Kornimate/medical-research-clean huggingface dataset:
occurrence of ventilator associated pneumonia in italian icu using cuffed tracheostomy tubes with subglottic secretion drainage

Conditions: Respiratory Failure

Summary: ventilator-associated pneumonia (vap) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation. vap is associated with the contamination and colonization of bacteria in the lower airway. these bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount. patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. these tubes may have a distal cuff which sits within the trachea. when the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. these secretions may leak around the cuff and cause tracheobronchial colonization. it has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of vap. the purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to vap incidence


Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation for respiratory failure for at least 72 hours. * a score of 35 to 65 on the simplified acute physiology score ii (saps ii). * does not have a pulmonary infection estimated by a clinical pulmonary infection score (cpis). * age \>= 18 years. * have no exclusion criteria exclusion criteria: * a history of esophageal, tracheal or pulmonary cancer or an existing malignancy within the trachea at the tracheostomy site. * previous surgery at the tracheostomy site (e.g. thyroidectomy). * bleeding diathesis (e.g. due to anticoagulation therapy). * emergency surgical airway management. * morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy tube too short). * pre-existing infection at the tracheostomy site. * uncertainty in identifying the anatomical landmarks. * patients with a do not resuscitate order. * immunosuppressed and/or immunodepressed patients (immunodepression being defined by the following conditions: 1-leukocytes \ 0.5 mg/kg) for more than 30 days) * patients already enrolled in other trials

Keywords: patients mechanical ventilation tracheostomy
estimation of (supar) in chronic periodontitis with post-radiotherapy on hncs patients

Conditions: Head and Neck Cancer; Chronic Periodontitis; Radiotherapy Side Effect

Summary: this study aims to improve a soluble urokinase plasminogen activator receptor supar is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (hnc post-rt).

the urokinase-type plasminogen activator receptor (upar) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. the study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (cp+hnc post-rt) patients, 50 chronic periodontitis (cp) without hnc patients, and 50 healthy controls. clinical attachment loss (cal), probing pocket depth (ppd), plaque index (pi), and gingival bleeding index (gbi) were recorded. an enzyme-linked immunosorbent assay (elisa) was constructed to quantify serum (supar) levels.

Eligibility criteria:
inclusion criteria: * a pathologically confirmed malignant neoplasm of hnc (derived from epithelial cells). * not having received radiation therapy previously. * no distant metastasis. * no history of salivary gland surgery (parotid, submandibular, or sublingual). * a generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability. exclusion criteria: * previous oral disease or salivary gland disease history. * definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease. * refusal to participate in the study.

Keywords: chronic periodontitis head and neck cancer radiotherapy
a study of rapastinel as adjunctive therapy in the prevention of relapse in patients with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: this study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (iv) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (adt) in the prevention of relapse in participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at screening * have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test. exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before screening * lifetime history of meeting dsm-5 criteria for: * schizophrenia spectrum or other psychotic disorder * bipolar or related disorder * major neurocognitive disorder * neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study * dissociative disorder * posttraumatic stress disorder * mdd with psychotic features * significant suicide risk, as judged by the investigator.
study of hydroxychloroquine with folfiri and bevacizumab in dtp-high metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this is a two arm, 2-center, phase ii, study of 5-fu, irinotecan, bevacizumab (folfiri-beva) and hydroxychloroquine (hcq) in patients with previously untreated metastatic colorectal cancer (mcrc). up to 155 patients will be screened for dtp-signature and up to 31 evaluable patients who are determined to be dtp-signature high will be treated with folfiri-beva and hcq. patients will continue to receive treatments until evidence of disease progression, intolerable side effects, withdrawal of consent or death.


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal cancer, not amenable to curative resection. * microsatellite stable/mismatch repair proficient (mss/pmmr) colorectal cancer. * no prior systemic therapy for metastatic disease. * evaluable disease based on recist 1.1 criteria. * adequate hematological, hepatic and renal functions * eastern cooperative oncology group (ecog) performance status 0-1. * estimated life expectancy of \> 6 months. * negative pregnancy test for female patients with child-bearing potential. * no history of retinal disorder. * no history of glucose-6-phosphate dehydrogenase deficiency (g6pd) . * considered to be dtp-signature high to receive hcq treatment exclusion criteria: * women who are pregnant or nursing. * have received radiotherapy, chemotherapy, biological therapy, or investigational treatment less than four weeks (six weeks for nitrosoureas or mitomycin c) prior to first dose of folfiri-beva or have not recovered from all acute toxicities from prior treatments to grade 1 or less, with the exception of alopecia and those deemed not to affect safety assessment. * have concurrent malignancy with exception of malignancy that was treated curatively and without evidence of recurrence within 3 years of study enrollment, or fully resected basal or squamous cell skin cancer and any carcinoma in situ which are considered to be of low risk of recurrence. * have had major surgery within 28 days of study enrollment. placement of a venous access device within 28 days of starting therapy is allowed. * have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting. * known central nervous system metastasis. patients with history of central nervous system metastases are eligible if they are clinically and radiographically stable for at least 3 months and not taking steroids or anticonvulsants.
chewing efficiency measured by a two colour chewing gum test in amyotrophic lateral sclerosis (als) patients?

Conditions: Amyotrophic Lateral Sclerosis 11

Summary: study aims: the primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in als patients.

study center: university hospitals of geneva study type: cohort study with matched controls study population: 25 als patients included in the multidisciplinary cohort study of the university hospital geneva between october 2012 and october 2014 and followed for 3 years maximum and 25 controls, matched for age, sex and dental status. study duration: inclusion from october 2012 to october 2016. follow-up for 3 years. study hypothesis: chewing efficiency, maximum bite and lip force decrease with time in als patients and may be a marker of texture adaptation and peg necessity. study aims: the primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in als patients. the secondary aims are to determine, in als patients, whether: * maximum bite and lip force decrease. * chewing efficiency, maximum bite and lip force decrease more in als patients with bulbar than with spinal onset. * chewing efficiency and bite force correlate with energy intakes, nasofibroscopic assessment, and a validated swallowing questionnaire. * saliva volume increases with time and progression of disease and influences masticatory efficiency. * saliva volume is associated with nasofibroscopy assessment. methods : every three months, we will perform: * as part of the ongoing cohort study (already accepted by the ethical committee) calculation of energy intakes through a 24h recall, nasofibroscopy, swallowing questionnaire and score of disease severity. * as part of this study: assessment of dental status at first visit, chewing efficiency test by a with a colour mixing ability test, maximum voluntary bite and lip force, saliva volume and calculation of a 3-day dietary recall instead of a 24h recall. statistics: evolutions with time and between groups, of chewing efficiency, bite and lip force will be assessed by repeated measures anova. correlations between two continuous variables will be examined by spearman's correlation coefficients at the different time points. correlations between a continuous variable and a binary variable (nasofibroscopic assessment) will be explored by logistic regression with mixed effect model.

Eligibility criteria:
inclusion criteria: * als patients * \> 18 years * participation in the cohort study exclusion criteria: * refusal of participating in the cohort study * presence of peg
a national school-based health lifestyles interventions among chinese children and adolescents against obesity

Conditions: Pediatric Obesity

Summary: the study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in china. in each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (primary: secondary=1:1). all of the selected schools were randomly allocated to either intervention or control group (intervention: control=1:1).the multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. the intervention consisted of four components: a) create supportive school and family environment, b) health lifestyles education and related compulsory physical activities, c) instruct and promote school physical education, d) self-monitor obesity related behaviors. four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.


Eligibility criteria:
inclusion criteria: grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools. exclusion criteria: suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Keywords: chinese multi-centered school based obesity intervention
time-restricted eating to address persistent cancer-related fatigue

Conditions: Neoplasms; Therapy; Fatigue; Diet Therapy; Time; Survivorship; Fasting, Intermittent

Summary: this study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. participants will be randomized 1:1 to one of two arms: time-restricted eating or control. those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. this study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. the hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. the second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.


Eligibility criteria:
inclusion criteria: * have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling, * have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "in the last week, how bad was your worst fatigue on a scale from 0-10?" * be able to speak and/or read and write in english, * be at least 18 years old, * own a smartphone, * be willing and able to adhere to study procedures, including use of a smartphone app, and * be able to provide informed consent. exclusion criteria: * already eat all their food within a window that is 10 h or shorter most (6/7) days of the week, * be underweight, as defined as a body mass index ≤18.5 kg/m2, * have surgery planned during the study duration, * have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder), * be taking insulin, or * be on enteral or parenteral nutrition.
a continuation study to monitor the long term safety of patients completing protocols acu-p08-020/020a

Conditions: Presbyopia

Summary: this is a 2 year follow up study to monitor the long term safety of the aci 7000pdt in subjects who are still implanted with the aci and have successfully completed the acu-p08-020/020a studies.

this is a two year follow up study designed to monitor and obtain long-term safety data of the aci 7000pdt in subjects who participated and successfully completed the acu-p08-020/020a studies. subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written informed consent form prior to participating. this continuation study follows subjects still implanted with the aci and includes two visits, at 12-month intervals, after subjects have been exited (at month 36) from the acu-p08-020/020a studies. the first visit is at month 48 following implantation followed by a final month 60 visit. the study parameters being measured at these two visits include: * specular microscopy * slit lamp and fundus examination (ocular health) * corrected and uncorrected visual acuity * manifest mid-point refraction * corneal topography * dry eye assessment * mesopic and photopic contrast sensitivity * adverse events and complications all sites participating in the acu-p08-020/020a studies were invited to participate in the continuation study.

Eligibility criteria:
inclusion criteria: * patients must have completed participation in the acu-p08-020/020a clinical trial. * patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written informed consent form. exclusion criteria: * patients who did not complete acu-p08-020/020a.

Keywords: presbyopia
post-transplant pt/flu+cy promotes unrelated cord blood engraftment in haplo-cord setting in childhood leukemia

Conditions: Leukemia; Stem Cell Transplant; Cord Blood

Summary: to determine if the novel regimen of pt/flu+cy promotes cord blood engraftment in children's leukemia hsct cohort

ptcy is a well-established haploidentical transplant regimen strategy. moreover, unrelated cord blood (ucb) plays a critical role in the effects of gvl. however, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. therefore, applying a novel post-transplant regimen of pt/cy+flu may selectively promote ucb engraftment in the setting of haplo-cord transplant.

Eligibility criteria:
inclusion criteria: * children acute leukemia exclusion criteria: * mods
interaction between the brain hemispheres - key to motor recovery after stroke

Conditions: Stroke

Summary: rationale: acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. non-invasive brain stimulation methods, like transcranial magnetic stimulation (tms), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. application of continuous theta burst stimulation (ctbs), an inhibitory form of tms, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. however, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional ctbs facilitates recovery of motor function remain unclear. objective: to determine if contralesional ctbs normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. age-matched healthy persons will serve as controls. study design: a prospective, open-label within-subject intervention study study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls. main endpoints: primary endpoint: interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. secondary endpoints: contralesional intracortical inhibition; effect of contralesional tms interference on finger tapping frequency.


Eligibility criteria:
inclusion criteria for patients: * age ≥ 18 years; * first-ever ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem; * unilateral paresis of an upper extremity with a motricity index (mi) between 9 and 99 * inclusion possible between 3 weeks and 6 weeks after stroke onset; * signed informed consent. inclusion criteria for healthy controls: * age ≥ 18 years; * signed informed consent. * normal motor function with a minimum motricity index (mi) of 99. exclusion criteria: * disabling medical conditions (severe heart disease, severe head trauma, severe mental illness); * severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician; * contraindications to tms and/or mri (ferrous implants, history of epilepsy, drug or alcohol abuse over a period of 6 months prior to the experiment, pregnancy); * life expectancy shorter than one year; * upper limb paresis prior to stroke onset.

Keywords: stroke transcranial magnetic stimulation continuous theta burst stimulation upper limb recovery tms ctbs interhemispheric inhibition
study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts

Conditions: Allergy, Peanut

Summary: a study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. the efficacy will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

this is a one month, phase 2, multi-center, randomized, investigator- and participant-blinded, placebo controlled study to assess the safety, efficacy and tolerability of remibrutinib (lou064) in 3 doses of oral tablet twice a day in participants with a medically confirmed diagnosis of ige-mediated peanut allergy. participants will be randomized to remibrutinib low, medium or high dose for one-month treatment period (up to 5 weeks). participants will have oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.

Eligibility criteria:
inclusion criteria: * medical history of allergy to peanuts * positive peanut ige \>= 0.35 kua/l * positive skin prick test for peanut allergen during screening for study * positive oral food challenge to peanut during screening for study * willingness to comply with study schedule and procedures and avoid other allergens during study period exclusion criteria: * history of severe or life-threatening hypersensitivity event leading to icu admission or intubation within 60 days of screening * uncontrolled asthma * bleeding risk or coagulation disorder(s) * use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted) * history of splenectomy * any significant disease that would put the safety of the patient at risk. this includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of gi bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: groundnut hypersensitivity hypersensitivity, peanut peanut allergy food allergy oral food challenge ige remibrutinib btki
ranolazine in ischemic cardiomyopathy

Conditions: Cardiomyopathy; Chest Pain; Dyspnea

Summary: patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. the purpose of this study is to determine the efficacy of taking ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.


Eligibility criteria:
inclusion criteria: 1. ischemic cardiomyopathy patients on optimal medical treatment. optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, ccb or nitrates). unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an acei/arb. 2. anginal chest pain or dyspnea 3. documentation of non treatable or optimally treated coronary artery disease 4. ejection fraction of less than or equal to 40% exclusion criteria: 1. less than 18 years of age 2. pregnant or breast feeding 3. patients with non ischemic cardiomyopathy