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NCT ID: NCT02659085 Completed - Clinical trials for Depressive Disorder, Major

Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder

Start date: February 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).

NCT ID: NCT02658890 Completed - Clinical trials for Non-Small Cell Lung Cancer

An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

Start date: April 14, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

NCT ID: NCT02657915 Completed - Clinical trials for Acute Optic Neuritis

Long-Term Assessment of Remyelinating Therapy

RENEWED
Start date: March 10, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.

NCT ID: NCT02654990 Completed - Multiple Myeloma Clinical Trials

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma

PANORAMA_3
Start date: April 27, 2016
Phase: Phase 2
Study type: Interventional

NOTE: The study data was transferred to zr pharma& following the divestment of Panobinostat to pharma&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression. Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.

NCT ID: NCT02654145 Completed - Asthma Clinical Trials

Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Start date: March 17, 2016
Phase: Phase 4
Study type: Interventional

Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic asthma. The aim of this study is to investigate whether subjects not optimally controlled on their current omalizumab treatment, who are eligible for therapy with mepolizumab can be effectively and safely switched to treatment with mepolizumab to improve asthma control. The study will provide data on the efficacy, safety, immunogenicity, and tolerability of mepolizumab when switched directly from omalizumab without any wash-out. The learnings from this study may help guide physicians when substituting one biologic with another for the treatment of patients with severe eosinophilic asthma. The study will be a multi-centre, open-label single arm trial. Patients with severe eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be eligible to participate. Subjects will remain on their current maintenance therapy including omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32 weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last dose of mepolizumab.

NCT ID: NCT02653183 Completed - Knee Injuries Clinical Trials

Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

MxBPo02
Start date: December 2015
Phase: N/A
Study type: Interventional

The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit. The secondary objectives are to evaluate: - the performance of the dressing - the comfort, conformability and the acceptability of the dressing - pain before and during dressing removal on the last visit

NCT ID: NCT02650128 Completed - Clinical trials for Coronary Artery Disease

Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

Start date: December 2015
Phase: N/A
Study type: Interventional

Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

NCT ID: NCT02645721 Completed - Clinical trials for Alcohol Use Disorders

Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders

ICBT-AUD
Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.

NCT ID: NCT02644811 Completed - Clinical trials for Orthodontic Space Closure

Miniscrews as Anchorage Device for Orthodontic Treatment

Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B. The hypotheses are: - that placement of miniscrews does not cause more pain or discomfort than premolar extractions - that molarblock provides increase of anchorage - that miniscrews have a better anchorage capacity than molarblock - that miniscrews are more cost-efficient than conventional anchorage techniques

NCT ID: NCT02644187 Completed - Pain Clinical Trials

Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol

Start date: December 2015
Phase: N/A
Study type: Interventional

This pilot study will try to minimize the pain during exposure to a new red light source (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without compromising its effect on AKs. The study design will have an open and prospective, two-armed, split-face design. Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to investigate if a modified irradiation protocol can lower the pain while having the same effect on AK clearance rates as compared to the standard PDT irradiation protocol. Before any study-related procedures are performed, the participants will be thoroughly informed about the study and will be given the opportunity to ask questions. The participants will thereafter sign and date the informed consent form. This constitutes as visit 0. On visit 1, a randomization to either the standard or the modified irradiation protocol will be performed on one side of the face/body and the other irradiation protocol will then be applied on the other side of the face/body. The participants should have AKs on two comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway), which is the traditional lamp used at our department as mentioned above. The treatment will be given at visit 1. During the treatment, the participants will be asked continuously, every third minute, to estimate the pain on each treatment side using the visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the end of the treatment, the participants will also be asked to summarize the treatment as a whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form with questions regarding adverse effects (AEs) during the hours and days after the treatment. The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation protocol should be at least as good as the standard irradiation protocol. The randomization is blinded for the investigator at the FU visit to minimize the possibility of favoring one irradiation protocol.