Kornimate/medical-research-clean huggingface dataset:
comparison of two resuscitative thoracotomy techniques

Conditions: Emergencies; Trauma; Procedural Training; Thoracotomy

Summary: resuscitative thoracotomy (rt) is a life saving procedure for patients who have suffered cardiac arrest or are at significant risk of cardiac arrest following significant trauma. the procedure is ideally performed by a surgeon, but in some circumstance must be performed by non-surgical specialists such as emergency medicine physicians. the purpose of this study was to evaluate the optimal rt technique taught to non-surgical specialists in an educational human cadaver lab. the objective was to compare time to successful completion of two different rt techniques; (1) left anterolateral thoracotomy (lat) and (2) modified clamshell thoracotomy (mct). the investigators hypothesized that the non-surgical specialist time to successful completion for the mct would be shorter than for the lat.

the investigators conducted a randomized crossover trial of two resuscitative thoracotomy techniques performed by emergency medicine (em) physicians using a fresh human cadaver model. the purpose was to identify the ideal technique to be taught to non-surgical specialists in a training lab setting. the two techniques compared were the left anterolateral thoracotomy (lat), commonly taught to em physicians in the united states, and the modified clamshell thoracotomy (mct) taught by london's air ambulance. the investigators hypothesized that the non-surgical specialists time to successful completion of the rt would be faster when performing the mct compared to the lat. the investigators conducted this study at a large level 1 trauma center with an emergency medicine residency program and recruited emergency medicine residents and staff physicians to participate. participants were trained on the mct as performed by laa and reviewed the lat technique in a standardized fashion. participants were then randomized to order of intervention, and conducted each procedure on a separate fresh human cadaver. participants were evaluated on time to successful completion of the procedure, successful completion of procedural steps, and identification of anatomy. cadaver specimens were examined for iatrogenic injuries. participants then completed a standardized survey regarding each procedure.

Eligibility criteria:
inclusion criteria: * licensed physician * emergency medicine residency trainee or graduate * privileged provider at sammc exclusion criteria: - unwilling to participate
toxicity/benefit ratio optimization of chemotherapy in colorectal cancer (crc) patients by determination of individual genotypic determinants

Conditions: Metastatic Colorectal Cancer

Summary: this study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (ts) and udp-glucuronosyltransferase 1 (ugt1a1) polymorphisms before the first administration. the results of this identification determine the chemotherapy type: high-dose irinotecan or not.


Eligibility criteria:
inclusion criteria: * has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice * ages between 18 and 85 years * histologically confirmed colorectal cancer * no treatment for metastatic disease * no irinotecan previously administered * world health organization (who) performance status \< 3 * laboratory values : * neutrophils \> 1.5 x 10\^9/l; * platelet count \> 100 x 10\^9/l; * serum creatinine \< 130µmol/l; * serum bilirubin \< 2 x upper limit of normal (uln); * asat and alat \< 2.5 x uln; * alkaline phosphatase \< 5 x uln. * at least one measurable lesion by response evaluation criteria in solid tumors (recist) criteria exclusion criteria: * history of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder. * other concomitant anticancer therapy. * pregnant or lactating women. * women of childbearing potential unless using a reliable and appropriate contraceptive method. * symptomatic cerebral or leptospiral metastasis. * intestinal obstruction. * uncontrolled seizures (diabetes, severe infection). * clinically significant cardiac disease. * central nervous system disorders or severe psychiatric disability. * participation in any investigational study within 4 weeks.

Keywords: genotypic profile metastatic colorectal cancer
the optimization of haploidentical hematopoietic stem cell transplantation

Conditions: Hematological Malignancy

Summary: the goal of this observational study is to compare the incidence of relapse in g-csf/atg based and pt-cy based haploidentical transplantation\] in \[patients aged 18 to 55 years with a diagnosis of hematological malignancies who unmanipulated haplo-hsct with myeloablative conditioning\]. the main question it aims to answer are: primary objective: to compare the incidence of relapse in g-csf/atg based and pt-cy based haploidentical transplantation and illustrate the possible immune mechanism. secondary objectives: to compare cmv infection, gvhd and survival outcomes, and to observe the dynamic immune reconstitution of g-csf/atg based or pt-cy based model. exploratory objectives: to compare the long-term quality of life among recipients who receive g-csf/atg based or pt-cy based protocol.


Eligibility criteria:
inclusion criteria: 1. subjects diagnosed as acute leukemia with transplant indications in ≤ cr2; 2. lack of available, hla-identical, related sibling or unrelated donor; 3. female or male, age: 18-55 years old; 4. ecog performance status 0-2; 5. adequate organ function as defined by the following criteria: serum aspartate transaminase (ast) and serum alanine transaminase (alt) ≤2.5× upper limit of normal (uln), or ast and alt ≤5× uln if liver function abnormalities are due to underlying malignancy total serum bilirubin≤1.5× uln serum creatinine≤2.5× uln 6. signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment; 7. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. exclusion criteria: 1. uncontrollable active infection; 2. severe organic impairment: hepatic and renal impairment; 3. any of the following within 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, or cerebrovascular accident including transient ischemic attack; 4. pregnancy or breastfeeding; 5. psychiatric disorders; 6. don't sign the informed consent; 7. prior/concurrent clinical study experience; 8. other conditions: * participant not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures * participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ich-gcp ordinance e6) * any specific situation during study implementation/course that may rise ethics considerations * sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.

