Kornimate/medical-research-clean huggingface dataset:
biological standardization of dactylis glomerata allergen extract

Conditions: Allergy to Grass Pollen (Dactylis Glomerata)

Summary: the objective of this study is to determine the biologic activity of a dactylis glomerata allergen extract in histamine equivalent prick (hep) units, in order to be used as in-house reference preparation (ihrp).

this is an open, unblinded and non-randomized biological assay. the study design is a slight modification of the recommendations proposed by the nordic guidelines. four concentrations of dactylis glomerata allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility criteria:
inclusion criteria: 1. a documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to dactylis glomerata. 2. subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable). 3. subject can be male or female of any race and ethnic group. 4. age \> 18 years and \< 50 years at the study inclusion day. 5. positive skin prick test with a standardized commercially available preparation of dactylis glomerata allergen extract. the skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study 6. a positive test for specific ige to dactylis glomerata(cap-rast ≥ 2). ige results are valid if performed within one year prior to the inclusion of the subject in the study. 7. allergic symptoms during the pollen season of dactylis glomerata. 8. mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm. exclusion criteria: 1. immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts). 2. use of drugs that may interfere with the skin reactions (e.g., antihistamines). see appendix 1 3. treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent). 4. pregnancy. 5. dermographism affecting the skin area at the test site at either study visit. 6. atopic dermatitis affecting the skin area at the test site at either study visit. 7. urticaria affecting the skin area at the test site at either study visit. 8. participation in another clinical trial within the last month. 9. subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,..)

Keywords: immunotherapy skin prick test standardization dactylis glomerata
safety and immunogenicity study of covid-19 protein subunit recombinant vaccine

Conditions: COVID-19

Summary: this trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. the population is healthy subjects aged 18 and above

the phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. the subjects will be given 2 doses of investigational product with 28 days interval between doses. one selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.

Eligibility criteria:
inclusion criteria: 1. clinically healthy subjects aged 18 years and above. 2. subjects have been informed properly regarding the study and signed the informed consent form. 3. subjects will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. history of vaccination with any covid-19 vaccine. 3. history of covid-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment. 4. evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 6. history of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 7. history of blood disorders contraindicating intramuscular injection. 8. patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 9. history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)). 10. history of uncontrolled epilepsy or other progressive neurological disorders, such as guillain-barre syndrome. 11. subjects receive any vaccination (other than covid-19 vaccine) within 1 month before and after ip immunization. 12. subjects plan to move from the study area before the end of study period.

Keywords: covid-19 vaccine healthy population
comparison of adaptive dose painting by numbers with standard radiotherapy for head and neck cancer.

Conditions: Primary Non-operated Squamous Cell Carcinoma of Oral Cavity; Primary Non-operated Squamous Cell Carcinoma of Oropharynx; Primary Non-operated Squamous Cell Carcinoma of Hypopharynx; Primary Non-operated Squamous Cell Carcinoma of Larynx

Summary: the investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. this trial compares standard intensity-modulated radiotherapy (imrt), using only pre-treatment planning 18f-2-fluoro-2-deoxy-d-glucose positron emission tomography to adaptive 18f-2-fluoro-2-deoxy-d-glucose positron emission tomography voxel intensity based imrt or volumetric-modulated arc therapy (vmat) using repetitive per-treatment planning 18f-2-fluoro-2-deoxy-d-glucose positron emission tomography for head and neck cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx * primary unresectable tumor and/or patients that refused surgery * stages t1-4; t3-4 n0 or t(any) n1-3 for glottic cancer * multidisciplinary decision of curative radiotherapy or radiochemotherapy * karnofsky performance status \>= 70 % * age \>= 18 years old * informed consent obtained, signed and dated before specific protocol procedures exclusion criteria: * high risk human papilloma virus (hpv) * treatment combined with brachytherapy * prior irradiation to the head and neck region * history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years. * distant metastases * pregnant or lactating women * creatinine clearance (cockcroft-gault) =\< 60 ml/min * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
metagenomic analysis of gut microbiome in preterm

Conditions: Microbial Colonization; Microbial Superinvasion; Microbial Substitution; Newborn Morbidity

Summary: this is single center study. the investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.

microbiome is the collection of all the microorganisms living in association with the human body which are consist of eukaryotes, archaea, bacteria and viruses. microbiome in an average human body number are ten times more than human cells and have about 1000 more genes than are present in the human genome. there are symbiotic relationships between human and microbiome. if investigators are able to know about relationships between newborn and intestinal microbiome, mortality and morbidity in preterm infants may be improved. the investigators will collect the first and weekly stool of participants and analyze dna of microbiome thorough metagenomic anlysis. the results between 3 groups(preterm, late preterm and full-term infants) will be compared. the investigators expect that a mean distribution of intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that relationships between mortality, morbidity and intestinal microbiome.

