Kornimate/medical-research-clean huggingface dataset:
fish oil in pregnancy for personalized prevention of early childhood asthma

Conditions: Asthma; Respiratory Tract Infections; Gastrointestinal Infection; Croup; Eczema; Allergy; Wheezing; Fractures, Bone; Development, Child; Cognition Disorders in Children; Psychiatric Diagnosis

Summary: the overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.

randomization of 2000 pregnant women to fish oil of 2.4 g/day (55% epa and 37% dha) in triacylglycerol form vs placebo. supplementation begins in gestational week 24 (22-26) until 1 week after delivery. allocation to the trial will be determined based on the pre-interventional maternal blood levels of epa+dha with a dried blood screening test. women with low levels (below 4.7% of total fatty acids) will be assigned to the fish oil rct. maternal blood will be used for genetic, metabolomic and proteomic profiling. a 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. the primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. a follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.

Eligibility criteria:
* pregnant danish women before week 26 with blood levels of epa+dha below 4.7% of total fatty acids * no planned use of fish oil supplementations * no endocrine-, heart-, kidney- or auto-immune disorders

Keywords: childhood asthma infections eczema allergy development psychiatry bone development cognition growth
cerclage vs cervical pessary in women with cervical incompetence

Conditions: Cervical Insufficiency

Summary: cervical insufficiency (ci), responsible for 8% of preterm births (pb), is used to describe painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. structural weakness of cervical tissue was thought to cause or contribute to these adverse outcomes. the term has also been applied to women with one or two such losses/births or at risk for second-trimester pregnancy loss/birth. cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for pb. this study aims to demonstrate that the cervical pessary could reduce the preterm birth rate before 37 weeks of gestation in women with prior pb due to cervical insufficiency or in women with prior pb and a short cervix in the current pregnancy.

methods/design: this is an open-label, pilot, multicentre, prospective, randomised controlled trial (rct). enrolees are women with singleton pregnancies and previous pb based on ci (primary intervention, \<16 weeks) or in case of previous pb and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, \<24 weeks). women are randomised (1:1) either to cervical cerclage or pessary treatment. the primary outcome is the spontaneous preterm birth rate before 34 weeks of gestation. the sample size was calculated, as a pilot study, based on the estimated population that we will be able to recruit during the duration of the trial: 60 women, 30 for each group (cervical cerclage and cervical pessary group) to observe, at least a reduction in the pb rate \< 34 weeks from 34% to 27% in the pessary group, as does cerclage. discussion: the outcome of this study will show the effectiveness of a cervical cerclage and of a cervical pessary in this group of patients.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * minimum age: 18 years * previous pb based on ci (primary intervention, \<16 weeks) or in case of previous pb and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, \<24 weeks). women are randomised (1:1) either to cervical cerclage or pessary treatment. exclusion criteria: * major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * threatened preterm labour at time of randomization * spontaneous rupture of membranes at time of randomization * chorioamnionitis at time of randomization * active vaginal bleeding * placenta previa

Keywords: cervical insufficiency cervical cerclage cervical pessary
epidemiological investigation and cohort study on food allergy in children aged 3 to 6 years in wenzhou and taizhou urban areas

Conditions: Food Hypersensitivity

Summary: objective 1. to investigate the status of food allergy among children aged 3 to 6 in wenzhou and taizhou urban areas. 2. to obtain the self-reported rate of parents or guardians of food allergy among children aged 3 to 6 in wenzhou and taizhou urban areas. 3. to obtain the prevalence of food allergy among children aged 3 to 6 in wenzhou and taizhou urban areas by conducting skin prick test (spt), blood eosinophil (eos) count, total immunoglobulin e (tige) measurement and serum specific ige (sige) determination in children who self-reported food allergy, and conducting the open food challenge (ofc) if it is needed for further diagnosis. methods the preschool children aged 3 to 6 from kindergartens in wenzhou and taizhou urban areas were selected by cluster sampling and random sampling to conduct a preliminary screening questionnaire. then telephone interviewe the children who had diseases or problems caused by certain food or certain types of food. make them finish further food allergy questionnaires, spt, eos, tige detection, sige detection. spt has 17 kinds of food allergens including milk, egg white, egg yolk, shrimp, crab, wheat, mackerel, perch, cod, peanut, cashew nut, soybean, peach, pineapple, mango, orange and kiwifruit. sige has 10 kinds of food allergens including milk, egg white, shrimp, crab, soybean, peanut, wheat, nut mixed group and food mixed group. children whose results of spt and/or sige didn't meet the diagnostic criteria and children whose results of spt and sige were negative but its history strongly supported food allergy need to conduct ofc. descriptive analysis and risk factor analysis were carried out on the results, and spss 18.0 statistical software was used in statistics analyzation.


