Kornimate/medical-research-clean huggingface dataset:
childhood allergy and the neonatal environment

Conditions: Asthma in Children; Allergy

Summary: the purpose of this research study is to study the relationship between childhood asthma, allergies, and early-life environmental factors that may cause childhood asthma and allergies. previous birth cohort studies have found early-life environmental factors such as allergies, pollutants, viruses and bacteria have all contributed to the development of asthma and allergies. investigators are doing this research because there continues to be a strong need to understand the root causes of asthma and allergies. the canoe study is an observational cohort study, which means investigators are not asking participants or participant's child to change their medications and investigators will not be giving participants or participant's child a study drug.

the canoe study will provide an opportunity to collect novel longitudinal samples not available from the current canoe birth cohorts, as well as enhanced and standardized environmental sampling in early life. one of the main goals of this study is to gather data and specimens, beginning in the prenatal periods, that will assess environmental exposures to toxins and microbes, and host characteristics including genetics, epigenetics, gene expression, the proteome and metabolome, microbial colonization and viral respiratory infections. the main study outcomes will be important interim conditions (e.g., recurrent wheeze, early multiple sensitization) that are highly associated with the development of asthma. additional outcomes (perinatal outcomes, growth, neurocognitive development) will be collected as part of the collaborative environmental influences on child health outcomes (echo)-wide cohort data collection protocol.

Eligibility criteria:
inclusion criteria: 1. history of or concurrent asthma or allergic rhinitis (hay fever) in either biologic parent or sibling (at least one shared biological parent) by parental report. the presence of paternal or sibling allergy or asthma will be ascertained by maternal report. 2. maternal age greater than or equal to 18 years at the time of study enrollment. exclusion criteria: 1. maternal hiv infection at time of delivery. 2. plans for the family to move out of the geographic area during the period of the study. 3. does not speak english. 4. current maternal use of progesterone during pregnancy to prevent preterm birth. * progesterone use is only an exclusion if currently being taken at time of enrollment for preterm birth. previous use to prevent preterm birth or use at any time for other indications is allowed. 5. pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are permitted). 6. past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Keywords: allergy, asthma, children, birth cohort
mouthwash of pomegranate against biofilm and gingival inflammation in school children

Conditions: Gingivitis

Summary: the mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. nevertheless, maintaining dental surfaces biofilm-free is not an easy task. in this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.

in vitro and clinical researches using punica granatum linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. the purpose of this study was to evaluate the clinical effectiveness of a mouthwash of punica granatum linn. against biofilm and gingival inflammation in school children

Eligibility criteria:
inclusion criteria: * age group: 09-12 years old * presence of at least 20 teeth * simplified oral hygiene index (s-ohi)≥ 1,6 exclusion criteria: * use of orthodontic appliance * recent (in the past 2 months)use of antibiotics and mouthwashes

Keywords: dental plaque medicinal plants gingivitis
effect of metformin and rosiglitazone over no diabetic with metabolic syndrome patients.

Conditions: Insulin Resistance

Summary: to compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (gh) in no diabetic metabolic syndrome individuals. a randomized blinded clinical trial did in patients with metabolic syndrome (n=30), without diabetes. prior to detailed information and signature of informed consent by patients were done three treatment groups by randomized technique; a) placebo, b) metformin (850 mg/day), c) rosiglitazone (4 mg/day), treatment was administered for 8 weeks. gh was measured before and after treatment using oral glucose tolerance test (ogtt), and ir-index (homeostatic model). determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, hdl-cholesterol and insulin.

metabolic syndrome is a risk factor for diabetes mellitus characterized by insulin resistance, hypertension, triglyceride elevation, low levels of high-density lipoproteins, and obesity. metformin and rosiglitazone are two insulinosensensitizers used in the treatment of diabetes. now there is controversy over the use of insulinossensitizers in non-diabetic patients with metabolic syndrome. to compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (gh) in no diabetic metabolic syndrome individuals. randomized blinded clinical trial in patients with metabolic syndrome without diabetes was done, sample size (n=30). prior to detailed information and signature of informed consent by patients was randomized forming three treatment groups, a) placebo, b) metformin (850 mg/day), c) rosiglitazone (4 mg/day), treatment was administered for 8 weeks. gh was measured before and after treatment using oral glucose tolerance test (ogtt), and ir-index (homeostatic model). determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, hdl-cholesterol and insulin. statistic no parametric (kruskal wallis, wilcoxon, u mann whitney) to compare characteristics inter o intra groups was done. exact fisher test was used for qualitative variable, and consider significance with p\<0.05.

Eligibility criteria:
inclusion criteria: * \> 18 years old. * metabolic syndrome criteria of world health organization . exclusion criteria: * diabetes mellitus * allergic to metformin, * allergic to rosiglitazone. * hepatic disease. * hearth disease.
define predictors of response to ozanimod in uc discovering biomarkers in the management of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: a diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in uc patients. using somascan from somalogic (boulder, co), our study aims to discover serum protein biomarkers in uc patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.


