Kornimate/medical-research-clean huggingface dataset:
blood transfusion by boston medflight registry

Conditions: Hemorrhagic Shock

Summary: the primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by boston medflight receiving blood products during transport.

boston medflight, a critical care transport organization, based on a consortium of the academic medical centers in boston, will begin carrying prbc in 2019. the program is intended to provide bmf clinicians with 24-hour immediate access to appropriate blood products to be utilized if needed for patients following life-threatening illness or injury. the four fundamental goals of this program are: save lives' ensure transfusion safety; minimize blood product waste; and conduct continuous quality assurance. our goal is to observationally evaluate this new protocol of administering blood products in the pre-hospital setting. we will collect data on patients with hemorrhagic shock being transported by boston medflight, who receive or would have been eligible to receive pre-hospital blood transfusion by the inclusion criteria.

Eligibility criteria:
inclusion criteria: * adult patients who would be eligible to receive blood products; * systolic blood pressure \<90 mmhg * a shock index of \> 0.9 * clinical signs of shock as determined by the transport clinicians. exclusion criteria: * age \< 18 years old

Keywords: blood transfusion pre-hospital care
role of the foregut in nutrient metabolism in lean and obese humans

Conditions: Obesity

Summary: the overall hypothesis of this proposal is that nutrient sensing in the foregut regulates metabolic hormone secretion and nutrient metabolism via enteric neural signals, and these mechanisms might be defective in obesity.

the study proposes two specific aims aim 1 will determine if blocking enteric neuronal signaling will alter: a) circulating levels of nutrient substrates and secretion of hormones that regulate nutrient metabolism; and b) glucose and fatty acid absorption, production, and utilization. obese (bmi = 30-50 kg/m2) subjects will be studied. the topical anesthetic benzocaine will be infused into the duodenum prior to infusion of glucose and oleic acid into the duodenum. duodenal infusions with a naso-intestinal feeding tube will circumvent the confounding effects of gastric emptying on the metabolic responses to a meal. substrates (glucose, free fatty acids), and lipoproteins) and hormones will be measured by standard biochemical and immunological methods. aim 2 will determine if enteric neural signals regulate appetite. the studies will be carried out in both lean and obese humans and the procedure will be performed as described above. in addition, the subjects will be asked to use a visual analog scale to estimate their level of appetite before, during and after enteral infusions.

Eligibility criteria:
inclusion criteria: * bmi 19 - 25 kg/m2 or 30 - 50 kg/m2 * age 20 - 50 years exclusion criteria: * contraindication to a nasoduodenal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) * prior gastric or intestinal surgery or pancreas resection * females with a positive pregnancy test * known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. ulcerative colitis, crohn's disease), celiac sprue * type 1 or type 2 diabetes * recent presence of or treatment for gastroenteritis (diarrhea and/or vomiting), constipation, or upper respiratory infection * anemia * abnormal electrocardiogram * prior adverse reaction to anesthesia * tobacco use

Keywords: normal body weight
combining registry data in haemophilia: target h

Conditions: Haemophilia

Summary: this is an investigator-initiated, multinational, retrospective, non-interventional pilot study conducted in five haemophilia treatment centres from different geographical regions that maintain a local (algeria, malaysia) or national (india, iran, south africa) haemophilia registry. data from a randomly selected sample of patients from national or local registries are anonymously collated and analysed.the aims are to determine the feasibility of combining data from national and local registries in countries with developing healthcare systems and to assess how existing registries implemented current recommendations for data collection in terms of available fields and their completion.

the study is conducted in five haemophilia treatment centres (htcs) from different geographical regions (algeria, india, iran, malaysia and south africa) that maintain a local or national haemophilia registry. data will be collected from 20 randomly selected, active patient records from each participating registry/country. in countries with national registries, data from local registries will not be permitted for inclusion to allow adequate assessment of the possibility of registry harmonisation across various regions. participating centres will report data as available in the data source without seeking additional information to fill source data gaps at the time of data collection. in addition, each investigator will complete a basic questionnaire on feasibility parameters to confirm the source and accuracy of the data, as well as challenges experienced during data collection. analysed parameters will be grouped into three categories: sociodemographic, disease, and treatment and disease outcome parameters. feasibility assessment will be performed for all study variables and the percentage availability of each study variable recorded in the participating registries wii be determined, as well as the proportion of missing data for existing variables.

