Kornimate/medical-research-clean huggingface dataset:
a randomized study to evaluate a novel method of specific allergen immunotherapy

Conditions: Rhinoconjunctivitis Due to Grass Pollen Allergy

Summary: allergen specific immunotherapy (sit) is the only causative treatment of ige-mediated allergies. the disadvantages of sit, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. we aim at enhancing grass pollen sit in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. in a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ilit) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (scit) using 54 injections over 3 years. * trial with immunodulatory product / biological


Eligibility criteria:
inclusion criteria: * written informed consent * history of allergic rhino-conjunctivitis in spring and summer * age 18 years to 65 years * positive skin prick test to grass pollen exclusion criteria: * blood donation within previous 30 days * surgery within the previous 30 days * use of investigational drugs within previous 90 days * pregnancy or nursing * mastocytosis * significant cardiovascular disease * hypertension * active infectious disease * significant hepatic disease * significant renal disease * significant hematological disorder * significant pulmonary disease * moderate or severe asthma * autoimmune disease * history of malignancy. * contraindicated medications were immunosuppressive agents, beta-blockers, ace-inhibitors, and tricyclic antidepressants.
comparison of intraoperative hemodynamic parameters and arterial-blood gas changes at two different pneumoperitoneal pressure values

Conditions: Pneumoperitoneum

Summary: clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering. methods. the aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value. we evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmhg (group a) and at a pressure of 8 mmhg (group b).

we evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmhg (group a) and at a pressure of 8 mmhg (group b) to highlight any significant alterations. the clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between july 2019 and february 2020. 20 patients, 9 men and 11 women, were enrolled. group a included 10 patients, 5 men and 5 women, with an average age of 47.9 years. group b included 10 patients, 4 men and 6 women, with an average age of 50.7 years. the parameters evaluated were: heart rate (hr), average arterial blood pressure (bp), respiratory frequency (rf), oxygen saturation (sao2), hemogasanalysis (pao2, paco2, ph and hco3-). the measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing. the hemodynamic parameters (hr, rf, bp, sao2) were extrapolated from the multiparameter monitor for each evaluation. the hemogasanalytic values (pao2, paco2, ph and hco3) were evaluated by the radial arterial sampling. the average and standard deviation were calculated for the quantitative data normally distributed. for the comparison of the quantitative data, the t-student test was used. a value of p ≤ 0,05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: cholelithiasis - exclusion criteria: immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin \< 7 gr/dl or hematocrit \< 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities -

Keywords: blood gas analysis alterations; hemodynamic alterations
trial to collect safety data and sera for immunogenicity testing

Conditions: Influenza

Summary: to provide centers for biologics evaluation and research (cber) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine fluzone® for further study by the food and drug administration (fda), center for disease control and prevention (cdc) and world health organization (who).


Eligibility criteria:
inclusion criteria: * participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday). * participant is considered to be in good health on the basis of reported medical history and limited physical examination. * participant is available for the duration of the study. * parent/legal acceptable representative is willing and able to provide informed consent. * parent/legal acceptable representative is willing and able to meet protocol requirements. * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs). exclusion criteria: * reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. * an acute illness with or without fever (for infants/toddlers: temperature ≥ 100.4 °f rectal; for children: temperature ≥ 99.5 °f oral/axillary) in the 72 hours preceding enrollment in the trial (enrollment may be deferred). * clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study. * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. * personal or immediate family history of congenital immune deficiency. * developmental delay, neurologic disorder, or seizure disorder. * chronic medical, congenital, or developmental disorder. * known human immunodeficiency virus (hiv)-positive mother. * prior personal history of guillain-barré syndrome. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Keywords: influenza influenza virus vaccine fluzone®
sibtime phase ii: web application for typically developing siblings

Conditions: Early Life Stress

Summary: most of the over 32.7 million people in the u.s. who have special health, developmental, and mental health concerns have typically developing (td) brothers and sisters who share high levels of involvement in their sibling's lives. disability and health agencies lack effective tools to support the information and support needs of td siblings and their families, in particular for ethnic minority and rural families. the aims of this proposal are to complete development and evaluation of the dual language sibtime app, designed to build parents' and children's knowledge, skills, and engaging family routines to nurture td siblings' (ages 3-6) social-emotional health and well-being.

an 8-week rct will be conducted to evaluate the full-scale sibtime program in a sufficiently powered randomized controlled trial evaluation (sample size = 160 parent/child dyads). sibtime will be assessed in terms of its relevance, acceptability, cultural appropriateness, and efficacy. participants will complete measures pre- and post- intervention selected to detect changes in parenting stress and adjustment, parent-child relationship, parents' self-efficacy and frequency of engagement in the targeted parenting strategies, and td sibling behavior and adjustment. information will also be collected on family demographics, consumer satisfaction, usability ratings, usage metrics, and recommendations for modifications to the program.