Eligibility criteria:
inclusion criteria: 1. patients ≥18 years of age with established diagnosis of uc starting ozanimod therapy as part of their clinical care 2. patients with moderate to severe uc, determined by a 3-component mayo score of 5-9 with an endoscopic subscore ≥ 2.endoscopy must be performed within 90 days of ozanimod initiation 3. elevated crp (greater than upper limit of normal on assay) and/or fecal calprotectin (\>250 mcg/g) within 90 days of drug initiation exclusion criteria: 1. diagnosis of crohn's disease or indeterminate colitis 2. total (procto)colectomy 3. ileoanal pouch anastomosis 4. current ileostomy or colostomy 5. untreated clostridium difficile infection 6. known pregnancy

Keywords: biomarkers ozanimod somascan
the effect of suturing material on scar healing

Conditions: Wound Heal; Cesarean Section Complications; Cesarean Wound Disruption; Suture Related Complication

Summary: we want to compare the effects of 2 suture materials (monofilament and multifilament) on healing of the uterine scar after a cesarean delivery.

cesarean section (cs) is the most common type of obstetric surgery. when medically justified, cs can effectively prevent maternal and perinatal mortality and morbidity however, there are many short and long-term complications of cs. one of the most common complications is the cs scar defect. cs scar defects can develop after transverse incision of the lower uterine segment, which may result in prolonged postmenstrual bleeding, spotting, pelvic pain, and infertility. suture material is an essential part of any major surgery, serving to hold opposing tissues together and accelerate the healing process, resulting in decreased scarring of the affected areas. we sought to evaluate the effects of different synthetic absorbable suture materials on cesarean scar defect formation.

Eligibility criteria:
inclusion criteria: * singleton pregnancy at term \>37 weeks of gestational age exclusion criteria: * history of previous cesarean section * history of previous uterine surgery * multiple gestation, placenta previa, polyhydramnious, fetal macrosomia * uterine atony history * gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath * active labor (with regular uterine contractions and cervical dilatation \>4 cm

Keywords: cesarean section scar heal isthmocele suture material saline infusion sonography
cross-neutralization capacity of immune serum from different dosage of sabin inactivated poliovirus vaccine immunization

Conditions: Poliomyelitis

Summary: this study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an sabin strain inactivated poliovirus vaccine (sipv) manufactured by sinovac biotech ltd., beijing china. the purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sipv against 10 individual virus strains.

this study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sipv in 600 healthy infants aged 2-months old. the purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sipv against 10 individual virus strains. paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wipv) group and control sipv group, was selected and sent to china center for disease control and prevention (cdc) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including sabin strains (type 1, 2, and 3), salk strains (mahoney, mef-1, and saukett), cvdpv (type 1, 2, and 3) and xinjiang wild strain of type 1(xinjiang wipv1). all the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.

Eligibility criteria:
inclusion criteria: * participants of the already finished phase 2 clinical trial; * subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial; * provide written informed consent. exclusion criteria: * none.
serial progesterone level measurements during the menstrual cycle in subfertile women

Conditions: Subfertility, Female; Ovulation Disorder

Summary: ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. ovulatory dysfunction may be more subtle in women with regular menses. detecting the day of ovulation is necessary for optimizing natural conception, diagnosis of cycle disturbances and also timing for embryo transfer in natural cycle frozen-thawed embryo transfers. in order to diagnose ovulatory dysfunction, ovulation physiology and change of reproductive hormones during the menstrual cycle should be understood. in the present study we aimed to evaluate serial serum hormonal cut-off levels referenced to ovulation in subfertile women with regular menses.


Eligibility criteria:
inclusion criteria: * women that have regular menses (menstrual cycle length 21-35 days) * women who will come visits regularly * women that are trying to conceive more than 1 year if women age is less than 35 years or more than 6 months if women age is \>35 years exclusion criteria: * women who do not menstruate regularly * women that use hormonal contraception * women who take drugs that will interfere with steroid hormone metabolism

Keywords: ovulation progesterone ovulatory dysfunction subfertility
a comparative study to evaluate the evolution of medication satisfaction and adherence in patients unsatisfied with current oral atypical antipsychotics by switching medication to paliperidone palmitate

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the change of medication satisfaction measured by medication satisfaction questionnaire (msq) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.

this is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study. the study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). in the treatment phase, patients will be randomly assigned equally in 2 groups (group 1 and group 2), on the basis of known and unknown characteristics. group 1 (immediate switch group): patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. group 2 (delayed switch group): patients will remain on current oral antipsychotics until week 8, and later on will be completely switched to paliperidone palmitate. however, during the first 8 weeks if the symptoms or satisfaction with msq further deteriorates for group 2, they may be switched into paliperidone palmitate earlier. safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study. the total duration of the study will be approximately 148 days.