Eligibility criteria:
inclusion criteria: * male * diagnosis of haemophilia a or b * with or without inhibitors * no other inherited bleeding disorder * active patient record * willing and able to provide written consent exclusion criteria: - unwilling or unable to provide written consent
periodontal inflammation and wound healing in multiple extractions

Conditions: Wound Heal

Summary: four participants requiring multiple dental extractions will be recruited for this study. two participants will be 21-50 years old, two participants will be 65-80 years old. following tooth extractions, soft tissue sampling will be completed from the extraction sockets at baseline, one week, two weeks and three weeks post-extraction. soft tissue will be processed for sc-rna sequencing and/or flow cytometry to determine what cells, genomic pathways are present at various timepoints during wound healing following dental extractions.

the purpose of this study is to better understand the cellular and immunological events occurring at various time points following dental tooth extractions as it relates to age of participants. four participants requiring multiple extractions prior to denture fabrication will be enrolled: two will be younger than 50 years old, two will be older than 65. inclusion criteria include: participants seeking multiple tooth extractions due to advanced bone loss or non-restorable teeth. prior to tooth extraction, baseline clinical and radiographic data will be collected; including participant's height and weight, gingival crevicular fluid sampling (gcf), hba1c reading, saliva sampling peripheral blood draw and smoking status. routine, atraumatic extraction of the teeth under local anesthetic will be performed. following extraction, a 3 mm x 3 mm soft tissue sample will be collected from one of the extraction sites and frozen/processed for sc-rna sequencing and/or flow cytometry; the extraction sites will be sutured closed. the participants will return to clinic in one week's time for suture removal and soft tissue sampling of an adjacent previously unsampled extraction site under local anesthetic. the participants will return to clinic in another week's time (two weeks post-extraction) for a third soft tissue sample under local anesthetic from a previously unsampled extraction site. all soft tissue samples will be processed for scrna sequencing and or flow cytometry. at all soft tissue sampling appointments, wound fluid will be collected from the extraction sites and processed for biomarkers via multiplex. saliva samples will be frozen at time of sampling and will be frozen for multiplex evaluation. the single blood draw will be processes via sc-rna sequencing and/or flow cytometry to assess presence of systemic immune cells. final evaluation will be 3 months post-extraction and will include clinical (pd, bop, cal) and radiographic (cbct) data collection. statistical analyses will be completed to determine associations between various time points in the wound healing process and variables of interest (age, gender, etc), clinical measures, including body mass index (bmi) and outcomes (endotypes, measures of healing).

Eligibility criteria:
inclusion criteria: * requires multiple dental extractions * aged 21-50, 65-80 years old exclusion criteria: * history of systemic inflammatory diseases or medications
a study to understand the use of palbociclib in canadian patients with breast cancer that has spread to other organs

Conditions: Breast Cancer

Summary: the purpose of this real-world study is to understand the use of palbociclib as first treatment for hormone receptor positive (hr+) and human epidermal growth factor receptor 2 negative (her2-) metastatic breast cancer in canada (palcan). the real-world study is not a research study. it involves real patients who receive medicines prescribed by their doctors in the real world. metastatic breast cancer is the type which has spread from breast to other organs. hr positive stands for hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. they are estrogen or progesterone. both these hormones help cancer cells grow. her2 negative describes cells that have a small amount or none of a protein called her2 on their surface. in normal cells, her2 helps control cell growth. cancer cells that are her2 negative may grow more slowly and are less likely to come back or spread to other parts of the body. this study will mainly measure: - duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (ibrance) in combination with hormone therapy as first line treatment for hr+ her2- metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * received at least one cycle of palbociclib as first line therapy for metastatic breast cancer between 01 january 2016 and 31 december 2022 * histologically confirmed hr+/her2- metastatic breast cancer * minimum of 3 months available follow-up on palbociclib exclusion criteria: * received a different cdk4/6 inhibitor before palbociclib in the first line * received other systemic therapy, including hormone therapy, 15-60 days prior to initiation of palbociclib * invalid or incomplete records (more specifically, complete duration of treatment on palbociclib, endocrine therapy or lhrh) * death date recorded on or before the date of index date

Keywords: metastatic breast cancer (mbc) human epidermal growth factor receptor 2 negative (her2-) hormone receptor positive (hr+) first line real world
exploring immune-related adverse events of immune checkpoint inhibitors using vigibase, the who pharmacovigilance database

Conditions: Cancer; Immune-related Adverse Event; Immune Checkpoint Inhibitor-Related Myocarditis

Summary: this is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in vigibase®, the who's international database. this study includes all reports identified as exposure to an ici and suspect of inducing adverse drug reaction. the aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.

over the past ten years, immuno-oncology (io) has gradually integrated the therapeutic arsenal of cancer treatment. ctla-4, program-death 1 (pd1) and its ligand (pd-l1) and lag3 were found to be major targets active in multiple tumor types. immune checkpoint inhibitors (ici) are antibodies blocking these targets and became a cornestone of cancer treatment. this is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in vigibase®, the who's international database. vigibase is managed by the uppsala monitoring centre (umc, uppsala, sweden) and contains about 30 million reports (as of jan 2023) submitted by national pharmacovigilance centers since 1967. the use of vigibase® for pharmacovigilance analyses is not dependent on institutional review board approval. it is conditioned on institutional access provided and approved by the uppsala monitoring centre. since spontaneous reporting systems are based on anonymity and the process only requires patient non-opposition, no informed consent was requested to use vigibase® in this study. this study includes all reports associated with an ici. the query is performed using the medical dictionary for regulatory activities (meddra), between january 1st 2008 (year of first report of ici in vigibase), and january 1st 2023. the analysis focused on reports suspected to be induced by an ici (as opposed to concurrent use).

Eligibility criteria:
inclusion criteria: * any report with an ici "suspect" or "interacting" with the reported adverse drug reaction. exclusion criteria: * ici not fda approved * no irae identified in report

Keywords: immune checkpoint inhibitors
renal protocol protection in ckd patients

Conditions: HCC; CKD

Summary: this study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low kev imaging in chronic kidney disease.


Eligibility criteria:
inclusion criteria: * high risk group for developing hcc * scheduled contrast-enhanced ct for hcc diagnosis or surveillance * chronic kidney disease (estimated gfr \< 60ml/min/1.73m2) exclusion criteria: * not a high risk group for developing hcc * congestive hepatopathy * on dialysis * no venous access on forearm * anticipated beam hardening artifact due to prosthesis * relative/absolute contra-indication of contrast-enhanced ct except ckd (estimated gfr \< 60ml/min/1.73m2)

Keywords: ct spectral
the association between obesity and early puberty

Conditions: Early Puberty

Summary: childhood obesity and early puberty are closely related, but existing reports usually focus on their relationship from the perspective of phenotype. this study was designed to investigate the association between obesity-related genic polymorphisms and the risk of early puberty in chinese han girls.

the genotypes of obesity-related snps were determined and the unstimulated luteinizing hormone, follicle stimulating hormone and estradiol levels were also detected.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of central precocious puberty or early and fast puberty. exclusion criteria: * the participants who were not the first visit to the hospital and had been treated before. * the participants who were with endocrine disorders.
pk study of pt003 and pt001 in japanese healthy subjects

Conditions: COPD

Summary: a randomized, double-blind, single-dose, four-period, four-treatment, cross-over, single-center, phase i, crossover study in healthy japanese adult subjects to evaluate the safety and pharmacokinetics of two doses of pt003 and two doses of pt001.


Eligibility criteria:
inclusion criteria: informed consent form (icf) prior to any study related procedures * male and female first generation japanese subjects 18 to 45 years, inclusive * good general health * medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential * clinical labs within normal ranges or determined to be not clinically significant by the investigator exclusion criteria: * pregnancy, nursing female subjects, or subjects trying to conceive * clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study * history of ecg abnormalities * cancer not in complete remission for at least 5 years * clinically significant, symptomatic prostatic hypertrophy * male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening * clinically significant bladder neck obstruction or urinary retention * inadequately treated glaucoma * history of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study * subjects with pre-existing anemia and/or iron deficiency

Keywords: japanese healthy volunteers
master ii - microvolt t wave alternans testing for risk stratification of post mi patients

Conditions: Myocardial Infarction; Arrhythmia, Ventricular; Ischemic Cardiomyopathy

Summary: the purpose of the study is to determine the usefulness of microvolt t wave alternans (mtwa) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. mtwa testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. the objective of the study is to prove that if a patient has a positive mtwa test, they will be more likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. the results of the study will help doctors to determine which patients would benefit the most from having an implantable cardioverter defibrillator (icd) implanted.


Eligibility criteria:
inclusion criteria: * patients with a history of heart attacks * lvef \>0.30 and \<= 0.40 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment. exclusion criteria: * patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (class i indications) * patients who have undergone an electrophysiologic study with ventricular stimulation or a mtwa test within 1 year prior to enrollment * patients with medical conditions that preclude the testing required by the investigational plan or limit study participation * patients unable to complete mtwa testing requirements due to current atrial fibrillation or flutter * patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for mtwa testing are not available * patients who have experienced an mi within 1 month prior to enrollment * patients with advanced cerebrovascular disease per physician's assessment * patients classified as nyha class iv at time of enrollment * patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment * patients with a life expectancy of less than 1 year

Keywords: myocardial infarction microvolt t wave alternans test implantable cardioverter defibrillator (icd) ventricular arrhythmia
the effect of botulinum toxin injection after hemorrhoidectomy in pain control.

