Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of dtp/hb/hib (bio farma)compared to dtp/hb given simultaneously with hib(registered)vaccine

Conditions: Healthy

Summary: the main objective of this study was to evaluate the protectivity and safety of dtp/hb/hib (bio farma) vaccine compared to dtp/hb and hib vaccine given simultaneously.

this trial was randomized, single blind, prospective intervention study. total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.

Eligibility criteria:
inclusion criteria: * infant 6-11 week of age * infant born after 37-42 week of pregnancy * infant weighing more than 2.5 kg at birth * father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form * parents commit themselves to comply with the indication of the investigator and with the schedule of the trial * mother at least graduate from elementary school * received hepatitis b vaccine (bio farma) at birth exclusion criteria: * child concomitantly enroll or schedule to be enroll in another trial * evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 celsius on day 0) * known history of allergy to any component of the vaccine component (e.g.formaldehyde) * history of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection * known history of congenital or acquired immunodeficiency (including hiv infection) * child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 weeks) * other vaccination within the 7 days prior to inclusion with the exception of bcg and poliomyelitis * any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective * infant with a known history of diphteria, tetanus, pertussis, hib, hepatitis b infection

Keywords: dtp/hb/hib vaccine immunogenicity infants safety
resistell phenotech ast to determine the antibiotic susceptibility of gram-negative bacteria causing bacteremia

Conditions: Bacteremia Sepsis

Summary: the aim of this study is to assess the sensitivity, specificity, and accuracy of the resistell phenotech device in testing antibiotic susceptibility of gram-negative bacteria (i.e., e. coli or k. pneumoniae) to clinically relevant antibiotics. the study is designed as a prospective, non-interventional, multi-center, single-arm study. the blood culture samples from bacteremia patients that are positive for e. coli or k. pneumoniae will be tested with the resistell phenotech device after strain identification by maldi-tof. the results of the resistell ast will be compared with the results from the disk diffusion tests (all sites use the kirby-bauer disk diffusion test), and site dependent tests (vitek® 2, bd phoenix™, microscan walkaway system, and/or eucast rast), which are currently the standard ast methods in the microbiology laboratories at the participating sites.


Eligibility criteria:
inclusion criteria: * patients who have signed a general consent form approving use of their residual blood samples for research purposes (applicable at chuv only) * patients who have signed a consent allowing the use of their residual sample (restprobenerklärung) (applicable at mui, only) * patients over the age of 18 years (\>18) * patients with bacteremia considered to be due to e. coli or k. pneumoniae * patients whose positive blood cultures were not older than 24 hours at the time of ast start exclusion criteria: * patients with documented refusal of the use of biological material for research purposes (applicable at chuv, only) * patients with polymicrobial bacteremia

Keywords: antibiotic susceptibility ast e.coli k. pneumoniae phenotech
a clinical trial with a new needle device comparing two needles for eus_fna of solid lesions.

Conditions: Pancreatic Cancer; Neuroendocrine Tumors; Lymphadenopathies; GIST; Gastric Wall Tumor

Summary: endoscopic ultrasound-guided fine-needle aspiration biopsy (eus-fna) is a reliable, safe, and effective technique for obtaining samples from the gi wall lesions and from organs adjacent to the gi tract (pancreas, nodes...).needles available for eus-fna include 25g, 22g and 19g. some studies have suggested that the 25g needle could be equal or even better than the 22g needle. the bxn system and neddles are is a newly developed for eus-fna. this trial is developed for testing the accuracy of the new neddle system for eus-fna and for comparing the two needles types, 25g and 22g.


Eligibility criteria:
inclusion criteria: * endosonographic appearance of a solid lesions * age \>18 years * informed consent. exclusion criteria: * alteration of the coagulation (inr \>1.5, plt \<50 x 103 /µl) * inability to express consent

Keywords: pancreatic cancer neuroendocrine tumors lymphadenopathies gist gastrointestinal wall neoplasia
rapid turnaround, home-based saliva testing for covid-19

Conditions: Covid19

Summary: the aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for sars-cov-2 infection. participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.


