Kornimate/medical-research-clean huggingface dataset:
a study with tarceva and chemotherapy vs. chemotherapy alone in patients with advanced lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to determine if tarceva plus standard chemotherapy is more effective than standard chemotherapy alone in the treatment of lung cancer.


Eligibility criteria:
inclusion criteria: * signed informed consent * age \>=18 years * histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage iiib or stage iv non-small cell lung cancer (nsclc) * a cytologic diagnosis is acceptable (i.e., fna or pleural fluid cytology) * measurable or non-measurable disease * ecog performance status of 0 or 1 * life expectancy of \>=3 months * \>= 3 weeks since any prior surgery or radiotherapy (\>=2 weeks for patients who receive \<=30 gy of radiotherapy involving \<25% of the marrow reserve) * use of an effective means of contraception (women of childbearing potential) * able to comply with study and follow-up procedures exclusion criteria: * evidence of small cell, carcinoid, or mixed small cell/non-small cell histology * malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer * symptomatic or untreated brain metastases * prior systemic chemotherapy for nsclc * prior exposure to agents directed at the her axis (e.g., zd1839 \[iressa\], c225 \[cetuximab\], trastuzumab \[herceptin\]) * unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) * history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications * gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (iv) alimentation, or prior surgical procedures affecting absorption * pregnancy or lactation any of the following abnormal baseline hematologic values: * granulocytes count \<=1500/ul * platelet count \<100,000/ul any of the following abnormal baseline liver function tests: * serum bilirubin \>1.5× upper limit of normal (uln) * serum alt and ast \>=2.5× uln (\>5× uln if due to liver metastases) * alkaline phosphatase \>=2.5× uln other baseline laboratory values: * serum creatinine \>1.5× uln or creatinine clearance \<60 ml/min * uncontrolled hypercalcemia (\>11.5 mg/dl)

Keywords: non-small cell lung cancer
a study of ro5185426 in patients with metastatic melanoma

Conditions: Malignant Melanoma

Summary: this is an open-label, non-comparative, multicenter, expanded access study of ro5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic melanoma with documented braf v600e mutation, determined by the cobas braf v600 mutation test * patients with either measurable or non-measurable disease * adequate recovery from most recent systemic or local treatment for metastatic melanoma * adequate organ function * for women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of ro5185426 * for men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of ro5185426 * negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study * agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of ro5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of ro5185426 exclusion criteria: * pregnant or breast-feeding * concurrent anti-tumor therapy * uncontrolled medical illness * history of congenital prolonged qt syndrome or patients with a mean qtc interval greater than 470 milliseconds at baseline, or ongoing grade 2 or greater cardiac arrhythmia
transoral gastric volume reduction as an intervention for weight management

Conditions: Obesity; Overweight; Weight Loss

Summary: this study assesses weight loss from the endoscopic vertical gastroplasty or fogel gastroplasty (fg). the purpose of the study is to: * document that weight loss occurs (12 months) * determine if it alters general wellbeing (emotionally and physically)

this will be a prospective study evaluating the percentage of weight loss in patients that have undergo the endoscopic vertical gastroplasty or fogel gastroplasty (fg). fogel's gastroplasty is a procedure where the subject will be placed under general anesthesia in accordance with the institution's standard practice. the procedure will last approximately 1-2 hours. following induction of anesthesia, the overtube will be placed, a gastroscope will be inserted to examine esophageal and gastric anatomy and re-confirm there are no anatomical contraindications to the procedure. the gastroscope will also be used to record images of the stomach prior to insertion of the overstitch. once the examination is complete the gastroscope will be removed. the overstitch system will then be inserted orally to the per-operative site. co2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. the physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the angle of his to the level of the incisura, creating a tube-like passage for gastric volume reduction. afterwards, the remaining gastric volume will be reduced using a circumferential running stitch. once complete, the overstitch system will be removed and a standard gastroscope will be inserted to record post procedure endoscopic images. anthropometric measurements as weight, height, bmi and waist circumference will be collected at baseline, 3, 6 and 12 months after procedure

Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age 2. subject has a bmi between 28 and 34.9 3. subject is willing to complete all follow-up visits after procedure ( 3, 6 and 12 months) exclusion criteria: 1. patients that are not willing to participate in the study 2. patients with history of gastrointestinal tumors, gastric cancer, previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy, esophageal or gastric varices, or gastroparesis, 3. subject has significant esophageal disease including zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility or hiatal hernia

