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NCT ID: NCT06195072 Recruiting - Scleroderma Clinical Trials

Platform Clinical Study for Conquering Scleroderma

CONQUEST
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

NCT ID: NCT06195865 Recruiting - Breast Cancer Clinical Trials

Autologous vs. Implant-based Breast Reconstruction

GoBreast II
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.

NCT ID: NCT06200207 Recruiting - Heart Failure Clinical Trials

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

ATHENA
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

NCT ID: NCT06204588 Recruiting - Bone Loss, Alveolar Clinical Trials

Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Background- Periodontitis, an inflammatory disease of the periodontium, is one of the major causes of tooth mortality. Of all the bone destruction patterns that are present in periodontitis, horizontal bone loss is the most common. Therefore, treatment modalities that help in rebuilding horizontal defects are vital in total periodontal reconstruction. Rationale- The supracrestal bone regeneration in cases of horizontal bone loss has remained a mirage with very little recorded success. Volume stable collagen matrix(VCMX), is a porous, cross-linked collagen matrix of porcine origin designed to facilitate cell and vascular ingrowth and soft-tissue volume augmentation, may be beneficial in maintaining the supracrestal space and may overcome the limitation of bone regeneration in horizontal defects. Evidence has shown that Low level laser therapy(LLLT) based on principal of biostimulation of osteoclastic cells, can have a positive effect on the regeneration of supracrestal bone in horizontal bone destruction. So, this study will be first of its kind using combination of VCMX with LLLT to assess regenerative outcome in treatment of horizontal bone destruction in patients with periodontitis. Objectives: To assess clinical and radiographic regenerative outcome of periodontal tissues using LLLT and placing VCMX with single flap approach(SFA) in treatment of horizontal bone loss as compared to LLLT and SFA. Method: A total of 60 patients will be randomly divided into three groups: Test Group 1: VCMX +LLLT +SFA, Test Group 2:LLLT+SFA, and Control group: SFA. Periodontal parameters will be evaluated at baseline, 3, 6, and 9 months. CBCT will be evaluated at baseline and 9 months. Expected outcome: VCMX with Laser could achieve supracrestal bone regeneration in horizontal bone loss.

NCT ID: NCT06206746 Recruiting - Clinical trials for Polycystic Ovary Syndrome

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

NCT ID: NCT06210594 Recruiting - Clinical trials for Staphylococcus Aureus Infection

Staph Intervention for Effective Local Defense

SHIELD
Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

Indigenous persons experience a high burden of Staphylococcus aureus (SA) invasive disease and skin and soft tissue infections. SA carriage on the skin is factor for development of SA infections. The goal of this clinical trial is to evaluate a community-informed approach to reduce carriage of SA. Participants will be assigned to education and household supplies for prevention of SA with and without a biomedical intervention. Researchers will compare SA carriage in the two groups.

NCT ID: NCT06216704 Recruiting - Cystic Fibrosis Clinical Trials

Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis

Start date: April 1, 2024
Phase:
Study type: Observational

The investigators will be evaluating bone marrow composition via magnetic resonance imaging in adolescents diagnosed with cystic fibrosis (CF) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT). This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with diagnosed with CF exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including glycemic control, inflammation, and bone turnover markers.

NCT ID: NCT06218147 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Socioeconomically disadvantaged (SED) pregnant Latina women are disproportionately burdened by type 2 diabetes (T2D). Although lifestyle interventions can help to improve diabetes control, there are barriers to SED, Spanish-speaking pregnant people participating. The purpose of this proposal is to develop and test a culturally tailored, dietary-lifestyle behavioral intervention that supports eating plant-based foods such as fruits, vegetables, nuts and grains instead of processed foods and meat, and is implemented through community health workers (CHWs) to prevent excessive weight gain during pregnancy and improve control of blood sugar levels in pregnant Latina women with T2D. This study takes advantage of our existing strong relationships with the local Latino community, CHWs, and Santa Barbara County Public Health, which includes eight multidisciplinary healthcare clinics with sliding fee programs, and Rooted Santa Barbara, a community plant-based lifestyle organization. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our program to be culturally sensitive, it will include delivery of the program by CHWs primarily in the Spanish language with English as needed and incorporation of culturally relevant eating and physical activity recommendations. The specific aims of the project are: 1) in year one, develop the dietary-lifestyle behavioral intervention that encourages a plant-forward diet for pregnant Latina women with T2D to prevent excessive weight gain during pregnancy and improve blood sugar control in collaboration with CHWs and participants by conducting focus groups to incorporate feedback on the program; 2) initiate in year one, and in year two, conduct a randomized controlled trial with 30 pregnant Latina women with T2D to evaluate the how well the nutrition-behavior lifestyle program works; and 3) evaluate the acceptance and delivery of the dietary-lifestyle behavioral intervention in CHWs and participants. If successful, this study will establish the how well a culturally sensitive program delivered by CHWs incorporating plant-forward diets for pregnant Latina women with T2D prevents excessive weight gain during pregnancy, and control of blood sugar levels.

NCT ID: NCT06218238 Recruiting - Clinical trials for Transfemoral Amputation

A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation

OPKTFA
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.

NCT ID: NCT06221358 Recruiting - Clinical trials for Attention-Deficit/ Hyperactivity Disorder (ADHD)

Pharmacogenomics of Stimulant Treatment Response

PGx-STaR
Start date: April 1, 2024
Phase:
Study type: Observational

The "Pharmacogenomics of Stimulant Treatment Response" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-17 with Attention deficit/hyperactivity disorder (ADHD).