Kornimate/medical-research-clean huggingface dataset:
spinal hydromorphone versus morphine for post-cesarean delivery analgesia

Conditions: Postoperative Pain

Summary: morphine is usually used for pain relief after cesarean delivery. however, sometimes it is not available, the patient might be allergic to morphine or intolerant to its side effects. hydromorphone, another drug from the same class, might be used alternatively, but we need to prove that it is not inferior to morphine.

spinal or intrathecal (it) morphine is the most commonly used opioid for post-cesarean delivery analgesia. factors that contribute to its widespread use include a favorable pharmacokinetic profile with duration of action up to 24 hours, ease of administration (during spinal block for surgical anesthesia) and low cost. most providers administer 100 to 200 mcg of it morphine for cesarean delivery analgesia with excellent analgesic results. nevertheless, subarachnoid use of morphine is not without adverse events. while dose-dependent respiratory depression is the most worrisome complication, other side effects such as pruritus, nausea, vomiting and urinary retention can be bothersome during early puerperium. furthermore, shortages of preservative free morphine in the united states has led clinicians to seek a reasonable alternative. for the last 20 years, spinal hydromorphone has been successfully used for chronic pain associated with neoplasms. its use for post-cesarean analgesia has been successfully reported. however, data regarding its efficacy in the it space for post-cesarean analgesia is scarce. in the past, doses of 40 to 100 mcg have been reported to provide adequate postoperative pain relief with minimal side effects. in a recent study, the effective dose in 90% of patients has been established for both hydromorphone and morphine to be 75 mcg and 150 mcg, respectively. no prospective studies have been conducted to specifically establish non-inferiority of hydromorphone when compared to morphine for post- cesarean analgesia. in addition, while all opioids share the same side effect profile, the frequency of those events are unknown for it hydromorphone. the current proposal is a blinded randomized controlled trial of intrathecal hydromorphone versus morphine in term pregnant women undergoing elective cesarean deliveries under spinal anesthesia.

Eligibility criteria:
inclusion criteria: * age \> 18 years; american society of anesthesiologist's physical status (asa-ps) \ 37 weeks gestational age); elective cesarean delivery; spinal anesthesia; exclusion criteria: * documented allergy or severe intolerance to opioids; intra-operative conversion to a general anesthetic technique; chronic pain syndrome with baseline pain levels \>3 on a visual analogue scale (0-10 cm); history of opioid use during this pregnancy; allergy or intolerance to nsaids or acetaminophen; morbid obesity- body mass index (bmi) \>40.
effects of norepinephrine and volume expansion in capillary refill time in septic shock

Conditions: Septic Shock

Summary: the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

an interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. this last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group. the strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. this is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered. however, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Eligibility criteria:
inclusion criteria: * septic shock * presence of a cardiac output monitoring device with the picco2 system (pulsion medical systems, feldkirchen, germany) * decision by the physician in charge to perform vascular filling or modification the norepinephrine dose exclusion criteria: * pregnant * patient under a tutelage measure or placed under judicial protection

Keywords: septic shock capillary refill time norepinephrine fluid infusion
retrospective cohort study on the impact of pdl treatment history on the efficacy of hmme-pdt in treating pws children

Conditions: Port-Wine Stain

Summary: this retrospective study investigated the influence of prior pulse dye laser (pdl) treatment on the effectiveness of hemoporfin-pdt in young children aged 1-3 years with pws. the study population included patients without a history of pdl treatment and patients with a history of pdl treatment.

background hemoporfin-mediated photodynamic therapy (hemoporfin-pdt) is considered a safe and effective treatment for port-wine stains (pws). this study aims to investigate the influence of prior pulse dye laser (pdl) treatments history on the effectiveness of hemoporfin-pdt in young children aged 1-3 years with pws. methods data was gathered for individuals with pws aged 1-3 years who received two or more hemoporfin-pdt treatments. the study population was stratified into two groups: cohort 1 (no pdl) comprised patients without a history of pdl treatment, while cohort 2 (prior pdl) consisted of patients with a history of pdl treatment. an analysis was conducted to investigate the relationship between treatment efficacy and variables including gender, age, location, and type of pws.

Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with pws (port wine stain) who were between 1 and 3 years old at the time of their first hmme-pdt treatment. * patients who, after evaluation by a clinician, are deemed eligible for hmme-pdt treatment and whose guardians have signed an informed consent form. * patients who have undergone two or more hmme-pdt treatments. ④ patients with complete basic information and treatment-related information. exclusion criteria: * exclusion of patients with syndromes associated with pws. * exclusion of patients with a history of treatments for pws other than pdl treatment. * patients with other vascular malformations. ④ exclusion of patients who have received any other pws treatment within 2 months prior to hmme-pdt treatment.

Keywords: pulse dye laser hemoporfin-pdt
use of vasopressin in patients at high risk of acute kidney injury admitted to the icu

Conditions: Critical Illness

Summary: renal dysfunction is a frequent complication in patients admitted to intensive care units (icus), associated with high morbidity and mortality. current therapeutic options to prevent this condition are limited and lack robust scientific evidence. this pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the icu.

this is a multicenter, placebo-controlled, double-blind, randomized feasibility clinical trial with a proposal to include 60 patients across 3 to 4 research centers. this study will be conducted in brazilian hospitals, covering both public and private healthcare profiles across various states of brazil. most of these hospitals are academic and teaching institutions, ensuring a wide diversity of data and perspectives for the research. the objective of this study is to assess the feasibility of conducting a larger subsequent trial to analyze whether the use of vasopressin in patients prone to developing acute kidney dysfunction after admission to intensive care units (icus) can prevent the condition (acute kidney dysfunction). this study is based on the null hypothesis (h0) that there will be no significant difference in the development of acute kidney injury between the group treated with vasopressin and the control group, while the alternative hypothesis (h1) proposes that the administration of vasopressin may reduce the risk of acute kidney injury in high-risk patients admitted to icus. the primary objective is to evaluate the feasibility of the study, specifically adherence to the established protocol and the monitoring of potential adverse effects during its conduct.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old); * admitted to intensive care units; * predicted risk of acute kidney injury calculated based on clinical and laboratory data at icu admission and is considered eligible if the value in the calculator is equal or greater than 5 points; exclusion criteria: * time since admission to the icu greater than 24 hours; * use of vasopressors at the time of inclusion; * map \>90 mmhg; * hyponatremia (\<130 mmol/l); * severe tbi with glasgow coma scale \< 8; * elective surgeries; * dialysis chronic kidney disease or acute kidney injury who received renal replacement therapy upon admission or are expected to receive renal replacement therapy within the next 24 hours; * suspected or confirmed acute mesenteric ischemia; * prospect of death in less than 24 hours; * medical team not committed to full investment at the time of inclusion; * prior inclusion in the study; * pregnancy.
clinical management of argatroban in patients with heparin induced thrombocytopenia type ii

Conditions: Heparin-induced Thrombocytopenia Type II

Summary: the purpose of this study is to collect data on the clinical management of argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia type ii, with or without ongoing thrombosis who require parenteral antithrombotic therapy


Eligibility criteria:
inclusion criteria: * subjects aged \>= 18 years * females of child bearing potential must have a negative urine pregnancy test prior to entry into the study * patients with suspected or confirmed heparin-induced thrombocytopenia type ii, with or without ongoing thrombosis who require parenteral anticoagulation * signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative exclusion criteria: * uncontrolled bleeding * severe hepatic impairment (child-pugh class c) * hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol) * pregnancy (exclusion by routine urine test) * lactating woman

Keywords: argatroban heparin induced thrombocytopenia (hit) direct thrombin inhibitor (dti)
aromatherapy and pain

Conditions: Chronic Pain

Summary: effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain.

the study will explore the effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain. this will be a blinded study where patients will act as their own control over two treatment visits. on one visit patient will be exposed to either the aromatherapy or a placebo. on their second visit patients will be exposed to the other compound. the study will collect demographic data, pain intensity and affect, and catastrophizing information.

Eligibility criteria:
inclusion criteria: * have received at least one (1) prior ims or trigger point injection treatment with researcher * 18 years of age or older * english language speaker * has completed pain tracker (clinic standard of care) questionnaire prior to study visit * any analgesic medication taken must be consistent for both sessions exclusion criteria: * non-english language speaker * age \<18 * allergy to essential oils * asthmatic * patient unable to self-administer aromatherapy

Keywords: intramuscular stimulation therapy trigger point injections aromatherapy
neurological and psychological effects of combat-related stress

Conditions: Stress Disorder, Posttraumatic; Stress, Psychological

Summary: the purpose of this study is to determine what is the neurological and cognitive impact of combat exposure and prolonged stress, in the form of service in the israeli defense forces.

attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. this study aimed to characterize the mental resilience of combat soldiers, and explore the neuro-cognitive impact of prolonged stress, using eye-tracking, mri and fmri measurements. participants will be assessed using questionnaires, cognitive tasks and magnetic imaging at 5 timepoints over the span of 4 years. outcome measures will be depression, anxiety and post-traumatic scores, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and blood oxygen level-dependent (bold) signals in magnetic resonance imaging (mri) measurements.

Eligibility criteria:
inclusion criteria: * soldiers in the paratroopers brigade or students in tel-aviv university; * a signed consent form; * hebrew native speakers. exclusion criteria: * a diagnosis of a neurological disorder (i.e., epilepsy, brain injury); * drug or alcohol abuse; * cannot undergo an mri scan, due to metal implants or other metallic foreign bodies, claustrophobia, large tattoos or irremovable piercings; * require glasses with a number greater than 7; * a diagnosis of psychotic or bipolar disorders.
noninvasive dual-mode stimulation therapy for neurorehabilitation in stroke

Conditions: Stroke

Summary: repetitive transcranial magnetic stimulation (rtms) or transcranial direct current stimulation (tdcs) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. in this study, simultaneous stimulation using both inhibitory rtms (1hz) and anodal tdcs (dual-mode stimulation) over bilateral primary motor cortices (m1s) was investigated to compare its modulatory effects with single inhibitory rtms stimulation in subacute stroke patients.


Eligibility criteria:
inclusion criteria: * first-ever stroke patients * subacute stage (less than 4 weeks) * total fugl-meyer assessment (fma) score under 84 exclusion criteria: * major active neurological disease or psychiatric disease * a history of seizure * metallic implants in their brain

Keywords: noninvasive brain stimulation repetitive transcranial magnetic stimulation transcranial direct current stimulation
calcium: magnesium balance, microbiota, and necroptosis and inflammation

Conditions: Colorectal Cancer

Summary: transient receptor potential melastatin 7 (trpm7), a magnesium (mg) -regulated chanzyme possessing both ion channel and kinase activities, has a much stronger affinity to mg2+ than calcium (ca)2+. we previously reported that individuals with the trpm7 ga/aa genotype and consumed diets high in ca:mg ratio had an increased risk of colorectal polyps. the trpm7 gene was also observed to possess "driver" mutations that contribute to developing multiple cancers. however, the molecular mechanism remains unclear. to identify if the gut microbiota plays a role in this association, we will investigate whether optimizing ca:mg intake ratios to 2.3 altered the abundance of the microbes (e.g. associated with trpm7 genotype and the risk of metachronous polyps) at the genus level in at least one sample type among stool, swab and tissue in a double-blind 2x2 factorial (trpm7 genotype and ca:mg ratios) randomized trial (personalized prevention of colorectal cancer trial, nct01105169).


Eligibility criteria:
inclusion criteria: • participants from the parent study (personalized prevention of colorectal cancer trial, nct#01105169, irb#100106) exclusion criteria: • participants did not provide any stool/swab/rectal biopsy sample in the parent study
inflammatory markers in sputum after lps inhalation

Conditions: Inflammation

Summary: the purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of lps (20 mcg) administered as particles of different sizes.

endotoxins are inflammatory substances present in the environment. in man, the inhalation of the lipopolysaccharride moiety (lps) induces measurable immune responses. with an inhaled single dose of 20 micron, the inflammatory response in man is sub-clinical. during bronchoprovocation tests with allergens, the particle size determines to a large extent the intensity of the response. the response to lps as a function of particle size is not known and will be studied in this study.

Eligibility criteria:
inclusion criteria: * healthy volunteer, non-smoking or ex-smoker \>1mth and \<10packs/year * normal ecg * normal lab values for hematology, ionogram, ast, alt, alk phosphatases, urea, creatinine and crp * fev1/forced vital capacity \>0.7 and fev1\>80% of predicted value * able to produce valid sputum following induction (\>=50% viable cells, \<50% squamous cells and \<60% neutrophils) * females must be using contraception * written informed consent exclusion criteria: * infection within 14 days * history of bronchial asthma * obstructive respiratory condition with fev1 \<70% of theoretical value

Keywords: lps endotoxin inflammatory markers healthy volunteers neutrophils in sputum
study of dalantercept in patients with squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied in patients with squamous cell carcinoma of the head and neck (scchn). dalantercept blocks the development of blood vessels that supply tumors.

for cancer cells to grow, they need to have nutrients supplied to them through blood vessels. the study drug, dalantercept, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. the purpose of this study is to find out if dalantercept can cause scchn tumors to shrink or stop growing. this study will also evaluate the safety of dalantercept in patients with scchn.

Eligibility criteria:
key inclusion criteria: * histologically and/or cytologically confirmed, recurrent or metastatic scchn of mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to further local therapy (surgery, or radiation including re-irradiation); patients with unknown primary scchn presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria. * previously treated with at least one platinum-containing regimen or contraindicated for treatment with a platinum containing therapy. (note: platinum therapy can occur upfront or after recurrence of disease. failure of platinum therapy is not required.) * eastern cooperative oncology group (ecog) performance status of 0 or 1. key exclusion criteria: * nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin scchn. * any other active malignancy for which chemotherapy or other anti-cancer therapy is indicated. * chemotherapy or other anti-cancer therapy or radiation therapy within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known. * treatment with another investigational drug or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known. * major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1). * clinically significant cardiovascular risk. * clinically significant active pulmonary risk. * clinically significant active bleeding. * peripheral edema ≥ grade 1 within 4 weeks prior to study day 1. * pregnant or lactating female patients.
vebreltinib combined with temozolomide for glioblastoma (gbm) after surgery

Conditions: Glioblastoma

Summary: the purpose of this study is to explore the effects of vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and met-tki.


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years, female or male 2. newly diagnosed gbm (who grade 4) patients with maximal surgical resection 3. c-met overexpression diagnosed by ihc 4. kps ≥60 5. adequate hematological, renal, and hepatic function. all patients should meet the following criteria: 1. absolute neutrophil count (anc) ≥1.5 × 109/l and platelet count≥100 × 109/l 2. serum creatinine clearance ≥80 ml/min 3. total bilirubin level ≤ 1.5 × uln (except patients with gilbert syndrome) 4. aspartate aminotransferase (ast) ≤ 3.0 × uln, alanine aminotransferase (alt) ≤ 3.0 × uln, and ast/alt \< 2.5 × uln 6. the patient and his/her family members were informed and provided signed and informed consent exclusion criteria: 1. any previous postoperative treatment except for concurrent chemoradiotherapy; 2. individuals unable to undergo cranial mri examination; 3. active hemorrhage detected by cranial ct or mri scan before enrollment; 4. uncontrolled hypertension; 5. decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment; 6. anti-hiv (+), or both anti-hcv and hcv-rna (+), or hbsag positive with hbv-dna \>1000iu/ml; 7. individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions; 8. pregnant or lactating women; 9. individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug; 10. individuals deemed unsuitable for participation in this clinical trial by the investigator.

Keywords: vebreltinib temozolomide
a registry study of biomarkers in mitral valve disease (bioms-mvd)

Conditions: Cardiovascular Diseases

Summary: the registry study aims to discover the prognostic value of bio-markers in mitral valve disease

the purpose of this study is to investigate the prognostic value of biomarkers in mitral valve disease.patients with confirmed diagnosis of mitral valve disease are enrolled.the primary outcome is all-cause mortality based on the death certificates. the secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with mitral valve disease in beijing anzhen hospital from april 2016 to december 2019 * the operator performs more than 25 mitral valve operations per year / the operator unit has surgeons who complete 50 operations per year exclusion criteria: * age ≤ 18 years * failure to obtain medical records and ultrasound data * refuse follow-up