Kornimate/medical-research-clean huggingface dataset:
telehealth based synchronous navigation to improve molecularly-informed care for patients with lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the goal of this trial is to design and test a telehealth nurse navigation intervention for patients with suspected locally advanced/metastatic nsclc to improve timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing.

the overarching goal of this pilot trial is to design and test a nurse navigation intervention delivered via telehealth for patients with suspected locally advanced/metastatic nsclc to improve timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing (i.e., tumor tissue and plasma-based molecular testing or plasma only when tumor tissue is insufficient/unavailable). the central hypothesis is that providing telehealth nurse navigation to support completion of concurrent molecular testing will result in higher rates of comprehensive testing, improved timeliness of molecularly-informed treatment recommendations (primary endpoint), earlier initiation of molecularly-informed treatment, more meaningful patient-clinician communication, and higher levels of overall satisfaction among patients and clinicians. drawing from systematic evidence on the role of navigation for coordination of cancer care and informed by insights from communication science and behavioral economics, the specific telehealth strategy to be tested is synchronous telehealth nurse navigation in combination with default ordering of plasma-based testing.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * based on cross-sectional imaging, suspected to have locally advanced/metastatic nsclc (as determined by the evaluating clinician) * scheduled for an appointment in the lung cancer evaluation clinic exclusion criteria: * are not suspected to have locally advanced/metastatic nsclc * have a concurrent active malignancy

Keywords: molecular testing lung cancer telehealth liquid biopsy
storytelling and mindfulness for graduate student wellbeing

Conditions: Depression; Anxiety; Burnout, Student

Summary: the purpose of this study is to evaluate an intervention for improving science, technology, engineering, and math (stem) graduate student wellbeing. participants will be recruited from the university of wisconsin-madison graduate student body. data will be collected from participants for up to 2 years, and the investigators anticipate that the study will last for 4 years.

the objective of this research is to evaluate the utility of storytelling and mindfulness practice in improving wellbeing in stem graduate students. the main questions it aims to answer are: 1. does engaging in mindfulness practice and storytelling increase measures of wellbeing in this population? 2. does engaging in mindfulness practice and storytelling increase measures of academic success? participants will be asked to: * complete a survey evaluating wellbeing and academic success * attend 2 storytelling workshops * use a guided mindfulness mobile app for 2 weeks researchers will compare survey results from participants in the control group (no intervention, survey only) to those from participants in the intervention group (workshops, mindfulness, and survey) to see if the measures of wellbeing and academic success differ between groups.

Eligibility criteria:
inclusion criteria: * 18 or older * current graduate student in a science, technology, engineering, and math (stem) field at the university of wisconsin-madison * no significant experience with mindfulness practice exclusion criteria: * under 18 * significant experience with mindfulness practice * not a current graduate student in a stem field at the university of wisconsin-madison

Keywords: student burnout mindfulness creative writing graduate students stem education
a study of the efficacy and safety of vernakalant hydrochloride (mk-6621) in patients with atrial fibrillation (mk-6621-010 am4)

Conditions: Atrial Fibrillation

Summary: this study will investigate if treatment with vernakalant hydrochloride (mk-6621) results in a greater proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm compared to placebo.

amendment 4 of the protocol revised the planned enrollment to 123 participants and removed china as one of the countries participating in the study.

Eligibility criteria:
inclusion criteria: * abstinent or willing to use 2 acceptable methods of birth control * patient has an atrial arrhythmia with dysrhythmic symptoms * patient is receiving adequate anticoagulant therapy * patient has stable blood pressure * patient weighs between 45 and 136 kg (99 and 300 lbs) * patient is adequately hydrated exclusion criteria: * patient is pregnant, breast-feeding, or expecting to become pregnant during the study * patient routinely consumes more than 2 alcoholic drinks per day * patient has known or suspected prolonged qt, familial long qt syndrome, previous torsades de pointes, brugada syndrome * patient has known bradycardia, advanced av block, or sick-sinus syndrome, unless controlled by a pacemaker * patient has severe aortic stenosis * patient has atrial flutter * patient has class iv congestive heart failure (chf) * patient has had a myocardial infarction (mi) or acute coronary syndrome (acs) * patient has had cardiac surgery within 30 days * patient has known atrial thrombus * patient has reversible causes of atrial fibrillation * patient has failed electrical cardioversion during current episode of atrial fibrillation * patient has uncorrected electrolyte imbalance * patient has clinical evidence of digoxin toxicity * patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days * patient is known to be hiv positive * patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers

Keywords: atrial fibrillation
pilot study for evaluation of cryobiopsy and correlation with standard forceps biopsy

Conditions: Gastrointestinal Disease

Summary: environmental enteric dysfunction (eed) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. eed is a major driver of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all children globally and causing over a million deaths each year. progress towards understanding eed and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. in order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in eed patients before the age of 2. currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. unfortunately, endoscopy is untenable for the study of eed because of limited resources and the high cost. as a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (lmics) to evaluate the intestine in population with eed. this work is supported by a grant from the bill and melinda gates foundation (bmgf). the overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective eed interventions. obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information. the purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults.

this study will test the capacity of a gastrointestinal tract cryobiopsy probe that tearney lab investigators have designed to obtain biopsies from the upper gi tract. a total of twenty (20) subjects, adults 18 years of age and older, scheduled for elective esophagogastroduodenoscopy with biopsy will be enrolled in this study. a maximum of 3 cryobiopsies per subject will be collected. after each cryobiopsy is complete, the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed. a maximum of 3 standard forceps biopsies for research purposes only will be taken. biopsy collection will be performed at the discretion of the endoscopist. the standard forceps biopsy sites will also be monitored directly throughout the entire experimental procedure. the total experimental procedure time will not exceed 15 minutes.

Eligibility criteria:
inclusion criteria: * scheduled for an elective esophagogastroduodenoscopy with biopsy. * 18 years of age or older. * able to provide informed consent. exclusion criteria: * according to standard of care.

Keywords: biopsy egd endoscopy cryobiopsy oct
optimal lesion preparation with non-compliant balloons before implantation of bioresorbable scaffolds (oprenbis)

Conditions: Coronary Artery Disease; Angina; Unstable Angina; Stable Angina

Summary: study aim : to compare a novel strategy of lesion preparation with noncompliant balloons before implantation of bvs (bioresorbable vascular scaffold). hypothesis: predilatation with non-compliant balloons could facilitate optimal deployment of bvs. by achieving good scaffold apposition a need for post-dilatation could be significantly reduced. this is expected to result in better short- and long-term outcomes.

study design: following pre-dilatation a bvs will be implanted and optical coherence tomography (oct) will be performed in all patients. after oct post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. final oct will be performed in all patients. 1:1 randomization of two strategies before the implantation of bioresorbable scaffolds: * opn strategy (study group): pre-dilatation with opn nc ® super high pressure ptca (percutaneous transluminal coronary angioplasty) balloons * standard strategy (control group): pre-dilatation with a standard (compliant) balloon enrolment: randomization of 50 patients * 25 in the opn strategy (study group) * 25 in the standard strategy (control group)

Eligibility criteria:
inclusion criteria: * age \> 18 years. * able and willing to give informed consent. * willing to comply with specified follow-up evaluations. * clinical manifestation of coronary artery disease: stable angina, unstable angina or non-st-elevation myocardial infarction. * de novo lesion. * angiographic diameter stenosis \> 70 % and/or fractional flow reserve \<0.80. * vessel diameter between 2.5 and 4.0 mm. * one- or two vessel disease (defined as diameter stenosis \> 70 % in vessels with a diameter \> 2.5 mm). * up to two lesions in one or two vessels can be treated exclusion criteria: * patient characteristics * pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure. * patient with contraindication for 12 months of dual antiplatelet therapy. * st-elevation myocardial infarction. * any contraindication to the implantation of bvs. lesion characteristics * visible thrombus in coronary angiography * chronic total occlusion

