Kornimate/medical-research-clean huggingface dataset:
improving emergency preparedness among 9/11 exposed population: implementation and evaluation of an emergency preparedness intervention

Conditions: Emergency Preparedness

Summary: a two-arm parallel randomized controlled trial will be conducted to compare the effectiveness of a phone-based household emergency preparedness intervention with a mailed informational brochure on household emergency preparedness amongst a sample of world trade center health registry enrollees residing within new york city.

an intervention to enhance household emergency preparedness was developed to include the following topics: (1) an introduction to why emergency preparedness is important; (2) definition of what a disaster is; (3) family communication and evacuation plan (including, what is a family communication plan, why you should have one, communication plan checklist, family communication card); (4) disaster supplies (including, what types of supplies are needed, how long supplies should last, supply checklist; assembling a go bag , and storing supplies); and (5) the brochure included several resources, including disaster contact numbers for emergency and non-emergency calls: 911 or 311,, nyc emergency management, as well as website for additional information of preparedness: nyc.gov/hazards, which includes information specific to new york city hurricane evacuation zones. the phone-based intervention consisted of a 15 - 20 minutes talk session completed over the phone following the format and topics noted above. the informational brochure intervention followed the format and topic above and was mailed to participants during the intervention period.

Eligibility criteria:
inclusion criteria: 1. english or spanish speaking world trade center health registry enrollees aged 18 or older at the time of 9/11 residing in new york city. 2. completed wave 4 (2015-2016) 3. those who are not rescue/recovery workers in either the nypd or fdny. - exclusion criteria: 1. world trade center health registry enrollees under the age of 18 at the time of 9/11 2. those with proxy interview at wave 1 3. enrollee was a rescue and recovery work affiliated with fdny or nypd at wave 1 -
ds-8201a in human epidermal growth factor receptor 2 (her2)-expressing or -mutated non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in her2-overexpressing and/or her2-mutated advanced nsclc participants.


Eligibility criteria:
inclusion criteria: * age ≥20 years old in japan, ≥18 years old in other countries * pathologically documented unresectable and/or metastatic non-squamous nsclc * has relapsed from or is refractory to standard treatment or for which no standard treatment is available * for cohort 1 and cohort 1a: her2-overexpression (ihc 2+ or 3+) status must be assessed and confirmed by clinical laboratory improvement amendments (clia)-certified laboratory or equivalent, from an archival tumor tissue sample * for cohort 2 only: participant has any known documented activating her2 mutation from an archival tumor tissue sample analyzed by clia laboratory or equivalent. note: her2 mutation documented only from a liquid biopsy sample cannot be used for enrollment. * presence of at least 1 measurable lesion assessed by the investigator and based on response evaluation criteria in solid tumors (recist) version 1.1 * is willing and able to provide an adequate archival tumor tissue sample * is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen * has eastern cooperative oncology group performance status (ecog ps) of 0 to 1 exclusion criteria: * had been previously treated with her2-targeted therapies, except for pan-her class tyrosine kinase inhibitors * for cohort 1 and cohort 1a: has known her2 mutation * has a medical history of myocardial infarction, symptomatic congestive heart failure (chf) (nyha classes ii-iv), unstable angina or serious cardiac arrhythmia * has a history of (non-infectious) interstitial lung disease (ild)/pneumonitis that required steroids, or current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out due to imaging at screening * has a qt interval corrected by fridericia's formula (qtcf) prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females * has a medical history of clinically significant lung disease * is suspected to have certain other protocol-defined diseases based on imaging at screening period * has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise: 1. safety or well-being of the participant or offspring 2. safety of study staff 3. analysis of results

Keywords: her2 over-expression her2 mutation unresectable or metastatic non-squamous nsclc
daance for chemotherapy-induced neuropathy

Conditions: Cancer of the Breast; Chemotherapy-induced Neuropathy

Summary: up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. the successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - adapted argentine tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.

this study will investigate a noninvasive, social, sensorimotor intervention which targets motor control restoration, symptom alleviation, and treatment participation in concert: partnered adapted argentine tango (tango). this project will expand the investigators' pilot work (r21-ag068831) into a multicenter clinical trial designed to investigate the effect of social dance on sensory relief, functional restoration, and key mechanisms of action among a diverse cohort of bc survivors suffering from chronic chemotherapy-induced sensorimotor deficits.

Eligibility criteria:
inclusion criteria: * breast cancer (bc) diagnosis of stage i-iv including metastatic disease * completed taxane-based chemotherapy for bc at least 3 months ago (no limit on how long ago) * symptomatic for chemotherapy-induced neuropathy (self-report) * postural control score that indicates potential fall-risk * able to understand and comply with directions associated with testing and study treatments exclusion criteria: * pre-existing vestibular dysfunction * poorly controlled diabetes (hga1c\>=8) * non-ambulatory (assistive and prosthetic devices allowed) * hearing impairment resulting in less than 10% hearing bilaterally * contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases) * currently in activity-based therapy (e.g., physical therapy, occupational therapy). may enroll if still meet eligibility criteria once activity-based therapy is complete.

