Kornimate/medical-research-clean huggingface dataset:
broad validation study of a management algorithm mild head injury in children

Conditions: Head Injury

Summary: head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a glasgow score greater than or equal to 13. in october 2009, the pediatric emergency care applied research network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of ct and unnecessary exposure to radiation ionizing. this clinical decision rule constructed from a multicenter prospective cohort 42,412 american children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions. since march 2012, the french emergency medicine society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established. the investigators' work aims to conduct this broad validation study prospective multicenter way in a french pediatric population, as recommended by the french emergency medicine society, in order to confirm or deny its predictive performance and allow its application and generalization. the investigators will check and if the rule clinical decision is adapted or not to the management of mild head injuries in the french pediatric population.


Eligibility criteria:
inclusion criteria: * children under 16 years admitted to an emergency room for mild head injury (glasgow coma scale score ≥14) in the previous 24 hours * children who have agreed to participate in the study (if age\> 8 years) * patient parents have accepted the participation of their child in the study exclusion criteria: * children with bleeding disorders * ventricular shunt presence * benin mechanism of trauma (fall of the height of the child or impact against an object while walking / running with no sign that the scalp dermabrasion) * penetrating trauma * known brain tumor * previously known neurological disorders * evaluation scanographic in another hospital before emergency review

Keywords: mild head injury - clinical decision rule - child
phase i cetuximab and concurrent radio-chemotherapy

Conditions: Non-small Cell Lung Cancer

Summary: to determine the mtd toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine

phase i trial with escalating doses of vinorelbine and standard doses of radiotherapy, cisplatin and cetuximab. eligible patients receive 2 cycles of carboplatin (auc 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. one cycle duration is 21 days. patients without progressive disease (pd) according to the recist criteria (appendix 1) will be entered in the phase i dose-escalation part of the study. chest radiation is given concurrently with cetuximab, cisplatin and vinorelbine. the latter drug will be escalated in three steps until dose-limiting toxicity occurs. on day 43, i.e. 14 days after the last gemcitabine delivery, radiotherapy is started. radiotherapy: in all patients in every dose-step, the radiation will be given as follows: first 3 weeks: 1.5 gy bid to a dose of 45 gy in 30 fractions, then 2 gy qd to a mean lung dose (mld, this is related to radiation-induced lung damage) of 19 gy. maximum dose: 69 gy given in 5.5 weeks. maximum dose to the spinal cord: 50 gy. cetuximab: all patients will receive a starting dose 400 mg/ m2 7 days before the beginning of radiotherapy (i.e. day 36), thereafter a weekly dose 250 mg/ m2 during the course of radiotherapy for 5 consecutive weeks. cetuximab will be delivered at the same days as chemotherapy. cisplatin: in all patients in every dose-step, cisplatin will be given as follows: step 1, 2 and 3: 50 mg/ m2 days 43, 50; 40 mg/m2 day 64. vinorelbine will be escalated in three steps: step 1: 10 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. step 2: 20 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. step 3: 20 mg/ m2 days 43, 50; 15 mg/m2 days 66 and 73.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer * inoperable stage iii (uicc 2002; sixth edition) (no pleural effusion) * who performance status 0 or 1 * less than 10% weight loss in the last 6 months * lung function: fev1 at least 50% and dlco at least 50% of the predicted value * no recent severe cardiac disease * adequate bone marrow function * adequate renal function * adequate hepatic function * life expectancy more than 6 months * measurable cancer * willing and able to comply with study prescriptions * 18 years or older * not pregnant or breast feeding * written informed consent * no previous radiotherapy to the chest exclusion criteria: * not non-small cell lung cancer histology * mixed pathology * history of prior chest radiotherapy * recent (\<3 months) myocardial infarction * uncontrolled infectious disease * less than 18 years old * inadequate pulmonary function * other active malignancy

Keywords: cetuximab concurrent iso-toxic nsclc
the ventricular catheter placement study: assessment of efficacy and safety of an ultrasound guided shunt insertion technique