Eligibility criteria:
inclusion criteria: * the date of birth is in the range of 2011.9.1-2015.8.31 exclusion criteria: * the date of birth is not in the range of 2011.9.1-2015.8.31 or the children who's parents cannot cooperate
efficacy and safety evaluation of tolvaptan in the treatment of patients with rhf caused by pah

Conditions: Pulmonary Arterial Hypertension; Randomized Controlled Trial

Summary: efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension

the study is a prospective, single-center, randomized controlled trial. specifically, the research focuses on patients with right heart failure due to pah in the pulmonary vascular ward of fuwai hospital. within 12 hours of admission, subjects were randomly assigned to two groups using the central randomization method. the dose of tolvaptan (15 mg/d) is added to standard therapy (including diuretics) for subjects in group a. traditional standard therapy (including diuretics) is used for subjects in group b. the treatment lasts for a total of seven days to assess the efficacy and safety of tolvaptan in the treatment of pah-induced right heart failure. an informed consent form must be signed by each participant in our study.

Eligibility criteria:
inclusion criteria: * patients who have no serious cerebrovascular, liver, kidney and lung organ and tissue diseases. * no corticosteroids or immunosuppressive agents had been administered to the - patients in the three months prior to enrollment in the study. * patients voluntarily participated in the study and signed an informed consent form. exclusion criteria: * patients who install the circulation aids. * patients who have been diagnosed with active myocarditis or amyloid cardiomyopathy. * fasting blood glucose level exceeded 12.21 mmol/l in individuals with uncontrolled diabetes. * patients who suffer from anuria, urethral strictures, stones, or tumors caused by urination disorders. * patients with acute myocardial infarctions, persistent ventricular tachycardias, or ventricular fibrillations, and cerebrovascular accidents within the first 30 days of the screening period. * patients with a history of allergy or specific reactions to benzodiazepines. (mozavaputan hydrochloride, benaepril hydrochloride) * any of the following laboratory tests were abnormal: serum creatinine\> 2.5 times the upper normal value limit, serum sodium\> 145 mmol/l, and serum potassium\> 5.5 mmol/l. * pregnant women, lactating women, or patients who may be pregnant or have pregnancy plans. * patients with other contraindications to the use of tolvaptan. * patients who have been taking tolvaptan within the first 3 months before inclusion in the study, either when the drug was marketed or when it was being clinically studied. * additionally, patients who were judged by the investigators not fit to be enrolled in this trial.

Keywords: pulmonary arterial hypertension randomized controlled trial
to assess the safety, tolerability, and pharmacokinetics of azd7624 in healthy volunteers and copd patients

Conditions: COPD; Healthy Subjects

Summary: this study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of azd7624 in healthy subjects and patients with chronic obstructive pulmonary disease.

a phase i, randomized, doubleblind placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of multiple ascending inhaled doses (mad) of azd7624 to healthy subjects and patients with copd

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * provision of signed and dated, written informed consent prior to any study specific procedures * plasma myoglobin and ck not above the upper reference range of the analysing laboratory at day -1 * male and/or female patients with copd aged above18 years with suitable veins for cannulation or repeated venipuncture. * clinical diagnosis of copd for more than 1 year at visit 1, according to the global initiative for chronic obstructive lung disease (gold) guidelines exclusion criteria: * any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the ip * receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the ip in this study * any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator * any positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Keywords: phase 1, safety, tolerability, healthy, copd patients
remote monitoring of cgm data in pediatric patients with newly diagnosed type 1 diabetes (t1d)

Conditions: Type 1 Diabetes

Summary: to determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. we will be using the gluvue platform to remotely view continuous glucose monitor (cgm) data.

based on alerts from gluvue, care team members will proactively reach out to patients and their families for more frequent dose adjustments. we will assess if remote monitoring facilitates contact between the care team and patients and improves glycemic control.

