Kornimate/medical-research-clean huggingface dataset:
intravenous treatment in nursing homes

Conditions: Infections; Dehydration

Summary: the primary objective for the project is to evaluate whether nursing home residents who require intravenous fluids and intravenous antibiotics, can be treated just as well or even better in the nursing home as in the hospital. in vestfold, norway, a structured training program in the intravenous treatment of dehydration and infections in nursing homes is planned. the 3iv study will evaluate if this leads to an equal or better patient trajectory and reduced hospital admittance.

1. can a structured training program in administration of intravenous fluids and antibiotics lead to a reduced number of admissions and days in hospitals among nursing home residents? 2. can treatment with intravenous fluids or antibiotics in nursing homes provide an equally good or better patient trajectory compared to patients hospitalized for the same treatment? we will look at duration of symptoms, direct and indirect complications, and mortality rates. 3. can treatment costs for the public health service be reduced when patients are treated with intravenous fluids and /or antibiotics in the nursing home instead of being admitted to the hospital? 4. can treatment for dehydration and infections in the nursing home rather than in a hospital provide an equally or better satisfaction in patients, next of kin and staff? 5. how are difficult ethical issues handeld by medical staff at the nursing homes and the hospital when nursing home patients receive intravenous treatment?

Eligibility criteria:
inclusion criteria: * nursing home residents in need of intravenous fluids or antibiotics exclusion criteria: * patients who needs hospitalization due to either co-morbidity or seriousness of disease

Keywords: nursing homes intravenous treatment patient trajectory hospital admissions
intermittent pneumatic compression for treating lower limb lymphoedema

Conditions: Lymphoedema

Summary: the treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited nhs resources. intermittent pneumatic compression, specifically the lymphassist (huntleigh healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.

this feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of ipc in the treatment of lymphoedema. the study methodology consisted of a pilot randomised control trial of ipc plus standard lymphoedema care versus standard lymphoedema care alone. feasibility outcomes included impact on lower limb volume.

Eligibility criteria:
inclusion criteria: * age 18 or over, * able to provide written consent, * confirmed diagnosis of lower limb isl stage ii or iii. exclusion criteria: any of these conditions * severe congestive heart failure * severe skin problems, lower limb ulcers or wounds. * presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the ipc device safely or adhering to instructions/study protocol. * non-pitting chronic lymphoedema. * known or suspected deep vein thrombosis. * pulmonary embolism. * thrombophlebitis. * acute inflammation of the skin (erysipelas, cellulitis). * uncontrolled/severe cardiac failure. * pulmonary oedema. * ischaemic vascular disease. * active cancer diagnosis. * active metastatic diseases affecting the oedematous region. * oedema at the root of the extremity or truncal oedema. * severe peripheral neuropathy.
an observational study to learn more about how safe rivaroxaban is and how well it works in children with congenital heart disease who had a heart surgery called the fontan procedure

Conditions: Prevention of Venous Thromboembolism; Congenital Heart Disease; Fontan Procedure; Children

Summary: this is an observational study in which the data from children with congenital heart disease will be collected and studied. these children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the fontan procedure. congenital heart disease (chd) is a heart problem that some children are born with. it sometimes requires a surgery called the fontan procedure to improve the blood flow in the body. the fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death. the study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. it is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. rivaroxaban can increase the risk of bleeding. a previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with chd who had undergone the fontan procedure. however, there is limited information available for japanese patients. to better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. the main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated. the data will be collected from december 2023 to june 2026. researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years. in this study, only available data from regular health visits will be collected. no visits or tests are required as part of this study. researchers will use the medical records or interview the children and/or their guardians during regular visits.


