Kornimate/medical-research-clean huggingface dataset:
lymph node mapping in patients with endometrial cancer

Conditions: Endometrial Cancer

Summary: this clinical trial studies lymph node mapping in patients with endometrial cancer. lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

primary objective: i. to estimate the negative predictive value of pelvic sentinel lymph node (sln) in endometrial cancer to predict nodal metastasis. secondary objective: ii. to examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (ihc) staining by comparing ihc results and standard hematoxylin and eosin (h\&e) results. outline: patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy. after completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.

Eligibility criteria:
inclusion criteria: * the patient must be willing and able to provide informed consent * the patient is willing and able to comply with the study protocol * the patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy * the patient agrees to follow-up examinations out to 5-years post-treatment exclusion criteria: * the patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy * the patient has known or suspected allergies to iodine, indocyanine green (icg) or isosulfan blue (isb) * the patient has hepatic dysfunction confirmed by bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)

Keywords: endometrial cancer robotic-assisted staging
evaluating the manage my pain app in pain clinics

Conditions: Pain

Summary: chronic pain is one of the most common reasons adults seek medical care, and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety and depression, and poor perceived health or reduced quality of life. chronic pain clinics are an effective solution, however, the resources available and investments have fallen behind the growing needs of patients. local waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting. tools and technology that can help patients and healthcare providers understand and manage the patients' pain are needed for the effectiveness of the healthcare system. in response to this problem, the manage my pain (mmp) app, which allows patients to log daily reflections of functionality, pain, and medication use; as well as, provide educational resources is a potential support for patients on the waitlist. this log is intended to support the patient understanding and management of their pain, and share their reports with their circle of care. this study will assess the impact of mmp on waitlist patients' health outcomes compared to a control group of waitlist patients over 60 days.

chronic pain is one of the most common reasons adults seek medical care and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety, depression, and poor perceived health or reduced quality of life. currently, local pain clinic waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting for an appointment. to address this problem, this study assesses the impact of the mmp app to support the health and medication use of patients on the waitlist. using this approach patients on the waitlist can use this app to report their pain, functionality, reflections, and medication use, as well as read educational resources about pain management. this study tests the effectiveness of the mmp app versus a control group (i.e., standard practice) on health outcomes and mediation use over 60 days in a randomized control trial (rct). the primary outcomes are pain, anxiety, pain self-efficacy, and quality of life. secondary outcome is medication usage. researchers will use descriptive and regression analysis to assess the data collected.

Eligibility criteria:
inclusion criteria: * 18 years or older * on the calgary pain clinic waitlist exclusion criteria: * participants were excluded if they did not meet any of the above criteria * patients declining or unable to complete the consent process for the study * no internet access * no access to a device or computer to display the app/website

Keywords: pain management digital health communication quality of life chronic pain psychology chronic disease management anxiety medication usage patient oriented research
trial of two dosing regimens of micafungin versus caspofungin for the treatment of esophageal candidiasis

Conditions: Candidiasis, Oral

Summary: to determine the efficacy and safety of daily doses of iv micafungin versus iv caspofungin for the treatment of esophageal candidiasis


Eligibility criteria:
inclusion criteria: * esophageal candidiasis confirmed by endoscopy * negative pregnancy test for female patients of childbearing potential exclusion criteria: * pregnant or nursing female patient * evidence of liver disease * another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection * concomitant esophagitis caused by herpes simplex virus or cytomegalovirus * received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug * known to be non-responsive to therapy in any prior systemic antifungal clinical trail * experienced \> 2 episodes of esophageal candidiasis requiring systemic antifungal therapy * history of anaphylaxis attributed to echinocandin class of antifungals

Keywords: micafungin esophageal candidiasis caspofungin
a safety study for prevenar 13 among chinese children

Conditions: Seizures; Urticaria and Angioedema; Apnea; Fever

Summary: this is an observational study based on a population-based ehr database.

this observational study based on a population-based ehr database in yinzhou district of ningbo city in china is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among chinese children after receiving prevenar 13. in addition, a validation study including validation of international classification of diseases, tenth revision (icd-10) codes or icd-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of icd-10 codes used to identify these safety outcomes in the ehr database.

Eligibility criteria:
inclusion criteria: to be eligible for the main study, children in yinzhou population-based ehr database must be aged 1 to 24 months and receive at least one dose of 13vpnc between may 1st, 2017 and july 24th, 2020 where the first dose is received before or on july 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vpnc is needed. for the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vpnc between august 1st, 2018 and july 24th, 2020 and an informed consent must be obtained from parents/legal guardians. exclusion criteria: there are no exclusion criteria for this study.
post-prandial lipid effects of raltegravir (ral) vs ritonavir -boosted darunavir (drv-r) in anti-retroviral therapy (art)- naive adults or adults recommencing art.

