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NCT ID: NCT03468582 Recruiting - Clinical trials for Human Immunodeficiency Virus

123I Radiolabeled 3BNC117

Start date: February 8, 2018
Phase: Early Phase 1
Study type: Interventional

The conventional way to control HIV infection is the usage of a drug cocktail capable of suppressing the viral replication cycle, commonly known as antiretroviral therapy (ART). Despite effective ART it is not possible to eradicate HIV. The virus hides in particular cells to form the latent HIV-reservoir.[1-9] Studies that emphasise on revealing hidden reservoirs would aid in designing novel therapeutic strategies for controlling HIV infection. Molecular imaging by SPECT/CT has the potential to reveal hidden reservoirs of HIV virus that are not eliminated by currently used drugs capable of suppressing and thereby controlling the viral replication cycle in HIV infected patients. New approaches, necessary to prevent and treat HIV-1 infection, are gradually emerging. A new generation of highly potent broadly neutralizing antibodies (bN/Abs) may represent a promising approach to combating HIV-1 infection.[10] The broadly neutralizing antibody 3BNC117 antibody that can mimic human CD4 binding targeted against the HIV gp120 envelope protein has been tested in various clinical trials.[11-14] It has found to be safe and effective in reducing viraemia and to improve host humoral responses in HIV-1 infected individuals, and to have effect on viral rebound in patients who are kept off antiretroviral treatment briefly for experimental purpose. Imaging of simian immunodeficiency virus (SIV) infection by PET/CT has been successfully performed in nonhuman primates with a 64Cu-labeled SIV gp120-specific antibody called 7D3.[15] This study aims to use a similar approach in human with the 3BNC117 antibody. The 3BNC117 antibody has been successfully radiolabeled with iodine 123. The half-life of this radioisotope is appropriate for antibody imaging in nuclear medicine. Radiolabeled 123I 3BNC117 was shown to keep a good immunoreactivity for gp120. By using state of the art SPECT scanner a semi-quantitative image will be obtained. In addition, the absence of any chelator and the well known use of iodine-123 in clinic make it suitable for human intervention. No HIV imaging in human has been achieved yet, which is however fundamental to understand some key steps in the pathogenesis of HIV-induced immunodeficiency. This research opens promising opportunities for drug and vaccine development. Indeed, identification of virus reservoirs in treated patients would facilitate the development of strategies for eradicating these reservoirs or for extending latency period.

NCT ID: NCT03467074 Completed - Clinical trials for Allogeneic Stem Cell Transplantation

Role of Interferon-λ and Vaccine Response

Start date: September 1, 2014
Phase: N/A
Study type: Observational

The following observational study will investigate whether the vaccine response (antibodies, T and B cells) after allogeneic stem cell transplantation is influenced by genetic polymorphisms in the interferon lambda signal.

NCT ID: NCT03465683 Recruiting - Clinical trials for Hospital Acquired Infection

Transmission of ESBL-producing Enterobacteriaceae

Start date: March 1, 2017
Phase: N/A
Study type: Observational

The aim of this research project is to investigate the transmission of ESBL-producing Enterobacteriaceae on both, the level of bacterial strains and mobile genetic elements, and to determine the source of hospital-acquired infections.

NCT ID: NCT03464578 Recruiting - Clinical trials for Proximal Humeral Fracture

Evidence Based Algorithm for Proximal Humerus Fractures

Start date: January 1, 2014
Phase: N/A
Study type: Observational [Patient Registry]

Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures. Objective(s): 1. Test the algorithm in terms of clinical applicability and clinical outcome 2. Compare general outcome and general complication/revision rate to the literature. Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded. Terminally ill patients and those not being able, or willing to sing the informed consent. Project Centre(s): Single-centre. Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05. Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.

NCT ID: NCT03463902 Recruiting - Clinical trials for Schizophrenia and Related Disorders

Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control

Start date: January 29, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The majority of schizophrenia patients is impaired in hand gesture performance, which contributes to poor functional outcome and poor communication skills. The left inferior frontal gyrus (IFG) and the left inferior parietal lobe (IPL) are key nodes of the gesture network, which is less active in patients with schizophrenia. Here, the investigators test single 10 min sessions of tDCS known to either enhance or inhibit local brain activity for app. 1 hour. The investigators aim to determine, which protocol may improve gesture performance in patients and healthy controls. This is a randomized, double-blind, cross-over, placebo-controlled single-center trial in 20 patients with schizophrenia spectrum disorders and 20 healthy controls. Gesture performance will be tested immediately after each tDCS session, which are separated by 24 hours. Results of this study will inform larger interventional trials comparing 2 tDCS protocols with repeated administration.

NCT ID: NCT03463746 Recruiting - Stroke Clinical Trials

Integrated, Practice-oriented Electromechanical-assisted Gait Training in Subacute Stroke Patients

Start date: January 13, 2018
Phase: N/A
Study type: Interventional

Background and Rationale: Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious rehabilitation programs 70% of those stroke patients still show limited gait ability after three months. Numerous RCTs have shown the superiority of over ground gait training and electromechanical-assisted gait devices in comparison with conventional over ground gait training alone. (Jan Mehrholz, Elsner, Werner, Kugler, & Pohl, 2013) However, most of these trials used the electromechanical-assisted gait devices in a very high frequency which is almost impossible to achieve in daily clinical routine. Therefore, the effect of a practice-oriented physical therapy protocol including electromechanical-assisted gait training remains unclear. Objective(s): The aim of this clinical trial is to investigate the effects of an integrated, practice-orientated individual physical therapy protocol with or without electromechanical-assisted gait training in subacute stroke patients, respectively. The effects of both physical therapy protocols will be compared with validated assessments covering the different components of the ICF framework: function, activity and participation. Primary objectives: Effects on gait ability and on basic activities of daily living (ADL). Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle force, spasticity and reintegration to normal living (RNLI). Furthermore, different training-related data are recorded to capture the efficiency (intensity and hassle) of both physical therapy protocols.

NCT ID: NCT03462823 Recruiting - ACL Injury Clinical Trials

Use of an Osteoconductive Scaffold in ACL-Reconstruction

Start date: August 29, 2017
Phase: N/A
Study type: Interventional

Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.

NCT ID: NCT03462810 Available - Clinical trials for Infection, Human Immunodeficiency Virus

GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

Start date: n/a
Phase: N/A
Study type: Expanded Access

The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and/or limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via 17.pdf.

NCT ID: NCT03461887 Recruiting - Chronic Disease Clinical Trials

Home-based Exercise Training for COPD Patients

Start date: January 24, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.

NCT ID: NCT03460782 Available - Glioblastoma Clinical Trials

An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas

Start date: n/a
Phase: N/A
Study type: Expanded Access

IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.