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Atrophy clinical trials

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NCT ID: NCT04705571 Completed - Clinical trials for Stress Urinary Incontinence

Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

NCT ID: NCT04698798 Completed - Critical Illness Clinical Trials

Skeletal Muscle Wasting in SARS-CoV-2

SMW
Start date: January 2, 2021
Phase: N/A
Study type: Interventional

The SARS-CoV-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (ICU). Short, and especially long admission on the ICU causes major reductions in skeletal muscle mass (3-4% a day) and strength. Since it is now possible to reduce mortality on the ICU, short and long-term morbidity should be considered another principal endpoint after SARS-CoV-2 infection. Cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. Its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. There is strong evidence that cachexia develops rapidly in patients hospitalized for SARS-CoV-2 infection, especially on the ICU. Several mechanisms are believed to induce cachexia in SARS-CoV-2. Firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ACE-2). In vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear DNA in cardiomyocytes. Similar results were found during autopsies. On a cellular level, nothing is known about the effects of SARS-CoV-2 infection on skeletal muscle cells. However, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (>200U/l), suggesting skeletal muscle injury. Moreover, patients with SARS-CoV-2 infection are shown to have elevated levels of C-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. The above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in SARS-CoV-2. There are other known factors to affect skeletal muscle mass on the ICU, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. SARS-CoV-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity. Until know there are no studies investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU. As a result, there is a need of more in-depth understanding the effects of SARS-CoV-2 infection on muscle wasting. An optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.

NCT ID: NCT04680143 Completed - Optic Atrophy Clinical Trials

Systemic Erythropoietin Injection in Patients Having Optic Atrophy

Start date: September 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy.

NCT ID: NCT04676464 Completed - Critical Illness Clinical Trials

VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient

VALIDUM
Start date: December 2013
Phase:
Study type: Observational

The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons. The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.

NCT ID: NCT04659668 Completed - Clinical trials for Urinary Incontinence

Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.

NCT ID: NCT04652817 Completed - Clinical trials for Labia Majora Atrophy and Hypotrophy

Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMI-22-04-2019" on the female genital area for the aesthetic, medicinal, functional and reconstructive indications.

NCT ID: NCT04629885 Completed - Clinical trials for Vulvovaginal Atrophy

Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms

Start date: May 3, 2016
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts: - The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms. - The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms. A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients. In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes. The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.

NCT ID: NCT04625179 Completed - Clinical trials for Edentulous; Alveolar Process, Atrophy

Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

Start date: December 3, 2019
Phase: N/A
Study type: Interventional

melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties. the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated

NCT ID: NCT04616456 Completed - Clinical trials for Multiple System Atrophy

Effect of Verdiperstat on Microglial Activation in Well-characterized MSA Patients

Start date: December 30, 2020
Phase: Early Phase 1
Study type: Interventional

This study will comprise of two phases, an observational phase and a treatment phase. In the observational phase the specific aims are: 1. To determine the presence and regional distribution of microglial activation, as assessed by 18F-PBR06 PET, in subjects with MSA as compared to healthy controls, at baseline and at 6-9 months' follow-up. 2. To assess the relationship between microglial activation and clinical progression at baseline and follow-up. In the treatment phase the specific aims of the study are: The specific aims of the study are: 1. To assess whether verdiperstat (BHV-3241) reduces 18F-PBR06 PET signal, and thus microglial activation and inflammation, in well-characterized MSA patients. 2. To assess the relationship between PET changes and clinical progression at baseline and follow-up in patients treated with verdiperstat. 3. To assess the relationship between PET changes and volumetric brain MRI at baseline and follow-up in patients treated with verdiperstat. Currently there is no known disease modifying therapy for MSA. Recently, the drug verdiperstat (BHV-3241) has appeared in the investigational arena specifically for the indication of Multiple System Atrophy. Verdiperstat (BHV-3241) is currently being used in a phase 3 active drug trial at Massachusetts Hospital. Verdiperstat (BHV-3241) is known to target Myeloperoxidase, an enzyme implicated in neuroinflammation, a major driver in disease pathogenesis. Our previous study (IRB protocol #2016P002373) demonstrated that applying TSPO (translator protein) PET imaging enabled us to track changes in neuroinflammation and thus provide a viable biomarker for disease progression. In this pilot study, the investigators aim to assess the effect of an investigational drug, verdiperstat (BHV-3241) on microglial activation in MSA patients using [F-18]PBR06 and to link it with clinical and morphometric MRI brain changes following treatment.

NCT ID: NCT04615325 Completed - Geographic Atrophy Clinical Trials

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Start date: December 8, 2020
Phase: Phase 1
Study type: Interventional

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.