Kornimate/medical-research-clean huggingface dataset:
oxitone sp02 hypoxia test versus reference pulse oximetry

Conditions: Hypoxia

Summary: the purpose of this study is to conduct a spo2 hypoxia evaluation of the oxitone medical oxitone 1000 pulse oximeter. the oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% spo2 in comparison to a reference pulse oximeter. the study is observational in nature which quantifies device performance and accuracy in compassion to a reference pulse oximeter.

the purpose of this study is to conduct a spo2 hypoxia evaluation of the oxitone medical oxitone 1000 pulse oximeter. the oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% spo2 in comparison to a reference pulse oximeter. the end goal is to show the spo2 accuracy performance of the oxitone 1000 and if needed, use the data to make improvements prior to an arterial blood hypoxia study. a clinimark 3900 reference pulse oximeter or nellcor n-600x will be used for the spo2 calibration. there are no risks or adverse device effects to be assessed. there are no contraindications for use in the proposed study / study population the control pulse oximeter, ge healthcare (datex-ohmeda) 3900, an fda cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. this device is used to assess the stability of the data.

Eligibility criteria:
inclusion criteria: * healthy individuals between the age of 18-50 exclusion criteria: * clotting disorders, diabetes, currently taking psychotropic medications

Keywords: pulse oximetry temperature respiratory rate respiratory gases this study determines the measurement accuracy of the physiological parameters
long-term follow-up gene therapy study for leber congenital amaurosis optirpe65 (retinal dystrophy associated with defects in rpe65)

Conditions: Leber Congenital Amaurosis (LCA); Eye Diseases; Eye Diseases, Hereditary; Retinal Diseases

Summary: this study is a longer-term follow-up study for patients who have been administered aav2/5-optirpe65 in the phase i/ii, open label, non-randomised, two-centre, dose escalation trial in adults and children with retinal dystrophy associated with defects in rpe65.

the follow up study is designed to collect data on longer-term safety and efficacy of aav2/5-optirpe65 administration in the optirpe65 trial.

Eligibility criteria:
inclusion criteria: * were enrolled and treated in the prior open-label, phase i/ii, dose escalation study involving intraocular administration of aav2/5-optirpe65 exclusion criteria: * individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
epicardial mitral touch system for mitral insufficiency

Conditions: Ischemic Mitral Regurgitation; Functional Mitral Regurgitation

Summary: to evaluate the safety and performance of the mitral touch system to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

the mitral touch systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (cpb) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional mr.

Eligibility criteria:
inclusion criteria: * moderate or greater (2+) ischemic * functional mitral regurgitation by 2d echocardiography using an integrative method * patient is scheduled for cardiac surgery (e.g. cabg including patients on the waiting list for heart transplantation) * patient is 22 years of age or older * patient is willing and able to sign informed consent form * within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the united states exclusion criteria: * any evidence of structural (chordal or leaflet) mitral valve disease * inability to derive ero, lvesvi or lvedvi by tte * prior surgical or percutaneous mitral valve intervention * contraindication to cardiopulmonary bypass (cpb) * clinical signs of cardiogenic shock * treatment with chronic intravenous inotropic therapy * severe, irreversible pulmonary hypertension in the judgement of the investigator * st segment elevation requiring intervention within 7 days prior to randomization * congenital heart disease (except pfo or asd) * evidence of cirrhosis or hepatic synthetic failure * renal insufficiency (egfr \< 30 ml/min) * history of endocarditis or current endocarditis * ejection fraction \<25% * ny heart class iv * mv diameters \> 7cm * any coronary artery calcification at site of placement as determined by angiogram * myxomatous mitral regurgitation * women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable) * abnormal cardiac anatomy discovered prior to surgery or during procedure * pericardial adhesions * insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (no device remains, patient moved to only 30-day follow-up.)
a comparative study of incentive spirometry and positive expiratory pressure in chest trauma

Conditions: Trauma Chest

Summary: chest trauma (ct) patients with 3 or more ribs fractures with or without pleuropulmonary injury are an indicator of severity. chest physiotherapy (cp) and analgesia is the first line treatment in these patients. the aim study is to evaluate the effect of positive expiratory pressure (pep) breathing compared to the incentive spirometry in terms of pain control in the recent phase of ct.

after acceptance to participate in the study, patients will be computerized randomized into 2 groups: * pep group: positive expiratory pressure (pep) breathing. * ins group: inspiratory incentive spirometry breathing. the period between day 0 and 20 days post-trauma is considered an immediate phase of tt. once admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary complications, the presence of respiratory failure, and pain control will be evaluated. the cp will perform a clinical, pain control, secretion and a dynamic costal examination. the medical treatment of pain control will begin, and the treatment of cp will begin, where it will be randomized in 2 groups: 1- pep group: positive expiratory pressure (pep) breathing the help of a pep bottle device. 2- ins group: inspiratory incentive spirometry device (coach®). will be daily fr sessions, on weekdays. upon admission, hospital discharge and post-discharge, radiological checks (simple radiography) will be performed and forced vital capacity will be measured with forced spirometry.

Eligibility criteria:
inclusion criteria: * chest trauma of 3 or more rib fractures with or without hemopneumothorax * signed informed consent. exclusion criteria: * non-collaborating patients. * failure to submit a duly completed follow-up sheet for carrying out a minimum daily guideline (3 times a day) for cp treatment. * presence of respiratory failure at admission: pao2 \ 50mmhg. * medical indication for invasive or non-invasive ventilatory support. * presence of undrained pneumothorax. * complications that limit early mobility.
co2-laser treatment in patients with diabetic infected foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the study is aimed at comparing debridement either with co2 laser or traditional surgery in patients with infected diabetic foot ulcers. the principal endpoint is bacterial load immediately after treatment.

the present study is designed to assess the antimicrobial effect of a single co2 laser beam (deka smartxide2 c80-el.en, florence italy) in the treatment of diabetic infected foot ulcers. co2 laser debridement will be compared with standard surgical care. the primary efficacy endpoint will be the reduction of bacterial load between pre- and immediately after debridement. secondary endpoints will be adverse events and pain during treatment. two bacterial sample with a flocked nylon swab will be collected before and after debridement.

Eligibility criteria:
inclusion criteria: * diabetes * infected foot ulcer (with clinical signs of infection) * ulcer area between 0.5 and 150 cm2 * more than 50% of ulcer area covered by fibrin and/or necrosis * texas score \<3 exclusion criteria: * need for revascularization * pregnancy or lactation
prepare - primary prevention parameters evaluation

Conditions: Tachycardia, Ventricular; Implantable Cardioverter Defibrillator (ICD); Fibrillation, Ventricular; Syncope

Summary: the purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a medtronic icd (implantable cardioconverter defibrillator) or icd with crt (cardiac resynchronozation therapy) device. the information learned from this study could be used to guide physicians in future icd or crt device programming.


Eligibility criteria:
inclusion criteria: patient is a candidate for a non-replacement medtronic icd device from the marquis family or has had a non-replacement medtronic marquis based icd system implanted within the previous 6 months and has not had any appropriately treated spontaneous vt/vf episodes during that time. exclusion criteria: patient has history of spontaneous sustained symptomatic ventricular arrhythmias. if patient has had an electrophysiology test in the past, and has sustained inducible vt \<180 bpm.

Keywords: implantable cardioverter defibrillator (icd) sudden cardiac death primary prevention
external oblique intercostal plane block for liver transplantation donors

Conditions: Liver Transplantation; Donor; Postoperative Pain

Summary: postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. external oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block and subcostal transversus abdominis plane block in living liver donors. researchers will compare the external oblique intercostal plane block group with subcostal transversus abdominis plane block to see if the external oblique intercostal plane block is effective for postoperative analgesia in living liver donors.

patients scheduled for living donor hepatectomy will be separated into 2 groups: subcostal transversus abdominis plane block group and external oblique intercostal plane block group. patients in subcostal transversus abdominis plane block will be performed subcostal transversus plane block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. patients in external oblique intercostal plane block group will be performed bilateral external oblique intercostal plane block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * patients with american society of anesthesiology (asa) physical status i-ii * patients scheduled for a living donor hepatectomy exclusion criteria: * allergy to local anesthetics * coagulopathy * skin infection at the block area * advanced renal failure * chronic pain syndromes * alcohol or drug abuse * psychiatric disorders
optimizing cognitive remediation outcomes in schizophrenia

Conditions: Schizophrenia; Psychosis

Summary: the purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. the investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.

the purpose of this study is to explicitly and aggressively drive an optimal response to neuroplasticity- based cognitive remediation in schizophrenia in order to maximize treatment response. we will investigate factors that have generally been ignored in computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. current research indicates that, unless we fully understand and harness these factors, we will not achieve meaningful treatment gains for individuals with schizophrenia. our specific aims are: 1. to perform an rct in which 100 schizophrenia subjects are assigned to either 60 hours of neuroplasticity- based computerized targeted cognitive training (tct) that focuses exclusively on "cold cognition" (a program which trains early sensory processing, attention, working memory and cognitive control in auditory and visual domains), or to 60 hours of training that combines the tct program with 20 minutes per day of adaptive computerized social cognition training (sct) exercises. 2. to compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome. 3. to assess subjects six months after the intervention to determine the durability of training effects. 4. to identify changes in brain activation patterns in key neural regions as a result of tct alone vs. tct+sct: during reward anticipation, and during emotion recognition. the timeliness of this approach is supported by recent evidence demonstrating only weak associations between traditional cognitive remediation approaches and functional outcome in schizophrenia, but a strong, direct relationship between social cognition and functional outcome. thus we must now examine the clinical, functional, and neural effects of a well-designed state-of-the-art cognitive training program that combines neurocognition with social cognition training.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizoaffective disorder * between 18-65 years of age * clinically stable * fluent in english exclusion criteria: * recent hospitalization, in the past 3 months * history of traumatic brain injury * neurological disorders * inability to participate in the study soberly
assessing diagnostic value of non-invasive ffrct in coronary care

Conditions: Coronary Artery Disease

Summary: the objective of the heartflow advance registry is to evaluate utility, clinical outcomes and resource utilization of ffrct-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (cad) in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of cad.

registry objective the objective of the heartflow advance registry is to evaluate utility, clinical outcomes and resource utilization of ffrct-guided evaluation in clinically stable, symptomatic patients with cad in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of cad. specific objectives: 1. to determine if the availability of ffrct, in addition to coronary anatomy from the ccta, will lead to a significant change in the coronary management plan. 2. to assess the real world outcomes of utilizing ffrct to guide invasive management and/or medical treatment. 3. to assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating ffrct as the preferred cad diagnostic test. 4. to provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with cad.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent 2. clinically stable, symptomatic patients who undergo ccta and are diagnosed with cad and meet eligibility criteria for ffrct. exclusion criteria: 1. ccta showing no cad 2. uninterpretable ccta by site assessment, in which severe artifacts prevent angiographic evaluation 3. any active, serious, life-threatening disease with a life expectancy of less than 1 year 4. inability to comply with follow-up requirements
clinical trial of sars-cov-2 vaccine (vero cells), inactivated in healthy population aged 3 to 17 years(covid-19)

Conditions: COVID-19

Summary: this study is a randomized, double-blinded, and placebo controlled phase ⅰ clinical trial of the sars-cov-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.


