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Atrophy clinical trials

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NCT ID: NCT02332213 Completed - Colorectal Cancer Clinical Trials

Volatile Markers in Digestive Cancer

VOLGACORE
Start date: January 2014
Phase:
Study type: Observational

The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon. The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

NCT ID: NCT02313545 Completed - Atrophic Vaginitis Clinical Trials

Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

In this open label study, 50 eligible women will be assigned to receive the investigational product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at baseline and after 2 and 6 weeks of treatment. The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).

NCT ID: NCT02310490 Completed - Face; Atrophy Clinical Trials

DermaVeil Versus Sculptra for the Treatment of Nasolabial Folds Wrinkles

Start date: December 2014
Phase: N/A
Study type: Interventional

Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DermaVeil (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DermaVeil and SCULPTRA on either the right or left side of the face.

NCT ID: NCT02307877 Completed - Multiple Sclerosis Clinical Trials

Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate

Start date: September 2014
Phase:
Study type: Observational

Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into whether there is continued progression of MS in these patients. What remains unknown is whether patients on a particular therapy have a slower rate of brain atrophy. This would provide convincing evidence that central nervous system tissue injury is further suppressed. Such information would be of substantial clinical benefit when deciding between various therapies. The investigators will estimate the impact of long term use of fingolimod therapy (defined as a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing forms of MS as compared to age and gender matched patients on Glatiramer Acetate. The investigators secondary goal is to determine the correlation between brain atrophy and cognitive performance in treated patients with relapsing forms of MS. The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL) PROs, patient self-reports of disability, clinical assessment of physical disability, work productivity, clinical assessments of cognitive functioning with whole brain volume loss for patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and gender. The investigators anticipate the findings of this study will generate relevant hypotheses about these relationships.

NCT ID: NCT02292537 Completed - Clinical trials for Spinal Muscular Atrophy

A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)

CHERISH
Start date: November 24, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA). The secondary objective is to examine the safety and tolerability of nusinersen administered intrathecally to participants with later-onset SMA.

NCT ID: NCT02289118 Completed - Clinical trials for Logopenic Progressive Aphasia

Tau Imaging in Young Onset Dementia

Start date: November 2014
Phase:
Study type: Observational

The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia.

NCT ID: NCT02288559 Completed - Geographic Atrophy Clinical Trials

A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

Start date: March 30, 2015
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.

NCT ID: NCT02270489 Completed - Clinical trials for Neurodegenerative Diseases

Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA

AFF009
Start date: December 11, 2014
Phase: Phase 1
Study type: Interventional

This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patients with early Multiple System Atrophy (MSA). In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A (with adjuvant) and 6 patients in the control group who will receive the reference substance (Placebo). Over a study duration of 52 weeks, the study participants will receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 30 to 75 years can participate in the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved. AFF009 is part of the project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).

NCT ID: NCT02268552 Completed - Clinical trials for Spinal Muscular Atrophy

An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA)

Start date: April 2, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label, multi-part, first-in-human study of oral branaplam in infants with Type 1 spinal muscular atrophy. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy after 13 weeks; and to estimate the Maximum Tolerated Dose (MTD) of orally administered branaplam; and to identify the dose that is safe for long term use as well as that can provide durable efficacy optimal dosing regimen in patients with Type 1 SMA.

NCT ID: NCT02253173 Completed - Menopause Clinical Trials

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

REJOICE
Start date: September 2014
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.