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NCT ID: NCT04118738 Completed - Hearing Loss Clinical Trials

International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy

Start date: June 12, 2019
Phase:
Study type: Observational

The International Cohort Study of Children Born to Women Infected with Zika Virus (ZIKV) During Pregnancy study is a prospective, observational, international cohort study of children previously enrolled in the ZIP study or other ZIP 2.0 Protocol Team approved ZIKV-cohort study that will continue the longitudinal follow-up of children born with documented confirmed or presumptive in-utero ZIKV exposure ("ZIKV-exposed" cohort) and children born without documented confirmed or presumptive in-utero ZIKV exposure, matched by site and birth sex ("ZIKV-unexposed" cohort). Follow-up evaluations and assessments will allow for the determination and comparison of long-term neurodevelopmental outcomes among in utero ZIKV-exposed and ZIKV-unexposed children. Each participant will be followed for about 2 years, beginning at approximately 18 months through 42 months of age.

NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

NCT ID: NCT04103892 Completed - Clinical trials for Adjunctive Treatment of Major Depressive Disorder

A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

Start date: September 5, 2019
Phase: Phase 2
Study type: Interventional

The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.

NCT ID: NCT04101526 Completed - Sleep Disturbance Clinical Trials

Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance

Start date: August 15, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.

NCT ID: NCT04085367 Completed - Actinic Keratoses Clinical Trials

Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face

Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).

NCT ID: NCT04084769 Completed - Clinical trials for Meningococcal Immunisation (Healthy Volunteers)

Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)

Start date: September 3, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine: - In Group 1 participants who were first vaccinated with 1 dose of MenACYW Conjugate vaccine 3-6 years before the booster dose. - In Group 2 participants who were first vaccinated with 1 dose of Menveo vaccine (meningococcal [Groups A, C, Y and W135] Oligosaccharide Diphtheria CRM197 Conjugate vaccine) 3-6 years before the booster dose. Secondary Objective: To describe: - The vaccine seroresponse, seroprotection (serum bactericidal assay using human complement [hSBA] titer greater than or equal to [>=]1:8), and antibody responses (geometric mean titers [GMTs]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50 participants per group (Groups 1 and 2). - The vaccine seroresponse, seroprotection (hSBA titer >=1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on Day (D)0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW Conjugate vaccine alone (Groups 1 and 2). - The antibody persistence (GMTs and vaccine seroprotection; hSBA titer >=1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in participants who received either MenACYW Conjugate vaccine or Menveo vaccine 3-6 years earlier. - The antibody persistence (GMTs and vaccine seroprotection; hSBA titer >=1:8) of meningococcal serogroups A, C, Y, and W in participants who received either a single dose MenACYW Conjugate vaccine (participants randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (participants assigned to MET59 Group 2), as part of study MET50, or MET43 (participants randomized to MET59 Groups 1, 3 and 4). - To describe the vaccine seroresponse, seroprotection (hSBA titer >=1:8), and antibody responses (GMTs) to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with meningococcal serogroup B (MenB) vaccine (Groups 3 and 4), compared to those when it was given alone (Group 1).

NCT ID: NCT04075604 Completed - Breast Cancer Clinical Trials

A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

CheckMate 7A8
Start date: October 18, 2019
Phase: Phase 2
Study type: Interventional

A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

NCT ID: NCT04064905 Completed - Zika Virus Clinical Trials

Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults

Start date: July 30, 2019
Phase: Phase 1
Study type: Interventional

This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants

NCT ID: NCT04064411 Completed - Clinical trials for Postmenopausal Osteoporosis

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

Start date: August 5, 2019
Phase: Phase 3
Study type: Interventional

A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

NCT ID: NCT04052516 Completed - Clinical trials for Non Alcoholic Steatohepatitis (NASH)

A Phase 2b Study of Icosabutate in Fatty Liver Disease

ICONA
Start date: July 17, 2019
Phase: Phase 2
Study type: Interventional

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis