Kornimate/medical-research-clean huggingface dataset:
surfactant administration in preterm infants

Conditions: Modified INSURE Technique

Summary: in preterm infants with respiratory distress syndrome, mechanical ventilation is related to increased risk of death and complications. surfactant is an important methods to reduce mortality and intubation rates. insure technique is a standard method to administrate surfactant. however, several preterm infants need two or more surfactant, and therefore one more intubation is needed. how to reduce the times of intubation is an challenges for neonatologists.

insure technique meas surfactant administration through intubation-surfactant-extubation. and noninvasive ventilation is immediately used after surfactant. the differences of modified insure compared with insure is intubation-surfactant-x-ray relieved-extubation. extubation and noninvasive ventilation is used after the x-ray relieving.

Eligibility criteria:
inclusion criteria: * all preterm infants with respiratory distress syndrome exclusion criteria: * congenital abnormalities or refuse the trials
hemodynamic changes during one lung ventilation in non-intubated vedio-assisted thoracoscopic operations

Conditions: Lung Neoplasms

Summary: non-intubated thoracoscopic surgery has been proved as an adequate alternative for management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary metastasectomy, removal of lung nodules, segmentectomy and lobectomy. however, the hemodynamic changes during one lung ventilation have not been fully investigated. the goals of this study are to compare the changes of hemodynamics (including blood pressure, heart rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic (vats) operations.

non-intubated vedio-assisted thoracoscopic (vats) is proved safely performed as well as traditional intubated vats. however, the differences of hemodynamic changes and fluid responsiveness during one lung ventilation(olv) between these two groups were rarely reported. for complete lung collapse, spontaneous negative pressure respiration must be well maintained on non-intubated vats. in comparison, positive pressure ventilation on dependent lung was applied during olv in intubated vats. this study planned to compared the changes of hemodynamics (including blood pressure, heart rate, cardiac output) during olv between groups. as functional hemodynamic monitoring (flotrac system) was mostly utilized with positive pressure ventilation, the applicability of flotrac in non- intubated vats was also testified. in this study, we also measure the fluid responsiveness by flotrac system with rapid infusion (within 10 minutes) of 10 ml/kg crystalloid fluid. we planned to compare the changes on cardiac output and the fluid responsiveness during olv between these two groups.

Eligibility criteria:
inclusion criteria: 1. age over 20 y/o, less than 70 y/o 2. scheduled to receive vats operations with olv exclusion: 1. previous thoracic surgery 2. cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.) 3. pulmonary disease

Keywords: one lung ventilation, cardiac output fluid responsiveness
gulf acute heart failure registry

Conditions: Acute Heart Failure

Summary: the gulf heart association (gha) sponsored gulf acute heart failure registry (gulf care)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(ahf) with 3 month and one year follow-up. study hypothesis: due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain gulf countries, variable medical practices and heart failure management setup in the gulf region, ahf patients in the gulf states are expected to have different presentation and receive different management than patients in european countries resulting in different outcome. it is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the gulf region.

the gulf heart association (gha) initiated gulf acute heart failure registry (gulf care)is designed to assess epidemiology, clinical data, management and outcomes of ahf in six gulf countries and whether published, professional guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure. the registry will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. the information gathered will identify management gaps in diagnosis and care of ahf patients that may be addressed by more effective implementation of current guidelines or development of ahf guidelines which may be appropriate to this region. findings from this registry may help in knowing the current status of heart transplantation in the middle-east countries as well as identify issues in establishing future heart transplant programme including selection of appropriate candidates and donors, requirements for pre- and post-transplant support.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute heart failure * admitted to the participating hospitals exclusion criteria: * patients with acute heart failure who are discharged from the emergency room without admission. * patients transferred from non-registry hospital * failure to obtain informed consent

Keywords: heart failure heart failure, diastolic heart failure, systolic middle-east
intelligence quotient assessment in children with autistic spectrum disorders.