Eligibility criteria:
inclusion criteria: * patients under the age of 18 years * patients diagnosed with chd who had undergone the fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice * informed consent form obtained from a legal representative exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice * contraindications according to the local marketing authorization * previous treatment with rivaroxaban

Keywords: prevention of thrombi/emboli formation
suture-based, minimally invasive technique used to correct nsd

Conditions: Nasal Septum; Deviation, Congenital; Nasal Obstruction

Summary: nasal septal deviation (nsd) is one of the most common indications for surgery seen by ent physicians, however, correction requires open surgery which is associated with several weeks of recovery. the purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address nsd.

nasal obstruction due to structural issues such as nasal septal deviation (nsd) is remarkably common. nsd is caused by warping of the midline cartilage and bone of the septum, which starts between the 2 nostrils, and extends 7 cm posteriorly to the nasopharynx. this crooked or deviated conformation in the nasal septum cartilage and/or bone leads to physical blockade of normal airflow through the nose, often leading to complaints of nasal congestion, sleep disturbance, exercise limitations, and even poor compliance with cpap mask use for treatment of obstructive sleep apnea (osa). to correct this structural issue in symptomatic patients, septoplasty surgery under general anesthesia is typically advocated. as an alternative to standard septoplasty, there are rare reports of simplified suture techniques that may be used to straighten the nasal septal cartilage. however, virtually all published studies to our knowledge have still required 1) some degree of cartilage/bone excision, which can destabilize the nasal support framework, and 2) use of non-locking sutures which can break, provide insufficient support, and be technically challenging given that it requires knot tying within the narrow nasal cavity corridors. the investigators have demonstrated in benchtop models that similar results to standard septoplasty techniques can may be achieved with the use of a non-retractable suture without the need for cartilage excision. this technique, therefore, could allow for a simple, and knotless, minimally invasive way to improve and/or correct symptomatic nsd.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * patients from all ethnic and geographic backgrounds within the stanford sinus center with symptomatic nsd * primary patients with nsd without past septum surgery * patients who have failed maximum medical therapy * patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon exclusion criteria: * age \< 18 * recent surgery of any kind (\<1 month) * inpatients * previous nasal septum surgery

Keywords: septoplasty suture-septoplasty excisional septoplasty
upfront surgery versus neoadjuvant chemotherapy followed by surgery for resectable advanced gastric cancer: snac study

Conditions: Gastric Cancer

Summary: based on the concerns about the actual low strength of evidence of the efficacy of nac on survival of proper gastric cancer treated with adequate d2 gastrectomy as compared to the results of optimal upfront surgery (s), and considering the actual difficulties of additional rcts, the aim of this study is to assess the non-inferiority of upfront surgery alone with optimal d2 dissection compared to nac regimens followed by surgery. methods: this is a nationwide multicenter observational retrospective study with matched comparison of two therapeutic strategies (nac vs s). we will include patients with ct\>2, every cn m0, or with every t and n+ m0, histologically proven adenocarcinoma of the stomach, submitted either to pre- or peri-operative treatment and d2 gastrectomy or to upfront d2 gastrectomy, between january 2012 and december 2019, followed by adjuvant treatment when recommended. all patients matching the inclusion/exclusion criteria will be registered into the study and classified into one of the two arms: a, patients who underwent pre- or perioperative treatment and d2 gastrectomy (nac) or b, patients submitted to upfront d2 gastrectomy (s). given the results reported in the "flot" trial, a 3-years os of 55% in the control arm (nac) was assumed. three-year os in the experimental arm (s) was assumed to be 47.4% under the null hypothesis of inferiority and 55% under the alternative hypothesis of non-inferiority. a sample size of 684 patients (342 in each arm) achieves 80% power to detect a non-inferiority margin hazard ratio of 1.25


Eligibility criteria:
inclusion criteria: * 3.1.1. locally advanced (t\>2 any n or n+ any t) histologically proven adenocarcinoma of the stomach without distant metastases (m0) and without infiltration of adjacent structures and organs. 3.1.2. d2 lymphadenectomy (based on japanese gastric cancer guideline) 3.1.3. age \> 18 years 3.1.4. surgical resectability 3.1.5. follow-up time of at least 36 months. exclusion criteria: 3.2.1. distant metastases (cm+) or infiltration of adjacent structures or organs (ct4b) and all primarily not resectable stages 3.2.2. other types of lymphadenectomy lower than d2 3.2.3. siewert type i and ii cardia cancers 3.2.2. relapsed gastric cancers 3.2.3. malignant secondary disease, dated back \< 5 years (exception: in-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) -

Keywords: upfront surgery perioperative treatment d2 lymphadenectomy
a trial of a comprehensive breast cancer treatment patient decision tool

Conditions: Breast Cancer

Summary: this study examines the impact of an online decision tool for patients with early stage invasive breast cancer. the study is a randomized controlled trial (rct) of 444 newly diagnosed patients, recruited from multiple surgical practices in two seer catchment areas. participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. currently many of these decisions do not meet the definition of a high quality decision, defined as one that is both informed (i.e., based on an accurate understanding of the treatment risks and benefits) and preference-concordant (i.e., consistent with the patients' underlying preferences). moreover, the introduction of evaluative tests has made these decisions more complicated for many patients. there is a need to improve the quality of locoregional and systemic treatment decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. ensuring patients can deliberate effectively about these decisions, assert their views and communicate with their clinicians is likely to improve their overall decision preparedness and satisfaction. this study will focus on the third pillar of individualized care by evaluating the impact of an innovative decision tool on locoregional and systemic therapy decision making for newly diagnosed breast cancer patients. the innovative online decision tool has been developed and tested over the past two years by the cansort team (r21 ca129859). pilot data suggests that this tool has a positive impact on patient knowledge and decision outcomes. the goal of this study is to evaluate the impact of this tool, after it is enhanced in collaboration with our communication and dissemination core, on the quality of decision making for locoregional and systemic breast cancer treatment decision making.

Eligibility criteria:
inclusion criteria: * stage 1-2 invasive breast cancer diagnosis, * dcis * ability to read english exclusion criteria: * male
referred vs spontaneous visits at pediatric er: an outcome study

Conditions: Emergency Surgical

Summary: since 80's, admissions in emergency medical services increase regularly. children represents 30% of the patients in emergency medical service. only 20% of admissions are hospitalized and only 3 % need emergency care. consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care. investigator decided to realize an epidemiologic prospective study in emergency medical and surgical pediatric service in strasbourg teaching hospital to compare coverage of children who are referred by a liberal doctor with children who are coming by themselves matched with age and complaint. this study will analyze the relevance of complaints and decision-making factors for the liberal doctor to send children in emergency medical and surgical service. investigator will talk about the importance of close collaboration between liberal doctor and hospital doctor, as well as patient's information about basic care service on nights and week-ends in order to decrease the number of emergency admission.


Eligibility criteria:
inclusion criteria: * any child attending the pediatric medical and surgical emergency department of strasbourg university hospital, accompanied by at least one of his parents. * age of the patient: from birth to 18 years. * patient sent by mail from a liberal doctor (general practitioner, liberal pediatrician, pmi, sos doctor ...) for the first group. * or emergency consultant spontaneously for the second group. * understanding and speaking french * having agreed to participate in the study if it is old, or whose parents have agreed to participate in the study. exclusion criteria: * patient unaccompanied by one of his parents * refusal to participate in the study. * vital emergency or immediate care needed * patient arriving at the emergency department at first alone with paramedics or the smur, then joined by his parents secondarily * patients referred by a liberal doctor but without mail.

Keywords: pediatric emergency surgical and medical service liberal doctor complaint
komate registry: korean multicenter angioplasty team

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Percutaneous Coronary Intervention

Summary: the investigators will enroll the patients who underwent pci and was based on real world clinical practice to collect the data regarding demographic, clinical, procedural information and clinical outcome using case report forms.


Eligibility criteria:
inclusion criteria: * 1. patients older than 19 years * 2. patients who undergo percutaneous coronary intervention exclusion criteria: * 1. refuse to participate * 2. pregnant women or women with potential childbearing
meditation and hypnosis for chronic depressed mood

Conditions: Long Term Depressed Mood

Summary: this study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood.


Eligibility criteria:
inclusion criteria: * currently meeting dsm-iv criteria for a chronic depressive disorder, with the requirement that depressive symptoms had to have lasted for at least 2 years without a remission of 2 months or more. * being 18 years of age or older. * being sufficiently proficient in english to be able to participate in group therapy. * being able to attend weekly meetings at stanford. exclusion criteria: * concurrent bipolar disorder or severe depressive disorder (this latter was determined in supervision for the scid interviews). * presence or history of psychosis. * a current primary diagnosis of panic disorder, generalized anxiety disorder, or ptsd. * a current primary diagnosis of drug or alcohol dependency or abuse (within the last 3 months). * serious suicidal risk, as defined by: * current suicidality, i.e., beyond simple ideation (e.g., making threats or attempts; gathering means; has a plan); or * serious prior attempts (bodily harm; gathered means; hospitalization). * has a significant medical condition that could interfere with participation in meditation/yoga. * current participation in psychotherapy or a meditation group. * has started (or changed level or type of) prescribed antidepressant medication or st. john's wort in the previous 3 months.
study of aslan004 in healthy subjects