Keywords: weight loss overweight endoscopic treatment for obesity
breast health education for underserved latino women

Conditions: Breast Cancer

Summary: subjects will be recruited from the participants in the union and mecklenburg county living room visits. participants in the living room visit will have been recruited using community event flyers. during the living room visits, the health educator will provide a general overview of the study. individuals who are interested in participating in the study will then be generally screened for eligibility by the protocol coordinator who will then proceed to provide informed consent to potential subjects.

in an effort to increase early detection of breast cancer our program is designed to remove some of the most common barriers faced by uninsured latino women including lack of breast health knowledge and inability to pay for screening. the levine cancer institute offers breast cancer education and screening in the growing latino populations of both mecklenburg and union counties through educational programs known as "living room visits." living room visits are educational sessions hosted at a participant's house that will be led by a carolinas healthcare system (chs) certified bilingual health educator. at least 250 women will participant in the educational sessions between both counties with each session hosting 12-15 participants. of those women participating in living room visits, those interested will be individually informed of the research opportunity and provided informed consent before being asked to take a pre-test survey. after the educational session, subjects who consented to the study will also complete a post-test survey. three months after each living room visit, subjects will also be called to complete another post-test survey to assess educational retention. phone calls and post-test surveys will be administered by collaborative institutional training initiative (citi) trained chs certified bilingual employees only. analysis of the pre and post-intervention surveys will be administered by a chs statistician using de-identified data.

Eligibility criteria:
inclusion criteria: * latino * female * at least 18 years old * resident of union county or mecklenburg county, north carolina exclusion criteria: * non-latino * male * less than 18 years old * not a resident of union county or mecklenburg county, north carolina

Keywords: breast health education latino women group education breast cancer
fronto-temporal tdcs mproves fluency & empathy in asd kids

Conditions: Autism; ASD

Summary: interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients with autism spectrum disorder (asd) are two types of intervention by transcranial random noise stimulation (trns), to improve verbal fluency and empathy.

interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients receive three types of intervention trns: one group received 35 sessions focused on the fronto-temporal cortex, another group received 35 sessions focused on the temporal fusiform cortex and last placebo group was operated with 35 sessions trns. after brain noninvasive stimulation sessions, a blind analysis of the improvement in verbal fluency and empathy in patients with autism spectrum disorder is made. for each patient included a follow up period of three months will be established.

Eligibility criteria:
inclusion criteria: * patients between 5 and 12 years. * meet dsm-iv criteria for autism spectrum disorder. * patients who have been diagnosed at least 2 years before inclusion in the study. exclusion criteria: * acute visual or hearing loss. * traumatic brain injury. * other neurological disorders: migraine, epilepsy, tuberous sclerosis ... * trauma at birth. * mental retardation. * pregnancy.

Keywords: tdcs qeeg erp asd autism verbal fluency empathy noninvasive brain stimulation
connact oa knee cohort

Conditions: Osteoarthritis, Knee

Summary: connact oa knee cohort is a prospective longitudinal cohort study where we aim to collect sociodemographic, psychosocial, clinical, health utilization and cost data in order to better understand the asian oa knee cohort and investigate for prognostic variables that can potentially influence a patients clinical outcome and treatment decisions. in addition, the connact oa knee cohort will form the basis for a cohort multiple randomized control trial (cmrct) study design where multiple interventions can be tested in a randomized fashion. each intervention is offered to a randomly selected sample of patients eligible for that intervention, who are then compared with the rest of the eligible patients from the cohort that are still being treated as usual.


Eligibility criteria:
inclusion criteria: 1. knee osteoarthritis (based on nice guidelines) 2. age \> 45 years 3. community ambulator with or without walking aid 4. conversant in english or chinese exclusion criteria: 1. alternative diagnosis to knee oa e.g. referred pain from spine or hip 2. other forms of knee arthritis e.g. inflammatory, post-traumatic 3. moderate to severe cognitive impairment e.g. dementia 4. previous knee arthroplasty 5. wheelchair bound patients 6. medical conditions that will medically interfere with rehabilitation involvement e.g. decompensated heart failure, stroke with significant deficit, end stage renal failure
biomarkers in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: n-methyl-d-aspartate (nmda)-type glutamate receptors are thought to play a pivotal role in neurocognitive dysfunction associated with schizophrenia. further, several novel glutamate-based classes of compound are presently in development as potential novel treatments for persistent negative and cognitive symptoms. the study will assess effectiveness of a nmda-based intervention on biomarkers related to schizophrenia as a mechanism for developing appropriate outcome batteries for future trials of novel compounds.

