semaj83/ctmatch_classification huggingface dataset:
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Urinary Retention Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form; 2. Males or females, >18 years of age inclusive at the time of study screening; 3. American Society of Anesthesiologists (ASA) Class I-III; 4. Infraperitoneal colorectal surgery (open and/or laparoscopic); 5. Elective Surgery  Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures; 2. Children <18; 3. No perioperative antibiotics; 4. Past or current urinary tract malignancy; 5. Urinary catheter inserted before surgery; 6. Chronic kidney insufficiency with Creatinine> 2 7. Diagnosis of benign prostatic hyperplasia 8. Chronic urinary infections 9. Neurogenic bladder 10. History of enterovesical fistula 11. Pregnancy 12. Prior surgery of the lower urinary tract 13. Epidural 14. Perioperative ureteral stents After randomization: 1. Catheter pulled out inadvertently; 2. Postoperative complications requiring prolonged monitoring of urine output 3. Postoperative complications requiring early reoperation
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-80.0,  Value of Central Landmark Method for Juguler Vein Catheterization -patients undergoing cardiovascular surgery who needed to have internal jugular vein catheterization aged 18y or older-  -previous neck surgery, burns, limited neck movement, diffuse goiter or bleeding problems
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Metastatic Prostate Cancer Confirmed metastatic prostate cancer for whom androgen deprivation therapy (ADT) is indicated Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening Serum PSA ≥ 5 ng/mL at screening Eastern Cooperative Oncology Group (ECOG) score of 0-2 A life expectancy of at least 12 months Is able to tolerate injection of study drug and comply with the study requirements Positive blood PSA mRNA at screening. A positive PSA mRNA in PBMCs (defined as exceeding the Limit of Detection [LoD] for the central lab assay, i.e. ≥ 10 copies per Polymerase Chain Reaction, PCR)  History of bilateral orchidectomy History of any hormonal treatment/therapy with GnRH agonist, GnRH anti-agonist within 6 months of enrolment Treatment with anti-androgens (except where used to prevent testosterone flare up, starting up to 2 weeks prior to Eligard injection, according to local treatment guidelines), 5-α reductase inhibitors, estrogens and/or other any investigational hormone-derivative within 3 months of enrolment or 5-times the half-life, whichever is longer Any previous treatment with chemotherapy treatment for prostate cancer prior to the screening visit or within 6 months prior to screening for any other cancer Patients previously treated for cancer with hormonal therapy in whom treatment was stopped due to lack of efficacy, progression of the disease or lack of tolerability Previous treatments for cancer (including prostate cancer) within 6 months prior to enrolment: immunotherapy, external beam radiotherapy, brachytherapy, thermotherapy, or biological response modifiers (e.g. cytokines) Known or suspected spinal cord compression or evidence of spinal metastases with risk of spinal compression Uni or bilateral ureteric obstruction Requiring concomitant use of anti-androgens during the course of the study (except where used to prevent testosterone flare up, starting up to 2 weeks prior to Eligard injection and continuing for up to 3 weeks, according to local treatment guidelines)
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Prostate Cancer Men at risk of PCa scheduled for first biopsy with serum total PSA ≤ 20 ng/ml (≤ 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago Signed informed consent  Previous prostate biopsy Confirmed PCa PSA > 20 ng/ml (or > 10 ng/mL if taking 5-alpha reductase inhibitors) Active urinary tract infection Presence/history of any confirmed cancer Recent prostatic surgery (past 6 months) History of pelvic radiotherapy
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 50.0-70.0,  Benign Prostate Hyperplasia •Qmax < 12 mL/s, IPSS >19 Age between 50 and 70 years Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure  •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 50.0-999.0,  Benign Prostatic Hyperplasia Age ≥50 years Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months IPSS ≥15 Maximum urine flow (Qmax) of 5 mL/sec Prostate volume of 30 mL as determined by TRUS Serum prostate-specific antigen (PSA) values <10 ng/mL Post-void residual (PVR) <= 200 mL  Inability to void ≥125 mL urine Prior surgery/MIST for BPH Presence of or history of certain conditions that could interfere with study results or endanger subject Use of certain prescribed medications that could interfere with study results
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 45.0-999.0,  Erectile Dysfunction Benign Prostatic Hyperplasia Men ≥ 45 years of age. 2. Sexually active, with a stable female partner with whom the participant expects to have a relationship for the entire duration of the study. 3. The participant has benign prostatic hyperplasia with lower urinary tract symptoms (BPH-LUTS) according to clinical diagnostic with ≥ 6 months of evolution at the screening visit. 4. Clinical history of erectile dysfunction (ED) (defined as the inability to achieve or maintain the penile erection to achieve a satisfactory sexual relationship) of at least 3 months of evolution. 5. Freely given informed consent at the screening visit (an essential requirement to participate in the study). 6. Bladder obstruction defined by maximal flow rate (Qmax) of 4-15 mI/sec (with a premicturition volume of 150 to 550 mL evaluated by ultrasound, with a minimum micturition volume of 125 mL) at Visit I immediately prior to active treatment initiation. 7. Total score of ≥ 13 points in the InternationaI Prostate Symptom Score (IPSS) questionnaire at Visit 1, immediately prior to active treatment initiation  Participants that are currently taking nitrates, antiandrogens, estrogens, luteninizing hormone-releasing hormone agonist/antagonist, or anabolic steroids at study entry. Participants that are taking a stable dose level of testosterone are not excluded. 2. Post-void residual (PVR) volume ≥ 300 mL, as assessed by ultrasound at the Visit 1. 3. Prostate-specific antigen (PSA) ≥ 10.0 ng/mL at the Visit 1. 4. PSA of 4.0 0 ng/ml if free PSA is < 0,25 (25%) at Visit 1. 5. Clinical evidence of prostate cancer. 6. Glycosylated hemoglobin (Hb1Ac) > 10 % at study entry. 7. Patients who have undergone bladder catheterization due to acute urine retention. 8. Medical history or clinical evidence of any pelvic, bladder or urinary tract condition, or urinary retention that, as judged by the urologist, might compromise protocol compliance. 9. Any surgical procedure in the lower urinary tract (including prostate biopsy) within 30 days prior to the Screening Visit
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 40.0-65.0,  Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic  Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage  Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French  Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-65.0,  Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months  Duration of pain less than 6 months Women who were pregnant in the last 12 months
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 45.0-999.0,  Lower Urinary Tract Symptoms Signed informed consent Age 45 or older Medical history of LUTS/BPH Use of a marketed α-blocker for LUTS/BPH in the last 8 weeks LUTS/BPH not adequately controlled by medical therapy with α-blockers Presence of moderate-severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4 week run-in period with tamsulosin 0.4 mg QD) Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS) Qmax < 15 mL/sec based on a minimum void of 125 mL Agree not to use any other approved or experimental BPH or overactive bladder (OAB) medication anytime during the core study Agree to perform follow-up visits even in case of oral treatment discontinuation before study end  Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months PSA ≥ 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must have been ruled out to the satisfaction of the clinical Investigator by an historical biopsy Prostate or bladder cancer, history of pelvic irradiation Active or recurrent urinary tract infections (more than 1 episode in the last 12 months) History of neurogenic bladder or LUTS secondary to neurologic disease Use of self-catheterization for urinary retention Post-void residual urine volume > 200 mL Haematuria which has not been appropriately evaluated to determine safe subject participation Renal insufficiency (serum creatinine >2.0 mg/dL)
Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 40.0-95.0,  Benign Prostate Hyperplasia Urinary Retention Male subjects, over 50 years of age at the time of enrollment. 2. Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates 3. Written informed consent to participate in the study. 4. Ability to comply with the requirements of the study procedures  Previous surgical treatment for BPH 2. Presence of bladder stones 3. History of prostate cancer 4. Prostate size > 150 g 5. History of urethral stenosis or its management 6. Known of suspected neurogenic bladder 7. History of recent hematochezia in the last 3 months 8. Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure 9. Uncorrected coagulopathy 10. Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. 11. Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. 12. Subjects who are uncooperative or cannot follow instructions. 13. Mental state that may preclude completion of the study procedure or obtention of informed consent