Kornimate/medical-research-clean huggingface dataset:
tesetaxel plus capecitabine and cisplatin in advanced gastric cancer

Conditions: Gastric Carcinoma

Summary: cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer. this study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.


Eligibility criteria:
primary inclusion criteria: * at least 20 years of age * histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma. * measurable disease (revised recist) based on computed tomography, or nonmeasurable disease * previously untreated, unresectable advanced (m0) or unresectable metastatic (m1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy. * ecog performance status 0 or 1 * at least 4 weeks and recovery from effects of prior major surgery * adequate bone marrow, hepatic, and renal function primary exclusion criteria: * operable gastric or gastroesophageal-junction cancer * known brain metastasis * second cancer * previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (previous adjuvant or neo-adjuvant monotherapy with capecitabine or s-1 or therapy with s-1 and cisplatin in combination or 5-fu and cisplatin in combination is allowed.) * uncontrolled diarrhea * nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy * symptomatic peripheral neuropathy ≥ grade 2 * malabsorption syndrome or other disease that significantly affects gastrointestinal function * other uncontrolled systemic illness

Keywords: gastric cancer first-line therapy tesetaxel taxane capecitabine oral fluoropyrimidine cisplatin platinum
predictability of echographic excursion of the diaphragm for intubation in copd- patients with acute respiratory failure in ed

Conditions: COPD Exacerbation; Respiratory Failure

Summary: the investigators seek to evaluate if the ultra-sound measure of the diaphragm expansion is predictive of admission into an icu and/or intubation for patients with copd. every patient coming to the er with shortness of breath and a known or suspected copd, will undergo standard of care associated with a diaphragm ultrasound. the investigators will then gather, through the internal databases of the recruiting hospitals, information about admission into icu and/or intubation. the investigators think that this technique will help improve early detection of copd patient requiring mechanical ventilation, using ultrasound, a non invasive technique.

inclusion of every lawful age patient presenting to the er with inclusion criterias the patient must not have exclusion criteria and must have received the information and consent sheets to be signed jointly then, the investigators perform an online randomization for the first and second operator and the side (left/right) from which they start the ultrasound assessment. the investigators then assess diaphragmatic excursion measurements in spontaneously ventilated patient at 45 ° proclive position for each hemi-diaphragm, with the 2 operators blinded to each other, for 3 consecutive respiratory cycles and save the images. the date of inclusion is then reported in the register.

Eligibility criteria:
inclusion criteria: * spontaneous ventilation at arrival to the er * with respiratory failure defined by at least of the following criterias : * respiratory frequency \> 25 and/or clinical signs of respiratory failure * hypoxia with a wpo2 \< 90% * hypercapnia \> 45mmhg with a respiratory acidosis exclusion criteria: * known diaphragmatic dysfunction * necessity of immediate intubation leaving no time for ultrasound measurements of diaphragmatic excursion * unable to provide informed consent * evolutive or degenerative neurological disease that could affect diaphragmatic function * intracranial hypertension * haemodynamic instability * acute heart failure * pregnant or breastfeeding
optimal approach for analysis of case-control genetic association studies

Conditions: Lung Diseases; Asthma

Summary: the purpose of this study is to examine the effectiveness of approaches to correct for the effects of population stratification on case-control genetic association studies.

background: in racially admixed populations, genetic associations may be confounded by population stratification. to control for population stratification, statistical methods that use marker genotype data to infer population structure have been proposed as an alternative to family-based tests of association. however, there are limited empirical data on how these methods perform in real populations. this study will use well characterized populations of mexican and puerto rican asthmatics, their parents, and control subjects recruited from the same sites to examine the effectiveness of approaches to correct for the effects of population stratification on case-control genetic association studies. design narrative: this study has three specific aims: 1) to test and compare methods of detecting and correcting for population stratification, the study will genotype a total of 100 ancestral informative markers (aims) for 400 asthma cases and an equal number of control subjects. these aims will then be used with three statistical methods developed to detect and correct for population stratification. the number and characteristics of markers required to correct false positive associations between aims, asthma, and asthma quantitative traits will be evaluated and compared; 2) to compare the power of genomically adjusted case-control studies to the transmission disequilibrium test (tdt). an allele from each of the 100 aims will be considered as a risk factor for a simulated "phenotype." the association between phenotypes and each aim will be tested with the tdt and with a case-control analysis after adjustment for stratification to compare the false negative rates for these study designs. 3) to use the results from aim 1 and 2 to define an optimal approach for analysis and interpretation of case-control association studies in these populations and apply this approach to analyze the association between asthma and a series of candidate genes. the results of these studies should provide important insights into optimal methods to control for population stratification in case-control association studies, thereby facilitating the inclusion of admixed populations in future genetic studies of complex diseases such as asthma.

Eligibility criteria:
no eligibility criteria; this study will be using existing blood samples of mexican and puerto rican asthmatics, their parents, and control participants who were recruited prior to the study.
dna methylation in adenocarcinoma of the prostate: analysis of validated biomarkers in urine

Conditions: Prostate Adenocarcinoma; Prostate Carcinoma

Summary: this study explores the potential use of dna markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests.

primary objective: i. to assess the accuracy of mdm candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of cap. outline: this is an observational study. phase i: participants undergo urine sample collection on study. phase ii: participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study. all participants complete a questionnaire and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * \* patient is 18 years or older * patient has a histologically confirmed diagnosis of prostatic carcinoma/adenocarcinoma with a corresponding gleason score or is scheduled for a prostate biopsy for an elevated prostate specific antigen (psa), palpable prostate nodule, an abnormal imaging finding, or worrisome psa velocity exclusion criteria: * \* patient has had a transplant prior to sample collection * patient has had androgen (e.g. flutamide, androcur, casodex, nilandron) or luteinizing hormone-releasing hormone (lhrh) (e.g. lupron, zoladex) therapy * patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection * patient has chronic indwelling urinary catheter * patient has had a urinary tract infection within the 14 days prior to sample collection * patient has immunotherapy (e.g. kwon study drugs) for prostate cancer prior to sample collection * patient has a history of bladder cancer * patient has had a biopsy within the last 6 weeks (excluding non-melanoma skin biopsies) of sample collection * patient has had surgery to completely remove current target pathology prior to sample collection * patient has a prior history of prostate carcinoma/adenocarcinoma * patient has received chemotherapy class drugs (e.g. docetaxel, methotrexate) within the 5 years prior to sample collection * patient has received therapeutic radiation prior to sample collection * patient has had focal ablation \[e.g. high-intensity focused ultrasound (hifu) or cryoablation\] of prostate cancer prior to sample collection * patient has known primary cancer outside of the prostate within the last 5 years (not including basal cell or squamous cell skin cancers) of sample collection
safety and pharmacodynamic study of sobetirome in x-linked adrenoleukodystrophy (x-ald)

Conditions: X-Linked Adrenoleukodystrophy; Adrenomyeloneuropathy

Summary: the purpose of this study is to assess the safety, tolerance, pharmacokinetics, and pharmacodynamics of sobetirome, a selective thyroid hormone analog, in adult male x-ald patients.

subjects will have a screening visit within 6 weeks prior to the baseline visit. at baseline visit blood will be drawn and to establish baseline values for plasma and red blood cell (rbc) very long chain fatty acids (vlcfa; c22, c24, and c26). subjects will receive an oral dose of 50 mcg sobetirome once daily for 14 days beginning on day 1. subjects will be kept in the clinic on day 1 for 16 hours following their initial dose of sobetirome for repeat blood sampling for pharmacokinetic analysis. subjects will return to the clinic on days 7, 15, 21 and 28 for blood collection for vlcfa measurements. on day 15, after safety assessment, subjects will receive an increased dose of 100 mcg and this dose will be continued once daily through day 28. subjects will continue to return to the clinic weekly for blood and urine collection and safety assessments. subjects will return to the clinic on day 42 for an end of study visit that will involve a final measurement of vlcfa and blood and urine safety labs to check for reversibility. safety labs will include serum chemistry, free fatty acid profile, hematology, urinalysis, and thyroid function. subjects will be monitored with ecgs, vital signs, physical exams and assessment of adverse events.

Eligibility criteria:
inclusion criteria: * males 18-65 years old * x-ald diagnosis by either elevated vlcfas or dna testing * must sign informed consent and agree to complete required clinic visits. exclusion criteria: * female gender * abnormal laboratory test results (except vlcfa) at screening visit * history of coronary artery disease * use of triiodothyronine therapy * abnormal thyroid function test at screening visit * untreated adrenal insufficiency * currently taking lorenzo's oil or other vlcfa lowering agent * participation in investigational drug study within 30 days

Keywords: x-linked adrenoleukodystrophy adrenomyeloneuropathy sobetirome thyroid thyromimetic
innovative central line securement device in the pediatric population

Conditions: Central Line Complication; Central Line Infection; Central Line-Associated Infection; Central Line Sepsis; Short Gut Syndrome; Quality of Life; Pediatric Disorder

Summary: this study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). these issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. the purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. the hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. a secondary outcome for evaluation will be quality of life. this will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. this study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.

Eligibility criteria:
inclusion criteria: * patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. exclusion criteria: * those children who currently wear a central line securement device (vest) * children with central lines who are 19 years or older * those females with central lines and tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications. * if the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. the investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.
safety evaluation of kx01 ointment 1% in japanese healthy male subjects

Conditions: Healthy Volunteer

Summary: skin irritation and phototoxicity study of kx01 ointment 1% in japanese healthy male subjects

a baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results. a total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for kx01kx2-391 ointment 1% and 2 sites for placebo vehicle ointment. one set (kx01 ointment 1% ip and placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. the distance between the patches will be no less than one centimeter. the numbering of the test sites will remain the same throughout the study. the sites will be marked with an indelible, surgical marker.

Eligibility criteria:
inclusion criteria: * healthy japanese male adult, whose age 20-65 years old exclusion criteria: * history of photosensitivity or photoallergy

Keywords: skin irritation phototoxicity
achalasia patient reported outcomes

Conditions: Esophageal Achalasia; Achalasia; Achalasia, Esophageal

Summary: patients that are either scheduled to undergo or have undergone an achalasia procedure at the mayo clinic rochester are asked to participate. the purpose of this study is to gather information and determine if one of these procedures is superior to the other.

this is a non-randomized, non-inferiority trial that has been created to compare results of achalasia procedures including but not limited to: poem + partial fundoplication (pf), poem and laparoscopic modified heller myotomy + pf and poem + peroral plication of the esophagus. using a set of consistent evaluation tools for patients undergoing treatment for achalasia allows a standardized evaluation and comparison of these groups of patients. the long term and comparative poem procedure outcomes are not currently known. patients undergoing poem, fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of reflux, dysphagia, and pain. providers also note varying degrees of esophagitis by endoscopy, reflux by impedance or ph scoring, and recurrence by repeat manometry. many of these issues can be quantified using ph probe testing, upper gi endoscopy, high resolution manometry, ct scans, endoflip device and esophagrams. there are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the promis global health score, ekhardt score, mayo ger score, modified dysphagia questionnaire-30 day, zubrod score, and pain scale. each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's postoperative outcome.

Eligibility criteria:
inclusion criteria: * \>18 years old * undergoing a poem or laparoscopic modified heller myotomy and anti-reflux procedures * esophagus diameter less \<8 cm on barium swallow test exclusion criteria: * pregnant * diverticular disease of the esophagus * barrett's esophagus * extensive abdominal adhesions * \<50% predicted fev1 on pulmonary function testing * cardiac ejection fraction \<25% * esophageal stricture from prior myotomy * sigmoidization of the esophagus * more than one prior balloon dilation (\>3 cm) or any prior dilation of 3 cm
the role of inflammation in amd and related disorders

Conditions: Age-Related Macular Degeneration

Summary: this prospective, non-therapeutic study will compare the relative utility of multiple ocular imaging modalities in the detection of the cellular immune response in patients with amd and related disorders.


