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NCT ID: NCT02446093 Active, not recruiting - Clinical trials for Borderline Resectable Pancreatic Adenocarcinoma

Neoadjuvant CAN-2409 in Combination With Chemoradiation or SBRT for Borderline Resectable Pancreatic Adenocarcinoma

PaTK02
Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the safety, preliminary efficacy, and immune biologic activity of CAN-2409 + prodrug (valacyclovir or acyclovir) in subjects with borderline resectable pancreatic cancer who are being treated with neoadjuvant chemoradiation (CR) or stereotactic body radiation therapy (SBRT). The Standard of Care (SOC) Control arm will be used as a benchmark for informal comparisons of efficacy, safety, and biomarkers.

NCT ID: NCT02444403 Completed - Clinical trials for Occupational Needlestick Injuries

Police Training to Reduce Occupational Needlesticks and HIV Among Substance Users

ESCUDO
Start date: June 2015
Phase: N/A
Study type: Interventional

Background: Policing practices are key drivers of HIV among people who inject drugs (PWID). This study prospectively examines the impact of a police education program (PEP) to align law enforcement and HIV prevention. PEPs incorporating HIV prevention, (including harm reduction programs like syringe exchange) have been successfully piloted in several countries but were limited to brief pre-post assessments; the impact of PEPs on policing behaviors and occupational safety is unknown. Objectives: Proyecto ESCUDO (Project SHIELD) aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID, adverse behaviors that interfere with HIV prevention, and protective behaviors (secondary outcomes). The investigators hypothesize that, over the course of the 24-month follow-up, the PEP will be associated with significant declines in NSI incidence, improved knowledge of HIV and related infections, uptake of occupational safety measures, and decreases in behaviors that undermine HIV prevention (e.g. syringe confiscation, police harassment of PWID at opioid substitution therapy and syringe exchange programs). Methods/Design: ESCUDO is a Hybrid Type 2 design that simultaneously tests an intervention and an implementation strategy. Using a modified stepped-wedge design involving all active duty street-level police officers in Tijuana (N= ~1200), the investigators will administer one 3-hour PEP course to groups of 20-50 officers until the entire force is trained. NSI incidence and geo-coded arrest data will be assessed from department-wide de-identified data. Of consenting police officers, a sub-cohort (N=500) will be randomly sampled from each class to undergo pre- and post-PEP surveys with semi-annual follow-up for 2 years to assess self-reported NSIs, attitudes and behavior changes. Impact on PWIDs will be externally validated through a parallel cohort of Tijuana PWIDs. Discussion: This is the first trial to assess efficacy of a PEP on policing behaviors that place PWID and police at elevated risk of HIV and blood-borne infections. Findings may help bring PEPs to scale in the growing number of countries where policing is a documented driver of HIV acquisition.

NCT ID: NCT02442752 Withdrawn - Clinical trials for Pediatric Gastroesophageal Reflux Disease

Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months

Start date: June 15, 2025
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.

NCT ID: NCT02441400 Terminated - GERD Clinical Trials

EndoStim Patient Registry

RESTORE
Start date: May 2013
Phase:
Study type: Observational [Patient Registry]

To provide a research tool enabling physicians to monitor long term clinical outcomes for patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES Stimulation System.

NCT ID: NCT02441023 Completed - Type 2 Diabetes Clinical Trials

Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes.

NCT ID: NCT02439307 Terminated - Liver Cirrhosis Clinical Trials

Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial

Start date: February 28, 2017
Phase: N/A
Study type: Interventional

A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. Besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.

NCT ID: NCT02438787 Terminated - Clinical trials for Axial Spondyloarthritis

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

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

The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

NCT ID: NCT02438020 Not yet recruiting - Clinical trials for Acanthosis Nigricans

Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity

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

Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin is a useful drug for conditions characterized by insulin resistance.The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as their effects on metabolic and anthropometric variables in a sample of obese children. This is a 12-week randomized, double-blind randomized trial involving obese children with AN to receive either metformin or placebo. Evaluations will be performed every three weeks. Clinical, histological and colorimetric assessments of AN lesions will be compared initially and at the conclusion of the study.

NCT ID: NCT02437890 Completed - Clinical trials for Lupus Erythematosus, Systemic

A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

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

Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.

NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.