Kornimate/medical-research-clean huggingface dataset:
evaluation and modeling of the effect of g-csf on the evolution of polynuclear neutrophils during dense dose epirubicin-cyclophosphamide regeneration

Conditions: Localized Breast Cancer

Summary: patients including of localized breast cancer will require chemotherapy treatment with epirubicin - cyclophosphamide (ec) followed by treatment with docetaxel or paclitaxel. in addition to this chemotherapy, the investigator will prescribe injections of granulocyte growth factors (g-csf), to stimulate the growth of white blood cells. patients will be randomized to either a peg-g-csf arm or a g-csf arm, prescribed at different times. the aim is to determine whether one of the two treatment regimens best limits the risk of a decrease in white blood cells

for this tudy : patients will be randomized to either : * with administration of peg-g-csf (administration on d2) * with administration of g-csf (administration on d4 to d7 or d8) this study aims to model the effect of exogenous g-csf for the evolution of polymorphonuclear neutrophils as a function of time and to explain the pharmacodynamic variability during the administration of chemotherapy such as ec-dense dose administered as an adjuvant or neo-adjuvant in patients treated for localized breast cancer.

Eligibility criteria:
inclusion criteria: * women * patient over 18 years old * patient with histologically documented, non-metastatic breast cancer who must receive dense dose epirubicin-cyclophosphamide (ec) type treatment as part of neoadjuvant or adjuvant treatment * patient to receive granulocyte growth factors (g-csf or peg-g-csf) as a preventive measure from the first cycle * neutrophils \> 1,500 /mm3; platelets \> 100,000 /mm3 * written informed consent, dated and signed * for patients of childbearing age, effective means of contraception during treatment and up to 3 months after stopping treatment exclusion criteria: * patient with a contraindication to treatment with anthracyclines * patient already undergoing treatment with ec dense dose * patient with a contraindication to treatment with g-csf such as hypersensitivity to the active ingredient or to one of the excipients * pregnant or breastfeeding women * patient under guardianship or curatorship or subject to a protection regime for adults * patient not affiliated to a social security scheme (beneficiary or beneficiary)

Keywords: breast cancer g-csf epirubicin-cyclophosphamide dose-dense
exploration of pregnant women's reluctance toward covid-19 vaccination

Conditions: Vaccinate Against Covid-19; Reluctance Pregnant Women&#39;s

Summary: this study aims to explore the reasons behind the reluctance of pregnant women to get vaccinated against covid-19. with the ongoing pandemic, it has become essential to understand the concerns that women have regarding the covid-19 vaccine, especially during pregnancy. pregnant women are at a higher risk of severe complications from covid-19, including premature birth, preeclampsia, and the need for intensive care.the goal of this research is to identify the barriers that prevent pregnant women from getting vaccinated, whether they are based on fears, misconceptions, or a lack of information. by understanding these concerns, healthcare providers can have better conversations with their patients and provide accurate, evidence-based information to help them make informed decisions about their health and the health of their unborn child.through interviews and visual methods, the study seeks to gather valuable insights into the emotional and psychological aspects of vaccine hesitancy among pregnant women. these findings will help develop a tool to assist healthcare providers in addressing vaccine hesitancy effectively, ensuring that women are given all the necessary information to make the best decision for their health and the well-being of their baby.


Eligibility criteria:
inclusion criteria: * during pregnancy follow-up consultations, * following their visit to the gynecology-obstetrics emergency department, regardless of the reason, * hospitalized in the diabetology department or in the high-risk pregnancy (hrp) or postpartum care department. exclusion criteria: * the patient is over 18 years old
pre-operative nutrition for elective resection surgery in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: this study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (ibd), and if adding immune modulation nutrition improves surgical outcomes. the primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. the secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide written informed consent 2. aged 18 years of age or older 3. confirmed diagnosis of inflammatory bowel disease 4. scheduled for disease-related intestinal resection at nyu langone health exclusion criteria: 1. no current diagnosis of inflammatory bowel disease 2. age less than 18 3. not proficient (able to read and answer questions) in english
xolair interventional study in asd patients with comorbid atopy

Conditions: Autism Spectrum Disorder; Atopy

Summary: following the publication of two case studies that reported behavioral benefit in asd patients treated with omalizumab, the investigators will conduct a pilot trial to test the proof-of-concept efficacy of omalizumab in asd patients with comorbid atopic disease. investigators will evaluate behavioral improvement using three questionnaires. investigators will also perform fmri on all subjects and obtain serum samples for quantification of immunological biomarkers. if the trial is conclusive, the investigators will conduct a larger-scale, randomized-controlled trial to further understand the pathology of allergy in this subpopulation of asd patients and the efficacy of this intervention.

this clinical trial is a phase i, single-arm, open-label study. all 20 subjects will be given the same dosage of the study drug. following baseline testing, subjects will undergo treatment during a 24 week treatment period and will receive six subcutaneous injections total, one injection every 4 weeks. a 24-week follow-up period after the treatment period will be concluded with patient interview. behavioral questionnaires will be administered throughout the duration of the trial. fmri will be conducted at baseline and at the conclusion of the treatment period. blood will be drawn for serum testing at baseline, at week 12 during the treatment period, and at the conclusion of the treatment period. vitals and cgi will also be assessed throughout the trial.

Eligibility criteria:
inclusion criteria: * age between 18-30 years old. * clinical diagnosis of asd during childhood that is still active. * history of atopic diseases, including asthma, atopic dermatitis, and allergic rhinitis. * total serum ige level ≥ 30 iu/ml and ≤ 400 iu/ml exclusion criteria: * history of omalizumab use. * subjects who have used oral or systemic steroid burst within 6 weeks of study enrollment. subjects who are receiving a maintenance dose of prednisone of 5 mg/day or less will be allowed provided the dose of prednisone is not changed during the study. * subjects actively taking the antipsychotic medication, loxapine. * history of cancer or pre-cancer. * subjects with active or unstable seizure disorder. * history or active signs of psychosis. * body weight \> 90kg * for subjects who meet allergic rhinitis inclusion criteria, rcat \>20 * iq \< 70 * adaptive behavior composite score \< 90, based on the vineland 3rd edition * lactating or pregnant females. xolair has not been sufficiently tested for safe use in pregnant females. * subjects who are deemed by the study staff to be unable to cooperate with or understand the instructions that will be given during the study. * subjects with severe medical condition(s) that in the view of a physician investigator prohibits participation in the study.

Keywords: omalizumab
evaluation of a parent-infant interaction model

Conditions: Premature Birth

Summary: when becoming a parent of a preterm infant there is an increased risk of stress. there are a number of studies showing that parental stress has a negative impact on their engagement with their child. other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions. the investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. the observational program is called limonid. our hypothesis is that limonid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. they will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. parental stress may also be reduced by increased understanding and control. regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. the emotional regulation should be strengthened by such an intervention. the aim is to study if limonid can have an impact on cognition, stress, parent-child interaction.

the design is a randomised controlled study in two groups; intervention group versus standard care. parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. if the parents consent they will be randomised to one of two groups. follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.

Eligibility criteria:
inclusion criteria: * preterm infants born 30-36 weeks gestational age without known major malformations or complications * families living in the county of ostergotland, sweden * swedish speaking parents * single or duplex birth exclusion criteria: * complications encountered during hospital stay that are known to affect cognition

Keywords: cognition family nursing infant, premature object attachment stress, physiological stress, psychological
tetrandrine tablets used in the treatment of covid-19

Conditions: Corona Virus Disease 2019,COVID-19

Summary: the study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

since december 2019, a number of cases of pneumonia infected with the new coronavirus have been found in wuhan, hubei province.has now become a global epidemic of crisis. after recent frontline anti-epidemic experience, the diagnostic and treatment specifications for new coronary pneumonia have been updated several times. in the latest country, "specifications for the diagnosis and treatment of new types of coronary pneumonia (trial version 6)", the traditional chinese medicines have again emphasized for the treatment of patients, traditional chinese medicine preparations such as xuebijing and qingfei paidu decoction have been recommended, but the introduction of anti-fibrosis related drugs is still lacking.tetrandrine is a traditional chinese medicine. previous research has shown that it is an antagonist of calmodulin, has anti-tumor, anti-inflammatory effects, and can effectively inhibit fibroblasts, thereby inhibiting pulmonary fibrosis.the study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

