A Registry for Participants With Chronic Hypoparathyroidism

IDENTIFIERS
Trial Protocol: PAR-R13-001
Clinicaltrials.gov: NCT01922440
EUPAS: EUPAS16927
PURPOSE

This is a prospective, observational disease and drug registry designed to evaluate the safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as a result of participating in this registry and all decisions on the participant's treatment are determined by his or her physician.

Recruiting
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Trial at a glance

What medical condition is being studied?   Hypoparathyroidism
What is the trial testing?   Combination product (Natpara) and drug or supplements [Disease and drug registry]
How many participants are being enrolled?   900
When is the trial being conducted?    - 
How long is participation in the trial?   Participation will consist of a minimum of 10 years of follow up for each participant. Management of the chronic hypoparathyroidism will be provided according to usual clinical practice by the participants\' physicians.

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   N/A
Trial Type:   Observational [Patient Registry]
Trial Arms/Groups or Cohorts:   
Chronic Hypoparathyroidism: A rare disease with a duration of longer than 6 months characterized by insufficient parathyroid hormone (PTH) secretion, which can result in hypocalcemia, hyperphosphatemia, and associated clinical findings.
Intervention:   Combination product (Natpara) and drug or supplements [Disease and drug registry]
Primary Outcome Measure(s):   
Hypoparathyroidism Laboratory Test [Time Frame: Baseline up to 10 years (follow-up)]
Clinical Laboratory Test Results [Time Frame: Baseline up to 10 years (follow-up)]
Renal Function [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Renal Events [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Soft Tissue Calcifications (site) [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Cataract [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Bone Fractures (site) [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Cardiovascular Events [Time Frame: Baseline up to 10 years (follow-up)]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 10 years (follow-up)]
Secondary Outcome Measure(s):   
Health-related Quality of Life (HRQoL) [Time Frame: Baseline up to 10 years (follow-up)]
Disease-specific Patient-reported Outcome Measures [Time Frame: Baseline up to 10 years (follow-up)]
Rate of Hospitalization/Emergency Room (ER) Visits [Time Frame: Baseline up to 10 years (follow-up)]
Entry Criteria:
Inclusion Criteria: 1. Participants diagnosed with chronic hypoparathyroidism, ie, hypoparathyroidism with a duration of longer than 6 months, including: 1. Adult participants (greater than or equal to [>=] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone. 2. Pediatric participants (less than [<] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone. Exclusion Criteria: 1. Participants or legally acceptable representatives unable to provide informed consent. 2. Participants using rhPTH(1-34) or used rhPTH(1-34) for more than 2 years and in the last 3 months. 3. Participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism). Note that this does not include participants enrolled in other observational registries. 4. History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene. 5. History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).

Trial Locations

Any
Recruiting
Any
RESULTS
University of Alabama at Birmingham

Birmingham, AL 35294, USA

Site Contact
Recruiting
1,051 miles (1,692 km)  awayfrom
Boston, Massachusetts
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University of Arizona Medical Center

1625 N Campbell Ave, Tucson, AZ 85719, USA

Recruiting
2,277 miles (3,665 km)  awayfrom
Boston, Massachusetts
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Children's Hospital Los Angeles

4650 Sunset Blvd, Los Angeles, CA 90027, USA

Site Contact
Recruiting
2,592 miles (4,171 km)  awayfrom
Boston, Massachusetts
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Cedars-Sinai Medical Center

8631 W 3rd St, Los Angeles, CA 90048, USA

Site Contact
Recruiting
2,597 miles (4,179 km)  awayfrom
Boston, Massachusetts
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Dr. Joselito Cabaccan

2690 S White Rd #50, San Jose, CA 95148, USA

Site Contact
Recruiting
2,674 miles (4,303 km)  awayfrom
Boston, Massachusetts
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University of Colorado Hospital

12605 E 16th Ave, Aurora, CO 80045, USA

Site Contact
Recruiting
1,758 miles (2,829 km)  awayfrom
Boston, Massachusetts
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Hanson Clinical Research

21216 Olean Blvd # 6, Port Charlotte, FL 33952, USA

Recruiting
1,231 miles (1,981 km)  awayfrom
Boston, Massachusetts
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Thyroid & Endocrine Center of Florida

5741 Bee Ridge Rd # 500, Sarasota, FL 34233, USA

Site Contact
Recruiting
1,222 miles (1,967 km)  awayfrom
Boston, Massachusetts
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East-West Medical Research Institute

1585 Kapiolani Blvd, Honolulu, HI 96814, USA

Recruiting
5,081 miles (8,177 km)  awayfrom
Boston, Massachusetts
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Suburban Endocrinology & Diabetes

2101 S Arlington Heights Rd, Arlington Heights, IL 60005, USA

Recruiting
865 miles (1,392 km)  awayfrom
Boston, Massachusetts
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University of Chicago Medical Center

5841 S Maryland Ave, Chicago, IL 60637, USA

Recruiting
848 miles (1,365 km)  awayfrom
Boston, Massachusetts
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Northshore University Health System

1000 Central St #800, Evanston, IL 60201, USA

Recruiting
850 miles (1,367 km)  awayfrom
Boston, Massachusetts
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Loyola University Medical Center

2160 S 1st Ave, Maywood, IL 60153, USA

Recruiting
859 miles (1,383 km)  awayfrom
Boston, Massachusetts
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Indiana University Hospital

550 N University Blvd, Indianapolis, IN 46202, USA

Recruiting
806 miles (1,297 km)  awayfrom
Boston, Massachusetts
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Tilak Mallik, MD F.A.C.E., LCC

1111 Medical Center Blvd, Marrero, LA 70072, USA

Recruiting
1,362 miles (2,192 km)  awayfrom
Boston, Massachusetts
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Model Clinical Research

6535 Charles St # 400, Towson, MD 21204, USA

Recruiting
356 miles (572 km)  awayfrom
Boston, Massachusetts
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Medstar Union Memorial Hospital

201 E University Pkwy, Baltimore, MD 21218, USA

Recruiting
358 miles (576 km)  awayfrom
Boston, Massachusetts
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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

Recruiting
0.43 miles (0.69 km)  awayfrom
Boston, Massachusetts
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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

Recruiting
2.97 miles (4.78 km)  awayfrom
Boston, Massachusetts
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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

Recruiting
2.97 miles (4.78 km)  awayfrom
Boston, Massachusetts
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Boston Medical Center

One Boston Medical Center Pl, Boston, MA 02118, USA

Recruiting
1.92 miles (3.09 km)  awayfrom
Boston, Massachusetts
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University of Minnesota

Minneapolis, MN 55455, USA

Site Contact
Recruiting
1,119 miles (1,801 km)  awayfrom
Boston, Massachusetts
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Mayo Clinic - Rochester

200 1st St SW, Rochester, MN 55905, USA

Recruiting
1,081 miles (1,740 km)  awayfrom
Boston, Massachusetts
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University of Missouri

Columbia, MO 65212, USA

Recruiting
1,136 miles (1,829 km)  awayfrom
Boston, Massachusetts
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Diabetes & Endocrine Associates, P.C

7831 Chicago Ct, Omaha, NE 68114, USA

Site Contact
Recruiting
1,284 miles (2,066 km)  awayfrom
Boston, Massachusetts
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Palm Research Center, Inc.

9280 W Sunset Rd, Las Vegas, NV 89148, USA

site contact
Recruiting
2,380 miles (3,830 km)  awayfrom
Boston, Massachusetts
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Northern Nevada Endocrinology

665 Sierra Rose Dr, Reno, NV 89511, USA

Recruiting
2,517 miles (4,051 km)  awayfrom
Boston, Massachusetts
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Rutgers Robert Wood Johnson Medical School

Clinical Academic Building (CAB, 125 Paterson St, New Brunswick, NJ 08901, USA

Site Contact
Recruiting
218 miles (351 km)  awayfrom
Boston, Massachusetts
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Rutgers-Robert Wood Johnson Medical School

Clinical Academic Building (CAB, 125 Paterson St, New Brunswick, NJ 08901, USA

Recruiting
218 miles (351 km)  awayfrom
Boston, Massachusetts
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Albany Med Endocrine Specialists

1365 Washington Ave # 300, Albany, NY 12206, USA

Site Contact
Recruiting
142 miles (228 km)  awayfrom
Boston, Massachusetts
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Brokhin Medical PC

103 Quentin Rd, Brooklyn, NY 11223, USA

Recruiting
194 miles (312 km)  awayfrom
Boston, Massachusetts
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Columbia University Medical Center

630 W 168th St, New York, NY 10032, USA

Recruiting
182 miles (293 km)  awayfrom
Boston, Massachusetts
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Endocrine Associates of Long Island, P.C.

732 Smithtown Bypass, Smithtown, NY 11787, USA

Recruiting
151 miles (243 km)  awayfrom
Boston, Massachusetts
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University Physicians Group Research Division

1460 Victory Blvd, Staten Island, NY 10301, USA

Recruiting
199 miles (320 km)  awayfrom
Boston, Massachusetts
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Joslin Diabetes Center at SUNY Upstate Medical University

3229 E Genesee St, Syracuse, NY 13214, USA

Recruiting
260 miles (418 km)  awayfrom
Boston, Massachusetts
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Mecklenburg Medical Group

3030 Randolph Rd STE 200, Charlotte, NC 28211, USA

Recruiting
721 miles (1,160 km)  awayfrom
Boston, Massachusetts
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Physicians East, PA

1850 W Arlington Blvd, Greenville, NC 27834, USA

Recruiting
578 miles (930 km)  awayfrom
Boston, Massachusetts
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Cleveland Clinic

9500 Euclid Ave, Cleveland, OH 44195, USA

Recruiting
546 miles (878 km)  awayfrom
Boston, Massachusetts
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Ohio State University Wexner Medical Center

410 W 10th Ave, Columbus, OH 43210, USA

Recruiting
642 miles (1,034 km)  awayfrom
Boston, Massachusetts
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Ohio Health Research Institute

3535 Olentangy River Rd, Columbus, OH 43214, USA

Recruiting
642 miles (1,034 km)  awayfrom
Boston, Massachusetts
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Endocrinology Associates of Armstrong

2255 Canterbury Commons, Rte 422 W, Indiana, PA 15701, USA

Recruiting
437 miles (704 km)  awayfrom
Boston, Massachusetts
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The Children's Hospital of Philadelphia

3401 Civic Center Blvd, Philadelphia, PA 19104, USA

Recruiting
272 miles (438 km)  awayfrom
Boston, Massachusetts
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Thomas Jefferson University

901 Walnut St, Philadelphia, PA 19107, USA

Site Contact
Recruiting
270 miles (435 km)  awayfrom
Boston, Massachusetts
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Allegheny Endocrinology Associates

420 E North Ave, Pittsburgh, PA 15212, USA

Site Contact
Recruiting
481 miles (775 km)  awayfrom
Boston, Massachusetts
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Hallett Center for Diabetes and Endocrinology

900 Warren Ave #302, East Providence, RI 02914, USA

Recruiting
41 miles (66 km)  awayfrom
Boston, Massachusetts
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University of South Carolina

Columbia, SC 29208, USA

Site Contact
Recruiting
791 miles (1,273 km)  awayfrom
Boston, Massachusetts
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Texas Diabetes and Endocrinology, P.A.

6500 N Mopac Expy #200, Austin, TX 78731, USA

Recruiting
1,691 miles (2,721 km)  awayfrom
Boston, Massachusetts
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Academy of Diabetes Thyroid and Endocrine

1516 Lomaland Dr, El Paso, TX 79935, USA

Site Contact
Recruiting
2,060 miles (3,316 km)  awayfrom
Boston, Massachusetts
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Diabetes and Thyroid Center of Fort Worth, PLLC

7801 Oakmont Blvd #101, Fort Worth, TX 76132, USA

Recruiting
1,584 miles (2,549 km)  awayfrom
Boston, Massachusetts
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University of Vermont

Burlington, VT 05405, USA

Recruiting
181 miles (292 km)  awayfrom
Boston, Massachusetts
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University of Wisconsin

Madison, WI, USA

Site Contact
Recruiting
931 miles (1,498 km)  awayfrom
Boston, Massachusetts
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Medizinische Universitat Graz

Auenbruggerpl. 2, 8036 Graz, Austria

Recruiting
4,035 miles (6,494 km)  awayfrom
Boston, Massachusetts
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AKH Wien, Universitaetsklinik fuer Innere Medizin III

Währinger Gürtel 18-20, 1090 Wien, Austria

Recruiting
4,031 miles (6,488 km)  awayfrom
Boston, Massachusetts
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Nova Scotia Health Authority

1276 South Park St, Halifax, NS B3H 2Y9, Canada

Recruiting
406 miles (654 km)  awayfrom
Boston, Massachusetts
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McMaster University

1280 Main St W, Hamilton, ON L8S 4L8, Canada

Recruiting
453 miles (729 km)  awayfrom
Boston, Massachusetts
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Aalborg Universitetshospital

Hobrovej 18-22, 9100 Aalborg, Denmark

Recruiting
3,528 miles (5,678 km)  awayfrom
Boston, Massachusetts
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Aarhus Universitetshospital

Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark

Recruiting
3,558 miles (5,726 km)  awayfrom
Boston, Massachusetts
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Nordsjaellands Hospital - Hillerod

Dyrehavevej 29, 3400 Hillerød, Denmark

Recruiting
3,642 miles (5,861 km)  awayfrom
Boston, Massachusetts
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Regions Hospitalet Viborg

Heibergs Alle 5A, 8800 Viborg, Denmark

Recruiting
3,524 miles (5,672 km)  awayfrom
Boston, Massachusetts
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Universitaetsklinik Aachen

Pauwelsstraße 30, 52074 Aachen, Germany

Recruiting
3,539 miles (5,696 km)  awayfrom
Boston, Massachusetts
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Charite-Universitiitsmedizin Berlin (CCM)

Luisenstraße 64, 10117 Berlin, Germany

Recruiting
3,777 miles (6,079 km)  awayfrom
Boston, Massachusetts
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Praxis an der Kaiserreiche

Wilhelm-Hauff-Straße 21, 12159 Berlin, Germany

Recruiting
3,777 miles (6,079 km)  awayfrom
Boston, Massachusetts
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Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Fiedlerstraße 27, 01307 Dresden, Germany

Recruiting
3,837 miles (6,176 km)  awayfrom
Boston, Massachusetts
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University Hospital Duesseldorf

Universitätsklinikum Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
3,558 miles (5,726 km)  awayfrom
Boston, Massachusetts
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Endokrinologikum Frankfurt

Stresemannallee 1/3, 60596 Frankfurt am Main, Germany

Recruiting
3,664 miles (5,896 km)  awayfrom
Boston, Massachusetts
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MVZ endokrinologikum Göttingen

Von-Siebold-Straße 3, 37075 Göttingen, Germany

Recruiting
3,673 miles (5,911 km)  awayfrom
Boston, Massachusetts
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Medizinische Hochschule Hannover (MHH)

Carl-Neuberg-Straße 1, 30625 Hannover, Germany

Recruiting
3,644 miles (5,865 km)  awayfrom
Boston, Massachusetts
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University of Leipzig

Perlickstraße 1, 04103 Leipzig, Germany

Recruiting
3,776 miles (6,076 km)  awayfrom
Boston, Massachusetts
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Universitaet Zur Luebeck

Ratzeburger Allee 160, 23562 Lübeck, Germany

Recruiting
3,639 miles (5,856 km)  awayfrom
Boston, Massachusetts
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Medicover Neuroendokrinologie MVZ

Orleanspl. 3, 81667 München, Germany

Recruiting
3,843 miles (6,184 km)  awayfrom
Boston, Massachusetts
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Medicover Neu-Ulm Mvz

Marienstraße 1, 89231 Neu-Ulm, Germany

Recruiting
3,768 miles (6,065 km)  awayfrom
Boston, Massachusetts
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Medicover Oldenburg MVZ

Elisenstraße 12, 26122 Oldenburg, Germany

Recruiting
3,563 miles (5,734 km)  awayfrom
Boston, Massachusetts
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Medicover Saarbuecken Mvz

Faktoreistraße 4, 66111 Saarbrücken, Germany

Recruiting
3,620 miles (5,825 km)  awayfrom
Boston, Massachusetts
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Diakonie-Klinikum Stuttgart

Rosenbergstraße 38, 70176 Stuttgart, Germany

Recruiting
3,722 miles (5,991 km)  awayfrom
Boston, Massachusetts
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Endokrinologie Zentrum Ulm

Weinbergweg 41, 89075 Ulm, Germany

Recruiting
3,766 miles (6,061 km)  awayfrom
Boston, Massachusetts
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Universitaetsklinikum Wuerzburg

Josef-Schneider-Straße 2, 97080 Würzburg, Germany

Recruiting
3,724 miles (5,994 km)  awayfrom
Boston, Massachusetts
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General Hospital Of Athens - Korgialenio-Benakio E.E.S.

Athanasaki 11, Athina 115 26, Greece

Recruiting
4,736 miles (7,622 km)  awayfrom
Boston, Massachusetts
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General Hospital of Athens Georgios Gennimatas

Leof. Mesogeion 154, Athina 115 27, Greece

Recruiting
4,736 miles (7,622 km)  awayfrom
Boston, Massachusetts
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General Hospital of Athens Alexandra

Lourou 4-2, Athina 115 28, Greece

Recruiting
4,736 miles (7,622 km)  awayfrom
Boston, Massachusetts
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AHEPA University General Hospital of Thessaloniki

Kiriakidi 1, Thessaloniki 546 21, Greece

Recruiting
4,592 miles (7,389 km)  awayfrom
Boston, Massachusetts
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Hippokrateion General Hospital of Thessaloniki

Konstantinoupoleos 49, Thessaloniki 546 42, Greece

Recruiting
4,592 miles (7,391 km)  awayfrom
Boston, Massachusetts
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Azienda Ospedaliero-Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
3,970 miles (6,390 km)  awayfrom
Boston, Massachusetts
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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

Recruiting
3,827 miles (6,159 km)  awayfrom
Boston, Massachusetts
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Azienda Ospedaliera San Giovanni Addolorata

Via dell'Amba Aradam, 8, 00184 Roma RM, Italy

Site Contact
Recruiting
4,092 miles (6,586 km)  awayfrom
Boston, Massachusetts
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Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette

Corso Bramante, 88, 10126 Torino TO, Italy

Recruiting
3,775 miles (6,075 km)  awayfrom
Boston, Massachusetts
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Haukeland University Hospital

Jonas Lies vei 65, 5021 Bergen, Norway

Recruiting
3,304 miles (5,317 km)  awayfrom
Boston, Massachusetts
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Spesialistsentret Pilestredet Park

Pilestredet Park 12A, 0176 Oslo, Norway

Recruiting
3,490 miles (5,617 km)  awayfrom
Boston, Massachusetts
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Hospital Del Mar

Passeig Marítim de la Barceloneta, 25, 29, 08003 Barcelona, Spain

Recruiting
3,645 miles (5,866 km)  awayfrom
Boston, Massachusetts
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Hospital Universitario 12 de Octubre

Av. de Córdoba, s/n, 28041 Madrid, Spain

Recruiting
3,401 miles (5,473 km)  awayfrom
Boston, Massachusetts
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Universitetssjukhuset I Linkoping

Universitetssjukhuset, 581 85 Linköping, Sweden

Recruiting
3,689 miles (5,937 km)  awayfrom
Boston, Massachusetts
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Universitetssjukhuset I Orebro

Södra Grev Rosengatan, 701 85 Örebro, Sweden

Recruiting
3,653 miles (5,878 km)  awayfrom
Boston, Massachusetts
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Karolinska Universitetssjukhuset Solna

Karolinska Vägen 22, 171 64 Solna, Sweden

Recruiting
3,741 miles (6,021 km)  awayfrom
Boston, Massachusetts
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Akademiska Sjukhuset - Uppsala University Hospital

Dag Hammarskjölds Väg 21, 752 37 Uppsala, Sweden

Recruiting
3,715 miles (5,978 km)  awayfrom
Boston, Massachusetts
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University of Hospitals of Leicester NHS Trust

Infirmary Square, Leicester LE1 5WW, UK

Recruiting
3,207 miles (5,161 km)  awayfrom
Boston, Massachusetts
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Norfolk And Norwich University Hospital - Norwich Medical School

Colney Ln, Norwich NR4 7UY, UK

Recruiting
3,301 miles (5,313 km)  awayfrom
Boston, Massachusetts
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View all (95)
Trial Protocol ID: PAR-R13-001
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