Kornimate/medical-research-clean huggingface dataset:
effectiveness of different interventions for implementing surviving sepsis campaign (ssc) guidelines on compliance and mortality: systematic review and meta-analysis

Conditions: Sepsis; Septic; Septicemia

Summary: this is a systematic review and meta-analysis of interventions for implementation of surviving sepsis campaign guidelines and their impact on compliance and mortality reduction

the implementation of the sepsis resuscitation bundle recommended by the ssc guidelines has been shown to increase compliance and reduce mortality in several settings. different implementation strategies have been utilized, including education, posters, reminders, audit and feedback, paper-based and electronic sepsis screening tools, clinical pathway and sepsis response teams. different studies showed a considerable variation effect on compliance and mortality.it has been suggested that implantation strategies vary in there effect from low impact for human-based interventions such as education and training, rules and policies, reminders, checklists and double checks, however, reaching high effect for system based interventions like automation and computerization and forcing function. however, this has not been studied in relation to the implementation of ssc bundle. as such, many projects continue to invest on low-impact interventions with modest change in compliance and mortality. multiple interventions were adopted by different centers worldwide to implement ssc guidelines. these interventions vary on their level of compliance and outcomes. the effectiveness of intervention if system oriented is more effective than human oriented. the hierarchy of effectiveness assigning forcing function intervention on the top of the pyramid and the training and education on the bottom. the investigators hypothesize that interventions system based interventions are more likely to be more effective in improving the compliance with sepsis resuscitation bundle and in improving mortality. the aim of this study is to assess the effectiveness of different interventions for implementation of surviving sepsis campaign guidelines and their impact on compliance and mortality reduction.

Eligibility criteria:
inclusion criteria: any study or data 1. assessing any intervention method for implementing ssc guidelines in regards to compliance and mortality, 2. has a comparison group, 3. reported data on sepsis resuscitation bundle compliance and mortality exclusion criteria: any study used other than ssc guidelines in sepsis management will be excluded.

Keywords: surviving sepsis campaign sepsis septic septicemia mortality compliance
optimizing mental health for young people at clinical high risk for psychosis (chr)

Conditions: Psychosis; Psychosocial Functioning

Summary: this proposal aims to adapt an evidence-based comprehensive psychosocial and mental health support program, the optimal health program (ohp), to improve functioning, reduce distress, and build resiliency in youth who are at clinical risk of developing psychosis (chr). the main aims of the studies are 1). to adapt an existing, effective, validated psychological intervention for use in young people with chr; 2). to evaluate the acceptability of ohp and the feasibility of conducting a clinical trial of ohp in individuals with chr; 3). to assess the preliminary efficacy of ohp in enhancing resiliency, reducing depression and anxiety, and improving functioning in individuals with chr in a single-arm exploratory clinical trial. participants will be delivered ohp intervention over 12-weeks. measures will be completed at study entry and repeated immediately post-treatment at 12-weeks.


Eligibility criteria:
inclusion criteria: 1. be 16-29 years old 2. being competent and willing to consent to study participation 3. meets chr criteria for a psychosis risk syndrome based on the structured interview for psychosis risk syndromes (sips) either currently or at some point in the past 3 years. exclusion criteria: 1. diagnostic and statistical manual of mental disorders (dsm-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features) 2. diagnosis of intellectual disability previously documented in the patient chart 3. severe developmental disorder 4. acute suicidality requiring immediate intervention
chemotherapy with raltitrexed and fluorouracil in treating patients with advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically removed.

objectives: i. determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma. ii. determine the toxicity and safety of this regimen in these patients. iii. assess, in a preliminary manner, the antitumor activity of this regimen in these patients. outline: this is a dose-escalation study of raltitrexed. patients receive raltitrexed iv over 15 minutes followed 24 hours later by fluorouracil iv. treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity. an additional 6-10 patients are treated at the mtd. patients are followed for 6 weeks. projected accrual: a total of 20-40 patients will be accrued for this study within 5-20 months.

