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ClinData Services, Inc.

3100 John Hinkle Place, Suite 105

Bloomington, Indiana 47408

Phone: 812.330.2766

Fax: 812.330.2768

Email: rbell@clindataservices.com


ClinData Services, Inc. provides data management systems and processes that are fully validated and compliant with 21 CFR Part 11, HIPAA and Data Protection Acts requirements.

Publications

Publications:

 

1. Izumi R, Hurt J, Maki KC, Bell M, Zavras AI, McCamish M. Clinical predictors of glycosylated hemoglobin

responses to thiazolidinedione therapy. Diabetes Care. 2007;(submitted).

 

2. Ansell BJ, Fonarow GC, Maki KC, Dicklin MR, Bell M, Davidson MH. Reduced treatment success in lipid

management among women with coronary heart disease or risk equivalents: results of a national survey. Am

Heart J. 2006;152:976-981.

 

3. Maki KC, Van Elswyk ME, McCarthy D, Hess SP, Veith PE, Bell M, Subbaiah P, Davidson MH. Lipid

responses to a dietary docosahexaenoic acid supplement in men and women with low levels of high density

lipoprotein cholesterol. J Am Coll Nutr. 2005; in press

 

4. Maki KC, Davidson MH, Ingram K, Veith P, Bell M, Gugger E. Lipid responses to consumption of a beta-

glucan containing ready-to-eat cereal in children and adolescents with mild-to-moderate primary

hypercholesterolemia. Nutrition Research. 2003;23:1527-35.

 

5. Maki KC, Davidson MH, Dicklin MR, Cyrowski M, Umporowicz DM, Bell M, Elliott JG. Bioavailability of

eicosapentaenoic and docosahexaenoic n-3 polyunsaturated fatty acids in salmon patties versus capsules.

Journal of Food Science. 2003:68:761-766.

 

6. Maki KC, Davidson MH, Tsushima R, Noboru M, Tokimitsu I, Umporowicz DM, Dicklin MR, Foster GS,

Ingram KA, Anderson BD, Frost SD, Bell M. Consumption of diacylglycerol oil as part of a mildly reduced-

energy diet enhances loss of body weight and fat compared with a triacylglycerol control oil. Am J Clin Nutr.

2002 Dec;76(6):1230-6.

 

Abstracts:

 

1. Izumi R, Hurt J, Maki KC, Bell M, Zavras AI, McCamish M. Clinical Predictors of Glycosylated

Hemoglobin Responses to Thiazolidinedione Therapy. Circulation 2007 (in press).

 

2. Maki KC, Carson ML, Miller MP, Turowski M, Wilder DM, Bell M, Ratcliff N, Reeves MS. High-viscosity

hydroxypropyl-methylcellulose blunts postprandial glucose and insulin responses. J Am Coll Nutr.

2006;25:464.

 

3. Maki KC, McKenney JM, Dicklin MR, Bell M, Joukova I, Caplan R, Davidson MH. Achievement of

National Cholesterol Education Program non-HDL cholesterol goals in clinical practice: Results of a national

survey. American Heart Association 5th Scientific Forum on Quality of Care and Outcomes Research in

Cardiovascular Disease and Stroke; 2004.

 

4. Maki K, Davidson M, Hess S, Bell M, McCarthy D, Van Elswyk M. Lipid responses to algal-derived

docosahexaenoic acid in men and women with low levels of high density lipoprotein cholesterol. Presented at

American College of Nutrition, 2003.

 

5. Maki KC, Bell M, Oldham KM, Davidson MH. Is hyperfibrinogenemia a component of the metabolic

syndrome? Presented at the American Diabetes Association. 2001.

 

6. Maki KC, Veith PE, Bell M, Dicklin MR, Davidson MH. Low-density lipoprotein subclass pattern B and

adiposity-associated dyslipidemia. Presented at the American College of Nutrition conference. 2001.

 

7. Maki KC, Davidson MH, Tsushima R, Matsuo N, Tokimitsu I, Umporowicz D, Ingram KA, Dicklin MR,

Bell M, Anderson BD, Frost SD, Tagala A. Diacylglycerol oil vs. soybean oil in a weight reduction diet.

Presented at North American Association for the Study of Obesity, 2000.

 

Statistical and/or Clinical Trial Reports (confidential information represented by XXX):

 

1. Maki KC, Bell M, Farmer M. A double-blind, controlled trial to assess the safety, tolerability and

bioavailability of XXX in health adults. Pharmavite LLC, 2005.

 

2. Galant R, Maki KC, Wheeler A, Hess, S, Bell M. A randomized double-blind, double-dummy, placebo-

controlled, phase III study to assess the efficacy and safety of 130 mg of XXX, with and without food, versus

a matching placebo, combined with a low saturated-fat diet in subjects with hypertriglyceridemia and

metabolic syndrome. Reliant Pharmaceuticals, 2004.

 

3. Maki KC, Umporowicz DM, Bell M, Quinn L. A placebo-controlled, randomized, double-blind, parallel-

group, dose-finding, at-home study to evaluate the efficacy and safety of intranasally administered XXX in

subjects with male erectile dysfunction. Palatin Technologies, Inc., 2004

 

4. Maki KC, Umporowicz DM, Bell M, Hess S. A randomized, open label, multicenter, crossover trial of XXX

vs. atorvastatin 10 mg utilization on NCEP ATP III goal achievement in persons with moderate risk for

coronary heart disease: The LAUNCH Study. Reliant Pharmaceuticals, 2003

 

5. Maki KC, Umporowicz DM, Bell M, Dicklin MR. A randomized, double-blind, placebo-controlled trial to

assess the effects of XXX on erectile dysfunction in men with chronic erectile dysfunction. Welch’s, 2003

 

6. Maki KC, Umporowicz DM, Bell M, Cyrowski M. A double-blind, randomized, placebo- controlled clinical

study to evaluate the effect of XXX on body fat mass in overweight or obese men and women. Glanbia,

2002.

 

7. Maki KC, Bookstein M, Hess SH, Umporowicz DM, Bell M. Double-blind, randomized, placebo-

controlled, multicenter trial to demonstrate the efficacy of 12 weeks of treatment with XXX synthetic

conjugated estrogens, XXX on vasomotor symptoms in postmenopausal women. Barr Research, Inc. 2002

 

8. Maki KC, Davidson MH, Dicklin MR, Cyrowski M, Umporowicz DM, Bell M. A comparison of the

bioavailability of omega-3 fatty acids from XXX. Roche Vitamins, Inc. 2001.

 

9. Maki KC, Bell M, Umporowicz DM. A 24-week, randomized, multicenter, multinational trial to evaluate the

efficacy and safety of XXX, alone and in various combinations, in the treatment of type IIb and IV

hyperlipidemia associated with type II diabetes mellitus (DM). AstraZeneca, 2001.

 

10. Maki KC, Bell M, Umporowicz DM. A 30-week, dose-titration and randomized, crossover, multicenter,

multinational trial to evaluate the efficacy and safety of XXX in subjects with homozygous familial

hypercholesterolemia. AstraZeneca, 2001.

 

11. Maki KC, Bell M, Umporowicz DM. A 18-week randomized double-blind multicenter placebo-controlled

trial to evaluate the efficacy and safety of XXX in the treatment of hypercholesterolemic postmenopausal

women receiving hormone replacement therapy (HRT). AstraZeneca, 2001.

 

12. Maki KC, Bell M, Umporowicz DM. A 24-week, randomized, multicenter trial to evaluate the efficacy and

safety of XXX, as well as selected combinations of XXX, in the treatment of subjects with type IIb or IV

hyperlipidemia. AstraZeneca, 2001.

 

13. Maki KC, Bell M, Umporowicz DM. A 24-week, randomized, double-blind, multicenter trial to evaluate the

efficacy and safety of starting and maximum doses of XXX in the treatment of high risk

hypercholesterolemic subjects. AstraZeneca, 2001.

 

14. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, multinational, multicenter trial to

compare the short-term and long-term efficacy and safety of XXX in the treatment of subjects with

hypercholesterolemia. AstraZeneca, 2001.

 

15. Maki KC, Bell M, Umporowicz DM. A 12-week, randomized, double-blind, multicenter trial to evaluate the

efficacy and safety of XXX in the treatment of subjects with hypercholesterolemia. AstraZeneca, 2000.

 

16. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, parallel-group dose-response study with

the HMG CoA reductase inhibitor XXX and placebo in subjects with primary hypercholesterolemia.

AstraZeneca, 2000.

 

17. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, multicenter trial to compare the short-

term and long-term efficacy and safety of XXX in the treatment of subjects with hypercholesterolemia.

AstraZeneca, 2000.

 

18. Maki KC, Bell M, Umporowicz DM. A 24-week, randomized, double-blind, multicenter, multinational trial

to evaluate the efficacy and safety of XXX in the treatment of subjects with heterozygous familial

hypercholesterolemia. AstraZeneca, 2000.

 

19. Maki KC, Bell M, Umporowicz DM. Study of blood cholesterol levels in subjects consuming a cholesterol

lowering diet including XXX. Proctor and Gamble, 2000.

 

20. Maki KC, Bell M, Umporowicz DM. A 12-week, randomized, open-label, multicenter trial to evaluate the

efficacy, safety, and tolerability of XXX and the combination of XXX and XXX in the treatment of subjects

with severe hypercholesterolemia. AstraZeneca, 2000.

 

21. Maki KC, Bell M, Umporowicz DM. A 6-week, randomized, double-blind multicenter trial to evaluate the

safety and efficacy of XXX and XXX across their respective dose ranges in the treatment of subjects with

hypercholesterolemia. AstraZeneca, 2000.

 

22. Maki KC, Bell M, Umporowicz DM. A 12-week, randomized, double-blind, multicenter, placebo-controlled

trial to evaluate the efficacy and safety of XXX in the treatment of subjects with hypertriglyceridemia.

AstraZeneca, 2000.

 

23. Maki KC, Bell M, Umporowicz DM. A double-blind, randomized, parallel, placebo-controlled clinical study

to compare the effects of XXX vs. placebo tablets on vulvovaginal atrophy in healthy postmenopausal

women. Duramed Pharmaceuticals, Inc., 2000.

 

24. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, controlled clinical trial to compare the

lipid responses, in men and women with elevated triglyceride levels, to consumption of eggs laid by chickens

who have eaten docosahexaenoic acid feed vs.control eggs. OmegaTech, 2000.

 

25. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, controlled two-way crossover clinical trial

to evaluate the effectiveness of a test food product for inducing satiety in healthy men and women. General

Mills, 2000.

 

26. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, controlled trial to evaluate the efficacy

and safety of a phytosterol-enriched reduced fat spread for reducing serum low density lipoprotein cholesterol

in subjects with mild-to-moderate primary hypercholesterolemia. Lipton, 2000.

 

27. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, controlled trial to evaluate the safety and

tolerability of three doses of phytosterols in healthy adult men and women. Lipton, 2000.

 

28. Maki KC, Bell M, Umporowicz DM, Davidson MH, Dicklin MR. Effects of consuming econa oil vs.

triglycerides on body composition and regional body fat distribution: a randomized, double-blind, controlled

trial. Kao Corporation, 2000.

 

29. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind clinical trial to evaluate the influence of

XXX on serum lipids in men and women with hypercholesterolemia. Archer Daniels Midland, 1999.

 

30. Maki KC, Bell M, Umporowicz DM. A randomized, double-blind, crossover clinical trial to evaluate the

effects of a XXX product on serum lipids in men and women with hypercholesterolemia. Archer Daniels

Midland, 1999.

 

31. Maki KC, Bell M, Umporowicz DM. Effects of an immune-booster beverage on immune response in

humans. Novartis, 1999.

 

32. Maki KC, Bell M, Umporowicz DM. The effects of a calcium-containing test beverage, compared to control,

on mineral metabolism. Pharmavite, 1999.

 

33. Maki KC, Bell M, Umporowicz DM. The influence of oat products on the postprandial metabolic profile: a

randomized, cross- over, controlled trial. Quaker Oats, 1999.