Kornimate/medical-research-clean huggingface dataset:
risk of central venous stenosis in patients with chronic renal failure after ij line placement

Conditions: Thrombosis

Summary: the purpose of this study is to compare the difference in thrombosis as a result of internal jugular (ij) catheters versus peripherally inserted central catheter (picc) lines. it is hypothesized that there will be a decreased rate of thrombosis in patients as a result of ij catheters verses picc lines.

in a cohort of patients from sept 1, 2010 until december 31, 2011 with chronic kidney disease (ckd) has shown that the incidence of ij thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. the current study is being done to compare this experience with the incidence of thrombosis from picc lines. a secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when picc lines are placed. this data will provide the first comparison of the incidence of thrombotic complications from short term ij catheter access versus picc lines.

Eligibility criteria:
inclusion criteria: * subjects who had a picc line placed at the university of chicago between september 1, 2010 and december 31, 2011 exclusion criteria: * subjects under the age of 18

Keywords: thrombosis central venosis catheter renal disease vascular access
cc486-chop in patients with previously untreated peripheral t-cell lymphoma

Conditions: Previously Untreated Peripheral T-cell Lymphoma

Summary: this is a phase ii, multi-center study to determine the efficacy and safety of first-line cc-486 plus chop in patients with ptcl who have received no prior systemic therapy. the study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.

study summary: this is a phase ii, multi-center study to determine the efficacy and safety of first-line cc-486 plus chop in patients with peripheral t-cell lymphoma (ptcl) who have received no prior systemic therapy. the main objective is to determine the complete response rate (cr) of cc486-chop in ptcl. cr rate after cycle 6 will be used for the purpose of interim efficacy analysis. * the study includes 6 cycles (\~18 weeks) of treatment and 2 years of follow-up. the projected end date is 12/31/2022. patients achieving complete remission will be evaluated every 6 months for 2 years or until disease progression. patients who have disease progression will be contacted every 6 months to assess for survival status. * standard dose chop will be provided on day 1 of each cycle and repeat every 3 weeks for a total of 6 cycles. * cc486 at 300 mg daily will be administered orally from day -6 to day 0 for cycle 1 priming, and on days 8-21 following cycles 1-5. * patients in cr/pr following 6 cycles of treatment have the option to proceed to consolidative autologous stem cell transplant. * will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Eligibility criteria:
inclusion criteria: - histologically confirmed diagnosis of ptcl of the following subtypes: nodal t-cell lymphoma with t-follicular helper (tfh) phenotype (tumor cells must express 2 or 3 tfh-related antigens, including pd1, cd10, bcl6, cxcl13, icos, sap and ccr5)\* angioimmunoblastic t-cell lymphoma follicular t-cell lymphoma ptcl/nos, t-follicular helper (tfh) variant ptcl-nos anaplastic large cell lymphoma, alk negative anaplastic large cell lymphoma, alk positive with ipi \> 2 adult t-cell leukemia / lymphoma * no prior systemic therapy for lymphoma * measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in two dimensions * ecog performance status ≤ 2 exclusion criteria: * known central nervous system (cns) involvement by lymphoma * active viral infection with hiv or hepatitis type b or c (seropositive hbv patients are eligible if they are negative for hbv dna by pcr and receive concomitant antiviral therapy). * prior history of malignancies other than ptcl unless the patient has been disease free for ≥ 5 years from the signing of the icf.

Keywords: peripheral t-cell lymphoma azacitidine lymphoma
study of duloxetine versus placebo in the treatment of fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: to assess the efficacy of duloxetine compared with placebo in the treatment of pain in patients with fibromyalgia syndrome, with or without major depressive disorder.


Eligibility criteria:
inclusion criteria: * meet criteria for primary fibromyalgia syndrome as defined by the american college of rheumatology exclusion criteria: * have any current primary axis i diagnosis other than major depressive disorder * have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder * have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, ocd, ptsd, gad and social phobia) * have regional pain syndrome, multiple surgeries or failed back syndrome * have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
neoadjuvant study of pyrotinib and trastuzumab plus docetaxel and carboplatin in her2 positive breast cancer patients.

Conditions: HER2 Positive Breast Cancer

Summary: pyrotinib is an oral tyrosine kinase inhibitor targeting both her-1 and her-2 receptors.this study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in her2 positive early stage or locally advanced breast cancer.

neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. in recent years, the anti-her2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. pyrotinib is an oral tyrosine kinase inhibitor targeting both her-1 and her-2 receptors. based on previous clinical studies, we designed the study to explore the possibility of pyrotinib in combination with trastuzumab plus docetaxel given as neoadjuvant treatment in her2 positive early stage or locally advanced breast cancer.

Eligibility criteria:
inclusion criteria: 1. female patients, 18 years ≤ age ≤ 75 years. 2. performance status- eastern cooperative oncology group (ecog) 0-1. 3. histologically confirmed invasive breast cancer（early stage or locally advanced）:primary tumour greater than 2 cm diameter 4. her2 positive (her2+++ by ihc or fish+) 5. life expectancy of more than 3 months 6. known hormone receptor status. 7. required laboratory values including following parameters: anc: ≥ 1.5 x 10\^9/l;platelet count: ≥ 100 x 10\^9/l;hemoglobin: ≥ 9.0 g/dl;total bilirubin: ≤ 1.5 x upper limit of normal (uln);alt and ast: ≤ 1.5 x uln (or ≤ 5×uln in patients with liver metastases);bun and creatine clearance rate: ≥ 50 ml/min;lvef: ≥ 50%;qtcf: \< 470 ms for female and \< 450 ms for male. 8. signed the informed consent form prior to patient entry. exclusion criteria: 1. metastatic disease (stage iv) or inflammatory breast cancer. 2. previous or current history of malignant neoplasms, except for curatively treated:basal and squamous cell carcinoma of the skin,carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease:known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. unable or unwilling to swallow tablets.
facing obstacles to rdi (relative dose intensity) through telephone intervention strategy

Conditions: Chronic Lymphocytic Leukemia

Summary: the investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of fludarabine-cyclophosphamide-rituximab (fcr) given frontline to chronic lymphocytic leukemia patients.


Eligibility criteria:
inclusion criteria: 1. cll whatever binet stage, but with at least one nciwg2008 criteria indicating a need for first line treatment. * matutes score must be 4-5/5. * initial cytopenia (due to cll) are not exclusion criteria. * lymph node biopsy is needed only if suspicion of richter syndrome. * mandatory pre-therapeutic check-up: fish in search for deletion del17p and del11q, dat test, haptoglobin levels, creatinine clearance. 2. eligibility to a treatment with fcr: clearance \> 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score cirs-g≤11. 3. signed informed consent 4. age\> or equal 18 years, ecog ps 0-2. 5. estimated overall survival\>6 months. 6. conserved liver function (bilirubin\<2,5mg/dl, sgpt\<4uln, sgot\<4uln) except infiltration due to the disease. 7. contraception for younger patients. 8. confident with the use of telephone, no disabling deafness. exclusion criteria: 1. richter syndrome or atypical cll (matutes score \<4), and/or del17p by fish 2. relapse of cll 3. contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance\<30 ml/mn. 4. serologies positive for hiv, hbv, or hcv. no active bacterial, viral or fungal infection 5. previous history of hypersensibility to any product used in this protocol 6. denial, or medical or psychological condition preventing completion of the signed informed consent. 7. treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study. 8. pregnant/breastfeeding women. 9. cns involvement by cll. 10. presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).
evaluation of the pharmacokinetics and pharmacodynamics of hydroxychloroquine in covid-19 intensive care unit patients

Conditions: Sars-CoV2

Summary: to date, no treatment has demonstrated clinical efficacy on covid 19. however, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. among these strategies, the use of hydroxychloroquine (hcq) seems promising. there is very little information on how to precisely administer hydroxychloroquine to patients infected with sars-cov-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. in addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. in view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with sars-cov-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.


Eligibility criteria:
inclusion criteria: * adult patients 18 years of age and older * patients hospitalized in the intensive care unit infected with cov-2-sars for whom a diagnosis of respiratory cov-2-sars infection has been made by nasopharyngeal swab or deep respiratory sampling. * patient receiving hcq treatment as part of care or as part of a clinical trial. * patient affiliated or entitled to a social security scheme exclusion criteria: * hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate. * retinopathies * combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes. * patient with known qt prolongation * known deficit in g6pd * pregnant woman

Keywords: sars-cov-2 hydroxychloroquine covid-19 intensive care unit pharmacokinetics
healtherx survey for pulmonary research registry recruitment

Conditions: Asthma; COPD

Summary: the purpose of this research is to study the utility of using the healtherx as a tool to recruit eligible patients into the pulmonary research registry (prr) (irb 15543b) at the university of chicago. healtherx is an example of a potential recruitment tool that has high reach in populations typically underrepresented in research studies, uses a high tech infrastructure that allows matching of research opportunities to patient characteristics, but that delivers information in a low-tech, patient-centered mode using the printed healtherx prescription.

1. patients living in one of 16 zip codes of the south and west sides of chicago who present for care at one or more of 30 clinical sites receive a personalized healtherx prescription with programs and services in the community from their health care provider. the healtherx is printed and delivered to the patient at the end of the visit. 2. patients age 18+ with a diagnosis of asthma and/or copd will receive a healtherx with programs/services to help manage their condition, as well as an advertisement to participate in a phone survey. 3. patients interested in completing the phone survey can call or text the lindau lab at the university of chicago. 4. an experienced survey researcher will first read the consent script and if oral consent is received, continue with the phone survey (the survey includes items pertaining to program participants' receipt of the healtherx, use of community services provided on the healtherx, thoughts about participation in clinical research. 5. participants who choose to complete the survey will receive a $10 check delivered via u.s. mail to their home address. patients interested in joining the prr will receive the prr consent form with their $25 check. 6. participants with interest in joining the prr will also receive, via mail, a $5 bill as thanks for reading, signing and returning the consent form. participants will be randomized to receive the $5 bill at 2 different time points. 7. once the signed consent form is received, a member of the asthma and copd center research staff will contact the participant by phone and complete the prr case report form by phone.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma/copd * receipt of healtherx exclusion criteria: -

Keywords: recruitment
post-fatigue vibration: impact on grip and reaction time

Conditions: Muscle Fatigue

Summary: this study aims to investigate the acute effects of local vibration applied after induced fatigue of the wrist flexor muscles on grip strength and upper extremity reaction time.

this randomized controlled study will be conducted with a minimum of 42 participants who meet the inclusion and exclusion criteria. participants will be randomly assigned to one of three groups: control, 50 hz local vibration, or 100 hz local vibration.

Eligibility criteria:
inclusion criteria: 1. female individuals aged 18-25 exclusion criteria: 1. having an open wound in the area where local vibration is applied 2. a history of previous or current upper extremity injury 3. use of anti-inflammatory drugs 4. having a diagnosis of epilepsy

Keywords: local vibration upper extremity function wrist flexors neuromuscular performance
impact of capillary leak and hypoalbuminemia on pk/pd of anidulafungin and caspofungin in critically ill patients

Conditions: Critically Ill Patients

Summary: this prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.

this non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin). the pharmacokinetics and pharmacodynamics of the echinocandins in plasma and bal will be determined. especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored. also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Eligibility criteria:
inclusion criteria: * treatment with anidulafungin or caspofungin * admitted to an icu ward exclusion criteria: * \< 18 years * dnr 2 or 3

Keywords: pharmacokinetics echinocandins critically ill patients
chronic low back pain - epiduroscopy treatment

Conditions: Chronic Low Back Pain

Summary: retrospective analysis of patients with low back pain after epiduroscopic procedure

retrospective analysis of patients with low back pain after epiduroscopic procedure retrospective analysis of ambulatory data and next phone survey

Eligibility criteria:
inclusion criteria: * all patients after epiduroscopy exclusion criteria: * patients disagreement
lucid - lung cancer circulating tumour dna study

Conditions: Non Small Cell Lung Cancer

Summary: this is a prospective observational pilot study to investigate levels of circulating tumour dna (ctdna) in plasma from patients with stage i to iiib non-small cell lung cancer (nsclc) who will undergo treatment with curative intent.

taking as reference tumour-specific somatic genetic alterations identified within individual cancer biopsies from patients, recent advances in genomic and next generation sequencing technologies now provide the opportunity to investigate whether each patient's tumour-specific dna can be reliably detected within their plasma. this offers the possibility to test a patient's response following treatment with curative intent. this technology has already been used to detect ctdna in metastatic nsclc, but not yet in early stage disease. the primary objective of this pilot study is to test the feasibility of detecting serial ctdna levels in stage i to iiib nsclc patients who undergo treatment with curative intent. as secondary endpoints, this study aims to measure ctdna levels and characteristics, and to correlate them with clinical features (such as burden of disease and treatment response) in order to test the value of ctdna as a diagnostic, prognostic and predictive biomarker for patients with nsclc. 100 patients planned for curative treatment (surgery or radical radiotherapy +/- chemotherapy) will be recruited.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old at the time of consent * male or female * patients with radiologically and histologically/cytologically confirmed stages i to iiib nsclc who are planning to undergo radical treatment (surgery or radical radiotherapy) with curative intent * ecog performance status 0-2 * able to give informed consent * able to give blood exclusion criteria: * unable to receive treatment with curative intent due to co-morbidity or personal choice patients participating in other clinical studies are not precluded from entering the study; however they must meet all the eligibility criteria for this study.
etanercept withdrawal and retreament study in subjects with nr-ax spa

Conditions: Spondylitis, Ankylosing

Summary: the purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

this multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax spa who achieved adequate response following 24 weeks of treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of axial spa duration of symptoms \>3 months and \<5 years back pain with a less than favorable response to nsaids exclusion criteria: * radiological sacroiliitis previous treatment with tnf inhibitor, biologic, immunosuppressive

Keywords: non-radiographic axial spondyloarthritis
genetic basis of abdominal aortic aneurysm

Conditions: Cardiovascular Diseases; Heart Diseases; Aortic Aneurysm, Abdominal

Summary: to identify the genetic (major genes) and environmental factors responsible for the significant aggregation of abdominal aortic aneurysm (aaa) among relatives of affected individuals.

background: abdominal aortic aneurysm (aaa) is a dilatation of the abdominal aorta which can, if undetected, lead to rupture. the mortality associated with ruptured aaa is estimated to be 90 percent, while elective repair has a mortality risk of approximately 6 percent. ruptured aaa is a leading cause of death among older americans. the identification of markers of aaa risk could lead to preventive intervention. aaa aggregates in families, and segregation analysis shows that familial risk of aaa is best explained by the segregation of a major gene with an autosomal recessive mode of inheritance. design narrative: affected relative pairs (primarily sibling pairs) with aaa and no evidence of a family history of a connective tissue disorder were genotyped for 150 highly informative microsatellite polymorphisms marking the autosomal genome at a resolution of 20 cm. the linkage between aaa and these loci was tested using robust affected pedigree member methods to identify genomic regions which might contain genes that predisposed individuals to develop aaa. the existence of predisposing gene(s) were confirmed and their location refined using a defined search strategy, genotyping at increasing levels of resolution, and re-analysis of family data. the predisposing gene(s) were identified by a combination of saturation mapping and molecular analysis of candidate loci. the association of aaa with environmental measures was investigated to determine an equation for estimating risk for relatives of aaa patients based upon environmental measures and genotype. power calculations based upon the number and structure of families already collected demonstrated the feasibility of identifying genes that predisposed to aaa using this strategy, even in the presence of significant heterogeneity with respect to the loci involved. in addition to identifying genes that were necessary for aaa by linkage analysis, a series of analyses of association were undertaken to identify true susceptibility genes that were neither necessary nor sufficient to cause disease, but which modified an individual's risk of developing aaa. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria