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NCT ID: NCT01894646 Terminated - Clinical trials for Measure of Uptake of XTRA in the Brain

PET Imaging of Extrathalamic α4β2-nicotinic Acetylcholine Receptors in Health and Disease With [18F]XTRA

Start date: February 2013
Phase: Phase 1
Study type: Interventional

Currently, only three radiotracers, (2-[18F]FA, 6-[18F]FA and [18F]AZAN), are available for studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET imaging. A crucial problem for 2-[18F] FA, 6-[18F] FA and ([18F] AZAN is low binding potential (BP) in extrathalamic (ET) regions, including hippocampus, cortex and caudate which have lower receptor densities than the thalamus. The importance of imaging ET-α4β2-nAChRs (ET-nAChR) has emerged from the post-mortem demonstration of altered densities of ET-nAChRs (but not thalamic nAChR) in neurodegenerative diseases and schizophrenia. PET imaging of ET-nAChR may prove to be useful in both detecting early changes and following functional deterioration in neurodegenerative diseases such as Alzheimers disease. Furthermore, PET imaging of ET-nAChR may allow investigation and development of new therapies acting on the acetylcholine system. The imaging drawbacks of the presently available nAChR radioligands have initiated the development of radioligands with greater binding potential by several research groups. The available pre-clinical data on the investigators' new radioligand [18F](-)-JHU86428 ([18F]XTRA) suggest that this radioligand is superior to 2-[18F]FA for quantitative PET imaging of α4β2-nAChR (Gao, J. Med. Chem, 2008). In baboon PET studies [18F]XTRA exhibits 200% greater brain uptake, 300% higher BPs and reaches steady-state in approximately 1.5 h in cortical regions post-bolus administration versus 6-8 h for 2-[18F]FA. In vitro binding assays shows greater binding affinity of XTRA and similar nAChR-subtype selectivity in comparison with 2-FA. Both ligands bind selectively with the β2-subtypes that are predominant nAChR subtypes in the mammal brain and display little binding affinity at ganglionic α3β4-nAChR. The current planned human protocol will be conducted to (1) determine brain distribution (brain uptake) and test the reproducibility (in test-retest design) of [18F]XTRA brain PET scans for validation of the radioligand; (2) generate estimates of the whole body and internal organ radiation absorbed doses from exposure to single iv administrations of [18F]XTRA in healthy human subjects; and (3) determine brain distribution of [18F]XTRA in patients with Alzheimer's disease.

NCT ID: NCT01893879 Terminated - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

PCTTPL
Start date: April 2014
Phase: N/A
Study type: Interventional

This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.

NCT ID: NCT01892345 Terminated - Clinical trials for Neuromyelitis Optica

A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

Start date: April 11, 2014
Phase: Phase 3
Study type: Interventional

The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.

NCT ID: NCT01891695 Terminated - Clinical trials for Oropharyngeal Squamous Cell Carcinoma (OPSCCA)

OPSCC N0 Nodal Control With Reduced IMRT

Start date: October 2013
Phase: N/A
Study type: Interventional

The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering. The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

NCT ID: NCT01891643 Terminated - Clinical trials for Newly Diagnosed, Previously Untreated Multiple Myeloma

PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab

NCT ID: NCT01890733 Terminated - Clinical trials for Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV

InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.

Start date: September 2012
Phase: N/A
Study type: Interventional

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear . The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living(ADL) and improvement of range of motion (ROM).

NCT ID: NCT01889654 Terminated - Clinical trials for Systemic Lupus Erythematosus With or Without Clinical Activity

Anti-nucleosome B Lymphocytes in Lupus

Start date: February 2014
Phase: N/A
Study type: Observational

Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.

NCT ID: NCT01889641 Terminated - Clinical trials for Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling

IL-26 and Systemic Lupus Erythematosus

Start date: February 2014
Phase: N/A
Study type: Observational

Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could be a marker of the disease activity and then a potential therapeutic target. In the present study, serum IL 26 level in lupus patients and control will be measured.

NCT ID: NCT01888796 Terminated - Clinical trials for Left Ventricular Diastolic Dysfunction

Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

Diast Dysfkt
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography. Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.

NCT ID: NCT01887587 Terminated - Clinical trials for Mixed Phenotype Acute Leukemia

Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia

Start date: June 2013
Phase: Phase 1
Study type: Interventional

This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma, lymphoblastic lymphoma or mixed phenotype acute leukemia.