Kornimate/medical-research-clean huggingface dataset:
the impact of charcot-marie-tooth disease in the real world

Conditions: Charcot-Marie-Tooth Disease

Summary: an observational, non-interventional registry study to collect real-world data from people living with charcot-marie-tooth disease (cmt) and its treatment, which will be available to researchers to further the knowledge of charcot-marie-tooth disease and improve patient care.

the registry uses vitaccess' digital real-world evidence platform and has been developed in collaboration with cmt experts, patient advocacy organizations (paos) and the biopharmaceutical company pharnext. eligible participants install a study app on their smartphone. researchers access aggregated, anonymised data via a cloud-based research portal. the platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to download a copy of their symptom diary, a clinically-validated knowledge feature, and access to high-level results from the study data. the aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location). state-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals. the study is ethics-approved in all scope countries and led by a scientific advisory board comprising representatives from international paos, patients and key opinion leaders from each country, and study leads from both pharnext société anonyme (sa) and vitaccess ltd.

Eligibility criteria:
inclusion criteria: (\*) aged 18 years and over (\*) diagnosed with any stage and any subtype of charcot-marie-tooth disease (\*) resident in france, germany, italy, spain, the uk, or the usa (\*) have a national health service (nhs) or community health index (chi) number, or equivalent (\*) willing to use their own smartphone exclusion criteria: (\*) no specific exclusion criteria.
translating dietary trials into the community

Conditions: Hypertension

Summary: a diet that is rich in fruits, vegetables, and low fat dairy foods is known to lower blood pressure in adults. this research project seeks to promote the adoption of the dietary approaches to stop hypertension(dash)eating pattern by african american adults with hypertension or prehypertension living in a lower income minority community. the randomized trial phase of this project will test a group-based intervention using materials adopted from prior studies and tailored to the community of interest.

hypertension (htn) is a prevalent risk factor for cardiovascular, cerebrovascular, and renal disease, and disproportionately affects african americans (aa). although htn awareness and treatment rates among aa are similar to, or exceed non-hispanic whites, control of htn among aas remains inadequate. randomized clinical trials have demonstrated the effectiveness of lifestyle measures in lowering bp, including the dietary approaches to stop hypertension (dash) diet, which lowers systolic bp 6-14 mmhg. dash calls for increased consumption of fruits, vegetables, and low fat dairy, and decreased saturated fat and sodium intake. there is limited evidence that dash has been widely adopted by the public and aa from lower income communities may be less able to adopt dash as currently disseminated due to barriers related to income, education, attitudes about foods, health beliefs, and neighborhood availability of healthier foods. we propose to utilize quantitative and qualitative research techniques (including focus groups and surveys) to assess environmental, intra-personal, interpersonal and cultural factors that could affect the translation of the dash diet in a low-income aa community, then utilize the knowledge gathered to adapt existing intervention strategies and tools. these will provide the materials for a randomized three month pilot lifestyle intervention implementing the dash diet. the 40 participants will be aged 21+ and have pre-htn or htn with blood pressure between 120-150/80-95 mmhg on 0,1 or 2 antihypertensive agents, and will be aa residents of two zip codes in winston-salem (a lower-income area whose population is significantly minority).

Eligibility criteria:
inclusion criteria: * being african american * age 21 years or older * residing in zip code 27105 or 27101 * formal education less than 4-year college degree * blood pressure between 120/80 mmhg and 150/95 mmhg, inclusive (patients on bp lowering drugs eligible if bp is in above range) * willing to provide informed consent * able to participate in english exclusion criteria: * clinical history of congestive heart failure * clinical history of diabetes, or newly diagnosed diabetes at screening * clinical history of renal insufficiency (stage 3 or higher chronic kidney disease) * bmi less than or equal to 18.5 kg/m2 or greater than or equal to 45.0 kg/m2 * pregnancy * non-english speaker

Keywords: hypertension
china peace-retrospective ami study

Conditions: Coronary Heart Disease

Summary: coronary heart disease (chd) and heart attacks pose a serious health risk to men and women, however the knowledge about the real-life ami management in china is limited. within a nation-wide and regional representative probability sample of hospitals in china, 27,800 ami inpatient cases will be sampled randomly from 2001 to 2011. the sampled medical records will be reviewed and abstracted in the national coordinating centre, in order to evaluate the treatment pattern, outcomes, and cost for ami patients, during the past decade. basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve ami patients outcomes finally.

