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NCT ID: NCT03229200 Enrolling by invitation - Solid Tumor Clinical Trials

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Start date: May 22, 2017
Phase: Phase 4
Study type: Interventional

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

NCT ID: NCT03011398 Enrolling by invitation - Orthopedic Disorder Clinical Trials

A Clinical Registry of Orthobiologics Procedures

Start date: February 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.

NCT ID: NCT02875548 Enrolling by invitation - Clinical trials for Advanced Solid Tumors

A Study to Assess the Long-term Safety of Tazemetostat

TRuST
Start date: August 30, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat.

NCT ID: NCT02796937 Enrolling by invitation - Clinical trials for Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

SPARTA-OLE
Start date: July 2016
Phase: Phase 3
Study type: Interventional

This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).

NCT ID: NCT02657694 Enrolling by invitation - Hepatitis C Clinical Trials

Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

REDEMPTION
Start date: July 1, 2015
Phase: N/A
Study type: Observational [Patient Registry]

REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.

NCT ID: NCT02306720 Enrolling by invitation - Clinical trials for Hypophosphatasia (HPP)

Registry of Patients With Hypophosphatasia

Start date: April 2, 2017
Phase:
Study type: Observational [Patient Registry]

In this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (HPP) are followed at participating sites in multiple countries.

NCT ID: NCT02040714 Enrolling by invitation - Clinical trials for Legg Calve Perthes Disease

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

IPSG1
Start date: August 2012
Phase:
Study type: Observational

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, >11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.

NCT ID: NCT01804686 Enrolling by invitation - Clinical trials for Chronic Lymphocytic Leukemia

A Long-term Extension Study of PCI-32765 (Ibrutinib)

CAN3001
Start date: September 9, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

NCT ID: NCT01414764 Enrolling by invitation - Supraspinatus Tear Clinical Trials

Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?

Start date: May 2011
Phase: Phase 3
Study type: Interventional

The aim of this study is to establish if the application of autologous conditioned plasma (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon repair beginning within two weeks of surgery, can improve patient outcomes over the course of 12 months. These outcomes will be measured by post-surgical pain and function scores, shoulder strength and range of motion (ROM), and radiological parameters of tendon healing. Outcome measures will be compared to a control group of patients receiving placebo injections following surgery (saline plus local anaesthetic). This study is significant for being the first double blind randomised control trial, using two PRP injections to examine the efficacy of a PRP preparation following surgical repair of supraspinatus tendon. The objective is to prolong and enhance the tendon healing response initiated by surgery. The research hypothesis is that enhanced tendon healing following the PRP injections will lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon compared to the control group.

NCT ID: NCT01038466 Enrolling by invitation - Breast Cancer Clinical Trials

Observation Only Study Involving Participants Enrolled in the CHAT Trial

Start date: March 2009
Phase: N/A
Study type: Observational

The aim of the CHAT study ("An open-label, randomized Phase II study of Herceptin (trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or metastatic breast cancers that overexpress HER2") was to test the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer. Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet its primary objective of showing a difference between the treatment groups, with equivalent high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus capecitabine arms. Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression, Overall Survival, duration of response and safety profile. Whilst analysis of the existing data is consistent with improvement with the triplet therapy, interpretation is compromised by the relatively short median follow-up of 24 months. In hindsight the statistical design was flawed by selection of a sub optimal primary endpoint and consequently data was collected and analysed early in relation to time-dependent endpoints. Beyond CHAT will permit capture of mature data for time-related endpoints. Time-to-Progression and Overall Survival are the co-primary endpoints for the Beyond CHAT protocol. The impact of treatment following the first progression, on survival, will be explored. Time-to-Progression will be defined from the time interval between the date of randomisation and the occurrence of progressive disease under therapy according to RECIST criteria. Overall Survival will be defined as the time from date of randomisation to date of death