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NCT ID: NCT01964391 Completed - Breast Cancer Clinical Trials

A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

Start date: February 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.

NCT ID: NCT01959529 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

DEVOTE
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

NCT ID: NCT01868477 Completed - Clinical trials for Low and Int 1-risk Myelodysplastic Syndrome

Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Start date: January 28, 2014
Phase: Phase 2
Study type: Interventional

The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin. This study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.

NCT ID: NCT01853839 Completed - Hypertension Clinical Trials

Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients

Start date: October 2011
Phase: N/A
Study type: Observational

This is an out-patient based prospective, multi-centre, observational post-marketing surveillance study amongst internists and cardiologists. In this study, patients with essential hypertension and at least one additional risk factor will be included. Patients may take any antihypertensive treatment which is approved for cardiovascular protection including Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from baseline to endpoint with an additional visit before and after the month of Ramadan.

NCT ID: NCT01833793 Completed - Clinical trials for Female Contraception

Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice

MARILIA
Start date: February 2013
Phase: N/A
Study type: Observational

MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.

NCT ID: NCT01753349 Completed - Cervical Dystonia Clinical Trials

Phase IV-Cervical Dystonia-INTEREST IN CD2

INTEREST_INCD2
Start date: December 2012
Phase:
Study type: Observational

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

NCT ID: NCT01720446 Completed - Clinical trials for Diabetes Mellitus, Type 2

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

SUSTAIN™ 6
Start date: February 21, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

NCT ID: NCT01713530 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Start date: February 21, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

NCT ID: NCT01680341 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

BOOST®
Start date: August 31, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

NCT ID: NCT01649856 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

Start date: August 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.