Kornimate/medical-research-clean huggingface dataset:
expanded access for idelalisib in combination with rituximab in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: this study is to provide idelalisib (idela) to individuals with relapsed, previously treated chronic lymphocytic leukemia (cll) who have limited treatment options and are not eligible for other gilead-sponsored studies.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age with a diagnosis of b-cell cll established according to the international workshop on chronic lymphocytic leukemia (iwcll) criteria and documented within medical records 2. cll that warrants treatment (consistent with accepted iwcll criteria for initiation of therapy) 3. prior treatment for cll comprising any of the following: 1. prior treatment with ≥ 1 regimen containing a therapeutic anti-cd20 antibody or 2. prior treatment with ≥ 2 regimens containing ≥ 1 cytotoxic agent 4. cll progression \< 24 months since the completion of the last prior therapy for cll 5. appropriate for noncytotoxic-containing therapy based on the presence of any of the following factors: 1. grade ≥ 3 neutropenia or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or 2. estimated creatinine clearance \< 60 ml/min (as determined by the cockcroft-gault method), or 3. a cumulative illness rating scale (cirs) score of \> 6 6. a negative serum pregnancy test for female subjects of childbearing potential 7. male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. 8. lactating females must agree to discontinue nursing before the study drug is administered. 9. evidence of a personally signed informed consent exclusion criteria: 1. known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s) 2. known histological transformation from cll to an aggressive lymphoma (ie, richter transformation) 3. known myelodysplastic syndrome 4. evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization 5. ongoing drug-induced liver injury, chronic active hepatitis c (hcv), chronic active hepatitis b (hbv), alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension 6. ongoing drug-induced pneumonitis 7. ongoing inflammatory bowel disease 8. history of anaphylaxis in association with previous administration of monoclonal antibodies
comparison of two extubation techniques in critically ill adult patients

Conditions: Weaning Failure; Mechanical Ventilation Complication

Summary: orotracheal extubation consists in the removal of the endotracheal tube (ett) when it is no longer required. this procedure may carry a considerable risk of complications and extubation failure. the literature points out two methods of extubation: the traditional method and the positive pressure method. in a noninferiority clinical trial it was demonstrated that eot with positive pressure and without endotracheal suction was a safe technique and could be better than traditional extubation. although prior studies reported better clinical outcomes with the positive pressure extubation technique, its superiority has not been deeply studied yet. therefore, the objective of our study is to determine whether the positive pressure ote technique, compared with the traditional ote technique, reduces the incidence of major postextubation complications (up to 60 minutes) in critically ill adult patients.

design: multicenter randomized controlled clinical trial methods: critically ill adult subjects on invasive mechanical ventilation who met extubation criteria will be included. will be randomly assigned to positive-pressure extubation (n=389) or to traditional extubation (n=389). the main variable will be incidence of major complications.

Eligibility criteria:
inclusion criteria: * age \>18 * invasive mechanical ventilation through an endotracheal tube, * successfully complete a spontaneous breathing trial * adequate level of consciousness (glasgow coma score \>8) * effective cough. * written informed consent from a relative or legal representative. exclusion criteria: * history of upper airway injury or surgery * previously extubated or tracheostomized * noninvasive ventilation (niv) as a weaning method * decision to not reanimate

Keywords: airway extubation extubation methods positive pressure positive-pressure extubation tracheal extubation positive-pressure ventilation extubation complications
radiology registry on pancreatic malignancies

Conditions: Pancreatic Cancer; Pancreas Neoplasm; Pancreas Disease; Pancreas Cyst

Summary: the purpose of this study is to collect all radiological data which evaluated with clinical data may help assess malignancy and prognosis of pancreatic disease.this registry aims to collect retrospective data from 2014 and prospective data until 2027 with a maximum follow-up of 3 years per patient.

single center, observational (retrospective and prospective) will collect all available parameters to assess the clinical outcome of the patients (progression free survival (pfs), overall survival (os), local progression free survival ltpfs), response to treatment) with pancreatic neoplasms presenting to san raffaele. patient assignment to a given diagnostic and/or therapeutic procedure is not related to random assignment methods but is part of the ordinary therapeutic strategy planned for each patient on an individual basis and after multidisciplinary discussion.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * patients with suspect (planned for investigation) or diagnosed pancreatic cancer at any stage. * able and willing to sign informed consent exclusion criteria: * patients with non-primary pancreatic disease
comparison of endoscopic sphincterotomy plus large-balloon dilatation and conventional treatment for large cbd stones

Conditions: Choledocholithiasis; Large Common Bile Duct Stone

Summary: bile duct stone extraction is impossible after endoscopic sphincterotomy (es) alone in approximatively 10% of cases (mostly because of stones' size). adjunction of a mechanical lithotripsy (ml) is well established to improve clearance of common bile duct (cbd) stones. because of inconstant success, high cost, and length of procedure, an alternative method was proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (eslbd). if the safety of eslbd is accepted in all recent published studies, it remains controversial wether eslbd is superior to conventional endoscopic treatment associating es± ml for cbd stones. procedure treatment and place of eslbd in cbd stones therapeutic strategy is unclear. the purpose of this prospective comparative multi center randomized study is to evaluate the superiority or not of eslbd on conventional treatment (es±ml) for the treatment of large bile duct stone (≥13mm) after standard es, and to propose a new cbd stones therapeutic strategy.


Eligibility criteria:
inclusion criteria: * patient with cbd stones with a smaller diameter ≥ 13mm on cholangiogram exclusion criteria: * active or history of acute pancreatitis * presence of intrahepatic stones * history of billroth ii or roux-en-y reconstruction * coagulation disorder (partial thromboplastin time \> 42 seconds, prothrombin time (quick value) \< 50% and platelet count of \<50 000/mm3) * current anticoagulation or clopidogrel treatment * pregnancy * inability to give informed consent

Keywords: cholangiopancreatography therapeutic strategy endoscopic retrograde
a case series study of negative pressure platform wound device

Conditions: Incisions, Surgical

Summary: this primary case series study will demonstrate the safety and feasibility of the np-pwd technology and treatment protocol to promote healing of surgical incision healing. in a first use in humans of the np-pwd's capability to deliver negative pressure wound treatment (npwt), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the npwt capability for future use in more tenuous situations of wound closure.

a case series study of 10 subjects will be conducted by enrolling patients who are scheduled for elective surgical incisions. patients will be screened for inclusion criteria and asked to consent to participate in the study for single application treatment with the np-pwd for 3-6 days. initial evaluation of the incision would occur on day 0, including screening, pre-procedure evaluation, measurement and photography of the closed surgical incision. follow up data is then gathered day 3-6 with removal of the np-pwd, surgical incision assessment and photography, and assessment for adverse effects. day 9-14 follow up include the same assessments of progression of wound closure. gathered clinical data of the 10 subjects will be used to evaluate the safety in using the npwt device for effective wound healing.

Eligibility criteria:
inclusion criteria: 1. patients 18-85 years of age. 2. scheduled for surgical intervention in which an incision will be made and skin closure will be performed. exclusion criteria: 1. active infection as judged by the investigator 2. inability to give informed consent 3. active malignant disease or subject is less than one year disease-free 4. use of immunosuppressive agents, radiation or chemotherapy within the past 30 days 5. any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing 6. on any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study 7. pregnant at enrollment
pediatric trauma centers re-aim at gun safety

Conditions: Firearm Injury; Safety Issues

Summary: universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling. barriers to its implementation must be addressed in order to effectively deliver firearm related injury prevention efforts. this study will implement a universal firearm injury prevention initiative within a national cohort of three pediatric trauma centers. the investigator's long-term goal is to demonstrate best practices for pediatric trauma center-based firearm injury prevention strategies that promote safe storage practices and reduce firearm related injury and death. this research will test the effectiveness of a comprehensive training strategy for improving the implementation of a universal firearm injury prevention effort, actfast (adopting comprehensive training for firearm safety in trauma centers), to 1) increase the adoption, implementation and sustainability of a universal firearm injury prevention initiative within participating pediatric level 1 trauma centers; 2) increase firearm safety knowledge, attitudes and safe firearm storage practices among parents of pediatric trauma patients and youth patients treated within participating pediatric level 1 trauma centers, and 3) increase trauma center clinicians' firearm safety knowledge and confidence in delivering a firearm safety intervention.


Eligibility criteria:
for parents/guardians of pediatric trauma patients: inclusion criteria: * live with an admitted pediatric trauma patient at a participating trauma center * be fluent in english or spanish exclusion criteria: - family members who do not live with the admitted pediatric trauma patient for youth trauma patients: inclusion criteria: * must be between the ages of 11-17 years * admitted to a participating trauma inpatient service for an injury * fluent in english or spanish * able to provide written assent and parent able to provide written consent exclusion criteria: * youth who are prisoners or in police custody * youth who are admitted due to suicide attempt * youth with acute conditions that would preclude provision of informed consent (i.e., acute psychosis, altered mental status, cognitive impairment)
integral study: a longitudinal study of surgeries and lasers in glaucoma: long-term results and success predictors analysed from a large-scale retrospective and prospective glaucoma register

Conditions: Glaucoma Open-Angle; Glaucoma Eye; Glaucoma; Drugs; Glaucoma, Angle-Closure; Glaucoma Secondary; Glaucoma, Neovascular; Glaucoma Congenital; Surgery; Glaucoma, Pigmentary; Glaucoma Capsulare

Summary: the study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective (for patients operated and data recorded before 2018) and prospective (for data collected after 2018) in nature.patients' medical data contained in the register will be analysed to determine the efficacy of the treatments they received during their follow-up at the investigation centre.

this study involves the creation and analysis of a large-scale register including all patients suffering from glaucoma, currently and previously followed-up and treated at a single tertiary centre in lausanne, switzerland. the design of the study is longitudinal, observational and comparative. patients are recruited retrospectively if they attended the research centre before september 2018, and prospectively if they attend the centre from this month onwards. their inclusion does not affect their care, treatment choice or follow-up. all data of recruited patients is be kept in their medical notes until a specific analysis is launched. data is then exported from their medical notes into a coded database for analysis. at the end of each analysis session (defined as the publication of the related article), all exported data is fully anonymised. data analysis will aim to assess the long-term efficacy, safety profile, and factors predictive of success/failure of treatments performed. to ensure the quality of all included data, health-related information will be extracted directly from the medical notes and coded into the register by a clinical research associate. conformity of the process and recorded data will be confirmed by regular internal auditing. for quality assurance the ethics committee may visit the research sites. direct access to the source data and all project related files and documents must be granted on such occasions.

Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (iop \> 24 mmhg, medicated or not) * patients who received treatment (medical, laser or surgical) at the glaucoma centre, montchoisi clinic * able and willing to provide informed written or verbal consent exclusion criteria: * patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
study of lung function in children who have undergone bone marrow transplantation

Conditions: Long-term Effects Secondary to Cancer Therapy in Children; Pulmonary Complications

Summary: rationale: assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment. purpose: this clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.

objectives: * determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy. * determine the relationship between pulmonary function and growth rates in these patients. * determine the effect of growth hormone treatment on pulmonary function in these patients. * determine the relationship between pulmonary function and age at time of transplantation in these patients. * determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients. outline: patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (pft) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement. patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. patients with abnormal pfts are assessed at more frequent intervals as clinically indicated. projected accrual: approximately 280 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * patients who have undergone bone marrow transplantation for hematologic malignancy at least 5 years ago * disease-free survivors at least 6 years of age and * under 18 years of age at time of transplantation * received prior allogeneic, unrelated donor, syngeneic, or autologous bone marrow transplantation * able to perform pulmonary function tests patient characteristics: age: * see disease characteristics performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * any prior preparative regimen allowed

Keywords: long-term effects secondary to cancer therapy in children pulmonary complications
vitamin d in egyptian children with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: there is an emergent evidence demonstrating the role of vitamin d deficiency in eczema. vitamin d supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate ad; however, the potential benefit of vitamin d in severe cases remains unclear


Eligibility criteria:
inclusion criteria: 1.diagnosis of severe ad according to hanifin and rajka criteria and the eczema area and severity index (easi) score exclusion criteria: 1. serious skin disorder other than ad. 2. taking systemic corticosteroids or anti-inflammatory medications, prior vitamin d supplementation 3. receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment 4. known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.
study of valproate in young patients suffering from epilepsy

Conditions: Epilepsy

Summary: main objective: therapeutic follow-up study evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays. secondary objectives: ancillary population kinetics study * estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data. * evaluate the influence of individual characteristics on the pharmacokinetic parameters. * describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.


Eligibility criteria:
inclusion criteria: * children aged between 6 months and 15 years. * suffering from any type of epilepsy. * receiving at the time of inclusion valproate in the form micropakine® sr 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment). * followed by hospital paediatricians or neuropaediatricians. * for whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself. * for whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
host-based immunoassay for differentiating bacterial from viral infections (post-marketing study of immunoxpert™ - spirit study)

Conditions: Fever

Summary: this is a retrospective external field study of a novel in vitro diagnostic (ivd) assay (immunoxpert™). the study will involve reviewing the medical charts of about 4500 pediatric patients that were tested using immunoxpert™ as part of the routine workup for acute febrile illness. immunoxpert™ uses a computer algorithm to combine immunoassay measurements of three host immune proteins (trail, ip-10, and crp) present in human blood. the test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. statistical analysis will be performed to compare the diagnostic accuracy of immunoxpert™ with that of current practice lab testing e.g., wbc, crp, and pct (whichever were taken as part of routine care) and clinical suspicion at time of requisition.


Eligibility criteria:
inclusion criteria: * patients aged 3 month to 18 years that were admitted due to acute febrile illness, and immunodx test was taken as part of their workup. the febrile illness should also fulfill the following criteria: * the patient had a peak temperature ≥38°c (and) * symptoms initiated ≤ 7 days before sampling (and) * a retrospective diagnosis of bacterial or viral or mixed infection was anonymously determined by a panel of three independent senior pediatricians. the non-infectious disease control group will include: * a retrospective diagnosis of a non-infectious disease was anonymously determined by a panel of three independent senior pediatricians physicians. * patients with a non-infectious disease ( and immunodx test was wrongly taken) exclusion criteria: * samples from patients who had one or more of the following criteria will be excluded from the study: * another infection episode during the last 3 weeks before sampling * congenital immune deficiency (cid) * a proven or suspected hiv-1, hbv, hcv infection * active hematological malignancy * current treatment with immune-suppressive or immune-modulating therapies including without limitations: * use of high dose steroids \>1 mg/kg/day prednisone or equivalent in the last two weeks * monoclonal antibody administration * intravenous immunoglobulin (ivig) * other illnesses that affect life expectancy and/or quality of life * suspicion of gastrointestinal infection