Kornimate/medical-research-clean huggingface dataset:
laparoscopic exploration versus abdominal ct scan

Conditions: Penetrating Abdominal Trauma

Summary: evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma

evaluate the role of laparoscopy and abdominal ct scan in diagnosis and treatment of abdominal trauma and which is more effective and safe laparoscopy or ct

Eligibility criteria:
inclusion criteria: * stable patients with definite occurrence of intra-abdominal injury * patients with equivocal result by clinical and radiological evaluation exclusion criteria: * patients with penetrating abdominal trauma * stable patients not in need for any intervention for conservative management * patients with marked haemodynamic instability * polyt-traumatized patients
gefitinib usage and outcomes in routine treatment

Conditions: Lung Cancer

Summary: the purpose of this study is to understand real world gefitinib usage patterns, patient characteristics and outcomes and to present these for a caucasian population

a multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment

Eligibility criteria:
inclusion criteria: * patients who received gefitinib first line in the uk single payment access (spa) scheme * locally advanced or metastatic egfr mutation positive nsclc * supplied with first pack of gefitinib prior to 1st january 2012 exclusion criteria: * patient was treated privately (i.e. outside the nhs) * gefitinib was second-line therapy following treatment failure on a prior therapy

Keywords: lung cancer epidermal growth factor receptor mutation gefitinib iressa
ongoing registry of treatment of chronic venous diseases

Conditions: Varicose Veins of Lower Limb

Summary: ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods

data of patients treated in different russian medical centers are entered in a prospective digital database, and continuously updated. there is planned to conduct prospective randomized, cohort and observational studies on the site of register

Eligibility criteria:
inclusion criteria: * varicose veins with any source of pathological reflux, c2 - c6 according to the ceap classification exclusion criteria: * no exclusion criteria

Keywords: registry varicose veins conventional surgery thermal ablation radiofrequency laser sclerotherapy
comparison of ertapenem distribution in the muscle of six healthy volunteers and six critically ill patients by microdialysis

Conditions: Healthy

Summary: ertapenem is an antibiotic that is highly bound to plasma protein (\> 95%). the effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet. in this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an ertapenem susceptible bacteria). indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins. it seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. that's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.


Eligibility criteria:
inclusion criteria: * age: from 18 to 80 years * patients with infection due to ertapenem susceptible bacteria. exclusion criteria: * patients who received ertapenem within 7 days prior to inclusion * known allergy to ertapenem or any excipients * neutropenia \< 500/mm3 * hemoglobin concentration \< 9g/dl * renal failure (creatinin clearance \< 30ml/min/1.73m²) * decompensated heart failure * patients receiving vasopressor (adrenalin, noradrenalin), \> 0.5µg/kg/min * known hypersensitivity to elma® * positive pregnancy test or currently lactating

Keywords: patients infected with a bacteria sensible to ertapeneme
effect of lithium carbonate in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of the study is to determine whether lithium is safe and effective in the treatment of als

daily doses of lithium, have been found to delay progression of amyotrophic lateral sclerosis (als) in a 15-month study of 44 patients with als. at the end of the trial, about 30 percent of the patients that took riluzole had died, while all those receiving riluzole plus lithium had survived. the lithium group had slower progression as measure by a test of breathing (fvc) and strength. this study will determine whether lithium in combination with riluzole delay progression of patients with amyotrophic lateral sclerosis disease in comparison of an historical cohort of als patients treated with riluzole alone.

Eligibility criteria:
inclusion criteria: * diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite als (according to wnf el escorial diagnostic criteria, revised according to the airlie house conference 1998) * concomitant standard riluzole therapy (50mg twice daily) * patients included in als reference center * women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test * capable of thoroughly understanding all information given and giving full informed consent according to gcp * patients with gastrostomy exclusion criteria: * evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms * any medical condition known to contre-indicate lithium treatment (dysthyroid, cardiopathy, renal insufficiency) * presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment * known hypersensitivity to any component of the study drugs

Keywords: amyotrophic lateral sclerosis lithium survival
biomarkers for intestinal permeability in patients with constipation

Conditions: Intestinal Diseases; Irritable Bowel Syndrome; Constipation

Summary: our overall objective with this study is firstly to provide a comprehensive assessment of intestinal permeability, mucosal barrier function using existing biomarkers and secondly to explore novel biomarkers for measuring intestinal permeability in patients with constipation predominant irritable bowel syndrome (ibs-c).