Keywords: coronary artery disease opn nc angina stable unstable
the prep (pre-exposure prophylaxis) smart study

Conditions: HIV/AIDS

Summary: the prep smart study is testing a stepped model of scalable adherence support strategies in south african young women who initiate prep using a smart (sequential multiple assignment randomized trial) design.

women enrolled in the study will be randomized to standard of care adherence support (brief counseling) and either whatsapp groups or weekly two-way sms messages. two months after prep initiation, tenofovir drug levels will be measured to determine if participants have achieved high adherence based on their initial randomization. women with high adherence (i.e., tfv-dp \>/=500 fmol/punch from dried blood spots \[dbs\]) will continue with the adherence support to which they were initially randomized. participants with low adherence (i.e., tfv-dp \<500 fmol/punch from dbs) will continue initial randomization (whatsapp or two-way sms) plus be randomized to more one of two more intensive adherence support interventions - continued monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly visits between months 3-9 with feedback about adherence based on drug levels at months 3 and 6.

Eligibility criteria:
inclusion criteria: * female at birth * age 18-25 years * per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening * literate in one or more of the study languages * willing and able to provide informed consent * able and willing to provide adequate locator information * regular access to a mobile phone with sms and whatsapp capacity * agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation exclusion criteria: * planning to relocate in the next 12 months * has a job or other obligations that would require long absences from the area (\> 4 weeks at a time) for 12 months * a reactive or positive hiv test at enrollment * any reported prep use within the last 6 months * concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents * prior participation in the active arm, or current participation in any arm, of an hiv vaccine trial * positive pregnancy test

Keywords: pre-exposure prophylaxis young women hiv infections/prevention smart design
research on vaginal microbiota evaluation unified standards based on gram staining

Conditions: Vaginal Infection

Summary: the goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.

this study consists of two sub-studies: 1. sub-study on standardized method of microscopic slide preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy. 2. sub-study on vaginal microbiota evaluation on gram staining: for patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. and it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. besides, for patients without diagnosed vaginal infection type, different methods such as 16s rrna gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.

Eligibility criteria:
inclusion criteria: * non-pregnant women who visit our research settings and conduct vaginal discharge examination based on gram-stained smear. * no sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours. * not during menstruation (menstrual period ended ≥3 days ago). exclusion criteria: * receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
mobile health app to mitigate the metabolic effects of androgen deprivation therapy

Conditions: Prostate Cancer

Summary: this research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits.

this research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits. the first phase of the research study seeks to evaluate the experience of the first version of the mobile health app within a group of participants and what they think of it. the investigators are interested in how individuals react to the use of a developed mobile health app and what they think of it.

Eligibility criteria:
inclusion criteria: phase 1 * all recruited participants must have owned a smartphone for \>1 year * english-speaking. * patients with prostate cancer aged between 40-75 years will be considered. * no specific timeframe after prostate cancer diagnosis will be required for these patients. * no limitations regarding their disease characteristics will be imposed (e.g. metastatic disease). * patients may or may not be currently receiving treatment staff members will be recruited from * dana-farber cancer institute department of medical oncology, * brigham and women's hospital, department of surgery. staff members aged between 40-75 years old will be considered. phase 2 * men diagnosed with prostate cancer presenting to df/bwhcc * about to initiate adt for the first time will be considered. * age range 40-75-years * the ability to walk 400 m * medical clearance from their primary physician * english speaking * cognitively alert * literate * ability to read or hear with or without contacts/glass and hearing aid * ownership of a smartphone for \>1yr exclusion criteria: * men who have been under a rigorous structured exercise regime, such as individuals who engage in more than 900 minutes of moderate physical activity per week in the last 6 months will not be considered * post-adt treatment * planned systemic chemotherapy * planned treatment with abiraterone or enzalutamide * bone metastases * acute illness * any musculoskeletal, cardiovascular, or neurologic disorders that could inhibit or put them at risk from exercising * subordinates to the pi

Keywords: prostate cancer
brain injury biomarkers in the general population

Conditions: Brain Injuries, Traumatic

Summary: the purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (tbi) in a general population. the data will be used in a correlative analysis with data collected under a separate study of severe tbi.


Eligibility criteria:
inclusion criteria: * at least 18 years of age and no more than 80 years of age * willing to undergo consent * pi believes volunteer is appropriate candidate for study exclusion criteria: * participating in another clinical study that may affect the results of either study * non-english speaking * venipuncture not feasible * blood donation within 1 week of screening * pi determines volunteer is not medically suitable for study participation
effects of behavioral contingencies on effects of nitrous oxide - 12

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. to examine the effects of different behavioral contingencies in modulating the reinforcing effects of nitrous oxide in healthy volunteers.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide subjective effects reinforcer inhalant healthy volunteer
validation of the accuracy of a novel poct dry electrolyte analysis system in the acute care setting

Conditions: Electrolyte Disorder; Arrhythmia; Stroke

Summary: the goal of this study is to compare the performance of a novel point-of-care testing (poct) dry electrolyte analyzer (p1) with the nova stat profile phox ultra analyzer system (nova) in an acute care setting. the main questions it aims to answer are: 1. how consistent are the results between p1 and nova in the emergency setting, including outliers, correlation, linearity, and bias? 2. whether p1 can serve as a suitable alternative to nova in the acute care setting for electrolyte measurement in the emergency environment. participants will be patients in the emergency department who will undergo simultaneous measurement with p1 and nova during their emergency care to assess the performance of both devices. additionally, the study will investigate electrolyte levels in emergency patients, focusing on the prevalence of abnormal ionized magnesium (img2+) levels, the correlation between img2+ and total magnesium (tmg), and the clinical significance of img2+ measurement.

this observational study aims to compare the performance of two electrolyte analysis systems, the electrolyte analyzer p1 and the nova stat profile phox ultra analyzer system, in an emergency department (ed) or emergency intensive care unit (icu) setting. the study will evaluate the consistency, correlation, and bias between the two electrolyte analysis systems. the study design is observational, with no intervention or treatment assigned to the participants. the comparison will be made using residual blood samples collected as part of routine care, following standard clinical procedures.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo electrolyte measuring in the emergency department (ed) or emergency intensive care unit (icu). exclusion criteria: * patients with a confirmed history of infectious diseases such as hepatitis b, syphilis, hiv/aids, etc. * missing residual sample types (serum or whole blood). * patients whose residual blood samples are not tested within the specified time frame after collection. * other patients deemed ineligible by the investigator.

Keywords: electrolyte analyzer accuracy p1 eaglenos
biomechanically compatible,minimally invasive technique for recurrence free groin hernia repair

Conditions: Inguinal Hernia

Summary: "a bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia repair by implantation of tensiflex mesh prosthesis for the enhancement of the tissue tensile strength of the fascia transversalis."

hernia recurrences post-repair remain a confounding problem. the prospective study described herein tested cooper's paradigm, which holds that abdominal pressure exceeding abdominal wall resistance causes hernia, by incorporating the tensiflex mesh prosthesis which is a modified version of mesh prosthesis of stoppa technique in the surgical treatment of patients with hernia. the study was 2-phased: the first phase involved the pre-peritoneal implantation of a bi-layered mesh for anatomical replacement of the damaged fascia. the second phase involved the implantation of the bi-layered tensiflex mesh prosthesis for definitive and seamless augmentation of tensile strength in the myopectineal orifice of fruchaud. eighty-three percent of our patients consumed analgesics for 3 days (3% reported no pain on day 3); however, by day 5, 86% reported pain intensity scores lower than 5. the median number of lost workdays was 7. most importantly, the primary endpoint of 100% recurrence-free outcomes was met, as were the secondary endpoints (minimal pain, morbidity, and loss of workdays).

Eligibility criteria:
inclusion criteria: * all patients with confirmed groin hernia of both sexes. exclusion criteria: * none

Keywords: tensile strength augmentation.