Keywords: haploidentical transplantation g-csf/atg pt-cy
mdashna-cc app to support a healthy diet and hypertension control for chinese canadian seniors

Conditions: Hypertension; Diet, Healthy

Summary: the aim of this proposed study is to translate the dietary approach to stop hypertension with sodium (na) reduction for chinese canadian (dashna-cc), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mdashna-cc) to enable chinese canadian seniors' access to this antihypertensive dietary intervention anytime, regardless of where they are.


Eligibility criteria:
inclusion criteria: * have a systolic blood pressure higher than 140 mmhg, or a diastolic blood pressure higher than 90mmhg, or are on antihypertensive medications, based on pre-intervention baseline assessment * are able to understand (listen) and speak in mandarin or cantonese, read and write in chinese * have access to a smartphone exclusion criteria: * have special dietary requirements * are a household member of another mdashna-cc participant * plan to leave the area prior to the anticipated end of study
"mantou" screening for gdm before 20 weeks of gestation

Conditions: GDM

Summary: gestational diabetes mellitus (gdm) can occur in overweight, hyperinsulinemia, insulin resistance pregnant women, or lean, insulin deficiency pregnant women. at least 5% of all pregnant women will develop gdm, which is even higher among asians. poor control of gdm in late pregnancy will increase the following risks: macrosomia, preeclampsia, shoulder dystocia, cesarean section, stillbirth and other risks. at present, the screening method for gdm is 75g of glucose ogtt test. however, when drinking sugared water on an empty stomach, the pregnant women will feel nausea, stomach burning, and hunger when waiting for blood drawing. some women vomit after drinking sugared water, resulting in inaccurate test results and poor compliance, affecting the accuracy of diagnosis of gdm. "sugar tolerance mantou" has been used for screening diabetes since 1982. it is made of 100g flour and contains 75g glucose of the same amount. it is a feasible method to use mantou instead of sugar powder to screen gdm. mantou is an acceptable diet for chinese people, which greatly reduces nausea, vomiting, hunger and other discomfort, and increases gdm screening rate. at present, the cesarean section rate in china remains high, and the weight and nutritional management of pregnant women are not satisfied. many pregnant women, especially those in country-level areas, have already gained excessive weight when referred from to delivery hospitals, leading to an increase in pregnancy complications such as preeclampsia and macrosomia, increasing the cesarean section rate and delivery risk. therefore, it is necessary to screen gdm in advance. moving forward the screening of gdm and strengthening the management of pregnant women's weight can effectively reduce the occurrence of pregnancy complications.


Eligibility criteria:
inclusion criteria:singleton , before 20 weeks of gestation, aged 18-40 years old, able to understand the experimental requirements, willing and able to follow the experimental and follow-up procedures. exclusion criteria: diabetes diagnosed before pregnancy, serious heart disease, blood disease, immune system disease and other unsuitable for pregnancy, twin or multiple pregnancy, age\ 40, fetal death in utero before 28 weeks, serious mental illness, and inability to communicate.
combined supraclavicular block and general anesthesia in pediatric patients with chronic kidney disease

Conditions: Post Operative Pain

Summary: * compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis. * compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.

established renal disease is a signiﬁcant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1). anesthetic management of pediatric patients is uniquely challenging. a large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. regional anesthesia is valuable for postoperative pain control (2). postoperative analgesia is dictated by the extent and nature of the surgery. regional block should be utilized where possible for its opioid-sparing effects. where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. non-steroidal anti-inﬂammatory drugs are always avoided due to their deleterious effects on urine output (3). pediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. it provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. upper extremity brachial plexus blocks in children various approaches to brachial plexus are available. the choice of the block is made depending on the indications. the supra-clavicular approach covers all the surgeries of the humerus and below (4). the use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.

Eligibility criteria:
inclusion criteria: * pediatric patients of less than 18 years old. * with chronic kidney disease. * undergoing upper limb superficialization of arteriovenous fistula for haemodialysis. exclusion criteria: * patient known to have allergy to the studied drugs. * patients with contraindications to regional anesthesia.
evaluation of an interdisciplinary decision guide for infant feeding assessment

Conditions: Premature Birth; Feeding and Eating Disorders of Childhood

Summary: preterm infants are at risk for feeding problems which can persist through early childhood. these feeding problems may include oral motor, sensory, digestive, nutritional, respiratory, and/or behavioral components. in north carolina's early intervention program, speech pathologists or occupational therapists are responsible for completing feeding evaluations, and may not know when to refer infants out to medical specialists to address these other domains. this study will test a decision support tool in hypothetical feeding evaluation scenarios. the hypothetical scenarios will consist of real feeding videos of preterm infants who recently participated in a multidisciplinary feeding evaluation. parent-reported outcomes of the infant's real evaluation will be compared to those of the speech pathologists and occupational therapists in our study who do, and do not, use the decision support tool. the investigators hypothesize that therapists with the tool will make recommendations that are closer to those of the multidisciplinary team, and that they will find the tool useful and easy to use. due to recruitment limitations with families, the study was adapted in october, 2021 prior to enrollment of subjects to use case studies, rather than infant videos, as the hypothetical situation from which to test the tool. therapists will then answer clinical questions without using the tool when viewing the first case study, and will use the tool to answer questions when viewing the second case study. order of case study presentation will be randomized among participants.


Eligibility criteria:
inclusion criteria: * at least 18 years of age, * speech language pathologist or occupational therapist, * at least 2 years of experience evaluating and treating pediatric feeding, * have worked in early intervention in last 5 years, * english proficiency, * currently reside in north carolina exclusion criteria: * \<2 years of experience in pediatric feeding, * have not worked in early intervention in last 5 years, * younger than 18 years old

Keywords: early intervention pediatric feeding assessment
a pilot study to evaluate a telepharmacy intervention to improve inhaler adherence in veterans with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: hypothesis: can a counseling intervention, delivered by a pharmacist, increase inhaler adherence in veterans with copd who have demonstrated poor inhaler adherence through pharmacy refill records? veterans who receive who receive daily maintenance inhalers from the william s middleton memorial veterans hospital pharmacy and who have a medication possession ratio less than 80% over the previous six months will be invited to participate in the study. this study will randomize 100 participants to a usual care arm or a pharmacist counseling intervention. final data collection will be six months after randomization to determine if both self-reported and refill record adherence has changed.


Eligibility criteria:
inclusion criteria: * male and female veterans established with the william s. middleton memorial veterans hospital and associated community based outpatient clinics * fill their inhaled copd medications with the vha * a diagnosis of copd and an active prescription for a twice daily long-acting beta-agonist and/or long-acting anticholinergic with or without a prescription for inhaled corticosteroids for at least 4 months. * non-adherence to at least one copd medication, a medication possession ratio of less than 80% or over 120% via the pharmacy refill records. exclusion criteria: * patients with a diagnosis or electronic medical record note regarding significant hearing impairment. * patients with a diagnosis regarding cognitive deficit and activated power of attorney. * patients who use daily nebulization instead of inhalers for maintenance medication.
evaluation of mk-1075 in participants with hepatitis c virus (hcv) infection (mk-1075-002)

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the safety and pharmacokinetics of mk-1075, and to determine the ability of mk-1075 to reduce hcv viral load, following administration of a single dose in hcv-infected participants.

per protocol, panels may be omitted if the objectives of the study are met in preceding panels.

Eligibility criteria:
inclusion criteria: * male or female of non-child bearing potential * in good health other than hcv genotype (gt) 1 infection exclusion criteria: * is mentally incapacitated or legally institutionalized * has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting hcv infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases * has a history of cancer * is positive for hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv) * has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to screening * consumes \>2 alcoholic beverages a day or uses illegal drugs * has evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, or autoimmune hepatitis * has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
locoregional control with radiotherapy of breast cancer patients with macrometastases treated with mastectomy (macma)

Conditions: Breast Cancer

Summary: sentinel lymph node biopsy (slnb) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (ibc) patients undergoing upfront surgery. the acosog-z0011 and the amaros trial demonstrated that slnb with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (alnd) in early-stage breast cancer patients with 1 or 2 positive slns. however, the acosog-z0011 trial did not included patients treated with mastectomy, and the amaros trial only included 17% of mastectomy patients. the investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after slnb. the study aim to demonstrate a 5-year disease-free survival of not less than 80% when alnd is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.

this is a multi-center, prospective study with an estimated sample size of 60 early-stage ibc patients. clinically node-negative t1-2 ibc patients undergoing mastectomy with up to 2 macrometases after slnb will be informed about this study. patients will be checked with annual mammography and clinical examination. the axilla will be checked with ultrasound at 3 and 5 years of the surgery. after surgery, patients will receive axillary radiotherapy, but no alnd, and adjuvant systemic treatment based on international guidelines.

Eligibility criteria:
inclusion criteria: * patients with t1-2 primary invasive breast cancer * no suspicion of lymph node involvement prior to sentinel lymph node biopsy * patients undergoing upfront mastectomy * macrometastasis in not more than 2 lymph nodes at sentinel lymph node biopsy * patients treated with adjuvant axillary radiotherapy exclusion criteria: * prior history of invasive breast cancer * medical contraindication for radiotherapy * medical contraindication for adjuvant systemic treatment * planned neoadjuvant systemic treatment * distant metastasis at initial diagnosis * inability to absorb or understand the meaning of the study information

Keywords: axillary radiotherapy mastectomy sentinel lymph node biopsy