Eligibility criteria:
disease characteristics: histologically proven metastatic, locally recurrent, or surgically unresectable colorectal carcinoma measurable disease no cns metastasis patient characteristics: age: 18 and over performance status: who 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 2,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl sgot no greater than 2.5 times normal (5 times normal if known liver metastases) renal: creatinine no greater than 1.5 mg/dl other: no severe concurrent infection not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no more than 1 prior chemotherapy regimen prior fluorouracil-based regimen for advanced colorectal cancer allowed prior fluorouracil with radiotherapy not considered therapy for advanced disease at least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered endocrine therapy: no concurrent steroids except for antiemesis or as replacement therapy radiotherapy: see chemotherapy no prior radiotherapy to more than 30% of bone marrow surgery: see disease characteristics at least 4 weeks since prior surgery unless fully recovered other: no concurrent vitamin supplements containing folic acid no other concurrent anticancer therapy

Keywords: stage iii colon cancer stage iv colon cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer
effects of gallopamil in severe asthma

Conditions: Asthma

Summary: severe asthma is a difficult to treat disease, characterized by bronchial remodelling, which is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. such remodelling is now considered as one of the main prognostic factors. gallopamil-sensitive calcium influx plays a key role in this remodelling process in vitro. the objective of this study is to compare the effects of gallopamil versus placebo on the bronchial smooth muscle remodelling in severe asthmatic patients.

bronchial remodelling mainly involves an increased mass of bronchial smooth muscle (bsm), which is related with an increase proliferation of smooth muscle cells. recently, using bsm cells obtained from severe asthmatics, we have demonstrated that such an increase proliferation was induced by an activation cascade (trian, j exp med, 2007). it first started with a gallopamil-sensitive calcium influx which induced the activation of calcium-calmodulin kinase iv (camk-iv). camk-iv then enhanced mitochondrial biogenesis through the subsequent activation of various transcription factors including pgc-1α, nrf-1 and mt-tfa. bsm cell proliferation was mainly mitochondria-dependent in vitro in severe asthma whereas that of controls was virtually mitochondria-independent. however, in vivo effects of gallopamil remain to be investigated. we will thus enrol 32 severe asthmatic patients in a phase 2 randomized double blind study against placebo and evaluate the effect of gallopamil on bsm remodelling. since inflammation also activates mitochondrial biogenesis in bsm cells, we will initially optimized asthma treatment for 3 months by both controlling co morbidities and decreasing bronchial inflammation using exhaled no and eosinophil count within the induced sputum. we will then perform fiberoptic fibroscopy before and after 12 month treatment with gallopamil.

Eligibility criteria:
inclusion criteria: * male or female aged more than 18 years * written informed consent * diagnosis of severe asthma according to ats criteria exclusion criteria: * smoker or former smoker * chronic viral infections (hepatitis, hiv) * aspergillosis * pregnancy * breastfeeding * contraindications to gallopamil or bronchoscopy

Keywords: asthma gallopamil airway remodelling smooth muscle
connection for latinos caring for a loved one with dementia

Conditions: Social Isolation; Loneliness

Summary: the purpose of this research study is to culturally adapt a personalized intervention for hispanic/latino caring for a loved one with significant memory problems. the intervention will be designed to help hispanics/latinos caring for a loved one with significant memory problems in their own unique context to: 1.) understand the importance of social connections for their own health and well-being, 2.) learn to become aware of their own personal barriers to social connections, and 3.) increase their knowledge of local resources for promoting social connections.


Eligibility criteria:
inclusion criteria: * current or previous hispanic/latino caregiver (english or spanish speaking) for a community-dwelling loved one with adrd, living with (or in close proximity to) loved one with dementia; * age 40 or older; * able to provide informed consent to participate in the research study. exclusion criteria: * primary language is not english or spanish; * current alcohol or substance abuse, psychotic disorders (current and lifetime), bipolar disorder and current mood disorders with psychotic features (mini international neuropsychiatric interview); * significant cognitive impairment on a cognitive screening measure at the harp screening assessment (telephone interview for cognitive status; tics \< 25); * hearing problems that preclude completion of the study.
radical radiotherapy and chemotherapy combined with maintenance chemotherapy in the treatment of stage n3 npc

Conditions: Nasopharyngeal Carcinoma

Summary: this study is a randomized, phase ii, prospective, multicenter clinical trial to evaluate the efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with n3.