Eligibility criteria:
inclusion criteria: * preterm infants who were born at gestational age of less than 36 weeks from approval date to feb 28th 2019 * full-term infants who were born at gestational age of greater than 37 weeks from approval date to feb 28th 2019 exclusion criteria: * newborns with congenital anomaly * newborns with genetic syndrome * newborns without consent of parents

Keywords: microbiome preterm newborn gut microbiome allergic predisposition
pharmacokinetic (pk) assessment of bibr 1048 in patients after primary elective total hip replacement surgery

Conditions: Venous Thromboembolism

Summary: to determine the pk profile of a single dose 150 mg bibr 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo a primary elective total hip replacement * male or female being 18 years or older (women of child bearing potential may not be included) * patients weighing at least 40 kg * written informed consent for participation exclusion criteria: * bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke * known renal disease * known liver disease, alcohol or drug misuse * known malignancy * treatment with another study drug in the past month
musidore ped study

Conditions: Pain Management; Music Therapy

Summary: the aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit. music therapy has real effects on the pain level already proven in adults units. our objective is to apply this technic to children. the investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.

pediatric intensive care units may be anxious places. a lot of painful and stressful procedures are done every day. a simple care such as a simple cleaning care may become painful or uncomfortable. usually those situation require the use of painkillers. for several years, new approaches are used in order to decrease the pain level without medication such as hypnosis or music therapy. music therapy proved efficacy to reduce pain in different procedures and is currently used in adult intensive care units in order to decrease anxiety and pain. one specific program, "music care" is based on a "u sequence" which use tempo and rhythm variations following the u scheme, to relax patients. this program will be evaluated in our department and the investigators will study the effects on the pain level during a cleaning care . the patients will be evaluated during two consecutive cleaning cares. one with and the other without music therapy. the investigators will compare the variation of the flacc scores (before and during cleaning care ) to show a difference between both methods. the order (with or without) will be randomized. the patient will be his one control.

Eligibility criteria:
inclusion criteria: * infants between 6 months and 15 years old * vigil child * admitted to the department of pediatric critical ill unit at university hospital in montpellier (france) * signed both parental consent. * signed both parental authorization for videotape recording * parents or person with legal authority who speaks and understands french exclusion criteria: * deaf child * refusal of the child to participate in the study

Keywords: pediatric critical ill care or intensive care anxiety pain
hypocaloric nutrition in critically ill patients

Conditions: Critically Ill

Summary: the aim of this study is to compare two nutritional regimes in critically ill patients. patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). the main outcome will be the sofa (sequential organ failure assessment) score. the hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.

the research site will be the intensive care unit (icu) of hospital universitario san ignacio; eligible patients will \>18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. in all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in iu), presence of hyper or hypoglicemia, presence of infections, among others. the sofa score will be assessed every two days until discharge from icu.

Eligibility criteria:
inclusion criteria: * \>18 years * estimated fasting period of at least 96 hours exclusion criteria: * parenteral nutrition * pregnancy * diabetes * liver or renal failure * transplantation * admitted from another hospital

Keywords: adults
promoting uptake and retention of option b+ in malawi

Conditions: HIV

Summary: the purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of pmtct care.

the malawi ministry of health (moh) has embarked on a novel and ambitious programme to prevent mother to child transmission of hiv (pmtct) known as "option b plus". this programme takes a public health approach to promote maternal health and eliminate paediatric hiv infections through a "test and treat" model, offering all hiv-infected pregnant and breastfeeding women lifelong art regardless of cd4 count or clinical stage. the overall goal is to improve art uptake and retention, and thus outcomes, of hiv-infected pregnant women and their infants in the continuum of art services. although the option b plus strategy offers an attractive rapid art scale-up alternative to the who pmtct recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. operational challenges throughout the cascade of pmtct services may affect the uptake and adherence to highly active art treatment (haart) by pregnant women, the follow-up of hiv-exposed infants and the long-term retention of this patient population. several issues identified at the national level are potential threats to the successful implementation and scale up of option b plus: a) potential suboptimal uptake of haart by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to haart and poor follow-up of hiv exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (schouten et al. 2011). the aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in pmtct care in malawi. our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of pmtct care. we will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the option b+ program. each of the 21 clinics will be randomized to one of the three adherence and support strategies. arm 1 is the standard of care arm as outlined by the ministry of health, arm 2 is facility level support by a peer educator and arm 3 is community level support by a peer educator.

Eligibility criteria:
inclusion criteria: * hiv infected women presenting for antenatal care, labor\&delivery, or post-partum infants of enrolled mothers husbands/spouses of enrolled mothers exclusion criteria: -

Keywords: hiv option b+ prevention of mother to child transmission
escort-hu extension: european sickle cell disease cohort - hydroxyurea - extension study

Conditions: Sickle Cell Disease

Summary: as safety information pertaining to the long-term use of hu remains incomplete in spite of the first safety study (escort-hu), an extension of the latter is proposed. escort-hu extension study aims at evaluating the long-term safety of siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with siklos® and followed for up to 5 years. the study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected aes causally related to siklos®.


Eligibility criteria:
inclusion criteria: * male or female patients with symptomatic scd, * ≥ 2 years old, * treated with siklos®, * having been informed of the study by the investigator and consenting to participate, or whose parents or legal guardians are consenting for their child to participate. to allow risk evaluation, participants must belong at least to one of the subpopulations defined below: * participants previously enrolled in escort-hu who agree to participate in escort-hu extension study, * new participants with any of the following criteria: * history of hu treatment for more than 5 years or * prepubescent over 10 years of age for girls and 13 years of age for boys at enrolment, or * with history of leg ulcer, or * pregnant women without interruption of siklos® 3 months before the beginning of the pregnancy or, * males treated with siklos® whose partner is pregnant and without discontinuation of siklos® 3 months before the beginning of the pregnancy.
adherence and outcomes in functional constipation with a constipation action plan

Conditions: Adherence, Medication; Functional Constipation; Pediatric ALL; Survey, Family Life

Summary: we will be assessing for improvement in reported symptoms as well as reported quality of life in pediatric patients with functional constipation using a constipation action plan and an adherence log.

functional constipation is one of the most common chief complaints for both the general pediatrician and the pediatric gastroenterologist. treatment for this disorder is multifactorial, and usually involves different medications combined with behavioral techniques, depending on the severity of the underlying constipation. studies have shown that medication compliance is one of the strongest predictors of successful treatment, but maintaining good medication adherence at home is uncommon for a variety of reasons. in this study, the investigators are aiming to improve home medication adherence for functional constipation to improve treatment outcomes. the investigators will be administering surveys for all enrolled participants to determine the child's and family's overall quality of life related to functional constipation. for the treatment group, the investigators will be providing tools to help with medication adherence. this will include a daily log to determine symptom severity, along with an "action plan" with instructions for how to adjust medicines, if necessary, depending on symptoms. by empowering families with this knowledge and medication roadmap, the investigators hypothesize that there will be overall symptomatic improvement in functional constipation, along with improved quality of life for both the patient and their family. the investigators will measure adherence (by reviewing symptom log and action plan at 2-month and 4-month follow up appointments.) with the treatment group. the investigators will be measuring overall quality of life and symptom improvement using a validated pediatric constipation quality of life survey (pedsql gi) with both the treatment group and the control group at follow up appointments.

Eligibility criteria:
inclusion criteria: * have been potty-trained for stool at some point * chief complaint constipation or encopresis * meets rome iv criteria for functional constipation exclusion criteria: * preexisting diagnoses of autism, cerebral palsy, developmental delay, and/or thyroid disease * prior gastrointestinal surgery * presence of "red flag" symptoms for organic etiology: * passage of meconium \>48 hours after birth in a term newborn * family history of hirschsprung's disease * "ribbon" stools * blood in stools (in absence of anal fissure) * coexisting diagnosis of malnutrition, bilious vomiting, abnormal anal positioning, absent anal reflex, decreased lower extremity strength/tone, sacral dimple, and/or tuft of hair on spine
study to investigate safety, tolerability and effect of multiple dosing with azd 4721 and/or with azd 5069

Conditions: Chronic Obstructive Pulmonary Disease (COPD).

Summary: study to investigate safety, tolerability and effect of multiple dosing with azd 4721 and/or with azd 5069

the purpose of the study is to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of azd 4721 in healthy volunteers after once daily administration of multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics of azd5069 given twice daily for 3 days

Eligibility criteria:
inclusion criteria: * 1.provision of signed and dated, written informed consent prior to any study specific procedures. * 2.healthy male and/or female caucasian (neither black/african american nor japanese) volunteers aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture. ("healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ecg and performed before first dose administration.). * 3.healthy volunteers should have a body mass index (bmi) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). exclusion criteria: 1. pyrexial with a body temperature higher than 37.7°c at day -1 (visit 2), or as judged by the investigator. 2. screening blood neutrophil counts (taken in the morning) not within the laboratory reference range (visit 1). 3. other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in the previous 90 days, or history of skin abscesses within the previous 90 days. 4. clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening (visit 1), as determined by the investigator.

Keywords: healthy volunteer multiple ascending dose