Conditions: Pediatric Hydrocephalus

Summary: shunt failure remains a significant problem in pediatric patients with hydrocephalus. if reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve. the purpose of this study is to assess the efficacy and safety of the ultrasound guided shunt insertion technique in the hands of experienced surgeons. the primary outcome measure is ventricular catheter location determined from post-operative brain images. the study is being conducted by the hydrocephalus clinical research network (hcrn), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus. pediatric neurosurgeons at hcrn centers enrolled in this study will perform either ultrasound guided shunt surgery or a conventional shunt surgery. patients who undergo conventional shunt surgery will serve as a contemporary control group.


Eligibility criteria:
inclusion criteria: * patients must have clinical and radiographic evidence of hydrocephalus as determined by a pediatric neurosurgeon and require a ventriculoperitoneal shunt (atrial, pleural, gallbladder and other shunt systems are excluded) * patients can have no prior history of shunt insertion for hydrocephalus. a history of an external ventricular drain, subgaleal reservoir-catheter, or subgaleal shunt is permissible * patients must be less than 18 years of age at the time of shunt insertion exclusion criteria: * active csf or abdominal infection * spread of tumor in the subarachnoid space documented on enhanced imaging (ct or mri) of the head or spine * csf leak without hydrocephalus * pseudotumor cerebri * dandy-walker malformation or arachnoid cyst as a cause of hydrocephalus * loculations within the ventricular system * hydranencephaly, alobar holoprosencephaly or any other congenital anomaly of the brain that severely distorts the ventricular anatomy such that ventricular catheter location cannot be determined * other systemic disorders that would preclude the insertion/revision of a ventricular shunt * other difficulties that would preclude follow-up at one year (e.g. terminal illness with life expectancy less than 1 year)

Keywords: pediatric hydrocephalus ultrasound guided surgery
ultrasound guided inguinal indocyanine green injection to identify and pre-emptively seal lymphatic leaks

Conditions: Lymphocele; Prostate Cancer

Summary: goal is to determine whether intraoperative icg injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.

the goal of this clinical trial is to determine whether intraoperative icg injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy. the main question is if it could improve patients' quality of life and infection risk post-surgery. it would also help to decrease emergency room visits as well as additional procedures. researchers will compare those who receive the icg and those who do not. patients will be randomized into the icg arm versus no icg arm after pelvic lymphadenectomy is done.

Eligibility criteria:
inclusion criteria: * patient undergoing robotic assisted laparoscopic lymph node dissection exclusion criteria: * patient not undergoing extended lymph node dissection * history of allergy to iodides
single rotary file pulpectomy in primary molars

Conditions: Pulpitis - Irreversible

Summary: the aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars

in pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years. in modern pedodontic practice, pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth. hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. these challenges lead to the introduction of rotary endodontics in pediatric dentistry. however, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. various modified protocols have been introduced to overcome such barriers to prevent undesirable complications. up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. thus, the present study aims to investigate the clinical effectiveness of those two techniques

Eligibility criteria:
inclusion criteria: * children criteria: * medically free . * cooperative patient. molar criteria : • mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis radiographic criteria: * no evidence of internal/external pathologic root resorption. * with or without periapical or furcal lesion . exclusion criteria: * • uncooperative children. * children with systemic disease. * lack of informed consent by the child patient's parent. * refusal of participation.