Conditions: Pain; Haemorriodectomy; Anal Sphincterotomy

Summary: hemorrhoids are a common disease in the general population. its prevalence is estimated to be 5-36 % and more prevalent in western countries . half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the remainders become asymptomatic and improved with the conservative treatment. conservative treatment in the form of diet modification as well as some medical treatment, is usually effective. on the other hand, a few patients require surgical intervention. surgery is indicated for those not responding to conservative management, those with grade iii, and grade iv hemorrhoids. surgical treatment is the only curative method for hemorrhoidal disease and indicated for advanced and complicated disease. the most radical operations with the best results are the milligan-morgan and ferguson hemorrhoidectomy . however, the major concern of hemorrhoidectomy is the post-operative pain that occurs in 20-40 % of patients and it is considered the main cause of refusing surgery. the cause of postoperative pain is multifactorial, including the type of anesthesia , hemorrhoidectomy technique. and spasm of the internal anal sphincter (ias) that becomes exposed after hemorrhoidectomy. the spasm of the ias is considered the target to relieve pain post operatively. lateral internal sphincterotomy (lis) is widely used as an adjunct to relieve pain post hemorrhoidectomy as it release the spasm of the sphincter and subsequently relieve pain. however, this procedure is not accepted by many surgeons due to its recorded complications as bleeding and mild degree of fecal incontinence, so its role following hemorrhoidectomy is still controversial. on the other hand, the spasm of the anal sphincter can be abolished by injection of the botulinum toxin which acts on the acetylcholine receptor and consequently temporary muscle paralysis occurs that is followed by decreased pain and wound healing. our hypothesis is botulinum toxin relaxes the internal sphincter, so prevent its spasm and so reducing the pain and promoting wound healing more rapidly.

many procedures have been described to decrease the pain post hemorridectomy. internal sphincterotomy botox injection giving strong analgesics we aim to evaluate the efficacy of botox and internal sphincterotomy in pain relief after hemorridectomy.

Eligibility criteria:
inclusion criteria: * both sexes, * aged between 18 and 70 years old. * grade iii and iv hemorrhoids. * those with failed conservative treatment. exclusion criteria: * surgically unfit patients due to multiple comorbidities, * patients who need emergency operation for complicated hemorrhoids, * patients with partial rectal prolapse * patients with rectal varices due to portal hypertension

Keywords: post hemorridectomy pain sphincterotomy botox injection
venous thromboprophylaxis in bariatric surgery

Conditions: Obesity

Summary: the main aim of this study is to compare the influence of total body-weight (tbw), lean body-weight (lbw), ideal body-weight (ibw) or body mass index (bmi) on peak anti-xa levels at steady-state in bariatric surgery (bs) morbidly obese patients receiving a fixed double dose of dalteparin (5000 iu subcutaneously, twice daily a day) for venous thromboembolism (vte) prevention. secondary aims of this study are to identify which body size descriptors (bsd) has the greatest impact and could further be explored for an adjusted low molecular weight heparin (lmwh) dosing algorithm for achieving optimal vte prevention in bs severely obese patients.

severely obese patients undergoing bariatric surgery (bs) are at increased risk for venous thromboembolism (vte). how standard lmwh regimen should be adapted to provide both sufficient efficacy and safety in this setting is unclear. the aim of this study is to compare the influence of four bsd on peak anti-xa levels in bs obese patients receiving high lmwh fixed doses to identify which one had the greatest impact and could further be proposed in lmwh-based thromboprophylaxis dosing algorithms.

Eligibility criteria:
inclusion criteria: * between 18 and 70 years old * bmi ≥ 40 kg/m² or bmi ≥ 35 kg/m² with at least one or more obesity-related co-morbidities ( including type ii diabetes (t2dm), hypertension, obstructive sleep apnea (osa), non-alcoholic fatty liver disease, severe osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease) * scheduled for sleeve gastrectomy (sg) or gastric bypass procedure (gbp) * informed consent exclusion criteria: * anticoagulant administration within 48 hours preceding surgery * on-going antiplatelet therapy * pregnancy

Keywords: obesity venous thromboembolism heparin, low-molecular-weight body composition glomerular filtration rate bariatric surgery