english. 5. resident of the united states. 6. agrees to have tumor tissue, if available, tested for hpv. no additional biopsy will be requested. exclusion criteria: 1. previous cancer diagnosis excluding non-melanoma skin cancer. 2. blood transfusion within the previous 6 months. 3. immune suppression, such as hiv disease or immune-suppressing therapy (i.e., steroids).

Keywords: oropharyngeal cancer non-oropharyngeal cancer head and neck cancer squamous cell carcinoma squamous cell carcinoma of the head and neck scchn hpv-16 questionnaire sexual behavior survey
long-term evaluation of patients treated by an emergency medical helicopter

Conditions: Wounds and Injuries

Summary: in may 2010 the first danish physician-staffed helicopter emergency medical service (ps-hems) was implemented in region zealand and the capital region (excluding bornholm) of denmark. in relation to the introduction of ps-hems, a team of collaborators lead by rasmus hesselfeldt, conducted an observational study to investigate the possible effects on time to definitive care, secondary transfers and 30-day mortality in a "before" and "after" design. results showed reduced time from first dispatch to arrival at the trauma centre from 218 min to 90 min. secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day mortality significantly reduced from 29 % to 14 % in the year after implementation. the present study is an observational cohort study with long-term follow-up of the same trauma population as mentioned above. patients were followed until may 1st, 2014. primary outcome is early retirement and secondary outcomes are quality of life and mortality. the investigators hypothesize that a greater proportion of trauma patients in the "after" period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients treated in the "before" period.


Eligibility criteria:
inclusion criteria: * patients treated by a trauma team in the catchment area of ps-hems. for all labor market attachment analysis the investigators only include patients between 18 to 60 years of age. for all other analysis (mortality and quality of life) there are no age limits. exclusion criteria: * patients transported by private means or by the police. * patients who at the emergency department were categorized as non-trauma patients.

Keywords: helicopter emergency medical service trauma early retirement iss quality of life
radiotherapy and atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common sustained cardiac arrhythmia. current european guidelines recommend catheter ablation of af in symptomatic patients refractory to antiarrhythmic therapy. pulmonary vein isolation (pvi) remains the cornerstone of any ablation procedure irrespective of patient characteristics. recently, stereotactic arrhythmia radioablation (star) with precise high-dose of radiation was used to treat ventricular arrhythmias in patients with a high risk of complications during transcatheter ablation.

exploratory study to investigate the feasibility of star for the treatment of paroxysmal af in elderly patients in which a rhythm control strategy is indicated. patients will be followed-up for 12 months after star treatment for a safety assessment and af recurrence.

Eligibility criteria:
inclusion criteria: 1. age \> 70 years 2. symptomatic paroxysmal af 3. antiarrhythmic drugs intolerance or non-response to antiarrhythmic drugs 4. understands the nature of the study, treatment procedure and provides written informed consent 5. willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements 6. expected to remain available for at least 24 months after enrollment exclusion criteria: 1. permanent af 2. need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial 3. unstable angina 4. presence of any disease that is likely to shorten life expectancy to \< 1 year 5. any cardiac surgery within three months prior to enrolment 6. awaiting cardiac transplantation or other cardiac surgery within the next year 7. myocardial infarction (mi) within 60 days prior to enrolment 8. contraindications to oral anticoagulation 9. active systemic infection or sepsis 10. left atrial thrombus (e.g., transesophageal echocardiogram (tee), ct and ice) 11. history of a documented thromboembolic event such as stroke or transient ischemic neurological attack (tia) in the three months prior to enrollment. 12. currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study. 13. any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol

Keywords: atrial fibrillation rhythm control strategy
efficacy and safety of xalatan compared to usual care in patients with open angle glaucoma or ocular hypertension.

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Summary: the primary purpose is to compare the intraocular pressure reducing effect of xalatan with that of usual care over 36 months. safety and health care utilization will be evaluated.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension * iop of \> 21 mm hg on current treatment exclusion criteria: * any previous or current treatment with latanoprost or other prostaglandin analogues
nantes bariatric surgery cohort

Conditions: Obesity

Summary: while current research suggests that inflammation of adipose tissue in obesity is linked to accelerated aging, it has yet to be determined in humans how this could enhance preventative and personalized medicine for obese individuals. the nbc study aims to investigate : 1. whether bariatric surgery is associated with changes in biological age 2. if bariatric surgery alters adipocyte dysfunction, the microbiota and biological rhythms 3. whether changes in adipocyte dysfunction, microbiota and biological rhythms are linked to changes in biological age. to achieve this, establishing a biocollection before, during and after bariatric surgery will be crucial in addressing these questions

the study of the nantes bariatric surgery cohort (nbc) aims to evaluate the impact of bariatric surgery on biological age, adipocyte dysfunction, microbiota, and biological rhythms in individuals with obesity. this observational study will include 300 participants over 3.5 years. it involves pre-operative, peri-operative, and post-operative visits to collect clinical, biological, and lifestyle data. key assessments include anthropometrics, blood tests, questionnaires, and biocollections

Eligibility criteria:
inclusion criteria : individuals selected for bariatric surgery (starting the bc pathway within the nantes university hospital bariatric unit). inclusion criteria are those of the bariatric surgery program. * male or female, adult over 18 years of age * bmi ≥ 35 kg/m2 with complication(s) or ≥ 40 kg/m2 with or without complication (the list of eligible complications is referenced in has 2024 recommendations). in the event of a change in access to bariatric surgery, this threshold could be revised without any substantial change to the protocol. * having consented to their participation in the cohort * participant affiliated to or benefiting from a social security scheme exclusion criteria : * persons protected by law (guardianship or trusteeship) or deprived of their freedom, * pregnant women (contraindication to cb) or nursing mothers.

Keywords: obesity bariatric surgery biological aging adipocyte dysfunction biological rhythms
human umbilical cord-mesenchymal stem cells for pneumoconiosis

Conditions: Pneumoconiosis

Summary: the purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(huc-msc) for pneumoconiosis.

human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. to investigate the effects of huc-msc treatment for pneumoconiosis, 10 patients with pneumoconiosis will be enrolled and receive 4 times of huc-msc transplantation.

Eligibility criteria:
inclusion criteria: * the patient who have signed the informed consent document; * clinical and radiological evidence of liver cirrhosis. exclusion criteria: * pregnant women or lactating mothers; * history of neurological disease, head injury or psychiatric disorder; * patients with positive human immunodeficiency (hiv) at screening indicative of current of pass infection; * with malignant tumors; * abnormal blood coagulation, combine other tumor or special condition; * patients who had participated in other clinical trials within three months prior to this study.

Keywords: stem cells mesenchymal stem cells umbilical cord-mesenchymal stem cells pneumoconiosis
feelfit: high-intensity interval training to improve self-reported physical fitness in brain tumor patients

Conditions: Brain Tumor, Primary; Exercise

Summary: the feelfit study aims to assess the effectiveness of high-intensity interval training (hiit) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. furthermore, several secondary and exploratory outcomes will be evaluated. the study is part of the grip (guarding quality survivorship) project, which aims to improve quality of life in brain tumor patients.


Eligibility criteria:
inclusion criteria: * reduced self-reported physical fitness; * minimum age of 18 years; * diagnosed with a primary brain tumor; * stable disease, i.e. no signs of radiological or clinical tumor progression; * no oncological treatment for at least two months prior to inclusion; * able to speak, read and write in dutch. exclusion criteria: * karnofsky performance score \< 70; * already participated in a hiit program \< 1 month prior; * contraindication of exercise.
choline and cardiometabolic health

Conditions: Cardiovascular Risk Factor

Summary: trimethylamine-n-oxide (tmao), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (cvd) risk in some but not all cohort studies. the relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking tmao to increased cvd risk. vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. whether tmao impairs vascular function in humans is not known. the purpose of this study is to determine if short term supplementation of dietary choline, which increases tmao, affects cvd risk factors, such as glucose homeostasis and vascular function.


