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  • Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

    Recruitment and group assignment: Participants will be recruited through one of Arm Dynamics's six Centers of Excellence. Potentially eligible participants will be identified by their care team and referred to a study team member to go over the details of the patient's involvement and the study protocol. After informed consent and medical clearance are completed, the study prosthetist and occupational therapist will meet with the participant and identify functional goals for their prosthesis. The prosthetist will then begin fabricating the prosthesis. A single prosthesis will be fabricated for use with both control strategies. Switching between control methods will be done through the Glide iPad application. Once fabrication is completed, a clinical team member will configure the assigned control strategy with the subject to achieve maximum functional efficiency. Prosthesis delivery and occupational therapy (Day 0): After the consenting process and group assignment, patients will return to the clinic to be fit with the prosthesis. Each prosthetic system will include IBT's Glide system, remote electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The Glide system also allows for Direct Control of the prosthesis without any hardware change, as long as two of the remote electrodes are positioned according to Direct Control site selection. The fitting process may take multiple visits to adjust the socket. The participant will be given instructions on how to use their prosthesis and activate the various functions of their initial device. Occupational therapy (OT) will be provided over 2 days to the patient to help patients accomplish their desired activities of daily living. At the conclusion of OT, participants will complete baseline assessments of the CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM measures. Phase I DC prosthesis: Over the course of the next 5-, 6-, or 7-weeks, subjects will use their DC prosthesis during their everyday lives. The Glide system is capable of recording usage data during these at-home periods (regardless of which control system is active at a given time). These measures include the Daily Mean Number of Movement Bouts (DMNMB). Using a web portal submission, subjects will report the DMNMB and their Mean Prosthesis Wear Duration (MPWD) for the previous week. At this time, subjects will also complete the CAPROQ and FIT surveys. This data submission will occur weekly. Phase I Midpoint: Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, the subject will continue Phase I. Phase I DC prosthesis: Phase I procedures will be repeated (DC prosthesis). Crossover checkpoint (Day 70, 84, or 98): Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, they will have their control strategy transitioned to Glide. They will then receive OT training and complete the same measurements using their prosthesis with Glide control. Phase II Glide prosthesis: Over the course of the next 7-, 6-, or 5-weeks, subjects will use their Glide prosthesis during their everyday lives. Using the Glide system, subjects will repeat the procedures outlined in Phase I. Phase II Midpoint: Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, the subject will continue Phase II. Phase II Glide prosthesis: Phase II procedures will be repeated (Glide prosthesis). Endpoint evaluation (Day 168): Measurements from the crossover checkpoint will be made with the Glide prosthesis only. The patient will be re-fit with their pre-study prosthesis, and OT provided as necessary.

    Phase

    N/A

    Span

    81 weeks

    Sponsor

    Infinite Biomedical Technologies

    Redondo Beach, California

    Recruiting

  • A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products

    Phase

    4

    Span

    81 weeks

    Sponsor

    AbbVie

    Redondo Beach, California

    Recruiting

  • Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures

    This non-interventional, observation study is to collect real-world data on the use of an autologous, hair follicle derived secretome topical cosmetic product following various medical aesthetic procedures.

    Phase

    N/A

    Span

    25 weeks

    Sponsor

    Acorn Biolabs Inc.

    Redondo Beach, California

    Recruiting

  • Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer

    This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) following progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status.

    Phase

    3

    Span

    209 weeks

    Sponsor

    Celcuity, Inc.

    Redondo Beach, California

    Recruiting

  • Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

    This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure. The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

    Phase

    3

    Span

    411 weeks

    Sponsor

    AstraZeneca

    Redondo Beach, California

    Recruiting

  • Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer

    Whole blood, plasma, and/or serum specimens will be collected from patients with active cancer, patients in cancer remission, patients diagnosed with benign disease, and healthy volunteers. These blood samples will be used to perform various studies to determine the utility of select DNA methylation markers for cancer diagnostic or prognostic indications.

    Phase

    N/A

    Span

    346 weeks

    Sponsor

    Helio Genomics

    Redondo Beach, California

    Recruiting

  • Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906

    Phase

    N/A

    Span

    12 weeks

    Sponsor

    Galderma R&D

    Redondo Beach, California

    Recruiting

    Healthy Volunteers

  • Detection of Tumor DNA in Blood Samples From Cancer Patients

    Phase

    N/A

    Span

    313 weeks

    Sponsor

    Lexent Bio, Inc.

    Torrance, California

    Recruiting

    Healthy Volunteers

  • Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma

    This study is a Phase 3b in Canada Minors will not be enrolled in Denmark

    Phase

    4

    Span

    123 weeks

    Sponsor

    Regeneron Pharmaceuticals

    Redondo Beach, California

    Recruiting

  • Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers

    Phase

    N/A

    Span

    134 weeks

    Sponsor

    City of Hope Medical Center

    Torrance, California

    Recruiting

    Healthy Volunteers

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