Keywords: single rotary file pulpectomy , primary molars
organized self-management support for chronic depression

Conditions: Depression

Summary: this study aims to adapt and pilot test two core elements of an organized care program (systematic telephone outreach and monitoring to improve quality and continuity of pharmacotherapy, and structured psychoeducational group programs focused on patient activation and self-management) in a population-based sample of patients with chronic or recurrent depression.

this study aims to adapt and pilot test two core elements of an organized care program (systematic telephone outreach and monitoring to improve quality and continuity of pharmacotherapy, and structured psychoeducational group programs focused on patient activation and self-management) in a population-based sample of patients with chronic or recurrent depression. two forms of group self-management training will be evaluated: a peer-led chronic disease self-management group (after that developed by lorig and colleagues) and a therapist-led cognitive-behavioral therapy group. approximately 100 patients with chronic or recurrent depression were randomly assigned to one of four conditions: 1) usual care; 2) phone care management; 3) phone care management plus peer-led self-management group; or 4) phone care management plus therapist-led cbt group. blinded assessments will examine clinical outcomes (scl depression score, depression diagnosis by scid), functional outcomes, and process variables (self-efficacy for managing depression, use of coping strategies) over 12 months. if patients choose not to participate in treatment, reasons for dropout were assessed. the data collected will provide:1) an evaluation of the feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs; 2) preliminary evaluation of effectiveness, i.e., the effects of each intervention on patient outcomes and process of care; and 3) information to inform the design and implementation of a full-scale effectiveness trial (refinement of intervention programs and measurement strategy, necessary sample size).

Eligibility criteria:
inclusion criteria: * history of at least one major depression in the last two years * history of recurent major depression or dysthymia * significant residual symptoms after 6 months of treatment exclusion criteria: * history of mania or hypomania * cognitive impairment * near-terminal medical illness * intent to disenroll from health plan emergent clinical needs -
study for the evaluation of "mitoscore" marker in the diagnosis of embryo viability in euploids embryos

Conditions: Infertility

Summary: the number of copies of mitochondrial genes (mtdna or "mitoscore") is related to the energy supply of the embryo, which can affect its ability to implant in the maternal uterus. the objective of this study is to analyse the potential of mitoscore before embryo transfer as a marker to identify and select the embryo with greater capacity of implantation. first of all, chromosomally normal embryos will be selected and mtdna copies will be quantified. finally, embryos with less copies of mtdna will be considered for embryo transfer.

the number of mitochondrial dna copies (mtdna) of a chromosomally normal embryo is related to a state of energy, which affects the ability of the embryo to implant in the maternal uterus. there is a decrease in the rate of implantation in euploid embryos containing a high number of mtdna copies. it is known that after a certain number of mtdna copies implantation is disrupted even in euploid embryos. the main purpose of this study is to evaluate the possible relationship between the mtdna content contained in developing embryos and the result of implantation in order to evaluate the potential of such relationship as a diagnostic tool. the number of mtdna copies present in chromosomally normal embryos will be quantified. subsequently, the transfer of euploid embryos after the randomization will be using either routine morphological or mitoscore criteria. study population: women undergoing either ivf or egg donation that go through preimplantation genetic screening (pgs) for different indications, either in day 5/6 or day 3. this is a triple blinded, randomized, prospective, clinical study where patients with embryos analyzed by pgs in blastocyst stage or day 3 and mitochondrial analysis with day 5/6 transfer, with deferred cycle for those analyzed in day 5/6 and fresh embryo transfer for those analyzed in day 3, will be randomized into two groups: group a: embryo selection for transfer will be based initially on chromosomal normality and secondly on embryo morphology criteria (specific for ivf lab). group b: embryo selection for transfer will be based initially on chromosomal normality and secondly on the mitoscore value, trying to transfer normal embryos containing the lowest number of mitochondrial dna copies.

Eligibility criteria:
* inclusion criteria: * pgs cycles for different indications * maternal age: ≤40 years old (fiv/icsi patients) * maternal age: \<50 years old (ovodon patients) * spermatocyte concentration: \> 2 million of spermatocyte/ml * single embryo transfer -≥ 8 oocytes mii * number of antral follicules (afc: ≥10 mii) * exclusion criteria: * detection in the moment of inclusion or previous diagnosis of congenital uterine malformations. * patients with embryo sex selection for those countries in which it is allowed.

