Kornimate/medical-research-clean huggingface dataset:
coronary calcification progression study

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to investigate use of fast gated helical computed tomography (fghct) measures of coronary artery calcium (cac), fghct-cac, for discrimination of coronary artery disease (cad) and to quantify progression of coronary artery calcium over time.

background: while advances have been made in control of some coronary heart disease (chd) risk factors, especially smoking and high dietary fat intake, much of the decline in age-adjusted chd mortality rates has been due to medical treatment and procedural interventions for overt chd as well as hypertension and hypercholesterolemia. in this context, the availability of an inexpensive, sensitive and specific method for noninvasive detection of both early coronary atherosclerosis and asymptomatic but advanced chd could allow beneficial treatments to be targeted at many high-risk individuals. the study was designed to determine whether fast-gated helical computed tomography (fghct), a more advanced and readily-available variant of a technique (ebct) that has not achieved its full promise, could play such a role. design narrative: dr. crouse and his colleagues augmented ongoing case-control studies, hl35333, "carotid atherosclerosis progression study" and hl59503, "vascular disease, structure and function". hl35333 comprises 280 symptomatic individuals \> 45 years equally divided between men and women, half with and half without angiographically defined coronary artery disease evaluated for risk factors and extracranial carotid intimal-medial thickness (ecimt, with b-mode ultrasound) at baseline and yearly for three years. the grant has quantified the associations of coronary artery disease and coronary artery disease risk factors for ecimt and its progression. hl59503 quantifies flow-mediated brachial artery reactivity (fm-bar) in this cohort. literature review suggests that while ecimt predicts coronary artery disease status in clinical samples it does less well in asymptomatic samples; longitudinal data (clas study) suggest that progression of ecimt best predicted incident coronary artery disease, and electron beam computed tomography (ebct) quantification of coronary artery calcium (cac) likely has even greater discriminatory power for coronary artery disease than ecimt. however, ebct has limited accessibility. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
strain and blood inflammatory markers as prognostic tools for ards amis (ards - markers of inflammation - strain)

Conditions: Acute Respiratory Distress Syndrome

Summary: the objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during acute respiratory distress syndrome (ards).

nowadays ards severity, and therapeutic efficiency are evaluated using pao2/fio2 ratio. inflammation is a cornerstone of ards and the ratio is not a sufficiently accurate tool to predict the evolution of ards. a reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects. the investigators made the hypothesis that patients moderate to severe ards (comparable pao2/fio2 ratio) with a higher strain may have higher inflammation. moderate/severe ards will be ventilate with protective ventilation (low tidal volume and peep set to limit plateau pressure under 30cmh2o). markers of inflammation will be measured in the broncho alveolar lavage the first day and in the blood the following days. strain will be measured at the bedside using the nitrogen washout-washin. markers of inflammation and strain will be analysed with ventilatory and oxygenation.

Eligibility criteria:
inclusion criteria: * moderate to severe ards (berlin definition) * acute beginning \<1 week * pao2/fio2 ratio ≤ 200 after 24h mechanical ventilation with peep≥5cmh2o * bilateral opacities on chest x-ray * respiratory failure not fully explain by cardiac failure or fluid overload * informed consent signed by the next of kin and secondarily by the patient when awake * patient with social insurance no inclusion criteria * age \< 18 * pregnancy a pregnancy test will be done to women of childbearing age * chronic obstructive pulmonary disease * severe hypoxemia pao2/fio2 \<50% with high peep * immunosuppressive treatment * immunodeficiency onco-hematology, hiv
extension study of ideal (imatinib) for chronic myelgenous leukemia (cml)

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Summary: this study is an extension study (prospective observational study) of 'ideal' study (a study to evaluate efficacy and safety of imatinib (glinib) 600mg/day depending on early molecular response in newly diagnosed patients with chronic myeloid leukemia in chronic phase, nct02204722) to evaluate the duration of treatment response, disease progression, and survival status up to 5 years after the inclusion.

we have started a prospective study of evaluating efficacy and safety of imatinib 600mg/day depending on early molecular response in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (ideal, nct02204722), which will enroll 150 patients and follow up them for 1 years for the purpose of evaluating the primary endpoints - difference of major molecular response rate at 1 year. however, chronic myelogenous is a disease which needs long-term for the outcome of treatment with bcr-abl tyrosine kinase inhibitor. after the end of follow-up period of ideal study, subjects who agree with this extension study (ideal-e) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. subjects who will be enrolled in this prospective observational study will be treated with drugs - imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg - which has been chosen by the each investigator according to the drug compliance and overall response. the drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study.

