Kornimate/medical-research-clean huggingface dataset:
response of feno, small airway dysfunction and lung heterogeneity to 2-week montelukast treatment in asthmatic children.

Conditions: Mild Persistent Asthma

Summary: this study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week ltra administration.

this study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period. after an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. during each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 a.m. short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test. inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.

Eligibility criteria:
inclusion criteria: * children diagnosed with mild persistent asthma patients based on the gina guidelines * children old enough to cooperate in performing pulmonary function testing * legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by irb * children with no respiratory symptoms 4 weeks prior to the beginning of the study * children without chronic respiratory symptoms. exclusion criteria: * presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy. * use of systemic corticosteroids in past 4 weeks. * admission or visit of the emergency department in past 4 weeks.

Keywords: leukotriene antagonists bronchodilator response
practical use of advagraf de novo after kidney transplantation according to recipient genetic polymorphism

Conditions: Kidney Diseases

Summary: to optimize the advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with mmf (or mpa) and corticosteroids (cs) regarding of the genetic cyp 450 3a5 polymorphism of the recipient. the study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.


Eligibility criteria:
inclusion criteria: * first or second kidney transplantation from deceased or living donor exclusion criteria: * donor age \< 5 years. * patients who require plasma exchange because of high immunological risk

Keywords: transplant immunosuppressive drug
observational study of the association between food intake and endometrial polyps

Conditions: Diet Habit; Endometrial Polyp; Women

Summary: there are currently no studies evaluating the association between diet and the incidence of endometrial polyps. we aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps.

the incidence of endometrial polyps is closely related to daily diet and living habits. due to the excessive use of food additives, the content of some common dietary hormones exceeds the standard, causing irreversible effects on female growth and development. the daily diet structure is closely related to women's health, and the enrichment of estrogen in common drinks may cause adverse effects such as premature puberty in women, abnormal thyroid function, and changes in uterine structure. therefore, the researchers conducted a retrospective analysis of patients with endometrial polyps and normal women to compare the associations and differences between daily diet and disease.

Eligibility criteria:
inclusion criteria: * consistent with the international clinical diagnosis of endometrial polyps.can complete content recall alone. exclusion criteria: * no other mental diseases. not associated with other major diseases, including tumors, immune system diseases

Keywords: diet endometrial polyp women milk tea
immunotherapy sbrt sensitization of the programmed death-1 (pd-1) effect

Conditions: Metastatic Nonsmall Cell Lung Cancer; Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine efficacy, safety of stereotactic body radiotherapy (sbrt) in combination with immunotherapy in participants with metastatic non-small cell lung cancer (nsclc) who are eligible for an immunotherapy agent.

blockade of the pd-1/pd-l1 t-cell checkpoint pathway is an effective and well tolerated approach to stimulating the immune response which is a critical option in the treatment of metastatic nsclc. however, progression free survival (pfs) is increased by only 2-4 months and median overall survival (os) by 3-9 months. there is compelling evidence that pfs is increased up to 3 fold and os by 2 fold in patients receiving a course of radiation therapy while on immunotherapy. radiotherapy is known to induce immunogenic tumor cell death and upregulation of dendritic cells and antigen presentation leading to activation of cytotoxic t-cells. dramatic t-cell activation has been demonstrated where tumor regression occurs outside the radiation treatment field in a phenomenon termed the abscopal effect and is associated with high dose radiation delivered via sbrt. as such, sbrt activation of t-cells could be complementary to immunotherapy and enhance t-cell mediated killing via pd-l1 blockade which could lead to lasting and durable tumor response with improved progression free survival and overall survival.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iv nsclc according to the 7th ajcc staging manual. * eligible for an immunotherapy agent. patients who progress after drug therapy (3 months) for alk, egfr or ros mutation positive lung cancer are eligible. * at least 2 lesions that are safely amenable to sbrt. ecog \<=2. * at least 1 measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1 criteria for response assessment or at least 1 lesion with fdg avidity and ct correlate that can be monitored for pet-ct response by suv max increase or decrease. * normal hepatic and renal function. * bone marrow reserve: 1. anc ≥ 1.5 x 109/l 2. hemoglobin ≥9.0 g/dl 3. platelet count ≥75 x 109/l * ability to comply with follow-up visits and evaluations, treatment planning and studies and other study related procedures and visits. * ability to sign informed consent. exclusion criteria: * patients with active cns metastases * active, known or suspected auto-immune disease. * patients with medical conditions that require systemic immunosuppression. * patients with a history of interstitial lung disease. * prior treatment with immune checkpoint inhibitors/immonotherapy. * other active malignancy requiring intervention. * prior lung radiation, with the only metastatic targets in the lungs. * unresolved toxicity from prior chemotherapy or anti-cancer treatment. * current or prior enrollment in clinical trial with an investigational drug within 4 weeks. * pregnancy or positive pregnancy test.

Keywords: opdivo, keytruda, cyberknife
effect of diabetes mellitus on success of spinal anesthesia

Conditions: Diabetes Mellitus

Summary: some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia failure. however, that opinion was not determined in a trial. thus the investigators aimed to investigate the effect of diabetes mellitus on spinal anesthesia.

the investigators will include all of the patients who will undergo surgery with spinal anesthesia. the investigators will observe the patients with or without diabetes mellitus. and the investigators will examine the effect of diabetes mellitus on failure of spinal anesthesia.

Eligibility criteria:
inclusion criteria: * surgery with spinal anesthesia exclusion criteria: * heart failure * coronary artery disease

Keywords: failure spinal anesthesia
detection of chlamydia dna by polymerase chain reaction in primary tubal and ovarian cancers tissues : a pilot study

Conditions: Malignant Neoplasm of Fallopian Tube

Summary: pcr for chlamydia dna is done in paraffin blocks of cases of primary tubal cancer and is compared to cases of high grade serous ovarian cancer and normal tubes .

the investigators shall review the early cancer detection unite pathology records for the past 10 years , for cases diagnosed with primary fallopian tube cancers , cases of high and low grade serous ovarian cancer and cases underwent hysterectomy and salpingectomy for non oncological reasons. paraffin blocks for suitable selected patients will be examined histologically to confirm the primary diagnosis . chlamydia dna in these paraffin blocks of the fallopian tubes and ovarian tissues will be examined using pcr techniques . the possible correlation between the presence of chlamydia dna and the ovarian serous tumours and primary tubal cancer will be analyzed statistically .

Eligibility criteria:
inclusion criteria: * any patient with primary tubal cancer and high grade serous cancer and normal tubes. exclusion criteria: * clinical pelvic inflammatory disease * salpingectomy for ectopic

Keywords: fallopian tubal cancer, high grade serous , ovarian cancer
ai driven biofeedback wearable

Conditions: Knee Injuries

Summary: the purpose of this study is to conduct a comprehensive clinical and biomechanical screening of high school, collegiate-level, recreational, and olympic/professional-level athletes with the goal of identifying individual functional and performance deficits that lead to future injury.


Eligibility criteria:
inclusion criteria: * male or female, age 12 - 65 years old. * athlete at high school, collegiate, recreational, olympic / professional level. exclusion criteria: * indidividual under 12 or over 65 years old. * lower extremity injury in the past 6 months. * history of neurological disease, vestibular or visual disturbance. * any other pathology that would impair motor performance.

Keywords: injury prevention biofeedback knee wearable rehabilitation
optical coherence tomography and optic neuritis not related to multiple sclerosis

Conditions: Optic Neuritis

Summary: the visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution. this prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (no) not related to a multiple sclerosis or to a clinically isolated syndrome.


Eligibility criteria:
inclusion criteria: * first onset of an optic neuritis lasting for less than 1 month * with a brain mri that does not meet the ms criteria exclusion criteria: * contra-indication to mri * pregnant or lactating woman * history of known ipsilateral optic neuritis * ophthalmologic comorbidity in the ipsilateral eye that may interfere with the interpretation of the examinations
belimumab (benlysta®) pregnancy registry

Conditions: Systemic Lupus Erythematosus

Summary: this global belimumab pregnancy registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (sle) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. the registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. this registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. it will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with sle. glaxosmithkline (gsk) will sponsor the belimumab pregnancy registry in countries where it holds marketing authorization.