Keywords: embryo implantation mitochondrial genes mitochondrial dna mitoscore embryo selection embryo viability embryo biomarker diagnosis of embryo viability in euploids embryos
validation of a computerised adaptive test for measuring caregiver well-being

Conditions: T1D

Summary: the main objective of this project is to test whether a tool (questionnaire) is suitable for assessing how caregivers of children and adolescents with td1 feel emotionally and psychologically. to do this, the investigators will use a technological system called 'computerised adaptive testing' (cat), which adapts the questions according to the answers of each participant. this allows the investigators to obtain a more accurate assessment tailored to each person's particular situation.


Eligibility criteria:
inclusion criteria: * caregivers aged ≥18 years who are the primary caregivers of a child with t1d. * the child should be younger than 18 years with a confirmed diagnosis of t1d. * willingness and ability to use a smartphone-based sensing system. * willingness to share retrospective continuous glucose monitoring (cgm) data from the child, specifically from the previous 2 months prior to joining the study. exclusion criteria: * caregivers with significant cognitive or physical impairments preventing study participation. * inability to read or understand the spanish language.

Keywords: type 1 diabetes mhealth caregiver cat
an extension long-term study of roactemra/actemra (tocilizumab) in patients with polyarticular juvenile idiopathic arthritis who completed the wa19977 study

Conditions: Juvenile Idiopathic Arthritis

Summary: this long-term, open-label extension study will evaluate the safety of roactemra/actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the wa19977 core study. patients aged 9-18 years with at least jia acr30 clinical response to roactemra/actemra in the core study will be eligible to receive roactemra/actemra 8 mg/kg intravenously every 4 weeks. anticipated time on study treatment is 104 weeks.


Eligibility criteria:
inclusion criteria: * patients 9 to 18 years of age who completed visit 33 (week 104) of wa19977 study with at least jia acr30 clinical response to roactemra/actemra relative to baseline in wa19977, with no aes, saes or conditions that lead to unacceptable risk of continued treatment * females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol exclusion criteria: * patients with, according to investigator judgment, not satisfactory benefit from roactemra/actemra therapy within wa19977 * treatment with any investigational agent since the last administration of study drug in the core study wa19977 or current participation in another clinical trial except wa19977 * patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course jia subsets: rheumatoid factor positive or negative jia or extended oligoarticular jia * patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug * any significant concomitant disease or medical or surgical condition * history of significant allergic or infusion reactions to prior biologic therapy * currently active primary or secondary immunodeficiency * current abuse of alcohol, drugs or chemical abuse * known and currently active acute, subacute, chronic infections or history of recurrent infection; patients suffering from ongoing active infections with epstein barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided * positive for latent tuberculosis (tb) * currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for \>/= 2 weeks within 6 months prior to entering the study * inadequate hepatic, renal or bone marrow function
relationship between alterations in the gi microbiome and gi inflammation on symptom burden in women with breast cancer receiving chemotherapy

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

Summary: this study evaluates the relationship between alterations in the gi microbiome and gi inflammation on symptom burden in women with breast cancer receiving chemotherapy.

primary objectives: i. to describe changes in gi inflammation and the gi microbiome profile in women with breast cancer throughout chemotherapy. ii. to examine how gi inflammation and gi microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy. iii. to examine associations between microbial composition functional profiles at t1 and t2, t3 as well as t4 in patients who report symptom severity in neuropsychological and gi symptoms at the last three timepoints. iv. to evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and gi symptom occurrence at t2, t3 and t4. outline: this is an observational study. patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * female with a new diagnosis of breast cancer (stage i-iii) * age 20 or older * able to read and write in english * chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (for example, taxotere + cyclophosphamide treatment +/- trastuzumab). patients who have not received chemotherapy for five years or more are considered chemotherapy naive exclusion criteria: * metastatic disease * cognitive impairment, based on clinician assessment, that would prevent completing measures * concurrent radiation therapy or radiation therapy within the last three months * gi co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months * a stoma preventing stool collection from the large intestine (i.e., ileostomy)