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Chronic Disease clinical trials

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NCT ID: NCT03204188 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start date: September 22, 2017
Phase: Phase 2
Study type: Interventional

Background: Chronic lymphocytic leukemia and small lymphocytic lymphoma (hereby referred as CLL) are tumors of B cells. A subset of patients categorized as high-risk CLL has a poor clinical outcome when treated with conventional chemotherapy. This single-arm, phase II study investigates the combination of ibrutinib, fludarabine and pembrolizumab for treatment of CLL. Ibrutinib is an orally administered therapy for CLL. Fludarabine is a well-tolerated drug that has been widely used to treat CLL. Also, fludarabine can modulate CLL cells as well as immune cells that support the growth of CLL cells. Pembrolizumab recruits immune cells to attack CLL cells. With this approach we hope to achieve a greater reduction in CLL cells than with single agent ibrutinib and to restore healthier immune system that could contribute to durable responses. Objective: To investigate the rate of complete response to ibrutinib, short course fludarabine and pembrolizumab. Eligibility: Patients with active CLL meeting treatment indications defined by 2008 International Workshop on CLL (IWCLL) consensus guideline. High-risk CLL defined by one of the following: - Relapsed/refractory disease status, or - Presence of high-risk mutations regardless of prior treatment status: deletion 17p, TP53 mutation, NOTCH1 mutation, SF3B1 mutation, MYC aberration, or complex cytogenetics. Design: This is a single-arm, open-label phase II study. Timeline: Treatment on this study is given in cycles from cycle -3 to 17, then in months beyond cycle 17. Cycles -3 to -1 are 28-day cycles. Cycles 1 to 17 are 21-day cycles. After completion of 1 year of pembrolizumab, the time on study is by chronological months on study from starting pembrolizumab. Treatment plan: - Ibrutinib is given starting from cycle -3 and continuously until disease progression or intolerable side effects occur. - Fludarabine is given on D1-D5 on cycle -2 only - Pembrolizumab is given every 3 weeks starting from cycle 1 for 1 year. - Minimal residual disease will be measured at 2 years from cycle 1 to determine the need for long- term treatment with ibrutinib. - Previously-untreated patients who achieve minimal residual disease negativity will stop ibrutinib. - Patients who do not achieve minimal residual disease negativity or who has Relapsed/refractory CLL will continue ibrutinib.

NCT ID: NCT03151694 Active, not recruiting - Obesity Clinical Trials

Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease

Start date: February 1, 2011
Phase: N/A
Study type: Observational

This multi-national program applies a breakthrough approach to childhood obesity called, Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) where Whole-of-Society (WoS) transformations are taking place (industrialized societal context with peaking childhood obesity and where a broad governmental plan to promote healthy lifestyle has been adopted -Canada; developing societal context with increasing childhood obesity if replication of past pathways that have lead to double burden; India) are taking place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to children. Individual-level BtS Diagnostic will examine the degree to which individual differences in genetics and biology and differences in the environmental exposures modulate the behavioral, body weight/fatness and nutritional risk over time in the context of WoS transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in policy, investment, business and innovation made by different stakeholders (government, private sector, civil society in health and non-health society systems including agriculture, business and media practices) on the community.

NCT ID: NCT03089177 Active, not recruiting - Obesity Clinical Trials

Community Activation for Prevention (CAPs): A Study of Community Gardening

CAPs
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The investigators previous studies show that community gardening is associated with reduction of key health behaviors for cancer prevention in diverse populations. Community gardeners eat more fruits and vegetables per day, are more physically active, and are more likely to avoid age-associated increase in body mass index (BMI). The effect is partially explained by the finding that gardeners are more socially involved, and feel more social support than non-gardeners. The investigators propose a randomized controlled trial to determine whether community gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult population and elucidate the pathways that shape cancer-preventive behaviors. A randomized controlled trial is needed to demonstrate that the observed behavioral differences are due to the effect of gardening as an intervention rather than self-selection by gardeners.