Conditions: Allergic Disorder

Summary: this is an open-label, two-part, single-center, first in human (fih), single ascending dose (sad) study to assess the effects of single doses of aslan004 when administered to healthy subjects. the objective of this study is to evaluate the safety, tolerability, and pharmacokinetics (pk) of aslan004 in healthy subjects.

the plan is to enroll between 38 to 50 subjects at 1 study center. the study is divided into 2 parts: part a is designed as a sad study using intravenous (iv) administration of aslan004, as a single mg/kg iv dose and will consist of up to 6 iv cohorts. part b is designed as a parallel sad study using subcutaneous (sc) administration of aslan004, as a single fixed milligram sc dose and will consist of up to 4 sc cohorts. all cohorts will have sentinel dosing with the first subject of each cohort being spaced with adequate observation time of 24 to 48 hours before dosing the remaining subjects in the cohort. all subjects would be follow up for up to 85 days from the last dosing day.

Eligibility criteria:
inclusion criteria: 1. must be able to sign informed consent form 2. male and female subjects who are of legal age 3. healthy, bmi 18.5 to 30 kg/m2 4. normal or clinically acceptable clinical laboratory value and ecg results exclusion criteria: 1. history of hypersensitivity reaction 2. have food and/or topical allergies 3. have recent history of conjunctivitis 4. have active or history of psoriasis

Keywords: allergic disorder
mechanical cardiopulmonary resuscitation during treatment of acute respiratory failure through extracorporeal membrane oxygenation.

Conditions: Cardiovascular Resuscitation; Venovenous Extracorporeal Membrane Oxygenation

Summary: in-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. the population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ecmo) due to pulmonary failure is a very challenging group of patients. to date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. we are aiming to conduct a retrospective observational study of all vv-ecmo patients treated at our ards centre.


Eligibility criteria:
inclusion criteria: patients treated with veno-venous extracorporeal membrane oxygenation (vv-ecmo) due to respiratory failure during acute respiratory distress syndrome (ards). exclusion criteria: patients treated with veno-arterial extracorporeal membrane oxygenation (va-ecmo)
german centre for cardiovascular research cardiomyopathy register

Conditions: Acute Myocarditis; Dilated Cardiomyopathies; Hypertrophic Cardiomyopathies; Left Ventricular Myocardial Noncompaction Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathies; Amyloidosis

Summary: this is a joint project by heidelberg university and greifswald university. our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (cmp) including in depth clinical, molecular and omics-based phenotyping to serve as: 1. central hub for clinical outcome studies. 2. joint resource for diagnostic and therapeutic trials. 3. common biomaterial bank. 4. resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.

the following basic research projects, called modules, will be tied to and rely on the recruitment of cmp patients and the infrastructure provided by torch: * well phenotyped patients will be the starting point for comprehensive next-generation genotyping, leading to advanced estimates of genotype-phenotype relationship and its clinical impact. * functional analysis of novel genomic loci and their related molecular pathways will be based on our established in-vitro (e.g. ips cells, yeast two hybrid) and in-vivo (e.g. zebrafish and mice) model systems. * the integrated analysis of viral load and replication, inflammation, genotype and clinical variables will define risk variables for inflammatory and hereditary cmp. * by longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic, molecular biomarkers and histopathology for diagnosis and out-come prediction will be defined on a national level. the registry will also facilitate investigator initiated clinical trials.

Eligibility criteria:
inclusion criteria: * patients with primary non-ischemic cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and acute myocarditis. exclusion criteria: * preexisting other cardiac diseases such as significant valvular, ischemic or pericardial disease; severe arterial hypertension; primary pulmonary artery hypertension; chronic advanced disorders; history of treatment with cardiotoxic agents and chest radiation; drug and alcohol abuse; patients \ 79 years of age; life expectancy less than 1 year due to non-cardiac comorbidity

Keywords: hereditary cardiomyopathy, inflammatory cardiomyopathy, registry, biomaterial, clinical trial patients