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Atrophy clinical trials

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NCT ID: NCT03981458 Recruiting - Clinical trials for Urinary Tract Infections

Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis

HATPIN
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

In post-menopausal women, the condition atrophic vaginitis results from the loss of oestrogen and is characterised by dyspareunia (pain during intercourse), vaginal dryness, and vaginal irritation. It is often diagnosed alongside recurrent urinary tract infections (rUTIs) and may increase susceptibility to rUTI. Topical vaginal oestrogen can be used to re-condition the vaginal epithelium and also reduces the incidence of rUTIs. However, patients often express concerns about using oestrogen, a hormonal treatment. Studies also report side-effects including vaginal bleeding, discharge, burning and itching that underpin significant (28%) drop-out rates. Hence, alternative non-hormonal, non-antibiotic based therapies that treat the vaginal atrophy, but also reduce the incidence of rUTI are needed. Recurrent UTI in adult women is common. Bacteria from the gut can colonise the vulvar epithelia and then the bladder, causing uncomfortable urinary symptoms (cystitis). The lifetime risk of a UTI is around 40% in adult women which increases in post-menopausal women. Annually, UTI incidence is 3%. Of those affected, 5% will suffer rUTI, rising to 13% in the over 60 population. This equates to over 300,000 of the adult female UK population annually affected by rUTI. The most frequent treatment for rUTIs is low dose antibiotics, but this treatment causes the bacteria carried by such women to become antibiotic resistant, which exacerbates the clinical problem. The prevalence of antimicrobial multi-resistance within post-menopausal women suffering from rUTI is around 25% and was shown to rise to more than 80% following prolonged antibiotics. These data support the use of non-antibiotic treatment strategies that prevent rUTI and the emergence of drug resistant micro-organisms. This study will compare two groups with differing treatment strategies. One group will be primarily treated for atrophic vaginitis with topical vaginal hyaluronate and the other will be primarily treated for their recurrent UTI with intravesical hyaluronate.

NCT ID: NCT03974373 Completed - Facial Expression Clinical Trials

Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

In recent years there has been a growing number of procedures for the removal of the buccal fat pad (BFP) or as frequently referred to as bichectomy. Buccal fat pad removal can be used as part of the therapeutic procedure in cases of: sinus buco fistulas, peri-orbital defects, congenital palatal fissure, patients with severe bruxism, patients with constant lesions caused by bites on the jugal mucosa and in patients who are dissatisfied with the facial contour. In cases of thinning of the face, biting lesions and bruxism, total or partial of the BFP removal is performed, always taking into account a facial harmonization. The aim of the present study was to demonstrate the procedure of BFP removal and its respective postoperative period. A total of 40 BFP removal surgeries were performed between 2016 and 2017 with intraoral access technique. After the bichectomy procedure the subjects were followed for: 4, 7, 10, 15, 30, and 90 days. The postoperative period can be compared to that of a third molar extraction, and the use of analgesics and anti-inflammatories can adequately control the pain symptomatology. Edema and mouth opening limited for about 15 days were the most commonly found alterations in surgeries performed. The surgical technique is a simple and safe procedure provided by trained and experienced professionals. The bichectomy should be performed following a precise indication and the procedure is becoming a new area of practice for the dental surgeon, who can perform the procedure safely, reliably and with aesthetic and therapeutic results provided that with precise indications.

NCT ID: NCT03972709 Terminated - Geographic Atrophy Clinical Trials

A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

GALLEGO
Start date: June 3, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.

NCT ID: NCT03970135 Completed - Clinical trials for Spinal Muscular Atrophy

Fat and Glucose Metabolism in Fed and Fasted State in Patients With Low Skeletal Muscle Mass

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

In a study from 2003 the investigators showed that adult patients with very low skeletal muscle mass (spinal muscular atrophy (SMA) type II, Duchenne muscular dystrophy, congenital muscular dystrophy) are prone to develop hypoglycemia during prolonged fasting. Since then case reports have described the same phenomenon with hypoglycemia and metabolic crises in children with low skeletal muscle mass provoked by infection, fasting and surgery. Pathophysiological mechanisms of metabolism have never been investigated in adults or children with SMA II. Thus the investigators studied fat and glucose metabolism during prolonged fasting in patients with SMA II and LAMA 2 and compared results to those found in healthy controls.

NCT ID: NCT03968536 Completed - Fall Clinical Trials

Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home

KitPA
Start date: May 6, 2019
Phase:
Study type: Observational [Patient Registry]

Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city

NCT ID: NCT03956563 Recruiting - Vaginal Atrophy Clinical Trials

Effect of Hybrid Laser 10600+1540 nm on GSM

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment. The secondary objectives are: 1. Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months. 2. Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment. 3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment - For the GSM symptoms - For the urinary symptoms and UI 4. To assess the patient's satisfaction with the laser treatment. - For the GSM symptoms - For the urinary symptoms and UI.

NCT ID: NCT03955679 Approved for marketing - Clinical trials for Spinal Muscular Atrophy

AveXis Managed Access Program Cohort for Access to AVXS-101

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

The purpose of this Cohort Treatment Protocol will allow access to AVXS-101 for eligible patients diagnosed with SMA.

NCT ID: NCT03952806 Completed - Clinical trials for Multiple System Atrophy

Study of BHV-3241 in Participants With Multiple System Atrophy

M-STAR
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of verdiperstat (BHV-3241) versus placebo in participants with Multiple System Atrophy

NCT ID: NCT03939078 Completed - Clinical trials for Urinary Incontinence

CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause

Start date: April 5, 2018
Phase:
Study type: Observational

Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing recurrent infections. The CO2 laser is a fractional ablative source of light, capable of inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and reorganizing the architectural structure of the treated epithelium. Recent studies in the laser field show great improvement of the SGM, with satisfying results in female's sexual disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the improvement in both patient's subjective reports and objective measurements, such as cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in questionnaires to the results of cytology, histology and immunohistochemistry for collagen I and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women after menopause complaining of symptoms of the GSM were selected from the ambulatory of the Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2 intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal wall will be taken one month before the start and one month after the end of the laser sessions, and material will be sent to histology, cytology and immunohistochemistry analysis. Results obtained will be compared to the patients' reports, in order to evaluate subjective and objective improvement due to the treatment.

NCT ID: NCT03935126 Terminated - Clinical trials for Age-related Macular Degeneration

Global Atrophie Biomarker Evaluation Study (GABiE)

GABiE
Start date: May 7, 2019
Phase:
Study type: Observational

To investigate the use of microperimetry and SS-OCT in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.