NCT ID: NCT03018717 Active, not recruiting - Clinical trials for Chronic Lung Disease

Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases

ATLAN_TIC01
Start date: June 13, 2016
Phase: N/A
Study type: Interventional

Information and communications technologies (ICT) currently constitute a key element in the innovation and improvement of providing health-care to frail populations with advanced chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven conclusively. The investigators are going to carry out a multi-center, randomized, parallel groups, phase III clinical trial in adult patient with heart and/or lung advanced diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of bio-parameters added to optimal standard of clinical care (shared clinical care plan) compared to the shared clinical care plan exclusively.

NCT ID: NCT02970461 Active, not recruiting - Chronic Disease Clinical Trials

Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record

Start date: July 2016
Phase: N/A
Study type: Interventional

A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record.

NCT ID: NCT02944591 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Evaluation of COPD Co-Pilot

Start date: October 2016
Phase:
Study type: Observational

The purpose of this research study is to investigate the potential benefits of participant use of a smartphone application ("App") called COPD Co-Pilot™. When used by the participant, COPD Co-Pilot™ may provide early detection of worsening COPD symptoms. Early symptom detection may allow the pulmonary providers and nurses to respond with timely medical advice and treatment. The goal for use of COPD Co-Pilot™ is to reduce the frequency and duration of hospitalizations, emergency department visits, and hospital readmissions. The study will also examine the financial impact of the COPD Co-Pilot™ program to determine whether costs of hospital stays, emergency department visits, and hospital readmissions differ when patients are enrolled in COPD Co-Pilot™ than when they are not enrolled. Another purpose of this study is to measure patient satisfaction with use of COPD Co-Pilot™.

NCT ID: NCT02937974 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

Start date: October 2016
Phase: Phase 4
Study type: Interventional

Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD). Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group,Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days;Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α,IFN-γ, APACHEⅡ, CAPS score.

NCT ID: NCT02832739 Active, not recruiting - Diabetes Mellitus Clinical Trials

Exploring Acceptance and Outcomes of an Online-based Self-management Support System in Chronic Illness

USECARE
Start date: November 2016
Phase: N/A
Study type: Interventional

The aim of the USECARE project is to improve and test SENACA, an ICT-based self-management support system for chronically ill patients and informal caregivers. 60 end-users will be instructed to use SENACA for approx. 3 months (in Israel and Norway). Amongst others, clinical and behavioural outcomes will be recorded. Additionally, SENACA's usability will be evaluated to determine its potential future scalability.

NCT ID: NCT02725294 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Understanding Patient Management of COPD Exacerbations

Start date: August 2016
Phase:
Study type: Observational

This observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Participants complete a baseline in-person visit and receive calls every two weeks for one year to monitor for COPD exacerbations. Detailed information about each exacerbation and time to care are obtained. A sample of participants and their caregivers participate in in-depth interviews. Approximately half the participants will also use a remote inhaler monitor to record their albuterol inhaler use to see if this approach can identify early exacerbations. Results from this study will be used to develop an intervention that will assist Veterans in the early identification, evaluation, and treatment of exacerbations, and will be integrated with the VA primary care team.

NCT ID: NCT02702440 Active, not recruiting - Obesity Clinical Trials

Systematic Review and Meta-analysis of Liquid Versus Solid Calories and Body Weight

Start date: May 2015
Phase: N/A
Study type: Observational

Consumption of sugar-sweetened beverages (SSBs) has been linked to rising rates of overweight and obesity. The most prominent mechanism to explain the link between SSBs and obesity is that liquid calories are not perceived by the body; thereby, promoting less satiety, less energy compensation and more weight gain than does the same energy consumed in solid form. This view is supported by pooled analyses of acute preload trials that have primarily measured food intake as the outcome. Though failure of short-term compensation has been observed with liquid calories, results from these acute preload trials should not be extrapolated to infer that liquid energy sources lead to weight gain over the long-term. To date, it is unclear whether liquid calories have differential effects than solid calories on body weight gain over the longer term. To increase clarity in this issue, the investigators propose to conduct a systematic review and meta-analysis from long-term controlled feeding trials to distinguish the contribution of liquid calories from solid calories on body weight over the long-term. The findings generated by this analysis will improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.