Eligibility criteria:
inclusion criteria: * hospitalized patients * hospitalized at stanford health care for covid-related complications and tested positive for sars-cov-2 with a pcr-based test * able to understand and consent to study and with a clinical trajectory likely to be consistent with multi-day participation * high-risk/positive population * seeking testing for suspected covid or a participant in a study of covid-positive outpatients * own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos. * willing to participate in the study for 6 months * low-risk population * own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos. * willing to participate in the study for 6 months exclusion criteria: * all participants: * participants with salivary gland dysfunction (including patients with sjogren's disease or those with xerostomia associated with lupus or rheumatoid arthritis) * participants will not be eligible if they identify any reason they are unable to participate in the study * high-risk/positive population * participants who have color blindness * participants unable to operate the snapdx device * low-risk population * participants with prior confirmed sars-cov-2 infection * participants who have color blindness * participants unable to operate the snapdx device
arsha vidya program for preventing drug abuse among disadvantaged children in urban slums

Conditions: Drug Abuse

Summary: substance abuse remain critical problems in both developed and developing countries. under privileged communities where health and economic system is weakest, use of drugs and illicit substances starts during adolescence and young adulthood. this not just affect physical development, mental health and social integration, but also family formation and stability, deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood pursuits. therefore, emphasises the need for preventive education at this impressionable age.


Eligibility criteria:
inclusion criteria: * parental consent to participate exclusion criteria: * family not involved in de-addiction program * planning to move the area * mental incapacity to consent or participate
pain navigator tool for self-management in back pain: patience trial

Conditions: Chronic Low-back Pain; Self Efficacy; Therapeutic Alliance; Communication

Summary: this study explores the experience of physiotherapists and patients using the pain navigator tool during outpatient musculoskeletal consultations.

chronic pain is the largest cause of disability globally and affects up to 28 million people in the uk alone. nearly half of those who experienced chronic pain in europe reported receiving insufficient pain management. conventional treatments commonly used in physiotherapy continue to show only moderate effects in pain management. a potential avenue to improve the global effect of treatments may lie in exploring non-specific treatment moderators such as the therapeutic alliance (ta). findings suggest that it is linked with engagement in rehabilitation and is a strong predictor of treatment outcomes and adherence. this study aims to evaluate and compare the quality of practice with or without the pain navigator tool (pnt). understanding the impact of the pnt on therapeutic alliance would open an avenue to improve chronic pain management, reduce healthcare-related expenses and increase the quality of life in the population studied. in addition, exploring the experience of the physiotherapists with using the pnt will provide an in-depth understanding of its use and applicability in similar settings. the aims of this study are to: 1. to evaluate and compare the quality of practice with or without the pnt in patients with chronic low-back. 2. to collect preliminary data on the usability and practicality of the pnt for physiotherapists.

Eligibility criteria:
inclusion criteria: patient: * participant aged \>18 years * low-back pain for more than three months * able to read and speak english to a level allowing satisfactory completion of the study procedures * initial appointment with a participating physiotherapist physiotherapist: * 2 years of experience in treating patients with chronic pain * currently working in an msk outpatient clinic * able to read and speak english to a level allowing satisfactory completion of the study procedures exclusion criteria: patient: * low-back pain is not the primary reason for physiotherapy appointment * return appointment with physiotherapist

Keywords: low back pain self-efficacy therapeutic alliance communication
retrospective analysis of pain after nerve block in surgical patients

Conditions: Regional Anesthesia Morbidity; Acute Pain; Knee Osteoarthritis

Summary: this is a retrospective study looking at patients who received a nerve block for surgery and assessing pain after the nerve block resolves, with or without an educational intervention, over two periods of time.

regional anesthesia (ra) is a vital tool that can serve as the primary anesthetic or as part of a multimodal perioperative pain regimen. ra is strongly associated with decreased acute and persistent pain and opioid consumption postoperatively. however, some patients experience an acute worsening of pain into the severe range around the time of ra resolution, also known as "rebound pain" (rp). the incidence of rp has been reported as high as 40-50% after a single shot nerve block for patients undergoing ambulatory surgery. this retrospective study aims to look at patients who received a nerve block for surgery and assessing pain after the nerve block resolves in the presence and absence of certain interventions, such as a multidisciplinary educational intervention. the investigators will assess patients who received a primary total knee arthroplasty who received a single shot adductor canal nerve block, received pericapsular injection by the surgeon, and had a length of stay \> 16 hours.