cardiovascular disease (cvd) is a major concern in public health globally, as well as in china, and remarkable variations of resources available and health system performance have been noted. relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. in addition, little information is available about the magnitude, prognosis, and optimal management of ami, which is one of the leading causes of mortality and morbidity, both in rural and urban area. practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction. to investigate the treatment pattern and outcomes of ami patients during the past decade in china, using a stratified two-stage cluster sampling design, from 175 sampled hospitals, 13,900 ami cases will be selected in 2011, and 6,950 in 2001 and 2006 separately. photocopies of the 27,800 medical records of ami cases will be sent to the national coordinating centre. demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted by well trained professional abstractors. by characterizing differences in patients' features, comparing the use of medications and procedures, and examining the in-hospital outcomes, we'll define the gaps between clinical practice and guidelines, as well as the disparities across different regions and hospitals, to evaluated the treatment pattern and outcomes in the last decade in china. new knowledge will be generated about ami management all over china, to provide evidence for policy-making and clinical guidelines, and to improve ami patients prognosis in future finally.

Eligibility criteria:
inclusion criteria: * hospitalized patients with acute myocardial infarction (ami) according to discharge diagnosis (icd-9 codes 410 or icd-10 codes i21) exclusion criteria:
impact of therapeutic alliance on dropout in a naturalistic sample of patients with borderline pathology receiving residential dbt

Conditions: Borderline Personality Disorder; Psychotherapy; Dropout

Summary: participants with borderline pathology (≥ 3 dsm-iv-criteria) receiving an inpatient dialectical behavior therapy (dbt) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. beyond that, changes of therapists were documented.


Eligibility criteria:
inclusion criteria: * three or more criteria for bpd as defined by dsm-5 (borderline personality characteristics; bpc) exclusion criteria: * inability to contract and consent, * other severe mental disorders (bipolar disorder, acute psychosis), * current alcohol, * illicit or not prescribed drug use, * simultaneous participation in other treatment studies, * pregnancy or breastfeeding, * an inability to negotiate a non-suicide agreement, * ongoing traumatic contact with the perpetrator, and * a body mass index \< 16.5.
hyperbaric oxygen therapy (hbot) as a treatment for covid-19 (covid-19) infection

Conditions: COVID-19

Summary: patients who meet inclusion criteria will be randomized into treatment vs control group. treatment groups will undergo hyperbaric oxygen therapy (hbot) and compared to the control group.

after enrollment, patients will be randomized into treatment vs control group. both populations will receive the same inpatient medical treatment. all patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. after completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Eligibility criteria:
inclusion criteria: * adult inpatients \>18 years old * positive pcr covid-19 testing * ct evidence of interstitial opacity * oxygen saturation \<90% on room air * po2 = 55-70. exclusion criteria: * increased oxygen requirements * hemodynamic instability (map\<65) * bradycardia (hr\<50) * history of seizure disorder * pneumothorax * gfr\<30 * hemodialysis * refractory anxiety/claustrophobia * current pregnancy * uncorrectable hypoglycemia

Keywords: covid-19
analysis of patients with post-traumatic vertebral fracture and accompanying rib fracture

Conditions: Vertebral Fracture; Rib Fractures; Trauma

Summary: the present study investigates the trauma mechanisms, the type and level of vertebral fractures, the number of accompanying rib fractures and thoracic pathologies, the surgical procedures employed and the development of complications in a sample of patients who presented with vertebral fractures and concurrent rib fractures after sustaining trauma.

the study aimed to analyze the mechanisms of trauma, type and level of vertebral fractures, number of accompanying rib fractures and thoracic pathologies, necessity of surgery and development of complications in patients who developed vertebral fractures and rib fractures after trauma. patients were divided into 3 groups: upper cervical , lower cervical and thoracolumbar. they were compared with each other in terms of trauma mechanisms, rib fracture numbers, accompanying thoracic pathologies, complication developments and need for surgery.

Eligibility criteria:
inclusion criteria: * patients who had vertebral and rib fractures due to trauma exclusion criteria: * patients whose electronic patient records and radiological imaging findings cannot be accessed * patients whose development of complications could not be evaluated due to not coming to post-discharge check-ups

Keywords: trauma rib fracture vertebral fracture complication
determination of venous thromboembolism risk and nursing practices in patients hospitalized in medical services

Conditions: Venous Thromboembolism

Summary: together with individual predisposition to form vascular clots and clinical conditions that further increase this risk, venous thromboembolism (vte) poses a significant additional morbidity and mortality risk for the majority of the world's population. although vte causes serious disability and death when undiagnosed, it is a medical condition that can be prevented when diagnosed early. although all hospitalized patients are at risk of dvt, studies have shown that 75% of hospitalized patients are hospitalized in internal clinics.as a result of this observational study, it was aimed to determine the vte risk levels of the patients from the time of hospitalization and to determine preventive nursing care for vte.

