Kornimate/medical-research-clean huggingface dataset:
surveillance with pet/ct and liquid biopsies of stage i-iii lung cancer patients after completion of definitive therapy

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. the investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body positron emission tomography combined with computer tomography (pet/ct) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.


Eligibility criteria:
inclusion criteria: * patient with non-small cell lung cancer (nsclc), proven by cytology or histology * patient in clinical stages i-iii * age≥ 18 years * performance status ≤ 2 at the time of referral to therapy * patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation). * patient has given his/her written informed consent before any specific procedure from protocol exclusion criteria: * patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on ct. * persons deprived of liberty or under guardianship or curators * dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial * pregnant or breastfeeding women * patient participating in another interventional study during the surveillance period. this is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in supe-r. participation in protocols related only to initial treatment will not preclude participation in supe-r. cases of doubt will be settled by the steering committee.

Keywords: positron emission tomography computed tomography x-ray computed tomography liquid biopsy quality of life medical oncology radiation oncology follow-up
computer-based self-help program for people with gambling problems

Conditions: Gambling, Pathologic

Summary: the study examines the effectiveness of a computer-based self-help-program for individuals with problematic or pathological gambling behavior.the main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling (primary outcome), depression and gambling-specific dysfunctional thoughts. the program is expected to lead to a significant reduction regarding all measures when compared to a control group. the study is conducted as a randomized-controlled trial with one intervention group and one wait-list control group.

the study examines the effectiveness of a computer-based self-help-program for individuals with problematic and pathological gambling behavior. the main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling. the primary outcome is the pg-y-bocs as a measure of the severity of pathological gambling symptoms. secondary outcomes are rates of depression, measured with the phq-9 as well as gambling-specific cognitive biases, measured with the gabs. the program is expected to lead to a significant reduction in problematic/pathological gambling behavior (pg-y-bocs) and also to declines in both depressive symptoms (phq-9) and gambling-specific cognitive biases (gabs). the study is conducted as a randomized-controlled trial with one intervention group and one wait-list control group. the intervention group receives the login data directly following the baseline survey and can use the program over a period of 8 weeks, whereas the wait-list control group receives access to the program after completion of the post-survey.

Eligibility criteria:
inclusion criteria: * informed consent * access to internet * adequate usage of german language * willingness to participate in two short (25-30 minutes) online surveys * willingness to use the online program over a period of 8 weeks (participants that do not use the program are also included in the analysis) * willingness to leave an (anonymous) email-address * existence of the wish to receive treatment exclusion criteria: * existence of a lifetime diagnosis of schizophrenia or bipolar disorder * existence of an acute suicidal tendency (assessed with item 9 of the phq-9, ≥3)

Keywords: gambling problematic gambling pathological gambling
comparison of low-dose epidural with intravenous narcotic versus intravenous narcotic alone

Conditions: Pain

Summary: the purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

post-operative pain in patients undergoing osteotomy can be severe. current methods of treatment involve parenteral narcotics and regional anesthesia. several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations. however, to our knowledge there have been none that directly compare bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). parenteral narcotic alone is associated with the possibility of significant side effects, overdose, and inadequate analgesia. epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics (4). we believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed, and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain. further, the prolongation of pain control shown with epidural clonidine may be beneficial during the transition (5,6).

Eligibility criteria:
inclusion criteria: * age 4-16 * english speaking * elective lower extremity osteotomy * expected length of stay greater than 24 hours exclusion criteria: * history of previous spine surgery * current infection overlying catheter insertion site * coagulopathy

Keywords: epidural bupivacaine clonidine
treatment of stress urinary incontinence by injection of autologous muscle fibers into the urethral sphincter.

Conditions: Urinary Incontinence, Stress

Summary: this pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. a muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.


Eligibility criteria:
inclusion criteria: * stress urinary incontinence refractory to conservative treatment. exclusion criteria: * urge urinary incontinence * pregnancy * pelvic organ prolapse \> grade 1

Keywords: urinary incontinence, stress autologous
effect of mother dha supplementation on term newborn.