Conditions: HIV; Cardiovascular Disease

Summary: this is a research study into the effects of three drugs used to treat hiv infection. some drugs used to treat hiv have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with hiv. now that hiv can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new hiv treatments that control hiv effectively but do not cause abnormal blood fats. hypothesis: that raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.


Eligibility criteria:
inclusion criteria: * provision of signed, informed consent * age \>18 years * hiv infection documented by hiv antibody test and western blot prior to study entry * no previous art or no art for 6 months prior to randomisation * cd4+ count of \ 10,000 copies/ml within 60 days prior to randomisation * no genotypic resistance to raltegravir, tenofovir/emtricitabine, darunavir, ritonavir * body mass index less than 30kg/m2 exclusion criteria: * primary hiv infection within the last 6 months * active infection or opportunistic illness within the previous 30 days * use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir * use of lipid-lowering therapy * diabetes mellitus (fasting glucose \>7.0mml/l or a prior diagnosis of diabetes) * use of oral prednisolone \> 7.5mg daily or equivalent * pregnancy or breast feeding * proven hypersensitivity to one or more components of the study meal

Keywords: hiv cardiovascular disease post prandial lipids ritonavir darunavir raltegravir arterial stiffness tonometry
building engagement using financial incentives trial - hypertension

Conditions: Hypertension; Health Behavior; Healthcare Patient Acceptance; Patient Engagement; Adherence, Patient

Summary: the goal of this pilot clinical trial is to determine feasibility and explore whether immediate versus delayed patient financial incentives improve patient engagement with self-monitoring of blood pressure in patients with uncontrolled hypertension at louisiana federally qualified health centers (fqhcs). the main questions it aims to answer are: * do patients randomized to receive financial incentives on a weekly basis during the study (immediate) have better adherence to blood pressure self-monitoring compared to patients randomized to receive financial incentives at the end of the study (delayed)? * do patients randomized to immediate financial incentives have better blood pressure control compared to patients randomized to delayed incentives? participants will: * attend a baseline visit to measure blood pressure, respond to a baseline survey, and receive remote patient monitoring devices and instructions to take home with them (home blood pressure monitor, wrist-worn sensor to track sleep activity, and associated apps) * receive a random allocation to one of two groups: control condition (receive cash incentives at the end of the study for measuring blood pressure as instructed) or intervention condition (receive weekly cash incentives throughout the study for measuring blood pressure as instructed) * use remote patient monitoring devices during a two month study period, receive weekly reports on adherence to blood pressure monitoring, and receive weekly financial incentives (intervention condition only) * attend one follow-up visit at 2 months to measure their blood pressure, complete a follow-up survey, return the remote patient monitoring devices, and receive financial incentives for blood pressure monitoring (control condition only) researchers will compare the immediate and delayed incentive groups to see if there are differences in blood pressure monitoring adherence rates and blood pressure control.


Eligibility criteria:
inclusion criteria: * age ≥40 years * receive care at a participating fqhc * taking blood pressure medication * uncontrolled blood pressure at most recent clinic visit (systolic blood pressure ≥130 mm hg or diastolic blood pressure ≥80 mm hg) * ability to understand and speak english * able to access a smartphone exclusion criteria: * currently participating in another clinical trial or research study on blood pressure, medication-taking, or sleep * unable or unwilling to give informed consent

Keywords: preventive healthcare patient financial incentives federally qualified health center (fqhc) remote patient monitoring (rpm) health services
max-10181 given orally to patients with advanced solid tumor

Conditions: Solid Tumor

Summary: this is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation phase i study to evaluate the safety and tolerability of max-10181 in patients with advanced solid tumor.


Eligibility criteria:
inclusion criteria: * males and/or females over age 18. * histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available. * at least one measurable lesion by ct or mri according to recist1.1, which is not in irradiated area (only for expansion phase). * recovered from toxicities of prior anti-cancer treatment to grade 1 or less (in case of alopecia, grade 2 is acceptable). * life expectancy of at least 3 months. * female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. a highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly. exclusion criteria: * laboratory values not within the protocol-defined range. * cardiac disease with new york heart association (nyha) class iii or iv, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease. * previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry. * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery. * medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product. * anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to trial entry. * known infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c. * history of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis. * history of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation. * concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this trial.

Keywords: pd-1/l1 immunotherapy advanced solid tumors
efficacy and safety of remdesivir and tociluzumab for the management of severe covid-19: a randomized controlled trial

Conditions: Covid19; Covid-19 ARDS

Summary: this randomized clinical trial was designed and intended to evaluate the efficacy of remdesivir and tocilizumab as a treatment for severe acute respiratory distress syndrome (ards) caused by coronavirus disease 2019 (covid-19). our aim is to find the best option for the treatment and management of ards in covid-19 patients.