Conditions: Autism Spectrum Disorder

Summary: the aim of this study is to assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and iq on stanford-binet intelligence scale, 5th edition. such analysis will help us for prompt and early intervention.

autism spectrum disorders (asds) are characterized by deficits in both social interaction and communication, as well as by restricted and repetitive patterns of behavior, and are a type of pervasive developmental disorder (pdd). intellectual disability (id) is characterized by deficits in adaptive functioning, an intelligence quotient (iq) that falls at least two standard deviations below average (i.e., below 70), and onset prior to adulthood (american psychiatric association, 2000). although id is not a core symptom of asd, there is an established relationship between the two constructs. seventy percent of children with ad have a co-morbid diagnosis of id (bolte \& poustka, 2002; fombonne, 2005). it has been suggested that many children who would have been diagnosed with id in the past would today receive an asd diagnosis, even with identical symptomatology (lecavalier et al., in press). the sb5 is a descendent of the very first intelligence measure ever created. it tests general intellectual ability, and the fifth edition affords the ability to report full scale, abbreviated, nonverbal, and verbal iq scores(roid, 2003).. one of the updated features of the sb5 is the nonverbal component, in that close to half of the responses no longer require verbal answers (coolican, bryson \& zwaigenbaum, 2008).the full scale iq is derived from the verbal and nonverbal scales, each with five subtests bearing the same names: fluid reasoning, knowledge, quantitative reasoning, visual spatial processing, and working memory.

Eligibility criteria:
inclusion criteria: * age: from3 to18 years * gender: both sexes will be included in the study * clinical asd diagnosis. * full scale test results available for sb5. exclusion criteria: * 1- age below 3years or above 18 years. 2- mental retardation due to other causes than autism. 3- presence of other chronic illnesses affecting their quality of lives.
andravalvulotome post-market study

Conditions: Peripheral Arterial Disease

Summary: the andravalvulotome post-market study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the andravalvulotome. a maximum of 70 patients will be enrolled with peripheral artery disease (pad) in up to 10 sites. study participants will be primarily observed during the bypass procedure. in addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation. the objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the ce marked andravalvulotome during the bypass procedure.


Eligibility criteria:
inclusion criteria: * patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous vena saphena magna and using a valvulotome. * patient has to be consented and a informed consent form needs to be signed. * patient is able to and willing to participate in the 30 days follow-up. * vein diameter is at least 2mm (4f system) and 3mm (5f system). * vein diameter does not exceed 8mm (otw-version) or 6mm (tip-version) * bypass needs to be a continuous vena saphena magna with a length of at least 20cm. * rutherford category iii - vi exclusion criteria: * patients who have not completed 18 years of age * patients who are pregnant or assuming to be pregnant, and breast feeding. * patients who cannot participate due to medical or physical condition based on the decision of the physician. * life expectancy less than 1 year * known allergies to materials of the tip, cutting basket, outer catheter, kink protection and braid. * rutherford category 0-2 * using varicose vein * exclusion criteria based on ifu
ibi334 in subjects with unresectable, locally advanced or metastatic solid tumors

Conditions: Solid Tumors

Summary: the primary objective of this study to evaluate the safety and tolerability of ibi334 and determine the maximum tolerated dose (mtd) and the recommended phase 2 dose (rp2d) of ibi334.


Eligibility criteria:
inclusion criteria： 1. male or female subjects ≥ 18 years old; 2. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; 3. anticipated life expectancy of ≥ 12 weeks; 4. adequate bone marrow and organ function; criteria for dose escalation phase only: 5. has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and ras-wildtype colorectal cancer); 6. at least 1 evaluable lesion per response evaluation criteria in solid tumors (recist) v1.1; criteria for dose expansion phase only: 7. has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or ras-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; 8. at least 1 measurable lesion per response evaluation criteria in solid tumors (recist) v1.1. exclusion criteria： 1. participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study; 3. received total pelvic radiotherapy; 4. pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours); 5. uncontrolled diseases; 6. history of endotracheal or gastrointestinal stent implantation; 7. multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured); 8. women who are pregnant, have positive results in pregnancy test or are lactating; 9. not eligible to participate in this study at the discretion of the investigator.
stepped-care telehealth for young children with asd