16 in- or outpatients with dsm-iv-tr schizophrenia or schizoaffective disorder and prominent negative symptoms will be recruited for this study. this study will consist of a randomized trial of d-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline lead-in, and two 6-week intervention arms separated by a two week, placebo controlled washout period. biomarkers will be assessed at baseline for each treatment arm, acutely (day 7) following treatment initiation, and following 6 weeks of treatment (6 biomarker sessions total). primary biomarker outcome measures will include 1) amplitude of the mismatch negativity (mmn) waveform and 2) amplitude of the visual p1 potential. symptomatic outcome measures will include panss and composite score of the matrics neuropsychological battery. the study will be supported from ongoing nimh-funded cooperative drug development grant (cddg) to the pi.

Eligibility criteria:
inclusion criteria: * age 18-64 * scid diagnosis of schizophrenia or schizoaffective disorder. * panss 3 factor negative symptom (screening and baseline visit 1 and visit 3) score of \>20 and panss total score between 60-110. any degree of positive symptoms is acceptable but the total panss score must not exceed 110. * sas total score less than or equal to 12 and a calgary depression inventory total score less than or equal to 10 and suicide (item 8) less than moderate (\<2). * two consecutive cgi ratings at screening and baseline (visit 1 and 3) with no change in score. * estimated glomerular filtration rate (gfr)(a measure of renal function) greater than or equal to 60. exclusion criteria: * organic brain disorder, including epilepsy; mental retardation; or a medical condition whose pathology or treatment would likely alter the presentation or treatment of schizophrenia or significantly increase the risk associated with any of the proposed treatments * current dsm-iv diagnosis of drug/alcohol abuse in last month and current dsm-iv diagnosis of drug/alcohol dependence in last 6 months * pregnant female patients * impaired renal function * significant extrapyramidal symptoms (as reflected by a total score of 10 or above on the sas scale), and depressive symptoms (as reflected by a score of 10 or above on the calgary depression scale for schizophrenia) * patients who are unable to or unwilling to participate in the cognitive assessment (matrics) and the electrophysiology tasks . * patients on clozapine

Keywords: biomarker eeg schizophrenia nmda d-serine
early or non-revoked in hospital-day in patients with acute heart failure

Conditions: Heart Failure; Acute Heart Failure

Summary: heart failure is one of the major causes of hospitalization in brazil and worldwide. recent studies attempt to identify readmission and prognostic markers at the time of discharge from these patients. the reassessment and possibility of early therapeutic adjustment may be relevant in this context. therefore, the prospective and randomized comparative use of early re-evaluation in hospital-day versus non-intervention group has not yet been described. the objective of this study was to evaluate the impact on the re-hospitalization rate in 30 days of the early re-evaluation of the patients in the day-hospital versus the non-intervention group in heart failure. for this, a unicentric, randomized and prospective study will be performed, in which the hospital-day strategy is performed versus no intervention in a comparative manner. hospital data (test results, medical outcomes, complications) of patients will be analyzed for safety and effectiveness. the hypothesis of this study is that the hospital-day strategy is superior to the non-intervention strategy and causes fewer rehospitalizations within 30 days.


Eligibility criteria:
inclusion criteria: * adult men and women aged\> 18 years. * presence of decomposed cf iii or iv of nyha characterized by\> 1 symptom (dyspnea, orthopnea or edema) + 1 clinical sign (rales, edema, ascites or pulmonary congestion on chest x-ray). * lvef \<45% on transthoracic echocardiography. * bnp\> 400 pg / ml. * clinical condition of hospital discharge. * signed consent form. exclusion criteria: * pregnancy * body mass index greater than 40 kg / m2. * chronic obstructive pulmonary disease. * acute coronary syndrome. * acute myocarditis. * valvular heart disease. * need to use vasoactive drug. * cirrhosis of the liver child c. * chronic dialysis renal insufficiency or creatinine\> 3.0 mg / dl. * indication of implantation device of artificial stimulation. * pulmonary thromboembolism. * neoplasm terminal. * sepsis or septic shock.
pemetrexed and gemcitabine in patients with advanced non-small cell lung cancer (nsclc)

Conditions: Lung Neoplasms

Summary: this is a phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. this treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. the primary goal is to find out if the tumor gets smaller or disappears with this treatment.