Eligibility criteria:
criteria: inclusion criteria: 1. parent of a child with a disability and a typically developing child aged 3-6 2. has a smartphone or tablet 3. speaks english or spanish exclusion criteria: 1. none

Keywords: siblings disability health concern
anti-inflammatory effects of intracoronary and intravenous abciximab administration during primary percutaneous coronary intervention

Conditions: Myocardial Infarction

Summary: intracoronary abciximab administration during primary percutaneous coronary intervention (ppci) could offer clinical advantages over the intravenous route. the aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. 87 consecutive stemi patients candidate to ppci were randomized to receive an intracoronary or intravenous abciximab bolus. the primary endpoint was the extent of inflammation, measured by c-reactive protein (crp), vcam-1 and icam-1 levels.

background: intracoronary abciximab administration during primary percutaneous coronary intervention (ppci) could offer clinical advantages over the intravenous route. besides antiplatelet effects, abciximab can modulate inflammation via cross-reactivity with gpiib/iiia, avb3, and amb2 receptors. the aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. methods: 87 consecutive stemi patients candidate to ppci were randomized to receive intracoronary (group a, 47 patients) or intravenous (group b, 42 patients) abciximab bolus. the primary endpoint was the extent of inflammation, measured by c-reactive protein (crp), vcam-1 and icam-1 levels.

Eligibility criteria:
inclusion criteria: * presence of stemi according to the universal definition of myocardial infarction (7); * hospital admission within 12 hours from symptom onset; * successful treatment by primary pci, defined as a procedure achieving infarct-related artery (ira) patency with less than 10% residual coronary stenosis based on visual estimation. exclusion criteria: * age \> 90 years; * cardiogenic shock at admission; * left main as ira; * saphenous vein graft as ira; * previous pci in the last 6 months; * severe renal impairment (egfr\<30ml/min) or dialysis treatment; * thrombolytic drug administration in the last 30 days before admission; * known malignancy diagnosed less than 5 years before admission; * known active infectious, coagulative or systemic inflammatory diseases.

Keywords: inflammation thrombosis platelets adhesion molecules endothelium
study of ace-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma

Conditions: Advanced Solid Tumors; Multiple Myeloma

Summary: for cancer cells to grow, they need to have nutrients supplied to them through blood vessels. the study drug, ace-041, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. the purpose of this study is to establish safe dose levels of ace-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma following multiple dose administration. this study will also evaluate if ace-041 has an effect on tumors.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists. * life expectancy of at least 12 weeks. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 (not declining within 2 weeks prior to study day 1). exclusion criteria: * central nervous system (cns) metastases. * chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1, and/or nitrosoureas within the 6 weeks prior to study day 1. * lack of recovery from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy with the exception of alopecia. * radiation therapy within 4 weeks prior to study day 1. * clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor or multiple myeloma * significant cardiac risk (e.g. history of myocardial infarction, unstable angina, pulmonary hypertension, clinically significant arrhythmia, congestive heart failure within 1 year prior to study day 1). * diagnosis or family history of hereditary hemorrhagic telangiectasia. * major surgery within 6 weeks prior to study day 1. * parenteral antibiotics, or any life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1. * therapeutic anti-coagulation. * uncontrolled hypertension. * autoimmune or hereditary hemolysis. * clinically significant gastrointestinal bleeding or any other clinically significant active bleeding within 3 months prior to study day 1. * treatment with another investigational drug or device, or approved therapy for investigational use within 28 days prior to study day 1. * pregnancy or lactation for female patients.
feasibility trial in urban pakistan for community engagement in preventing type ii diabetes and risk factors

Conditions: Type II Diabetes Mellitus

Summary: this project aims to adapt, implement, and evaluate pla based intervention in urban karachi, pakistan for tiidm prevention and control.

the pivotal components of this approach include adapting, implementing, and evaluating the participatory learning and action (pla) based intervention for the prevention and control of type ii diabetes (tiidm). tiidm is considered the fastest-growing health emergency, affecting 537 million adults worldwide. global projections for the year 2045 suggest that a 12.2% rise in tiidm is anticipated with an additional 11.4% rise for intermediate hyperglycemia (ihg). around 80% of people with tiidm reside in low-and middle-income countries (lmics), exhausting the already burdened healthcare system. the intervention, adapted from the "community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in bangladesh (dmagic)" trial, has been tested and found effective in the rural context of bangladesh. however, pla-based intervention has not been previously tested in urban communities. considering the distinct sociocultural environment of urban settings, a feasibility trial will be conducted in urban karachi, pakistan. the feasibility trial will assess the intervention's adaptability and effectiveness in this new context. it is anticipated that the use of evidence-based approaches, best practices, and meaningful community participation through pla will enhance the social and behavioral determinants of health and lead to improved health outcomes. this approach aims to control tiidm and pave the way for managing other non-communicable diseases through similar focused interventions.

Eligibility criteria:
inclusion criteria: * individuals aged 20 years and above. * participants residing in the randomized clusters of karachi, pakistan * individuals willing to participate in the study and provide consent. * both individuals with normoglycemia, intermediate hyperglycemia, and diabetes are encouraged to participate. * participants who can attend the scheduled meetings and interventions as per the study protocol. exclusion criteria: * individuals below the age of 20 years. * individuals unwilling to provide consent for participation. * participants with severe health conditions that may hinder their active involvement in the study. * individuals with non-compliance with research protocols

Keywords: community-based participatory research participatory learning and action research type ii diabetes mellitus intermediate hyperglycemia
ureteric identification using indocyanine green dye versus conventional ureteric stenting to reduce post-operative pain and surgical morbidity during endometriosis surgery

Conditions: Endometriosis; Deep Endometriosis

Summary: endometriosis is a common (around 1 in 10 women), non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. symptoms vary but can include intense pelvic pain and infertility. endometriosis that is very deep and painful may need surgery, which risks damage to the tubes that drain urine from the kidneys to the bladder (ureters). to reduce this risk, surgeons may put tiny plastic tubes called "stents" inside the ureters. these stents can stay for up-to 4 weeks following surgery but can cause severe pain and blood in the urine. squirting a dye into the ureters, rather than using stents, may cause less pain for women after surgery whilst not making the removal of endometriosis worse, the operation take longer, or increasing the rates of complications (such as bleeding or damage to internal organs). before a full clinical study can be run, the investigators need to understand whether this is possible, by doing a feasibility study


Eligibility criteria:
inclusion criteria: * women aged 18 to 50 years * scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (de) where ureteric stenting is planned. * willing and able to provide consent for participation in the study exclusion criteria: * confirmed or suspected pregnancy at the time of enrolment. * suspicion or confirmation of malignancy. * history of ureteric injury from prior surgery or trauma * medically unfit for surgery due to the following conditions: * uncontrolled diabetes mellitus. * severe chronic obstructive pulmonary disease (copd). * hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis). * history of stroke or severe kyphoscoliosis. * uncontrolled hypertension. * body mass index (bmi): bmi greater than 45
clinical pharmacist-led inpatient anticoagulation stewardship program

Conditions: Deep Vein Thrombosis; Atrial Fibrillation; Mitral Valve Disease

Summary: this study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in egyptian tertiary hospital to promote a culture of safety around anticoagulants.

one of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. it is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories. this prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.

Eligibility criteria:
inclusion criteria: all hospitalized patients on therapeutic anticoagulant medication during their hospitalization period. exclusion criteria: 1. patients whose age is less than 18 years old. 2. patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin. 3. patients already admitted for bleeding or thrombosis. 4. malignancy patients.

Keywords: anticoagulation stewardship program anticoagulants clinical pharmacist heparin warfarin
the impact of comprehensive post hospital management based on dhi on cardiac function in patients with hf

Conditions: Heart Failure

Summary: due to the complex nature of hf patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. with the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (dhi) has emerged as a new medical model in the treatment of diseases. this study will establish a comprehensive post hospital management model of hf based on dhi, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (reds™) technology, etc., comprehensively strengthen the post hospital intervention and management of hf. objective to explore the effect of comprehensive post hospital management based on dhi on cardiac function of patients with hf 6 months after discharge.


Eligibility criteria:
inclusion criteria: 1. patients hospitalized for hf, nyha classification ii-iv upon admission 2. the patient's residence is within the urban area of each center, and reds™ technology can be performed at home or at the outpatient clinic 3. no difficulty using smartphones, with basic chinese reading and writing skills 4. accept the terms and conditions of the study and obtain informed consent from the subjects/their families exclusion criteria: 1. age\<21 years old 2. patients with height\ 190 cm, bmi\ 36 kg/m2, chest circumference\ 115 cm, and flail chest or rib fractures 3. history of pulmonary embolism 4. chronic renal failure（scr \> 443umol/l） 5. history of heart transplantation or pacemaker implantation 6. severe pulmonary hypertension 7. suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy 8. massive pleural effusion 9. the subject is unable to complete the 6-minute walking test 10. expected lifespan\<6 months 11. researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.) 12. individuals who are unable to understand and/or comply with this research procedure (such as those who are addicted to alcohol, substance abuse, or have mental illnesses) 13. currently participating in clinical trials of other devices or drugs 14. researchers involved in the design and execution of this study

Keywords: heart failure digital health intervention remote dielectric sensing reds™ comprehensive health care 6 min walk test randomized controlled trial
effect of repositioning frequency neonates receiving phototherapy

Conditions: Bilirubinemia; Newborn Jaundice

Summary: purpose: the present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort. design and methods: this was a single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial conducted in a neonatal intensive care unit. participants were randomly assigned to one of three groups: supine position group (n = 20), hourly position change group (n = 20), and control group (n = 20). the bilirubin level and comfort levels of the neonates were evaluated.

purpose: the present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Eligibility criteria:
inclusion criteria: * gestational age between 35-42 weeks * birth weight of 2000 g or more * indication for phototherapy * no previous phototherapy, * no medical diagnosis other than prenatal hyperbilirubinemia * stable health status * no clinical signs of dehydration * transition to oral feeding, no sucking problems * being at least 2 days old on the day of phototherapy exclusion criteria: * a sudden change in stability during phototherapy and * phototherapy duration of less than 24 hours

Keywords: bilirubin comfort neonates phototherapy positioning