Kornimate/medical-research-clean huggingface dataset:
droplet digital pcr combines with transcriptome analysis in early warning of sepsis in the emergency department

Conditions: Sepsis; Emergent Infections, Treatment

Summary: rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. this prospective multicenter clinical study will combine droplet digital pcr (ddpcr) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. the purpose is to (1) compare the efficacy of ddpcr with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger rna for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddpcr combined with transcriptome analysis methods.

rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. therefore, based on our preliminary single-center study, this prospective multicenter clinical study will combine droplet digital pcr (ddpcr) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. the purpose is to (1) compare the efficacy of ddpcr with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger rna for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddpcr combined with transcriptome analysis methods. in a word, this study will be undertaken to assess the diagnostic and therapeutic monitoring value of early warning models for sepsis in emergency department and to promote them to improve the identification ability of emergency infections.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, regardless of sex * mss≥2 score * written informed consent obtained exclusion criteria: * age \< 18 years, regardless of sex * patient's icu length of stay \<24 hours * malignant tumor, hiv patients or any terminal-stage disease * known pregnancy or lactation * participation in other clinical trials * inadequate clinical information or missing experimental data * no signed informed consent obtained

Keywords: droplet digital pcr transcriptomic molecular target assay
intra-operative inspiratory oxygen fraction and postoperative respiratory complications

Conditions: Respiratory Failure; Acute Respiratory Failure Requiring Intubation; Pulmonary Edema; Pneumonia; Surgical Wound Infection; Mortality

Summary: respiratory complications represent the second most frequent type of postoperative complications with an incidence estimated to range from 2.0% to 7.9% it has been shown that intra-operative protective ventilation is associated with a reduced risk of respiratory complications. the effects of intra-operative inspiratory oxygen fraction (fio2) remain to be investigated. in this study, the investigators aim to investigate the association between intra-operative fio2 and respiratory complication as well as surgical site infection and icu admission in patients undergoing non-cardiothoracic surgery. the investigators primary hypothesis is that high intra-operative fio2 increases the risk of postoperative respiratory complications independent of predefined risk factors.


Eligibility criteria:
inclusion criteria: * non-cardiothoracic surgery at massachusetts general hospital between january 2007 and august 2015 * tracheally intubated at the beginning of the procedure and extubated at the end of the procedure * above18 years of age exclusion criteria: * missing information regarding main characteristics or the exposure variable
the effect of circuit exercise program in gestational diabetes

Conditions: Gestational Diabetes

Summary: gestational diabetes (gdm) is defined as 'pregnancy-onset or first noticed glucose intolerance'. the aim of this study is to investigate the effect of circuit exercise program applied in addition to diet therapy on cognitive function, functional exercise capacity, mobility, depression and quality of life in women with gestational diabetes. 60 female participants between the ages of 18-35 who meet the inclusion criteria will be included in the study. participants will be randomly divided into 2 groups as diet group (n=30) and exercise group (n=30). all participants will receive gdm-specific dietary therapy for 6 weeks. in addition to diet therapy, individuals in the exercise group will be given a circuit exercise program for 6 weeks. participants will be evaluated for blood values, cognitive status and functionality at the baseline and 6 weeks later.


Eligibility criteria:
inclusion criteria: * being diagnosed with gestational dm * being between the ages of 18-35 * being in 24-32 weeks of pregnancy * being inactive physical activity level - (\<300 met weeks/day) exclusion criteria: * diagnosed with diabetes before pregnancy * have given birth before * multiple pregnancy (\>2) * intrauterine growth restriction * preeclampsia * having high risk of preterm labor and on strict bed rest * treatment with insulin or oral hypoglycemic agents during pregnancy * other significant severe or poorly controlled medical conditions (thyroid disease, cardio-respiratory disorders, ...) * taking medications that affect cognitive function, including corticosteroids, anti-depressants, or anti-epileptics

Keywords: gestational diabetes circuit exercise cognition
clinical study to assess therapeutic delay and resolution of induced gingivitis

Conditions: Gingivitis

Summary: evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

a 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Eligibility criteria:
inclusion criteria: 1. male or female volunteers aged 18-70 years 2. in good general health, asa i 3. no clinical signs of gingival inflammation at \>90% sites observed 4. probing depth (pd) \< 3.0 mm 5. attachment loss (al) = 0 mm 6. no periodontal disease history 7. non-smokers 8. fluent in english exclusion criteria: 1. presence of orthodontic bands. 2. presence of partial removal dentures. 3. tumour(s) of the soft or the hard tissues of the oral cavity. 4. cavitated carious lesions requiring immediate restorative treatment. 5. history of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study. 6. participation in any other clinical study or test panel with a one month period prior to entering the study.
an immunogenicity and safety study of sabin inactivated poliovirus vaccine (vero cell) in 2-month-old infants

Conditions: Poliomyelitis

Summary: the purpose of this phase iii study is to evaluate the immunogenicity and safety of sabin inactivated poliovirus vaccine (vero cell) in 2-month-old infants.

the study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. the purpose of this study is to evaluate the immunogenicity and safety of sabin inactivated poliovirus vaccine (vero cell) manufactured by sinovac vaccine technology co., ltd in 2-month-old infants. the control vaccine is a commercialized inactivated poliovirus vaccine manufactured by sanofi pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.

Eligibility criteria:
inclusion criteria: * healthy volunteer between 60-90 days old; * healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; * proven legal identity; * participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment; * complying with the requirement of the study protocol; exclusion criteria: * prior vaccination with poliovirus vaccine; * history of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc; * congenital malformation, developmental disorders, genetic defects, or severe malnutrition; * autoimmune disease or immunodeficiency/immunosuppressive; * severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; * diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry; * blood product prior to study entry; * any other investigational medicine(s) within 30 days prior to study entry; * any live attenuated vaccine within 14 days prior to study entry; * any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * acute disease or acute stage of chronic disease within 7 days prior to study entry; * axillary temperature \> 37.0 °c; * any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Keywords: sabin strain inactivated poliovirus vaccine poliomyelitis safety immunogenicity infant
venetoclax based regimen for r/r t-all

Conditions: Acute T-Lymphocytic Leukemia

Summary: this study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy t cell acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 15 and ≤ 70 years. 2. patients diagnosed with t-all/lbl according to 2017 who lymphoid malignant disease diagnosis standard. 3. patients with t-all/lbl must meet one of the following criteria, a or b. a: refractory t-all/lbl disease was defined as follows: failure to achieve cr at the end of induction. b: relapsed t-all/lbl disease was defined as follows: reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a cr. 4. ecog performance status score less than 3. 5. expected survival time \>3 months. 6. patients without serious heart, lung, liver, or kidney disease. 7. ability to understand and voluntarily provide informed consent. exclusion criteria: 1. patients who are allergic to the study drug or drugs with similar chemical structures. 2. pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. active infection. 4. active bleeding. 5. patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met. 7. liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, alt/ast \> 2.5 times the upper limit of the normal range or patients with liver involvement whose alt/ast \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value). 8. patients with a history of clinically significant qtc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, ii-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. surgery on the main organs within the past six weeks. 10. drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. patients who have received organ transplants (excepting bone marrow transplantation). 12. patients not suitable for the study according to the investigator's assessment.

Keywords: venetoclax relapse refractory
screening protocol for a gene therapy trial in subjects with homozygous familial hypercholesterolemia

Conditions: Hypercholesterolemia, Familial

Summary: the purpose of this protocol is to identify and screen potential candidates for future enrollment in a gene therapy clinical trial for hofh.

homozygous familial hypercholesterolemia (hofh) is a rare genetic metabolic disorder characterized by markedly elevated ldl-cholesterol (ldl-c) levels, resulting in severe atherosclerosis often leading to early onset of cardiovascular disease. the most frequent cause is mutation in the ldl receptor gene (ldlr). ldl-c levels remain frequently above acceptable levels despite treatment with multiple existing lipid lowering drugs and/or ldl apheresis. thus, the functional replacement of the defective ldlr via aav-based liver-directed gene therapy may be a viable approach to treat this disease and improve response to current lipid-lowering treatments. the purpose of this protocol is to identify and screen potential candidates for future enrollment in a gene therapy clinical trial. no study drug will be administered in this screening study.

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * clinical presentation consistent with homozygous fh * subjects must be able to comprehend and willing to provide a signed irb approved informed consent form exclusion criteria: * known to carry confirmed mutations in genes affecting ldl receptor functionality other than the ldlr gene * history of cirrhosis based on documented histological evaluation or non-invasive imaging * documented diagnosis of any of the following liver diseases: hepatitis b or c; biopsy-proven nonalcoholic steatohepatitis; biopsy-proven alcoholic liver disease; autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; wilson's disease; hemochromatosis; alpha1 anti-trypsin deficiency * history of immunodeficiency diseases, including a positive hiv test result * previous organ transplantation * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study * inability to participate
cybersenga: internet-based hiv prevention in uganda

Conditions: Sexual Abstinence; Condom Use

Summary: the investigators propose to design and test an internet-based hiv prevention program for adolescents in uganda.

