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PORTAS2_Trial - Screening Visite

- 2023-02-20 - 4 Formulär, 20 Item-grupper, 67 Dataelement, 1 Språk
Item-grupper: Einschluss, Einschlusskriterien, Ausschluss, Ausschlusskriterien, Biometrische Daten, Risikofaktoren, Raucher, Raucher, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen, Vorerkrankungen / Voroperationen
Portas2 P. Knebel1*, L. Fischer1*, J. Huesing2, R. Hennes1, K. Buhl1, M. W. Büchler1, C. M. Seiler1 Totally implantable access port in oncology patients:Success of implantation with and without the Seldinger technique through venae sectio - A randomized surgical trial (ISRCTN: 52368201)

OP Tag

4 Item-grupper 27 Dataelement

Patientendokumentation

1 Item-grupp 4 Dataelement

Follow-Up

5 Item-grupper 14 Dataelement

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

- 2020-12-12 - 1 Formulär, 5 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Administrative Data, slit lamp examination, slit lamp biomicroscopy, visual acuity, Indirect Ophtalmoscopy
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening and Follow-Up Visits.

REJUVENATE NCT02655419 - Screening Visit

- 2018-01-24 - 1 Formulär, 21 Item-grupper, 212 Dataelement, 1 Språk
Item-grupper: Administrative Information, Patient Information, Demography, Alcohol and Smoking History, Type of Substance, Eligibility determination, Failed IE criteria, Medical and surgical history, Medical / surgical event, Physical Examination, Physical examination, Diagnosis of Current Intra-Abdominal Infection, Site of Source of Infection, Radiological Examination, Infection-related Examination, Infection related Signs and Symptoms, Vital Signs examination, Temperature, Laboratory Tests, Laboratory Screening, Microbiology
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults. NCT02655419 Sponsors and Collaborators: Pfizer Innovative Medicines Initiative (IMI) COMBACTE-CARE Investigators: Study Director:Pfizer CT.gov Call Center;Pfizer Principal Investigator:Oliver Cornely;Clinical Trials Centre Cologne

Second cycle of therapy- BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Second cycle of therapy

- 2017-11-01 - 1 Formulär, 10 Item-grupper, 111 Dataelement, 1 Språk
Item-grupper: Physical examination, Medication: AraC, AraC Protocol, Medication: BIBF 1120, BIBF 1120 protocol, Haematology, Differential blood count, Clinical chemistry, Bone marrow examination, investigator signature
Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

Second cycle of therapy- BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Second cycle of therapy

- 2017-11-01 - 1 Formulär, 10 Item-grupper, 111 Dataelement, 1 Språk
Item-grupper: Physical examination, Medication: AraC, AraC Protocol, Medication: BIBF 1120, BIBF 1120 protocol, Haematology, Differential blood count, Clinical chemistry, Bone marrow examination, investigator signature
Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

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