Kornimate/medical-research-clean huggingface dataset:
evaluation of co2 rebreathing during exercise with the increasing ventilation assisted by niv with a dual-limb circuit

Conditions: Chronic Obstructive Pulmonary Disease

Summary: ventilated by a single-limb tubing with pev caused co2 rebreathing to copd patients during exercise with the increasing ventilation. the aim of this study was to evaluate whether co2 rebreathing could be avoided with the use of the dual-limb circuit, to provide a theoretical basis of more rational clinical application of niv in the setting of increasing ventilation(eg, after exercise).

exercise training is a key component of pulmonary rehabilitation. it has shown signifcant improvements in both exercise tolerance and quality of life in patients with copd. the intensity of exercise training is of great importance to yield a true physiologic effect. however, in patients with severe copd, exertional dyspnea and leg fatigue make it impossible for the patient to maintain intensity of training for enough time to achieve a physiologic training effect. niv has been reported to be used as support for exercise to improve exercise tolerance and respiratory performances in patients with mild-to-severe copd with inconsistent results. evidence from previous studies have suggested that niv with a single-limb circuit with whisper swivel ii expiratory valve or plateau exhalation valve assisted during exercise in patients with copd caused co2 rebreathing. co2 rebreathing may have a negative impact on efficacy. previous studies have proved that exercise tolerance was improved ventilated by niv with a dual-limb circuit. in theory, niv with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing. however, there was no report on whether there's no risk of rebreathing in copd patients ventilated during exercise by a dual-limb circuit. therefore, the aim of the study was to determine whether there was no co2 rebreathing occurred assisted with niv with dual-limb circuit in patients with stable severe copd after exercise with exertional dyspnea.

Eligibility criteria:
inclusion criteria: * presented clinically stable (no exacerbation in the 4 weeks prior to study * participation or with no change in medications); * physician diagnosed copd, forced expiratory volume in 1s (fev1) \< 50% predicted; dyspnea as a main symptom that limited daily activities. exclusion criteria: * subjects with obvious pulmonary bullae demonstrated by chest ct scan or x-ray; examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving niv therapy; * a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations; * a history of uncontrolled hypertension, or other respiratory diseases; * patients with musculoskeletal or neurological disorders; * failure to comply with the research protocol.
study of chlorhexidine as the hub antiseptic to prevent catheter related infections in newborn infants

Conditions: Catheterization

Summary: the purpose of this study is to prevent catheter-related infections in newborn infants admitted to the neonatal intensive care unit (nicu). this study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters.

catheter-related bloodstream infections (crbsis) are a major cause of morbidity and mortality in infants admitted to the nicu. in adults, chlorhexidine used as a skin antiseptic has been shown to reduce the incidence of crbsis, and recent evidence indicates the inner surface of long-term central catheters as the likely route of infection. this study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce catheter tip microbial colonization, an indication of high risk for acquiring crbsi. the purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus isopropyl alcohol in reducing central catheter-related infections in neonates. this study also aims to compare the time to catheter hub microbial colonization in the two groups and to determine the route of catheter tip colonization by comparing cultures taken from the catheter tip, hub, and skin insertion site. this study will last 1 year. there are no study visits. the placement and removal of the catheter will be determined by the discretion of the attendant caring for the participant. participants will be randomly assigned to one of two groups. catheters of group 1 participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous tubing change. catheters of group 2 participants will be treated with isopropyl alcohol. for both groups, cultures of the inner surface of the catheter hub will be performed twice a week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site will be performed upon removal of the catheter.

Eligibility criteria:
inclusion criteria: * admitted to the nicu * umbilical vein catheter or peripherally inserted central venous catheter (picc) anticipated to be in place for more than 48 hours * parent or guardian able to give informed consent prior to first hyperalimentation and total parenteral nutrition tubing change exclusion criteria: * known crbsi-positive blood culture at the time of catheter line placement. * not expected to survive for more than 48 hours * broviac or any other surgically-placed central catheters * any condition that, as determined by the investigator, would interfere with evaluation of the line or be a potential health risk to the participant

Keywords: catheter related bloodstream infections infant, newborn intensive care units, neonatal neonatal central line infections
a study comparing daily treatment with valaciclovir to placebo for suppression of herpes simplex virus hsv-2 genital herpes in newly diagnosed patients. valtrex® tablet is a trademark of the glaxosmithkline group of companies.

Conditions: Herpes Genitalis

Summary: genital herpes (gh) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (hsv). there are two types of hsv, type 1 (hsv-1) and type 2 (hsv-2); both can cause gh, although the latter is much more likely to produce frequent recurrences of gh lesions. evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with hsv-2 genital herpes.


Eligibility criteria:
inclusion criteria: * in overall general good health. * females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use gsk stipulated contraceptive methods. * must be newly diagnosed with a first recognized episode of gh at the time of the screening visit or within 3 months prior to the screening visit. exclusion criteria: * known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for hiv). * received an investigational drug in the 30 days prior to the study. * receiving systemic antiviral or immunomodulatory treatments. * must not have received systemic antiviral treatments (e.g., valaciclovir, famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug. * clinically significant impaired renal function as defined by a creatinine clearance \<30 ml/min, calculated using the cockcroft-gault formula. * clinically significant impaired hepatic function defined as an alt (alanine transaminase) level \> 5 times the normal upper limit. * subjects with active liver disease. * known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations. * known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir. * subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics. * women contemplating pregnancy within the duration of the study drug dosing period. * women who are pregnant and/or nursing mothers * current history of alcohol or drug abuse. * received suppressive (daily) therapy for genital herpes prior to enrollment.

Keywords: valtrex® valaciclovir genital herpes hsv-2 suppression
first in man study of implantable alginate hydrogel

Conditions: Heart Failure

Summary: the objective of this clinical research is to evaluate the safety and effectiveness of implantable alginate hydrogel to reconstruct the left ventricle in the treatment of heart failure


Eligibility criteria:
inclusion criteria: 1. the patients must have been able and willing to give written informed consent 2. the patients should be adult (age≥ 18 years and \<75 years) males or females 3. the patients must have been on stable, evidence-based therapy for hf 4. the patients have a lvef ≤35% 5. nyha is classified as grade iii or iv 6. if female, the patients must have been (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of the study device. exclusion criteria: 1. have undergone any therapeutic traumatic heart surgery within 30 days. 2. hemodynamic instability or cardiogenic shock. 3. right-sided hf. 4. patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis. 5. history of constrictive pericarditis. 6. history of stroke (within 60 days prior to the surgical procedure). 7. history of myocardial infarction (within 30 days prior to the surgical procedure). 8. an lv wall thickness of the lv free-wall, at the mid-ventricular level, of \< 6 mm. 9. serum creatinine \> 2.0 mg/dl, or calculate creatinine clearance rate \<25 ml/min 10. clinically significant liver enzyme abnormalities, i.e., aspartate aminotransferase (ast) or alanine aminotransferase (alt) more than 2 times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal. 11. had been receiving concurrently an investigational product in another clinical trial or had received an investigational product in another clinical trial in the 30 days prior to enrollment. 12. a life expectancy of \< 1 year due to comorbidities . 13. unfit for the minimal invasive treatment.

Keywords: caused by ischemic cardiomyopathy caused by non-ischemic cardiomyopathy
echocardiography-based motion integration and management for substrate characterization and star therapy in ventricular tachycardias

Conditions: Ventricular Arrythmia

Summary: prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia radioablation.

this is a prospective, observational, single center, pilot study. data from preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3d transthoracic echocardiography of patients receiving catheter ablation for ventricular arrhythmia will be analyzed by means of artificial intelligence in order to better characterize the ventricular arrhythmogenic substrate and to improve the definition methods of the planning target volume during the stereotactic arrhythmia radioablation therapy by integrating the motion data into volume demarcation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * indication for catheter ablation of ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions) * indication for preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization exclusion criteria: * platelet count \< 100,000 cells/mm3 * bmi \> 45 kg/m2 or \< 18 kg/m2

Keywords: ventricular arrhythmia ventricular tachycardia stereotactic arrhythmia radioablation artificial intelligence motion management motion integration
correlation between intraoperative tourniquet use and limb ph, functional measures and patient-reported outcomes after ankle fracture surgery