Eligibility criteria:
inclusion criteria: * age 18-79 years * weight stable for previous 6 months (+2.0kg) * sedentary to recreationally active (\<30 min aerobic exercise \<2x/wk) * no plans to gain/lose weight or change physical activity level * verbal and written informed consent * willing to be randomized to treatment order * fully vaccinated against covid-19 exclusion criteria: * bmi \> 35 kg/m2 * smoking * pregnant or plans of becoming pregnant * vegetarian or vegan * changed dietary patterns within the last month * diabetes (or use of diabetes medications) or unstable heart disease * untreated high blood pressure or high cholesterol * health problems that mide it unsafe to participate * taking medications, vitamins or supplements that could affect study outcomes (including but not limited to aspirin, antibiotics, prebiotics, and probiotics) * known allergy, hypersensitivity, intolerance to choline supplement or its ingredients * trimethylaminuria or "fish odor" syndrome

Keywords: insulin sensitivity vascular function blood pressure continuous glucose monitoring trimethylamine n-oxide (tmao)
endoscopic frontal sinus surgery draf iii in moderate to severe eosinophilic chronic rhinosinusitis with polyps

Conditions: Endoscopic Frontal Sinus Surgery; Chronic Rhinosinusitis With Nasal Polyps; Draf III; Draf I or IIa

Summary: the aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and secondary outcome measures include lund mackay score, snot-22 and need for corticosteroid to control polyp postoperatively.

chronic rhinosinusitis with nasal polyps (crswnp) is a common inflammatory disorder, affecting about 4% of the population worldwide and strongly impacts the quality of life of affected patient. eosinophilic chronic rhinosinusitis (ecrs) is a subtype of recalcitrant chronic rhinosinusitis . patients with ecrs and generally having a tissue eosinophil \>10 cells per high power field (hpf), have worse disease severity and poorer treatment outcomes compared to non-eosinophilic chronic rhinosinusitis.

Eligibility criteria:
inclusion criteria: • patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months . exclusion criteria: * narrow anteroposterior diameter of frontal sinus ostium(1cm or less) * patients showing less or highest degree of radiological complexity of surgery on studying the computed tomography. * any contraindication for general anesthesia. * patients below age of 18 years. * incomplete follow up * previous sinus surgery
efficacy of a cosmetic shampoo rv3438g in reccurent squamous states

Conditions: Dermatitis, Seborrheic

Summary: the aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of rv3438g shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single. this is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks. 4 visits are planned. the maximum duration of the study is 74 days from inclusion visit to the end-of-study visit. the study area is the whole scalp.

4 visits are performed: visit 1: inclusion (day1) : start of the short intensive treatment phase (phase 1) visit 2: intermediate visit (day15 ± 3 days, week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) visit 3: intermediate visit (day 43 ± 3 days, week 6) : middle of the maintenance phase visit 4: end-of-study visit (day 71 ± 3 days, week 10) : end of the maintenance phase

Eligibility criteria:
inclusion criteria: criteria related to the population: - subject aged between 18 and 60 years included criteria related to the disease: subject having a squamous state of the scalp : * clinically visible (squire score ≥ 20), * with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas * recurrent (at least twice a year) * associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days) exclusion criteria: criteria related to the diseases / skin condition: * subject having frizzy hair * subject with an alopecia having caused hair loss on the upper part of the scalp (norwood hamilton stage\> iii, ludwig ≥ i-4, alopecia aerata, alopecia totalis), seborrheic dermatitis requiring medical treatment criteria related to treatments and/or products: * systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments * topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ... * any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion

Keywords: dermatitis, seborrheic scalp adults maintenance of effects