West Coast Clinical Trials

West Coast Clinical Trials has the equipment and experts to provides a variety of specialized procedures carefully coordinated with the clinical pharmacology aspects of Phase I-IIa studies. The attention to detail in conducting these procedures is what sets West Coast Clinical Trials apart.

Cardiovascular

• Echocardiograms
  
  A test in which ultrasound is used to examine the heart. It allows accurate measurement of the heart chambers and offers far more sophisticated imaging. The echocardiograph is capable of displaying a cross-sectional “slice” of the beating heart, including the chambers, valves and the major blood vessels that exit from the left and right ventricles.
• Holter Monitoring
  
  A device for making prolonged electrocardiograph (ECG) recordings on a portable flash memory device. The monitor is usually worn for 24 – 48 consecutive hours during normal activity. Since the recording is done on a continuous basis, Holter monitoring is much more likely to detect an abnormal heart rhythm when compared to the EKG which lasts less than a minute and is administered under controlled conditions.
• Multiple / Serial Electrocardiograms (ECG)
  
  An electrocardiogram (EKG or ECG) is a recording of the heart’s electrical activity as a graph or series of wave lines on a moving strip of paper. This gives the physician important information about the electrical conduction system of the heart. Many pathological conditions can be identified using ECGs including those caused by genetic, life style, or toxicological etiologies.
• Platelet Aggregometry
  
  Platelet aggregometry is a functional test performed on whole blood or platelet-rich plasma. An agonist (platelet activator) is added to the suspension as a positive control and a dynamic measure of platelet clumping is recorded. ATP release is simultaneously measured using a luminescence marker. The test is used to assess the effects of a study drug on platelet aggregation.
• Pulse Oximetry
  
  The technique is used intermittently or continuously to non-invasively monitor oxygen saturation. A photo detector slipped over the finger measures transmitted light as it passes through the vascular bed, detects the relative amount of color absorbed by arterial blood, and calculates exact mixed venous oxygen saturation without interference from sur¬rounding venous blood, skin, connective tissue, or bone.
• Telemetry
  
  Telemetry is a way to send data electronically from one point to another. In the telemetry unit, instruments record electronic data related to each patient. The instruments then send this data to a central area where it can be displayed on monitors for staff to observe. This allows staff to simultaneously monitor the hearts of multiple patients at once. Heart rhythms are continuously measured and data relayed to computers. Specially trained technicians monitor the computers.

Respiratory

• Allergen bronchial challenges
  
  Is used to detect allergic asthma at times when no symptoms are present. It can diagnose occupational asthma when the allergen is unknown; can evaluate response to workplace allergens. If allergic asthma is present, exposure to the allergen will cause constriction of the bronchial tubes. The resulting decrease in lung function can be measured with a spirometer.
• Bronchoscopy with BAL
  
  A bronchoscopy is a diagnostic procedure in which a tube with a tiny camera on the end is inserted through the nose or mouth into the lungs. The procedure provides a view of the airways of the lung and allows doctors to collect lung fluids. Bronchoalveolar Lavage (BAL) uses salt water saline to flush the area and collect cells to be analyzed. BAL is performed to obtain a sample of the cells, fluids, and other materials present in the very small alveoli (air sacs).
• Methacholine Challenge
  
  A methacholine challenge is a test to determine if you have asthma. It is performed by inhaling a medication (methacholine) in increasing doses in an attempt to produce a change in your pulmonary function test results.
• Nasal challenges and lavages
  
  The nasal challenge test is for confirming/excluding allergic rhinitis and causative allergens and involves applying a small amount of allergen solution directly to the nares.
  Nasal lavage is a noninvasive method of obtaining inflammatory exudates following nasal allergen challenge (NAC), and permits cells and released mediators to be evaluated.
• Nitric Oxide
  
  An exhaled nitric oxide test is a specialized tests that can be used to check for asthma. A nitric oxide test involves breathing into a mouthpiece attached to a machine that can measure the level of nitric oxide in your breath. Nitric oxide gas is produced by the body normally, but high levels in your breath can mean your airways are inflamed — a possible sign of asthma.
• Pulmonary Function Tests
  
  Pulmonary function tests are a group of tests that measure how well the lungs take in and release air and how well they move gases such as oxygen from the atmosphere into the body’s circulation.
• Sputum Induction
  
  Sputum induction is used to obtain sputum for diagnostic purposes. The procedure uses sterile water or hypertonic saline to irritate the airway, increase secretions, promote coughing, and produce a specimen.

Ophthalmology

• Corneal Staining
  
  A piece of blotting paper containing the dye will be touched to the surface of your eye. You will be asked to blink. Blinking spreads the dye around and coats the “tear film” covering the surface of the cornea a blue light is then directed at your eye. Any problems on the surface of the cornea will be stained by the dye and appear green under the blue light.
• Endothelial cell count
  
  Corneal endothelial microscopy involves the use of a specular microscope to visualize the cornea and perform an endothelial cell count. The cornea consists of several layers, including the epithelium, stroma, and single-celled endothelium. The endothelium is the most posterior layer, interfacing with the aqueous humor of the anterior chamber of the eye.
• Gonioscopy
  
  Gonioscopy describes the use of a goniolens (also known as a gonioscope) in conjunction with a slit lamp or operating microscope to gain a view of the iridocorneal angle, or the anatomical angle formed between the eye’s cornea and iris. The importance of this process is in diagnosing and monitoring various eye conditions associated with glaucoma.
• IOP measurements: sitting and supine
  
  Between the cornea and the lens, which is located behind the cornea, there is a clear fluid that helps keep the eye healthy. If there is too much pressure or fluid in the eye, the optic nerve can become damaged. This can result in decreased vision.
  Intraocular pressure (IOP) varies significantly during the wake–sleep cycle It is known that a simple postural change from upright to recumbent elevates IOP, because of the hydrostatic responses in the episcleral venous pressure and the distribution of body fluid.
• Pachymetry
  
  The pachymeter is an instrument that measures the thickness of the cornea. It is useful in monitoring the progression of certain disorders that cause the cornea to become thickened (or filled with water), resulting in a loss of vision.
• Pupillometry
  
  Measurement of the diameter or width of the pupil of the eye.
• Slit lamp assessments
  
  The slit lamp is an instrument consisting of a high-intensity light source that can be focused to shine a thin sheet of light into the eye. It is used in conjunction with a biomicroscope. The lamp facilitates an examination of the human eye, which includes the eyelid, sclera, conjunctiva, iris, natural crystalline lens, and cornea. The binocular slit-lamp examination provides stereoscopic magnified view of the eye structures in detail, enabling anatomical diagnoses to be made for a variety of eye conditions.
• Visual Acuity
  
  Visual Acuity is a quantitative measure of the ability to identify black symbols on a white background at a standardized distance as the size of the symbols is varied. It is the most common clinical measurement of visual function. In the term “20/20 vision” the numerator refers to the distance in feet from which a person can reliably distinguish a pair of objects.
• Visual Field examinations
  
  The visual field refers to the total area in which objects can be seen in the side (peripheral) vision while you focus your eyes on a central point. The exam can be performed using different methods and equipment.

Biopsies

• Liver
  
  A diagnostic procedure in which a special needle is introduced into the liver under local anesthesia to obtain a specimen for pathologic examination.
• Bronchial Biopsy via bronchoscopy
  
  A bronchoscopy is a diagnostic procedure in which a tube with a tiny camera on the end is inserted through the nose or mouth into the lungs. The procedure provides a view of the airways of the lung and allows doctors to collect lung fluids, or air tube samples by biopsy (a small pinch of tissue about the size of the head of a pin), or airway cells recovered by brushing the air tube.
• Bone marrow bopsy and aspirate
  
  Bone marrow examination refers to the pathologic analysis of samples of bone marrow obtained by bone marrow biopsy (often called a trephine biopsy) and bone marrow aspiration.
  Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. However, an aspirate can also be obtained from the sternum (breastbone).
• Skin punch biopsy
  
  This is done with a round shaped knife ranging in size from 1mm to 8 mm. Some punch biopsies are shaped like an ellipse, although one can accomplish the same desired shape with a standard scalpel. Ideally, the punch biopsy includes the full thickness skin and subcutaneous fat.
• Muscle Core biopsy
  
  A core needle biopsy is a procedure that removes small but solid samples of tissue using a hollow “core” needle. The core biopsy needle has a special cutting edge allowing removal of a bigger sample of tissue. With core needle biopsy a relatively large sample can be removed through a small single incision in the skin. A core needle biopsy procedure takes a few minutes to perform and is almost painless.

Body Fluid collections

• 24 hour urine collections
  
  24-hour urine collection is a simple diagnostic procedure that measures the components of urine. The test is noninvasive (the skin is not pierced).Twenty-four hour urine collection is performed by collecting a person’s urine in a special container over a 24-hour period. The container must be kept cool during this time until it is returned to the lab for analysis
• Continuous CSF collection
  
  Cerebrospinal fluid (CSF) collection is a test to look at the fluid that surrounds the brain and spinal cord. Cerebrospinal fluid acts as a cushion, protecting the brain and spine from injury. The fluid is normally clear. The test can also be used to measure pressure in the spinal fluid. There are different ways to get a sample of CSF. Lumbar puncture, commonly called a spinal tap, is the most common method.
• Fecal effluent collections
  
  A rectal effluent collection is the process of collecting fecal effluent from a subject. This can be as simple as a stool specimen or as expanded as collecting all of the fecal effluent for a specified amount of time.
• Saliva collection
  
  Saliva testing is convenient because it allows samples to be collected in a non-invasive manner, and on a repeated basis.
• Sperm Collection
  
  Semen collection refers to the process of obtaining semen from humans with the use of various methods, for the purposes of medical study.

Radiologic procedures

• CT Scans
  
  A computerized axial tomography scan is an x-ray procedure that combines many x-ray images with the aid of a computer to generate cross-sectional views and, if needed, three-dimensional images of the internal organs and structures of the body. Computerized axial tomography is more commonly known by its abbreviated names, CT scan or CAT scan. A CT scan is used to define normal and abnormal structures in the body and/or assist in procedures by helping to accurately guide the placement of instruments or treatments.
• Dexa Scans
  
  Bone density scanning, also called dual-energy x-ray absorptiometry (DXA) or bone densitometry, is an enhanced form of x-ray technology that is used to measure bone loss. DXA is today’s established standard for measuring bone mineral density (BMD).
• Mammogram
  
  Mammography is the process of using low-dose amplitude-X-rays (usually around 0.7 mSv) to examine the human breast and is used as a diagnostic as well as a screening tool.
• MRI Scans
  
  Magnetic resonance imaging (MRI), or nuclear magnetic resonance imaging (NMRI), is primarily a medical imaging technique most commonly used in radiology to visualize detailed internal structure and limited function of the body. MRI provides much greater contrast between the different soft tissues of the body than computed tomography (CT) does, making it especially useful in neurological (brain), musculoskeletal, cardiovascular, and oncological (cancer) imaging.
• Transvaginal ultrasounds
  
  Transvaginal ultrasound is a type of pelvic ultrasound. It is used to look at a woman’s reproductive organs, including the uterus, ovaries, cervix, and vagina. Transvaginal means across or through the vagina.

Pediatric growth procedures

• 24 hour urine collections
  
  24-hour urine collection is a simple diagnostic procedure that measures the components of urine. The test is noninvasive (the skin is not pierced).Twenty-four hour urine collection is performed by collecting a person’s urine in a special container over a 24-hour period. The container must be kept cool during this time until it is returned to the lab for analysis.
• Cortosyn stimulation testing
  
  ACTH (Cortrosyn) stimulation test measures the ability of the adrenal cortex to respond to ACTH by producing cortisol appropriately. ACTH is a hormone produced in the pituitary gland that stimulates the adrenal glands.
• Stadiometry
  
  A stadiometer is an accurate and reproducible way to measure height in mm’s for pediatric and adults studies.

Other

• Continuous glucose monitoring in clamp studies
  
  Blood glucose monitoring is a way of testing the concentration of glucose in the blood (glycemia). A tiny glucose-sensing device called a “sensor” is inserted just under the skin of your abdomen. Tape is used to hold it in place. The sensor measures the level of glucose in the tissue and sends the information via a wire to a pager-sized device called a “monitor” that you attach to a belt or the waistline of your pants.
• FACS
  
  Flow Cytometry (FACS) is a technique for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid and passing them by an electronic detection apparatus. It allows simultaneous multiparametric analysis of the physical and/or chemical characteristics of up to thousands of particles per second.