venous thromboembolism (vte) refers to interrelated diagnoses such as deep vein thrombosis (dvt) and pulmonary embolism (pe). 10-20% of venous thromboembolic events occur in medical patients and 10-80% in intensive care patients. recognized as a major complication for medical and surgical patients, vte has been described as the 'silent killer' of hospitalized patients. during the covid-19 pandemic in recent years, high rates of thrombolytic events have been reported in hospitalized covid-19 patients. nurses have an important role in identifying risk factors for vte, taking precautions and assessing patient compliance with these precautions. the nurse should identify risk factors in the preoperative period, long-term and intensive care hospitalizations by taking a comprehensive history and physical assessment of the patient before hospitalization. there are several risk assessment models developed to assess the risk of vte for application to inpatient medical patients. there are various risk assessment models developed for application to inpatient medical patients. padua and improve vte risk assessment models are frequently used. in the literature, it is stated that the padua model gives moderate results and the improve model gives moderate-good results in predicting risk (1). therefore, risk levels were not determined with the improve risk assessment tool in this study.

Eligibility criteria:
inclusion criteria: * to be conscious, * consent of the patient's relatives to participate in the study in unconscious patients * 24 hours have passed since hospitalization * the patient admitted to hospitalization has been pre-assessed by the nurse and the pre-assessment form and nurse observation form have been completed exclusion criteria: * surgical patients * pregnant patients * refusing to participate in the study during the completion of the data collection forms. * in unconscious patients, the patient's relatives did not give consent to participate in the study * unconscious patient whose relatives cannot be reached * the patient admitted to hospitalization was not pre-assessed by the nurse and the pre-assessment form and nurse observation form were not filled out

Keywords: venous thromboembolism nursing practise
assessing the wave extra soft coil in intracranial aneurysms and comparing imaging modalities

Conditions: Aneurysm, Brain

Summary: the objective of this study is to demonstrate the safety and efficacy of the penumbra smart coil® system, including the wave™ extra soft coils (wave) as a fill and finish coil, in the treatment of intracranial aneurysms. imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.


Eligibility criteria:
inclusion criteria: * patient age ≥ 18 years * patient having embolization of intracranial aneurysms * wave extra soft coil is final finishing coil * penumbra smart coil system accounts for at least 75% of total number of coils implanted * informed consent obtained per institutional review board/ethics committee (irb/ec) requirements exclusion criteria: * life expectancy less than 1 year * patient previously enrolled in the surf study * known multiple intracranial aneurysms requiring treatment during index procedure * patient is unwilling or unable to comply with protocol follow up schedule and/or based on the investigator's judgment the patient is not a good study candidate * participation in an interventional drug or device study that may confound the results of the study
ilumien-v - aero: all-comer registry of oct (aero)

Conditions: Myocardial Ischemia

Summary: the study aims to assess contemporary practice in oct use during routine interven-tional practice and to assess the impact of the mld-max algorithm on real-world pci in a large unselected european all-comer-study cohort.

angiography is the current standard method to guide pci strategy in clinical practice. however, angiography has a number of well-described limitations, primarily through only providing an assessment of luminal dimensions without delineation of the burden of atheroma-tous disease. angiography also provides suboptimal assessment of post pci complications such as stent underexpansion or malapposi-tion, residual dissections or thrombus, and tissue prolapse. these limi-tations may be overcome in part by intravascular imaging (ivi), which allows tomographic, cross-sectional imaging of the vessel wall. meta-analyses of randomized and registry studies of ivi-guided vs. angi-ography-guided pci have suggested that ivi-guidance may improve clinical outcome following pci. optical coherence tomography (oct) provides high-resolution (10-20 μm) cross-sectional images of plaque microarchitecture, stent place-ment and size and strut coverage. recently the mld-max algorithm was developed to guide and stand-ardize coronary stent implantation based on sizing of the vessel at the proximal and distal reference using the eel.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with evidence of myocardial ischemia (e.g. stable angi-na, silent ischemia, unstable angina, or acute myocardial infarc-tion) undergoing oct-guided lesion evaluation (oct-scan using the devices must be performed either to guide pci (following the mld-max-algorithm) or to investigate a coronary lesion for fur-ther clinical treatment) * written informed consent (defined as legally effective, docu-mented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical inves-tigation exclusion criteria: * none
trial of folf(ha)iri versus folfiri in mcrc

Conditions: Metastatic Colorectal Cancer

Summary: trial design: * phase iii, folfiri versus folf(ha)iri (the folfiri regimen with "hyaluronic acid-irinotecan" or "ha-irinotecan") regimen. * patients with mcrc (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. * randomized 1:1, double-blinded, multi-centre, multi-national (australia, bulgaria, poland, serbia, russia, ukraine and the united kingdom). * dosing regimen: * irinotecan (180 mg/m2) or ha-irinotecan (180 mg/m2), iv, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan and ha-irinotecan dose in must be reduced to 150 mg/m2). * leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, iv over 90 minutes with irinotecan. * 5-fluorouracil (5-fu), 400 mg/m2 iv bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * repeat every 2 weeks for 8 months. * patient accrual over approximately 12-14 months. * monitoring to 18 months post-randomization. * 390 patients. * progression free survival (pfs) primary endpoint. * safety analysis on the initial 20 patients.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer with disease progression after first or second line chemotherapy * irinotecan naïve. * ecog performance status of 0 or 1. * measurable disease, i.e. at least one measurable metastatic lesion (spiral ct or mri). * histological proof of colorectal cancer. * 18 years of age and older. * adequately recovered from and at least 4 weeks after recent surgery or chemotherapy. * women of child-bearing potential (wocbp) and male partners of wocbp must agree to use adequate contraception. * patient consent obtained and signed according to local and/or national ethics. * ct or mri scan of chest/abdomen/pelvis within 21 days prior to randomization. * hematology done within 14 days prior to randomization. * chemistry done within 14 days prior to randomization. exclusion criteria: * history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 5 years. * locally advanced or recurrent disease only. * unsuitability for irinotecan including known gilbert's syndrome, active inflammatory bowel disease or chronic diarrhea greater than or equal to grade 2. * abdominal or pelvic radiation therapy within the last 12 months. * women who are pregnant or breastfeeding. * any condition (e.g., psychological, geographical) that would render the protocol treatment dangerous. * significant cardiac disease. * untreated or symptomatic brain or central nervous system (cns). * presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis. * current partial or complete bowel obstruction. * concomitant active infection. * enrolled in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to signing the informed consent for the aco-002 study.

Keywords: mcrc crc colorectal irinotecan hyaluronic acid hyaluronan
effects of exercise on the renin-angiotensin system

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: angiotensin converting enzyme-2 (ace2) is part of the renin-angiotensin system (ras), which is involved in maintaining blood flow and electrolyte balance. it has been shown in obese and hypertensive individuals that levels of another molecule angiotensin converting enzyme (ace) are much higher, leading to inflammation, fibrosis, vasoconstriction and high blood pressure. ace2 has a protective effect from ace, leading to anti-inflammatory, anti-fibrotic and vasodilating effects. in animal models, it has been shown that aerobic exercise can increase levels of ace2, while decreasing levels of ace and offers protection to the cardiovascular system by keeping these two molecules balanced. although the effects of exercise on the classical arm of the ras have been studied significantly, ace2 is a relatively new discovery and has not been studied as extensively in humans. the purpose of this research is to determine the effects of exercise training status on the ras, specifically on ace2 and its products.

the design of the proposed study is an intervention study, where participants are selected into either a physically active group or a sedentary group. the physically active group will be set as our control, as the physiological stress of the exercise protocol should be lower in the physically active group and limit the magnitude of the response. both groups will be exposed to the same experimental procedure. participants will be placed in their group based on their responses to the csep get active questionnaire. individuals who do not accumulate less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group, while those who accumulate more than 150 minutes will be placed in the active group. participants will be asked to avoid anti-inflammatory medications, drugs, alcohol and smoking 48 hours prior to any of the sessions. participants in both groups will undergo the same testing procedure. tests will include densitometry and a graded exercise test to measure maximum vo2 and associated parameters. venipuncture (10 ml) will be performed before, after and 30 minutes post vo2 max test. the proposed study analysis will be conducted using a dependent groups anova and tukey's post hoc testing.

Eligibility criteria:
inclusion criteria: * between the ages of 18-39 * ability to exercise to exhaustion * ability to give informed consent exclusion criteria: * chronic consumption of recreational drugs, tobacco or alcohol * on any prescription medication or anti-inflammatory medications * diagnosed with any chronic conditions * current diagnosis with covid-19 * bmi \>30 * engage in 75-150 minutes of moderate to vigorous physical activity a week