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NCT ID: NCT03000452 Completed - Multiple Myeloma Clinical Trials

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

FUSION-MM-005
Start date: March 14, 2017
Phase: Phase 2
Study type: Interventional

This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2 weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.

NCT ID: NCT02999997 Completed - Parkinson Disease Clinical Trials

Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease

RGM/PD
Start date: January 2017
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is typically associated with cognitive and movement related functional disabilities. One commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner Method (RGM) is a rhythm and music based rehabilitation intervention that includes components that will train this ability specifically in addition to postural control, motor learning, movement ability and general cognitive function. The aim with the present randomized controlled single-blinded trial is to evaluate the RGM with main focus on dual-task performance, compared to a control group, in individuals with PD. The control group will continue with everyday activities, including ordinary exercise activities, with no additional activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention. Following outcome measures will be analyzed: 1. dual task performance (motor-motor, and motor-cognitive) 2. level of physical activity, motor function and balance 3. cognitive function including memory and spatial function 4. health-related quality of life, fear of falling, and freezing of gait 5. qualitative interviews from focus group discussions

NCT ID: NCT02999854 Terminated - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer

HATCY
Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.

NCT ID: NCT02999412 Completed - Medication Review Clinical Trials

Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial

MedBridge
Start date: February 6, 2017
Phase: N/A
Study type: Interventional

Background: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence. Aim: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews. Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial. Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties. Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion criteria: Palliative stage; residing in other than the hospital's county; medication review within the last 30 days; one-day admission. Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care. Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up period. Data collection and analyses: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using log-linear Poisson generalized linear mixed models and frailty models. Relevance: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.

NCT ID: NCT02998996 Completed - Influenza, Human Clinical Trials

Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU

Start date: September 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.

NCT ID: NCT02997995 Completed - Breast Cancer Clinical Trials

Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure

ULTIMATE
Start date: February 15, 2017
Phase: Phase 2
Study type: Interventional

This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane.

NCT ID: NCT02997982 Completed - Alzheimer Disease Clinical Trials

Feasibility and Effects of Valaciclovir Treatment in Persons With Early Alzheimer's Disease

VALZ-Pilot
Start date: December 2016
Phase: Phase 2
Study type: Interventional

This study investigates the effects of Valaciclovir treatment to individuals with Alzheimer's disease or Mild Cognitive Impairment of Alzheimer's Disease Type. It is an open pilot trial where 36 participants will receive 4 weeks of Valaciclovir treatment. Participants will be investigated using different measures before and after the treatment period.

NCT ID: NCT02994927 Completed - Clinical trials for ANCA-Associated Vasculitis

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

ADVOCATE
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.

NCT ID: NCT02994563 Terminated - Ischemic Stroke Clinical Trials

Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study

Start date: October 7, 2019
Phase: N/A
Study type: Interventional

Prospective, single-arm, open label, Safety and Performance clinical investigation.

NCT ID: NCT02993783 Terminated - Clinical trials for Allogeneic Hematopoietic Stem Cell Transplantation

A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Start date: April 28, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal GvHD in participants who have undergone allo-HSCT.