Eligibility criteria:
inclusion criteria: 1. pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; 2. no distant metastatic stage n3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition uicc/ajcc nasopharyngeal carcinoma staging system defined as any t and n3m0 stage nasopharyngeal carcinoma). 3. aged 18-65; 4. at least one measurable tumor lesion; 5. ps (ecog standard) 0-1; 6. adequate hematopoietic function: wbc≥3.5×109/l, hb≥100g/l, plt≥100×109/l; 7. normal liver and kidney functions: alt/ast \< 2.5 times the upper limit of normal value (uln), total bilirubin \< 1.5×uln;serum creatinine \< 1.5×uln; 8. expected survival period ≥6 months; 9. signing informed consent; 10. follow up regularly and comply with test requirements. exclusion criteria: 1. patients with distant organ metastasis; 2. recurrent nasopharyngeal carcinoma; 3. creatinine clearance rate \<60ml/ min; 4. have received chemotherapy, radiotherapy or targeted therapy; 5. have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer); 6. serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc. 7. active systemic infection; 8. history of serious lung or heart disease; 9. drug or alcohol abuse; 10. no or limited capacity for civil conduct; 11. the patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; 12. receive chronic systemic immunotherapy or hormone therapy outside the study; 13. pregnancy or lactation period; 14. patients receive blind treatment in other clinical studies.
purified cd34+ cells versus peripheral blood mononuclear cells in treatment of critical limb ischemia

Conditions: Thromboangiitis Obliterans; Arteritis; Peripheral Arterial Disease

Summary: to compare the efficacy and cost-effectiveness between purified cd34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia


Eligibility criteria:
inclusion criteria: * rutherford scale of 4-5 * thromboangiitis obliterans, peripheral arterial disease, or arteritis caused by other etiologies, such as collagen diseases * surgical or endovascular procedures are considered unlikely to have successful long-term revascularization, or have failed * more than 4 weeks of critical limb ischemia * if present, a non-healing ulcer after more than 4 weeks of optimal care by a wound care physician and a nurse exclusion criteria: * within 3 months of an acute myocardial infarction * any contraindication for the administration of granulocyte colony stimulating factor (g-csf)
sequential vs. standard laser treatment of twin-twin transfusion syndrome

Conditions: Twin Twin Transfusion Syndrome

Summary: the investigators hypothesize that treatment of twin-twin transfusion syndrome (ttts) using sequential laser photocoagulation of communicating vessels (sqlpcv) over the predominant method, selective laser photocoagulation of communicating vessels (slpcv), may provide vascular stability to the donor fetus. the primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of ttts managed by sqlpcv vs. slpcv in a prospective, randomized trial.


Eligibility criteria:
inclusion criteria: * gestational age: 16 weeks, 0 days to 26 weeks, 0 days. * confirmed ttts patients, who by definition meet the following sonographic criteria: * single placenta. * polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage. * oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage. * thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic). * same gender, if visible. * quintero stages 1-4. * patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included. * patients with an anterior placenta may be included. * triplet gestations with two or three fetuses sharing the same placenta may be included. * patients must be able to give written informed consent. exclusion criteria: * patients unable or unwilling to participate in the study or to be followed up. * patients unable to give written informed consent. * presence of major congenital anomalies that may not warrant surgery. * known unbalanced chromosomal complement. * prior intentional septostomy (purposely making a hole in the dividing membrane). * ruptured membranes. * chorioamnionitis. * abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, dandy-walker syndrome, holoprosencephaly and agenesis of the corpus callosum. isolated ventriculomegaly (atrium 10-19 mm) may or may not be used as exclusion criteria. * placental abruption. * active labor. * patient unwilling to receive blood products. * recipient twin with a middle cerebral artery peak systolic velocity \> 1.5 multiples of the median (indicative of fetal anemia). * any other patient deemed inappropriate for the study by the principal investigator.

Keywords: twin twin transfusion syndrome sequential laser photocoagulation of communicating vessels
add-on study for protocol g200802 (nct02463032): effect of gtx-024 on maximal neuromuscular function and lean body mass

Conditions: ER+ and AR+ Breast Cancer

Summary: this is a multiple site, proof of concept feasibility study to describe the effect of gtx-024 9 or 18 mg on physical function in female subjects, from protocol g200802, with er+/ar+ breast cancer.


Eligibility criteria:
inclusion criteria: 1. in screening for, and ultimately randomized into, protocol g200802 2. give voluntary, written and signed, informed consent for this add-on study 3. age 18 to 70 years old 4. physically capable of mounting and riding a stationary bicycle 5. subject agrees to not significantly alter physical activity or current physical training during the study period exclusion criteria: 1. subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the investigator 2. subjects unwilling to or unable to comply with the protocol 3. any other condition which per investigators' judgement may increase subject risk
rivaroxaban (10mg) given once daily in patients undergoing total hip replacement compared to enoxaparin

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to assess if 10 mg bay 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years or above * patients scheduled for elective total hip replacement exclusion criteria: * planned, staged total bilateral hip replacement * active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin * contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin * conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)

Keywords: prevention thromboembolism
a study to evaluate edp-235 in non-hospitalized adults with covid-19

Conditions: COVID-19

Summary: study of edp-235 in non-hospitalized adults with mild or moderate covid-19.


Eligibility criteria:
inclusion criteria: * sars-cov-2 infection confirmed by positive test ≤24 hours before randomization * covid-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to covid-19 present and one of at least moderate severity at screening exclusion criteria: * prior sars-cov-2 infection \<90 days before enrollment and/or received any covid-19 vaccine dose \<90 days before enrollment * has one or more conditions associated with high risk for severe covid-19 * history of hospitalization for the medical treatment of covid-19 * currently hospitalized or anticipated need for hospitalization in the clinical opinion of the investigator * known medical history of active liver disease * receiving dialysis or have known moderate to severe renal impairment * suspected or confirmed concurrent active systemic infection other than covid-19 that may interfere with the evaluation of response to the study drug * any comorbidity requiring hospitalization and/or surgery within 7 days before study entry, or that is considered life threatening within 30 days before study entry * known hiv infection with a hiv viral load greater than 400 copies/ml or medication for hiv treatment that is prohibited in this study based on medical history within 6 months before the screening visit * history of hypersensitivity or other contraindication to any of the components of the study drug * has received or is expected to receive pre-exposure prophylactic sars-cov-2 mab * has received or is expected to receive convalescent covid-19 plasma * oxygen saturation of ≤93% on room air obtained at rest within 24 hours before randomization * participating in another interventional clinical study with an investigational agent or device, including those for covid-19, within 30 days or five half-lives of the agent, whichever is longer, before signing the icf * females who are pregnant or breastfeeding

Keywords: sars-cov-2, standard risk
connective tissue disease patients with pulmonary hypertension

Conditions: Connective Tissue Diseases; Pulmonary Hypertension

Summary: adult patients with suspected or confirmed connective tissue disease patients (ctd)with pulmonary hypertension(ph)will be recruited. patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. the collection of data and biological material will mirror usual clinical practice as far as possible. subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.


Eligibility criteria:
inclusion criteria: * definite diagnosis of ctd included systemic lupus erythematosus（sle） diagnosed according to the 2019 the european alliance of associations for rheumatology（eular） criteria, primary sjogren's syndrome (pss) defined according to the 2016 american college of rheumatology(acr) criteria, systemic sclerosis(ssc) defined according to the 2013 acr criteria, mixed connective tissue disease (mctd) defined by sharp criteria, and rheumatoid arthritis(ra) defined according 2010 acr criteria of two or more ctd at the same time were defined as having overlap syndrome (os). patients who had clinical and serological manifestations suggestive of systemic autoimmune diseases but did not fulfil the classification criteria for ctd were defined as having undifferentiated ctd (uctd). * pah was diagnosed by right heart catheterization was defined as mean pulmonary artery pressure (mpap)\>20 millimeters of mercury（mmhg）, pulmonary artery wedge pressure（pawp）≤15mmhg, pulmonary vascular resistance（pvr）\>2 wood exclusion criteria: * significant interstitial lung disease or chronic obstructive pulmonary disease; * left heart disease or congenital heart disease associated with pulmonary hypertension; * chronic thromboembolic pulmonary hypertension; * portal hypertension; * drug or toxin exposure; * hiv infection; * any other diseases known to be associated with pah; * age\<18 years.

Keywords: prognosis , biomarker, pulmonary hypertension