Eligibility criteria:
inclusion criteria: * all individuals within one month of t1d diagnosis seen at the stanford children's diabetes clinic * individuals who plan to receive follow up care at the stanford children's diabetes clinic * individuals who agree to cgm data integration into the electronic medical record (emr) for remote monitoring * age: birth to \< 21 years of age exclusion criteria: * diabetes diagnosis other than t1d * diagnosis of diabetes \> 1 month prior to initial visit * individuals with the intention of obtaining diabetes care at another clinic * individuals who do not consent to cgm use, cgm data integration, or remote monitoring * individuals \> 21 years of age

Keywords: pediatrics
correlation between serum tk1 and pathological remission of breast cancer with neoadjuvant chemotherapy

Conditions: Breast Neoplasms; TK1

Summary: the levels and changes of stk1 among different outcome groups in bcs with different molecular types were compared by stratification to explore whether stk1 can be used as one of the tumor markers to predict pathological remission of nact in bc patients.the changes of serum stk1 level and adc before surgery were continuously monitored, and combined with other clinicopathological factors, the pathological remission prediction model of nact in bc patients was constructed and verified.

female patients diagnosed with breast cancer by breast biopsy and receiving neoadjuvant chemotherapy in our hospital from 2020 to 2024 were selected as the study objects, and their puncture pathology data, general clinical characteristics, hematology test data, imaging data and surgical pathology data were collected, and the data were collated for statistical analysis. the influencing factors of pcr after neoadjuvant therapy were determined by univariate and multivariate logistic regression analysis, and the nomogram and roc curve were drawn. the model was verified internally through bootstrap resampling 1000 times, and the correction curve was drawn to evaluate the prediction ability of the model.

Eligibility criteria:
inclusion criteria: ① the patient was diagnosed with breast cancer by biopsy, and there were complete pathological data. ② complete the course of neoadjuvant chemotherapy; ③ after the end of neoadjuvant therapy, the operation was performed and the postoperative pathology was obtained; mri and serum tk1 data were complete (baseline, after 2 cycles of chemotherapy, 4 cycles of chemotherapy, and 6 cycles of chemotherapy). exclusion criteria: ① distant metastasis at first diagnosis (stage iv); ② with other primary malignant tumors.
heparin for pregnant women with thrombophilia

Conditions: Pregnancy and Thrombophilia

Summary: the purpose of this study is to investigate whether heparin is an effective treatment in pregnant women at risk for thrombosis and other pregnancy-associated complications.

women with thrombophilia, i.e. carriage of a factor v leiden mutation, a factor ii prothrombin g20210a mutation or a reduced amount of antithrombin iii, protein c or protein s, are at elevated risk for thrombosis and related sequelae. specifically, pregnant women with thrombophilia are at risk for pregnancy-associated thrombosis, pregnancy-associated thromboembolism as well as early miscarriage (until 20 weeks gestation) late miscarriage (after 20 weeks gestation), preeclampsia, and intrauterine growth retardation \<10th percentile. uncontrolled retrospective and prospective studies indicate that a therapy with unfractionated heparin or low molecular weight heparin in pregnancy significantly reduces these pregnancy complications and improves maternal and fetal outcome. the use of low molecular weight heparin in pregnancy is safe with complication rates between 1% and 3%, mainly thrombocytopenia and bleeding complications. randomized trials to adequately assess the safety and efficacy of heparin in pregnant women with thrombophilia are not available to date. thus, we intend to randomize pregnant women with thrombophilia during weeks of gestation 11 to 14 into a therapy with nadroparin calcium (fraxiparin®) 0.3 ml daily during pregnancy and six weeks post partum and usual care. the primary end point of this study is a composite endpoint of pregnancy-associated thrombosis, pregnancy-associated thromboembolism, early miscarriage (until 20 weeks gestation) late miscarriage (after 20 weeks gestation), preeclampsia, and intrauterine growth retardation \<10th percentile. we hypothesize that a prophylactic therapy with nadroparin calcium will significantly reduce pregnancy complications in pregnant women with thrombophilia.

