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NCT ID: NCT03385226 Active, not recruiting - Clinical trials for Cutaneous T Cell Lymphoma

A Trial Assessing the Effect of Pembrolizumab Combined With Radiotherapy in Patients With Relapsed, Refractory, Specified Stages of Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF)/Sezary Syndrome (SS)

PORT
Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

Trial Subjects (patients), will receive single infusions of pembrolizumab every 3 weeks until disease progression or unacceptable toxicity develops. They will receive radiotherapy at week 12.

NCT ID: NCT03383458 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

CheckMate 9DX
Start date: April 18, 2018
Phase: Phase 3
Study type: Interventional

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

NCT ID: NCT03383302 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Stage I

SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects

STILE
Start date: February 8, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single arm, multi-centre, phase II open label study of nivolumab with stereotactic body radiotherapy (SBRT) for early stage non-small cell lung cancer. SBRT will be delivered in either 3 or 5 fractions for peripheral disease or 8 fractions in central disease. A flat dose of 240 mg nivolumab infusion will begin after the final fraction of SBRT, within 24 hours and typically on the same day. Nivolumab will subsequently be given every 2 weeks at a flat dose of 240 mg for a further 13 cycles followed by Nivolumab 480mg Q4W for 7 cycles until 20 cycles in total are complete, unless any study drug discontinuation criteria are met. Treatment (20 cycles) will take a minimum of 1 year to complete but may exceed this timeframe if treatment delays are encountered. (Patients who have enrolled on Nivolumab Q2W 240mg regimen for 26 cycles and are beyond cycle 14 will receive 26 cycles Q2W in total to complete treatment). Assessment of toxicities will be performed at each clinic visit during treatment, at 30 days after the final nivolumab infusion and until 100 days after the final nivolumab infusion. Changes in spirometry values and PFTs will be assessed throughout the trial. Relapse rates will be assessed with staging CT scans at 3, 6, 12, 18 and 24 months post SBRT. An exploratory assessment will be made of the effect pre-treatment pulmonary function tests (PFTs) have on outcome measures.

NCT ID: NCT03379818 Active, not recruiting - Clinical trials for Language Development Disorders

Vocabulary Intervention for Late Talkers

Start date: June 19, 2018
Phase: N/A
Study type: Interventional

Most studies regarding word learning have focused on understanding when and how infants learn words. At 24 months, typically developing infants know between 200 and 300 words and add new words to their vocabularies at a rapid rate. It is also during the first years of life that some principles that promote vocabulary learning are developed. The shape bias, which is a tendency to infer that objects that share the same shape will also share the same name, is the one that has been studied the most. At 24 months, typically developing infants use this principle as a strategy to learn novel words. In contrast, Late Talkers (children with a language delay in the absence of a physiological, cognitive or genetic disorder that may account for this delay) do not exhibit this preference. It has been found that teaching typically developing infants a shape bias prior to the end of the second year of life can boosts their word learning. Despite this, the possibility of teaching Late Talkers this principle and its effect on their vocabulary and language development has not been explored. Over a series of 9 weekly sessions, Late Talkers (diagnosed by Language Therapists from the Birmingham Community Healthcare National Health Services Foundation Trust, United Kingdom) will be introduced to one of two possible interventions: a shape bias intervention and a more conventional intervention called "specific word intervention". Both interventions will be compared after 9 weeks. One year later, a follow up study will be conducted to assess the long-term effects each intervention has in word learning. Participants will be referred by a Speech and Language Therapists from the Birmingham Community Healthcare National Health Services Foundation Trust, United Kingdom, and all assessments and interventions will take place at the Infant and Child Lab at the University of Birmingham, United Kingdom.

NCT ID: NCT03374085 Active, not recruiting - Multiple Myeloma Clinical Trials

A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Start date: February 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.

NCT ID: NCT03372278 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

Start date: January 2013
Phase:
Study type: Observational

This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

NCT ID: NCT03371017 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

IMpassion132
Start date: January 11, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

NCT ID: NCT03370913 Active, not recruiting - Hemophilia A Clinical Trials

Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)

BMN 270-301
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP) (from Week 5 post-BMN 270 infusion (Study Day 33) or the end of FVIII prophylaxis plus the washout period (3 days for products of standard half-life or plasma-derived and 5 days for products of extended half-life), whichever is later, to last visit by the data cut-off for the 2-year analysis, hereafter referred to as "Post FVIII Prophylaxis to Last Visit"). The study will also assess the impact of BMN 270 (compared to FVIII prophylaxis) on: the number of bleeding episodes requiring exogenous FVIII treatment in "Post FVIII Prophylaxis to Last Visit", FVIII activity as measured by chromogenic sustrate assay at Week 104 following intravenous infusion of BMN 270, usage of exogenous FVIII replacement therapy in "Post FVIII Prophylaxis to Last Visit", health-related quality of life patient-reported outcomes at week 104 following intravenous infusion of BMN 270. The study will also evaluate the safety of the BMN 270.

NCT ID: NCT03368664 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

LemKids
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).

NCT ID: NCT03364868 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)

Start date: February 7, 2018
Phase: Phase 2
Study type: Interventional

The GPPAD-POInT Study is designed as a randomized, placebo-controlled, double blind, multicentre, multinational primary prevention phase IIb study aiming to induce immune tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of 29 to 32 months. The hypothesis is that regular exposure to oral insulin throughout the period in life where beta-cell autoimmunity usually initiates will tolerize against insulin and train the body's immune system to recognize the treatment product without reacting adversely to it in a manner seen in children who develop T1D. This immune tolerance induction therapy would reduce the likelihood of beta-cell autoimmunity. The study objective is to determine whether daily administration of oral insulin from age 4 months - 7 months until age 3.00 years to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies and diabetes in childhood.