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NCT ID: NCT04115956 Terminated - AL Amyloidosis Clinical Trials

A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis

Start date: August 6, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy. Melflufen will be administered on Day 1 of each 28-day cycle in combination with dexamethasone on days 1 and 2. In both phases, treatment of each individual participant will continue for up to 8 cycles or until any stopping events occur. Approximately 46 participants will be enrolled. The study was intended to be a Phase 1/2 trial but was early terminated and never moved forward to Phase 2.

NCT ID: NCT04108949 Terminated - Clinical trials for Emotional Disturbances

Small Children, Big Emotions

Start date: August 15, 2019
Phase: N/A
Study type: Interventional

The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.

NCT ID: NCT04106505 Terminated - Migraine Disorders Clinical Trials

Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study

Start date: January 11, 2019
Phase: N/A
Study type: Interventional

This study evaluates biofeedback delivered through a smartphone as a treatment for migraine in adolescents. Three out of four participants will receive treatment as smartphone delivered biofeedback training, and one out of four participants will receive treatment as a sham-biofeedback app.

NCT ID: NCT04099888 Terminated - Cholangiocarcinoma Clinical Trials

PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

RELEASE
Start date: May 23, 2019
Phase: Phase 2
Study type: Interventional

This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

NCT ID: NCT04095247 Terminated - Epilepsy Clinical Trials

Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy

ERAS
Start date: April 3, 2018
Phase:
Study type: Observational

This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an increase in heart rate. One auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered. It has been shown that this can interrupt attacks that are about to develop. In this project the investigators will test how well that works for patients in daily life. The new type of stimulator has similar design and location as the old one. Patients who have already been treated with VNS and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate. The study is a randomized and blinded cross-over. The activation of the extra feature is done either in the first or the second treatment phase. Which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started. The study period is 11 months. Patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.

NCT ID: NCT04079439 Terminated - Clinical trials for Intellectual Disability

Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability

PA-IDe
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

NCT ID: NCT04067180 Terminated - Clinical trials for Acute Myeloid Leukemia

Randomized Clinical Study Assessing Haplo vs. URD in AML

Start date: November 12, 2019
Phase: N/A
Study type: Interventional

This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the hypothesis that haplo SCT is as good as URD SCT. Background: A haplo-identical family donor is a relative sharing 50% of the human leukocyte antigens (HLA) of the patient. SCT with this type of donor is increasing, and a number of retrospective studies have demonstrated its feasibility, but prospective randomized studies are still lacking. Such studies are necessary to establish the benefits of haplo SCT. For the ≈70% of the patients that lack the 1st choice donor, an HLA-matched sibling, the 2nd choice is an URD at most centers. However, if haplo-identical donors are as good as URDs, this could change. Haplo-identical donors have several advantages. Almost all patients have at least one available haplo-identical donor, while URDs can be difficult to find. It also eliminates the need for time-consuming donor searches, and is considerably less costly. The Study: Patients can be included in the study if they have AML and require SCT, ≥18 years, DO NOT have an HLA-matched sibling donor, and DO have potential haplo-identical family donors AND URDs. After enrollment in the study, the patients are assigned randomly to either haplo SCT or URD SCT. The treatment surrounding the transplantation differs according to the donor type. Patients receiving haplo-identical transplantation are treated with a specified chemotherapy protocol before transplantation and a chemotherapy combined with immunosuppressive drugs after the transplantation to prevent graft-vs. host disease (GVHD). The patients receiving URD SCT will be treated according to the standard protocol at their center. Thus, haplo SCT will be compared to what is currently used in patients without an HLA-identical sibling today. The primary endpoint of this study is graft-vs.-host disease- and relapse free survival two years after study inclusion. This measurement takes into account the side effect that causes the most long-term suffering, graft-vs-host disease, as well as leukemia relapse and thus indicates to what extent the treated patients remain relapse-free and without significant side effects. Secondary end points include relapse-free survival, frequencies of graft-versus-host disease and of infections, and the patients will be followed in the study for five years.

NCT ID: NCT04065997 Terminated - Clinical trials for Chronic Heart Failure

Apogee International

Start date: September 6, 2019
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Apogee International registry to further confirm safety and efficacy of the HVAD™ System when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a Medtronic HeartWare™ HVAD™ for bridge to transplant and destination therapy indications.

NCT ID: NCT04059458 Terminated - Clinical trials for Periodontal Diseases

Mandibular Furcation III Regeneration (FURC-III-REGEN)

FURC-III-REGEN
Start date: October 15, 2019
Phase: Phase 4
Study type: Interventional

Teeth with furcation grade III defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.

NCT ID: NCT04059445 Terminated - Clinical trials for Periodontal Diseases

Mandibular Furcation II Regeneration

FURC-II-REGEN
Start date: October 15, 2019
Phase: Phase 4
Study type: Interventional

Teeth with furcation grade II defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.