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NCT ID: NCT02280694 Completed - Colorectal Cancer Clinical Trials

Low Dose Metronomic Poly-chemotherapy for Metastatic CRC

LDMchemoCRC
Start date: January 2015
Phase: Phase 2
Study type: Interventional

This study investigates the activity of a new regimen of treatment for patients with metastatic colorectal carcinoma. This includes a combination of well-known chemotherapy agents and anti-inflammatory agents, when administered orally at low daily doses and without planed brakes (Low Dose Metronomic regimen), in contrast with the conventional and already exhausted regimens of treatment at Maximal Tolerated Doses (MTD) which required pre-planned brakes between treatment days.

NCT ID: NCT02279927 Recruiting - Nephrolithiasis Clinical Trials

Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy

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

A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy

NCT ID: NCT02279524 Completed - Liver Diseases Clinical Trials

A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH

Aramchol_005
Start date: April 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic. Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1. The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

NCT ID: NCT02279498 Completed - Cystic Fibrosis Clinical Trials

SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis

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

Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI). Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.

NCT ID: NCT02279173 Completed - Clinical trials for Immune Thrombocytopenia

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Start date: December 10, 2014
Phase: Phase 3
Study type: Interventional

This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.

NCT ID: NCT02278445 Withdrawn - Clinical trials for Pulmonary Hypertension

Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

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

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

NCT ID: NCT02278133 Completed - Clinical trials for Metastatic Colorectal Cancer

Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions. The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.

NCT ID: NCT02277990 Completed - Clinical trials for CIED Related Infection

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

WRAP-IT
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

NCT ID: NCT02277444 Active, not recruiting - Arthritis, Juvenile Clinical Trials

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

GO-VIVA
Start date: December 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for >= 2 months.

NCT ID: NCT02277223 Withdrawn - Ulcerative Colitis Clinical Trials

Curcumin in Pediatric Ulcerative Colitis

Start date: March 1, 2020
Phase: Phase 3
Study type: Interventional

Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental models of colitis including a positive effect on maintenance of remission in adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as complementary medication in induction and maintenance therapy in pediatric patients with mild to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or corticosteroids induction treatment. Main outcome measures: Disease activity defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version 21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate associations between primary outcomes and categorical variables. Associations of continues variables with primary outcome measures will be examined using ANOVA with repeated measures. P-values <0.05 will be considered significant.