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Pharmacy Department
Project numbers
A Pilot Study of Cimetidine-aided Creatinine Clearance to Assess Glomerular Filtration Rate in Children
Development of a Once Daily Aminoglycoside Dosing Nomogram Specific for Critically Ill Patients
A Multiple Drug Interaction Study of Stavudine with Agents for Opportunistic Infections in HIV-infected Patients
Comparison of Asymptomatic Carotid Atherosclerosis between Frequent and Infrequent Blood Donors
The Early Reversibility of Rocuronium Different Doses of Neostigmine
Comparison of a Restrictive and Nonrestrictive Levothyroxine Formulary System
Effects of Niacin-induced Changes in Lp(a) on Fibrinolytic Parameters in Hyperlipidemic Lupus and Membranous Nephropathy Patients
Effects of Thyroid Hormone-induced Changes in LP(a)on Hemostasis in Thyroid Cancer Patients
Development of a Questionnaire to Assess HIV-related Knowledge
The Effect of Ritonavir on the Pharmacokinetics of Meperidine in HIV-negative Subjects
Pharmacokinetics of BID vs. QID Dosing of Sulfadiazine in HIV-infected Patients
INTRAMURAL RESEARCH PROJECT Z01 CL-0042-02 PHAR
October 1, 1997 to September 30, 1998
Title of Project: A Pilot Study of Cimetidine-aided Creatinine Clearance to Assess Glomerular Filtration Rate in Children
Principal Investigator: K.A. Calis, Pharm.D., M.P.H.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: M. Mohassel, Pharm.D., PHAR
Collaborating Units: NIDDK (H.A. Austin III, M.D.)
NCI (S.M. Steinberg, Ph.D.)
NICHD (K. Winer, M.D.)
Staff-Years: 0.1
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
x (a1) Minors
(a2) Interviews
Summary of Work: Determination of early or subtle changes in glomerular filtration rate (GFR) is essential in the management of patients with many renal diseases. GFR is used in making decisions about medical regimens, monitoring disease progression, and initiating and monitoring drug therapy. Inulin clearance is the gold standard procedure used to determine GFR. Creatinine clearance measurements are used to estimate GFR since inulin studies are difficult to perform and expensive. However, creatinine clearance overpredicts GFR because creatinine is also secreted in the renal tubules. Therefore, creatinine clearance measurements are not as sensitive at detecting changes in GFR as is desirable.
Cimetidine is an antiulcer agent that also blocks the tubular secretion of creatinine; thus creatinine acts
like inulin. Cimetidine-aided creatinine clearance studies in adults show an excellent correlation with inulin
clearance and GFR. Therefore, we propose to study the hypothesis that a cimetidine-aided creatinine clearance approximates
inulin clearance and
can be used to assess GFR in children. We hope to enroll patients who are already enrolled in the hypoparathyroid
and cystinosis studies at NIH. These patients are already undergoing two 24-hour creatinine clearance studies.
Patients will be asked to undergo a pretreatment with cimetidine before the second 24-hour creatinine clearance
and then have an inulin clearance study performed. To detect a 20 percent difference between the two creatinine
clearance regimens with 80 percent power and a two-tailed significance level of 0.05, eight available patients
need to be enrolled. Twenty percent is an estimate of the standard deviation. With the data collected, we will
also identify a ratio of cimetidine-aided creatinine clearance to inulin clearance and identify the precision of
that estimate. We will also establish the confidence interval around that estimate. We request enrollment of up
to 14 patients in anticipation of some patients withdrawing from the study. (Return to project
list)
INTRAMURAL RESEARCH PROJECT Z01 CL-0070-02 PHAR
October 1, 1997 to September 30, 1998
Title of Project: Development of a Once Daily Aminoglycoside Dosing Nomogram Specific for Critically Ill Patients
Principal Investigator: G.M. Susla, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: S.C. Piscitelli, R.Ph., PHAR
Collaborating Units: George Wash. Univ. Med. Ctr. (A. Rosenberg, M.D.;
R.B. Becker, M.D.)
