Kornimate/medical-research-clean huggingface dataset:
the everyprem project: evaluating the inter-nda for standardized neurodevelopmental screening at 2 years of age for children born preterm.

Conditions: Prematurity

Summary: neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. valid tools should be available for screening infants with developmental problems even where resources are limited. such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. while in switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants. to fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the intergrowth-21st neurodevelopment assessment (inter-nda, www.inter-nda.com assessment) at age 2 years.

the pirmary objectives of the study are: 1. in very preterm born infants (born \< 32 weeks' gestation) - to assess the concurrent validity of the inter-nda with the bayley-iii\[13\] at 2 years of corrected age in vpt infants. 2. in moderate to late preterm infants (born between 32 and 36 weeks' gestation) - to screen neurodevelopment performances at corrected 2 years of corrected age in mlpt infants by means of the inter-nda and to compare values with international inter-nda standard values.

Eligibility criteria:
inclusion criteria: * former patient of the department of neonatology of the university hospital zurich * born between 01.01.2019 and 31.12.2021, i.e. aged 18 to 30 months at the time of the research visit * gestational age below 370/7 weeks * parent consent exclusion criteria: * genetically defined syndrome (including chromosomal aberration) or inborn error of metabolism adversely influencing life expectancy or neurodevelopment. * major congenital malformations requiring surgical correction or potentially affecting neurodevelopmental outcome. * hypoxic ischemic encephalopathy after perinatal asphyxia defined as grade 2 or 3 according to sarnat and sarnat\[19\]. * neonatal drug withdrawal syndrome or known maternal substance consumption of following illicit drugs during pregnancy: cocaine, heroin, lysergic acid diethylamide (lsd), 3,4-methylenedioxymethamphetamine (ecstasy), phencyclidine (pcp), and other amphetamine/methamphetamine. * children of parents who are not speaking german

Keywords: prematurity neurodevelopement follow-up screening inter-nda
evaluation of a multidisciplinary care pathway on the evolution of renal function in patients with advanced chronic kidney disease

Conditions: Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5

Summary: the number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in france and worldwide. a quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation before dialysis initiation is very low. this is also reflected in the very low number of pre-emptive renal transplantations. in order to reduce the number of dialysis patients, the french state has induced a national program proposing a multidisciplinary care pathway including the nephrology visits and at least one consultation with a dietitian and a specialist renal nurse in all patients with chronic kidney disease stage 4 and 5.

the aim of this single-center retrospective study is to evaluate the influence of the complete, partial or no participation in this program on the evolution of renal function and clinicobiological parameters in this group of patients.

Eligibility criteria:
inclusion criteria: * all stage 4 and 5 chronic kidney disease patients that were included in the program from 01/01/2021 to 31/12/2021 in the clinics of aura sante exclusion criteria: * patients without a medical follow up during this year (2021) * patients with insufficient or no data during the 24 month of follow up period * active treatment with corticosteroids, cytotoxic or immunosuppressive drugs, ongoing infection, autoimmune disease or active tumor process.

Keywords: multidisciplinary care pathway chronic kidney disease patients' education
a study of nivolumab, ipilimumab, and chemotherapy in participants with non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to describe the real-world patient and disease characteristics of metastatic non-small cell lung cancer (nsclc) participants initiated on first-line (1l) treatment with nivolumab, ipilimumab, and platinum-based chemotherapy (nivo/ipi/pbc), in the overall study population and the subpopulations per histological subtype of nsclc and pd-l1 expression level.


Eligibility criteria:
inclusion criteria: * participants with histologically- or cytologically-confirmed diagnosis of metastatic nsclc (of any histological subtype) whose tumors have no sensitizing egfr mutation or alk translocation. * participants who have been initiated on 1l treatment with nivo/ipi/pbc (nivolumab combined with ipilimumab and 2 cycles of pbc) as per the products' summary of product characteristics (smpc) prior to informed consent obtainment, and for whom the treatment regimen is ongoing and no more than one nivolumab infusion has been administered from treatment initiation to obtaining the signed informed consent. * participants for whom the decision to prescribe treatment with nivo/ipi/pbc has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the participant in the current study. exclusion criteria: * participants with a current primary diagnosis of a cancer other than nsclc that requires systemic or other treatment. * participants who have been treated with any prior systemic therapy in the metastatic setting of nsclc. * participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to nivo/ipi/pbc therapy initiation.

Keywords: non-small-cell lung cancer nsclc nivolumab ipilimumab platinum-based chemotherapy
venclose rf ablation system for the treatment of ipvs

Conditions: Chronic Venous Insufficiency

Summary: a feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the venclose rf ablation system.


Eligibility criteria:
inclusion criteria: * patient is \>= 18 years. * ipvs to be treated have an outward flow duration of \>= 0.5 seconds immediately after release of manual distal compression with patient standing or in reverse trendelenburg. * ipv(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle. * has been diagnosed with refractory symptomatic disease attributable to the ipv to be treated. * is able to ambulate. * is able to comprehend and has signed the informed consent form (icf) to participate in the study. * is willing and able to comply with the clinical investigation plan and follow-up schedule. exclusion criteria: * has venous insufficiency secondary to venous obstruction proximal to the intended treatment site. * has thrombus in the vein segment to be treated. * has untreated critical limb ischemia from peripheral arterial disease. * is undergoing active anticoagulant therapy for deep vein thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of deep vein thrombosis within the last 6 months or hypercoagulable state. * patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively. * has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy). * has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure. * has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study. * is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure. * is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
performance evaluation of four pharmacokinetic-pharmacodynamic(pkpd) models of propofol in elderly patients

Conditions: Propofol Overdose of Undetermined Intent

Summary: despite the wide use of propofol target-controlled infusion (tci) in elderly patients, pharmacokinetic (pk) and pharmacodynamic (pd) models performance has not been prospectively assessed in this population. the aims of this study are to derive four pkpd models using previously published pk parameters sets, and to prospectively assess their performance in elderly people. with the obtained data we propose to build a specific pkpd model for this population.

after bis® and routine monitors were placed, 14 asa i-ii elderly patients (\>65 yr) will be anesthetized with plasma tci of propofol based on schnider model. after partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. all bis and tci data will be continuously record. arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. a three compartment effect site model linked to a sigmoidal emax pd model, will be used to fit all the data simultaneously in nonmem. median performance errors(mdpe), and median absolute performance errors(mdape) were calculated to measure bias and accuracy of each model. comparisons between models will be performed.

Eligibility criteria:
inclusion criteria: * patients older than 65 years, asa 1,2 exclusion criteria: * included less than 70% or more than 130% of ideal body weight * neurologic disorder * use of psychoactive medication, including alcohol intake during the last 48 hours

Keywords: pkpd propofol tci elderly patients
positron emission tomography in patients with breast cancer

Conditions: Breast Neoplasms

Summary: this is a prospective study evaluating the role of positron emission tomography (pet scan) in breast cancer. the radiopharmaceutical \[18f\] 2-deoxyglucose will be used as both an imaging modality and to evaluate tumor metabolism in patients with breast cancer. patients with stage ii, stage iiia or iiib, or stage iv breast cancer and evaluable disease in the breast and/or at metastatic sites will be studied. patients will be injected intravenously with \[18f\]2-deoxyglucose and a pet scan conducted over 90 minutes. examination of the role of pet scan in assessing the response of breast cancer to chemotherapy, especially in stage ii and stage iii patients, will be done. up to three pet scans within one year may be performed. findings by pet scan will be correlated both with those of concurrent imaging techniques (x-ray, ct scan, mri, bone scan or mammogram), and with histologic, biochemical, and flow cytometric information on the tumor, and with findings in subsequent surgical specimens. changes in tumor glucose metabolism with treatment will be assessed by pet imaging studies and by biochemical methods when possible.

this is a prospective study evaluating the role of positron emission tomography (pet scan) in breast cancer. the radiopharmaceutical \[18f\] 2-deoxyglucose will be used as both an imaging modality and to evaluate tumor metabolism in patients with breast cancer. patients with stage ii, stage iiia or iiib, or stage iv breast cancer and evaluable disease in the breast and/or at metastatic sites will be studied. patients will be injected intravenously with \[18f\]2-deoxyglucose and a pet scan conducted over 90 minutes. examination of the role of pet scan in assessing the response of breast cancer to chemotherapy, especially in stage ii and stage iii patients, will be done. up to three pet scans within one year may be performed. findings by pet scan will be correlated both with those of concurrent imaging techniques (x-ray, ct scan, mri, bone scan or mammogram), and with histologic, biochemical, and flow cytometric information on the tumor, and with findings in subsequent surgical specimens. changes in tumor glucose metabolism with treatment will be assessed by pet imaging studies and by biochemical methods when possible.

Eligibility criteria:
histologically proven invasive carcinoma of the breast. patients with stage ii, stage iiia or iiib, or stage iv breast cancer who have not received local therapy to the breast or axillary lymph nodes. evaluable tumor, either gross or microscopic, at locoregional and/or distant sites. no current pregnancy. no second invasive malignancy in addition to breast cancer. no significant concurrent medical disorders (cardiac, renal, hepatic).

Keywords: cancer diagnosis cancer metabolism fdg fdg breast imaging pet positron emission mammography radiopharmaceutical scintimammography
peptide-based glioma vaccine ima950 in patients with glioblastoma

Conditions: Glioblastoma

Summary: background: active immunotherapy of cancer is based on the premise that the vaccine raises a cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells without harming normal cells. ima950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides (tumaps) found in a majority of glioblastomas, and is designed to activate tumap-specific t cells. the use of 11 tumaps increases the likelihood of a multi-clonal, highly specific t-cell response against tumor cells leading to decreased likelihood of immune evasion of the tumor by down-regulation of target antigens. purpose: the primary objective of this study is to determine the safety and tolerability of ima950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor (gm-csf) and imiquimod in patients with glioblastoma and to determine if ima950 shows sufficient immunogenicity in these patients. eligibility: patients with histologically proven gbms who have completed radiotherapy, and have stable disease following at least 4 cycles of adjuvant temozolomide.


Eligibility criteria:
disease characteristics: * histologically proven glioblastoma * stable disease following ≥ 4 cycles of adjuvant temozolomide * no progression or recurrence of disease patient characteristics: * hla-a\*02 positive * ≥ 18 years old * life expectancy \> 8 weeks * karnofsky performance status ≥ 60 * wbc \>3,500/µl * alc \>350/mm3 * anc \>1,500/mm3 * platelet count \>100,000/mm3 * hemoglobin \>10gm/dl * ast, alt and alkaline phosphatase \<2.5 times upper limit of normal (uln) * bilirubin \<1.5 times uln * creatinine \ 60cc/min * serum potassium, magnesium and calcium within normals levels (supplementation is allowed) * not pregnant or nursing * negative pregnancy test * practice birth control during and for 2 months after treatment with ima950 (both genders) * women of childbearing age must agree to use adequate contraceptive methods * no significant active hepatic, renal, infectious or psychiatric disease * no hiv, active hepatitis infection, or any other active severe infectious disease * no history of autoimmune disease or immunosuppression * no clinically significant cardiovascular event within 3 months before study entry or an increased risk for ventricular arrhythmia * no malignancy other than glioblastoma that required treatment during the last 12 months prior and/or concurrent therapy: * see disease characteristics * completed radiotherapy and at least 4 cycles of adjuvant temozolomide * not be receiving steroids or be on stable dose of steroids for ≥ 5 days prior to registration * no other prior immunotherapy for glioblastoma * no major surgery within 4 weeks prior to treatment start * at least 4 weeks from cytotoxic therapies (incl. temozolomide) * at least 2 weeks from non-cytotoxic therapies (e.g. interferon, tamoxifen) * at least 3 weeks from bevacizumab * no current treatment with imiquimod; prior use of imiquimod is allowed

Keywords: glioblastoma stable disease
probiotic vsl#3 for the treatment of gastrointestinal symptoms associated to fibromyalgia

Conditions: Fibromyalgia; Gastrointestinal Disease

Summary: the study evaluated the efficacy and tolerability of probiotic vsl#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.the treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.

many patients with fibromyalgia experience associated gastrointestinal symptomatology such as abdominal pain, abdominal bloating, meteorism, diarrhea and/or constipation. to date there is not any specific treatment for these symptoms that markedly impair the quality of life of these subjects. this trial intended to investigate if the addition of a polymicrobial probiotic product, which has shown efficacy in patients with irritable bowel syndrome, was also be useful to ameliorate the gastrointestinal symptomatology of patients with fibromyalgia.

Eligibility criteria:
inclusion criteria: * diagnosed of fibromyalagia * experiencing at least 3 chronic gastrointestinal symptoms * signed informed consent to participate * accept to not change previously prescribed treatment during study duration exclusion criteria: * mental illness excepting depression * severe organic disease * additional gastrointestinal disease excepting irritable bowel syndrome * pregnancy * breastfeeding

Keywords: probiotic efficacy tolerability
impact of new standards for tobacco products among dual e-cigarette/combusted cigarette users - project 2

Conditions: Smoking; Smoking, Cigarette; E-Cig Use; Nicotine Dependence

Summary: the purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.

participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. during the screening session, participants will also be asked to complete surveys. eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. during the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. they will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. the 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.

Eligibility criteria:
inclusion criteria: 1. legal age to purchase tobacco products; 2. regular user of ec and cc; 3. owns the e-cigarette device used most often; 4. agrees to abstain from using all tobacco products for 12 hours prior to each experimental session; 5. self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid exclusion criteria: 1. unstable medical conditions as determined by the licensed medical professional; 2. unstable psychiatric conditions as determined by the licensed medical professional or pi; 3. currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy; 4. serious quit attempt of either or both products in the past 3 months resulting in \>30 days of abstinence; 5. currently using nicotine replacement therapy or other pharmacotherapies as cessation aide; 6. plans to quit use of either ec or cc, or all tobacco products in the next 45 days; 7. self-reporting nicotine-free, cbd, or thc liquid is preferred or usual e-liquid; 8. vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): 1. systolic blood pressure (bp) greater than or equal to 160 mm/hg 2. diastolic bp greater than or equal to 100 mm/hg 3. heart rate greater than or equal to 115 bpm; 9. allergy to propylene glycol or vegetable glycerin; 10. previous adverse reaction when using vaping device or e-liquid; 11. current or recent alcohol or drug abuse problems; 12. previous use of spectrum or other reduced nicotine content cigarettes in past 3 months; 13. literate and able to independently complete and comprehend the consent form and other written study materials and measures.

Keywords: nicotine reduction dual users
previous abdominal surgery and obesity does not affect unfavorably the outcome of total laparoscopic hysterectomy

Conditions: Laparoscopic Surgical Procedure; Obesity; Surgery--Complications

Summary: previous surgery and obesity has disputed as an unfavorable factor during total laparoscopic hysterectomy. the aim of the investigator's study was to assess the effects of previous abdominal surgery and obesity on intra-operative and post-operative outcomes of tlh.

abstract: objective: to assess the effects of previous abdominal surgery and obesity on the intra-operative and post-operative outcomes of total laparoscopic hysterectomy (tlh). method: in this retrospective cohort study, women who underwent tlh for benign conditions between january 2011 and december 2016 in tertiary academic center were included. patients were grouped according to previous abdominal surgery. the study group consisted of patients who had at least one previous abdominal surgery and the control group consisted of patients with no previous abdominal surgery. in a further analysis, a subgroup of obese patients with bmi (body mass index) ≥30 kg/m2 was evaluated. for this analysis, the obese patients who underwent tlh were picked up and the results were compared to the results of obese patients who underwent total abdominal hysterectomy (tah) during the same time period. the main outcome parameters were duration of hospital stay and major complication rate.

Eligibility criteria:
inclusion criteria: * all women who underwent tlh for benign conditions during study period * all obese ≥30 kg/m2 women who underwent tah for benign conditions during study period exclusion criteria: * no

Keywords: complication previous surgery total laparoscopic hysterectomy obesity