hiv/aids is a major contributor to morbidity and mortality in uganda. despite aggressive advances in hiv prevention efforts, recent data suggest that hiv prevalence is increasing generally, and hiv knowledge, a direct contributor to behavior, is on the decline among young people specifically as compared to a decade ago. the internet is a promising mode of intervention delivery in resource poor-settings because the costs associated with scaling up are minimal; dissemination online is the same if one person or 100,000 people use the program. just as important, it provides access to important health information in a stigma-free, anonymous atmosphere. our recent data indicate that 45% of adolescents in mbarara, uganda have used the internet, 78% of whom went online at least once in the previous week. eighty-one percent of respondents in the same survey indicated they would go to an hiv prevention web site if it existed. based upon these data, we propose to develop a culturally appropriate, internet-based hiv prevention program designed specifically for ugandan adolescents between the ages of 12 and 18 years. our specific aims are as follows: specific aim 1: design a 6-hour, internet-based hiv prevention program for adolescents. content will be culturally tailored to the hiv preventive information, motivation, and behavioral skills needs of ugandan adolescents. specific aim 2: test the intervention in a randomized controlled trial (n=500) among adolescents attending grades secondary 1-4 (similar to us high school grades 8th - 11th) at day schools in mbarara. this project has the potential to develop low-cost and salable interventions to hiv transmission risk behaviors among adolescents in uganda.

Eligibility criteria:
inclusion criteria: * enrollment in grades secondary 1 through 4 at a partner secondary school * having used a computer or the internet at least once in the past year * not having been part of the intervention development activities * caregiver informed permission and adolescent informed assent exclusion criteria: * none

Keywords: hiv prevention technology adolescent developing countries
cluster randomized trial of peer health education in malaria in the gambia

Conditions: Malaria

Summary: health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health. we incorporated a malaria component to an established peer health education programme in schools in the gambia, and evaluated its impact on knowledge attitudes and practice (kap) of school students and their families using a cluster randomized design. since malaria is a particular problem among children under 5 and pregnant women, students were encouraged to explain what they learned to their families, and we sought to evaluate whether the malaria messages were taken up by the students' families. evaluation endpoints are kap in students, and kap in women living in the school students' home compound.

12 communities in the gambia, each including an upper basic and/or a senior secondary school, were pair-matched on urban/rural location and school type, and one community in each pair randomly selected to receive the peer-health education programme immediately or after a delay, to permit evaluation. the intervention programme comprised training of peer health educators, teacher coordinators, and members of drama troupes, in key malaria messages and principles of health education. the peer educators then conducted a rolling programme of presentations to children and youth in their own schools using drama, puppetry, small group and in-class presentations about malaria, as well as community outreach programs targeting out-of-school youth and the general public. in each school a systematic sample of 75 students were interviewed 10 weeks and 6 months after the start of the programme, and in each school catchment area a sample of 80 women were interviewed at the same time, and bednet use by children under 5 yrs in their care was recorded. from the interviews scores were derived for knowledge about malaria treatment and prevention and knowledge scores and net coverage in children compared between intervention and control schools.

Eligibility criteria:
inclusion criteria: * woman caring for a child under 5 years of age, living in the compound of one of the peer health educators * student attending school exclusion criteria: * not caring for a child under 5 years (for women) * not living in a compound of a peer health educator (for women)

Keywords: malaria knowledge attitudes and practice (kap) bednets peer health education
inflammasomes nlrp3 in platelets and leukocytes during sepsis in intensive care unit

Conditions: Sepsis

Summary: septic shock is the first cause of mortality in intensive care unit. innate immunity is the body's first line of defense against pathogens

since their discovery, inflammasomes have an important role during inflammatory response following an aggression. there are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including il-1β. one study focused on the role of the nlrp3 inflammasome in monocyte during sepsis has shown its early alteration that is correlated with mortality. most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets. the aim of the study is to analyze the activation of nlrp3 inflammasome in platelets and leukocytes during sepsis, from patients hospitalized in intensive care unit compare to a control group, until its resolution to better understand the pathophysiology of sepsis

Eligibility criteria:
sepsis group: inclusion criteria: * hospitalized in intensive care unit with central catheter * age \> or = 18 years * patients suffering from sepsis * hospitalized from less than72 hours exclusion criteria: * patients with curatorship or guardianship * pregnant women * patients suffering from malignant blood disease * patients suffering from disease associated with nlrp3 inflammasome activation control group: inclusion criteria: * hospitalized in intensive care unit with central catheter for other reason than infection * age \> or = 18 years exclusion criteria: * patients with infection disease * patients with curatorship or guardianship * pregnant women * patients suffering from malignant blood disease * patients suffering from disease associated with nlrp3 inflammasome activation

Keywords: nlrp3 inflammasome platelets cytokines thrombus septic shock sepsis