Kornimate/medical-research-clean huggingface dataset:
ancillary t cell based studies in spiromics

Conditions: Smoke Induced Lung Disease

Summary: the long-term objectives of this ancillary application are to characterize a subpopulation of smokers with auto-reactive t cell response, to validate immunodiagnostic assays that could detect emphysema, and to find molecular signatures for pathogenic t cell development in a well-characterized cohort participating in spiromics (ucsf center).

one of the major medical challenges facing us is that susceptibility to smoking-induced lung diseases varies greatly and essentially precludes our ability to predict which smokers will develop emphysema. because the spiromics study is designed to phenotype a large and heterogeneous group of smokers, we have chosen this cohort to identify the subpopulation who have auto-reactive t cells, as this may represent a contributing mechanism in the development of emphysema, which may need alternative therapies, and may represent a group of patients who will have progressive disease despite smoking cessation. in aim 1, we will prospectively determine the presence of auto-reactive t cell responses as determined by increased cytokine release in 180 ever-smokers with and without emphysema; in aim 2 we will focus on the longitudinal aspect of the factors that could predispose development of auto-reactive t cells in the population at risk. these studies form the prerequisite basis for developing additional novel immune-based diagnostic and therapeutic strategies in human emphysema. the short-term objectives outlined here are based on our preliminary data, and provide the necessary platform that will be used to answer the following urgent questions: i) in a distinct prospective cohort of ever smokers, can auto-reactive t cells predict the presence of radiographic emphysema? ii) can we identify unique and persistent transcriptional signature(s) that are associated with autoimmune emphysema? the observational and longitudinal design of spiromics allows for detailed assessment of the association between emphysema as the primary clinical endpoints and could validate the novel t cell specific immunodiagnostic potential that has been developed in our laboratory. we propose to explore the role of autoimmunity as a contributing mechanism in the development of emphysema with the additional aim of bringing current technologies to bear on clinical and future diagnostic tests. public health relevance: we have discovered specific autoreactive t cells in ever-smokers with emphysema and there is growing evidence linking these particular effector cells with the pathophysiology of smoking related lung disease. our proposed studies are important because they will provide new diagnostic and prognostic assays (e.g. gamma-6-spot, based on th1 and th17 cytokines) in ever-smokers who have, or are at risk of developing emphysema.

Eligibility criteria:
inclusion criteria: * over 4o, former or active smokers exclusion criteria: * hiv infection, chronic hepatitis b and c, immune suppressive medications.

Keywords: copd, chronic obstructive pulmonary disease, emphysema
ikkb-matured, rna-loaded dendritic cells for metastasised uveal melanoma

Conditions: Melanoma, Uveal Metastatic

Summary: a phase i vaccination trial in patients suffering from recently diagnosed metastatic uveal melanoma not cureable with local therapy and needing systemic therapy. ikkb-matured dendritic cells loaded with autologous tumor-rna + rna coding for defined antigens and driver mutations will be added to a standard therapy chosen by the tumor board (either checkpoint blockade or chemotherapy).

intravenous infusion of 7.5 to 30 mio dcikkb at 9 vaccination time points (week 1, 3, 7, 13, 19, 25, 31, 37 and 42) and in intervals of 2, 4, and 6 intervals of 6 weeks) is scheduled; the first 4 patients will receive reduced doses for the first 4 vaccinations, namely 7.5 mio (1st and 2nd vaccination) and 15 mio (3rd and 4th vaccination) dc followed by the full dose of 30 mio for subsequent vaccinations. patients number 5 to 8 will receive initially reduced doses of 15 mio (1st and 2nd vaccination) dc for the first 2 vaccinations, and the full dose of 30 mio for subsequent vaccinations. patients number 8 to 12 will receive the full dose of 30 mio cells from vaccination 1 onwards provided that no major side effects occurred. patients will be vaccinated in a staggered approach by selectively decelerating release of the vaccine. dcikkb = autologous, monocyte-derived dc that are matured with the standard cocktail (tnf-alpha, il-1 beta, il-6 and pge2) and ikkb-rna loaded by electroporation with 1) autologous pcr-amplified total tumor mrna, 2) rna coding for defined tumor associated antigens (taa) namely gp100, tyrosinase, prame, mage-a3, ido) and 3) rna coding for driver mutations (gnaq/gna11q209 or r183, or the less frequently occurring sf3b1r625, cysltr2l129q or plcb4d630) by electroporation; rnas for selected taas are in stock and will be transfected into the dcs only if expressed in the individual tumor of a patient (shown by rna sequencing of the tumor); rnas for selected driver mutations are in stock and will be loaded into the dcs only if the respective mutation is found (proven by exome and rna sequencing) in the individual tumor.

