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NCT ID: NCT03719690 Completed - HNSCC Clinical Trials

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

AIM-HN/SEQ-HN
Start date: March 15, 2019
Phase: Phase 2
Study type: Interventional

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

NCT ID: NCT03719508 Completed - Abdominal Surgery Clinical Trials

Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery

Start date: January 5, 2013
Phase:
Study type: Observational

Predictive Value of Various Nutritional Screening and Assesment Tools and a Surgery Scoring System (POSSUM Score) for Predicting Postoperative Complications in Patients Scheduled for Abdominal Surgery.

NCT ID: NCT03719313 Completed - Clinical trials for Hepatitis Delta Virus

Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

D-LIVR
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

NCT ID: NCT03713632 Completed - Clinical trials for Hidradenitis Suppurativa

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

SUNRISE
Start date: February 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.

NCT ID: NCT03713619 Completed - Clinical trials for Hidradenitis Suppurativa

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

SUNSHINE
Start date: January 31, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

NCT ID: NCT03711838 Completed - Redox Status Clinical Trials

Redox Regulation of Satellite Cells and Skeletal Muscle Healing

Start date: July 22, 2019
Phase: N/A
Study type: Interventional

Skeletal muscle stem cells (Satellite cells) are indispensable for muscle growth and remodeling following myofibril damage. Skeletal muscle trauma is present in numerous catabolic conditions, characterized by elevated proteolysis and muscle wasting such as, cancer cachexia and muscular dystrophy, which result in physical capacity impairment and a deteriorated quality of life. Recent studies performed in animals and cell cultures indicate that the increased levels of inflammation and oxidative stress and the reduction of antioxidant defense may blunt the satellite cells response and myogenic programming during muscle healing. However, evidence regarding the effects of redox status on satellite cells and muscle myogenic potential in humans is lacking. Exercise-induced muscle damage bears striking similarities with the aforementioned conditions, which makes it a valuable tool to investigate the redox-dependent regulation of satellite cells during muscle healing. Thus, the objectives of the present study are to examine the effects of redox status perturbation (via N-acetylcysteine administration) on intracellular pathways responsible for satellite cells responses at rest and following aseptic muscle trauma induced by damaging exercise.

NCT ID: NCT03710824 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

QUALIFY IPF
Start date: February 28, 2019
Phase:
Study type: Observational

Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.

NCT ID: NCT03709498 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Nutritional Status in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Start date: January 2016
Phase:
Study type: Observational

A cross sectional observation study of body composition in COPD patients consecutively hospitalized with acute exacerbation.

NCT ID: NCT03705949 Completed - Cataract Clinical Trials

Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

NCT ID: NCT03689374 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

SUSTAIN 11
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.