Kornimate/medical-research-clean huggingface dataset:
electrocardiographic mapping and imaging

Conditions: Cardiac Arrhythmia

Summary: the purpose of this study is to evaluate a novel non-invasive cardiac electric imaging methodology for localizing and imaging cardiac electrical activity from body surface electrocardiographic recordings in patients with ventricular tachycardia (vt). using non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.

specific aims 1. use non-invasive cardiac electric imaging to provide information as to the sites of origin of arrhythmias and sequence of cardiac activation and repolarization. methods and procedures approximately 8 patients with recorded premature ventricular contractions (pvc), wolff-parkinson-white (wpw) or other ventricular tachycardia cases which need ensite/carto endocardial mapping and radiofrequency ablation treatment will be enrolled. one day before catheterization and ablation, patients will undergo approximately 30 minutes of body surface potential mapping (bspm) recordings with about 200 surface electrodes arranged in 20 strips, attached on his/her front and back. bspms will be recorded in the baseline resting rhythm. on the day of ablation, before catheterization in the surgical room, the bspm recording procedure will be carried out with the patient using the same technique used during the first bspm study. clinical endocardial mapping data may also be obtained concurrently with bspm recordings before the ablation procedure. another bspm recording will be made 30-60 minutes after successful ablation with the patient still in normal sinus rhythm if possible. patients will be followed up 1 month after ablation with the same method of bspm recorded at the baseline resting rhythm.

Eligibility criteria:
any patient undergoing ablation.

Keywords: ecg mapping ecg mapping arrythmias
use of multiple brain imaging modalities (pet and mrs) to identify metabolic abnormalities in major depression

Conditions: Major Depressive Disorder

Summary: several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. the current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (fdg) positron emission tomography (pet) and multinuclear magnetic resonance spectroscopy (mrs), to better understand the nature of these metabolic abnormalities in major depressive disorder (mdd). the investigators hypothesize that individuals with depression will have increased metabolic activity as measured by pet in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on mrs findings. for this study, the investigators will study 10 medication-free, currently depressed participants with recurrent mdd, 10 depressed participants with recurrent mdd currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. depressed and healthy participants will each undergo one pet scan and one mrs scanning session.


Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for major depressive disorder (mdd), recurrent * montgomery-asberg depression rating scale (madrs) score \> 18 exclusion criteria: * any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias * any history of substance dependence * substance abuse within the past 6 months * significant risk of suicide, as defined by score \>4 on item 10 of the madrs or in the clinical judgment of the study physician * any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of mrs or pet imaging * for the subset of unmedicated mdd patients, any psychotropic medications within 4 weeks prior to scanning. for the subgroup of medicated patients, they may be taking a stable dose (i.e., same dose for at least 4 weeks at the time of scanning) of standard antidepressant medications, but may not be taking any other psychotropic medication. * inability to give informed consent * contraindication to mri (e.g., pacemaker, ferromagnetic implants in the body)

Keywords: depression positron emission tomography magnetic resonance spectroscopy glucose metabolism atp phosphocreatine
a clinico-biological database of lung cancers

Conditions: Lung Cancer

Summary: this prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. the subjects are treated according to standard of care. clinical data are collected at each sampling time. the primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according soc treatment.


Eligibility criteria:
inclusion criteria: * documented new diagnosis of lung cancer by histology or cytology, or lung tumor leading to lung cancer suspicion without diagnosis for which an antineoplastic treatment is indicated * indication of a treatment by surgery, chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy as first line of lung cancer treatment * ability of the subject to follow study procedures * age \> 18 years * subject must have at least one measurable and/or assessable lesion in regard with recist 1.1 criteria * subject is registered with a social security scheme * subject is taken in charge at pneumology department of lille uh * subject has signed an informed consent form exclusion criteria: * patient with a history of treatment by antineoplastic chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy, or presenting a contra indication to antineoplastic treatment administration * subject is not willing to sign the informed consent form * subject is not registered with a social security scheme * subject is not francophone * subject is deprived of his/her liberty or under trusteeship

Keywords: banking, biological sampling, tumor tissue, tumor response
mri in cystic fibrosis and primary ciliary dyskinesia

Conditions: Cystic Fibrosis; Primary Ciliary Dyskinesia

Summary: this is a small pilot / feasibility study (approximately 50 patients) to assess the possibility of clinical implementation of mri assessment of patients with cystic fibrosis and primary ciliary dyskinesia. patients will undergo their standard ct imaging and lung function investigations and additionally will undergo mri examination. reports from ct (the current gold standard) and mri will be assessed for concordance and patient acceptability and examination implementation costs will also be assessed. novel mri-based potential markers of cf and pcd disease state will also be assessed.