in order to determine the differences in permeability in ibs-c in comparison with healthy volunteers, the following will be determined: differences in in vivo small intestinal and colonic permeability, differences in small intestinal and colonic mucosal barrier function, differences in effects of fecal supernatants on barrier function of t84 monolayers, and differences in novel biomarkers for intestinal permeability

Eligibility criteria:
inclusion criteria: 1. 18 - 65 years old 2. ibs-c by rome iii criteria (for ibs-c participants) 3. no abdominal surgery (except appendectomy and cholecystectomy) exclusion criteria: 1. history of inflammatory bowel disease (ibd) , microscopic colitis or celiac disease 2. use of tobacco products within the past 6 months 3. use of nsaids or aspirin within the past week 4. use of oral corticosteroids within the previous 6 weeks 5. ingestion of artificial sweeteners such as splenda (sucralose), nutrasweet (aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda 6. ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins 1. any treatment specifically taken for ibs, including loperamide, cholestyramine, alosetron 2. drugs with a known pharmacological activity at 5-ht4, 5-ht2b or 5-ht3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine); 3. all narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination) 4. anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline). 5. ultram 6. gi preparations * anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine) * osmotic laxative agents (e.g, lactulose, sorbitol or peg solutions as miralax and glycolax) * prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone); 7. antimuscarinics; 8. peppermint oil; 9. systemic antibiotics, rifaximin, metronidazole. 7. bleeding disorders or medications that increase risk of bleeding from mucosal biopsies. 8. score \> 8 for anxiety or depression on hospital anxiety and depression scale. 9. pregnancy
chemo-immunotherapy plus thoracic radiotherapy in extensive stage small-cell lung cancer

Conditions: Small-cell Lung Cancer

Summary: studies have shown that combining chemotherapy and immune checkpoint inhibitors (ici) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (es sclc), but the survival benefit is modest. the main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in es sclc patients receiving carboplatin/etoposide/durvalumab.

studies show that adding ici therapy to standard chemotherapy prolongs survival in es sclc. the survival benefit, however, is modest, and there is a need for more effective therapy. it has been hypothesized that there is a synergistic effect of combining ici with radiotherapy. in this randomized phase iii study, the main aim is to investigate whether concurrent thoracic radiotherapy of 30 gy/10 fractions improves survival in es sclc patients receiving carboplatin/etoposide/durvalumab. it is currently not possible to classify the patients who benefit from icis in sclc. in this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers. prophylactic cranial irradiation in es sclc is debated, mainly due to the potentially detrimental effect on cognition. thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years at time of study entry 2. ecog performance status of 0 or 1 3. body weight \>30 kg 4. adequate bone marrow, liver and kidney function 5. life expectancy of at least 3 months 6. at least one measurable (recist 1.1), thoracic lesion that can be irradiated with 30 gy/10 fractions 7. histologically or cytologically confirmed sclc 8. stage iii-iv disease (tnm v8) 9. fev1 \>1 l or \>30 % of predicted value and dlco \>30 % of predicted value 10. patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment exclusion criteria: 1. previous chemo-, immuno- or radiotherapy for sclc 2. major surgical procedure last 28 days 3. history of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or hiv 4. uncontrolled intercurrent illness 5. other active malignancy 6. leptomeningeal carcinomatosis 7. immunosuppressive medication 8. pregnant or breastfeeding women

Keywords: cancer chemotherapy radiotherapy immunotherapy
treatment strategy for relapsed/refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Relapsed Hodgkin's Disease, Adult

Summary: the choice of the best second-line therapy in patients with high lh r/r risk, it is a niche of knowledge not covered at the moment, especially the role of brentuximab (bv) plus pd-1 blockade and auto-hsct. what is the progression-free survival and rate of metabolic responses complete in patients with high-risk r/r hl with the treatment strategy: bv+ pd-1 blockade consolidation with auto-hsct and maintenance with bv + pd-blockade 1?

patientes with refractory/relapsed hodgkin lymphoma (hl r/r) with multiple failed therapies represent a therapeutic dilemma. the goal of next-line treatment is long-term disease control with manageable adverse reactions. given the limited therapeutic options for patients with hl r/r, better therapies should be sought, more effective, with better tolerability, less toxicity, with increased overall survival (os) of the patients, with the aim of improving outcomes in terms of disease-free survival progression (pfs) of the current standard treatment. since currently only 50% of the patients with high-risk r/r hl treated with the standard regimen achieve healing. the high effectiveness and low toxicity of immunotherapy with prolonged remission or stabilization of the disease make it a new treatment option promising for hl r/r. based on the above, a treatment strategy is proposed to rescue base with brentuximab plus pd-1 blockade followed by autotransplantation and consolidation with brentuximab plus pd-1 blockade in patients with hodgkin lymphoma high-risk relapse/refractory compared to reported os and pfs rates in the literature obtained with standard treatment.

Eligibility criteria:
inclusion criteria: 1. relapsed/refractory hodgkin lymphoma to abvd with definition of high risk. 2. age ≥ 18 years and ≤ 90 years. 3. adequate liver function, defined as: * total serum bilirubin ≤ 1.5 x upper limit of normal (uln) * serum aspartate aminotransferase (ast) ≤ 3.0 x uln * serum alanine aminotransferase (alt) ≤ 3.0 x uln 4. adequate renal functions, defined as: • serum creatinine ≤ 1.5x uln or glomerular filtration rate \&gt; 50ml/min. 5. ecog performance status ≤ 3 6. women of reproductive potential should have a serum pregnancy test or negative urine. 7. prior signature of the informed consent. exclusion criteria: 1. voluntary withdrawal from the study. 2. develop grade 3 or 4 toxicity according to the inh scale. 3. loss of follow-up

Keywords: refractory relapsed hodgkin lymphoma
ngs-based comprehensive genomic ctdna panel in nsclc with immunotherapy

Conditions: Lung Cancer

Summary: liquid biopsy based on next-generation sequencing (ngs) method has become an increasingly powerful detection tool for clinical research and practice. as a companion diagnostic panel, circulating tumor dna (ctdna) assay has the considerable potential to detect the blood tumor mutation burden (btmb), and btmb calculated by ctdna assay is regarded as a novel and promising biomarker for immunotherapy nowadays. though immune checkpoint inhibitors (icis) in immunotherapy are highly effective but can induce severe immune-related adverse events (iraes), which cannot be better predicted in advance. meanwhile adoptive transfer of t cells transgenic for tumor-reactive t-cell receptors (tcr) is an attractive immunotherapeutic approach. however, clinical translation is so far limited due to challenges in the identification of suitable target antigens as well as tcrs that are concurrent safe and efficient. definition of key characteristics relevant for effective and specific tumor rejection is essential to improve current tcr-based immunotherapy. this research is to characterize in-depth tcrs derived from hla-mismatched allogeneic repertoire targeting different myeloperoxidase (mpo)-derived peptides presented by the same hla-restriction element. overall the purpose of this trial is to investigate the combined predictive biomarkers (including btmb and hla) related to the immunotherapy effects and the biomarker (tcr) associated with adverse reactions during immunotherapy and hold a predictive role, thus further benefit patients receiving immunotherapy, especially in the advanced stage lung cancer patients where tissue samples are unavailable.

blood samples including the plasma and pbmc (peripheral blood mononuclear cell) from immunotherapy-naive lung cancer patients will be analyzed by cgp panel (origimed, inc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, btmb, hla, etc. treatment methods and outcomes will be followed-up to inspect the clinical benefit and safety with cgp-panel analysis.

Eligibility criteria:
inclusion criteria: * participant aged 18 or above, and gender unrestricted * individual with pathologically diagnosed lung cancer exclusion criteria: * patients with concomitant other tumors * individual with severe cardiopulmonary insufficiency and hypoproteinemia * women who were pregnant and were during their lactation
efficacy and safety study of kiacta in preventing renal function decline in aa amyloidosis

Conditions: Amyloidosis

Summary: the primary purpose of this study is to assess the efficacy and safety of treatment with kiacta in adult patients with aa amyloidosis.


Eligibility criteria:
inclusion criteria: * females must be of nonchildbearing potential (more than 1 yr postmenopausal)or use effective contraception for at least 2 months prior to the baseline visit and through 30 days after the last dose of study medication * confirmed diagnosis of aa amyloidosis demonstrated by positive biopsy using congo red staining and immunohistochemistry or immunoelectronmicroscopy. mass spectroscopy will be used upon approval of the sponsor on a case to case basis. * persistent proteinuria greater than 1 g/24h at 2 distinct 24-hr urine collections * must have crcl greater than 25 ml/min/1.73 m2 at 2 distinct 24 hr urine collections exclusion criteria: * evidence or suspicion of chronic kidney disease secondary to a disease other than aa amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney disease, recurring polynephritis, or systemic lupus erythematosus) * history of kidney transplantation * evidence or suspicion of a cause of potentially reversible acute renal failure within 3 months prior to baseline visit * presence of concomitant diseases or medication that could interfere with the interpretation of study results or compromise patient safety * presence of condition that could reduce life expectancy to less than 2 yrs * type 1 or 2 diabetes mellitus * significant hepatic enzyme elevation * unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 6 months prior to the baseline visit; presence of ny heart assoc class iii or iv heart failure * presence of, or history of stroke or transient ischemic attack within 6 months prior to baseline visit * initiation of, or any changes in, angiotensin converting enzyme inhibitor, angiotensin ii receptor antagonist therapy, or renin inhibitor within 3 months prior to baseline visit * initiation of, or any changes in, cytotoxic agents, anti-tumor necrosis factor agents, anti interleukin-1 or 6 agents, or colchicine therapy within 3 months prior to baseline visit * previous use of kiacta * history of malignancy within 5 yrs prior to study entry, except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has been surgically cured * use of investigational drug within 30 days prior to the first screening visit * active alcohol and/or drug abuse

Keywords: kiacta for aa amyloidosis
feasibility of tight blood glucose control with the space tgc system in surgical icu patients

Conditions: Critical Illness

Summary: hyperglycemia is common in critically ill patients and associated with an adverse outcome. thus, glycaemic control is an important issue in critical care. despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. a fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. space glucosecontrol (tgc system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. information on parenteral and enteral nutrition is automatically integrated into the calculations. the primary objective of the current study is to investigate the performance and usability of the space tgc system for glucose control over an tight glucose control range (4.4 to 6.1 mmol/l) in surgical intensive care patients.


Eligibility criteria:
inclusion: * age: \> 18 years of age * stay in the icu expected to be \> 20 h * blood glucose \> 110 mg/dl or patient on insulin treatment exclusion: * patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency. * known or suspected allergy to insulin * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures) * moribund patients likely to die within 24 hours

Keywords: algorithm tight glycemic control glucose control intensive care insulin icu
impact of teacher training and the introduction of early adjustments on the developmental trajectory of children at risk of slld in pre-school.

Conditions: Language Disorders in Children; Learning; Developmental Disorder

Summary: the high incidence of neurodevelopmental disorders, including specific language and learning disorders, and their profund impact on the schooling of the children concerned remains a major public health concern. early identification and intervention are a valuable tool for improving these problems. the developmental trajectory of children could be improved by knowledge enhancement, identification and strategies to support the teachers through the involvement of health professionals in the classroom

prisme - tsla is a clinical trial developing experiment project for the intervention arm involving teacher training, the implementation of identification grids, follow-up observations in classroom of identified pupils, and the development of special arrangments. for the control arm, the teachers work with standard procedures of the french national education policy.

Eligibility criteria:
inclusion criteria: pupils : * in a kindergarten school with at least 3 classes of primary school age children. * at least 5 years old on 31/12/2023. * whose 2 parents have given their consent (the consent of a single parent if no contact is possible with the second parent despite repeated attempts) * have received age-appropriate explanations about the study and have not refused to take part. exclusion criteria: pupils in : * in a kindergarten school with fewer than 3 classes, making it impossible to randomise the school * under 5 years of age on 31 december of the current school year. * under guardianship

Keywords: professional development preventive approach neurological development preschool education
seroquel- agitation associated with dementia

Conditions: Alzheimer's Disease; Vascular Dementia

Summary: the purpose of this study is to determine how safe and effective seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of dementia compatible with probable or possible alzheimer's disease (ad) * subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy * subject must have a score of at least 14 on the panss exclusion criteria: * current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder * symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance * failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression

Keywords: seroquel dementia agitation symptoms alzheimer's disease vascular dementia quetiapine fumarate