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Atrophy clinical trials

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NCT ID: NCT06200077 Completed - Clinical trials for Alveolar Ridge Augmentation

Patient Outcomes of Staged Ridge-splitting Using Piezo-electric Surgery in Atrophic Posterior Mandible

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate the clinical and radiographic outcomes of different staged ridge-splitting techniques for management of severely resorbed lower jaws in the posterior region. The study is designed as a clinical trial, so that three different interventions would be compared for a conclusion highlighting the relative best of them.

NCT ID: NCT06194539 Recruiting - Fertility Issues Clinical Trials

Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)

Start date: February 2024
Phase:
Study type: Observational

This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies. Participants will: 1. Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives. 2. Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory. 3. Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels. During the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.

NCT ID: NCT06191354 Recruiting - Clinical trials for Spinal Muscular Atrophy 1

A Clinical Study Evaluating the Safety and Efficacy of SKG0201 Injection in Patients With Spinal Muscular Atrophy Type 1

Start date: June 25, 2023
Phase: N/A
Study type: Interventional

This is a clinical study to evaluate the safety and efficacy of gene therapy drug SKG0201 Injection in patients with spinal muscular atrophy Type 1 (SMA 1).

NCT ID: NCT06178653 Active, not recruiting - Clinical trials for Muscular Atrophy, Spinal

Two Different Treatment Modalities in Patients With Spinal Muscular Atrophy

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Spinal Muscular Atrophy (SMA) is a severe neuromuscular disorder characterized by the degeneration of alpha motor neurons in the spinal cord, resulting in progressive muscle atrophy and weakness, particularly in proximal and axial muscles. SMA causes respiratory muscle weakness, recurrent infections, and nocturnal hypoventilation, contributing significantly to morbidity and mortality. Children with SMA often display respiratory and trunk muscle weakness compared to healthy controls. Our project aims to investigate the impact of pulmonary rehabilitation, including inspiratory muscle training, along with trunk control exercises in children with SMA. The study will include 30 SMA patients aged 5-18, with maximum inspiratory capacity below 60 centimeters of water (cmH2O), predicted vital capacity over 25%, and the ability to sit unsupported for more than 5 seconds. The participants will be randomly assigned to two groups: Pulmonary Rehabilitation Group (Group 1, n=15) and Trunk Control Training Group (Group 2, n=15). Group 1 will undergo breathing exercises and inspiratory muscle training (IMT), involving diaphragmatic, pursed-lip, and segmental breathing. IMT will be administered with a portable device, starting at appropriate resistance and consisting of 10 cycles, 10 minutes each, once a day, with designated rest intervals. Also applied by calculating 30% of the maximal inspiratory pressure (MIP). During weekly clinic visits, the MIP value will be recalculated and the current threshold pressure value will be determined. In Group 2, alongside pulmonary rehabilitation, children will engage in trunk control exercises, progressively increasing in difficulty, focusing on pelvic control, proximal stabilization, and strengthening trunk and gluteal muscles. All interventions will be performed in front of a mirror. At the end of the 8-week intervention, MIP and Maximal Expiratory Pressure (MEP) will be used to measure respiratory muscle performance, spirometry will be used to monitor lung volume changes, and Peak Cough Flow will be used to evaluate the effectiveness of cough. The Trunk Control Measurement Scale, the Revised Upper Extremity Module, and the Children's Quality of Life Scale will assess trunk control, upper extremity functions, and quality of life, respectively. The Hammersmith Functional Motor Scale will assess gross motor functions and the Zarit Caregiver Burden Scale will inquire about familial factors affecting the child.

NCT ID: NCT06178393 Completed - Clinical trials for Spinal Muscular Atrophy

Real-World Use of Novel Treatments in Patients With Spinal Muscular Atrophy (SMA): A Multi-Site Retrospective Chart Review of Pediatric SMA Patients Outside of the United States

Start date: May 5, 2022
Phase:
Study type: Observational

This global, retrospective, non-interventional, medical chart review (MCR), descriptive study collected patient-level data in regions outside the US. The study required a repeated data collection at follow-up dates from start of treatment with nusinersen, onasemnogene abeparvovec-xioi (OA), and/or risdiplam. At the start of data collection, the study team reached out to the health care providers (HCPs) involved in treating pediatric SMA patients for participating in this study. The physicians across the participating countries conducted a retrospective MCR of pediatric patients diagnosed with SMA who were treated with at least 1of the 3 novel disease-modifying treatments (DMTs): nusinersen, OA, and/or risdiplam. All health care encounters data i.e., emergency and inpatient admissions, surgery, and outpatient consultations of recruited patients, including their treatment with nusinersen, OA, and/or risdiplam, were abstracted to understand the treatment patterns as per routine clinical practice for SMA management globally. The first date of initial administration of 1 of the 3 target drugs was used as the "index date." Based on this, the record abstraction was performed through a retrospective MCR during the pre-index period, at index date and in the post-index period.

NCT ID: NCT06176417 Completed - Atrophic Ridge Clinical Trials

Comparison Between Different Horizontal Ridge Augmentation Techniques

Start date: August 26, 2021
Phase: N/A
Study type: Interventional

Sixteen patients were selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth / teeth in posterior atrophic mandible by dental implant. Patients' grouping: Patients were divided randomly into two equal uniform groups as follow: Group I: Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique. Group II: Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery. All patients were evaluated clinically and radiographically at regular time interval immediately, 6 and 12 months after surgery.

NCT ID: NCT06169046 Recruiting - Clinical trials for Spinal and Bulbar Muscular Atrophy

A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy

BetaSBMA
Start date: April 13, 2024
Phase: Phase 2
Study type: Interventional

There is no cure to arrest or delay SBMA progression. It is estimated that ~1000 individuals are affected by SBMA in Italy at any given time (prevalence: 1.5/100000) with an annual incidence of 0.19/100000 males. Here, we are going to test the potential of beta2-agonist stimulation on muscle as a therapeutic avenue for SBMA. We have provided pre-clinical evidence that β-agonist stimulation may be a therapeutic strategy for SBMA. Moreover, we have shown that beta2-agonists are effective in improving motor function without relevant adverse events in a small cohort of SBMA patients. To establish safety and efficacy of clenbuterol as a cure for SBMA, we are conducting a multicenter, phase II, randomized, double-blind, parallel-group, single dose, placebo-controlled trial. Indeed, based on our preliminary data, some concerns remain to be addressed.

NCT ID: NCT06167954 Recruiting - Cerebral Palsy Clinical Trials

Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment

Start date: December 4, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy. Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.

NCT ID: NCT06167642 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

Start date: May 22, 2023
Phase:
Study type: Observational

This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.

NCT ID: NCT06164587 Recruiting - Clinical trials for Age-Related Macular Degeneration

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

K8 for GA
Start date: April 18, 2024
Phase: Phase 1
Study type: Interventional

This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.