Keywords: survivorship music dance
a study of mabthera (rituximab) in patients with rheumatoid arthritis and an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: in this open-label single arm study the safety and efficacy of mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. patients will receive mabthera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). after the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with mabthera. the anticipated time on study treatment is 1-2 years and target sample size is \<50


Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age * rheumatoid arthritis das28 \>/= 3.2 * receiving treatment on an outpatient basis * experienced an inadequate response to previous or current treatment with methotrexate exclusion criteria: * rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra * history of or current inflammatory joint disease other than ra * previous treatment with any cell-depleting therapies
intracranial stimulation mapping in epilepsy

Conditions: Epilepsy

Summary: this is a single group prospective study to determine the feasibility for generating brain maps that localize cerebral functions and inter-regional information flow in partial epilepsy in adult patients.


Eligibility criteria:
inclusion criteria: * male or female 18 years and older at screening. * written informed consent is obtained from the participant to comply with the requirements of the study. * stated willingness to comply with all study procedures and availability for the duration of the study * currently undergoing clinically indicated intracranial eeg monitoring for planning of epilepsy surgery in the university of minnesota/mincep program. exclusion criteria: * pregnancy ruled out prior to approval for intracranial eg monitoring. * persons who are rendered temporarily or permanently invulnerable by inability to understand the research due to study complexity, cognitive impairment, or by inability to make independent decisions owing to university of minnesota or to fairview health services.
acute effects of inspiratory muscle exercise on glucose level and glucose variability in patients with type 2 diabetes.

Conditions: Diabetes Mellitus, Type 2

Summary: type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. the exercise of inspiratory muscles has been investigating in various clinical situations and may cause similar benefits as the conventional exercises. the assessment of glucose variability has been used as an alternative tool to evaluate the others mechanisms than the absolute values of glucose levels, special during the exercise. however, the effect of inspiratory muscle exercise on glucose levels and glucose variability is not clear yet. the aim of the proposed research is to evaluate the acute effects of inspiratory muscle exercise using a high load of 60% of mip on glucose levels and glucose variability in patients with type 2 diabetes.

high-intensity exercise of inspiratory muscle was able to reduce glucose levels in previous studies, but the mechanisms underlying this reduction remain largely unknown. the present study will investigate this phenomenon, and whether confirmed, the inspiratory muscle loading would be a new approach for lowering glucose levels and glucose variability in type 2 diabetes. the subjects with type 2 diabetes will be recruited from the ambulatory of the hospital de clinicas de porto alegre. the patients will be randomized to inspiratory muscle exercise with a high intensity load (mip 60%) or to exercise with a load placebo (mip 2%), on two different days. the subjects will come in the laboratory for three days consecutively during 2 weeks. on the first day will be placed the cgms device. on the second day will be the controlled ventilation protocol with subsequently inspiratory muscle exercise, using 2% or 60% of mip as randomized a priori. on the third day the cgms will be removed. individuals who are using beta-blockers will be advised to withdraw the medication 24 hours before the protocols. during all protocols will be recorded the continuous blood pressure to assess heart rate and blood pressure variabilities, both time and frequency domains will be analyzed. also, the calf blood flow, inspiratory pressure, end-tidal carbon dioxide and oxygen saturation will be taking.

Eligibility criteria:
inclusion criteria: * type 2 diabetes; * hba1c from 7,5 to 10%; exclusion criteria: * subjects taking insulin; * pregnant women; * subjects taking betablocker only * documented arrythmia * documented fibrillation * gfr\<30 * documented pulmonary disease or asthma, * current smoking; * varicose vein problems; * musculoskeletal disease.
a study of persons with gout who do not respond to or are allergic to conventional therapy

Conditions: Gout

Summary: this is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of puricase, administered intravenously, in 40 patients with symptomatic gout. subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.


Eligibility criteria:
inclusion criteria: subjects to be included in the study are: * outpatients of either gender, age 18 or older * diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis) * hyperuricemic: screening serum uric acid must be \>=8 mg/dl. * the patient must be willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed) * women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. such methods include oral, injectable, or implantable contraceptives; iuds and barrier contraceptives in combination with spermicide exclusion criteria: subjects to be excluded are those for whom any of the following apply: * unstable coronary artery disease or uncontrolled hypertension * history of end stage renal disease requiring dialysis * history of liver disease, as defined by baseline serum transaminase elevation \>3x the upper limit of normal in the absence of any other known cause * organ transplant recipient requiring immunosuppressive therapy * concurrent use of prednisone at a dose \>10 mg qd (or equivalent) at or within one week before dosing * concurrent use of uric acid-lowering agents * prior treatment with puricase® or other recombinant uricase * an acute gout flare within one week prior to first treatment with puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol * glucose-6-phosphate dehydrogenase deficiency * a history of anaphylactic reaction to a recombinant protein or porcine derivatives * lactation * has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study * known allergy to urate oxidase or pegylated products * has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements

Keywords: elevated uric acid elevated serum uric acid level symptomatic gout
a comparison of fecal microbiota transplantation and steroid therapy in patients with severe alcoholic hepatitis.

