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NCT ID: NCT01738555 Withdrawn - Clinical trials for Human Immunodeficiency Virus Infection

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.

NCT ID: NCT01740570 Withdrawn - Brain Cancer Clinical Trials

Phase I/II Cabazitaxel for Recurrent Malignant Glioma

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be studied in both parts. Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell division.

NCT ID: NCT01744015 Withdrawn - Clinical trials for Mechanical Low Back Pain

Influence of Patient-Informed Choice in a Novel Treatment Model for LBP

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

1. (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain. (We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach) 2. (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)

NCT ID: NCT01757015 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS

GLOW8
Start date: April 2013
Phase: Phase 3
Study type: Interventional

This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).

NCT ID: NCT01762852 Withdrawn - Clinical trials for Glomerulonephritis, Membranous

Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

Start date: April 2013
Phase: Phase 2
Study type: Interventional

The main clinical study will be a randomized, double-blind, placebo-controlled, long term study involving a 100 week treatment period. The purpose of this study is to test for superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study is also to investigate the effect of initiating earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens. The study will also determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of action of Belimumab as well as effects on quality of life. All subjects (on either active treatment or placebo) will receive background supportive therapy throughout the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study treatment at any time during the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to week 104. A subject will be regarded as having completed the main clinical study if they complete all phases of the main clinical study (screening, treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects who complete the main clinical study will therefore participate in the main clinical study for approximately 28 months. After the main clinical study, there will be a 5 year (long term) follow-up phase to assess long term outcomes.

NCT ID: NCT01764672 Withdrawn - Clinical trials for Attention Deficit Hyperactivity Disorder

Effect of Methylphenidate on Connectivity

Start date: April 2013
Phase: Phase 4
Study type: Interventional

The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.

NCT ID: NCT01766115 Withdrawn - Viral Hepatitis C Clinical Trials

Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

Start date: April 2013
Phase: Phase 4
Study type: Interventional

To assess the safety and tolerability of the use of telaprevir in the setting of post-exposure prophylaxis among HCW exposed to HCV genotype 1 or genotype 2. To assess the election rate of postexposure prophylaxis for HCV-related occupational exposures in HCW.

NCT ID: NCT01777230 Withdrawn - Cervical Cancer Clinical Trials

The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer

Start date: April 2013
Phase: N/A
Study type: Observational

Objective of the study: To study the concordance of sentinel node (SN) localization between preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the intra-operative SN procedure for low stage cervical cancer. Background: The SN procedure for surgically treated cervical cancer is promising. Unfortunately, efficient and direct intra-operative SN localisation, without an extensive surgical exploration, remains a challenge even with combined use of patent blue dye en technetium-99m (99mTc). Preoperative imaging (= mapping) with 99mTc based SPECT-CT, which is increasingly adopted, has partly alleviated this problem. The investigators aim to investigate the feasibility of a new SN mapping modality, which visualises the (sentinel) lymph nodes using a Magnetic Resonance Imaging (MRI) technique (so called; Magnetic Resonance Lymphangiography), and compare it to SPECT-CT. Design: Prospective, feasibility type diagnostic study. 40 subjects targeted. Via vaginal speculum exam, a specific MRI contrast-agent will be intracervically injected. Subsequently, on a wide bore 1.5T MRI system multiplanar imaging is performed, followed by a blinded review (experienced radiologist) for bilateral SN localization. Standard care with a preoperative SPECT-CT (after intracervical 99mTc administration). A blinded nuclear medicine specialist will localize the SN on the SPECT-CT images. Open or (robot-assisted) laparoscopy performed for localization of the blue stained and/or 99mTc-hot SN. Excision of the SN with freeze sectioning and histological review. Statistical analysis with intrapatient testing for concordance of MR Lympangiography and SPECT-CT based SN localization against the reference standard: the intra-operative sentinel node procedure.

NCT ID: NCT01782391 Withdrawn - Clinical trials for Mild Cognitive Impairment, So Stated

Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments

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

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in MCI patients.

NCT ID: NCT01783340 Withdrawn - Malaria, Falciparum Clinical Trials

Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis

MMV
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.