Eligibility criteria:
inclusion criteria: 1. have a diagnosis of advanced stage non-small cell lung cancer. 2. are able to be active at home and/or work. 3. have not received chemotherapy for this cancer disease. 4. have good organ function (for example, most blood work is normal). 5. have completed any prior radiation treatment at least 4 weeks ago. exclusion criteria: 1. have been treated with an investigational/research drug within the last month. 2. have cancer that has spread to the brain and is causing symptoms. 3. have an active infection or other serious medical condition. 4. have a second cancer in addition to non-small cell lung cancer. 5. can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
evaluation of ifr vs ffr in stable angina or acute coronary syndrome

Conditions: Angina Pectoris; Acute Myocardial Infarction

Summary: previous trials have demonstrated that the use of physiological assessment of stenosis severity using fractional flow reserve (ffr) is superior to angiographic assessment in percutaneous coronary intervention (pci) and improves clinical outcome. despite the clinical utility, ffr is used only in 10-15% of patients today. the main reasons for the low adoption rate of ffr are the prolonged procedural time, adenosine related discomfort and cost associated with adenosine. instantaneous wave-free ratio (ifr®) is a novel method to assess coronary lesions for functional significance. the main benefits of the method compared to ffr are that the measurement is instantaneous and does not require adenosine infusion. thus, the patient does not experience any discomfort from the measurement and procedural time could be shortened compared to when using ffr. this could potentially increase the adoption rate of physiologic assessment of coronary lesions. the aim of this trial is to compare the clinical outcome of patients assessed by ifr® with patients assessed by ffr. furthermore, the trial will be conducted as a registry based randomized clinical trial (rrct) which is a novel strategy to conduct clinical trials. the randomization will occur online in the swedish angiography and angioplasty registry (swedeheart) using a web based platform.


Eligibility criteria:
inclusion criteria: * patients with suspected stable angina pectoris or unstable angina pectoris/non-st-segment elevation myocardial infarction (nstemi) who are scheduled to undergo coronary angiography, and who has an indication for physiology guided assessment of coronary lesions (usually 30-80% stenosis grade). in patients with suspected stable angina pectoris, any lesion may be assessed. in patients with unstable angina pectoris/nstemi, only the non-culprit lesion may be assessed. exclusion criteria: * inability to provide informed consent * age below 18 years * previous randomization in the ifr-swedeheart trial * known terminal disease with a life expectancy of less than one year. * in patients with multi-vessel disease and other indication than stable angina pectoris, difficulty in assessing which the culprit lesion is. * patient with unstable hemodynamics (killip class iii-iv) * inability to tolerate adenosine * previous coronary artery bypass graft (cabg) with patent grafts to the interrogated vessel. * heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire is expected.

Keywords: instantaneous wave free ratio fractional flow reserve
icbt for mental health problems related to the climate crisis

Conditions: Depression and Quality of Life

Summary: the study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (icbt) programme on adult mental health problems related to the climate crisis. icbt will be compared to a wait-list control group. participants will be recruited in sweden with a nationwide recruitment.

the study is set up as a randomized controlled trial. quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. given uncertainties regarding the psychological effects connected to the climate crisis, a transproblematic tailored treatment approach will be used that has been tested in several previous trials. however, the present program has been adapted for the target population of people who are affected directly or indirectly by the societal and individual consequences of the climate crisis.

Eligibility criteria:
inclusion criteria: experience mental health problems that are caused or exacerbated by the climate crisis and/or its consequences 18 years or older. adequate ability to understand and speak swedish. access to the internet and a smartphone/computer. exclusion criteria: other ongoing psychological treatment or counselling that interfere with trial treatment. recent (within the past 3 months) changes in the dose of psychotropic medication. any severe psychiatric or somatic conditions that would interfere with trial treatment