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NCT ID: NCT02494986 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus Type 1

A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment.

NCT ID: NCT02492711 Completed - Clinical trials for HER-2 Positive Breast Cancer

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

SOPHIA
Start date: August 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

NCT ID: NCT02492217 Completed - Clinical trials for Ankylosing Spondylitis

Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients

Start date: May 2015
Phase: Phase 4
Study type: Interventional

To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.

NCT ID: NCT02490826 Completed - Speech Disorders Clinical Trials

Table to Tablet (T2T): A Novel Intervention Framework for Children With Speech Sound Disorders

Start date: October 2014
Phase: N/A
Study type: Interventional

The primary aim of this study is to develop software as a tool in speech and language therapy for the treatment of children (Portuguese and English) with phonologically based Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this approach with two groups of preschool and school aged children with phonologically based SSD, with one group consisting of European Portuguese (EP) speakers and one group of British English (BE) speakers. Performance across the two groups will be compared. The total duration of the project will be 30 month.

NCT ID: NCT02488044 Completed - Hyperargininemia Clinical Trials

A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued dosing. A data safety monitoring board (DSMB) will provide independent review of study safety data and recommend whether the sponsor should continue the study as planned, modify the study protocol, or discontinue the study.

NCT ID: NCT02486718 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

Start date: October 31, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

NCT ID: NCT02484651 Completed - Neuromuscular Block Clinical Trials

Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?

Start date: September 2016
Phase: Phase 4
Study type: Interventional

The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).

NCT ID: NCT02483585 Completed - Migraine Clinical Trials

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention

ARISE
Start date: July 20, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

NCT ID: NCT02477839 Completed - Clinical trials for Epilepsy With Partial-onset Seizures

Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

Start date: June 5, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

NCT ID: NCT02477800 Terminated - Alzheimer's Disease Clinical Trials

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

ENGAGE
Start date: August 13, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].