Kornimate/medical-research-clean huggingface dataset:
saline-enhanced radiofrequency (serf) catheter ablation for the treatment of ventricular tachycardia

Conditions: Tachycardia, Ventricular

Summary: the purpose of this study is to demonstrate the technical feasibility of the serf catheter and serf cardiac ablation system to eliminate or control ventricular tachycardia (vt)


Eligibility criteria:
inclusion criteria 1. patient has recurrent, symptomatic, monomorphic vt 2. patient has drug refractory or drug intolerant vt following use of at least one class iii antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy 3. a prior failed ablation as evidenced by icd device therapy within the prior 6 months. 4. patient has minimum 3 month icd interrogation history available for evaluation 5. patient has lvef \> 20%, confirmed by echo or comparable technique during baseline evaluation 6. patient is at least 18 years old 7. patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements exclusion criteria 1. patients with idiopathic vt 2. patients with vt with ecg or mri/ct findings suggestive of right ventricular free wall origin findings. 3. patients with vts of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the av node/proximal conduction system. patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk. 4. patient with myocardial infarction (mi) or unstable angina within previous 60 days 5. patient with cardiac surgery or percutaneous coronary intervention (pci) within previous 60 days 6. patient with class iv (nyha) heart failure 7. patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet 8. patient with left ventricular assist device planned or required for the procedure 9. patients with co-morbidities such that they have less than 1 year life expectancy 10. patient with significant intracardiac and/or laminated thrombus evident by transesophogeal echo (tee) or transthoracic echo (tte) (with contrast) within 2 days of the ablation procedure 11. patient with thrombocytopenia or other coagulopathy 12. women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test) 13. patient with other acute illness or active systemic infection (unrelated to vt or its origin) 14. significant congenital anomaly heart disease or anomaly 15. allergy or contraindications to the medications/agents used during a standard ablation/ep intervention. 16. patient concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results.
prevalence of latent tuberculosis in high risk children

Conditions: Latent Tuberculosis

Summary: identify the prevalence of latent tuberculosis (according to new guideline ;nice tuberculosis) among these high risk groups of children and notify ministry of health

tb is an infectious disease caused by the bacillus mycobacterium tuberculosis. it typically affects the lungs (pulmonary tb) but can also affect other sites (extrapulmonary tb). the disease is spread when people who are sick with pulmonary tb expel bacteria into the air, for example by coughing. overall, a relatively small proportion (5-15%) of the estimated 1.7 billion people infected with m. tuberculosis will develop tb disease (active disease) during their lifetime. however, the probability of developing tb disease is much higher among people infected with hiv, and also higher among people affected by risk factors such as under-nutrition, diabetes, smoking and alcohol consumption. latent tuberculosis infection (ltbi) is defined as a state of persistent immune response to stimulation by mycobacterium tuberculosis antigens with no evidence of clinically manifest active tb. as there is no "gold standard" test for ltbi, the global burden is not known with certainty; however, up to one third of the world's population is estimated to be infected with m. tuberculosis , and the vast majority have no signs or symptoms of tb disease and are not infectious, although they are at risk for active tb disease and for becoming infectious. several studies have shown that, on average, 5-10% of those infected will develop active tb disease over the course of their lives, usually within the first 5 years after initial infection . the risk for active tb disease after infection depends on several factors, the most important being immunological status

Eligibility criteria:
inclusion criteria: children aged under 5 yearsold with one of the following risk factor : 1. have diabetes 2. have chronic kidney disease or receive haemodialysis exclusion criteria: 1. all children aged above 12 years old 2. history of recent contact with tb positive patient 3. all children under 5 yearsold without any other risk factor
study of sitravatinib, nivolumab and ipilimumab in advanced or metastatic clear-cell renal cell carcinoma or other solid malignancies

Conditions: Clear-Cell Renal Cell Carcinoma

Summary: study 516-008 is an open-label phase 1 dose escalation/phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and pk of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccrcc and potentially other solid tumor types.

sitravatinib is a spectrum-selective receptor tyrosine kinase (rtk) inhibitor that inhibits several closely related rtks including the tam family (tyro3/axl/mertk), vegfr2, kit, and met. nivo/ipi are monoclonal antibodies (mabs) that inhibit the immune checkpoint proteins programmed death receptor-1 (pd-1) and cytotoxic t- lymphocyte antigen-4 (ctla-4), respectively. the current study is designed to evaluate the triple combination of sitravatinib plus nivo/ipi in patients with solid tumor malignancies that have shown favorable responses to nivo/ipi combinations in previous clinical trials. combining sitravatinib and nivo/ipi is predicted to have complementary effects in triggering a tumor-directed immune response.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of clear-cell renal cell carcinoma (for initial cohorts under consideration) * no prior treatment with systemic therapy (for initial cohorts under consideration) * adequate bone marrow and organ function exclusion criteria: * known or suspected presence of other cancer * brain metastases (for initial cohorts under consideration) * carcinomatous meningitis * immunocompromising conditions * impaired heart function * active or prior documented autoimmune disease
a study of mircera in hemoglobin control of patients transitioning to dialysis.

