Kornimate/medical-research-clean huggingface dataset:
treatment of type ii odontoid fractures among the elderly

Conditions: Neck Injuries; Spinal Injuries

Summary: the purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type ii odontoid fractures among patients \> 64 years of age. of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

hypotheses are as follows: * patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively. * the rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management. * the rate of non union will be greater in the conservative group compared to the surgical group. * the complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.

Eligibility criteria:
inclusion criteria: * all new type ii odontoid fractures including those in which the fracture line crosses into the body of c2 * age \> 64 * stable and unstable fractures * \< 3 months post-injury * no previous treatment for an odontoid fracture exclusion criteria: * pathological fractures unrelated to osteoporosis * severe dementia or severe mental health problems * participation in other trials or unlikely to attend follow-ups

Keywords: odontoid fx surgical intervention conservative treatment nonunion odontoid fractures surgical treatment
pacing activity self-management for patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (ms), it is examined whether physical behavior and health status of patients with ms improve in response to a pacing self-management program. the effects of pacing will be compared with those observed when applying relaxation therapy to patients with ms.

up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (ms) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. all treatments will be delivered by occupational therapists or physiotherapists. one treatment session lasts for about 45 minutes each.

Eligibility criteria:
inclusion criteria: * adult * age range between 18 and 65 years of age * willing to sign informed consent form * fulfilling the criteria for the diagnosis of multiple sclerosis exclusion criteria: - not fulfilling each of the inclusion criteria listed above.

Keywords: neurology physiotherapy physical therapy occupational therapy stress management activity management treatment
gingival health and malocclusion among type 1 diabetic children and adolescents

Conditions: Gingivitis; Periodontal Diseases; Diabetes; Diabetes Mellitus, Type 1; Malocclusion; Malocclusion in Children

Summary: introduction: this study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. methods: the sample consisted of 36 children, who were distributed into two groups: dm; n=18 and ndm; n=18. periodontal parameters considered were plaque index (pi), gingival index (gi), probing depth of pocket (ppd), gingival recession (gr) and clinical attachment level (cal). gingival biotype clinical parameters: gingival transparency to probing, height of keratinized mucosa and gingival thickness on permanent incisors and molars. malocclusion were evaluated by the dental aesthetic index (dai) and the angle's classification. the statistical analyses were shapiro wilk test and t test.

introduction: this study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. methods: the sample consisted of 36 children (age 8 to 18 years old), who were distributed into two groups: patients with type 1 diabetes (dm; n=18) and control patients without diabetes (ndm; n=18). periodontal parameters considered were plaque index (pi), gingival index (gi), probing depth of pocket (ppd), gingival recession (gr) and clinical attachment level (cal). gingival biotype clinical parameters were evaluated by three aspects: gingival transparency to probing, height of keratinized mucosa and gingival thickness on permanent incisors and molars. malocclusion, its prevalence, severity and need of treatment were evaluated by the dental aesthetic index (dai) and the angle's classification. the statistical analyses were shapiro wilk test and t test.

Eligibility criteria:
inclusion criteria: - child or adolescent with the age between 8 and 18 years old exclusion criteria: * child or adolescent who had an active or inactive caries lesion, on the buccal surface, in the cervical region of the elements to be analyzed; * participants with probing depth greater than or equal to 4 mm, which is characterized as periodontitis; * the patient who is undergoing orthodontic treatment, with fixed appliance; * smokers; * pregnant women, nursing mothers.
ultrasound- guided mid point transverse process to pleura block

Conditions: Regional Anesthesia for Postnephrectomy Pain

Summary: radical nephrectomy is the surgical process for the resection of malignant tumors of the kidney necessitating a subcostal flank incision.mild to severe pain is observed in the postoperative period ineffective pain management leads to several complications. the mid point transverse process to pleura block (mtp) , this technique was used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

ineffective pain management leads to several complications including immobilization, thromboembolism, persisting chronic pain, increased opioid consumption, and delayed hospital discharge.\[3\] multimodal analgesic (mma) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief. regional anesthesia techniques, mainly epidural analgesia and more recently, paravertebral blocks became crucial parts of a mma regimen after the introduction of ultrasound (us) in the regional anesthesia practice. the mid point transverse process to pleura block (mtp) block was first described as a modified paravertebral block in 2017. the local anesthetic drugs are administered between the transverse process and the pleura. this results in a local anesthetic drugs spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotranverse ligament (sctl) at the level of injection, and frequently to adjacent levels. this technique was used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

Eligibility criteria:
* inclusion criteria: - asa ii and iii patients * scheduled for partial or radical nephrectomy * standard flank incision either subcostal ,intercostal or supracostal approach * under general anesthesia. exclusion criteria: * bleeding disorders, * mental or cognitive dysfunction, * history of chronic analgesic or drug abuse, * allergy to local anesthetics * local infection at site of block

Keywords: nephrectomy pain
safety and immunogenicity of an intramuscular pandemic influenza vaccine in adults and the elderly

Conditions: Influenza; Orthomyxoviridae Infections

Summary: based on the results from a previous formulation/dosage ranging trial, this phase ii multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the european medicines agency (emea) guideline. the antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.


Eligibility criteria:
inclusion criteria : * aged over 18 years on the day of inclusion * informed consent form signed * able to attend all scheduled visits and to comply with all trial procedures * for a woman, inability to bear a child or negative urine pregnancy test * for a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination. exclusion criteria : * systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances * febrile illness (oral temperature ≥ 37.5°c) on the day of inclusion * breast-feeding * previous vaccination with an avian flu vaccine * participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy * chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders) * current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures * receipt of blood or blood-derived products within the past 3 months * any vaccination within 4 weeks prior to the first trial vaccination * vaccination planned within 4 weeks after any trial vaccination * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Keywords: influenza orthomyxoviridae infections influenza pandemics a/h5n1 strain
autoimmune cytopenia: genetics and pathophysiological mechanism in pediatric evans syndrome

Conditions: Evans Syndrome

Summary: characterization of the genetic causes, and of the immunopathological clinical and biological manifestations in children with pediatric evans syndrome included in a prospective national observational cohort of rare diseases.

pediatric evans syndrome (pes) is a rare and severe disease combining immunologic thrombocytopenic purpura (itp) and autoimmune hemolytic anemia (aiha). french patients from the 30 hematologic pediatric centers are from 2004 included in a prospective national obs'cerevance cohort. a first pilot study revealed a monogenic cause in 7/18 patients (40%) with mutations in the ctla-4, lrba, stat3 gof, and kras. tngs or exome studies were performed between 2015 and 2018 inn 80 patients with pse from the obs'cerevance cohort. this approach, combined with by immunophenotyping lymphocyte, identified a genetic cause of the disease in 26 patients (32%) (tnfrsf6, ctla4, lrba, stat3 gof, pik3cd, rag1, kras) and potential causal mutations in 18 other patients (22%), bringing the proportion of potential single gene cause to 76%. the central hypothesis of this study is that most, if not all, cases of pse are related to a monogenic or digenic cause, possibly with the intervention of genetic modifiers such as somatic mutations.

Eligibility criteria:
inclusion criteria: * patient registered in the french national prospective obs'cerevance cohort * diagnosis of pediatric evans syndrome (pti+ahai) * age strictly under 18 years at the initial onset * child residing in metropolitan france and affiliated to a french health insurance system * free, informed, written and signed consent exclusion criteria: * evans syndrome secondary to chemotherapy, bone marrow transplantation or organ transplantation. * refusal to participate from parents/patients

Keywords: pediatric evans syndrome genetic causes immunophenotyping immunologic explorations
examining the effect of a scripted debriefing on resuscitation performance in pediatrics

Conditions: Pediatric Cardiac Arrest (Simulated)