Staff-Years: 0.5
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: It has been suggested that peak aminoglycoside concentrations four to eight times the minimum inhibitory concentration (MIC) are necessary to treat infections commonly found in critically ill patients, such as gram-negative sepsis and pneumonia. Consolidating conventional multiple daily doses into a single large daily dose has been proposed to take advantage of aminoglycoside concentration dependent killing and to ensure peak aminoglycoside concentrations above the MIC of organisms. Using once daily aminoglycoside dosing may be a way of attaining high peak concentrations and immeasurable trough concentrations without increased risk of nephrotoxicity and ototoxicity. Recently, Nicolau et al. studied once daily aminoglycosides in 2,184 adult patients, and developed a once daily dosing nomogram using a fixed volume of distribution (Vd) of 0.3 1/kg. However, the study excluded patients with highly variable or altered aminoglycoside pharmacokinetic parameters including critically ill patients. Therefore, this nomogram may not predict aminoglycoside doses in critically ill patients. The rationale for developing a dosing nomogram individualized to the Intensive Care Unit patient is to tailor aminoglycoside therapy using pharmacokinetic parameters specific for critically ill patients to optimize peak serum concentrations while avoiding measurable trough concentrations.
The purpose of this study is to develop a once daily aminoglycoside dosing nomogram specific for critically ill patients.
An initial nomogram has been developed using mean aminoglycoside pharmacokinetic parameters of 134 dosing segments of 94 adult critically ill patients who received single or multiple courses of aminoglycoside therapy during their admission to the Medical Intensive Care Unit. The nomogram recommendations will be prospectively evaluated with aid of serial age of 18 with gram-negative infections needing treatment with aminoglycoside and exclude pediatric patients and patients with changing renal function. The study will be conducted at the National Institutes of Health, W.G. Magnuson Clinical Center, Medical Intensive Care unit and the Clinical Pharmacokinetics Research Laboratory. Due to the low patient census seen in the Clinical Center Medical Intensive Care Unit, the investigators of this study also request the approval of George Washington University Hospital, Medical Intensive Care Unit as an additional site for study. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-0102-03 PHAR
October 1, 1997 to September 30, 1998
Title of Project: A Multiple Drug Interaction Study of Stavudine with Agents for Opportunistic Infections in HIV-infected Patients
Principal Investigator: S. Piscitelli, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Other Personnel: H. Masur, M.D., CCMD
Collaborating Units: LIR/NIAID (M. Polis, M.D.; R.T. Davey, M.D.; J. Falloon, M.D.)
Staff-Years: 0.55
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: This is a drug interaction study in human immunodeficiency virus-infected patients.
The objective of the study is to characterize the pharmacokinetics of stavudine when given alone and in combination
with three commonly used drugs used
in the management of opportunistic infections.
Ten patients were enrolled in the study (one female, nine males). The racial demographics were eight Caucasians, one Hispanic, and one Africa American. The mean CD4 count at enrollment was 62 cells/mm3 (range 9 to 143).
There were two Grade III toxicities. Two patients had neutropenia presumably due to their TMP/SMX prophylaxis. These episodes were resolved by switching the patients to aerosolized pentamidine. Adverse effects by study medication included the following: D4T -- one patient with peripheral neuropathy; clarithromycin -- four patients reporting of "bad taste", three with gastrointestinal symptoms, one with rash; rifabutin -- one rash; fluconazole ganciclovir -- three patients with gastrointestinal symptoms.
As of January 1997, only the D4T levels have been analyzed. Combinations of fluconazole, rifabutine, clarithromycin, and ganciclovir did not significantly alter the peak D4T level, D4T area under the curve, or time to maximum D4T level. This study suggests that these drugs can be safely used concurrently with D4T.
Pharmacokinetics of the concomitant drug levels is currently ongoing. Final results are expected in the next 3 to 4 months.
This study is terminated. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-0113-02 PHAR
October 1, 1997 to September 30, 1998
Title of Project: Comparison of Asymptomatic Carotid Atherosclerosis between Frequent and Infrequent Blood Donors
Principal Investigator: S. Leitman, M.D.
DTM, CC, NIH, Bethesda, MD 20892
Others Personnel: G. Csako, M.D., CP
P. Choyke, M.D., DR
M. Leser, R.D., NUTR
B. Sink, R.N., DTM
X. Fu, R.N., DTM
F. Pucino, Pharm.D., PHAR
Collaborating Units: NHLBI/IR (R. Cannon, M.D.; K. Koh, M.D.; A. Blum, M.D.)
Staff-Years: 0.5
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation of lipoproteins. This observational study will evaluate the association between frequency of blood donationexpected to be associated with relatively reduced body iron stores in frequent donorsand carotid atherosclerosis. The primary outcome variable will be whether the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is greater in infrequent (less than or equal to one donation/year greater than or equal to 5 years) vs. frequent (greater than or equal to four donations/year greater than or equal to 5 years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than 40 years of age, n=20 females greater than 50 years of age) and 60 infrequent (n=40 males greater than 40 years of age, n=20 females greater than 50 years of age) blood donors will be recruited for this study from the Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be assessed for study eligibility and cardiovascular risks during the screening visit. The presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters will be assessed during a second visit. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-0122-02 PHAR
October 1, 1997 to September 30, 1998
Title of Project: The Early Reversibility of Rocuronium Different Doses of Neostigmine
Principal Investigator: G.M. Susla, Pharm.D. PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: K.S. Williams, M.D., ANES
S.W. Menis, M.D., ANES
Collaborating Units: None
Staff-Years: 0.5
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: Neuromuscular blocking agents are commonly used to facilitate endotracheal intubation. Succinylcholine, a short-acting, depolarizing neuromuscular blocking agent, is the most commonly used agent for paralysis in this setting because of its rapid onset and short duration of paralysis. In patients with contraindications to succinylcholine or in whom a difficult airway is anticipated, a neuromuscular blocking agent with a pharmacodynamic profile similar to succinylcholine would be an attractive alternative. Rocuronium, a new intermediate-acting nondepolarizing neuromuscular blocking agent produces paralysis within 60 seconds, similar to succinylcholine, but has a duration of paralysis of approximately 20 to 30 minutes. If rocuronium-induced paralysis could be chemically reversed within 10 to 15 minutes after the administration of an intubating dose, it may be an appropriate alternative in patients with contraindications to succinylcholine or in patients in whom a difficult airway is anticipated. Neostigmine is an anticholinesterase agent that inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase. Inhibition of the breakdown of acetylcholine allows the neurotransmitter to be present in the neuromuscular junction for a longer period of time, so that each molecule can bind repeatedly with the acetylcholine receptor. The purpose of this study is to determine the dose of neostigmine necessary for the early reversal of rocuronium-induced paralysis. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-05081-03 PHAR
October 1, 1997 to September 30, 1998
Title of Project: Comparison of a Restrictive and Nonrestrictive Levothyroxine Formulary System
Principal Investigators: F. Pucino, Pharm.D.
T. Dorworth, M.S.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: J. Drass, R.N., NURS
G. Csako, M.D., CP
R. Wesley, Ph.D., IS
C. Clark, R.Ph., PHARM
P. Gobel, PHARM
Collaborating Units: LBP/NIDDK (K. Crawford, Ph.D.)
Seattle, WA (P. Ketteridge, R.Ph.)
Lexington, KY (K. Ain, M.D.)
Staff-Years: 0
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
x (a1) Minors
x (a2) Interviews
Summary of Work: Levothyroxine is a thyroid hormone product which is commerically available in 11 different dose strengths, of which only five strengths are permissible on the hospital formulary. The purpose of this prospective, randomized controlled trial is to determine whether limiting dosage strengths of levothyroxine, affects physicians' ability to effectively manage patients. This trial will assign participating endocrinologists from the NICHD and NIDDK outpatient clinics to restrictive (25, 50, 100, 125, and 150 ug dosage formulations permitted) or nonrestrictive (25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 ug dosage formulations permitted) levothyroxine prescribing groups. Success in achieving therapeutic objectives as measured by thyroid function studies and clinic visits, medication distribution accuracy, and inventory cost will be compared statistically between groups.
Preliminary results from 241 patients of 33 endocrinologists suggest that the differences in therapeutic success between restricted and nonrestricted thyroid patients were not clinically significant. The compliance, frequency of thyroid function tests, clinical visits and medication errors were also similar. The restricted formulary, however, was significantly more often associated with complex levothyroxine dosing regimens. Futher, the inventory and prescription costs were slightly lower with use of the nonrestrictive formularly system. Presently 890 patients are followed in this protocol.
This study is terminated. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-05084-05 PHAR
October 1, 1997 to September 30, 1998
Title of Project: Effects of Niacin-induced Changes in Lp(a) on Fibrinolytic Parameters in Hyperlipidemic Lupus and Membranous Nephropathy Patients
Principal Investigator: F. Pucino, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: K. Goad, M.D., CP
H. Gnalnick, M.D., CP
C. Yarboro, R.N., NURS
Collaborating Units: NHLBI/MD (J. Hoef, M.D.)
NIAMS/SARB (J. Pando, M.D.)
NIAMS/ARB (J.H. Klippel, M.D.)
FDA/NIAMS (D. Scott, M.D.)
FDA/NHLBI (T. Eggerman, M.D.)
Univ. of Montana (L.R. Macklin, Pharm.D.)
Staff-Years: 0.1
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: Systemic lupus erythematosus (SLE) is a relatively common rheumatologic condition affecting one in 700 females. Besides SLE, another autoimmune disorder is idiopathic membranous nephropathy which is the most common primary cause of nephrotic syndrome in adults in Western societies. Both SLE and membranous nephropathy are associated with an increased risk of coronary artery disease (CAD) and thrombotic events. Hypercholesterolemia, common to these autoimmune diseases, is a risk factor for CAD. Additionally, elevated levels of Lp(a), an independent risk factor for CAD in the general population, are also frequently seen in these patient populations. Lp(a) is a low-density plasma lipoprotein composed of lipids and two major protein components, apolipoprotein (apo) B-100 and apo (a). Apo(a) has structural similarities to plasminogen, but is not a protease zymogen. Several studies have shown that Lp(a) competes with plasminogen for the cellsurface binding sites that are necessary for tissue-type plasminogen activator (t-PA) to cleave plasminogen to plasmin. Additionally, elevated levels of Lp(a) may be a risk factor for thrombotic events, as increased levels have been associated with cerebrovascular disease.
This study will evaluate the effects of niacin-induced changes in cholesterol and Lp(a) on fibrinolytic parameters (FP). This open-label, parallel-design pilot trial involves a total of 30 patients who have SLE and/or membranous nephropathy with hyperlipidemia (15 with and 15 without elevated Lp(a) greater than or equal to 25mg/dL). Patients will receive niacin 3 g/day for a 6-week period following an initial 4-week titration period. FP will be assessed at baseline, at weeks 2 and 4 of the titration period, and at weeks 7 and 10 of full-dose niacin therapy. Niacin therapy will then be discontinued, and FP will be reassessed in 6 weeks.
This study is terminated. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-05085-05 PHAR
October 1, 1997 to September 30, 1998
Title of Project: Effects of Thyroid Hormone-induced Changes in LP(a) on Hemostasis in Thyroid Cancer Patients
Principal Investigators: F. Pucino, Pharm.D.
K. Sing, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: K. Goad, M.D., CP
G. Csako, M.D., CP
D. Blum, R.N., NURS
R. Wesley, Ph.D., IS
H. Granlnick, M.D., CP
P. Merryman, CP
Collaborating Units: NIDDK (Monica Skarulis, M.D.)
FDA (A. Patterson, M.D.; T. Eggerman, M.D.)
Staff-Years: 0.1
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: LP(a) is a low-density lipoprotein that is structurally similar to plasminogen. Although it competes for plasminogen binding sites, it is not cleaved to plasmin by t-PA. In vitro studies suggest an association between elevated LP(a) serum concentrations and altered fibrinolysis. In vivo data is lacking. Thyroid hormones stimulate synthesis, mobilization, and degradation of plasma lipids, including Lp(a). The natural course of current thyroid cancer management predisposes patients to definite and often extreme fluctuations in thyroid hormone levels, making this population potentially useful for observing maximal thyroid hormone-induced changes in Lp(a). This open-label, pilot trial involves a total of 26 thyroid cancer patients receiving levothyroxine suppression therapy who are scheduled for radioiodine scanning. The study will evaluate the effects of thyroid hormone-induced changes in plasma Lp(a) concentration on hemostasis. Patients will discontinue levothyroxine and triiodothyronine therapy 6 and 2 weeks prior to the thyroid scan, respectively. Hemostatic parameters will be assessed at baseline (while receiving suppression therapy), at the time of scan (clinically hypothyroid), and after weeks 1 and 6 of restarting full-dose thyroid hormone treatment.
This study is terminated. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-05087-01 PHAR
June 19, 1998 to September 30, 1998
Title of Project: Development of a Questionnaire to Assess HIV-related Knowledge
Principal Investigator: A.K. Pau, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Other Personnel: R.B. Slone, Pharm.D., PHAR
Collaborating Units: LIR/NIAID (J.M. Mican, M.D.)
Staff-Years: 0.25
Human Subjects: (a) Human subjects (b) Human tissues x (c) Neither
(a1) Minors
x (a2) Interviews
Summary of Work: Major advances in the treatment of human immunodeficiency virus (HIV) infection have recently been made. Highly active antiretroviral therapy (HAART) has made it possible to reduce the quantity of plasma HIV-1 RNA to levels below the detection limits of currently available assays. However, for optimum and persistent viral load reduction, patients are required to adhere to complex drug regimens. Suboptimal adherence to HAART may result in viral load increases and the emergence of drug-resistant strains of HIV-1. Long-term effectiveness of these drugs will not be possible if viral resistance occurs. We postulate that a good understanding of the rationale of HAART and the risks and consequences of viral resistance from medication nonadherence are essential incentives to encourage adherence to these tedious regimens. Patient education is a crucial part of the management of HIV infection. Educational efforts may be augmented by using validated instruments to assess HIV-related knowledge.
The objective of this study is to develop and validate a questionnaire for use in HIV-infected individuals to assess their knowledge of HIV infection and its drug therapy. Such an instrument would enable health educators to determine a patient's baseline knowledge and develop a patient-specific plan for education. The HIV Knowledge Questionnaire (HKQ) consists of two sections (drug therapy and disease state) of multiple-choice questions. In order to evaluate the ability of the HKQ to differentiate between individuals with varying degrees of HIV-related knowledge, each section of the HKQ has been administered to two groups of nonHIV-infected individuals consisting of medical experts and individuals with limited HIV-related knowledge. To date, 27 medical experts and 185 individuals with limited HIV-related knowledge have completed the HKQ. Data analysis will begin when the required number of individuals have completed the HKQ (47 experts, 192 individuals with limited HIV-related knowledge). (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-05088-01 PHAR
October 1, 1998 to September 30, 1998
Title of Project: The Effect of Ritonavir on the Pharmacokinetics of Meperidine in HIV-negative Subjects
Principal Investigator: S.C. Piscitelli, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: A. Pau, Pharm.D., PHAR
Collaborating Units: NIAID; OP8 clinic, 11West day hospital
(D. Rock-Kress, R.N.; R.T. Davey, M.D.)
CCMD (H. Masur, M.D.)
Staff-Years: 0.5
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: Human immunodeficiency virus (HIV)-infected patients may require administration of meperidine for pain control or chills and rigors associated with interleukin-2 or amphotericin B. Ritonavir (Norvir) is a protease inhibitor that is a potent inhibitor of cytochrome P-450, the major enzyme system involved in drug metabolism. The combination of ritonavir and meperidine could theoretically lead to increased meperidine concentrations and toxicity, and thus, their concomitant administration is contraindicated. This study will characterize the pharmacokinetics of meperidine and its major metabolite, nor-meperidine, in eight HIV-negative, healthy patients. Subjects will receive a 50 mg dose of PO meperidine on day 0 of the study. Serial samples will be drawn over 48 hours for determination of meperidine and nor-meperidine concentrations. Ritonavir will be initiated on day 2 and escalated to a dose of 500 mg BID over 5 days. After a total of 10 days of ritonavir, a 50 mg PO dose of meperidine will again be administered and samples will be collected over 72 hours while continuing ritonavir through the sampling period. Maximum blood level, time to maximum blood level, area under the curve, and clearance will be compared between the two groups. The study will provide data on meperidine disposition in patients receiving concomitant ritonavir. Currently, subject enrollment and study has been completed and data are being analyzed. (Return to project list)
INTRAMURAL RESEARCH PROJECT Z01 CL-05089-01 PHAR
October 1, 1997 to September 30, 1998
Title of Project: Pharmacokinetics of BID vs. QID Dosing of Sulfadiazine in HIV-infected Patients
Principal Investigator: S.C. Piscitelli, Pharm.D.
PHAR, CC, NIH, Bethesda, MD 20892
Others Personnel: W. Knebel, Pharm.D, PHAR
Collaborating Units: NIAID; OP8 clinic, 11West day hospital
NIAID (R. Davey, M.D.; R. Walker, M.D.;
J. Falloon, M.D.; M. Polis, M.D.)
CCMD, NIH (H. Masur, M.D.; J. Kovacs, M.D.)
Staff-Years: 0.5
Human Subjects: x (a) Human subjects (b) Human tissues (c) Neither
(a1) Minors
(a2) Interviews
Summary of Work: This study is an open-label, randomized, cross-over study to compare the pharmacokinetics of sulfadiazine given on a twice daily or four times daily schedule. Ten human immunodeficiency virus-infected patients with CD4 counts below 500 will be enrolled. Patients must not have concurrent opportunistic infections and must be willing to comply with the study regimen. The study is designed to compare pharmacokinetic parameters and serum concentrations of sulfadiazine at two doses: 1000mg QID and 2000mg BID. Additionally, this study will assess the safety and tolerability of these dosage regimens. Currently, the study has received IRB approval and will begin enrolling within the next 1 to 2 months. (Return to project list)