Eligibility criteria:
inclusion criteria: * pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy * pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry) * pregnant women with full contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable hcps if initial reporter is the pregnant woman * consent provided by the pregnant woman for her participation and assent for participation of her infant. exclusion criteria: * reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry

Keywords: systemic lupus erythematosus belimumab pregnancy
non-interventional study with nab-paclitaxel (abraxane®)

Conditions: Metastatic Breast Cancer

Summary: the purpose of this non-interventional study is to collect data on the efficacy and safety of nab-paclitaxel in the routine application.

the main focus of this non-interventional study is set on answering the following questions: * can the results observed in controlled clinical trials regarding efficacy and safety be reproduced in the routine clinical setting? * are the side-effects of nab-paclitaxel therapy observed in this study comparable to the previously described safety-profile in terms of frequency and intensity? * what are the main reasons for modification or termination of the nab-paclitaxel therapy? * how does nab-paclitaxel therapy influence the patients' quality of life? * what are the criteria for selecting nab-paclitaxel as therapy for metastatic breast cancer?

Eligibility criteria:
inclusion criteria: * female patients with metastatic breast cancer, who are at least 18 years old (no upper age limit) exclusion criteria: * contraindication according to the summary of product characteristics of abraxane® * no signed patient informed consent form available * pregnant or breastfeeding patients.

Keywords: nab-paclitaxel abraxane nabucco safety breast cancer daily routine peripheral neuropathy iomedico
enteral administration of docosahexaenoic acid to prevent necrotizing enterocolitis in preterm neonates

Conditions: Necrotizing Enterocolitis

Summary: * the purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis (nec) in preterm neonates \< 1500 g at birth who are starting enteral feeding. * if nec is prevented, this study will measure whether hospital stay is also reduced in neonates who receive docosahexaenoic acid (dha)

* preterm neonates with birth weight less than 1500 g are in higher risk to develop nec. * nec is an inflammatory condition that: 1. is the medical urgency most frequent of gastrointestinal tube that requires neonatal intensive care 2. may perforate infant´s bowel requiring surgery from 20% to 60% of the cases 3. may cause infant's death in 20% to 42% of the cases. 4. has no adequate treatment worldwide, therefore prevention is needed * dha by enteral feeding has been administrated by our research group to attenuate inflammatory response in septic and surgical neonates. * our results showed: 1. lower interleukin(il)-1 beta in septic neonates, but in surgical neonates, they also showed less il-6 and anti-inflammatory cytokines il-10 and il-1ra, after adjusting by confounders 2. increased weight, length and fat mass gain in septic neonates 3. decreased organic failures in surgical neonates, and 4. lower stay at neonatal intensive care in surgical neonates dha has not been used as unique intervention at a high but physiological dose; in addition, our previous results found an anti-inflammatory effect in neonates.therefore, we expect that preterm infants may have a reduced bowel inflammatory response and lower nec events and or severity

Eligibility criteria:
inclusion criteria: * birth weight lower than 1500 g * adequate weight for gestational age * clinically stable to begin enteral feeding * written informed consent by both parents plus the sign of two witnesses exclusion criteria: * clinical and biochemical data of inflammatory response such as body core temperature altered, cardiac and respiratory frequency -low or high according to age-, leucocytosis or leucopenia, taking into account the thresholds reported by goldstein in pediatric critical care medicine 2005 vol 6 n°1. * persistent bleeding at any level * mother taking n-3 supplements and planning to breastfed * parents who decline the authorization for participating in the study * early discharge to other hospital outside the metropolitan area * persistent vomiting * receiving medication to avoid coagulation * gastrointestinal malformations

Keywords: docosahexaenoic acid n-3 fatty acids necrotizing enterocolitis preterm infants
impact of the introduction of orkambi on anxiety, depression, quality of life and adherence of adolescents and young adults

Conditions: Cystic Fibrosis

Summary: the aim of this project is to evaluate the psychological reshuffle induced by orkambi. the particular focus of this study is the consequence of its introduction on anxiety, depression, quality of life and adherence to all cystic fibrosis (cf) treatment. to answer this question investigators will monitor the psychological function of cf adolescents and young adults treated with orkambi and compare them to cf adolescents and young adults not treated with orkambi.

introduction of kalydeco then orkambi, as a personalized medicine in the therapeutic strategy of cystic fibrosis (cf) may deeply modify the prognosis of patients with cf. these approaches realize the dream of short-circuiting the molecular mechanism of the disease and therefore opens the perspective of an extended and functional survival. it suddenly offers the possibility of a completely new future to the patient and his family, and therefore must deeply impact on the psychological function of all involved. moreover, those new therapies may also modify the adherence to cf basic treatment, as it brings a new feeling of good health and the hope of a longer life. for that reason there is a need to investigate modifications of the psychological state of mind induced by the treatment with orkambi in cf adolescents and young adults. this project aims to understand the psychological impact and to study the consequences of the introduction of orkambi on adherence to cf treatment, anxiety, depression and quality of life. to answer this question, investigators will evaluate the psychological function of adolescents and young adults, aged 12 to 20 years, with cf treated with orkambi, and compare it to other adolescents and young cf adults not treated with orkambi. this is a cohort prospective study, with a 1 year follow-up.

Eligibility criteria:
inclusion criteria: * treated group: patients with proven cf (sweat-test \> 60 meq, 2 df508 cf causing mutations, 12 to 20 years, and treated with orkambi * control group: patients not carrying 2 df508 cf causing mutations, not treated with orkambi, and not carrying the g551d, g178r, s549n, s549r, g551s, g1244e,s1251n, s1255p or g1349d mutation or treated with kalydeco exclusion criteria: * transplanted patients * patients younger than 12 years * patients older than 20 years

Keywords: cystic fibrosis orkambi adherence adolescent anxiety depression psychology
molecular characterization and treatment of thyroid carcinoma on struma ovarii

Conditions: Ovarian Cancer

Summary: thyroid carcinoma on struma ovarii (tcso) is a rare ovarian tumor, derivate from monodermic teratomas. it represents about 0.01% of overall ovarian tumours, and 5 to 10% of struma ovarii. the diagnosis is histologic and retrospective after pelvic surgery. because of its rarity, the treatment of tcso is not consensual and should be validated in multidisciplinary team involved in rare ovarian carcinoma. tcso should be taken care of as a thyroid carcinoma, in case of relapse, with systemic treatment, as tyrosine kinase inhibitor (tki), without any clinical trial proving this benefit. indeed, molecular profiles and genomic expression is unknown, because of studies with few patients (less than 10) contrary to thyroid carcinomas with the tcga genomic classification. the study purposes are the outcome of the patients after the first treatment and the comparison of the genomic profil in next generation sequencing (ngs) with tcga thyroid carcinoma profile. thus, the treatment could be tailored, confirming the same therapy as in thyroid carcinoma.

this is a retrospective cohort with collection of tissues samples (ffpe or frozen), including female patients \>18-year-old treated in french between 2009 and 2016 for a thyroid carcinoma on struma ovarii. clinical data and tissues will be centralized for assessment. one of the endpoint is the description of the population (such as baseline clinical and pathologist characteristics, first treatment, survival, treatment relapse) ; the other endpoint is the comparison between the genomic profile of the tumor tissues obtained in ngs and those of the thyroid carcinomas obtained from the tcga.

Eligibility criteria:
inclusion criteria: * alive patients, * age \> 18 years, * treatment in france for a tcso, proven by an histologic diagnosis and registered in the " rare malignant gynecologic tumors " network. exclusion criteria: - patient lost to follow up.

Keywords: ovarian teratoma struma ovarii thyroid carcinoma next generation sequencing