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Sommario
  1. 1. Test clinico
  2. 2. Documentazione di routine
  3. 3. Registro / studio di coorte
  4. 4. Garanzia di qualità
  5. 5. Dati Standard
  6. 6. Risultato segnalato dal paziente
  7. 7. Specialità mediche
    1. 7.1. Anestesiologia
    1. 7.2. Dermatologia
    1. 7.3. orecchio naso gola
    1. 7.4. Geriatria
    1. 7.5. Ginecologia / Ostetricia
    1. 7.6. Medicina Interna
      1. Ematologia
      1. Malattie infettive
      1. Cardiologia / Angiologia
      1. pneumologia
      1. Gastroenterologia
      1. Nefrologia
      1. Endocrinologia / Malattie metaboliche
      1. Reumatologia
    1. 7.7. Neurologia
    1. 7.8. Oftalmologia
    1. 7.9. Cure palliative
    1. 7.10. Patologia / Forense
    1. 7.11. Pediatria
    1. 7.12. Psichiatria / Psicosomatica
    1. 7.13. Radiologia
    1. 7.14. Chirurgia
      1. Chirurgia generale / viscerale
      1. Neurochirurgia
      1. Chirurgia plastica
      1. Chirurgia toracica
      1. Trauma / Ortopedia
      1. Chirurgia vascolare
    1. 7.15. Urologia
    1. 7.16. Medicina odontoiatrica / OMS
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NINDS CDE Headache Diagnosis - Headache Diagnosis

- 15/06/16 - 1 modulo, 3 itemgroups, 26 elementi, 1 linguaggio
Itemgroups: Demographics, Headache Diagnosis, Additional Pediatric-specific Elements
NINDS Common Data Elements (Headache Diagnosis; Headache) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Headache Mail Questionnaire - Headache Mail Questionnaire

- 23/04/19 - 1 modulo, 1 ItemGroup, 86 elementi, 1 linguaggio
ItemGroup: Headache Mail Questionnaire
NINDS Common Data Elements (Headache Mail Questionnaire) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Symptoms, Frequency and Severity - Headache - Symptoms, Frequency and Severity - Baseline

- 15/06/16 - 1 modulo, 2 itemgroups, 27 elementi, 1 linguaggio
Itemgroups: Demographics, Symptoms, Frequency and Severity - Baseline
NINDS Common Data Elements (Symptoms, Frequency and Severity - Baseline; Headache) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Physical Examination Headache - Physical Examination

- 20/06/16 - 1 modulo, 1 ItemGroup, 48 elementi, 1 linguaggio
ItemGroup: Physical Exam
NINDS Common Data Elements [Physical Examination] [Headache] Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Medical and Family History of Headache/Migraine - Medical and Family History of Headache/Migraine

- 15/06/16 - 1 modulo, 1 ItemGroup, 122 elementi, 1 linguaggio
ItemGroup: Medical and Family History of Migraine Headache
NINDS Common Data Elements (Medical and Family History of Headache/Migraine) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

dbGaP phs000682 Genetics of Neuropsychiatric and Neurodevelopmental Disorders - Eligibility

- 24/01/23 - 6 moduli, 1 ItemGroup, 15 elementi, 1 linguaggio
ItemGroup: IG.elig
Principal Investigator: David Goldstein, PhD, Duke University, Durham, NC, USA MeSH: Schizophrenia,Schizoaffective disorder,Attention Deficit Hyperactivity Disorder,Seizures,Oppositional defiant disorder,Anxiety,Depression,Autism,Autism Spectrum Disorders,Bipolar Disorder,Developmental Disabilities,Ataxia,Migraine,Paranoid schizophrenia,Obsessive compulsive disorder,Kluver-Bucy syndrome,Intellectual disability https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000682 Although schizophrenia is a highly heritable disease, relatively little progress had been made in securely identifying the genetic causes of this disorder, and most instances of schizophrenia in the general population remain unexplained. One avenue of explanation for the genetic basis of schizophrenia, however, has been effectively closed by recent research. Genome-wide association studies (GWAS) have now shown that common variation makes at most a modest contribution to the risk of schizophrenia. At the same time that the role of common variation has been circumscribed by GWAS, however, the analysis of copy number variants that are detectable on a genome-wide scale has revealed and replicated a number of very rare variants that associate with schizophrenia. These rare copy number variants that have been implicated in schizophrenia, however, have one striking feature in common: they are all risk factors for other brain related disorders beyond schizophrenia such as mental retardation, autism and epilepsy. These findings argue that genetic risk factors may confer a highly penetrant vulnerability to neuropsychiatric disorder, which is then further modified by interacting genetic or environmental factors to determine the ultimate manifestation. Most schizophrenia collections that are being studied today, however, have been selected precisely for their homogeneity: including only schizophrenia patients with no comorbidities, or schizophrenia patients with relatives who have schizophrenia but no other neuropsychiatric conditions. These selection criteria are inconsistent with what we now know about the bulk of the genetic differences that have been associated with disease. The central hypothesis of this project is that there are rare genetic variants that strongly elevate the risk of various neuropsychiatric diseases, and that these risk factors can be identified most readily in families segregating multiple neuropsychiatric conditions.

pht003594.v1.p1

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pht003595.v1.p1

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pht003596.v1.p1

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pht003597.v1.p1

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pht003598.v1.p1

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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Headache Classification

- 20/09/21 - 1 modulo, 4 itemgroups, 12 elementi, 1 linguaggio
Itemgroups: Administrative Information, IHS Headache Classification, Migraine History, Subject Recruitment
https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 Study Title :A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data :Study Listed on ClinicalStudyDataRequest.com Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

dbGaP phs000304 Genes and Blood Clotting Study (GABC) - pht004468.v1.p1

- 12/10/22 - 6 moduli, 1 ItemGroup, 7 elementi, 1 linguaggio
ItemGroup: pht004468
Principal Investigator: David Ginsburg, MD, University of Michigan, Ann Arbor, MI, USA MeSH: von Willebrand Disease,Epistaxis,Stomatitis, Aphthous,Menarche,Menorrhagia,Acne Vulgaris,Eye Color,Hair Color,Sunburn,Skin Pigmentation,Freckles,Dental Caries,Migraine Disorders,Rhinitis, Allergic, Seasonal,Eye Diseases,Refractive Errors,Flatfoot,Functional Laterality,Venous Thromboembolism https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000304 *Objectives:* Use genome-wide approaches to identify genetic variants that influence common thrombosis and hemostasis factors, as well as selected common human traits. *Design/Methods:* The GABC study was a prospective sibling cohort design. Siblings were recruited by targeted email to the undergraduate and graduate student email lists at the University of Michigan. Healthy persons between 14 and 35 years old who had healthy siblings within the same age restriction were able to participate. Study participants agreed to an online informed consent and subsequently completed a 52-question online survey describing their specific bleeding traits as well as many common human traits. Fifty milliliters of blood was collected into a citrate-dextrose solution (ACD) from each participant. An aliquot of whole blood was used for an automated complete blood count analysis and the remainder was processed into platelet poor plasma and buffy coat portions. Plasma and buffy coat aliquots were snap frozen and stored in liquid nitrogen for future studies. 1189 individuals representing 507 sibships were collected between 06/26/2006 and 01/30/2009. *Phenotyping Survey Details:* To characterize individual bruising and bleeding history, the online survey recorded answers to questions based on a modified von Willebrand Disease (VWD) screening questionnaire. To characterize a collection of participant's common human traits, the survey recorded answers to questions about height, weight, presence of skin tags, history of acne, eye color, hair color, hair line characteristics, skin sunburn sensitivity, skin tanning ability, natural skin color, freckling, cheek dimpling, earlobe shape, shoe size, foot arch characteristics, hand fifth digit morphology, history of dyslexia, history of migraine headaches, history of seasonal allergies, history of apthous ulcers, tendency to sneeze while walking into a bright sunny place, history of dental caries, need for corrective eye lenses, handedness and like or dislike of strongly flavored foods. *Biochemical phenotyping:* Assays for plasma Von Willebrand Factor (VWF) antigen were performed using ELISA and "Alphalisa" techniques. Automated complete blood count analysis was performed on a Bayer Advia 120 on all participants (including WBC differential, RBC indices, and platelet count.) For the dbGaP v2 update, new biochemical phenotypes have been submitted and include von Willebrand Factor, von Willebrand Factor propeptide, plasminogen, gamma prime fibrinogen, ADAMTS 13, antithrombin III, protein C, and protein S. All new phenotypes were obtained using "Alphalisa" techniques. *Genotyping Details:* SNP genotyping was performed using genomic DNA extracted from peripheral blood at the Broad Institute, (MIT/Harvard). Genotyping was performed on the Illumina Omni-1 quad chip at the Broad Institute. For the dbGaP v2 update, genotyping data from the Illumina Human Exome was deposited. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to blood clotting through large-scale genome-wide association studies of siblings. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization was performed by the primary investigators at the University of Michigan, Ann Arbor, and at the GEI-funded GENEVA Coordinating Center at the University of Washington. This study serves as a resource for investigators who are interested in the genetic determinants of specific plasma proteins in a healthy population. The sibling cohort design allows for linkage analysis in addition to association studies. Analysis of thrombosis and hemostasis related traits should help elucidate specific biochemical and genetic networks that maintain hemostasis. We hope to identify specific genetic determinants of VWF levels in order to better understand the factors that influence the development of VWD.

Eligibility

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pht001907.v2.p1

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pht001904.v1.p1

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pht001905.v1.p1

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pht001906.v2.p1

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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Screen

- 17/09/21 - 1 modulo, 17 itemgroups, 92 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Inclusion, Exclusion Criteria, Demography, Vital Signs, Demography, Female, Medical History, Disease, Current, Pharmaceutical Preparations, Medical History, Physical Examination, Electrocardiography, Laboratory Procedures, Abnormality, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Abnormality, Laboratory Procedures, Urinalysis, Abnormality, Drug abuse, Serologic tests, HIV Screen, Therapeutic procedure, Assignment
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Serious Adverse Event (SAE)

- 03/07/19 - 1 modulo, 14 itemgroups, 54 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Demography, Serious Adverse Event, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Disease, Relevance, Serious Adverse Event, Risk Factors, Other, Serious Adverse Event, Experiment drug, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Comment, Serious Adverse Event, Evaluation, Details, Investigator Signature, Serious Adverse Event, Additional Information, Clinical Investigators
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Serious Adverse Event (SAE)

- 03/07/19 - 1 modulo, 14 itemgroups, 54 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Demography, Serious Adverse Event, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Disease, Relevance, Serious Adverse Event, Risk Factors, Other, Serious Adverse Event, Experiment drug, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Comment, Serious Adverse Event, Evaluation, Details, Investigator Signature, Serious Adverse Event, Additional Information, Clinical Investigators
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - End of Study Record

- 03/07/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Clinical Trials, End
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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