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
4,979 miles (8,013 km)  awayfrom
Czech Republic
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University of Arizona Medical Center

1625 N Campbell Ave, Tucson, AZ 85719, USA

Recruiting
5,886 miles (9,473 km)  awayfrom
Czech Republic
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Children's Hospital Los Angeles

4650 Sunset Blvd, Los Angeles, CA 90027, USA

Site Contact
Recruiting
5,986 miles (9,634 km)  awayfrom
Czech Republic
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Cedars-Sinai Medical Center

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

Site Contact
Recruiting
5,990 miles (9,640 km)  awayfrom
Czech Republic
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Dr. Joselito Cabaccan

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

Site Contact
Recruiting
5,877 miles (9,458 km)  awayfrom
Czech Republic
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University of Colorado Hospital

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

Site Contact
Recruiting
5,266 miles (8,475 km)  awayfrom
Czech Republic
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Hanson Clinical Research

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

Recruiting
5,129 miles (8,254 km)  awayfrom
Czech Republic
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Thyroid & Endocrine Center of Florida

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

Site Contact
Recruiting
5,127 miles (8,251 km)  awayfrom
Czech Republic
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East-West Medical Research Institute

1585 Kapiolani Blvd, Honolulu, HI 96814, USA

Recruiting
7,511 miles (12,087 km)  awayfrom
Czech Republic
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Suburban Endocrinology & Diabetes

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

Recruiting
4,587 miles (7,382 km)  awayfrom
Czech Republic
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University of Chicago Medical Center

5841 S Maryland Ave, Chicago, IL 60637, USA

Recruiting
4,586 miles (7,381 km)  awayfrom
Czech Republic
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Northshore University Health System

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

Recruiting
4,575 miles (7,363 km)  awayfrom
Czech Republic
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Loyola University Medical Center

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

Recruiting
4,591 miles (7,388 km)  awayfrom
Czech Republic
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Indiana University Hospital

550 N University Blvd, Indianapolis, IN 46202, USA

Recruiting
4,636 miles (7,461 km)  awayfrom
Czech Republic
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Tilak Mallik, MD F.A.C.E., LCC

1111 Medical Center Blvd, Marrero, LA 70072, USA

Recruiting
5,294 miles (8,521 km)  awayfrom
Czech Republic
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Model Clinical Research

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

Recruiting
4,294 miles (6,910 km)  awayfrom
Czech Republic
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Medstar Union Memorial Hospital

201 E University Pkwy, Baltimore, MD 21218, USA

Recruiting
4,296 miles (6,914 km)  awayfrom
Czech Republic
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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

Recruiting
3,940 miles (6,341 km)  awayfrom
Czech Republic
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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

Recruiting
3,943 miles (6,346 km)  awayfrom
Czech Republic
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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

Recruiting
3,943 miles (6,346 km)  awayfrom
Czech Republic
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Boston Medical Center

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

Recruiting
3,942 miles (6,344 km)  awayfrom
Czech Republic
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University of Minnesota

Minneapolis, MN 55455, USA

Site Contact
Recruiting
4,616 miles (7,428 km)  awayfrom
Czech Republic
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Mayo Clinic - Rochester

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

Recruiting
4,640 miles (7,467 km)  awayfrom
Czech Republic
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University of Missouri

Columbia, MO 65212, USA

Recruiting
4,899 miles (7,884 km)  awayfrom
Czech Republic
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Diabetes & Endocrine Associates, P.C

7831 Chicago Ct, Omaha, NE 68114, USA

Site Contact
Recruiting
4,903 miles (7,890 km)  awayfrom
Czech Republic
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Palm Research Center, Inc.

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

site contact
Recruiting
5,785 miles (9,310 km)  awayfrom
Czech Republic
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Northern Nevada Endocrinology

665 Sierra Rose Dr, Reno, NV 89511, USA

Recruiting
5,696 miles (9,166 km)  awayfrom
Czech Republic
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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
4,157 miles (6,691 km)  awayfrom
Czech Republic
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Rutgers-Robert Wood Johnson Medical School

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

Recruiting
4,157 miles (6,691 km)  awayfrom
Czech Republic
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Albany Med Endocrine Specialists

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

Site Contact
Recruiting
4,033 miles (6,490 km)  awayfrom
Czech Republic
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Brokhin Medical PC

103 Quentin Rd, Brooklyn, NY 11223, USA

Recruiting
4,134 miles (6,653 km)  awayfrom
Czech Republic
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Columbia University Medical Center

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

Recruiting
4,122 miles (6,633 km)  awayfrom
Czech Republic
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Endocrine Associates of Long Island, P.C.

732 Smithtown Bypass, Smithtown, NY 11787, USA

Recruiting
4,091 miles (6,583 km)  awayfrom
Czech Republic
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University Physicians Group Research Division

1460 Victory Blvd, Staten Island, NY 10301, USA

Recruiting
4,139 miles (6,660 km)  awayfrom
Czech Republic
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Joslin Diabetes Center at SUNY Upstate Medical University

3229 E Genesee St, Syracuse, NY 13214, USA

Recruiting
4,104 miles (6,604 km)  awayfrom
Czech Republic
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Mecklenburg Medical Group

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

Recruiting
4,661 miles (7,501 km)  awayfrom
Czech Republic
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Physicians East, PA

1850 W Arlington Blvd, Greenville, NC 27834, USA

Recruiting
4,506 miles (7,252 km)  awayfrom
Czech Republic
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Cleveland Clinic

9500 Euclid Ave, Cleveland, OH 44195, USA

Recruiting
4,383 miles (7,054 km)  awayfrom
Czech Republic
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Ohio State University Wexner Medical Center

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

Recruiting
4,509 miles (7,256 km)  awayfrom
Czech Republic
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Ohio Health Research Institute

3535 Olentangy River Rd, Columbus, OH 43214, USA

Recruiting
4,507 miles (7,254 km)  awayfrom
Czech Republic
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Endocrinology Associates of Armstrong

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

Recruiting
4,334 miles (6,975 km)  awayfrom
Czech Republic
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The Children's Hospital of Philadelphia

3401 Civic Center Blvd, Philadelphia, PA 19104, USA

Recruiting
4,212 miles (6,778 km)  awayfrom
Czech Republic
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Thomas Jefferson University

901 Walnut St, Philadelphia, PA 19107, USA

Site Contact
Recruiting
4,210 miles (6,776 km)  awayfrom
Czech Republic
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Allegheny Endocrinology Associates

420 E North Ave, Pittsburgh, PA 15212, USA

Site Contact
Recruiting
4,373 miles (7,038 km)  awayfrom
Czech Republic
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Hallett Center for Diabetes and Endocrinology

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

Recruiting
3,976 miles (6,399 km)  awayfrom
Czech Republic
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University of South Carolina

Columbia, SC 29208, USA

Site Contact
Recruiting
4,729 miles (7,611 km)  awayfrom
Czech Republic
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Texas Diabetes and Endocrinology, P.A.

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

Recruiting
5,555 miles (8,939 km)  awayfrom
Czech Republic
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Academy of Diabetes Thyroid and Endocrine

1516 Lomaland Dr, El Paso, TX 79935, USA

Site Contact
Recruiting
5,769 miles (9,284 km)  awayfrom
Czech Republic
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Diabetes and Thyroid Center of Fort Worth, PLLC

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

Recruiting
5,415 miles (8,715 km)  awayfrom
Czech Republic
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University of Vermont

Burlington, VT 05405, USA

Recruiting
3,929 miles (6,324 km)  awayfrom
Czech Republic
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University of Wisconsin

Madison, WI, USA

Site Contact
Recruiting
4,585 miles (7,378 km)  awayfrom
Czech Republic
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Medizinische Universitat Graz

Auenbruggerpl. 2, 8036 Graz, Austria

Recruiting
184 miles (296 km)  awayfrom
Czech Republic
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AKH Wien, Universitaetsklinik fuer Innere Medizin III

Währinger Gürtel 18-20, 1090 Wien, Austria

Recruiting
115 miles (185 km)  awayfrom
Czech Republic
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Nova Scotia Health Authority

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

Recruiting
3,548 miles (5,709 km)  awayfrom
Czech Republic
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McMaster University

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

Recruiting
4,237 miles (6,818 km)  awayfrom
Czech Republic
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Aalborg Universitetshospital

Hobrovej 18-22, 9100 Aalborg, Denmark

Recruiting
551 miles (887 km)  awayfrom
Czech Republic
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Aarhus Universitetshospital

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

Recruiting
494 miles (796 km)  awayfrom
Czech Republic
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Nordsjaellands Hospital - Hillerod

Dyrehavevej 29, 3400 Hillerød, Denmark

Recruiting
446 miles (717 km)  awayfrom
Czech Republic
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Regions Hospitalet Viborg

Heibergs Alle 5A, 8800 Viborg, Denmark

Recruiting
524 miles (843 km)  awayfrom
Czech Republic
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Universitaetsklinik Aachen

Pauwelsstraße 30, 52074 Aachen, Germany

Recruiting
416 miles (670 km)  awayfrom
Czech Republic
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Charite-Universitiitsmedizin Berlin (CCM)

Luisenstraße 64, 10117 Berlin, Germany

Recruiting
210 miles (338 km)  awayfrom
Czech Republic
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Praxis an der Kaiserreiche

Wilhelm-Hauff-Straße 21, 12159 Berlin, Germany

Recruiting
207 miles (334 km)  awayfrom
Czech Republic
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Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Fiedlerstraße 27, 01307 Dresden, Germany

Recruiting
114 miles (183 km)  awayfrom
Czech Republic
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University Hospital Duesseldorf

Universitätsklinikum Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
389 miles (626 km)  awayfrom
Czech Republic
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Endokrinologikum Frankfurt

Stresemannallee 1/3, 60596 Frankfurt am Main, Germany

Recruiting
298 miles (479 km)  awayfrom
Czech Republic
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MVZ endokrinologikum Göttingen

Von-Siebold-Straße 3, 37075 Göttingen, Germany

Recruiting
267 miles (430 km)  awayfrom
Czech Republic
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Medizinische Hochschule Hannover (MHH)

Carl-Neuberg-Straße 1, 30625 Hannover, Germany

Recruiting
302 miles (485 km)  awayfrom
Czech Republic
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University of Leipzig

Perlickstraße 1, 04103 Leipzig, Germany

Recruiting
169 miles (272 km)  awayfrom
Czech Republic
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Universitaet Zur Luebeck

Ratzeburger Allee 160, 23562 Lübeck, Germany

Recruiting
345 miles (555 km)  awayfrom
Czech Republic
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Medicover Neuroendokrinologie MVZ

Orleanspl. 3, 81667 München, Germany

Recruiting
203 miles (327 km)  awayfrom
Czech Republic
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Medicover Neu-Ulm Mvz

Marienstraße 1, 89231 Neu-Ulm, Germany

Recruiting
259 miles (417 km)  awayfrom
Czech Republic
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Medicover Oldenburg MVZ

Elisenstraße 12, 26122 Oldenburg, Germany

Recruiting
386 miles (621 km)  awayfrom
Czech Republic
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Medicover Saarbuecken Mvz

Faktoreistraße 4, 66111 Saarbrücken, Germany

Recruiting
376 miles (605 km)  awayfrom
Czech Republic
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Diakonie-Klinikum Stuttgart

Rosenbergstraße 38, 70176 Stuttgart, Germany

Recruiting
286 miles (460 km)  awayfrom
Czech Republic
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Endokrinologie Zentrum Ulm

Weinbergweg 41, 89075 Ulm, Germany

Recruiting
260 miles (419 km)  awayfrom
Czech Republic
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Universitaetsklinikum Wuerzburg

Josef-Schneider-Straße 2, 97080 Würzburg, Germany

Recruiting
240 miles (386 km)  awayfrom
Czech Republic
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General Hospital Of Athens - Korgialenio-Benakio E.E.S.

Athanasaki 11, Athina 115 26, Greece

Recruiting
913 miles (1,469 km)  awayfrom
Czech Republic
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General Hospital of Athens Georgios Gennimatas

Leof. Mesogeion 154, Athina 115 27, Greece

Recruiting
913 miles (1,469 km)  awayfrom
Czech Republic
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General Hospital of Athens Alexandra

Lourou 4-2, Athina 115 28, Greece

Recruiting
913 miles (1,469 km)  awayfrom
Czech Republic
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AHEPA University General Hospital of Thessaloniki

Kiriakidi 1, Thessaloniki 546 21, Greece

Recruiting
730 miles (1,175 km)  awayfrom
Czech Republic
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Hippokrateion General Hospital of Thessaloniki

Konstantinoupoleos 49, Thessaloniki 546 42, Greece

Recruiting
731 miles (1,177 km)  awayfrom
Czech Republic
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Azienda Ospedaliero-Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
453 miles (730 km)  awayfrom
Czech Republic
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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

Recruiting
411 miles (662 km)  awayfrom
Czech Republic
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Azienda Ospedaliera San Giovanni Addolorata

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

Site Contact
Recruiting
560 miles (901 km)  awayfrom
Czech Republic
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Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette

Corso Bramante, 88, 10126 Torino TO, Italy

Recruiting
483 miles (778 km)  awayfrom
Czech Republic
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Haukeland University Hospital

Jonas Lies vei 65, 5021 Bergen, Norway

Recruiting
832 miles (1,339 km)  awayfrom
Czech Republic
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Spesialistsentret Pilestredet Park

Pilestredet Park 12A, 0176 Oslo, Norway

Recruiting
726 miles (1,169 km)  awayfrom
Czech Republic
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Hospital Del Mar

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

Recruiting
857 miles (1,379 km)  awayfrom
Czech Republic
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Hospital Universitario 12 de Octubre

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

Recruiting
1,127 miles (1,814 km)  awayfrom
Czech Republic
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Universitetssjukhuset I Linkoping

Universitetssjukhuset, 581 85 Linköping, Sweden

Recruiting
598 miles (963 km)  awayfrom
Czech Republic
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Universitetssjukhuset I Orebro

Södra Grev Rosengatan, 701 85 Örebro, Sweden

Recruiting
659 miles (1,060 km)  awayfrom
Czech Republic
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Karolinska Universitetssjukhuset Solna

Karolinska Vägen 22, 171 64 Solna, Sweden

Recruiting
672 miles (1,082 km)  awayfrom
Czech Republic
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Akademiska Sjukhuset - Uppsala University Hospital

Dag Hammarskjölds Väg 21, 752 37 Uppsala, Sweden

Recruiting
704 miles (1,133 km)  awayfrom
Czech Republic
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University of Hospitals of Leicester NHS Trust

Infirmary Square, Leicester LE1 5WW, UK

Recruiting
739 miles (1,189 km)  awayfrom
Czech Republic
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Norfolk And Norwich University Hospital - Norwich Medical School

Colney Ln, Norwich NR4 7UY, UK

Recruiting
642 miles (1,033 km)  awayfrom
Czech Republic
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View all (95)
Trial Protocol ID: PAR-R13-001
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