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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

- 4/10/18 - 1 form, 5 itemgroups, 48 items, 1 language
Itemgroups: Administrative data, Vital signs, Pedal Oedema, Physical examination, Pulmonary function tests / FEV 1
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Follow-Up Part 1: Physical Examination, Vital Signs and Pedal Oedema as well as Pulmonary Function Test.

Follow-up - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 5 itemgroups, 42 items, 1 language
Itemgroups: Vital Signs Follow-up, 12-Lead Electrocardiogram Follow-up, Hematology Follow-up, Clinical chemistry Follow-up, Urinalysis Follow-up
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Follow-Up Part 2 - Laboratory Results

- 4/10/18 - 1 form, 2 itemgroups, 34 items, 1 language
Itemgroups: Laboratory result data - Haematology, Laboratory result data - Clinical chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Follow-Up Part 2: Laboratory Results.

follow-up salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 8/8/17 - 1 form, 4 itemgroups, 8 items, 1 language
Itemgroups: administrative data, oropharyngeal candidasis examination, vital signs, laboratory blood
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Follow-Up Contact

- 12/6/18 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Follow-Up contact question
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Follow-Up - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pregnancy Test; Local Laboratory; Urinalysis

- 2/15/21 - 1 form, 15 itemgroups, 54 items, 1 language
Itemgroups: Administrative, Vital Signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Pulmonary Function Test - Pre-Dose, Pregnancy Test, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Local Laboratory - Haematology, Local Laboratory - Haematology, Urinalysis - Local, Urinalysis - Local, Urinalysis - Microscopy, Urinalysis - Microscopy
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Follow-UP Serious Adverse Event Form

- 11/30/18 - 1 form, 10 itemgroups, 61 items, 1 language
Itemgroups: Randomisation, Serious Adverse Event Entry, Seriousness, Relevant Concomitant/Treatment Medication, Relevant Medical Conditions/Risk Factors, Relevant Diagnosis Results, Rechallenge, Investigational Product, General narrative comments, Non Clinical
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Status of Treatment Blind, Vital Signs, ECG, Study Conclusion, Pregnancy Information, Electronically Transferred Lab Data - Follow- Up

- 10/21/18 - 1 form, 6 itemgroups, 29 items, 1 language
Itemgroups: Status of Treatment blind, Vital signs, 12 lead ECG, Study Conclusion, Pregnancy Information, Electronically transferred lab data
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Lung Cancer NCT00045162 Follow-Up - SOUTHWEST ONCOLOGY GROUP LUNG CARCINOMA FOLLOW UP FORM - 2402496v1.0 - SOUTHWEST ONCOLOGY GROUP LUNG CARCINOMA FOLLOW UP FORM

- 1/9/15 - 1 form, 3 itemgroups, 25 items, 1 language
Itemgroups: Header, VITAL STATUS, Comments
SOUTHWEST ONCOLOGY GROUP LUNG CARCINOMA FOLLOW UP FORM S0124: Cisplatin Combined With Either Irinotecan or Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=001C3566-4C51-5842-E044-0003BA3F9857

GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Main CRF (Follow-up) - Main CRF (Follow-up)

- 10/2/17 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet, Pregnancy test
Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Lung Cancer NCT00946712 Follow-Up - Southwest Oncology Group S0819 Lung Carcinoma Follow Up Form - 2863407v1.0 - Southwest Oncology Group S0819 Lung Carcinoma Follow Up Form

- 1/9/15 - 1 form, 3 itemgroups, 28 items, 1 language
Itemgroups: Header Module, VITAL STATUS, Comments
Southwest Oncology Group S0819 Lung Carcinoma Follow Up Form Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=684CF883-6531-1929-E040-BB89AD4373A3

S0023 LUNG CARCINOMA FOLLOW UP FORM NCT00020709

- 6/3/15 - 1 form, 7 itemgroups, 25 items, 1 language
Itemgroups: SWOG clinical trial administrative data, VITAL STATUS, DISEASE FOLLOW UP STATUS, NOTICE OF NEW PRIMARY, NON-PROTOCOL TREATMENT, LONG TERM TOXICITY, Notes
S0023 LUNG CARCINOMA FOLLOW UP FORM NCT00020709 S0023: Combination Chemo Plus RT With or Without Gefitinib in Treating Patients With Unresectable Stage III NSCLC Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9CB6D1D2-A964-34E4-E034-080020C9C0E0

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