Conditions: Severe Alcoholic Hepatitis

Summary: study population: patients attending the out patient department and admitted to institute of liver and biliary sciences. study design: prospective randomized controlled trial study period: one year- january 2017- december 2018 sample size: 130 (65 cases in each group) intervention: the subjects will be given fecal microbiota transplantation through a nj tube placed after admission to the hospital. participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days. monitoring and assessment: the recipient will be monitored every day after fecal microbiota transplantation therapy. the recipient will undergo physical examination, complete blood counts, at baseline and a chest x ray, serum procalcitonin, crp and tumor necrosis factor alpha levels, liver function tests, kidney function tests, international normalized ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy. microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 \& 180.


Eligibility criteria:
inclusion criteria: * patients with severe alcoholic hepatitis . * eligible for steroid therapy. exclusion criteria: * upper gastrointestinal bleed within the past one month. * active sepsis * serum creatinine \> 1.5 mg/dl (hepato renal syndrome) * intestinal paralysis * hepatic or extrahepatic malignancy * disseminated intravascular coagulation * discriminant function (df) \>90
transvaginal notes nephrectomy versus conventional laparoscopic nephrectomy

Conditions: Renal Disease

Summary: recent reports have suggested that transvaginal notes nephrectomy is feasible, yet comparative studies are lacking. the aim of this study was to compare the surgical outcomes of transvaginal notes nephrectomy to conventional laparoscopic nephrectomy.


Eligibility criteria:
inclusion criteria: * female sex, * indication for nephrectomy due to benign or malignant kidney disease, * age between 18 and 65 years, and * legal competence exclusion criteria: * emergency surgery, * contraindications to laparoscopic surgery, * class iv or v as defined by the american society for anesthesiologists (asa), * body mass index (bmi) of \> 30 kg/m2, * advanced tnm staging (≥ t3), * history of major abdominal surgery, * gravidity or breast-feeding, and * no written informed consent signed
speech therapy for aphasia: comparing two treatments

Conditions: Stroke

Summary: this is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. the name of this disorder is called "aphasia." individuals in this study will receive one of two treatments. the first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

purpose: the ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session as well as generalization to untrained exemplars and contexts. phonomotor treatment (pmt) has shown such effects but has not yet been compared to a commonly used lexical/semantic based treatment (semantic feature analysis; sfa). methods: in a between group randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56-60 hours of intensively delivered treatment over 6 weeks with testing pre-, post- and three-months post treatment termination.

Eligibility criteria:
inclusion criteria: * single, left-hemisphere stroke * english as primary language prior to stroke exclusion criteria: * other neurological disorders * untreated depression

Keywords: aphasia anomia
efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery

Conditions: Anesthesia; Hip Fracture Surgery; Nursing

Summary: this study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. this is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.

to evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new "guidelines"; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. the central stochastic system was adopted to determined the stratification factors by age, possum score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. therefore, there are two groups including the new version of "guidelines" anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. the mortality is the primary indicator will be collected in 1,6,12 months after surgery. and vas score, mmse, length of hospital stay and so forth, which would be collected as the secondary indicators.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 75 years old; 2. patients with hip fracture purely and surgical treatment is scheduled. exclusion criteria: 1. surgical treatment has been performed after entering hospital; 2. multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc. 3. refuse to sign informed consent; 4. investigator thinks he/she is inappropriate to carry out this study.

Keywords: anesthesia hip fracture
spirit ii: a clinical evaluation of the xience v® everolimus eluting coronary stent system

Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Summary: prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing xience v® everolimus eluting coronary stent system to the approved commercially available active control taxus™ express2™ paclitaxel eluting coronary stent system. taxus™ express2™ paclitaxel eluting coronary stent system is manufactured by boston scientific.

the spirit ii trial was a randomized, single blind, active control, multi-center clinical evaluation. subject eligibility criteria were similar to spirit iii and enrollment duration overlapped between studies. in this study, 300 subjects (3:1 randomization xience v® eecss: taxus™ pecss were enrolled at 31 sites outside the united states. the primary endpoint was in-stent late loss at 6 months. secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and ivus results at 6 months and 2 years. follow-up through 3 years is currently available.

Eligibility criteria:
inclusion criteria: * de novo target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate * the target lesion(s) must be in a major artery or branch with a visually estimated stenosis of \>= 50% and \ = 1 * non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done \>= 90 days prior to the index procedure or if planned to be done \> 9 months after the index procedure exclusion criteria: * de novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) \< 9 months prior to index procedure * target lesion(s) restenotic from previous intervention * target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy * target vessel(s) contains visible thrombus * patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy) * patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

Keywords: drug eluting stents stents angioplasty coronary artery disease total coronary occlusion coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis