Kornimate/medical-research-clean huggingface dataset:
a study evaluating bsi-201 in combination with chemotherapeutic regimens in subjects with advanced solid tumors

Conditions: Tumors

Summary: the purpose of the study is to assess the safety and establish the maximum tolerated dose (mtd) of the combination of bsi-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors. based on data generated by bipar/sanofi, it is concluded that iniparib does not possess characteristics typical of the parp inhibitor class. the exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-h2ax (a marker of dna damage) in tumor cell lines, induces cell cycle arrest in the g2/m phase in tumor cell lines, and potentiates the cell cycle effects of dna damaging modalities in tumor cell lines. investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor * eastern cooperative oncology group (ecog) performance status of ≤ 1 * absolute neutrophil count (anc) ≥ 1.5 x 10\^9/l (without granulocyte colony-stimulating factor \[g-csf\] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10\^9/l (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dl (erythropoietic agents allowed) * at least a 14-day period from end of last dose of chemotherapy received * any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1 exclusion criteria: * subject enrolled in another investigational device or drug trial, or is receiving other investigational agents * hematological malignancies * symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids. * history of seizure disorder * myocardial infarction (mi) within 6 months of study day 1, unstable angina, congestive heart failure (chf) with new york heart association (nyha) \> class ii, or uncontrolled hypertension * concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed) * specified concomitant medications * serum creatinine \> 1.5 x upper limit of normal (uln) * elevated liver enzymes (ast/alt) \> 2.5 x uln, or \> 5.0 x uln if secondary to liver metastases; alkaline phosphatase \> 2.5 x uln or \> 5.0 x uln if secondary to liver or bone metastases; total bilirubin \> 1.5 x uln * radiation therapy within 14 days of study day 1 * antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1 * concurrent radiation therapy is not permitted throughout the course of the study

Keywords: solid tumors
upstroke time measured by photoplethysmography

Conditions: Diabetes

Summary: peripherial arterial disease (pad) and diabetes are major public health issues. in 2020, according to the latest epidemiological data, it is estimated that there will be more than one million patients with pad and more than 3.5 million diabetic patients in france. in the diabetic patient, screening for pad is carried out by calculating the toe-brachial pressure index (tbi), a technique that remains time-consuming and technically demanding, which limits its use for clinical routine screening. a new photoplethysmographic method (ppg) makes possible to determine the quality of peripheral perfusion thanks to the automatic computation of the upstroke time (tms in ms). this method appears to be a promising, inexpensive, faster and easier technical alternative to improve the dissemination of the vascular screening in diabetics. to date, no prospective study has established a relationship between the measurement of upstroke time using the ppg method and tbi in a specific diabetic population.we will perform a two-centre prospective study (nice university hospital and antibes hospital) comparing the two techniques. the main objective of our study will compare the values of the upstroke time obtained by a ppg method and the tbi in a population of diabetic patients. the secondary objectives will be to compare the tbi values to the ratio of the tms measurements at the toe to the reference tms measured at the hand and to determine the sensitivity-specificity of the tms measured by ppg compared to the tbi in the detection of a significant pad in diabetics.


Eligibility criteria:
inclusion criteria: * patient \> 18 years, with no upper age limit * vascular assessment for pad (screening or follow-up). * patient diagnosed with type 2 diabetes according to who diagnostic criteria (blood glucose \> 1.26 g/l (7.0 mmol/l) after an 8-hour fast and checked twice ; or the presence of symptoms of diabetes (polyuria, polydipsia, weight loss) associated with a blood glucose level (on venous plasma) \> 2 g/l (11.1 mmol/l); or a blood glucose level (on venous plasma) \> 2 g/l (11.1 mmol/l) 2 hours after an oral glucose load of 75 g), under medical treatment or under dietary treatment alone. * patient having signed the informed consent form for the study. * patient with social security coverage. exclusion criteria: * patient under 18 years of age * major amputations including transfemoral and transtibial amputations * ankle or toe lesions * any clinical condition of the patient not allowing measurements (acute ischaemia, pain, tremors...). * pregnant women, pregnant and breast feeding women, persons deprived of their freedom by a judicial or administrative decision, persons hospitalised without consent who are not covered by the provisions of article l. 1121-8, and persons admitted to a health or social establishment for purposes other than research.
dyspnea in patients with pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: this study has two aims: 1. to determine the relationship of shortness of breath (dyspnea) to other conditions present in patients with pulmonary fibrosis. 2. to define the relationship between shortness of breath and rate of functional decline in patients with pulmonary fibrosis.

idiopathic pulmonary fibrosis is the most common form of chronic fibrosing lung disease seen by pulmonologists, with an estimated 128,000 cases in the united states alone. it is almost surely a disorder related to aging, with a median age at the time of diagnosis of approximately 65 years; ipf is almost unheard of under the age of 50. dyspnea is common in patients with ipf, and is often the primary symptom of the disease. it is tightly linked to quality of life in ipf, suggesting that the experience of dyspnea has wide-ranging and clinically-significant consequences. despite its importance, surprisingly little is known about the etiology or functional impact of dyspnea in this disease. this research proposal focuses on defining the relationship of dyspnea to comorbidity and the rate of functional decline in patients with ipf aim 1: to determine the relationship of dyspnea to other conditions present in patients with ipf. dyspnea is a complex symptom, related to both mechanical and cognitive factors. the mechanisms of dyspnea in ipf remain unknown, but there are several likely contributors that are both ipf and non-ipf related. although ipf is a chronic disease of the elderly, no one has investigated the relationship between common geriatric conditions and dyspnea. it is well established that the perception of dyspnea depends equally on factors that influence the intensity of the experience of breathlessness (such as thoracic restriction and weakness) and the distress which that intensity produces. gender, ethnicity, anxiety, pain, and depression all may contribute to the distress caused by dyspnea (and therefore its intensity) in ipf. aim 2: to define the relationship between dyspnea and rate of functional decline in ipf. numerous studies have looked at predictors of survival in patients with ipf, and both baseline and change in dyspnea over time have been shown to be significantly associated. the prediction of future morbidity, however, is largely unstudied. established markers of functional decline in geriatric patients include weight loss, decline in walking speed over 4 meters, and the onset of disability as defined by the ability to perform activities of daily living (adls) and instrumental activities of daily living (iadls). dyspnea likely impacts patients' activity levels and/or motivation to stay active, and may contribute to worsening functional decline.

Eligibility criteria:
inclusion criteria: * 18 years of age and older with pulmonary fibrosis, and able to travel to university of california san francisco for study visits exclusion criteria: * none

Keywords: dyspnea pulmonary fibrosis interstitial lung disease shortness of breath
prognostic role of primary non small cell lung carcinoma standardized f18-fdg uptake values (suv and tlg) measured with f18-fluorodeoxyglucose positron emission tomography (f18-fdg-pet): a non interventional study.

Conditions: Non Small Cell Lung Carcinoma

Summary: the primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18f-fdg uptake value (suvmax) measured on 18fluorodeoxyglucose positron emission tomography (18f-fdg-pet) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).


Eligibility criteria:
inclusion criteria: * pathologically demonstrated nsclc * stage i-iii treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy * inoperable patients treated by exclusive radiotherapy * a whole-body (skull base to mid thighs) fdg-pet or a combined fdg-pet/ct on a dedicated machine, performed before any anticancer treatment * fdg-pet or combined fdg-pet/ct has to be previously standardised according to the procedure described in appendix iv * written informed consent * accessibility to follow-up * age \> 18 years exclusion criteria: * prior anticancer treatment (surgery, radiotherapy or chemotherapy) * stage iv nsclc * a history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) * uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl) * pregnancy and lactating woman * unavailability to send a copy of the pet or pet-ct (dicom format) to the data centre

Keywords: non small cell lung carcinoma pet scan observational study non metastatic treated curative intent
feasibility study evaluating the silva module during the anaesthesiology consultation before an elective surgery

Conditions: Preoperative Anxiety

Summary: in this feasibility study, feasibility, acceptability and an initial clinical efficacy of the new module of hypnosis and virtual reality (or digital sedation), silva, will be evaluated. this feasibility study meets objectives of oncomfort's design validation and design verification steps. silva will be tested on a sample of 10 patients in the environment where the product is intended to be used, a hospital environment. if results do not fit with user needs, design will be adapted according to results and a new phase of design validation will be implemented. the silva module is a digital sedation module designed for management of pain and anxiety in perioperative patients.

subjects will be recruited during the anaesthesiology consultation preparing to an elective surgery. first, subject will be asked to self-assess anxiety and comfort. in order to evaluate anxiety, subject will use a 0-10 rating visual analogue scale (vas) where 0 = no anxiety at all, and 10= the worst imaginable anxiety. the same scale will be used to measure the level of comfort where 0 means no comfort at all and 10 very comfortable. subject should be positioned laying on a reclining chair during the session. this session will last for 30 minutes. after the experiment, participants will be asked to rate anxiety, level of comfort, level of immersion and dissociation. several questions will be asked to the patient to evaluate his/ her experience, the silva module, and the sensations experienced. the study will be ended by an evaluation of adverse event (ae) and the evaluation of the caregivers.

Eligibility criteria:
inclusion criteria: • subject more than 18 years old exclusion criteria: * deaf subject * blind * non-proficiency in french (module language) * psychiatric disorder * head or face wounds * neurological disease * chronic pain and/or chronic analgesics consumption * medication affecting the autonomic nervous system * dizziness
french national observatory of the patients with non-small cell lung (nsclc) and molecular testings

Conditions: Carcinoma, Non-Small-Cell Lung; ALK Gene Mutation; KRAS Gene Mutation; BRAF Gene Mutation

Summary: the french national cancer institute (inca) support a 28 hospital platforms network for molecular testing of cancer patients. these platforms routinely assess a panel of biomarkers in order to speed up access of french cancer patients to targeted therapies (commercially available or through clinical trials). the objective of the biomarkers-france study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival).

the french national cancer institute (inca) support a 28 hospital platforms network for molecular testing of cancer patients. these platforms routinely assess a panel of biomarkers in order to speed up access of french cancer patients to targeted therapies (commercially available or through clinical trials). regarding stage iv non-squamous nsclc patients, 7 biomarkers are assessed including activating egfr mutations, eml4-alk translocation and egfr t790m, kras, braf, her2 and pi3kca mutations. in 2012, up to 17 to 20,000 patients will be tested on this platform network. the objective of the biomarkers-france study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival). this study will collect, in a prospective way, data from a unique national cohort in order to guide future decisions regarding biomarker assessments (type? number? methods? etc) in connexion with all the other research works currently ongoing in france.

Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer (nslc) * biomarkers analysis on hospital platforms exclusion criteria: - histology other than nslc

Keywords: lung cancer biomarkers egfr kras alk her2 pi3k braf ifct
pain and microbial reduction of antimicrobial corticosteroid mixture versus cryotherapy in necrotic teeth

Conditions: Dental Pulp Necrosis

Summary: the aim of this study is to compare the effect of antimicrobial-corticosteroid mixture and cryotherapy as final root canal irrigating solutions on post-instrumentation pain in single-canal teeth with necrotic pulps.

the trial participants are patients with single-canal teeth with necrotic pulps undergoing root canal treatment on two visits. during the 1st visit, access cavity, root canal cleaning and shaping using rotary files and 2.5% naocl irrigation. after apical preparation, a final flush with either a levofloxacin-fluconazole-dexamethasone mixture or cold saline will be used then the tooth access cavity will be sealed with a temporary filling. after the first visit, the participants will be given a pain chart with a numerical rating scale to rate their pain levels from zero to 10 at 6, 12, 24, and 48 hours. three microbial swabs will be collected for each participant: before instrumentation (s1), after instrumentation before final irrigation (s2), and after final irrigation (s3). after collecting data from all participants, statistical analysis will be conducted to compare the pain intensity and microbial load reduction percentages between the two groups.

Eligibility criteria:
inclusion criteria: 1. patients in good physical health; american society of anesthesiologists class i or ii. 2. patients whose age ranges between 18 and 50 years. 3. male and female patients. 4. patients having a single canal-tooth with necrotic pulp. 5. patients who can understand the number rating scale (figure). 6. patients who accept to participate in the trial and can sign the informed consent (figure). exclusion criteria: 1. pregnant females. 2. patients with swelling. 3. patients whose tooth is non-restorable. 4. teeth with open apices. 5. teeth with radiographic evidence of root resorption.

Keywords: antibiotic antifungal corticosteroid cryotherapy
systemic therapy with or without upfront transarterial embolization for inoperable liver metastasis of neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: the purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-tae) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (net) with inoperable liver metastases


Eligibility criteria:
inclusion criteria: * diagnosis of net of gastroenteropancreatic (gep), pulmonary or unknown primary site origin * unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit) * hepatic involvement ≤50% volume of the organ * radiological evidence of hepatic lesions (contemporaneous progression or appearance of extrahepatic lesions are allowed if not critical sites) that require change or initiation of systemic pharmacotherapy * patients undergoing , previously treated , or never treated with systemic medical therapy are eligible * patients with or without carcinoid syndrome are eligible * well (g1) or medium (g2) differentiated histology (according to who 2010 classification) * ki67 ≤ 20% (g1-g2) * life expectancy \> 6 months * age ≥ 18 and \< 80 years exclusion criteria: * previous loco-regional post-surgical treatment * poorly differentiated histology * severe concomitant morbidities such as: severe coagulopathy, severe liver failure (to be detailed), renal failure (creatinine \> 2.0 mg/dl) and heart failure (nyha 3-4 or unstable ischemic heart disease), contraindicating the interventional procedure or influencing the general prognosis (investigator to provide details of exclusion) * extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions * patients with only extra-hepatic lesions

Keywords: locoregional treatment liver metastases transarterial embolization upfront treatment inoperable octreotide gastroenteropancreatic (gep)primary pulmonary primary primary unknown origin systemic therapy
eortc-endorsed, prospective european multicenter imaging survey and protocol

Conditions: Metastatic Colorectal Cancer

Summary: a prospective, multicenter imaging delphi survey among european radiological societies for mcrc imaging standardization.

background: computed tomography (ct) is the imaging reference standard for initial staging and response assessment in randomized, controlled clinical trials (rct) dealing with metastatic colorectal cancer (mcrc). however, comparability of imaging data among recruiting centers in rcts is highly hampered by diverging imaging protocols and different technical specifications. over the last years, analysis of radiomic features in mcrc patients has gained increasing interest for image evaluation beyond the mere assessment of extent. also, these radiomic features are highly susceptible to technical parameters such as slice thickness. hence, comparability of radiomic features among recruiting centers are also highly limited due to diverging imaging protocols. aims: this prospective, multicenter imaging survey aims at assessing current differences regarding mcrc ct imaging protocols and technical specifications among large academic sites in europe and at drafting a consensus imaging protocol endorsed by the european organisation for research and treatment of cancer (eortc). methods: this survey will be in close cooperation of the eortc imaging group, eortc gastro-intestinal tract group, european society of oncologic imaging (esoi) and european society of gastrointestinal and abdominal radiology (esgar). among the eortc imaging group, eortc gastro-intestinal tract group, esoi and esgar, imaging experts will be prospectively recruited and will serve as expert panelists in this prospective survey. following the delphi approach for survey conduction, several survey rounds will be performed. the answers of each survey round will be analyzed by the survey facilitators, blinded results will then be forwarded to the expert panelists prior to every following survey round. statements / answers can then be modified by the expert panelists in the following survey round.

Eligibility criteria:
inclusion criteria: * researchers / academics with expertise in gastro-intestinal / oncologic imaging * association with eortc imaging group, eortc gi group, esgar or esoi. exclusion criteria: * participants not meeting the inclusion criteria

Keywords: computed tomography (ct) radiomics delphi survey pet/ct expert panelists standardization imaging protocol