Conditions: Anemia

Summary: this study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. patients will be randomized either to receive mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to mircera. at the initiation of dialysis, patients in the mircera group will receive monthly intravenous (iv) mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. the anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic kidney disease stage iv not requiring dialysis; * expected to initiate dialysis within 18 months; * 15\<=glomerular filtration rate (gfr)\<=29. exclusion criteria: * failing renal allograft in place; * acute or chronic bleeding within 8 weeks prior to screening; * transfusion of red blood cells within 8 weeks prior to screening; * poorly controlled hypertension; * immunosuppressive therapy in the 12 weeks prior to screening.
p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma

Conditions: HCC; Diabetes

Summary: an open-labeled phase ii study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (hcc).

it was found in the treatment of hcc using p53 gene therapy that the concurrent diabetes was controlled as well. the objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. this is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. the study endpoints for anti-diabetic role are fasting plasma glucose (fpg), postprandial glucose (ppg) and glycosylated hemoglobin (a1c) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.

Eligibility criteria:
inclusion criteria: * histopathologically diagnosed unresectable hcc * over 18 years old * with an eastern cooperative oncology group (ecog) score of 0-2 * with barcelona clinic liver cancer (bclc) stage of b or c * with child-pugh score a or b; with normal tests of hemogram, blood coagulation, liver and kidney function * signed the informed consent form. exclusion criteria: * hypersensitive to study drug * with an abnormal coagulation condition or bleeding disorder * infections * with serious conditions which prevent using the study treatment * pregnant or lactating

Keywords: concurrent
impact of hla-e overexpression by tumor cells on the biology of til in colorectal cancer

Conditions: ColoRectal Cancer

Summary: accumulating evidences suggest that colorectal cancer (crc) progression is not solely determined by the genetic abnormalities of the tumor cells but also by the host response. indeed, recent studies in crc have associated improved survival with a high number of tumor-infiltrating (til) memory and cytotoxic t lymphocytes, suggesting a link between tumor progression and in situ t cell response. gene expression profiling studies have clearly isolated a well-known subgroup of crc characterized by microsatellite instability (msi) crc, associated with a strong immune response signature involving both th1/cytotoxic and immune evasion pathways. moreover, the investigators have previously shown that hla-e/β2m is overexpressed by tumor cells in roughly 20% of crc and is associated with a worse prognosis, most likely due to nk and t effector cell functions upon engagement with the inhibitory nk receptor cd94/nkg2a. however, our recent results on an enlarger cohort of patients suggest that if this observation holds true for mss crc, hla-e over-expression is inversely associated with a good prognosis in msi crc. thus, the phenotype and function of til, depending on the msi/mss status of crc have to be precised. the investigators hypothesized that in msi crc, known to express a high number of msi-h related frameshift peptides which represent a pool of tumor specific antigens, hla-e could present peptides to tcr of non conventional cd8+ hla-e-restricted alpha-betat cells (also expressing cd94), then inducing a strong antitumor cytolytic activity. therefore, the aim of this project is to determine the exact phenotype, function and specificity of the cd94+ til in crc, depending on both the hla-e and the msi/mss status of tumor cells. these results could impact the clinical practice as anti-nkg2a monoclonal antibodies or frameshift peptide based immunotherapy that could be promising new therapeutic options in crc patients.


Eligibility criteria:
inclusion criteria: * major patients treated surgically for colorectal cancer at the nantes university hospital or the west institute of cancerology * patients agreeing to participate in the study non inclusion criteria: * age\> 85 years * neoadjuvant or immunosuppressive therapy for other pathology * size of the tumor insufficient to carry out all the samples dedicated to the research without constraining the diagnostic step (tumoral sampling at least equal to 1 cm3)
a placebo-controlled study of clenbuterol in spinal and bulbar muscular atrophy

Conditions: Spinal and Bulbar Muscular Atrophy

Summary: there is no cure to arrest or delay sbma progression. it is estimated that \~1000 individuals are affected by sbma in italy at any given time (prevalence: 1.5/100000) with an annual incidence of 0.19/100000 males. here, we are going to test the potential of beta2-agonist stimulation on muscle as a therapeutic avenue for sbma. we have provided pre-clinical evidence that β-agonist stimulation may be a therapeutic strategy for sbma. moreover, we have shown that beta2-agonists are effective in improving motor function without relevant adverse events in a small cohort of sbma patients. to establish safety and efficacy of clenbuterol as a cure for sbma, we are conducting a multicenter, phase ii, randomized, double-blind, parallel-group, single dose, placebo-controlled trial. indeed, based on our preliminary data, some concerns remain to be addressed.


Eligibility criteria:
inclusion criteria: 1. males who have received a genetically confirmed diagnosis of sbma (ar cag repeat number \>= 38); 2. aged between 18 and 75 (+364 days) years; 3. displaying one or more of the following clinical symptoms: muscle atrophy, limb weakness, bulbar palsy; 4. able to walk independently with or without a cane or other supporting device (all supporting devices are acceptable except on wheelchair); 5. providing a written informed consent. exclusion criteria: 1. a documented cardiovascular disease precluding the use of beta2 agonists (in the judgment of the investigators); 2. glaucoma, severe prostatic hypertrophy, hyperthyroidism, pheochromocytoma, and other medical conditions that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study; 3. concomitant treatment with either beta-blockers or sympathomimetic drugs (if a beta-blockers concomitant medication is ongoing before the study inclusion, the patient can be enrolled if the beta-blocker is discontinued for 3 weeks prior to randomization visit); 4. inability to walk or walking only with the support of a caregiver; 5. use of beta2 agonists in the preceding 6 months; 6. participation to an interventional trial in the preceding 3 months; 7. neuromuscular disease other than sbma.

Keywords: sbma clenbuterol trial
study comparing the tolerability and viral reduction of the combination of ifn a-2b xl + ribavirin versus peg ifn a-2b + ribavirin in patients with chronic hepatitis c, genotype 1 or 4

Conditions: Chronic Hepatitis C

Summary: three-parallel-arm, open-label, international (france and romania) study, comparing three treatments the purpose of this study is to confirm if ifn alfa-2b xl has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

interferon alfa-2b xl (ifn alfa-2b xl) is a novel sustained release interferon α-2b drug product that is being developed by flamel technologies using its medusa® technology, aiming at reducing the toxicity and enhancing the biological response. in the present study, patients will be randomly assigned to either ifn alfa-2b xl 27 mui, ifn alfa-2b xl 36 mui, or ifn peg alfa-2b 1.5 µg/kg, all administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses. doses will be adapted according to the dose modification guidelines for combination therapy labelled in the ribavirin prescribing information.

Eligibility criteria:
inclusion criteria: * patient having voluntarily signed the informed consent form prior to any study specific procedure being performed * male or female hcv genotype 1 or 4 infected patients (positive serum hcv rna), aged between 18 and 65 years inclusive, with a body mass within the range over or equal of 45kg and below or equal to 100 kg * patient being either naïve to therapy, either non-responder to previous standard peg-interferon α + ribavirin therapy, * with no absolute contra-indication to interferon α or ribavirin * female patients must be non-lactating and of non-childbearing potential, or have a negative pregnancy test results to enter the study * no evidence of acute or advanced liver disease, uncontrolled diabetes, cardiovascular, immunological, or thyroid disease, and no recently diagnosed malignancy * vital signs within normal ranges, or if outside the normal ranges, not deemed clinically significant in the opinion of the investigator. an ecg with no clinically significant abnormalities exclusion criteria: * history of solid organ transplantation * severe systemic infection, uncontrolled diabetes, cancers, associated liver disease * general anesthesia or recent blood transfusion

Keywords: hepatitis c viral kinetics antiviral response genotype 1 or 4
categorized pt for non-arthritic hip and groin pain

Conditions: Hip Pain; Groin Pain

Summary: there is currently limited literature on a categorized physical therapy protocol for management of hip pain. only a handful of studies have looked at the treatment of osteoarthritis of the hip with a standardized physical therapy treatment, primarily looking at manual therapy versus exercise therapy protocols. however, there are no studies observing the effect of a standardized physical therapy program on patients presenting with non-arthritic hip and groin pain. based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting with non-arthritic hip and groin pain.


Eligibility criteria:
inclusion criteria: * new patient presenting with non-arthritic hip impingement, hip pain, and groin pain (tonnis 0-1) * 18-60 years old exclusion criteria: * arthritic hip pain (tonnis 2+) * \ 60 years old * history of spinal fusion surgery * history of low back pain with radicular pain * history of hip arthroscopy * history of inflammatory conditions, and other concurrent problems interfering with hip therapy (i.e., concurrent back/knee/foot/ankle/shoulder issues) * patients currently taking tnf-alpha inhibitors for inflammatory conditions * history of prior knee osteotomy * non-english speakers
pravastatin as a prophylactic to reduce endothelial injury in pediatric patients with elevated body mass index

Conditions: Hematopoietic Stem Cell Transplant (HSCT); Endothelial Injury

Summary: chemotherapy and radiation used in patients undergoing bone marrow transplant (bmt) disrupts the endothelial lining (a thin layer of cells inside the blood vessels) which is found all throughout the body including the kidney, heart, lungs, and intestines. disruption of this endothelial lining can lead to complications such as graft-vs-host disease (gvhd), thrombotic microangiopathy (tma) and veno-occlusive disease (vod). the purpose of this research study is to help investigators see if pravastatin is safe and well tolerated in patients undergoing bmt to see if it will reduce endothelial injury after bmt. the investigator hypothesizes that prophylactic pravastatin in pediatric allogeneic hematopoietic stem cell transplant recipients with elevated bmi is safe and feasible.


Eligibility criteria:
inclusion criteria: * scheduled for allogeneic stem cell transplant * ages ≥ 2 - ≤ 25 years old * elevated bmi defined by the center for disease control and prevention definitions. both overweight (bmi between 85th-94th percentile) and obese (bmi \>95th percentile) patients are eligible * all diagnoses are eligible exclusion criteria: * patients with documented anaphylaxis to pravastatin * patients will be ineligible if they are unable to take medication orally or enterally (i.e. intestinal failure) * patients with elevations in alt/ast levels 3x uln at time of enrollment * patients with renal impairment as clinically measured (gfr \<50 ml/min/1.73m2) at time of enrollment * patients with known neuromuscular and metabolic disorders associated with an increased risk of rhabdomyolysis (ie metabolic muscle disorders, mitochondrial disorders, and muscular dystrophies) * patients taking any drugs that are known substrates for oatp1b1 and oatp1b3 transporters
pilot imaging study with 89zr-trastuzumab in her2-positive metastatic breast cancer patients

Conditions: Breast Neoplasms; Secondary; HER2 Positive Carcinoma of Breast

Summary: evaluation of the diagnostic potential of her2 imaging using zirconium 89 labelled trastuzumab.

this is the first belgian feasibility study of her2 imaging using a labelled monoclonal antibody, namely trastuzumab labelled with zirconium 89. the aims of this study are: i/ evaluate the diagnostic potential of her2 imaging using zirconium 89 labelled trastuzumab (based on the groningen experience), through the analysis of the correlation between the fdg-pet/ct and the her2 immunopet. ii/ pet quantification of her2 receptor by using the images and the blood pharmacokinetic of the tracer. iii/ in the subset of patients for whom biopsies of metastatic sites have not been carried out previously and are of an easy access, tissue will be acquired as part of the validation of the her2 immunopet and as an attempt to better understand the molecular heterogeneity of her2 positive breast cancer at the time of relapse. iv/evaluate the concentration of circulating her2 extracellular domain in the blood and study his possible role as on imaging quality

Eligibility criteria:
inclusion criteria: 1. all patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced her2 positive breast cancer (this includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy). 2. histologically confirmed her 2 positive (defined as fish amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease. 3. patients with fdg-pet positive metastatic lesions. 4. brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease. 5. patient planned to have metastatic site biopsy for her2 status control. 6. age ≥ 18 years 7. eastern cooperative oncology group (ecog) performance status (ps) 0 to 1 8. for women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception. 9. agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions. 10. signed written informed consent (approved by the ethics committee) obtained prior to any study procedure exclusion criteria: 1. current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) 2. pregnant or lactating women 3. current known infection with hiv, hbv, or hcv 4. known severe hypersensitivity to trastuzumab 5. assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol 6. patients with bone only metastases are not eligible 7. psychiatric illness/social situations that would limit compliance with study requirements 8. patients who received lapatinib within the 7 days prior to her immunopet/ct.