Eligibility criteria:
inclusion criteria: * patients with mild and severe cases who have been diagnosed with new coronavirus pneumonia according to the "pneumonitis diagnosis and treatment - * plan for new coronavirus infection" * age 18 to 75 years; * sign the informed consent voluntarily. exclusion criteria: * with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, patients with chronic respiratory failure or other severe respiratory disease; * according to the "pneumonia diagnosis and treatment program for new coronavirus infection" (trial version 6), critically ill patients * with severe patients with disease of heart head blood-vessel, malignant arrhythmia, unstable angina, acute myocardial infarction and death, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.); * with severe liver and kidney diseases (severe liver disease refers to cirrhosis, portal hypertension and varices bleeding, severe kidney disease including dialysis, kidney transplantation); * pregnant and lactating women; * severe cognitive and mental disorders; * clinical investigators who were participating in other interventions within 1 month prior to inclusion

Keywords: covid-19 tetrandrine
a phase i study to evaluate the safety, tolerability and efficacy of medi4736 (durvalumab) with tremelimumab in head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pk, pharmacodynamics, and immunogenicity of medi4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: 1. male and female subjects 2. 18 years and older 3. histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy. 4. subjects who are treatment-naive or pretreated (prior anti-pd-1 or anti-pd-l1 required) in the recurrent/metastatic setting. 5. subject eligibility will be based on pd-l1 expression as determined by a specified ihc assay. exclusion criteria: 1. any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days 2. concurrent or prior use of immunosuppressive medication within 14 days 3. active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
effectiveness of an ehealth intervention for uptake of cervical cancer screening in hispanic women

Conditions: Cervical Cancer Screening

Summary: this study will test the effectiveness of an ehealth promotora (lay health advisor) outreach strategy to increase cervical cancer screening in hispanic women. the investigators will recruit 160 hispanic women ages 21-65 who are not up to date with cervical cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on cervical cancer screening outcomes. the study will utilize a two-arm, cluster randomized trial design, and participants will be randomly assigned to the cervical cancer education intervention or a nutrition education control group. the cervical cancer education arm will utilize a promotora to deliver an educational session virtually to encourage cervical cancer screening and receive a resource list for screening sites. the control group will participate in an educational session virtually about the importance of healthy nutrition. the primary study outcome is receipt of cervical cancer screening measured six months following receiving the intervention. the secondary outcomes will include cervical cancer screening knowledge and self-efficacy (confidence to receive cervical cancer screening). the research objective is to test the ehealth promotora intervention effectiveness for promoting cervical cancer screening in an under-screened hispanic population.


Eligibility criteria:
inclusion criteria: 1. between the age of 21 and 65 years 2. identify as hispanic 3. not up-to-date with cervical cancer screening \[never screened or last pap test ≥ 3 years - based on u.s. preventive services task force guidelines\] 4. have no history of cervical cancer 5. have not had a hysterectomy. exclusion criteria: 1. under the age of 21 or over the age of 65 years 2. do not identify as hispanic 3. up-to-date with cervical cancer screening \[last pap test \< 3 years - based on u.s. preventive services task force guidelines\] 4. history of cervical cancer 5. have had a hysterectomy.
dexmedetomidine vs. remifentanil undergoing cataract surgery in geriatrics

Conditions: Geriatrics; Outpatients; Personal Satisfaction

Summary: dexmedetomidine is an α2-adrenergic receptor agonist used for its sympatholytic effect, providing sedation, analgesia, and cardiovascular stabilization in the perioperative period. remifentanil is a µ opioid agonist with a rapid onset and short duration of action, which is degraded by plasma esterase in tissues. investigators aimed to compare the effects of dexmedetomidine and remifentanil infusions on sedation quality, side effects, and surgeon's satisfaction in geriatric outpatients who underwent cataract surgery.

dexmedetomidine is an α2 agonist and remifentanil is a short-acting μ, opioid agonist. the aim of this study was to compare dexmedetomidine and remifentanil infusions used for conscious sedation in geriatric patients undergoing outpatient cataract surgery in terms of sedation quality, hemodynamic stability, and surgeon satisfaction. eighty patients were divided into two groups according to the administration of dexmedetomidine (group d) and remifentanil (group r) infusion in this randomized, prospective, double-blinded study. in group d (n = 40), after a loading of 1 µg/kg dexmedetomidine in 10 minutes, 0.4 µg/kg/h-1 infusion was administered. in group r (n = 40), remifentanil at a dose of 0.05 µg/kg-1 was administered for 10 minutes, and then 0.05 µg/kg/min-1 infusion was continued.

Eligibility criteria:
inclusion criteria: * patients between the ages of 65-80, * who will undergo cataract surgery, * with the american society of anesthesiologists (asa) score i-iii. exclusion criteria: * second or third-degree heart block, * chronic α2-agonist use, * inability to communicate with the patient, * uncontrolled systemic disease, * allergy to local anesthetics, * chronic analgesic or sedative drug use, * history of alcohol or substance addiction.

Keywords: geriatrics ambulatory surgery cataract anesthesia conscious sedation dexmedetomidine remifentanil
molecular markers of chemosensitivity for bladder cancer

Conditions: Bladder Cancer; Effects of Chemotherapy

Summary: the purpose of this study is to try to figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older, estimated life expectancy ≥ 6 months. 2. .gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable. 3. transitional cell carcinoma of bladder, stage pt3n0m0,t2n1m0-t3-4n1-2m1.transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. 4. electrocorticography(ecog) performance status 0-2. 5. blood routine:absolute neutrophil count (anc) ≥ 1500/μl,white blood cell count ≥ 3000/μlplatelets ≥ 100,000/μl,hemoglobin ≥ 10.0 g/dl, 6. total serum bilirubin≤ 1.5 x upper limit of normal (uln).serum aspartate transaminase (ast; serum glutamic oxaloacetic transaminase(sgot)) and serum alanine transaminase (alt; serum glutamic pyruvic transaminase (sgpt)) ≤ 2.5 x upper limit of normal (uln). 7. creatinine clearance rate,ccr ≥ 60% 8. ecg：no arrhythmias, no myocardial infarction. signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures. exclusion criteria: 1. past history of systemic chemotherapy 2. serious heart and lung dysfunction. 3. associated with central or peripheral neuropathy greater than 2 grade.
prevention relapse of graves' disease by intrathyroid injection of dexamethasone

Conditions: Graves' Disease

Summary: antithyroid drugs are widely used in treatment of graves' disease (gd), but after therapy withdrawal, relapse rate is very high. the aim this trail is to evaluate the effects of intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with newly diagnosed gd.

the morbility of gd is nearly 0.5% and the underlying cause of 50 to 80% of cases of hyperthyroidism.recently,anti-thyroid drugs are still the main therapy for graves'hyperthyroidism in a lot of districts, but the relapse rate is very high (51\~68%) after withdrawal of anti-thyroid treatment.in order to reduce the relapse rate, some studies tried to prescribe replacement thyroxine, either with the anti-thyroid drug treatment, or after this was completed, but there is no clear evidence in favour of giving thyroid hormone supplementation following the initial treatment of graves' thyrotoxicosis with anti-thyroid medication. therefore, the optimal medical therapy for graves' hyperthyroidism remains a subject of debate. it is well known that glucocorticoids have anti-inflammatory, immunomodulation and immunosuppression effects and they has long been used to treat go, and is one of the most effective medicine ,it can decrease some cytokines and reduce inflammatory status ,and improve some thyroid specific antibody, like as thyrotropin receptor antibodies (trab), antithyroperoxidase antibodies (tpoab) and antithyroglobulin antibodies (tgab).these studies suggested that glucocorticoids might affect autoimmune process and have some benefit effects on gd. moreover glucocorticoids have been used to treat gd in several early reports, in which serum free triiodothyronine (ft3) and thyroxine (ft4) or total t3(tt3) and tt4 levels decreased after 8 days or three weeks treatment with glucocorticoids . but in those studies, the number of selected patients is small, and the duration of the therapy is relatively short, so that might not confirm the effects of glucocorticoids on gd.

Eligibility criteria:
inclusion criteria: * newly diagnosed of graves' disease exclusion criteria: * pregnancy * allergy to atd, alanine aminotransferase (alt) or asparate aminotransferase (ast) above 2 times of upper normal range * non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study.

Keywords: graves' disease dexamethasone relapse methimazole