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NCT ID: NCT01972529 Completed - Clinical trials for Thrombocytopenia Associated With Liver Disease

Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure

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

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

NCT ID: NCT01972295 Completed - Atrial Fibrillation Clinical Trials

Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry

WASP
Start date: January 13, 2014
Phase:
Study type: Observational [Patient Registry]

This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

NCT ID: NCT01971736 Completed - Skin Laxity Clinical Trials

Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening

Start date: September 2012
Phase: N/A
Study type: Observational

We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for skin tightening immediately post laser and 3 months follow up.

NCT ID: NCT01968018 Completed - Cancer Clinical Trials

A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain

Start date: July 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.

NCT ID: NCT01967940 Completed - HIV Infections Clinical Trials

Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults

Start date: October 25, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.

NCT ID: NCT01966471 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

NCT ID: NCT01965093 Completed - Clinical trials for Disorder of Growth and Development

Growth and Intelligence Outcome in Children Who Developed Perioperative Desaturation

Start date: November 2012
Phase: N/A
Study type: Observational [Patient Registry]

The most serious peri-operative respiratory event (PRE) in pediatric anesthesia is desaturation or hypoxemia which could lead to cardiovascular collapse or cardiac arrest. Intermittent hypoxic episode especially in infants are also associated with impaired growth, longer-term cardiorespiratory instability and poor neurodevelopmental outcome.12 The mechanism of peri-operative desaturation occurring in normoxia infant brain is quite similar to overabundance of oxygen in the acutely hypoxic infant by using 100% oxygen or hyperoxia for resuscitation of acutely asphyxiated infants which can generate excessive neurotoxic compounds and increase oxidative stress markers.17 Anesthetic agents which involve gamma-aminobutyric acid (GABA)receptors eg; volatile agents, midazolam and N-methyl-D-aspartate receptor (NMDA) receptors eg; nitrous oxide, ketamine can cause neuronal apoptosis, neuronal necrosis, neuronal cell death and memory deficit in rat pups. Moreover, prolonged anesthetic exposure, irrespective of open heart surgery, can influence neurodevelopment of the brain in rodents.17 However, the evidence for anesthetic agents causing apoptosis and neurodegeneration in human neonatal brain is still not clear. Thus, peri-operative desaturation occurred in young age regardless of severity combined with general anesthesia might possibly affect the long-term impact regarding growth and neurodevelopmental outcome in infant or intelligence outcome in older children. In our study, we are interested in looking at the intelligence outcome, which is a part of neurodevelopment outcome, in preschool children aged ≤ 5 years who developed desaturation peri-operatively. Because we include a wide range of age between newborn to five years old to test neurodevelopment outcome in older children, the intelligence outcome may be more appropriate and can be applied to infants and younger ages. Therefore, the objective of study was to compare intelligence outcome between children who developed peri-operative desaturation and children who did not develop PRE.

NCT ID: NCT01964989 Completed - Influenza Virus Clinical Trials

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

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

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

NCT ID: NCT01964560 Completed - Epilepsy Clinical Trials

A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

Start date: August 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

NCT ID: NCT01963013 Completed - Clinical trials for Critically Ill Patients

Non-returning Catheter Valve for Reducing CAUTI

Start date: June 2012
Phase: N/A
Study type: Interventional

This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.