Conditions: Oxidative Stress; Inflammation; Infant Development

Summary: in the present study, we evaluate the effect of the mother suplementación with dha during the gestation and lactation on diverse aspects of the development of newborn. the effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. in addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (dha) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.

the sample will be 120 volunteers that will be enrolled in the services of gynaecology of the infantile hospital of granada. the pregnant women will be assigned from random form to one of 2 groups that are described later: group a: balanced diet mediterranean, intake of 2 glasses / day of the dairy drink control. group b: balanced mediterranean diet together with the consumption of 400mg/day of dha in the dairy product (2 glasses / day). the dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). every volunteer will be assigned a key that guarantees the confidentiality of their analytical values. the dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). there will be obtained samples of blood (5 ml) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. there will take a sample of blood of umbilical cord (5ml) in the moment of the childbirth (vein and artery). in addition there will take a sample of blood of the child (5ml) to 2.5 months. there will take also samples of mother milk (10ml), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. the samples will be preserved in freezer of-80ºc and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). in the first year of life of the child there will be practised tests of motive and cognitive development (bayley's test and fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.

Eligibility criteria:
inclusion criteria: 1. consent 2. mother with normal gestation. exclusion criteria: 1. risk factors during gestation. 2. lactose intolerance 3. systemic illness. 4. kwashiorkor. 5. metabolic illness. 6. foetal pathologies

Keywords: dha, term neonates, mother milk
investigation of the gut microbiota in patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Cachexia

Summary: this cohort study aims to investigate the composition and activity of the gut microbiota of patients newly diagnosed for acute myeloid leukemia (aml), in relationship with their food habits and cachectic hallmarks. the recruitment for this study is currently ongoing with the help of clinicians, nurses and data managers at the saint-luc clinics, university hospital leuven (campus gasthuisberg) and university hospital gent. primary objective •to assess the composition and activity of the gut microbiota in patients with acute myeloid leukemia (aml) compared to matched control subjects. secondary objectives * to investigate correlations between the gut microbiota, cachectic hallmarks and gut microbiota-related markers in the blood (gut permeability markers, microbial compounds, microbial metabolites). * to characterize the changes in the gut microbial ecosystem that are induced by chemotherapy and associated with colitis. * to assess whether the composition of the gut microbiota can predict the severity of chemotherapy-related colitis. study design this is an academic multi-centric prospective study. the study is composed of two cohorts (fig. 1). in cohort a, patients are included before any chemotherapy. biological samples (urine, feces, blood) are collected, alongside information on nutritional habits, appetite and medical records. muscle strength and body composition are also measured. only patients receiving a standard chemotherapy are included in cohort b. in cohort b, biological samples are collected and body composition, muscle strength and appetite are evaluated at 2 different time points, at the end of the chemotherapy (t1) and at discharge (t4).


Eligibility criteria:
inclusion criteria: * patients with * a diagnosis of aml and related precursor neoplasms according to who 2008 classification (excluding acute promyelocytic leukemia) including secondary aml (after an antecedent hematological disease (e.g. mds) and therapy-related aml) * acute leukemia's of ambiguous lineage according to who 2008 * a diagnosis of refractory anemia with excess of blasts (mds reab) 2 and ipss (international prognostic scoring system)-r score \> 2. * world health organization performance status 0, 1 or 2 * sampled bone marrow and/ blood cells at diagnosis with molecular analysis. * written informed consent * good command of the french or dutch language exclusion criteria: * age \< 18 years * age \> 75 years * pregnancy * antibiotics consumption during the last 30 days before inclusion * recent chemotherapy (\< 3 months), with exclusion of hydroxyurea * bmi \>30 * any history of chronic intestinal affections (crohn disease, inflammatory bowel disease, gluten intolerance) * gastric bypass * current treatment with antidiabetic or hypoglycemic drugs
risk prediction of carotid endarterectomy by vascular ultrasound evaluation

Conditions: Stroke

Summary: carotid endarterectomy (cea) is one of the surgical treatment methods for the reconstruction of arterial stenosis or occlusion. perioperative stroke, cerebral hemorrhage,hyperperfusion syndrome and death are main complications of cea. investigator have established a risk prediction model of the procedure based on vascular characteristics and hemodynamic parameters retrospectively. this prospective study was aimed to verify the predictive ability of cea comprehensive prediction model through the analysis of patients receiving cea procedure in the investigator's center in the next two years.

subjects: in this study, a total of 600-800 patients with severe carotid artery stenosis or occlusion who scheduled for cea are recruited. data collection: 1. the plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by ultrasound prior to the procedure. 2. ct, mri and digital subtraction angiography (dsa) were applied pre- and post-procedure to identify the clinical events. endpoint: the combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome within 30-day after the procedure. statistical analysis plans: the statistical package of social sciences (spss version 22.0) software are used for statistical analysis. the area under the receiver operating characteristic (roc) curve and hosmer-lemeshow test were used to evaluate the discrimination and calibration of the risk prediction model.

Eligibility criteria:
inclusion criteria: 1. patients with carotid artery severe (70-99%) stenosis or occlusion diagnosed by color duplex flow imaging (cdfi) and confirmed by ct angiography (cta) or digital subtraction angiography (dsa). 2. patient has the indications for carotid artery stenting or cea according to the guidelines published by the stroke prevention engineering committee, the national health commission of china. 3. mri and ct were applicated pre- and postoperation. exclusion criteria: 1. patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism, et al. 2. lack of any imaging evaluation results, such as ultrasound, mri or ct.

Keywords: ultrasound carotid endarterectomy risk prediction model
effect of neprilysin on glucagon-like peptide-1 in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: glucagon-like peptide-1(glp-1) is secreted during a meal and increases glucose induced insulin secretion. the enzyme dipeptidyl peptidase 4(dpp-4) cleaves intact glp-1 within minutes and dpp-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. a few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of glp-1 but if this is the case in humans with type 2 diabetes is unknown. we therefore administered a nep inhibitor, 194mg sacubitril, a dpp-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or placebo, to patients with type 2 diabetes during a standardized meal and measured plasma concentrations of glp-1


Eligibility criteria:
inclusion criteria: * type 2 diabetes * oral antidiabetics medicine only * body mass index of 25-35 * type 2 diabetes exclusion criteria: * acute diseases within the two weeks * chronic diseases * smoker * alcoholism, drug addiction or recent weight loss * blood donation within the last 3 months

Keywords: glp-1 neprilysin diabetes
levetiracetam versus valproate in idiopathic generalized tonic-clonic seizures

Conditions: Epilepsy, Idiopathic Generalized

Summary: this study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.


Eligibility criteria:
inclusion criteria: * age≥16 * at least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months * normal brain mri or mri without epileptogenic lesion * normal electroencephalography(eeg) or existence of generalized epileptiform discharges without any focal epileptiform discharges. * signing consent form exclusion criteria: * history of treatment by sodium valproate or levetiracetam * history of treatment by any anti-epileptic drug in last 6 months * plan for pregnancy * using no certain contraceptive method * history of past or current hepatic disease * history of past or current renal disease * history of past or current hematologic disease * history of known psychiatric disease * history of status epilepticus
study to evaluate an 8 mg aflibercept (eylea®) prefilled syringe (pfs)

Conditions: Diabetic Macular Edema (DME); Neovascular Age-Related Macular Degeneration (nAMD)

Summary: regeneron pharmaceuticals developed a single-dose pre-filled syringe (pfs) to deliver 8 mg aflibercept. the pfs is a convenient device that contains the study medication that will be injected in your study eye. a pfs offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial. this phase iiib study is focused on patients with diabetic macular edema (dme) and neovascular (wet) age-related macular degeneration (namd). the main aim of the study is to evaluate if the 8 mg aflibercept pfs allows for successful preparation and administration of 8 mg aflibercept by retina specialists. the study will also assess the safety of 8 mg aflibercept pfs use. regeneron will use the information from the study to better understand if the pfs can be used safely and effectively by retina specialists to administer 8 mg aflibercept.


Eligibility criteria:
key inclusion criteria: 1. patient must have diabetic macular edema (dme) or neovascular "wet" age-related macular degeneration (namd) in the study eye 2. study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept key exclusion criteria: 1. any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past ivt injections with any agent in either eye 2. treatment with any ivt injection in the study eye within the 25 days prior to day 1 3. intraocular pressure (iop) \>25 mm hg in the study eye at screening 4. any intraocular surgery in the study eye at any time during the past 3 months 5. any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye note: other protocol defined inclusion/exclusion criteria apply

Keywords: neovascular "wet" age-related macular degeneration
renal function during pediatric anesthesia

Conditions: Renal Failure; Anesthesia

Summary: it is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. however, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. in this study the investigators want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a pediatric setting and also investigate humoral changes induced by these anesthetics.

prior studies by the investigators research group have shown water and sodium retention in experimental animals undergoing sevoflurane anesthesia. preliminary data suggest that this is not as obvious with propofol anesthesia. the investigators aim to study if this difference is present in children. subjects are collected from ordinary routine operations of hypospadia. by routine, all boys undergoing this surgery get a sacral blockade and a urine catheter. the children are randomized to either sevoflurane or propofol anesthesia. before or immediately after induction of anesthesia baseline blood samples are collected for analysis of sodium, potassium, creatinine, osmolality, angiotensin ii, arginine-vasopressin and aldosterone. perioperative fluids are started, a balanced glucose infusion with 132mmol sodium content, covering basal fluid need + 20%. this infusion is continued until the end of the protocol at the ward. at the induction of anesthesia the investigators start measuring urine output every 20th minute. the same blood samples as above are collected again during mid-operation. at the end of anesthesia the investigators collect all the urine and send a sample for urine analysis of sodium, potassium, osmolality and creatinine. in the postoperative ward the investigators again start collecting urine every 20 minutes for 120 minutes. all urine after 120 minutes are collected, and a sample sent for analysis. after 60 minutes at the postoperative ward, blood samples are again collected for analysis. in the childrens ward the protocol for the postoperative ward is repeated, with urine collection and sample, as well as blood samples. after 120 minutes the protocol ends.

Eligibility criteria:
inclusion criteria: * eligible for hypospadia surgery. exclusion criteria: * american association of anesthesiology class above 2 * weight above 50 kg or below 10 kg * hypersensitivity towards the anesthetic agents (difficult peanut or soy allergy) * inability for parent to understand study information
89zr-atezolizumab pet scan and lobular breast cancer

Conditions: Lobular Metastatic Breast Cancer

Summary: the exploratory single center feasibility imagelato study is conducted as an imaging side study to the dutch gelato trial (assessing efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer). ten patients with lobular metastatic breast cancer, who are included in the gelato trial at the umcg, are eligible for the imagelato study. all patients will undergo two zirconium-89 (89zr)-atezolizumab positron emission tomography (pet) scans, one at baseline and one after two doses carboplatin induction treatment. the 89zr-atezolizumab pet scan will be performed 4 days after tracer injection. procedures within the imagelato study will be completed after the two 89zr-atezolizumab pet scans, but patients will continue treatment with carboplatin combined with atezolizumab in the gelato trial.


Eligibility criteria:
inclusion criteria: 1. a patient must meet the inclusion criteria of the gelato trial 2. able to give written informed consent and to comply with the imagelato protocol exclusion criteria: 1. contra-indication for 89zr-atezolizumab pet scan 2. any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89zr-atezolizumab injection. treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89zr-atezolizumab injection.