Kornimate/medical-research-clean huggingface dataset:
effect of preoperative immunonutrition in upper digestive tract

Conditions: Immunonutrition; Gastric Cancer; Esophageal Cancer; Pancreas Cancer; Surgery--Complications

Summary: randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). the aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.

background: perioperative nutritional status is a key factor in the evolution, as well as, postoperative morbidity and mortality of cancer patients. particularly, digestive neoplasms have a high risk of malnutrition and this is related to a higher rate of surgery complications and mortality in the postoperative period. the immunonutrition seems to modulate the immune system and the inflammatory response in patients operated on for digestive neoplasia. however, the results to date are controversial. aim: to compare the effect of an immunomodulatory oral nutritional supplement (enriched in arginine, nucleotides, omega 3 fatty acids, olive oil polyphenols, l-carnitine, and antioxidants) against an equivalent in protein-energy without immunonutrients, administrated in the preoperative period, in the surgical evolution of the cancer patient with neoplasia of the upper digestive tract. methods: it is a randomized, double-blind, multicenter clinical trial. 178 patients with neoplasms of the esophagus, stomach or pancreas, with indication of surgical treatment, will be included. the patients will be randomized into two groups (intervention group and control group) and both will receive 2 daily bricks of the assigned formula (with or without immunonutrients, respectively) 5 days prior to surgery. the main variables of the study are: appearance of infectious or noninfectious complications in the postoperative period, length of hospital stay, and mortality. these variables will be compared by group (immunonutrition vs. non immunonutrition).

Eligibility criteria:
inclusion criteria: * diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery * signing informed consent exclusion criteria: * pregnant or breastfeeding * advanced renal insufficiency prior to dialysis (gfr \<25 ml / min) * allergy or intolerance to any of the components of the dietary supplement (including fish allergy) * patients with contraindications for enteral nutrition

Keywords: immunonutrition surgery postoperative complications length of hospital stay nutritional status
efficacy and safety study of zk219477 in patients with recurrent ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during, or in the last six months since a treatment of platinum-based chemotherapy. we also aim to look at the safety of the study drug and assess the impact of the infusion duration on tolerability.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria:- females aged 18 or over - cancer of any of the following types: -- epithelial ovarian cancer -- peritoneal cavity cancer -- fallopian tube cancer - up to 2 previous chemotherapies; the most recent must have been a platinum- containing therapy - progression of disease or symptomatic relapse during, or within 6 months of previous therapy - 4 weeks or more since prior radiotherapy or chemotherapy - 3 weeks or more since prior immunotherapy - adequate recovery from previous surgery, radiotherapy, and chemotherapy ( excluding alopecia) - survival expectation of 3 months or more exclusion criteria: - more than 2 previous chemotherapies - previous treatment with epothilones - use of any investigational drug within 4 weeks of start of study treatment or inadequate recovery from any toxic effects of such therapy - previous radiation to the whole pelvis - symptomatic brain metastases requiring whole-brain irradiation - active infection - any other malignancy except: -- non-melanoma skin cancer -- carcinoma in situ of cervix -- malignancy with treatment 5 or more years ago without relapse - mixed mesodermal tumor - prior hormone therapy for any malignancy in the previous month - women of childbearing potential
resin infiltration and resin infiltration with bleaching in improving the esthetics for fluorosis stains

Conditions: Caries Infiltration; Fluorosis; Dental Care

Summary: dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development. the present study is planned to evaluate the efficacy of resin infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (wsls), particularly post orthodontics wsls, in in-situ and in-vivo studies. the resin infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions. therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and resin infiltration therapy in children with fluorosed teeth.


Eligibility criteria:
inclusion criteria: * only the non-pitted fluorosis opacities shall be included for this purpose; opacities in anterior teeth shall be classified according to russell's criteria for differentiating fluoride and non- fluoride opacities * subjects classified /teeth classified with dental fluorosis of 1-4 according to thylstrup, fejerskov classification of dental fluorosis 20 * patients who will be willing to participate in the study and who will be accepting for recall visit. exclusion criteria: * history of allergy towards any dental material. * teeth classified as non-fluoride opacities * subjects with any systemic and local conditions not permitting the treatment * subjects who had undergone any treatment for dental fluorosis earlier * subjects with direct or indirect restorations in maxillary central or lateral incisors. * subjects not willing to participate in the study * subjects with fractured teeth maxillary central or lateral incisors.

Keywords: caries caries infiltration fluorosis treatment
viral infections and airway microbiome in young children with cystic fibrosis

Conditions: Cystic Fibrosis in Children; Respiratory Bacterial Infection; Respiratory Viral Infection; Inflammation Lungs; Respiratory Morbidity

Summary: cystic fibrosis (cf) is the most common hereditary life-threatening condition in belgium. because of a dysfunctional cystic fibrosis transmembrane conductance regulator (cftr) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. consequently, cf patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure. cf lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without cf. additionally, young children with cf suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. moreover, frequent viral infections in children with cf contribute towards a more pathogenic airway microbiome at a young age. although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated. a pulmonary exacerbation in cf is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. most young children with cf suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. despite the current novel therapies in cf, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival. the key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with cf. about forty participants will be recruited at the paediatric cf clinic of the antwerp university hospital. inclusion criteria are an age of less than 5 years and a diagnosis of cf. there are no exclusion criteria. duration of the study is 1 year to cover for seasonality of clinical symptoms. study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. from all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. for the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of cf. next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis exclusion criteria: * none
brain emotion circuitry-targeted self-monitoring and regulation therapy (be-smart)

Conditions: Mood Disorders

Summary: new treatments to help to reduce the emotional dysregulation of mood disorders are critically needed. this is a study of an emotional dysregulation psychotherapy treatment in which participants will learn skills to help to down-regulate maladaptive emotional responses and learn beneficial, healthy habits. investigators will perform symptom and behavioral assessments and scanning prior to the treatment and will then repeat scanning, symptom and behavioral assessments at the midpoint, and after the psychotherapy is completed. this collected information will assess whether the treatment can improve functioning of emotion regulation brain circuitry.

aim: to use functional magnetic resonance imaging (fmri), before, at mid point, and after an emotional regulation intervention, to assess intervention-associated changes in brain circuitry responses to emotional stimuli. hypothesis : the emotional regulation psychotherapy treatment will be associated with changes in emotional regulation circuitry. at the time of registration, the primary outcome "changes in functioning of emotional brain circuitry" was the only outcome registered. this outcome is comprised of multiple measurements and was split up individually at the time of results entry and the original primary outcome measure was deleted.

Eligibility criteria:
inclusion criteria: * participants meeting diagnostic and statistical manual fifth edition (dsm-5) criteria for bdi, bdii or bd other specified bipolar (bd-os). * participants with mood symptoms, such as hamilton depression rating scale (ham-d) score ≥ 15 and/or for hypomania/mild mania such as young mania rating scale (ymrs) ≥ 12. exclusion criteria: * history of significant medical illness, particularly illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g. hypertension) * history of neurologic abnormality, including significant head trauma (defined by loss of consciousness of ≥5-minutes duration), seizure disorder, cerebrovascular or neoplastic lesion, or neurodegenerative disorder. * contraindication to mri scanning, e.g. presence of a ferromagnetic object, including orthodontic braces, or claustrophobia. * intelligence quotient (iq) lower than 70 * pregnancy * alcohol/substance use may be permitted if participant does not meet for dsm-5 current use disorder but will not be permitted for illicit substance use in the week prior to study.

Keywords: psychotherapy
a study to evaluate the safety and efficacy of ccx168 in subjects with anca-associated vasculitis

Conditions: Vasculitis

Summary: the aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (aav). the intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement c5a receptor plus cyclophosphamide or rituximab.

the primary safety objective of this study is to evaluate the safety and tolerability of ccx168 in subjects with aav on background cyclophosphamide or rituximab treatment. the primary efficacy objective is to evaluate the efficacy of ccx168 based on the birmingham vasculitis activity score (bvas) version 3. the secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with anca-associated vasculitis without the need for rescue corticosteroid measures and the effect of ccx168 on several disease parameters. study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
key inclusion criteria: * clinical diagnosis of granulomatosis with polyangiitis (wegener's), microscopic polyangiitis or renal limited vasculitis * male and postmenopausal or surgically sterile female subjects aged at least 18 years with new or relapsed aav where treatment with cyclophosphamide or rituximab would be required * positive indirect immunofluorescence (iif) test for p-anca or c-anca, or positive elisa test for anti-proteinase-3 (pr3) or anti-myeloperoxidase (mpo) at screening * estimated glomerular filtration rate (egfr) ≥ 20ml/min * have at least one "major" item, or at least 3 non-major items, or at least 2 renal items on the bvas version 3 key exclusion criteria: * severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement * any other multi-system autoimmune disease * medical history of coagulopathy or bleeding disorder * received cyclophosphamide within 12 weeks of screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on day 1 * received high-dose intravenous corticosteroids within 4 weeks of screening * on an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the time of screening * received rituximab or other b-cell antibody within 52 weeks of screening or 26 weeks provided b cell reconstitution has occurred; received anti-tnf treatment, abatacept, alemtuzumab, ivig or plasma exchange within 12 weeks of screening
identification of predictive factors of postoperative pain after oral surgery from phenotypic parameters easily accessible preoperatively (phedopo)

Conditions: Pain, Postoperative; Anxiety, Dental

Summary: this project aims to study various predictive factors of postoperative pain after oral surgery among different parameters accessible preoperatively, in order to build a predictive model. it also aims to validate the external consistency of the pain sensitivity questionnaire in an odontological context.

this project aims to study various predictive factors of postoperative pain after oral surgery among different phenotypic parameters accessible to preoperative interrogation (anxiety about dental care, personal perception of pain sensitivity, gender, eye color, hair color, blood group) in order to build a predictive model. it also aims to validate the external consistency of the pain sensitivity questionnaire (psq) in an odontological context, by studying the relationship between the personal perception of pain sensitivity (measured by the psq) and anxiety about dental care (measured by the corah dental anxiety scale), as well as dramatization in the face of pain (measured by the pain catastrophizing scale).

Eligibility criteria:
inclusion criteria: * adult patient, male or female, eligible for dental extraction under local anesthesia, * either a tooth on the arch, * either wisdom tooth(s) (2 homolateral wisdom teeth (maxilla + mandibular) or a mandibular wisdom tooth). * fluent in speaking and reading french. * able to give informed consent to research. * affiliation to a social security scheme. exclusion criteria: * pregnant or breastfeeding women. * contraindication to paracetamol, nsaids, tramadol, or anesthetic agents local. * patient uncooperative, unlikely or unable to comply with all procedures of the protocol. * chronic use of opiates, in a therapeutic or illicit context. * chronic depression on long-term antidepressants. * stomatological pathology that may interfere with the conduct of the intervention or modify the results: insufficient mouth opening, pathologies of the temporal mandibular joints ... * active medical pathology, or any medical condition judged by the investigator to be incompatible with the study. * patient under guardianship, curatorship or safeguard of justice. * refusal to participate.

Keywords: pain oral surgery postoperative gender eye color blood group hair color
opioid free anesthesia vs. opioid anesthesia techniques.

Conditions: Analgesic Drug Dependence; Colectomy

Summary: a comparison of post-operative opioid use in laparoscopic colectomy patients receiving opioid or opioid-free anesthesia.

the study population will be composed of 100 patients total, 50 opioid-free anesthesia laparoscopic colectomy patients and 50 opioid anesthesia laparoscopic colectomy patients at tampa general hospital. after consent is obtained patients will be electronically randomized using redcap in a 1:1 ratio and assigned to a opioid anesthesia or opioid free anesthesia group. patients will also consent to be asked survey questions preoperatively and be followed for 12 months postoperatively at specific intervals to evaluate pain, satisfaction, and opioid prescription use. this will be done through a data mining platform and service known as redcap. redcap is partnered with usf to allow for subject management, data collection and the distribution of surveys via mobile phone. all data collected by redcap is stored on a hippa compliant server. patients will receive automated push notifications to their mobile phones to fill out surveys regarding their pill usage, pain, and satisfaction for a year or until cessation of opioid use is confirmed. confirmation of opioid cessation will be performed on a case by case basis by the principal investigator, dr. camporesi. in addition to the surveys performed, nausea and pain scores will be collected prospectively from observation in the pacu

Eligibility criteria:
inclusion criteria: * patients admitted to tgh for laparoscopic colectomy under dr. sanchez's care * adults aged 18 and older exclusion criteria: * patients who are pregnant * patients that are not registered within tampa general hospital electronic medical records system * patients without smart phone capabilities * patients younger than 18 years * patients older than 80 years * patients who cannot speak or read english

Keywords: opioid dependence analagesia opioid-free anesthesia
poc study to evaluate the efficacy and safety of esk-001 in patients with active intermediate, posterior, or pan niu

Conditions: Uveitis Posterior Non-Infectious; Uveitis, Intermediate; Noninfectious Panuveitis

Summary: this is a multi-center, randomized, double-masked, proof-of-concept study in patients with active noninfectious intermediate, posterior, or panuveitis.

this study will consist of a 2-week screening period (+7 days), 24-week treatment period, followed by a 24-week extension period, and a 4-week follow up period for a total of up to 55 weeks. each participant will be randomized to receive one of two doses of esk-001 daily for 24 weeks. participants that do not meet the treatment failure criteria at week 24 will continue into the extension period.

Eligibility criteria:
key inclusion criteria: * able and willing to provide consent * male and females, age 18 to 70 years * diagnosis of active noninfectious intermediate, posterior or panuveitis * must have active uveitis at screening in at least one eye as defined by: 1. active inflammatory chorioretinal and/or inflammatory retinal vascular lesion or lesions, or 2. ≥ 2+ vh in accordance with the nei/sun criteria * males and females must use highly effective methods of contraception for the entirety of the study key exclusion criteria: * diagnosis of infectious uveitis * has elevated intraocular pressures or severe glaucoma * positive for hiv, hepatitis b or c or active or inadequately latent tuberculosis at screening * positive for syphilis at screening * patients with qtcf \>450 msec (both males and females) at screening * known active malignancy or history of malignancy within the past 5 years * history of chronic drug or alcohol abuse * live vaccines * no planned ocular or any other surgery during the course of the study other protocol-defined inclusion/exclusion criteria apply.
adjuvant concurrent chemoradiotherapy versus radiotherapy in early-stage cervical cancer patients

Conditions: Cervical Cancer

Summary: to evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after radical surgery.

adjuvant therapy for patients with cervical cancer (cc) with intermediate-risk factors remains controversial. according to result of gog 92 trail, adjuvant radiotherapy significantly improved recurrence-free survival in early stage cervical cancer with intermediate risks (sedlis criteria). however, significant heterogeneity exists in sedlis criteria, high risk of relapse and death occurred in patients with (1) lympho-vascular space invasion(lvsi+) and deep 1/3 stromal invasion;(2) lvsi(+) and middle 1/3 stromal invasion, and tumor size≥4cm when compared with other factors. in addition, multiple studies have confirmed that (3)non-squamous histology is an independent prognostic factor in early stage cervical cancer, who might be benefited from adjuvant concurrent chemoradiotherapy. as a result, the objective of the trial is to evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after radical surgery. the primary endpoint of the study is the recurrence-free survival from the day of randomization.

Eligibility criteria:
inclusion criteria: * • 18 years to 80 years * histologically proven cervical cancer, figo stage ia2-iib,and no previous chemotherapy and radiotherapy * accepted radical hysterectomy 3-4 weeks before * karnofsky score \>70 * postoperative pathology with one of the three risk factors criterials: (1) lympho-vascular space invasion(lvsi+) and deep 1/3 stromal invasion; (2 ) lvsi(+) and middle 1/3 stromal invasion, and tumor size≥4cm (3)non-squamous cell carcinoma; * examination results showed no radiation or chemotherapy contraindication * willing to accept treatment * ability to comply with trial requirements exclusion criteria: * • postoperative residual * postoperative recurrence or metastasis * pelvic lymph node metastasis * parametrial invasion * positive surgical margin * without lymph node dissection * postoperative pathology showed aortic lymph node metastasis * examination results showed radiotherapy contraindications * no indications for radiotherapy

Keywords: cervical cancer early stage chemoradiotherapy radiotherapy survival