Eligibility criteria:
inclusion criteria: * patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, were enrolled to 'ideal study (a phase iv study to evaluate efficacy and safety of imatinib(glinib®) 600mg/day depending on early molecular response in newly diagnosed patients with chronic myeloid leukemia in chronic phase, nct02204722) * subjects who agreed with the participation of this study after informed consent exclusion criteria: * patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, agree with the participation to 'ideal study (a phase iv study to evaluate efficacy and safety of imatinib(glinib®) 600mg/day depending on early molecular response in newly diagnosed patients with chronic myeloid leukemia in chronic phase, nct02204722) after informed consent, but were excluded finally from the 'ideal' study
effect of electronic and mail outreach from primary care physicians for covid-19 vaccination among elderly patients

Conditions: Vaccination

Summary: this randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage covid-19 vaccination among adults aged 65 and older.

this randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage covid-19 vaccination among adults aged 65 and older. patients who had not received a covid-19 vaccination or appointment after previous outreach attempts were randomized to receive (a) an electronic secure message and/or mail outreach from their pcp, (b) similar outreach with additional culturally tailored content, or (c) usual care. the primary outcome was receipt of covid-19 vaccination during the 8 weeks after the initial study outreach date.

Eligibility criteria:
inclusion criteria: - exclusion criteria: received covid-19 vaccine prior to study outreach 1.
study to evaluate the pharmacokinetics (pk), safety, tolerability of single-dose transdermal rotigotine in japanese and caucasian healthy male / female subjects

Conditions: Healthy

Summary: to investigate the pharmacokinetics (pk) of transdermally delivered rotigotine in japanese and caucasian female and male healthy subjects.


Eligibility criteria:
inclusion criteria: * subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, electrocardiogram (ecg), hematology, clinical chemistry, urinalysis) * subject is of normal body-weight as determined by a body mass index ranging between 18 to 28 kg / m² * subject is japanese or caucasian. japanese subjects are born in japan and left japan not more than 10 years ago. both parents of the japanese subjects are 100 % japanese exclusion criteria: * subjects (females) without medically adequate contraception (e.g. mechanical contraception (intrauterine-device iud), sterilization, hysterectomy) or on lactation or pregnant women. subjects with oral contraception or hormone replacement within 4 weeks prior to eligibility assessment * subject has a history of chronic alcohol or drug abuse * subject has a consumption of more than 20 g of alcohol / day (amount corresponds to 0.5 l of beer / day or 0.25 l of wine / day or 3 glasses (à 2 cl) of liquor / day * subject has a clinically relevant allergy * subject has a known or suspected drug hypersensitivity in particular, to any component of the trial medication * subject has any clinically significant abnormality in physical examination * subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100 bpm * subject has systolic blood pressure lower than 100 mmhg or higher than 145 mmhg or diastolic blood pressure higher than 95 mmhg or lower than 60 mmhg * subject has an atopic or eczematous dermatitis and / or an active skin disease or skin tumors * subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis

Keywords: rotigotine neupro japanese caucasian male female single dose pharmacokinetics
esophageal varices prophylaxis in hepatocellular carcinoma treated with atezolizumab and bevacizumab

Conditions: Esophageal and/or Gastric Varices; Hepatocellular Carcinoma (HCC)

Summary: the goal of this prospective cohort study is to evaluate the progression of esophagogastric varices in patients treated with atezolizumab-bevacizumab. assess the efficacy of primary prophylaxis of small esophageal varices with no risky signs and shortening endoscopic follow-up time intervals to reduce the risk of variceal hemorrhage. researchers will assess the progression of esophageal varices (evs) with no bleeding stigmata in patients treated with atezolizumab-bevacizumab therapy at 3, 6, 9, and 12 months with endoscopic examination. evaluate the effect of shortening the endoscopic follow-up intervals to reduce the risk of variceal bleeding in patients treated with atezolizumab-bevacizumab therapy. researchers will also assess the efficacy of variceal band ligation in small varices without bleeding stigmata before starting atezolizumab-bevacizumab therapy to reduce the progression of evs. participants will undergo history-taking, clinical examination, laboratory investigations, triphasic ct abdomen with contrast or mri (for evaluation of tumor site, size and number), abdominal ultrasonography, and upper endoscopy (within 6 months before beginning of systemic therapy and followed up after 3, 6, 9, and 12 months).


