- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02526524
Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
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Carolina, Portoryko, 00987
- Puerto Rico Renal and Health Research, Inc.
-
Cidra, Portoryko, 00736
- Advanced Medical Concepts
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Manati, Portoryko, 00674
- Manati Center for Clinical Reserach Doctor's Center Hospital
-
-
-
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Alabama
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Anniston, Alabama, Stany Zjednoczone, 36207
- Pinnacle Research Group, LLC
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Birmingham, Alabama, Stany Zjednoczone, 35294
- University of Alabama at Birmingham
-
Birmingham, Alabama, Stany Zjednoczone, 35216
- Achieve Clinical Research, LLC
-
Birmingham, Alabama, Stany Zjednoczone, 35209
- Central Alabama Research
-
Tuscumbia, Alabama, Stany Zjednoczone, 35674
- Terence T. Hart, MD
-
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Arizona
-
Chandler, Arizona, Stany Zjednoczone, 85224
- Radiant Research - Phoenix
-
Glendale, Arizona, Stany Zjednoczone, 85306
- Arrowhead Health Centers
-
Peoria, Arizona, Stany Zjednoczone, 85381
- Holland Center for Family Health, LTD
-
Phoenix, Arizona, Stany Zjednoczone, 85018
- Elite Clinical Studies
-
Phoenix, Arizona, Stany Zjednoczone, 85037
- Thunderbird Internal Medicine - Indian School Rd.
-
Surprise, Arizona, Stany Zjednoczone, 85374
- Clinical Research Institute of Arizona, LLC
-
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Arkansas
-
Fayetteville, Arkansas, Stany Zjednoczone, 72703
- Summit Clinical Trials Center
-
Searcy, Arkansas, Stany Zjednoczone, 72143
- Searcy Medical Center
-
-
California
-
Escondido, California, Stany Zjednoczone, 92025
- Advanced Metabolic Care & Research Institute (AMCR)
-
Fountain Valley, California, Stany Zjednoczone, 92708
- MD Studies, Inc.
-
Huntington Park, California, Stany Zjednoczone, 90255
- National Research Institute
-
La Jolla, California, Stany Zjednoczone, 92037
- Scripps Whittier Diabetes Institute
-
Lincoln, California, Stany Zjednoczone, 95648
- Clinical Trials Research
-
Long Beach, California, Stany Zjednoczone, 90806
- Collaborative Neuroscience Network, LLC
-
Los Angeles, California, Stany Zjednoczone, 90057
- National Research Institute
-
Montclair, California, Stany Zjednoczone, 91763
- Catalina Research Institute
-
National City, California, Stany Zjednoczone, 91950
- SRSD, Inc. dba Synergy San Diego
-
North Hollywood, California, Stany Zjednoczone, 91606
- Providence Clinical Research
-
Oakland, California, Stany Zjednoczone, 94607
- Pacific Research Partners, LLC
-
Orange, California, Stany Zjednoczone, 92868
- SDS Clinical Trials, Inc.
-
Sacramento, California, Stany Zjednoczone, 95825
- Superior Research LLC
-
Sacramento, California, Stany Zjednoczone, 95823
- Center for Clinical Trials of Sacramento
-
Sacramento, California, Stany Zjednoczone, 95823
- Center for Clinical Trials of Scaramento
-
Santa Ana, California, Stany Zjednoczone, 92705
- Syrentis Clinical Research (formerly Research Across America)
-
Spring Valley, California, Stany Zjednoczone, 91978
- Encompass Clinical Research
-
Tustin, California, Stany Zjednoczone, 92780
- Clinical Trial Investigators
-
Van Nuys, California, Stany Zjednoczone, 91405
- Infosphere Clinical Research
-
-
Colorado
-
Colorado Springs, Colorado, Stany Zjednoczone, 80906
- Colorado Springs Health Partners
-
Denver, Colorado, Stany Zjednoczone, 80209
- Creekside Endocrine Associates
-
-
Florida
-
Brooksville, Florida, Stany Zjednoczone, 34601
- Meridien Research - Brooksville
-
Cooper City, Florida, Stany Zjednoczone, 33024
- ALL Medical Research, LLC
-
Hialeah, Florida, Stany Zjednoczone, 33012
- Neostart Corporation dba AGA Clinical Trials
-
Jacksonville, Florida, Stany Zjednoczone, 32277
- Care Partners Clinical Research
-
Jupiter, Florida, Stany Zjednoczone, 33458
- Health Awareness, Inc.
-
Kissimmee, Florida, Stany Zjednoczone, 34741
- Family Health Care Clinical Studies
-
Lakeland, Florida, Stany Zjednoczone, 33810
- Clinical Research of Central Florida-Lakeland
-
Miami, Florida, Stany Zjednoczone, 33014
- Clinical Pharmacology of Miami, Inc.
-
Miami, Florida, Stany Zjednoczone, 33173
- Tellus Clinical Research, Inc.
-
Miami, Florida, Stany Zjednoczone, 33183
- Internal Research Associates LLC - Breton
-
Orlando, Florida, Stany Zjednoczone, 32801
- Clinical Neuroscience Solutions, Inc. Healthcare Orlando
-
Ormond Beach, Florida, Stany Zjednoczone, 32174
- Ormond Medical Arts Pharmaceutical Research Center
-
Pembroke Pines, Florida, Stany Zjednoczone, 33026
- Private Practice - Andres Patron, DO
-
Port Orange, Florida, Stany Zjednoczone, 32127
- Progressive Medical Research
-
Saint Petersburg, Florida, Stany Zjednoczone, 33709
- Meridien Reserach - St. Petersburg
-
Tampa, Florida, Stany Zjednoczone, 33634
- Meridien Research - Tampa
-
Tampa, Florida, Stany Zjednoczone, 33607
- Clinical Reserch Trials of Florida
-
West Palm Beach, Florida, Stany Zjednoczone, 33401
- Metabolic Research Institute, Inc.
-
-
Illinois
-
Addison, Illinois, Stany Zjednoczone, 60101
- Biofortis, Inc.
-
Aurora, Illinois, Stany Zjednoczone, 60506
- AMR Sakeena Research
-
Chicago, Illinois, Stany Zjednoczone, 60607
- Cedar-Crosse Research Center
-
Evanston, Illinois, Stany Zjednoczone, 60201
- Evanston Premier Healthcare Research LLC
-
-
Indiana
-
Valparaiso, Indiana, Stany Zjednoczone, 46383
- Buynak Clinical Research, PC
-
-
Iowa
-
West Des Moines, Iowa, Stany Zjednoczone, 50266
- The Iowa Clinic; Cardiovascular Services
-
-
Kansas
-
Augusta, Kansas, Stany Zjednoczone, 67010
- Heartland Research Associates, LLC - Augusta
-
Topeka, Kansas, Stany Zjednoczone, 66606
- Cotton-O'Neil Clinical Research Center
-
-
Kentucky
-
Edgewood, Kentucky, Stany Zjednoczone, 41017
- Otrimed
-
Lexington, Kentucky, Stany Zjednoczone, 40503
- Kentucky Diabetes Endocrinology Center
-
Louisville, Kentucky, Stany Zjednoczone, 40213
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
-
Paducah, Kentucky, Stany Zjednoczone, 42003
- Four Rivers Clinical Research
-
-
Louisiana
-
Crowley, Louisiana, Stany Zjednoczone, 70526
- Avant Research Associates
-
Lake Charles, Louisiana, Stany Zjednoczone, 70601
- Centex Studies, Inc. - Lake Charles
-
-
Maryland
-
Columbia, Maryland, Stany Zjednoczone, 21045
- Columbia Medical Practice
-
Hyattsville, Maryland, Stany Zjednoczone, 20782
- Medstar Health Research Institute
-
Oxon Hill, Maryland, Stany Zjednoczone, 20745
- MD Medical Research
-
-
Massachusetts
-
Quincy, Massachusetts, Stany Zjednoczone, 02169
- Beacon Clinical Research
-
-
Minnesota
-
Edina, Minnesota, Stany Zjednoczone, 55435
- Radiant Research - Edina
-
-
Mississippi
-
Port Gibson, Mississippi, Stany Zjednoczone, 39150
- Planters Clinic
-
-
Montana
-
Butte, Montana, Stany Zjednoczone, 59701
- Mercury Street Medical Group, PLLC
-
-
Nebraska
-
Omaha, Nebraska, Stany Zjednoczone, 68114
- Quality Clinical Research, Inc.
-
Omaha, Nebraska, Stany Zjednoczone, 68134
- Heartland Clinical Research
-
-
Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89119
- AB Clinical Trials
-
Las Vegas, Nevada, Stany Zjednoczone, 89101
- Alliance Against Diabetes
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Palm Medical Research
-
Las Vegas, Nevada, Stany Zjednoczone, 89146
- Ingham Neuroscience Group, LLC
-
-
New Jersey
-
Berlin, New Jersey, Stany Zjednoczone, 08009
- Comprehensive Clinical Research
-
-
New Mexico
-
Albuquerque, New Mexico, Stany Zjednoczone, 87109
- Albuquerque Neuroscience, Inc.
-
Albuquerque, New Mexico, Stany Zjednoczone, 87102
- Albuquerque Clinical Trials
-
-
New York
-
Brooklyn, New York, Stany Zjednoczone, 11235
- NY Scientific
-
Great Neck, New York, Stany Zjednoczone, 11023
- Long Island Gastrointestinal Research Group
-
Hopewell Junction, New York, Stany Zjednoczone, 12533
- Mid-Hudson Medical Research, PLLC
-
Westfield, New York, Stany Zjednoczone, 14787
- Great Lakes Medical Research
-
-
North Carolina
-
Greensboro, North Carolina, Stany Zjednoczone, 27408
- PharmQuest
-
Greensboro, North Carolina, Stany Zjednoczone, 27410
- Triad Clinical Trials LLC
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Rocky Mount, North Carolina, Stany Zjednoczone, 27804
- PMG Research of Rocky Mount
-
Salisbury, North Carolina, Stany Zjednoczone, 28144
- PMG Research of Salisbury, LLC
-
Wilmington, North Carolina, Stany Zjednoczone, 28401
- PMG Research of Wilmington, LLC
-
-
Ohio
-
Cincinnati, Ohio, Stany Zjednoczone, 45242
- New Horizons Clinical Research
-
Cincinnati, Ohio, Stany Zjednoczone, 45219
- Sterling Research Group, Ltd
-
Cincinnati, Ohio, Stany Zjednoczone, 45227
- Metabolic Atherosclerosis Research Center
-
Columbus, Ohio, Stany Zjednoczone, 43214
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
-
Franklin, Ohio, Stany Zjednoczone, 45005
- Prestige Clinical Research
-
Huber Heights, Ohio, Stany Zjednoczone, 45424
- Hometown Urgent Care and Research - Huber Heights
-
Marion, Ohio, Stany Zjednoczone, 43302
- RAS Health LTD
-
Stow, Ohio, Stany Zjednoczone, 44224
- Summit Reserach Group, LLC
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73103
- COR Clinical Research, LLC
-
-
Oregon
-
Eugene, Oregon, Stany Zjednoczone, 97404
- Willamette Valley Clinical Studies
-
-
Pennsylvania
-
Downingtown, Pennsylvania, Stany Zjednoczone, 19335
- Brandywine Clinical Research
-
-
South Carolina
-
Charleston, South Carolina, Stany Zjednoczone, 29407
- Medical Research South, LLC
-
Greer, South Carolina, Stany Zjednoczone, 29651
- Mountain View CLinical Research - Greer
-
Mount Pleasant, South Carolina, Stany Zjednoczone, 29464
- PMG of Charleston, LLC
-
Myrtle Beach, South Carolina, Stany Zjednoczone, 29588
- Family Medicine of SayeBrook, LLC
-
Simpsonville, South Carolina, Stany Zjednoczone, 29681
- Hillcrest Clinical Research, LLC
-
Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Spartanburg Medical Research
-
Spartanburg, South Carolina, Stany Zjednoczone, 29301
- Palmetto Proactive Healthcare, LLC
-
Summerville, South Carolina, Stany Zjednoczone, 29485
- Palmetto Clinical Research
-
-
Tennessee
-
Bristol, Tennessee, Stany Zjednoczone, 37620
- PMG Research of Bristol, LC - State
-
Knoxville, Tennessee, Stany Zjednoczone, 37912
- PMG Research of Knoxville
-
Memphis, Tennessee, Stany Zjednoczone, 38119
- Clinical Neuroscience Solutions, Inc. - Memphis
-
Tullahoma, Tennessee, Stany Zjednoczone, 37388
- Trinity Clinical Research
-
-
Texas
-
Austin, Texas, Stany Zjednoczone, 78705
- Central Texas Clinical Research
-
Carrollton, Texas, Stany Zjednoczone, 75007
- Trinity Universal Research Associates, Inc.
-
Dallas, Texas, Stany Zjednoczone, 75230
- Dallas Diabetes and Endocrine Center
-
Dallas, Texas, Stany Zjednoczone, 75231
- Research Institute Of Dallas
-
Dallas, Texas, Stany Zjednoczone, 75251
- Galenos Research
-
Houston, Texas, Stany Zjednoczone, 77058
- Centex Studies, Inc.
-
Houston, Texas, Stany Zjednoczone, 77036
- Pioneer Research Solutions, Inc.
-
Houston, Texas, Stany Zjednoczone, 77074
- Clinical Trial Network - Houston
-
Houston, Texas, Stany Zjednoczone, 77074
- Juno Research, LLC-Houston
-
Katy, Texas, Stany Zjednoczone, 77450
- Juno Research, LLC-Katy
-
San Antonio, Texas, Stany Zjednoczone, 78215
- Sun Research Institute
-
San Antonio, Texas, Stany Zjednoczone, 78231
- Victorium Clinical Research
-
San Antonio, Texas, Stany Zjednoczone, 78207
- Texas Diabetes Institute Research Center
-
Shavano Park, Texas, Stany Zjednoczone, 78231
- Consano Clinical Research
-
Sugar Land, Texas, Stany Zjednoczone, 77478
- Southwest Health Associates, P.A.
-
-
Utah
-
Saint George, Utah, Stany Zjednoczone, 84790
- Chrysalis Clinical Research
-
-
Virginia
-
Burke, Virginia, Stany Zjednoczone, 22015
- Burke Internal Medicine & Research
-
Manassas, Virginia, Stany Zjednoczone, 20110
- Manassas Clinical Research Center
-
Richmond, Virginia, Stany Zjednoczone, 23235
- Clinical Research Partners, LLC
-
-
Washington
-
Tacoma, Washington, Stany Zjednoczone, 98405
- Universal Research Group, LLC
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Is at least 25 years old at Visit 1 (Screening).
Is male, or is female and meets all of the following criteria:
- Not breastfeeding
- Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
- Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study.
- Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
- Has a physical examination with no clinically significant abnormalities as judged by the investigator.
- Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.
- Has an estimated glomerular filtration rate (eGFR) value of ≥60 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation.
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Visit 1:
- Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and alpha-glucosidase inhibitors
- Hormone replacement therapy (female subjects) and testosterone (male subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Ability to understand and willingness to adhere to protocol requirements.
Exclusion Criteria:
Has a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:
- Hepatic disease
- Gastrointestinal disease
- Endocrine disorder (T2DM is allowed)
- Cardiovascular disease
- Central nervous system diseases
- Psychiatric or neurological disorders
- Organ transplantation
- Chronic or acute infection
- Orthostatic hypotension, fainting spells or blackouts
- Allergy or hypersensitivity.
- A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
- Prior major surgery of any kind within 6 months of Visit 1.
- A history of >3% weight change within 3 months of Visit 1.
- A clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormality, other than that related to T2DM, judged by the investigator to be clinically significant at Visit 1.
- An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
- A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
- Metformin within 2 months of Visit 1 (Screening)
- Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3 months of Visit 1 (Screening)
- Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2 inhibitors within 3 months of Visit 1
- Drugs known to affect body weight, including prescription medications and over-the-counter anti obesity agents within 3 months of Visit 1.
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of Visit 1
- Planned use of any drug treatment that affects gastric pH (prescription or over-the-counter), such as H2-receptor antagonists and proton pump inhibitors, after Visit 2 (Week -2), or planned chronic use of any antacids (i.e., more than twice per week) after Visit 2 (Week -2)
- Cationic drugs that are eliminated by renal tubular secretion within 1 week of Visit 1.
- Iodinated contrast dye within 1 week prior to Visit 1.
- Investigational drug within 2 months (or five half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication.
- Met DR or double-blind matching placebo for Met DR at any time prior to Visit 1 (Screening)
- Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures.
- Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 2 months prior to Visit 1 (Screening), or is planning to donate blood during the study.
- Has known immune system based allergies or hypersensitivity to any component of study treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.
- Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or designee of the company).
- Has a fasting plasma glucose value >270 mg/dL at Visit 1 (Screening), Visit 2 (Week -2), and an unscheduled visit to be completed within 1 week following Visit 2. The unscheduled visit is to be completed only for subjects with a fasting plasma glucose value >270 mg/dL at Visit 1 and Visit 2.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
|
tabletki o opóźnionym uwalnianiu z metforminą
|
|
Eksperymentalny: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
|
tabletki o opóźnionym uwalnianiu z metforminą
|
|
Eksperymentalny: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
|
tabletki o opóźnionym uwalnianiu z metforminą
|
|
Eksperymentalny: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
|
tabletki o opóźnionym uwalnianiu z metforminą
|
|
Komparator placebo: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
|
|
|
Komparator placebo: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
|
|
|
Aktywny komparator: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
|
metformin immediate-release tablets
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Change in HbA1c (%) at 16 Weeks
Ramy czasowe: Baseline and 16 weeks after the first dose of study medication
|
Baseline and 16 weeks after the first dose of study medication
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Juan P Frias, MD, National Research Institute - Wilshire
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- LCRM112
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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National Institute on Drug Abuse (NIDA)ZakończonyUżywanie konopi indyjskichStany Zjednoczone
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyZakończonyMężczyźni z cukrzycą typu II (T2DM)Niemcy
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Heptares Therapeutics LimitedZakończonyFarmakokinetyka | Problemy z bezpieczeństwemZjednoczone Królestwo
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CellmedisMedical Network Sp. z o.o.Jeszcze nie rekrutacja
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Soroka University Medical CenterZakończony
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Regado Biosciences, Inc.ZakończonyZdrowy ochotnikStany Zjednoczone
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West Penn Allegheny Health SystemZakończonyAstma | Alergiczny nieżyt nosaStany Zjednoczone