Eligibility criteria:
inclusion criteria: * pregnant women with a singleton pregnancy * age \>18 years * ability to understand informed consent form exclusion criteria: * allergy/hypersensitivity for nadroparin calcium * heparin-associated thrombocytopenia * organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm * uncontrolled hypertension * liver and/or renal dysfunction * known hematologic disease

Keywords: thrombophilia pregnancy heparin
calcium dobesilate vs flavonoids for the treatment of early hemorrhoidal disease

Conditions: Hemorrhoids

Summary: haemorrhoids are vascular cushions in the anal canal that help in the control of stool. when inflamed they become pathological and may present with protrusion and bleeding. a randomized, triple blind , controlled study will be conducted to compare the efficacy of calcium dobesilate against flavanoids in the management of early haemorrhoidal disease.


Eligibility criteria:
inclusion criteria: * grade i and grade ii hemorrhoids exclusion criteria: * cld * colorectal/ anorectal malignancy * self medication * local quack hakeem medication * pregnancy
effect of full-thickness gastroplication with the gerd-x system on atypical gastro-esophageal-reflux-symptoms

Conditions: Atypical Gastroesophageal Reflux Symptoms; Objectified Gastroesophageal Reflux Disease

Summary: patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example ph/mii).


Eligibility criteria:
inclusion criteria: * age between 18 years and 80 years * symptomatic, objectified reflux disease (atypical symptoms - montreal-classification) exclusion criteria: * rejection of study-participation, * pregnancy * negative ph-metry / impedance monitoring (non-objectified reflux) * hiatal hernia bigger than 2 cm or gastroesophageal junction \> hill iv classification * different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal esophagus * achalasia, esophageal spasm * presence of contraindications for the interventions
a study of different endoscopic surgery procedures in eosinophilic chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis (Diagnosis); Surgery

Summary: crs remains a common challenging clinical entity due to variable phenotypes with different underlying mechanisms that lead to persistence or recurrence polyps. the eosinophils dominant inflammation was considered as a major pathological hallmark and challenges of crs with nasal polyps (crswnp). differentiate surgical approaches towards eosinophilic crswnp (ecrswnp) should be addressed on the basis of the inflammatory endotypes. ecrswnp has been recognized as the most easily relapsed type of crs, and the combination of asthma increases the difficulty of treatment. till now there is no recognized surgical strategy for ecrswnp with asthma.


Eligibility criteria:
inclusion criteria: * the diagnosis of crswnp was based on the standard criteria issued in the european position paper on rhinosinusitis and nasal polyps guidelines. * participants had at least 1 previous sinus surgery underwent fess (middle turbinate (mt) preserved), good gasification of frontal sinus and with concomitant asthma. * the diagnosis of asthma was confirmed by a chest physician according to global initiative for asthma (gina) guidelines. * polyp biopsy was undertaken 1 week before surgery and the ecrswnp was confirmed by the number of eosinophils exceeded 10% of total infiltrating inflammatory cells in the polyp tissue through the evaluation by using hematoxylin and eosin (h\&e) staining. exclusion criteria: * patients were excluded if they had unilateral disease, allergic fungal rhinosinusitis, antrochoanal polyps, or cysts.
a study to evaluate adverse events and change in disease activity with the xen45 glaucoma treatment system implantation in adult participants with open-angle glaucoma in china

Conditions: Open-angle Glaucoma; OAG

Summary: glaucoma is the second most common cause of blindness in the world, second only to cataracts. the purpose of this study is to assess adverse events (aes) and changes in disease activity in participants with open-angle glaucoma (oag) receiving the xen45 glaucoma treatment system (xen45). xen45 is an approved device for the treatment of oag in participants in china who have not achieved satisfactory effectiveness with or are not suitable for intraocular pressure (iop)-lowering medication, laser surgery, or are not tolerant of traditional filtration surgery. adult participants with a diagnosis of oag will be randomized to receive either xen 45 or trabeculectomy. around 130 participants will be enrolled in the study at approximately 15 sites in china. participants will receive xen45 implanted using the ab interno approach or trabeculectomy on day 1 and will be followed for 60 months an adverse event (ae) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.


Eligibility criteria:
inclusion criteria: * area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva. * visible trabecular meshwork with shaffer angle grade =\> 3 in the study eye at the screening visit. * iop =\> 20 mm hg and \<= 44 mm hg for the study eye, measured by goldmann applanation tonometer, at the screening visit and baseline visit. exclusion criteria: * active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the screening visit in the study eye. * prior xen45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation \[uc3\], etc.) or prior major conjunctival surgery (i.e., scleral buckle) in the study eye.

Keywords: open-angle glaucoma oag xen45 intraocular pressure iop