Conditions: Autism Spectrum Disorder

Summary: this proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (ndbi), online rit. online rit is an interactive website introducing reciprocal imitation training (rit), an ndbi focused on enhancing social imitation. rit uses a naturalistic behavioral approach to teach object and gesture imitation to young children with asd within a play-based context. the efficacy of rit has been demonstrated through a small randomized control trial, several single-subject design studies, as well as in independent replications. prior research also suggests that parents can be taught to effectively use rit with their children in person, and two single-subject design studies detail the development and feasibility testing of online rit plus therapist assistance. these preliminary data suggest online rit may serve as an ideal platform for examining the potential of individualized telehealth delivery formats, such as stepped-care. therefore, the goal of this study was to compare a stepped-care format of online rit to a waitlist control condition to determine initial feasibility and effectiveness of this innovative intervention and service delivery model.


Eligibility criteria:
inclusion criteria: * have a diagnosis of asd or significant concerns of asd * parent reported imitation deficits exclusion criteria: * children of parents who are non-english speaking * actively participating in other parent training programs
systemic metabolic rate of diabetic patients before and after bariatric gastric bypass using the breezing® device.

Conditions: Obesity; Diabetes Mellitus, Type 2

Summary: to evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the breezing® device.

objective of the research: primary to evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the breezing® device. secondary * to measure the indirect metabolic rate by quantifying o2 gas consumption (g) and co2 gas release (g); * to analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated; * to correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor; * to validate the accuracy of the breezing® device. evaluation of the risks and benefits risks as the patient only needs to blow on the breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. thus, the risks are indirect and are more associated to the malfunctioning of the device. benefits the advantage is that the procedure is simple and can provide results with important information about the metabolic rate even just using the iphone or ipad of patients as a strategy to monitor metabolic control.

Eligibility criteria:
inclusion criteria: over 18 years - exclusion criteria: obesity -
oral hpv infection in young men

Conditions: Head and Neck Cancer; Infection; Precancerous Condition

Summary: rationale: gathering information about human papillomavirus infection of the mouth in young men may help doctors learn more about risk factors for oropharyngeal cancer. purpose: this research study is assessing human papillomavirus infection of the mouth in young men and risk factors for oropharyngeal cancer.

objectives: * estimate the prevalence of oral human papillomavirus (hpv) type 16, 18, 6, or 11 infection in young adult men. * assess the independent effect of distinct sexual practices, including kissing, oral sex, and vaginal intercourse, on oral hpv prevalence. * estimate the 6-month incidence of hpv infection in this study population. outline: participants are assessed for oral human papillomavirus virus (hpv) infection (i.e., types 16, 18, 6, and 11) and for known or potential risk factors associated with the infection, including sexual behavior (e.g., kissing, performing oral sex, or vaginal intercourse), demographic characteristics (e.g., age or race), and history of hpv or other sexually transmitted infections. prior exposure to hpv vaccine is also assessed. oral rinse samples are collected from participants at baseline and at 6 months for detection of hpv genomic dna in oral exfoliated cells. baseline serum samples are also collected.