Conditions: Ankle Fractures; Ankle Fracture - Lateral Malleolus; Ankle Fracture, Bimalleolar; Ankle Fracture, Trimalleolar; Ankle Fracture - Medial Malleolus; Maisonneuve's Fracture; Syndesmotic Injuries; Fibula Fracture

Summary: this study aims to 1) characterize skeletal muscle ph during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.

tourniquets are widely accepted as "safe" for up to two hours of continued use, despite known risks and a paucity of literature supporting this duration. complications of tourniquets include tourniquet site pain, increased surgical site pain and swelling from reperfusion, neuropraxia, vascular injury, functional weakness, and decreased muscle endurance. similar to compartment syndrome, tourniquets eliminate the tissue perfusion gradient necessary for oxygen, glucose, and lactic acid exchange. lack of molecular exchange within the tissue is thought to result in tissue anoxia and acidosis, leading to cellular death of skeletal muscle and nerves. this study randomizes patients undergoing ankle fracture surgery to tourniquet or no-tourniquet arms and studies outcomes including continuous intramuscular ph during and after surgery, and patient-reported outcomes and functional measures up to 3 months postoperatively.

Eligibility criteria:
inclusion criteria: * adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at ohsu exclusion criteria: * sepsis * other significant long bone or internal injuries (including ipsilateral limb injuries).
ag & im in ca stomach protocol

Conditions: Gastric Cancer; Atrophic Gastritis; Intestinal Metaplasia

Summary: this is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.

the case control study would compare which type of assessment (endoscopic / histological) is more accurate in predicting the risk of gastric cancer development. the risk factor assessment would be based on the following criteria. endoscopic assessment: 1. atrophic gastritis, based on kimura takemoto classification 2. kyoto classification of gastritis 3. intestinal metaplasia, based on endoscopic mapping and grading of intestinal metaplasia (eggim) histological assessment (based on random biopsies) 1. operative links on gastritis assessment 2. operative links on gastric intestinal metaplasia

Eligibility criteria:
two groups of patients would be recruited in this case control study. 1. gastric neoplasia group patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia. 2. control group patients with no prior history of gastric dysplasia or cancer inclusion criteria: 1. age 40 or above 2. undergo elective upper gastrointestinal endoscopy exclusion criteria: 1. patients with history of gastrectomy 2. patients with severe thrombocytopenia (platelet count \ 1.5 or on anticoagulation) 3. contraindication to upper gastrointestinal endoscopy 4. allergy towards sedative agents (midazolam / diazepam) or local anaesthetic spray (lignocaine) 5. patients who cannot give informed consent

Keywords: gastric cancer gastroscopy atrophic gastritis intestinal metaplasia
musical intervention on stress effects in critically ill patients

Conditions: Critical Care; Respiration, Artificial; Sedation

Summary: aim: to evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.

design, setting and study subjects: a randomized clinical trial will be conducted in the icu of a spanish tertiary hospital. the study subjects will be adults, intubated, subjected to invasive mechanical ventilation, arterial catheter undergoing invasive mechanical ventilation, carrying an arterial catheter, with an adequate level of sedation and who do not present pain during the intervention. variables: the main variable will be total serum cortisol, prolactin, interleukin-6 levels. secondary variables: secondary variables will be those used to measure physiological parameters to assess the patient's hemodynamic status of the patient in relation to the intervention. data collection: there will be 2 groups: intervention and control. the sample will be randomized as patients are admitted. first, they will be receiving the corresponding daily care. the first group of patients will receive the corresponding daily care. the patients in the intervention group will start the music therapy session through headphones, the patients in the control group will remain relaxed without any interruption during this time. all the variables will be collected before starting the study, during the study and at the end of the study. data analysis: a descriptive analysis of each variable will be performed. subsequently, a bivariate analysis, previously checking the normality and homoscedasticity of the data.and homoscedasticity of the data. if statistically significant, post-hoc tests will be performed using dunn's test.dunn's test. statistical significance will be accepted when p ≤ 0.05.

Eligibility criteria:
inclusion criteria: * adults * admitted to the icu for a minimum of 24 hours * intubated patients undergoing invasive mechanical ventilation * arterial catheter carriers / central venous catheter * sedation level: bis: 40 - 60 * no pain at the time of and during the procedure, which will be measured by a score of 0 on escid scale * not having previously undergone any other musical intervention. exclusion criteria: * severe neurological disease or injury (cns pathologies such as encephalitis, diffuse axonal injury, etc.) * severe psychiatric illness * suspected or confirmed drug or alcohol overdose/intoxication/abstinence * hearing impairment * skull lesions that preclude the use of headphones * patients with limitation of therapeutic effort or death expected within 24 hours * brain death diagnosis * failure to obtain informed consent from the legal representative within 72 hours of presentation * refusal of the responsible physician.

Keywords: music therapy anxiety critical care nursing stress, psychological respiration, artificial
exercise training in icd recipients; effect on therapy delivered, depression and anxiety

Conditions: Ventricular Tachycardia

Summary: interventional study in patients with icd. controlled, open intervention with exercise training. assessment of changes in physiological and psychological parameters.

icd therapy with dc shock is associated with impaired quality of life and development of anxiety and depression. in a selected group of patients with icd the intervention with organized high intensity training is evaluated. peak vo2, inflammatory profile, performed interventions by the icd and psychological profile is assessed. in addition a qualitative evaluation using interviews is performed.

Eligibility criteria:
inclusion criteria: * inclusion criteria: age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by cmr, implanted icd exclusion criteria: * planned revascularisation by bypass surgery or percutaneous coronary intervention following the icd implantation, planned arrhythmia ablation, long qt-syndrome, brugada syndrome, wpw syndrome, drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, myocardial bridging, ongoing myocarditis, recent chest trauma,

Keywords: icd, training
study of immune thrombocytopenia pathogenesis:

Conditions: Primary Immune Thrombocytopenia (ITP)

Summary: immune thrombocytopenia (itp) is an autoimmune disease characterized by a low platelet count responsible for bleedings. the disease is mostly mediated by antiplatelet antibodies produced by specific b cells. however, t cells are also involved but their role is not completely understood. the aim of this study is to determine the implication of t cells in the pathogenesis of itp, notably regulatory t cells (treg, cd4+cd25highfoxp3+), cytotoxic t cells (cd3+cd8+) and t follicular helper cells (tfh, cd3+cd4+cxcr5+pd-1+icos+), in blood and in the spleen of primary itp patients, compared to healthy controls.


Eligibility criteria:
inclusion criteria: * patients with itp, defined as thrombocytopenia \< 30 g/l, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out * persons who have provided written informed consent exclusion criteria: * persons without national health insurance * persons under 18 years old * patients under guardianship * pregnancy * subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
to compare the ability of discovisc® ovd to protect the corneal endothelium and maintain anterior chamber space with healon® and amvisc® plus during cataract surgery.

Conditions: Cataract

Summary: the objective of the study is to assess how discovisc ophthalmic viscosurgical device (ovd) compares with healon and amvisc plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.


Eligibility criteria:
inclusion criteria: * patients able to understand and sign a document of informed consent; * patients aged ≥49 years with age-related cataract formation; * patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens; * patients that have healthy eyes excluding the formation of cataract. exclusion criteria: * pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye; * a congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye; * iris atrophy in the operative eye; * glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye; * any abnormality which prevents reliable goldmann applanation tonometry in the operative eye; * ocular hypertension (lntraocular pressure (iop) \> 21 mmhg) in the operative eye at the baseline exam; * corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement; * baseline endothelial cell density \< 1500 cells/mm2, in the operative eye; * planned multiple procedures during cataract/intraocular lens (iol) implantation surgery (e.g., trabeculoplasty, corneal transplant). note: a minor relaxing keratotomy * patients 48 years of age or younger; * proliferative diabetic retinopathy in the operative eye; * uncontrolled diabetes mellitus; * marfan's syndrome; * an ocular disease and/or condition that may compromise results; * a history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye; * lens for the correction of astigmatism may be performed; * previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). note: history of non-invasive laser surgery (with the exception of laser treatment for pdr) is acceptable for inclusion; * a non-functional fellow eye; * participation in any other clinical study within the 30 days before surgery

Keywords: cataract