araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

Summary: Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.


Eligibility: Inclusion Criteria:
  -  patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.
  Exclusion Criteria:
  -  inability to provide consent
  -  <18 years old
  -  non-English speaking
  -  patients using intermittent self-catheterization
  -  patients sustaining bladder injury during surgery
  -  prisoners
  -  pregnant women

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Efficacy of Diclofenac BCG Irrigations

Summary: This study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.

Detailed description: This study is designed as a double blind placebo controlled randomized study to evaluate the effectiveness of diclofenac suppositories in the prevention of side effects of BCG bladder irrigation in bladder cancer patients. After signing an informed consent, the patients will be randomized to either receive an unmarked suppository of Diclofenac or a placebo suppository. The effectiveness of the drug will be tested weekly by quality of life questionnaires and bladder symptom questionnaire. Another questionnaire is designed to monitor the time in minutes that the BCG is retained in the bladder before the patients urinates.

Eligibility: Inclusion Criteria:
  1. Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre
  2. Male and female
  3. Age 20-80.
  4. Patients capable of understanding reading and signing the informed consent form in Hebrew.
  Exclusion Criteria:
  1. Diclofenac hypersensitivity
  2. Pregnancy, Lactation
  3. Elevated creatinine at baseline (male > 1.2 mg/% female 1.0 mg/%)
  4. Peptic gastric or duodenal ulcer
  5. Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding)
  6. Gross hematuria (which is per se a contraindication for BCG irrigation)

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Summary: The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Detailed description: CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility: Inclusion Criteria:
  -  histologically confirmed metastatic colorectal adenocarcinoma
  -  KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
  -  has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
  -  ECOG performance status 0 to 1
  -  Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
  Exclusion Criteria:
  -  Previous irinotecan or anti-EGFR therapies
  -  hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
  -  liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
  -  Renal function: serum creatinine, more than 1.5 times the upper limit of normal
  -  Patients with symptomatic central nervous system metastases

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Onabotulinumtoxina Intradetrusorial Injections and NGF Expression

Summary: In the last years, botulinum toxin type A (onab/A) has been increasingly used as a treatment option for overactive bladder symptoms in patients affected by either neurogenic and idiopathic detrusor overactivity (DO). How onab/A injected into the detrusor muscle improves overactive bladder symptoms in neurologic patients has been only partially investigated.Some evidence suggested that the neurotoxin probably reduces detrusor muscle contraction blocking detrusor muscle cholinergic innervation. However, recent experimental observations indicated that onab/A determines more complex effects on bladder activity acting on afferent innervations as well as on the efferent one. Only few experimental studies have investigated the activity of onab/A on bladder afferent nervous transmission. Experimental studies in animals showed that Nerve Growth Factor (NGF) elicits increased sensation, urgency and DO. Although there are some evidence on the ability of onab/A to improve DO and to reduce bladder and urinary content of NGF, how onab/A influences NGF expression and the expression of TrKa, p75 and TRPV1 receptors is still unclear. The hypothesis is that onab/A reduces NGF bladder tissue levels and in the same time it modulates the gene expression of NGF associated receptors (TrkA, p75 and TRPV1).

Detailed description: NGF has been suggested to modulate neurotransmitters' release, induces synaptic reorganization and influences neuronal excitability acting on Trk/A and p75 associated receptors. Moreover, recent observations indicated that NGF-induced DO and noxious input depend on the interaction of NGF with TRPV1, that is over-expressed in overactive bladders and interstitial cystitis/painful bladder syndrome. From a clinical point of view, a decrease in urinary NGF levels has been detected in patients with DO treated with onab/A. Although there are some evidence on the ability of onab/A to improve DO and to reduce bladder and urinary content of NGF, how onab/A influences NGF expression and the expression of TrKa, p75 and TRPV1 receptors is still unclear.

Eligibility: Inclusion Criteria:
  Patients affected by refractory overactive bladder (OAB) symptoms and detrusor overactivity (idiopathic and neurogenic DO) refractory to conventional anticholinergics (at least 3 antimuscarinic agents -- tolterodine, oxybutynin and solifenacin -- each taken for at least 1 month).
  Exclusion Criteria:
  -  OAB symptoms due to bladder outlet obstruction because of urogenital prolapse in females and benign prostatic hyperplasia in males,
  -  recurrent urinary tract infections,
  -  cognitive impairment,
  -  pregnancy,
  -  anticoagulant therapy,
  -  psychoactive agents modulating bladder function (venlafaxine, amitriptyline), aminoglycosides, and other drugs thought to interfere with bladder function

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes

Summary: To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.

Detailed description: Following guidance from the United States Food and Drug Administration (FDA) and European Medicines Agency, the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and conducted this study using the KPNC database to assess the potential association between pioglitazone and bladder cancer among patients with type 2 diabetes mellitus.
  The study was conducted over the course of 10 years, with a series of interim analyses undertaken during this period and provided to the sponsor (Takeda) and the appropriate regulatory agencies.
  In 2011, the planned 5-year interim analysis of this study was published in Diabetes Care. That report included data from 1 January 1997 to 30 April 2008. Following reporting of these data, there was a request from the FDA for an additional fourth interim analysis at 8 years including data from 1 January 1997 to 31 December 2010.
  In August 2011 the FDA requested inclusion of a sensitivity analysis to assess change of cohort entry criteria to minimize left censoring of exposure. Included in the FDA request was a duration analysis for other antidiabetic medications.
  In August 2014, the final 10-year analyses were completed and submitted to the sponsor and regulatory agencies.
  Interim results previously posted on clinicaltrials.gov are available in the public archive

Eligibility: Inclusion Criteria:
  -  The study cohort included both patients with an established diagnosis of diabetes mellitus prior to January 1, 1997 and those who were newly diagnosed prior to December 31, 2002. Patients were eligible for the study cohort if they met any of the following criteria:
  1. As of January 1, 1997 they had been diagnosed with diabetes mellitus, were age 40 or older and were members of KPNC,
  2. They had been diagnosed with diabetes mellitus, reached age 40 between January 1, 1997 and December 31, 2002 and were KPNC members on their 40th birthday, or
  3. Had diabetes mellitus and were age 40 or older when they joined KPNC between January 1, 1997 and December 31, 2002.
  Exclusion Criteria:
  -  Diagnosis of bladder cancer recorded in the KPNC cancer registry prior to entry to the cohort or within 6 months of entry into KPNC.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer

Summary: This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer.

Detailed description: This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer. All patients will undergo baseline FDG-PET-MRI and routine (standard of care) contrast enhanced abdominal/pelvic multi-detector computed tomography (MDCT). The imaging results will ultimately be compared to final pathology as the gold standard. If the accuracy of FDG-PET-MRI is improved as compared to standard MDCT, the investigators plan to conduct a larger follow-up study to confirm the results of this pilot study. In addition, this pilot study will set the stage for the evaluation of novel PET tracers in the imaging of bladder cancer.

Eligibility: Inclusion Criteria:
  -  ≥ 18 years of age (no upper age limit)
  -  Informed consent obtained and signed
  -  cT2/T3-N0-M0 urothelial carcinoma of the bladder
  -  Planned radical cystectomy with pelvic lymph node dissection
  -  No known local regional or distant metastatic disease
  -  Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI
  Exclusion Criteria:
  -  History of severe reaction to contrast-enhanced CT scan
  -  Poorly controlled diabetes mellitus
  -  Inability to tolerate PET and/or MRI
  -  Presence of pacemaker or intracranial aneurysm clip
  -  Serum creatinine >1.8 mg/dL OR GFR < 30mL/min
  -  Pregnant or lactating female
  -  Inability to lie flat for >1 hour
  -  Body Mass Index (BMI) >35
  -  History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer.
  -  Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer

Summary: To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.

Detailed description: Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.

Eligibility: Inclusion Criteria:
  -  patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, >3 cm in diameter)
  -  WHO performance status ≤2
  -  age ≤85years
  -  BCG naive
  -  patients not treated with intravesical chemotherapy in the last 3 months.
  Exclusion Criteria:
  -  presence of T1G3 or CIS
  -  preoperative urinary cytology positive for high-grade atypia
  -  inadequate bone marrow reserve (white blood cells <3 x 109/l, platelets <100 x 109/l)
  -  history of genito-urinary tuberculosis
  -  presence of uncontrolled urinary infections.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia

Summary: Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO by the medical or surgical treatment have not been fully investigated. If the elevated urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the operation.
  The aims of this study are to measure the urinary NGF levels in patients with BPO and to compare the results between the patients with detrusor overactivity (DO) and without detrusor overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of postoperative 3 months and 6 months, and compare changes between the two groups.

Detailed description: -  Investigators are going to enroll age-matched control group and measure the urinary NGF levels as a baseline value (30 males).
  -  Investigators are going to enroll BPO patients group (DO group 50 and Non-DO group 50 patients).
  -  Administration of the anti-cholinergic agents was reported to decrease urinary NGF levels. Investigators are going to try to avoid the effect of anti-muscarinic drugs.

Eligibility: Inclusion Criteria:
  -  Male aged 50 yrs or greater
  -  International prostatic symptom score >= 12
  -  Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
  -  Ability and willingness to correctly complete the micturition diary and questionnaire
  -  Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
  Exclusion Criteria:
  -  Patients with urologic malignancies such as prostate cancer and bladder cancer
  -  Patients underwent urethral, prostate surgery
  -  Patients with urethral stricture or bladder diverticulum or bladder neck contracture
  -  Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

Summary: To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses will be compared to eplerenone, another marketed drug approved to treat heart failure.


Eligibility: Inclusion Criteria:
  -  Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
  -  Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
  -  Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
  -  Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
  -  Subjects with type 2 diabetes mellitus and / or
  -  Subjects with 30 mL/min/1.73m2 </= eGFR </= 60 mL/min/1.73m2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
  -  Left ventricular ejection fraction (LVEF) </= 40%
  -  Blood potassium </= 5.0 mmol/L at screening
  -  Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit
  Exclusion Criteria:
  -  Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
  -  Acute coronary syndrome (ACS) in last 30 days prior to screening
  -  Cardiogenic shock
  -  Valvular heart disease requiring surgical intervention during the course of the study
  -  Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
  -  Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: MicroRNAs as Biomarkers in Patients With Chagas Disease

Summary: The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

Detailed description: The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:
  -  Collection of Blood samples for biochemical analysis;
  -  Electrocardiogram;
  -  Holter Electrocardiogram;
  -  Echocardiogram;
  -  Treadmill Test;
  -  X-Ray Imaging;
  -  Magnetic Resonance Imaging;
  -  Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).

Eligibility: Inclusion Criteria:
  -  Chagas disease diagnosis confirmed by 2 different serologies
  -  Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.
  Exclusion Criteria:
  -  Significant valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg
  -  Mitral stenosis with a valve area inferior than 1,5 cm2
  -  Severe or moderate aortic and/or mitral regurgitation
  -  Chronic use of immunosuppressive agents
  -  Dialysis treatment of terminal renal failure
  -  Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
  -  Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
  -  Any other comorbidities that impact patient's survival within the next 2 years
  -  Liver disease in activity
  -  Continuous use of steroids as treatment for COPD
  -  Hematologic, neoplastic or bone diseases
  -  Homeostasis disturbances
  -  Inflammatory diseases or chronic infectious diseases

Relevance to patient case: not relevant