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NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01853826 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Start date: July 17, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

NCT ID: NCT01851824 Completed - Clinical trials for Malignant Melanoma, Neoplasms

A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 [NCT01739764]).

NCT ID: NCT01851707 Completed - Clinical trials for Rheumatoid Arthritis

A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

ASPIRA
Start date: April 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), IPI-145, in combination with methotrexate compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.

NCT ID: NCT01847274 Completed - Ovarian Neoplasms Clinical Trials

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

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

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

NCT ID: NCT01846299 Completed - Macular Edema (ME) Clinical Trials

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Start date: October 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to macular edema (ME).

NCT ID: NCT01844765 Completed - Clinical trials for Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

DIALOG
Start date: August 20, 2013
Phase: Phase 2
Study type: Interventional

To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).

NCT ID: NCT01840410 Completed - Clinical trials for Choroidal Neovascularization (CNV)

Assess the Efficacy/Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Choroidal Neovascularization.

Start date: September 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to choridal neovascularization (CNV).

NCT ID: NCT01839214 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis

Start date: January 2013
Phase: Phase 2
Study type: Interventional

This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.

NCT ID: NCT01839201 Completed - Dreamy State Clinical Trials

The Effect of Preoperative Suggestions on Perioperative Dreams and Dream Recalls

dream
Start date: November 2009
Phase: N/A
Study type: Interventional

Hypothesis: By employing suggestions before the induction of narcosis dreams may be evoked and their content may be directed. The main goal of suggestive techniques in the perioperative phase is to turn the content of dreams toward a favourable direction that is considered a pleasant event by the patient. So far little attention has been paid to the administration of perioperative psychological methods that may meet these requirements. Along these lines, in the present study we intended to assess whether dream recalls can be influenced by two different psychological methods administered in the preoperative setting