Summary: the investigative team's purpose for conducting this research is to improve effective and efficient translation and implementation of evidence based advanced life support practice to providers of care for children. this specific project aims to accomplish 2 major goals. the investigators aim to evaluate the utility of a debriefing script specifically designed to facilitate debriefing when used by novice pediatric advanced life support instructors during low and high realism simulation-based learning. secondly, the investigators hope to evaluate the effectiveness of high realism simulation vs. low realism simulation in achieving pals-based educational outcomes, such as knowledge and skill acquisition. the investigators hypothesize that scripted debriefing by novice instructors following low and high fidelity simulation-based learning will : 1. improve the cognitive performance and knowledge of multidisciplinary team members as assessed by a cognitive performance tool and multiple choice testing compared with more traditional, non-scripted debriefing; 2. improve the behavioural, teamwork and communication skills of multidisciplinary team members as assessed by a validated assessment tool compared with more traditional, non-scripted debriefing; the investigators hypothesize that high realism simulation-based learning will: 1. improve the cognitive performance and knowledge of multidisciplinary team members as assessed by a cognitive performance tool and multiple choice testing compared with more traditional, low realism simulation; 2. improve the behavioural, teamwork and communication skills of multidisciplinary team members as assessed by a validated assessment tool compared with more traditional, low realism simulation;


Eligibility criteria:
inclusion criteria (novice instructors): * senior residents (general pediatric, emergency medicine, pediatric subspecialty) in year three of training or above * nursing staff, respiratory therapists or paramedics with greater than 5 years of clinical experience * recent pals certification within the past 2 years inclusion criteria (team composition) * 1 or 2 pediatric nurses, 2 physicians (residents/fellows in pediatrics, anesthesia, family medicine, emergency medicine, pediatric emergency medicine, pediatric critical care or pediatric anesthesia) and/or 1 pediatric respiratory therapist or 1 pediatric transport paramedic exclusion criteria (novice instructors): * experienced instructors, defined as having taught three or more courses for healthcare professionals where simulation was followed by debriefing exclusion criteria (team composition) * n/a

Keywords: pediatric cardiac arrest simulation debriefing realism
precision adjuvant therapy after surgery for hepatocellular carcinoma

Conditions: HCC

Summary: vessels that encapsulate tumor clusters (vetc) is an invasive metastatic factor in hcc independent of the epithelial mesenchyme transition (emt), and vetc-positive patients have a higher rate of postoperative recurrence. how to improve the prognosis of this group of patients is an urgent issue to be addressed.

previous studies have identified vetc as a new metastatic pattern independent of emt that may be associated with immunosuppression as well as poor prognosis. multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in vetc-positive patients. how to improve surgical prognosis in vetc-positive patients needs to be explored. there are no published studies on how to improve prognosis for this population. one of our unpublished retrospective studies found that vetc-positive patients receiving pd-1 monoclonal antibody was not effective in improving prognosis. however, pd-1 monoclonal antibody in combination with pd-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in vetc-positive patients. based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.

Eligibility criteria:
inclusion criteria: 1. aged 18-75. 2. no previous local or systemic treatment for hepatocellular carcinoma. 3. child-pugh liver function score ≤ 7. 4. ecog ps 0-1. 5. no serious organic diseases of the heart, lungs, brain, kidneys, etc. 6. pathologic type is hepatocellular carcinoma. 7. confirmation of the presence of vetc vascular pattern by cd34 immunohistochemical staining. exclusion criteria: 1. pregnant and lactating women. 2. suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.). 3. a history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator. 4. active infection. 5. other significant clinical and laboratory abnormalities that affect the safety evaluation. 6. inability to follow the study protocol for treatment or follow up as scheduled.