Eligibility criteria:
inclusion criteria: * patients with confirmed advanced hcc (diagnosed by two imaging modalities or liver biopsy) eligible for atezolizumab-bevacizumab therapy. * patients with preserved liver function (compensated child-pugh a if there is underlying cirrhosis). * patients with performance status ≤2 at staging work-up. * patients with no or grade 1 non-risky esophageal varices on pretreatment endoscopic examination. exclusion criteria: * child-pugh class c patients. * patients with performance status \>2 at staging work-up. * vascular disorders and arterial hypertension. * severe autoimmune disorders. * patients who lost follow-up. * pregnant or breastfeeding women. * unwilling to participate in our study.

Keywords: esophageal varices hepatocellular carcinoma atezolizumab-bevacizumab therapy
improving patient reported outcome measures in catheter ablation

Conditions: Ventricular Tachycardia; ICD; Quality of Life

Summary: this study will assess whether more frequent measurement of patient reported outcome measures (proms) - specifically health related quality of life (hrql) - can improve the evaluation of the clinical effectiveness and cost-effectiveness of catheter ablation of ventricular tachycardia (vt) in patients with an implantable cardioverter defibrillator (icd). it is designed to have feasibility outcomes which contribute to answering the above.

patients who have been implanted with an icd are at risk of suffering from dangerous arrhythmias such as vt. patients can experience clinical events including worsening of any underlying heart failure regardless of either vt ablation or medical therapy treatment strategy (anti-arrhythmic drugs (aad)). vt ablation is a specialist procedure which has been proven in randomised clinical trials (rcts) to confer symptomatic relief from vt, reduced hospitalisations and reduced shocks from icds. however, there is no effect on mortality. the frequent nature of clinical events in this group of patients may affect their health status quite dramatically and yet based on current trial evidence, only 3 out of 6 randomised trials in vt ablation reported proms. this can lead to brittle conclusions about the overall cost-effectiveness profile of a procedure such as vt ablation. this study will assess for the feasibility of more frequent hrql monitoring and its impact on whether it is able to better capture the clinical narrative and quality of life changes of patients with severe heart failure and an icd. and thus the assessment of both clinical effectiveness and cost effectiveness of catheter ablation of vt or continuing anti arrhythmic drug therapy. method \& setting single centre study at st bartholomew's hospital london. patients will be identified through established local pathways - there are traditional outpatient specialist clinics where consultant cardiologists receive referrals of patients for consideration of managing patients with vt, including ablation. in addition, there are joint vt clinics operated by consultants as well as by cardiac physiologists. in the outpatient vt clinic, 85 patients were seen in a 10-month window - it is assumed that this scale will allow feasible identification of patients to be recruited to the both the groups of this study.

Eligibility criteria:
inclusion criteria: adults (\>18 years) with an implantable cardioverter defibrillator (icd) implanted \>3 months from time of recruitment and a previous episode of documented vt requiring therapy from the icd. and impaired lv/rv function willing and able to give written informed consent exclusion criteria: patients who are planning to move away from study site within 12 months of enrolment who wished to use postal method to complete their hrql patients who are unable to give informed consent

Keywords: catheter ablation patient reported outcome measure incremental cost effectiveness ratio
r-chop combined with lenalidomide in the first-line treatment for patients with diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is a prospective single-arm, multi-center, phase ii clinical trial to observe the efficacy and safety of r-chop (rituximab-cyclophosphamide, epirubicin, vincristine and prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large b cell lymphoma.