in this small single site pilot / feasibility study we aim to recruit approximately 50 patients over the age of 6 years with known cystic fibrosis (cf) or primary ciliary dyskinesia (pcd). patients will be recruited from routine clinic appointments or at admission for inpatient investigation and/or treatment at the point of referral for computed tomography (ct) examination. if they consent to participation they will undergo mri examination in addition to their standard clinical ct (within 7 days of the ct scan - on the same day if practicable). the magnetic resonance imaging (mri) scans will be anonymised and reported by radiologists, blinded to the ct findings. the reports and scores (eichinger and brody2) will then be compared those of the standard ct to assess concordance between the modalities and inter and intra observer variability. potential novel biomarkers (pulmonary ventilation and perfusion (non-contrast) and sinus mucus and liver tissue characteristics) will be compared with established markers (including lung clearance index) and known cf mutation / pcd type. patients or their carers will also be asked to fill in a short questionnaire comparing the differential patient acceptability of ct and mri examinations. the cost (time, resources etc) of each examination will be calculated and compared.

Eligibility criteria:
inclusion criteria: * known cf or pcd referred for ct chest exclusion criteria: * contraindication to mri (pacemaker etc) unable to stay still for mri

Keywords: lung mri cystic fibrosis primary ciliary dyskinesia
safety and efficacy of sa4ag vaccine in adults having elective open posterior spinal fusion procedures with multilevel instrumentation

Conditions: Staphylococcal Vaccine

Summary: the purposes of the clinical trial are to determine whether the sa4ag vaccine can prevent postoperative staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of sa4ag in patients who are undergoing elective spinal surgery.


Eligibility criteria:
inclusion criteria: * subject must be scheduled to undergo an elective open posterior spinal fusion procedures with multilevel instrumentation, 10 to 60 days after study vaccination. * subject must be available for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary for 10 days after study vaccination. * aged 18 to \<86 years old exclusion criteria: * planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure). * surgical indication of malignancy, infection or acute or emergency trauma. * history of major surgery within 3 months prior to enrollment, or anticipated major surgery other than the index surgical procedure between study enrollment and completion of study participation. * history of any spinal surgery performed within 6 months prior to study enrollment. * history of any previous spinal surgery resulting in postoperative bsi or ssi. * congenital or acquired immunodeficiency disorder, rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies within a year of enrollment or the use of systemic corticosteroids for \> 14 days within 30 days prior to enrollment. * history of leukemia, lymphoma, underlying bone marrow disorder or history of bone marrow transplant.

Keywords: staphylococcal vaccine post-operative surgical site infection spinal surgery mrsa staphylococcus aureus
safety and efficacy of hoodia gordonii for treatment of non alcoholic fatty liver disease (nafld)

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this clinical study is designed to evaluate the safety of oral administration of the medical food hoodia to patients with non alcoholic fatty liver disease. oral administration of hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes. nonalcoholic steatohepatitis or nash is a common, often "silent" liver disease which affects about 2%-5% of americans. nash is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, hcc, liver transplantation or death.this clinical trial has been designed to assess the safety of short term oral administration of hoodia to patients with nash.


Eligibility criteria:
inclusion criteria: * subjects who have completed the informed consent process culminating with written informed consent by the subject * men and women age 18 to 65 years inclusive. * patients with biopsy proven nash with a score of 4 or above. * altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance. * hba1c between 5.5 and 14%. exclusion criteria: -

Keywords: hoodia gordoni nash nafld
hexadecasaccharide (sr123781a) in patients with unstable angina or non-st-segment elevation myocardial infarction

Conditions: Coronary Atherosclerosis

Summary: the purpose of this study is to test whether sr123781a is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (pci) within 48 hours after inclusion in the study. two doses of sr123781a are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein iibiiia (gpiibiiia) antagonist.


Eligibility criteria:
inclusion criteria: * a person with a diagnosis of acute coronary syndrome who is scheduled to undergo a pci within 48 hours. * a person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent exclusion criteria: * a person with known allergy or any contra-indication to active control. * a person who has received heparin during more than 48 hours before inclusion in the study. * a person treated with warfarin (oral anticoagulant). * a person with current bleeding or recognized increased risk of bleeding or history of intracranial hemorrhage. * a person who has had a stroke within the last 6 months. * a person with uncontrolled hypertension despite antihypertensive therapy. * a person with history of clinically significant reduction in blood platelets or neutrophils (white blood cells). * a person who has laboratory evidence of significantly reduced renal function or who is dependent on renal dialysis. * a person who has a coronary bypass performed during the previous month. * a pregnant or nursing woman or a woman of childbearing potential (before menopause) who does not have a negative pregnancy test and does not use a reliable method of birth control. * a person who has received any investigational treatment in the preceding month.

Keywords: coronary disease
everolimus in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer

Conditions: Head and Neck Cancer

Summary: rationale: everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.

objectives: primary * to determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma. secondary * to determine maximum percentage of tumor reduction in these patients. * to describe activity time to event endpoints. * to assess toxicity. * to determine evolution of serum thyroglobulin. * to perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory) * to investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer. outline: patients receive oral everolimus once daily on days 1-28. treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * diagnosis of thyroid cancer meeting ≥ 1 of the following criteria: * progressive or recurrent disease * metastatic disease * unresectable disease * meeting any of the following thyroid cancer subtypes: * differentiated thyroid cancer (i.e., papillary, follicular, or hurthle cell disease) that is radio-iodine refractory * undifferentiated thyroid cancer (i.e., anaplastic disease) * medullary thyroid cancer * must have received prior everolimus or other mtor inhibitor therapy * patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed patient characteristics: * karnofsky performance score 70-100% * anc ≥ 1,500/mm\^³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 5.6 mmol/l * serum bilirubin ≤ 1.5 times upper limit of normal (uln) * alt and ast ≤ 2.5 times uln (≤ 5 times uln for known liver metastases) * serum creatinine ≤ 2 times uln * negative pregnancy test * no other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years prior concurrent therapy: * see disease characteristics

Keywords: anaplastic thyroid cancer recurrent thyroid cancer stage iii follicular thyroid cancer stage iii papillary thyroid cancer stage iv follicular thyroid cancer stage iv papillary thyroid cancer thyroid gland medullary carcinoma
japanese phase ib/ii copanlisib in relapsed, indolent b-cell nhl

Conditions: Lymphoma Non-Hodgkin

Summary: the primary objective of this study is to assess the safety profile of copanlisib at the recommended dose (primary endpoint). the recommended dose of copanlisib for japanese patients will be determined in the dose escalation/safety evaluation part.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of indolent b-cell nhl, with histological subtype limited to the following: follicular lymphoma (fl) grade 1-2-3a small lymphocytic lymphoma (sll) with absolute lymphocyte count \< 5 x 109/l at the time of diagnosis and at study entry lymphoplasmacytoid lymphoma/waldenström macroglobulinemia (lpl/wm) marginal zone lymphoma (mzl) (splenic, nodal, or extra-nodal) * relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). patients must have previously received rituximab and alkylating agent(s). * japanese patients ≥ 20 years of age * ecog performance status ≤ 2 (eastern cooperative oncology group:ecog) * life expectancy of at least 3 months * adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment * left ventricular ejection fraction (lvef) ≥ lower limit of normal (lln) for the institution * availability of fresh or archival tumor tissue exclusion criteria: * uncontrolled hypertension (blood pressure ≥ 150/90 mmhg, defined as systolic blood pressure \> 150 mmhg and/or diastolic blood pressure \> 90 mmhg, despite optimal medical management) * patients with evidence or history of bleeding diathesis. any hemorrhage or bleeding event ≥ ctcae grade 3 (nci-ctc version 4.0) within 4 weeks of start of study medication (ctcae: common terminology criteria for adverse events, nci: national cancer institute). * history or concurrent condition of interstitial lung disease or severely impaired pulmonary function * unresolved toxicity higher than ctcae grade 1 attributed to any prior therapy/procedure excluding alopecia. * prior treatment with pi3k inhibitors * systemic corticosteroid therapy (ongoing) * type i or ii diabetes mellitus with hba1c \> 8.5% or fasting plasma glucose \> 160 mg/dl at screening * known history of human immunodeficiency virus (hiv) infection. * hepatitis b or c requiring treatment * cytomegalovirus (cmv) pcr positive at baseline * known lymphomatous involvement of the central nervous system

Keywords: non hodgkin's lymphomas
efficacy and safety of a citrate-based anticoagulation with calcium-free phosphate-containing fluid in renal replacement therapy

Conditions: Critical Care

Summary: in the present prospective multicenter rct we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new rca protocol for continuous venovenous hemodiafiltration (cvvhdf) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. the new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted rca protocol for continuous venovenous hemofiltration (cvvh), based on a 18 mmol/l citrate solution (regiocit) combined with calcium and phosphate-free dialysate fluid (prismocal b22) and a conventional phosphate-containing replacement fluid (phoxilium) to prevent crrt-related phosphate depletion


Eligibility criteria:
inclusion criteria: 1. acute renal failure requiring crrt 2. suitability for regional anticoagulation of the crrt circuit 3. clinical equipoise regarding the method of circuit anticoagulation 4. subject is affiliated with a social security system (if required by individual country regulations). 5. subject meets national regulatory criteria for clinical trial participation. 6. subject or subject's legally authorized representative (lar) has signed the study informed consent form exclusion criteria: 1. age less than 18 years 2. expected stay in icu less than 24 hours 3. pregnant or breastfeeding 4. suspected ischemic hepatitis or liver failure 5. chronic kidney disease requiring dialysis prior to icu admission 6. as applicable by french law, subject who is a protected individual such as an incompetent adult or incarcerated person 7. metformin and acethaminophen intoxication

Keywords: crrt renal failure citrate phosphore
rad001 combined with chop in newly diagnosed peripheral t-cell lymphomas

Conditions: Peripheral T Cell Lymphoma Unspecified; Anaplastic Large Cell Lymphoma, ALK-negative; Angioimmunoblastic T Cell Lymphoma; Cutaneous T Cell Lymphoma

Summary: the urgent need for new effective therapy for t-cell lymphoma patients and promising results observed so far in trials with rad001(everolimus, mtor inhibitor) strongly warrants the investigation of rad001 combined with chop as a first-line treatment in peripheral t-cell lymphoma patients. thus, we designed a phase i/ii study with the combination of rad001 with chop chemotherapy for newly diagnosed peripheral t-cell lymphoma patients. phase i 1. primary objective : to define the maximum tolerable dose 2. secondary objective * to evaluate the dose-limiting toxicity * to evaluate the pharmacokinetics of rad001 * pharmacogenomic profiling phase ii 1. primary objective : to evaluate the overall response rate 2. secondary objective * to estimate the time to progression * to estimate overall survival * pharmacogenomic profiling

phase i level 1: rad001 2.5 mg po daily d1-14 + chop level 2: rad001 5 mg po daily d1-14 + chop level 3: rad001 7.5 mg po daily d1-14 + chop level 4: rad001 10 mg po daily d1-14 + chop chop every 3 weeks d1 cytoxan 750mg/m2 + d5w 100ml miv over 1hr d1 doxorubicin 50mg/m2 + d5w 100ml miv over 30mins d1 vincristine 1.4mg/m2 (max.2mg) iv push d1-d5 prednisolone 100mg/d po (40-30-30) phase ii determined dosage of rad001 + chop every 3 weeks treatment will be continued until planned 6 cycles or disease progression

Eligibility criteria:
inclusion criteria: 1. histologically proven peripheral t-cell lymphoma, unspecified, (ptcl), alk-negative anaplastic large cell t-cell lymphoma (alcl), angioimmunoblastic t cell lymphoma (aitl), cutaneous t-cell lymphoma 2. adequate organ function as defined by the following criteria: a.serum aspartate transaminase (ast; serum glutamic oxaloacetic transaminase (sgot)) and serum alanine transaminase (alt; serum glutamic pyruvic transaminase (sgpt)) ≤2.5 x local laboratory upper limit of normal (uln), or ast and alt less than or equal to 5 x uln if liver function abnormalities are due to underlying malignancy b.total serum bilirubin ≤1.5 x uln c.absolute neutrophil count (anc) ≥1500/µl d.platelets ≥100,000/µl e.hemoglobin ≥9.0 g/dl (may be transfused or erythropoietin treated) f.serum calcium ≤12.0 mg/dl g.serum creatinine ≤1.5 x uln 3. at least one measurable lesion 4. ecog ps 0-2 5. informed consent 6. age 20 to 70 years old exclusion criteria: 1. prior radiation therapy or surgery within 4 weeks prior to study entry 2. history of central nervous system (cns) metastases 3. ongoing cardiac dysrhythmias of nci ctcae grade ≥2. 4. pregnancy or breastfeeding. 5. hepatitis b virus surface antigen positive 6. extranodal nk/t cell lymphoma 7. mycosis fungoides 8. alk-positive anaplastic large cell lymphoma

Keywords: rad001 chemotherpy t cell lymphoma