Eligibility criteria:
inclusion criteria: severe covid-19 patients require hospitalization under hdu/icu. the sars-cov-2 infection will be confirmed by rt pcr / ct chest in every case. exclusion criteria: * participants with uncontrolled clinical status who were hospitalized from the before. * contraindication / possible drug interaction. * participants who have any severe and/or uncontrolled medical conditions like, severe ischemic heart disease, epilepsy, malignancy, pulmonary/renal/hepatic disease, aids, pulmonary tb, pregnancy, corpulmonale, and etc.

Keywords: covid 19 remdesivir ticilizumab covid-19 ards
evaluation of esmo guidelines applicability and adherence in cancer pain management in the palliative care setting

Conditions: Cancer Pain; Pain; Cancer

Summary: palliative care (pc) is focused on improving the quality of life (qol) of patients living with a life-threatening illness. each year, an estimated 40 million people need pc management in the world. in the european union, it is estimated that about 4,5 million of people are in the need of pc every year, with about 40% affected by malignant neoplasia. data from a recent systematic review of the literature report that the prevalence of pain is 66% (95% confidence interval 58-75) in cancer patients with advanced stages of the disease. in 52% of cases, pain was moderate or severe in intensity (nrs, numeric rating scale ≥4). furthermore, in addition to the basic pain, having characteristics of continuity over time even in the presence of fluctuations in intensity, the presence of acute painful episodes must also be considered, which are defined with the term of breakthrough cancer pain, (btcp), whose prevalence is estimated between 21 and 59%. the positive impact on the quality of life of cancer patients of adhering to current guidelines has been amply demonstrated. recently, new guidelines or recommendations produced by scientific societies have published, including the european association of palliative care, the national comprehensive cancer network and the european society for medical oncology (esmo). in clinical facilities directly involved in the treatment of pain in cancer patients, implementing the directives set out in the guidelines appears to be a correct objective for the appropriateness of treatments. nevertheless, there are no studies in europe that have evaluated the applicability and adherence to guidelines in the treatment of cancer pain in advanced cancer patients. the present study intends to collect detailed information on the characteristics of pain and the treatment in a population of cancer patients cared by a network of specialized palliative care centers in order to assess the applicability and adherence of the latest european guidelines published by esmo in 2018 for the treatment of pain in the specific area.


Eligibility criteria:
inclusion criteria: * age \>18 years; * cancer diagnosis; * patient enrolled within 48h from admission in pc; * presence of pain with or without analgesic therapy or absence of pain being already on atc analgesic therapy; * life expectancy longer than two weeks; * written patient informed consent. exclusion criteria: * diagnosis of primary brain tumor or leukemia (acute or chronic); * clinical conditions that, at investigator evaluation, prevent the follow up visits; * absence of pain without analgesic therapy.

Keywords: palliative care pain cancer
exploration of the mechanism of movement improvement during rbd in parkinson's disease using nirs

Conditions: Parkinson Disease

Summary: the purpose of this study is to confirm the improvement of movement during rbd in parkinson's disease and to explore the neuronal network involved in this improvement using nirs.

the aim of this study is to compare the quality of movement during rem sleep during rbd episodes and movement awake without and with dopaminergic treatment while measuring cortical activity using nirs.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (hughes aj et al., 2001) * patients with rem sleep behaviour sleep disorder according to the icsd2 (international classification of sleep disorders 2) criteria and frequent reported several times per week by the spouse * informed written consent signed * patient aged 40 to 90 years * affiliate or benefiting from a social security scheme. exclusion criteria: * atypical parkinson's syndromes * patient not accepting polysomnography * contraindications to cerebral magnetic resonnance imaging (mri): pacemaker, cochlear implants, certain heart valves, claustrophobia, pregnancy. * limit of validity of the mri: if the patient presents dyskinesias preventing immobile maintenance of a few minutes in the mri for the acquisition of images

Keywords: parkinson disease near infrared spectroscopy rem sleep behaviour disorder supplementary motor area
preoperative rri and long-term risk for ckd

Conditions: Acute Kidney Injury; Acute Kidney Disease; Chronic Kidney Disease; Cardiac Surgery; Renal Resistive Index

Summary: renal resistive index (rri) is calculated from ultrasonographic doppler measurements of flow velocities in intraparenchymal renal arteries. normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. both preoperative and postoperative elevation of rri has shown promise in early detection of aki after cardiac surgery. further, elevated rri before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. the role of preoperative rri in predicting long-term renal and cardiovascular complications after elective surgery is however not known. the aim of this study is to assess the role of preoperative rri to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 * elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at karolinska university hospital between september 2014 and april 2015 * preoperative measurement of rri performed with satisfactory doppler reading * written informed consent exclusion criteria: * kidney transplant * dialysis-dependent kidney disease * cancelled surgery * missing follow-up data