Eligibility criteria:
inclusion criteria:- meet diagnostic criteria for schizophrenia according to diagnostic and statistical manual of mental disorders version iv * dissatisfied with current medication (medication satisfaction questionnaire score of less than or equal to 4) or by clinician's judgment and who may benefit from switching medication * have received an oral antipsychotic for at least 4 weeks before randomization * agrees to protocol-defined use of effective contraception exclusion criteria: history of neuroleptic malignant syndrome * presence of congenital prolongation of the qt interval - history of treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 90 days of the screening visit; or any treatment with clozapine within the previous 60 days * any relevant medical history or current presence of systemic disease * significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator

Keywords: schizophrenia paliperidone palmitate invega sustenna antipsychotics atypical antipsychotics medication satisfaction and adherence
pulmonary condensate: non-invasive evaluation of pulmonary involvement in asthma and cystic fibrosis.

Conditions: Bronchial Asthma; Pulmonary Cystic Fibrosis

Summary: exhaled breath condensate (ebc) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like (cf) cystic fibrosis or (ab) bronchial asthma would be highly beneficial. investigators propose to establish ebc "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of cf patients and ab. investigators hypothesize that the analysis of ebc can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as p. aeruginosa (pa). with these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and cf lung disease severity. together, the studies will advance the development and validation of ebc as a novel tool for the proper diagnosis of ab and monitoring of cf disease activity, treatment efficacy and pa or another opportunistic infections.

exhaled breath condensate (ebc) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like cystic fibrosis (cf) or bronchial asthma (ab) would be highly beneficial. investigators propose to establish ebc "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of cf patients and ab. investigators hypothesize that the analysis of ebc can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as p. aeruginosa (pa). with these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and cf lung disease severity. together, the studies will advance the development and validation of ebc as a novel tool for the proper diagnosis of ab and monitoring of cf disease activity, treatment efficacy and pa or another opportunistic infections.

Eligibility criteria:
inclusion criteria: * children/adults with moderate or ige mediated asthma * children/adults with cystic fibrosis * healthy control children/adults without lung disorders exclusion criteria: -

Keywords: breath condensate bronchial asthma cystic fibrosis
safety and efficacy of repeated infusion of celyvir in children and adults with metastatic and refractory tumors.

Conditions: Children; Solid Tumors; Metastases

Summary: the investigators will evaluate the safety of weekly infusions (n=6) of celyvir in children and adults with metastatic and refractory solid tumors. celyvir consists in bone marrow-derived autologous mesenchymal stem cells (mscs) infected with icovir5, an oncolytic adenovirus. in addition to data on toxicities the investigators will evaluate clinical response.


Eligibility criteria:
inclusion criteria: * children: up to 18 yrs. refractory to at least 2 previous therapy lines. life expectancy more than 6 months. measurable disease. * adults: 18-75 yrs. refractory to at least 2 previous therapy lines. ecog (eastern cooperative oncology group) \<2. measurable disease. exclusion criteria: * pregnancy. * central nervous system metastasis. * experimental therapy during the previous month. * chemotherapy less than 3 weeks previous. * any organ functionally impaired. * concurrent infectious disease.

Keywords: mesenchymal stem cells oncolytic adenovirus
high intensity cycling before scuba diving reduces post-decompression microparticle production and neutrophil activation

Conditions: Decompression Sickness; SCUBA Diving

Summary: the purpose of this study is to determine the impact of high intensity,anaerobic exercise, in the form of cycling, on scuba diving. outcomes are determined by the quantification and subtype of circulating microparticles, complete blood counts, and the quantification of venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.


Eligibility criteria:
inclusion criteria: * experienced divers (\> 250 logged dives) * male * physician clearance to dive exclusion criteria: * prior incidence of decompression sickness

Keywords: scuba diving exercise, microparticles neutrophil activation, high intensity exercise
pressure wire guidance for infrapopliteal artery interventions

Conditions: Chronic Limb-Threatening Ischemia

Summary: "• a prospective, single-center randomized controlled comparison trial. * a total of 100 patients with symptoms of chronic limb-threatening ischemia (rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria. * patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group. * patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions. * in the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. optimal results are defined as antegrade blood flow without residual stenosis \>50% or flow-limiting dissection. * in the pressure wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. optimal pressure gradient is less than 10 mmhg by measurement using a pressure wire. * the primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmhg within 1-3 days after the index procedure. * patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events."

1. prospective, singlecenter, open label, randomized controlled study 2. eligible patients with chronic limb-threatening ischemia (rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be randomized to pressure wire-guided or angiography-guided groups. 3. all patients will undergo balloon angioplasty for anterior or posterior tibial artery lesions, with the angiography-guided group aiming for optimal procedural results based on angiography, and the pressure wire-guided group aiming for optimal results based on both angiography and pressure gradient measurements. 4. the primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmhg within 1-3 days after the procedure. 5. clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.

Eligibility criteria:
inclusion criteria: * patient with chronic limb threatening ischemia (rutherford 5) * anterior tibial artery or posterior tibial artery lesions ≥ 10 cm age ≥19 years exclusion criteria: * acute limb ischemia * contraindication to antiplatelet or anticoagulation agents: 1. thrombocytopenia (platelet \<100,000/ul) 2. previous cerebral hemorrhage, gi bleeding, other reasons for increased bleeding risk within 6 months * pregnant women or women with potential childbearing * life expectancy \< 1 year