Keywords: hcc adjuvant therapy vetc pd-1 inhibitor lenvatinib
evaluation of a protocol for dose reduction in patients with spondylarthropathies and clinical remission with anti-tnf

Conditions: Spondylarthropathies

Summary: the purpose of this study is to demonstrate that patients with spondylarthropathies in remission under antitnf therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.

it has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. a multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. the study will include 190 patients with spondylarthropathies in stable treatment with any single anti-tnf agent and compliance with criteria of clinical remission for at least 4 months. patients will be randomized to intervention or control arm, with stratification according to the antitnf product thet were receiving prior to inclusion. patients will be followed with the calendar of visits recommended by the spanish society of rheumatology for clinical practice. the proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients with spondylarthropathies according asas group criteria. * patients under treatment with anti-tnf therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission * patients to give their informed consent to participate in the study exclusion criteria: * patients with secondary spondylarthropathies * patients with spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-tnf therapy by peripheral symp tons. * patients with spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders...) * patients with bowel inflammatory disease * patients under chronic therapy with anti-tnf therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion

Keywords: spondylarthropathies persistent clinical remission with anti-tnf therapy standardized protocol for dose reduction anti-tnf therapy
effectiveness and underlying mechanisms of applied relaxation as indicated preventive intervention

Conditions: Anxiety Disorders; Depressive Disorder; Stress Disorder

Summary: as mental disorders constitute a core health care challenge of the 21th century, increased research efforts on preventive interventions are indispensable. in the field of clinical psychology, indicated preventive interventions targeted to those with initial symptomatology appear particularly promising. applied relaxation (ar) is a well-established intervention technique proven to effectively reduce tension/distress, anxiety and depressive symptoms in the context of treatment of a wide variety of manifest mental disorders as well as somatic illnesses. however, it has not been studied so far whether ar as indicated preventive intervention in subjects with initial symptomatology but no full-threshold mental disorder yet is capable to prevent a further symptom escalation. this randomized controlled trial in subjects with elevated tension/distress, anxiety or depressive symptomatology aims to investigate whether an ar intervention (10 sessions à 60 min) can (a) effectively reduce present psychopathological symptoms as well as (b) prevent a further symptom progression to full-threshold dsm-5 mental disorders. putative mediators (physiological, emotional, cognitive and behavioral changes including heart rate and heart rate variability, hair and salivary cortisol secretion, affectivity, self-efficacy, internal locus of control and cognitive / behavioral coping) and moderators (sex, age, symptom severity at baseline and homework adherence during the intervention course) of the intervention/preventive efficacy will be additionally studied. predictor and outcome measures will be assessed both conventionally (via personal interview, questionnaires and physiological measures during the respective main assessment) and with ecological momentary assessments (ema, applied via smart phone over a 1-week interval following the respective main assessment) in everyday life.


Eligibility criteria:
inclusion criteria are as follows: at least mild symptoms of tension/distress, anxiety or depression (dass-21 score of 8 or higher on tension/stress, of 4 or higher on anxiety, and of 5 or higher on depression) exclusion criteria are as follows: (1) a 12-month diagnosis of any mental disorder, (2) lifetime psychotic symptoms, (3) current psychological or psychopharmacological intervention, (4) acute suicidality
angiopoietin and adverse outcomes in cardiac surgery

Conditions: Cardiac Surgery; Acute Kidney Injury

Summary: cardiac surgery and cardiopulmonary bypass can lead to systemic organ failure trough excess inflammation and endothelial injury. the angiopoietin family represented by angiopoietin 1 and 2 can reflect endothelial injury by a decrease in angiopoietin 1 and an increase in angiopoietin 2. the investigators hypothesized that angiopoietin dysregulation could reflect organ failure related to cardiac surgery. the purpose of this project is to assess the association between angiopoietin dysregulation and adverse outcomes on cardiac surgery.


Eligibility criteria:
inclusion criteria: * adult patient scheduled for cardiac surgery under cardiopulmonary bypass exclusion criteria: * patient less than 18 years old, * redo surgery, * urgent surgery, * endocarditis, * aortic root repair surgery * aortic dissection * heart beating surgery, * heart transplantation

Keywords: angiopoietin endothelial injury macce