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NCT04566822
The Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic, with more than 70 million US adults experiencing insomnia each year. However, access to current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for Insomnia \[CBT-I\]) is limited due to the need for specialized providers as well as monetary and logistical barriers that prevent many individuals from attending in-person treatment sessions (e.g., scheduling, transportation, childcare). Novel modes of delivery are needed to extend the benefits of these treatments to a wider range of individuals in need. The purpose of this study is to evaluate Calm Sleep Coaching in adults with sleep disturbance (score of greater than or equal to 8 on the Insomnia Severity Index) by 1) determining the feasibility (i.e., acceptability, demand) of Calm Sleep Coaching and 2) determining the preliminary effects of Calm Sleep Coaching on primary (sleep quality) and secondary outcomes (i.e., symptoms of insomnia, mental health, well-being, resilience, and productivity). Investigators also aim to explore coaches' experiences with implementation of Calm Sleep Coaching using an investigator developed survey and assess the participants stage of change (transtheoretical model) throughout the program. Investigators hypothesize that 1) Calm Sleep Coaching will be feasible among individuals with sleep disturbance and 2) participating in the Calm Sleep Coaching program is associated with improvements in primary and secondary outcomes compared to the control group (with greater improvements observed among those participating in higher touch coaching interventions). Investigators aim to recruit N=200 participants. Participants will be randomized into one of four groups: 1) High-touch intervention (N=50; real-time video and chat messaging, coach response via live videos), 2) medium-touch intervention (N=50; real-time video and pre-recorded video and chat messaging with response from coach), 3) low-touch intervention (N=50; chat messaging with response from coach), or 4) Sleep education control (N=50; no coaching).
NCT00232180
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients. The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population. On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
NCT01156415
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study. Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
NCT03800303
In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to: 1. evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity); 2. evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.
NCT00411099
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
NCT00084929
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection. PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
NCT00411242
NCT03464565
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
NCT01110889
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
NCT00082589
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
NCT00492869
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
NCT02780115
This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).
NCT01268059
The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).
NCT00825539
Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as measured by functional magnetic resonance imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and tolerability of multiple doses of AQW051 in people with schizophrenia.
NCT01128335
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
NCT00147615
To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.
NCT00615693
The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.
NCT01602315
This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab: Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719. The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3. Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.
NCT01064791
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
NCT02608125
This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.