Eligibility criteria:
disease characteristics: * currently enrolled at one of the following institutions: * johns hopkins university * university of maryland * towson university patient characteristics: * able to understand the procedures and the potential risks involved as determined by clinic staff prior concurrent therapy: * no prior gardasil® off label

Keywords: recurrent squamous cell carcinoma of the oropharynx oropharyngeal cancer oropharyngeal squamous cell carcinoma infection precancerous condition human papilloma virus infection
effect of metformin on lactate metabolism

Conditions: Hyperlactatemia

Summary: the main objective of this study is to evaluate the influence of metformin on lactate metabolism. the main outcome is the lactate production following an exogenous lactate overload in healthy male subjects without metformin and one week later with metformin.

study design: physiological study, controlled, open, non randomised healthy male subjects, 18 to 30 years old principal objective : to evaluate the influence of metformin on lactate metabolism (production) following exogenous lactate overload. * objective 2: to evaluate the influence of metformin on lactate metabolism (production) after muscular exercise. * objective 3: to evaluate the influence of metformin on lactate metabolism (elimination) after exogenous lactate overload. * objective 4: to evaluate the influence of metformin on lactate metabolism (elimination) after muscular exercise. principal outcome : lactate production following exogenous lactate overload. * outcome 2: production of lactate following muscular exercise test. * outcome 3 and 3': parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model). * outcome 4 and 4': parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model). inclusion criteria: * healthy male subjects, 18 to 30 years * body mass index (bmi) between 21 and 25 kg/m2 inclusive * informed consent exclusion criteria : * ward of court or under guardianship (sheltered adults) * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalised without their consent * person under legal protection * existence of a previously diagnosed pathology * existence of a metabolic condition (obesity, diabetes) or a family history of such * ongoing medical treatment.

Eligibility criteria:
inclusion criteria: * healthy male subjects, 18 to 30 years * body mass index (bmi) between 21 and 25 kg/m2 inclusive * informed consent exclusion criteria: * ward of court or under guardianship (sheltered adults) * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalised without their consent * person under legal protection * existence of a previously diagnosed pathology * existence of a metabolic condition (obesity, diabetes) or a family history of such * ongoing medical treatment

Keywords: diabetes metformin hyperlactatemia
a study to evaluate the safety, tolerability and immunogenicity of v114 in healthy adults and infants (v114-005)

Conditions: Pneumococcal Infections

Summary: this study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of v114 in healthy adults and infants.


Eligibility criteria:
inclusion criteria: adult cohort: 18 to 49 years and in good health * highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine. infant cohort: approximately 2 months (42 to 90 days) and in good health. exclusion criteria: adult cohort: prior administration of any pneumococcal vaccine * history of invasive pneumococcal disease * known hypersensitivity to any vaccine component * known or suspected impairment of immune function * coagulation disorder contraindicating intramuscular vaccination * received a blood transfusion or blood products within 6 months * participated in another clinical study of an investigational product within 2 months * breast feeding. infant cohort: prior administration of any pneumococcal vaccine * known hypersensitivity to any vaccine component * known or suspected impairment of immune function * history of congenital or acquired immunodeficiency * has or mother has documented human immunodeficiency virus (hiv) infection * has or mother has documented hepatitis b surface antigen positive result * functional or anatomic asplenia * history of failure to thrive * coagulation disorder contraindicating intramuscular vaccination * history of autoimmune disease or autoimmune disorder * known neurologic or cognitive behavioral disorder * received systemic corticosteroids within 14 days * received other licensed non-live vaccine within 14 days * received other licensed live virus vaccine within 30 days * received a blood transfusion or blood products * participated in another clinical study of an investigational product * history of invasive pneumococcal disease
effect of rhil-11 in patients with thrombocytopenia for childhood all

Conditions: Pancytopenia Due to Chemotherapy

Summary: the goal of this clinical research study is to find out if rhil-11（interleukin 11） may increase the platelet count in childhood patients with acute lymphocytic leukemia (all) who develop low platelet counts while receiving standard cat（cyclophosphamide+cytosine arabinoside+mercaptopurine，7d） therapy.

group a：patients receive rhil-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/ml group b：control group

Eligibility criteria:
inclusion criteria: * new diagnosis of all * tbil≤34umol/l，cr≤120umol/l，a normal ef * age \<18 years exclusion criteria: * patients with uncontrolled infection * patients with acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias