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

CLICK TO EXPANDCLICK TO COLLAPSE
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
6,289 miles (10,120 km)  awayfrom
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University of Arizona Medical Center

1625 N Campbell Ave, Tucson, AZ 85719, USA

Recruiting
6,350 miles (10,220 km)  awayfrom
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Children's Hospital Los Angeles

4650 Sunset Blvd, Los Angeles, CA 90027, USA

Site Contact
Recruiting
6,151 miles (9,899 km)  awayfrom
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Cedars-Sinai Medical Center

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

Site Contact
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6,151 miles (9,900 km)  awayfrom
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Dr. Joselito Cabaccan

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

Site Contact
Recruiting
5,889 miles (9,478 km)  awayfrom
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University of Colorado Hospital

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

Site Contact
Recruiting
5,872 miles (9,450 km)  awayfrom
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Hanson Clinical Research

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

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6,700 miles (10,783 km)  awayfrom
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Thyroid & Endocrine Center of Florida

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

Site Contact
Recruiting
6,682 miles (10,753 km)  awayfrom
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East-West Medical Research Institute

1585 Kapiolani Blvd, Honolulu, HI 96814, USA

Recruiting
6,073 miles (9,773 km)  awayfrom
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Suburban Endocrinology & Diabetes

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

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5,708 miles (9,185 km)  awayfrom
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University of Chicago Medical Center

5841 S Maryland Ave, Chicago, IL 60637, USA

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5,723 miles (9,211 km)  awayfrom
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Northshore University Health System

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

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5,705 miles (9,181 km)  awayfrom
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Loyola University Medical Center

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

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5,720 miles (9,205 km)  awayfrom
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Indiana University Hospital

550 N University Blvd, Indianapolis, IN 46202, USA

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5,854 miles (9,421 km)  awayfrom
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Tilak Mallik, MD F.A.C.E., LCC

1111 Medical Center Blvd, Marrero, LA 70072, USA

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6,554 miles (10,548 km)  awayfrom
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Model Clinical Research

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

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5,801 miles (9,336 km)  awayfrom
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Medstar Union Memorial Hospital

201 E University Pkwy, Baltimore, MD 21218, USA

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5,805 miles (9,343 km)  awayfrom
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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

Recruiting
5,535 miles (8,908 km)  awayfrom
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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

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5,538 miles (8,912 km)  awayfrom
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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

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5,538 miles (8,912 km)  awayfrom
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Boston Medical Center

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

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5,537 miles (8,911 km)  awayfrom
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University of Minnesota

Minneapolis, MN 55455, USA

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5,523 miles (8,888 km)  awayfrom
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Mayo Clinic - Rochester

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

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5,587 miles (8,992 km)  awayfrom
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University of Missouri

Columbia, MO 65212, USA

Recruiting
5,938 miles (9,556 km)  awayfrom
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Diabetes & Endocrine Associates, P.C

7831 Chicago Ct, Omaha, NE 68114, USA

Site Contact
Recruiting
5,783 miles (9,307 km)  awayfrom
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Palm Research Center, Inc.

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

site contact
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6,050 miles (9,736 km)  awayfrom
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Northern Nevada Endocrinology

665 Sierra Rose Dr, Reno, NV 89511, USA

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5,770 miles (9,286 km)  awayfrom
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Rutgers Robert Wood Johnson Medical School

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

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Recruiting
5,702 miles (9,177 km)  awayfrom
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Rutgers-Robert Wood Johnson Medical School

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

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5,702 miles (9,177 km)  awayfrom
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Albany Med Endocrine Specialists

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

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Recruiting
5,548 miles (8,928 km)  awayfrom
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Brokhin Medical PC

103 Quentin Rd, Brooklyn, NY 11223, USA

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5,689 miles (9,156 km)  awayfrom
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Columbia University Medical Center

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

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5,673 miles (9,130 km)  awayfrom
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Endocrine Associates of Long Island, P.C.

732 Smithtown Bypass, Smithtown, NY 11787, USA

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5,663 miles (9,114 km)  awayfrom
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University Physicians Group Research Division

1460 Victory Blvd, Staten Island, NY 10301, USA

Recruiting
5,690 miles (9,158 km)  awayfrom
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Joslin Diabetes Center at SUNY Upstate Medical University

3229 E Genesee St, Syracuse, NY 13214, USA

Recruiting
5,549 miles (8,930 km)  awayfrom
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Mecklenburg Medical Group

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

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6,128 miles (9,862 km)  awayfrom
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Physicians East, PA

1850 W Arlington Blvd, Greenville, NC 27834, USA

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6,067 miles (9,763 km)  awayfrom
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Cleveland Clinic

9500 Euclid Ave, Cleveland, OH 44195, USA

Recruiting
5,705 miles (9,181 km)  awayfrom
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Ohio State University Wexner Medical Center

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

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5,818 miles (9,364 km)  awayfrom
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Ohio Health Research Institute

3535 Olentangy River Rd, Columbus, OH 43214, USA

Recruiting
5,816 miles (9,360 km)  awayfrom
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Endocrinology Associates of Armstrong

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

Recruiting
5,744 miles (9,243 km)  awayfrom
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The Children's Hospital of Philadelphia

3401 Civic Center Blvd, Philadelphia, PA 19104, USA

Recruiting
5,748 miles (9,250 km)  awayfrom
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Thomas Jefferson University

901 Walnut St, Philadelphia, PA 19107, USA

Site Contact
Recruiting
5,747 miles (9,250 km)  awayfrom
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Allegheny Endocrinology Associates

420 E North Ave, Pittsburgh, PA 15212, USA

Site Contact
Recruiting
5,762 miles (9,273 km)  awayfrom
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Hallett Center for Diabetes and Endocrinology

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

Recruiting
5,576 miles (8,974 km)  awayfrom
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University of South Carolina

Columbia, SC 29208, USA

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Recruiting
6,212 miles (9,997 km)  awayfrom
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Texas Diabetes and Endocrinology, P.A.

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

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6,537 miles (10,521 km)  awayfrom
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Academy of Diabetes Thyroid and Endocrine

1516 Lomaland Dr, El Paso, TX 79935, USA

Site Contact
Recruiting
6,415 miles (10,324 km)  awayfrom
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Diabetes and Thyroid Center of Fort Worth, PLLC

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

Recruiting
6,377 miles (10,263 km)  awayfrom
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University of Vermont

Burlington, VT 05405, USA

Recruiting
5,420 miles (8,723 km)  awayfrom
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University of Wisconsin

Madison, WI, USA

Site Contact
Recruiting
5,643 miles (9,081 km)  awayfrom
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Medizinische Universitat Graz

Auenbruggerpl. 2, 8036 Graz, Austria

Recruiting
2,862 miles (4,606 km)  awayfrom
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AKH Wien, Universitaetsklinik fuer Innere Medizin III

Währinger Gürtel 18-20, 1090 Wien, Austria

Recruiting
2,783 miles (4,478 km)  awayfrom
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Nova Scotia Health Authority

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

Recruiting
5,276 miles (8,491 km)  awayfrom
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McMaster University

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

Recruiting
5,571 miles (8,965 km)  awayfrom
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Aalborg Universitetshospital

Hobrovej 18-22, 9100 Aalborg, Denmark

Recruiting
2,685 miles (4,321 km)  awayfrom
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Aarhus Universitetshospital

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

Recruiting
2,705 miles (4,353 km)  awayfrom
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Nordsjaellands Hospital - Hillerod

Dyrehavevej 29, 3400 Hillerød, Denmark

Recruiting
2,641 miles (4,251 km)  awayfrom
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Regions Hospitalet Viborg

Heibergs Alle 5A, 8800 Viborg, Denmark

Recruiting
2,722 miles (4,380 km)  awayfrom
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Universitaetsklinik Aachen

Pauwelsstraße 30, 52074 Aachen, Germany

Recruiting
3,052 miles (4,912 km)  awayfrom
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Charite-Universitiitsmedizin Berlin (CCM)

Luisenstraße 64, 10117 Berlin, Germany

Recruiting
2,725 miles (4,386 km)  awayfrom
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Praxis an der Kaiserreiche

Wilhelm-Hauff-Straße 21, 12159 Berlin, Germany

Recruiting
2,729 miles (4,391 km)  awayfrom
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Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Fiedlerstraße 27, 01307 Dresden, Germany

Recruiting
2,766 miles (4,451 km)  awayfrom
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University Hospital Duesseldorf

Universitätsklinikum Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
3,009 miles (4,843 km)  awayfrom
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Endokrinologikum Frankfurt

Stresemannallee 1/3, 60596 Frankfurt am Main, Germany

Recruiting
2,988 miles (4,808 km)  awayfrom
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MVZ endokrinologikum Göttingen

Von-Siebold-Straße 3, 37075 Göttingen, Germany

Recruiting
2,884 miles (4,642 km)  awayfrom
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Medizinische Hochschule Hannover (MHH)

Carl-Neuberg-Straße 1, 30625 Hannover, Germany

Recruiting
2,857 miles (4,597 km)  awayfrom
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University of Leipzig

Perlickstraße 1, 04103 Leipzig, Germany

Recruiting
2,806 miles (4,515 km)  awayfrom
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Universitaet Zur Luebeck

Ratzeburger Allee 160, 23562 Lübeck, Germany

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2,770 miles (4,458 km)  awayfrom
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Medicover Neuroendokrinologie MVZ

Orleanspl. 3, 81667 München, Germany

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2,963 miles (4,768 km)  awayfrom
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Medicover Neu-Ulm Mvz

Marienstraße 1, 89231 Neu-Ulm, Germany

Recruiting
3,010 miles (4,845 km)  awayfrom
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Medicover Oldenburg MVZ

Elisenstraße 12, 26122 Oldenburg, Germany

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2,883 miles (4,639 km)  awayfrom
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Medicover Saarbuecken Mvz

Faktoreistraße 4, 66111 Saarbrücken, Germany

Recruiting
3,083 miles (4,962 km)  awayfrom
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Diakonie-Klinikum Stuttgart

Rosenbergstraße 38, 70176 Stuttgart, Germany

Recruiting
3,024 miles (4,867 km)  awayfrom
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Endokrinologie Zentrum Ulm

Weinbergweg 41, 89075 Ulm, Germany

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3,011 miles (4,846 km)  awayfrom
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Universitaetsklinikum Wuerzburg

Josef-Schneider-Straße 2, 97080 Würzburg, Germany

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2,954 miles (4,753 km)  awayfrom
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General Hospital Of Athens - Korgialenio-Benakio E.E.S.

Athanasaki 11, Athina 115 26, Greece

Recruiting
2,943 miles (4,737 km)  awayfrom
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General Hospital of Athens Georgios Gennimatas

Leof. Mesogeion 154, Athina 115 27, Greece

Recruiting
2,943 miles (4,736 km)  awayfrom
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General Hospital of Athens Alexandra

Lourou 4-2, Athina 115 28, Greece

Recruiting
2,945 miles (4,739 km)  awayfrom
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AHEPA University General Hospital of Thessaloniki

Kiriakidi 1, Thessaloniki 546 21, Greece

Recruiting
2,853 miles (4,591 km)  awayfrom
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Hippokrateion General Hospital of Thessaloniki

Konstantinoupoleos 49, Thessaloniki 546 42, Greece

Recruiting
2,853 miles (4,592 km)  awayfrom
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Azienda Ospedaliero-Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
3,163 miles (5,091 km)  awayfrom
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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

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3,166 miles (5,096 km)  awayfrom
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Azienda Ospedaliera San Giovanni Addolorata

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

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3,203 miles (5,155 km)  awayfrom
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Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette

Corso Bramante, 88, 10126 Torino TO, Italy

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3,242 miles (5,217 km)  awayfrom
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Haukeland University Hospital

Jonas Lies vei 65, 5021 Bergen, Norway

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2,718 miles (4,374 km)  awayfrom
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Spesialistsentret Pilestredet Park

Pilestredet Park 12A, 0176 Oslo, Norway

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2,567 miles (4,131 km)  awayfrom
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Hospital Del Mar

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

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3,616 miles (5,819 km)  awayfrom
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Hospital Universitario 12 de Octubre

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

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3,881 miles (6,246 km)  awayfrom
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Universitetssjukhuset I Linkoping

Universitetssjukhuset, 581 85 Linköping, Sweden

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2,454 miles (3,950 km)  awayfrom
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Universitetssjukhuset I Orebro

Södra Grev Rosengatan, 701 85 Örebro, Sweden

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2,443 miles (3,931 km)  awayfrom
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Karolinska Universitetssjukhuset Solna

Karolinska Vägen 22, 171 64 Solna, Sweden

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2,349 miles (3,781 km)  awayfrom
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Akademiska Sjukhuset - Uppsala University Hospital

Dag Hammarskjölds Väg 21, 752 37 Uppsala, Sweden

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2,349 miles (3,781 km)  awayfrom
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University of Hospitals of Leicester NHS Trust

Infirmary Square, Leicester LE1 5WW, UK

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3,218 miles (5,180 km)  awayfrom
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Norfolk And Norwich University Hospital - Norwich Medical School

Colney Ln, Norwich NR4 7UY, UK

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3,141 miles (5,055 km)  awayfrom
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Trial Protocol ID: PAR-R13-001
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