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Found 3 Actively Recruiting clinical trials

C

Actively Recruiting

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Age: 18Years +All GendersPhase 3
555 locations
C

Actively Recruiting

Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.

Age: 18Years +All GendersPhase Not Applicable
54 locations
U

Actively Recruiting

Researchers are evaluating how different virtual landscape environments affect gait therapy in older adults with walking instability. The study focuses on the impact of urban, rural, and forest scenes viewed through virtual reality VR goggles during gait training. The goal is to understand how these environments influence stress reduction, attention restoration, and changes in walking patterns to improve gait stability. Participants will be randomly assigned to one of four groups three intervention groups using VR-assisted gait therapy in forest, urban, or rural landscapes, and a control group receiving standard gait therapy. Those in the VR groups will attend five training sessions within ten days, each lasting 25 minutes, including sitting and walking phases within the virtual environments. Walking aids may be used as needed during the sessions. During the study, participants will undergo assessments of stress levels, attention, and gait parameters before and after the intervention. Measurements include heart rate variability, skin conductance, gait speed, variability, and asymmetry, as well as interviews and eye-tracking during sessions. The study aims to identify which virtual landscapes best support gait stability by promoting stress relief and attention recovery. Participation spans the initial and final testing days, with training sessions occurring between these points.

Age: 65Years +All GendersPhase Not Applicable
3 locations