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  • The Effects of Caregiver Training on DTTC Treatment Outcomes in CAS

    Forty children with CAS, between 2;5 and 7;11 years of age will receive DTTC treatment 2x/week over an 8-week period along with home practice with a caregiver. Prior to treatment, all caregivers will complete an online self-guided educational module about CAS and DTTC. Participants will be randomized to one of two groups: 1) Direct Training Group (DTTC + Home Practice + Direct Caregiver Training); 2) Indirect Training Group (DTTC + Home Practice + Indirect Caregiver Training). Children in the Direct Training Group will receive DTTC treatment during one half of each session administered only by the SLP, while the caregiver observes. DTTC will be administered by the caregiver with direct coaching by the speech language pathologist (SLP) in the other half of the session. Children in the Indirect Training Group will only receive DTTC treatment administered by the SLP, while the caregiver observes. In both groups, caregivers will review home practice guidelines with the clinician at the end of each therapy session, and engage in home practice with their children. Home practice will consist of 30-minute practice sessions 3x/week during the 8-week treatment phase and 6x/week during the 4-week follow-up phase. Caregivers in the Direct Training Group will be provided specific guidance regarding practice techniques, whereas caregivers in the Indirect Training Group will only be provided treatment words to be practiced at home and instructed to apply what they have observed during SLP-administered DTTC. Probe data will be collected during the Pre-Treatment, Treatment and Follow-Up phases. The study duration is 16 weeks in total duration, for all participants. Probe words will consist of 20 potential treated items to evaluate treatment gains and 30 generalization items to assess carryover of treatment gains to untreated words. The study will address the following aims: Aim 1: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on whole word accuracy in treated and generalization probes at post-treatment and maintenance. Aim 2: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on phoneme accuracy in treated words and generalization probes at post-treatment and maintenance. Aim 3: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on speech intelligibility at post-treatment and maintenance. Aim 4: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on functional communication at post-treatment and maintenance.

    Phase

    N/A

    Span

    128 weeks

    Sponsor

    New York University

    Hempstead, New York

    Recruiting

  • Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

    Phase

    2

    Span

    209 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

  • A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)

    Phase

    1/2

    Span

    107 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

  • A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

    Phase

    2

    Span

    108 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

  • Acupuncture for People Experiencing Period Loss Due to Chemotherapy

    Phase

    2

    Span

    105 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Rockville Centre, New York

    Recruiting

  • A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

    Phase

    3

    Span

    159 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

  • Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

    PRIMARY OBJECTIVE: I. To determine investigator assessed progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (non-inferiority) for one versus (vs.) two years of maintenance olaparib. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS360) in the modified intent to treat (ITT) population, with time at risk for progression/death starting 360 days after randomization. II. To evaluate progression-free survival (PFS), PFS2 and overall survival (OS) in the ITT population. III. To evaluate PFS, PFS2, and OS in the as-treated population. IV. To evaluate toxicity, including rates of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and other secondary malignancies, in the safety population. EXPLORATORY OBJECTIVE: I. To evaluate the moderating effect of physician-choice bevacizumab (as stratified) on randomized treatment effect estimates. TRANSLATIONAL OBJECTIVES: I. To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid (ctDNA) as a predictor of poor response in the BRCA mutated (BRCAm) population. II. To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair (HRR) genes with clinical homologous recombination deficiency (HRD) testing and outcomes in the BRCA wildtype (BRCAwt) population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (REFERENCE): Patients receive olaparib orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study. ARM II (EXPERIMENTAL): Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.

    Phase

    3

    Span

    512 weeks

    Sponsor

    NRG Oncology

    Uniondale, New York

    Recruiting

  • A Study of Sotorasib in People with Non-Small Cell Lung Cancer

    Phase

    2

    Span

    105 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

  • A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People with Hairy Cell Leukemia (HCL)

    Phase

    2

    Span

    157 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

  • A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

    Phase

    2

    Span

    105 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Uniondale, New York

    Recruiting

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