Eligibility criteria:
inclusion criteria: * primary total knee arthroplasty * received an adductor canal nerve block * received pericapsular injection by surgeon intraoperatively * admitted for overnight stay and \> 16 hours post-nerve block exclusion criteria: * age \< 18 * prior total knee arthroplasty on ipsilateral knee
the visiting child and his family in icu

Conditions: Intensive Care; Child; Acute Stress Disorder; Post Traumatic Stress Disorder

Summary: according to literature, it's difficult to evaluate the impact of the visit of the child in icu. currently, no recommendations are available regarding welcome and accompany children who visit their relative hospitalized in icu. collaboration between humanities and medical sciences brings to this question a complementary look. majority of studies investigated the question of the impact of young child icu visit in a unidirectional linear causality scheme visit = psychopathological impact. the visit of the child in icu should not be considered as an isolated event whose objective characteristics would be alone vectors of trauma. contrary, the child visit must be apprehended in relation to the quality of the supports on which the child can count. the investigators hypothesize that children can overcome the visit of a kin hospitalized in icu if accompanying people can support the child and contain, before and after the visit, the emotions of the child.


Eligibility criteria:
inclusion criteria: * family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative * family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit * parent hospitalized in icu is at least 18 years old * informed consent of children, non-hospitalized and/or hospitalized relatives * informed consent of the accompanying caregiver exclusion criteria: * moribund patient * child unaccompanied by his/her parent/relative during the visit * non-hospitalized non-french-speaking parent/relative (need to be able to answer the questionnaires) * child benefiting from a psychological follow-up prior to the hospitalization of his/her parent * non french-speaking child * child under 6 years old or older than 14 * hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. the loss of the hospitalized parent will not allow for an interview on the experience of the visit).

Keywords: icu acute stress ptsd child parent hospitalized
study to assess the effect of hepatic impairment on the pharmacokinetics of ctp-543

Conditions: Hepatic Impairment

Summary: this is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic impairment on the pharmacokinetics (pk) of ctp-543 and its major metabolites following administration of a single 12 mg oral dose of ctp-543.


Eligibility criteria:
inclusion criteria: * adult males or females aged 18-75 * body mass index (bmi) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening * if of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication * capable of giving informed consent and complying with study procedures additional inclusion criteria for subjects with hepatic impairment: * for moderate hepatic impairment, the subject must have a child-pugh score of 7 to 9 at the time of screening. for mild hepatic impairment, the subject must have a child- pugh score of 5 to 6 at the time of screening. * no clinically significant change in disease status within the last 30 days before screening * the subject must have a condition consistent with hepatic impairment and associated symptoms, but otherwise be determined to be healthy in the opinion of the investigator * if diabetic, the subject must have the disease controlled exclusion criteria: * history of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study * known history of any gi surgery or any condition possibly affecting drug absorption * history of prolonged qt syndrome or a qtc interval with fridericia's correction (qtcf) \> 470 msec for males or qtcf \> 480 msec for females at screening visit. * females who are nursing or pregnant prior to drug administration * positive for human immunodeficiency virus (hiv) * positive results for coronavirus infection (covid-19) at screening or check-in * positive drugs of abuse or alcohol results at screening or check in (day -1) additional exclusion criteria for subjects with hepatic impairment: * history or current diagnosis of uncontrolled or significant cardiac disease * gilbert's syndrome, liver transplant, wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening * previous diagnosis of hepatocellular carcinoma * acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function

Keywords: ctp-543
technology knowledge optimization in type 1 diabetes (tekno t1d): parents

Conditions: Type 1 Diabetes

Summary: this study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and cgm for pediatric t1d management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve t1d outcomes.

despite increased use of insulin pumps and continuous glucose monitors (cgm) for pediatric type 1 diabetes (t1d) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with t1d has worsened in recent years. although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in t1d. psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal t1d management approaches. there are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. the development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of t1d. interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and cgm. these results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with t1d. finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.

