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NCT ID: NCT04075955 Completed - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Feasibility of Olanzapine at REduced doSe in hIGHly Emetogenic chemoTherapy

FORESIGHT
Start date: April 29, 2019
Phase: Phase 3
Study type: Interventional

Olanzapine is frequently used off-label as an adjunct antiemetic in clinical oncology settings. North American oncology guidelines recommend it as salvage therapy and as add-on to the standard triple regimen; some suggest it may also be effective as an initial triple therapy (olanzapine replacing the NK-1 antagonist) based on phase II and III trials. This prospective, multi-center, open-label study aims to evaluate the feasibility of a large scale randomised controlled trial to compare the effectiveness and tolerability of 5mg orally once daily olanzapine in triple antiemetic therapy versus the standard treatment of aprepitant + ondansetron + dexamethasone in treatment-naive patients receiving the first cycle of a highly emetogenic chemotherapy. Secondary outcomes include effectiveness, tolerability and quality of life assessments. Effectiveness will be measured with complete response and complete remission rates in each treatment arms. Tolerability and patient quality of life will be evaluated with a standardised side effect form and validated questionnaires; ESAS-R and FLIE. The role of olanzapine-based triple therapy in prevention of chemotherapy-induced nausea and vomiting remains founded on low-quality evidence. To the investigator's knowledge, this study will be the first large scale direct comparison of 5mg olanzapine versus aprepitant in triple therapy.

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: NCT04075123 Completed - Clinical trials for Respiratory Insufficiency Syndrome of Newborn

CPAP vs NIPPV: A COMPARATIVE EFFECTIVENESS RESEARCH

Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

Aim: Investigators aim is to conduct two complementary and concurrent CER projects using a pragmatic clinical trial design and registry-based RWD to identify the optimal respiratory management practices for extremely preterm neonates and reduce the risk of BPD and SNI. Objectives: Two complementary objectives are proposed. Objective 1: To determine the efficacy and safety of "mandatory non-extubation" until 72 hours of postnatal age for preterm neonates born at 23 -25 weeks' GA who receive mechanical ventilation. Objective 2: To determine whether optimal nasal continuous positive airway pressure post-extubation is as efficacious as nasal intermittent positive pressure ventilation in preterm neonates born at 23 -28 weeks' GA who have received mechanical ventilation.

NCT ID: NCT04074655 Completed - Dementia Clinical Trials

Investigating the Effect of Training With a Virtual Reality Driving Simulator

Start date: September 10, 2019
Phase: N/A
Study type: Interventional

The proposed study aims to investigate the use of a driving simulator in a virtual reality (VR) environment to improve the cognition state and spatial navigation of individuals with mild/moderate memory impairment. All volunteers will be assessed by the Montreal Cognitive Assessment (MoCA),Montgomery-Asberg Depression Scale (MADRS) and Morris Water orientation tests for baseline assessment after they sign the consent form and are enrolled into the study. Participants will also be scheduled for post-intervention assessments (MADRS, Morris Water Orientation and a simple questionnaire on how they evaluate the experiment). Participants of the study will play the driving simulator daily (5 days/week) for 15-20 minutes/day over a period of 2 consecutive weeks. Participants' daily performance data are recorded and uploaded on the secure server of the Priciple Investigator (PI). Simulator Sickness Questionnaire (SSQ) test will also be run after the first session of the experiment and at the end of the training period.

NCT ID: NCT04074174 Completed - Obesity Clinical Trials

Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

Start date: September 12, 2019
Phase: Phase 1
Study type: Interventional

The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.

NCT ID: NCT04073303 Completed - Clinical trials for Masseter Muscle Prominence

BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

Start date: August 29, 2019
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

NCT ID: NCT04073043 Completed - Anxiety Clinical Trials

Telephone Coaching Intervention for Postpartum Depression and Anxiety

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

Mental health problems affect up to 20% of women at some point during the perinatal period (i.e., from pregnancy to one year postpartum. Perinatal mental health (PMH) problems have been associated with many negative obstetric outcomes, such as higher elective caesarean section, premature delivery, pre-eclampsia, lower fertility rates, and longer postpartum hospital stay. This research study is a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential benefits of a low cost sustainable web-based intervention (WBI) with telephone coaching for women with mild to moderate symptomatology of postpartum depression and anxiety. The intervention contains modules that will help postpartum mothers: 1. Learning new information to better understand their condition. This can help mothers feel that they are not alone, and that their experience is not abnormal. It gives a better understanding that can help them feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends. 2. Learning and practicing new skills. This can help mothers feel confident that they can engage in the behaviours that have been shown to be beneficial for mood and to improve stress. This can include learning to plan activities like physical exercise, practice proper sleep hygiene or learning to use a new way of thinking about problems to help you find solutions. This trial represents a first step to implement a sustainable intervention for PMH problems in order to better serve women's PMH needs and preferences for support. This will help inform the current gap in low cost web-based interventions for PMH.Specific deliverables (in both French and English) include: a manual detailing coaching procedures; reports for decision makers and short summaries for stakeholder groups

NCT ID: NCT04072887 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

Start date: September 12, 2019
Phase: Phase 2
Study type: Interventional

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

NCT ID: NCT04072835 Completed - Clinical trials for Paroxysmal Supraventricular Tachycardia

Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303

Start date: September 23, 2019
Phase: Phase 3
Study type: Interventional

NODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT). Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when they felt the onset of PSVT symptoms. Participants self-administered etripamil NS if vagal maneuver was ineffective. After an episode of PSVT where study drug was administered, the participant returned to the investigative site and had the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes.

NCT ID: NCT04072380 Completed - Narcolepsy Clinical Trials

A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy

SUVN-G3031
Start date: September 21, 2019
Phase: Phase 2
Study type: Interventional

This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.