Eligibility criteria:
inclusion criteria: * healthy residents aged 3 to 17 years at the time of consent * subjects and/or their guardian agree to sign the informed consent forms voluntarily. * be able to comply with study requirements/procedures. * axillary temperature ≤ 37.0℃ exclusion criteria: * within 14 days before vaccination, subjects have been abroad and to villages/communities experienced covid-19 epidemics, and in contact with covid-19 cases or suspected cases. subjects are under isolation observation, or living in the villages/communities with covid-19 cases or suspected cases; * confirmed cases, suspected cases or asymptomatic cases with covid-19 (refer to information system of china disease prevention and control); * subjects with history of sars virus infection by self-reported; * positive in throat swab through rt-pcr; * history of vaccination of various covid-19 vaccines or positive in sars-cov-2 antibody test; * positive urine pregnancy test for females with menarche * with abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration; * history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated sars-cov-2 vaccine; * history or family history of convulsion, epilepsy, encephalopathy or mental illness; * subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; * subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; * diagnosed with congenital or acquired immunodeficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases; * history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease); * subjects receiving anti-tb treatment; * subjects receiving other research drugs within 6 months before vaccination; * subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); * subjects receiving blood products within 3 months before administration; * subjects vaccinated with live attenuated vaccine within 14 days before vaccination; * subjects vaccinated with other vaccine within 7 days before vaccination; * the researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
air dissection in percutaneous radiofrequency ablation of t1a renal cell carcinoma

Conditions: Unrecognized Condition

Summary: the investigators aimed to evaluate the feasibility and safety of using ambient air to protect against thermal injury during radiofrequency ablation (rfa) for renal cell carcinoma (rcc) based on data from cases at their institute.

the incidence of renal cell carcinoma (rcc) has been increasing, particularly among patients \>65 years of age. as older individuals are at higher risk for surgical complications, the use of radiofrequency ablation (rfa) for small renal masses (srm) \<4 cm in size, which include t1a tumors,may be a compelling treatment option for elderly patients. however, rfa uses heat to destroy abnormal tissue, with the risk of thermal injury to tissues and organs, including gastric tissue and nerve roots, which are in proximity to the targeted treatment zone. the incidence rate of major complication with rfa, including thermal wounds, has been reported to vary between 3.2% and 5.2%. different thermal protection methods have been developed to lower the risk of injury to adjacent tissues during ablation, such as air dissection using co2 injection and hydrodissection using g5% for shielding. although both of these options are effective, they are expensive. to lower the cost of thermal protection, the investigators have been using ambient air instead of co2 for air dissection prior to rfa for srm-rccs.

Eligibility criteria:
inclusion criteria: * patients with renal cell carcinoma (rcc) * patients with a single srm of \<4 cm, confirmed as rcc on biopsy * rcc status : pt1a * eligible patients for an radiofrequency ablation (rfa) treatment exclusion criteria: * patients who have already received a rfa treatment for an other tissu or tumor * patients who have a bleeding tumor or prior local treatment

Keywords: radiofrequency thermal protection percutaneous thermal ablation kidney neoplasms
twice daily versus twice weekly soak-and-seal baths in pediatric atopic dermatitis

Conditions: Atopic Dermatitis

Summary: there are few studies evaluating best bathing practices in the management of pediatric atopic dermatitis (ad). trans-epidermal water loss plays a key role in the pathophysiology of ad. in concert with application of topical corticosteroids (tcs), we sought to investigate whether frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent soaking baths (i.e. twice weekly for two weeks) in the management of ad.

to evaluate the effectiveness of twice daily soak-and-seal baths for improving severity of disease in children with ad, we implemented a randomized clinical trial using a single-blind, crossover-controlled design. patients received the same moisturizer, cleanser, and class vi topical corticosteroid (tcs), and only bathing varied. after a 1 week run-in, children were randomized 1:1 into 2 groups: group 1 underwent twice weekly soak-and-seal baths for 2 weeks ("dry method") followed by twice daily soak-and-seal baths for 2 weeks ("wet method"), and group 2 did the converse. a single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. participants and their caregivers could not be masked. analyses were based on intention to treat.

Eligibility criteria:
inclusion criteria: * infants and children ages 6 months to 11 years of age with moderate to severe atopic dermatitis according to the criteria of hanifin and rajka. exclusion criteria: * patients with suspected or established primary immune deficiency, patients receiving systemic corticosteroids, ultraviolet light therapy, immuno-therapeutic agents, and/or anti-infective drugs less than 1 month from the onset of the study.

Keywords: atopic dermatitis bathing baths