Eligibility criteria:
inclusion criteria study eye any tentative clinical diagnosis of the following: 1. early dry amd (drusen) with clinical suspicion of cnv 2. late dry amd (ga) with clinical suspicion of cnv 3. reticular pseudodrusen with clinical suspicion of cnv 4. polypoidal choroidal vasculopathy 5. retinal angiomatous proliferation 6. central serous retinopathy 7. rpe detachment 8. conversion to wet amd (cnv) 9. decade matched controls inclusion criteria control eye * subjects \> 18 years of age * best corrected visual acuity (bcva) of 20/32 or better exclusion criteria study/control eye: * patients not able to provide consent for the study. * patients with a poor view of the fundus due to cataract or vitreous hemorrhage. * patients \< 18 years of age * patients with known allergy to angiographic dye * patients with any concurrent unrelated eye diagnosis that would interfere with image acquisition or interpretation (eg advanced diabetic retinopathy, vascular occlusion, uveitis, or others). exclusion criteria control eye * suspect diagnosis of amd, rpd, pcv, rap, csr or rped * family history of amd * 2 or more large drusen (\>125um) or 20 or more medium drusen (64-124um) * diabetes * patients using plaquenil/chloroquine/hydroxychloroquine * diagnosis of inflammatory disease * patients with inherited eye disease * note: patients with a diagnosis of nevi are not excluded from this study
the possible correlations between the genes related to pain sensation and the pain sensitivity in the general population

Conditions: Pain; Surgery

Summary: objective: this study was conducted to explore the possible correlation between some gene related to pain sensation and individual basal pain perception and postoperative pain intensity in the general population. methods: patients receiving elective surgery under general anesthesia were recruited into this study. the investigators measured their preoperative pressure pain threshold (ppt) and pressure pain tolerance (pto). pain intensity at rest and movement after the operation was evaluated . and the pca drug consumption were recorded. also there were healthy college students volunteer be recruited into this study. the investigators measured their experimental pain sensitivity including pressure pain threshold (ppt) and pressure pain tolerance (pto), etc. then genotyping was carried out.

subjects with the following diseases were excluded: known history of chronic disease, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at lactation period .

Eligibility criteria:
inclusion criteria: * •aged 18-65 years * receiving elective gynecological laparoscopic surgery * anesthesiologists (asa) physical status i or ii * agreed to participate the research exclusion criteria: * •history of chronic pain * psychiatric diseases * diabetes mellitus * severe cardiovascular diseases * kidney or liver diseases * alcohol or drug abuse * heavy smoker * pregnancy or at lactation period * disagree to participate to the research

Keywords: gene polymorphism pain perception postoperative pain
how reducing anxiety in schizophrenia

Conditions: Schizophrenia

Summary: introduction: health care that addresses the emotional regulation capacity of patients with schizophrenia confronted with daily stress may contribute to a less anxious life. a psycho-physiological training (cardiac coherence training; cct) focusing on emotion regulation is known to decrease anxiety for non-clinical individuals. methods: the investigators performed a pilot cross sectional survey to explore the benefits of cct for clinically stable patients with schizophrenia. ten patients were enrolled in the program consisting in height to twelve weekly one hour session program during a 2-month follow-up. standardised questionnaires were used before and after the intervention assessing anxiety, well-being outcomes, and how patients deal with stress and stressors.

ten subjects, five women and five men, all volunteers, were included in the study. the patients were all clients of the rehabilitation center for psychotic disorders (le vinatier hospital) situated in lyon, france. criteria for entry into the study included: a diagnostic and statistical manual of mental disorder-4 diagnosis of schizophrenia as confirmed by the mini international neuropsychiatric interview for dsm-iv (mini); age between 18 and 65; being clinically stable (i.e. not having required hospitalization or increases in medication as a result of an exacerbation of acute symptoms over the previous three months. all subjects completed a set of "paper and pencil" standardized assessments at pre-intervention and immediately after the end of the intervention. trait and state anxiety was assessed using the french version of the spielberger state-trait-anxiety inventory (s-stai). three questionnaires were used in order to evaluate the outcomes quality of life of patients. 1/ the positive and negative syndrome scale (panss); 2/ patient's body/mind perceptions were assessed using mindfulness concept (freiburg mindfulness inventory, fmi), and 3/ patients' quality of life was evaluated using the warwick-edinburgh mental well-being scale (wemwbs). one questionnaire was used to assess how patients deal with stress and stressors (the derogatis stress profile, dsp).

Eligibility criteria:
inclusion criteria: * diagnosis of remitted schizophrenia exclusion criteria: * exacerbation of schizophrenic symptoms over the previous three months (hospitalization or increases in medication)