Eligibility criteria:
inclusion criteria: 1. child 8-12 years of age with a diagnosis of t1d ≥ 6 months 2. currently using insulin pump( ip) and cgm ≥ 1 month \[including hybrid closed loop (hcl) systems\] 3. participation of primary diabetes caregiver 4. english fluency 5. mean a1c \>7.5% over the past 6 months (aim 3 only) exclusion criteria: 1. major illnesses other than t1d in the child 2. significant cognitive limitations or major psychiatric disorders in the child or parent 3. the use of medications other than insulin to control blood glucose levels.

Keywords: pediatric continuous glucose monitor insulin pump automated insulin delivery hybrid closed loop systems medical education diabetes technology
neurocognitive outcome assesment in patients with peri-optic meningiomas after excision with or without pealing of the outer layer of the cavernous sinus: a randomized controlled single blinded trial.

Conditions: Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas

Summary: neurocognitive outcome assesment in patients with peri-optic meningiomas after excision with or without pealing of the outer layer of the cavernous sinus: a randomized controlled single blinded trial.


Eligibility criteria:
inclusion criteria: * preoptic meningioma, not recurrent, size is operative. exclusion criteria: * other meningiomas than preoptic , recurrent cases, size is not operative, other medical conditions affect the mental condition of the patient.
fibroblast growth factor 23 and hypertensive disorder complicating pregnancy

Conditions: Hypertension, Pregnancy-Induced

Summary: hypertensive disorder complicating pregnancy is a set of diseases of pregnancy coexisting with elevated blood pressure. the incidence of it is approximately 5-12%. pregnancy-induced hypertension is a pregnancy-specific disorder, severely impairing both maternal and fetal health, and the major cause of maternal and perinatal mortality rate increased. but so far, the specific etiology is still unclear. recently, fibroblast growth factor 23 (fgf23) has emerged as key endocrine regulators of the metabolism of vitamin d and calcium and phosphorus by combining fgfr-α- klotho receptor complex. current studies showed that α- klotho involved the development of gestational hypertension via the production of endothelial nitric oxide, angiogenesis, and the formation of antioxidant enzymes. on the other hand, vitamin d deficiency during pregnancy has an adverse impact on maternal and fetal health, including gestational hypertension. therefore, the relationship of the expression of fgf23 and the development of gestational hypertension has attracted the attention of relevant scholars. the aim of this study is to detect the difference of the expression of fgf23 between the hypertensive women and normal pregnant women.

100 pregnant women with hypertensive disorder complicating pregnancy and 200 normal pregnant control women matched for maternal and gestational age were enrolled in the study. all the subjects underwent antepartum screening in the first affiliated hospital of sun yat-sen university. blood samples were obtained after overnight fasting at the first, second and third trimester respectively. serum fgf23 levels were determined by enzyme-linked immunosorbent assay (elisa) and were correlated with anthropometric, metabolic, and endocrine parameters. data were analyzed by spss 20.0 database. the results were expressed as mean ± standard deviations or median with interquartile range. differences between groups were assessed by student's unpaired t test, mann-whitney u test, or chi-square test as appropriate. correlation analysis was performed using the spearman rank correlation method. to identify independent relationships and adjust the effects of covariates, multiple linear regression analyses were performed. p values of \<0.05 were considered significant.

Eligibility criteria:
inclusion criteria: * women with singleton pregnancy; * regular antenatal examination from the first trimester; * give birth in the university hospital (the 1st affiliated hospital of sun yat-sen university) exclusion criteria: * younger than 18 years old; * older than 40 years old; * multiple pregnancy; * complicated with other diseases such as hypertension, eclampsia, thyroid diseases, etc.

Keywords: hypertension, pregnancy-induced fgf23