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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Age: 18Years - 130YearsAll GendersPhase 3
709 locations
C

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of two types of abutmentspre-fabricated standardized titanium and customized anatomical zirconiaon the health of tissues around single implant-supported posterior teeth. This randomized controlled clinical trial focuses on how these abutments impact implant biocompatibility, peri-implant tissue stability, bone loss seen on X-rays, and the quality of life related to oral health. The study builds upon a previous phase where participants had tooth extractions, alveolar preservation, and implant placement with a six-month healing period. Participants who have successfully integrated implants will be randomly assigned to receive prosthetic rehabilitation with either titanium abutments or zirconia abutments, both supporting single zirconia crowns in back teeth. The prosthetic and lab procedures follow standardized digital protocols. The study includes follow-up visits at prosthesis delivery and 1, 3, 6, and 12 months afterward to monitor changes and responses. During the study, researchers will collect samples of peri-implant crevicular fluid and biofilm for biomolecular analysis and measure periodontal health, mucosa thickness, and bone levels using standardized X-rays. Digital scans will assess soft tissue volume and stability. The main outcome is microbial colonization at the implant sites over 12 months. Secondary outcomes include demographic data, clinical parameters, bone level changes, and soft tissue stability. This research aims to improve understanding of how abutment materials influence long-term implant health.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
1 location