Eligibility criteria:
inclusion criteria: * histologically confirmed unresectable stage iv metastatic uveal melanoma as per ajcc staging system 2014, 7th edition (updated 2018) not curable with local therapy modalities * who performance status of 0, 1 or 2 * age from 18 and ≤ 75 years * negative pregnancy test * signed informed consent exclusion criteria: * major serious illness * evidence for hiv-1, hiv-2, htlv-1, hbv or hcv infection * active autoimmune disease requiring immunosuppressive therapy * splenectomy or radiation therapy of the spleen * organ allografts * pregnancy * lactation * psychiatric disorders * severe organic brain syndrome

Keywords: local treatment not sufficient systemic treatment indicated
study of the intra-patient variability of the quantitative parameters of tumor perfusion evaluated with ultrasound contrast

Conditions: GIST Metastatic Cancer; Breast Metastatic Cancer; Kidney Metastatic Cancer; Colon Metastatic Cancer; Rectal Metastatic Cancer

Summary: recist criteria for evaluating tumor response are often inadequate for the evaluation of anti-angiogenic drugs. an evaluation model of tumor perfusion with contrast-enhanced ultrasonography was developed at gustave roussy. it assesses the tumor vascular response through the analysis of 7 different parameters. several studies (four at igr, involving 117 patients, and a multicenter study involving 400 patients) showed that ceus allows early evaluation of the effect of anti-angiogenic drugs. two of these parameters are particularly interesting for the early identification of patients responding (or not) to treatment. those are area under curve , and area under the wash-out. to further validate the use of these parameters, it is essential to measure and describe the level of their intra-patient variability.


Eligibility criteria:
inclusion criteria: 1. patient being treated at igr for metastatic cancer by anti-angiogenic (s) drug (s) in the following indications: * gastrointestinal sarcoma (gist) * breast cancers * kidney cancers * colorectal cancers * melanoma these anti-angiogenic drugs are used alone or in combination: bevacizumab (avastin), imatinib (gleevec), sorafenib (nexavar), sunitinib (sutent), everolimus (afinitor) temsirolimus (torisel), ... (non exhaustive list). 2. with at least one clearly identified metastatic tumor lesion (and accessible to ultrasound for acquisition 3 minutes without losing the target), measuring more than 2 cm, less than 50% of the volume is necrotic. metastatic lesions are: * liver (30 patients) * or outside the liver (30 patients) 3. physiological age: 18-80 years 4. performance status \<2 5. patient information and signature of informed consent exclusion criteria: 1. background known hypersensitivity to sulfur hexafluoride or one of the components, 2. recent history of acute coronary syndrome or unstable ischemic heart disease, 3. acute heart failure, heart failure stage iii or iv, or severe rhythm disorders, 4. uncontrolled hypertension or severe pulmonary hypertension, 5. right-left shunt, 6. respiratory distress syndrome, 7. patient without vascularized tumor (without contrast enhancement) 8. patient whose antiangiogenic has already started, 9. pregnant woman likely to be or breastfeeding, 10. persons deprived of liberty or under guardianship, 11. unable to submit to medical monitoring of the trial for geographical, social or psychological reasons
a study of the use of factor xiii concentrate in patients with inherited fxiii deficiency

Conditions: Factor XIII Deficiency

Summary: congenital deficiency of factor xiii is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. this study will evaluate the safety and recommended (best) amount or level of factor xiii in a patient's blood. factor xiii concentrate (human) is given to people whose blood is lacking factor xiii. factor xiii concentrate (human) works by assisting your blood in the usual clotting process, thereby preventing bleeding.


Eligibility criteria:
inclusion criteria: * written informed consent/assent for study participation obtained before undergoing any study-specific procedures * documented congenital fxiii deficiency that requires prophylactic treatment with a fxiii containing product. * males and females of any age with congenital fxiii deficiency. * received full hepatitis b vaccination and/or is hepatitis b surface antibody positive exclusion criteria: * diagnosis of acquired fxiii deficiency * administration of a fxiii-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned day 0 * any known congenital or acquired coagulation disorder other than congenital fxiii deficiency * known or suspected to have antibodies towards fxiii * use of any other investigational medicinal product within 4 weeks prior to the baseline visit (day 0) * positive result at screening for human immunodeficiency virus (hiv) * serum aspartate transaminase (ast) or serum alanine transaminase (alt) concentration \>2.5 times the upper limit of normal * fibrinogen \< lower limit of normal * active bleeding * pregnant or breast-feeding * intention to become pregnant during the course of the study * female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study * surgical procedure anticipated during the study period * suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance

Keywords: factor xiii
impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks: (r-impac)

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks

to date, the assessment of ciliary beat is only possible ex vivo on epithelial cells obtained from upper airway brushing. a previous prospective study (i-isbac) showed a change in ciliary beat (in terms of coordination and frequency) in bacterial rhinosinusitis. the study of ex-vivo ciliary movement appears to be an interesting tool to understand the pathophysiology of csrs and to guide and evaluate treatment. a new tool to evaluate the effectiveness of the ex-vivo lash beat has been developed. this tool measures shear stress by tracking balls along the ciliary margin. this measurement of ex-vivo shear stress by bead tracking is a validated technique. however, microbead tracking is limited by its low spatial and temporal resolution, long measurement time and heavy post-processing of acquisition data, making this method difficult to use in clinical routine. monitoring ex-vivo fluorescent nano-batons could represent a simpler alternative for the clinician. this measurement is now made possible by phosphate lanthanum lanthanum nano-batons (lapo4) whose luminescence is directly proportional to the shear. the objective of this research project is to validate this new tool in patients with csr by comparing it to a group of control subjects free of nasal inflammation.

Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years old * having chronic rhinosinusitis (rcs) requiring surgical treatment. or * with an indication for endonasal surgery for nasal obstruction (turbinoplasty and septoplasty) or for an endonasal surgical approach 2. acceptance to participate in the protocol with signed informed consent 3. affiliated or beneficiary of a social security scheme exclusion criteria: 1. refusal to participate in the study 2. no one who does not speak or understand french 3. pregnant or breastfeeding woman 4. persons who are incapable of reaching the age of majority, under guardianship, guardianship or protection of justice. 5. simulated participation in another intervention research
adding sitagliptin or pioglitazone to type 2 diabetes mellitus insufficiently controlled with metformin and sulfonylurea

Conditions: Type 2 Diabetes

Summary: this 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.

this is a prospective, open-label, randomized, parallel, 24-week study. inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas \> half maximal dose, and metformin \> 1500 mg/d) for \> 10 weeks. \> 20 years old; a1c:\> 7.0 % and \ 1.4 mg/dl), alanine aminotransferase (alt) or aspartate aminotransferase levels (ast) \> 2.5 times the upper limit of normal (uln), current or prepare to pregnancy and lactation. primary purpose: compare the change in hemoglobin a1c and the proportion of patients achieving a1c \< 7% between the 2 groups secondary purposes: 1. changes in fasting plasma glucose, high sensitive c-reactive protein (hscrp) 2. homeostasis model assessment-β cell function(homa-β) will be calculated to assess changes in β-cell function and homa-insulin resistance(homa-ir)to assess changes in insulin resistance 3. body weight change, proportion of side effects

Eligibility criteria:
inclusion criteria: * type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas \> half maximal dose, and metformin \> 1500 mg/d) for \> 10 weeks * \> 20 years old * a1c: \> 7.0 % and \< 11% exclusion criteria: * insulin use within 12 weeks of the screening visit * any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine \> 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels \> 2.5 times the upper limit of normal * current or prepare to pregnancy and lactation

Keywords: sitagliptin pioglitazone type 2 diabetes
light therapy for obsessive-compulsive disorder (ocd)

Conditions: OCD

Summary: the goal of this clinical trial is to test whether light therapy is effective for reducing symptoms in young adults with ocd and late bedtimes (1am or later). the main question\[s\] it aims to answer are: does light therapy reduce ocd symptoms? does light therapy advance the circadian clock? if there is a comparison group: researchers will compare a higher dose of light therapy to a lower dose to see if dose amount affects symptom reduction. participants will asked to: 1. wear light therapy glasses for 1 hour each morning and complete a daily light therapy log for 5 weeks 2. track their sleep every day with a wearable monitor and an electronic sleep diary for 5 weeks 3. complete a 1-time assessment of sensitivity to light exposure 4. complete self-report measures of ocd 4 times/day at baseline (2 weeks), mid-treatment (1 week), and end of treatment (1 week)


Eligibility criteria:
inclusion criteria: 1. primary dsm-5 ocd diagnosis 2. bedtime 0100 or later 3. age 18-35 4. english speaking exclusion criteria: 1. subjects must not be currently participating in another research study that would influence their participation in our study. 2. diagnostic status 3. treatment status 4. night shift work or travel more than 1 time zone outside of central standard time (cst) in the past month 5. pregnancy status 6. medication status 7. regular nicotine or marijuana use

Keywords: ocd sleep light therapy circadian behavioral treatment
18f-fmau pet/ct in diagnosing and characterizing prostate cancer

Conditions: Prostate Neoplasm

Summary: this pilot clinical trial studies how well fluorine f 18 d-fmau (18f-fmau) positron emission tomography (pet)/computed tomography (ct) works in diagnosing and characterizing prostate cancer. a pet/ct scan is an imaging test that uses a small amount of radioactive tracer that is given through the vein to take detailed pictures of areas inside the body where the tracer is taken up. radiotracers such as 18f-fmau may help to find the cancer and see how far the disease has spread.

primary objectives: i. to perform a prospective clinical imaging evaluation of 18f-fmau pet/ct in addition to multiparametric magnetic resonance imaging (mpmri) and standard transrectal ultrasound (trus)-guided 12-core biopsy for detection and localization of primary tumor in 40 men with suspected prostate cancer based on elevated/rising prostate specific antigen level, abnormal digital rectal exam, or those with prior negative standard biopsy who are now returning for a standard of care follow-up. ii. to examine the associations between the pet derived imaging parameters, serum psa, mpmri parameters (apparent diffusion coefficient \[adc\], ktrans) and the biopsy histopathology parameters. outline: patients receive radiotracer f 18 d-fmau intravenously (iv) over 1 minute and then undergo 18f-fmau pet/ct on day 1. patients then undergo standard of care multiparametic mri and standard of care transrectal ultrasound-guided biopsy. after completion of study treatment, patients are followed up at 24-96 hours.

Eligibility criteria:
inclusion criteria: * scheduled to undergo standard of care biopsy for suspected prostate cancer, or re-biopsy with prior negative systemic biopsy or restaging biopsy in patients with known prostate cancer on active surveillance exclusion criteria: * history of myocardial infarction within 6 months of the enrollment * active infection (except mild upper respiratory infections) * active prostatitis * non-prostate cancers currently on treatment
panobinostat/bortezomib/dexamethasone in relapsed or relapsed-and-refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: note: the study data was transferred to zr pharma\& following the divestment of panobinostat to pharma\&. prior to study completion under the sponsorship of secura bio, the study was initiated and conducted in part under the sponsorship of novartis. the purpose of this study is to investigate the safety and efficacy of 3 different regimens of panobinostat (20 milligrams \[mg\] thrice a week \[tiw\], 20 mg twice a week \[biw\], and 10 mg tiw) in combination with subcutaneous bortezomib and dexamethasone and to provide exposure, safety and efficacy data to identify the optimal regimen of panobinostat in a randomized, 3-arm parallel design. this study will also assess the impact of administering subcutaneous bortezomib (in combination with panobinostat and dexamethasone) twice weekly for 4 cycles, and then weekly starting from cycle 5 until disease progression in participants ≤ 75 years of age. participants \> 75 years of age will receive subcutaneous bortezomib weekly for the entire treatment period (in combination with panobinostat and dexamethasone) until disease progression. participants will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. participants who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. all participants will be followed for survival until the last participant entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.


Eligibility criteria:
inclusion criteria: * multiple myeloma per international myeloma working group 2014 definition * requiring treatment for relapsed or relapsed/refractory disease * measurable disease based on central protein assessment * received 1 to 4 prior lines of therapy * prior immunomodulatory agent(s) exposure * acceptable lab values prior to randomization exclusion criteria: * primary refractory myeloma * refractory to bortezomib * concomitant anti-cancer therapy (other than bortezomib/dexamethasone and bisphosphonates) * prior treatment with pan-deacetylase inhibitors * clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization) * unresolved diarrhea ≥ common terminology criteria for adverse events grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome and inflammatory bowel disease) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple myeloma relapsed or relapsed/refractory lbh589 panobinostat bortezomib dexamethasone
endosonography for right side acute intestinal mal-symptoms (efraim- study)

Conditions: Abdominal Pain

Summary: hypothesis: endosonography (eus) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain. patients with acute right side abdominal pain will be randomized in one of two groups. in each group all examinations (sonography, gastroscopy, endosonography) will be performed. the study group only defines the order of the examinations. abdominal sonography will always be performed before endoscopic procedures. in group 1, gastroscopy is first followed by endosonography. in group 2 endosonography is first followed by gastroscopy. two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis. yield of the clinical diagnosis by eus results alone will be compared to the yield by combined results of sonography, egd and eus.


Eligibility criteria:
inclusion criteria: * acute right side abdominal pain * willing participate study exclusion criteria: * acute disease * malignancy * other disease which might cause discomfort

Keywords: endosonography, right side abdominal pain endosonography (diagnostic value in right side abdominal pain)