diffuse large b cell lymphoma (dlbcl) is the most common type of non-hodgkin's lymphoma (nhl). currently, r-chop is world-widely used in the first-line treatment for dlbcl. there are about one second of patients suffering relapse and drug resistance. lenalidomide is an analog of thalidomide, the mechanism of anti-tumor action has not been fully elucidated. lenalidomide has been proved to inhibit the proliferation of tumor cells in certain hematopoietic systems. at present, it has been approved for the treatment of multiple myeloma with good efficacy and safety. the goal of our trial is to assess the efficacy and safety of r-chop combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large b cell lymphoma.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 70 years old (including 18 and 70) 2. diagnosed as diffuse large b cell lymphoma 3. subjects must be untreated (medium to high risk/high risk: international prognostic index (ipi) score 3-5 or aaipi score 2-3/ immunohistochemical staining of double expression (bcl2 ≥ 50% and c-myc ≥ 40%) or p53 protein mutation positive ≥ 50%) 4. no receiving chemotherapy before enrollment 5. having at least one measurable lesions 6. world health organization-eastern cooperative oncology group performance status (ecog) 0-2 7. life expectancy no less than 3 months 8. enough main organ function 9. pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. agreeing to sign the written informed consents exclusion criteria: 1. diagnosed as high-grade b-cell lymphoma, including non-specified and double-strike or triple-strike 2. diagnosed as grey-zone lymphoma 3. diagnosed as central nervous system lymphoma 4. diagnosed as primary mediastinal large b-cell lymphoma 5. diagnosed as cd20 negative diffuse large b-cell lymphoma 6. other malignant tumor history or active malignant tumor need be treated 7. serious surgery and trauma less than two weeks 8. systemic therapy for serious acute/chronic infection 9. congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 10. vaccination with live attenuated vaccine less than 4 weeks 11. hiv-positive, aids patients and untreated active hepatitis 12. patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 13. patients with a history of mental illness 14. researchers determine unsuited to participate in this trial

Keywords: diffuse large b cell lymphoma r-chop lenalidomide
a retrospective analysis of laboratory testing on chronic wound patients

Conditions: Wound Chronic Draining

Summary: the purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. it elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.

the information was processed from culture results that were processed to compile an antibiogram for a laboratory.

Eligibility criteria:
inclusion criteria: -patients with chronic wounds. exclusion criteria: -patients without chronic wounds.

Keywords: wound chronic
balance diet implementation in primary health care: a cluster randomized type ii hybrid implementation study

Conditions: Obesity; Hypertension; Diabetes; Dyslipidemias

Summary: this is an implementation type ii hybrid study with randomisation in cluster, whose objective is to compare two strategies of implementation of the brazilian cardioprotective diet guidelines in primary health care in two brazilian cities. all health professionals from the health units (clusters) randomized to the intervention group will receive training on the subject. the health professionals from the health units randomized to the control group will follow the usual activities, receiving only the printed guidelines, as usually done. after 6 months, the prescription rate of the brazilian cardioprotective diet will be evaluated, as well as the quality of the diet of patients in both groups.


Eligibility criteria:
clusters inclusion criteria: all public primary care units from both cities will be included. however, the health services that encourage health professionals to use the cardioprotective food manual before randomization will be excluded. participants (patients) inclusion criteria: * individuals aged ≥20 years of either sex who have a previous medical diagnosis of at least one of the following conditions: * type 2 diabetes mellitus; * systemic arterial hypertension (systolic blood pressure ≥140 mmhg or diastolic blood pressure greater than ≥90 mmhg or in drug treatment for hypertension); * isolated hypercholesterolemia: isolated increase in ldl-c (ldl-c ≥ 160 mg/dl). * isolated hypertriglyceridemia: isolated increase in triglycerides (tg ≥ 150 mg/dl or ≥ 175 mg/dl if the sample is obtained without fasting). * obesity or overweight (body mass index ≥25.0 kg/m2). exclusion criteria: * prior cardiovascular event (acute myocardial infarction, stroke, peripheral arterial disease); * psychiatric or neurocognitive condition that prevents understanding of guidelines (defined by the clinical judgment of the investigators); * life expectancy less than 6 months (example: metastatic malignant neoplasm) to be defined by the investigator's judgment; * pregnancy or lactation; * liver failure with a previous history of encephalopathy or anasarca; * chronic renal failure; * organ transplantation; * gastroplasty for less than a year; * impossibility of oral feeding. * no access to internet or mobile phone.