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NCT ID: NCT03353012 Completed - Breastfeeding Clinical Trials

Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.

NCT ID: NCT03351010 Completed - Pain, Chronic Clinical Trials

Mindfulness for Pain Management in Patients With Cancer

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

Using pharmacologic agents are often effective to treat patients with cancer pain, but there are associated with serious side-effects and risks of dependence and addiction. The Thai Buddhism-based Mindfulness (TBbM) intervention created by a widely respected Buddhist monk focuses on testing a meditation technique to manage pain. If effective, millions of patients who suffer with cancer pain will benefit from use of a safe, culturally appropriate, non-pharmacologic approach to pain management.

NCT ID: NCT03346720 Completed - Data Sharing Clinical Trials

Ethical Challenges of Consent in Data Sharing

Data Sharing
Start date: February 1, 2017
Phase:
Study type: Observational

In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings. It has been our policy for many years to support sharing of data across collaborative research networks in order to maximize their utility. However there is increasing support from research funders, regulatory agencies and journals for sharing individual-level data from genomic, medical and public health research beyond research collaborations. A number of potential advantages of sharing individual level data from clinical and public health research have been identified in the literature. These include maximizing the utility of data, allowing verification of research results, and minimizing the burdens and costs of unnecessary duplication of research. In low- and middle-income settings it may be particularly important to effectively share data to maximize its utility and enable timely responses to important public health issues such as resistance to antimalarial treatments. Many authors have called for data sharing to be carefully curated, to minimize potential harms including breaches of privacy, the publication of poor quality or biased secondary research, and insufficient acknowledgment of the contribution of researchers generating datasets. In low- and middle-income settings, the need for data sharing policies and processes to promote equitable use of data, including the development of sustainable capacity to both share and analyse datasets, has been recognized. It is foreseeable that the impact of this policy will be significant both practically and ethically. In the practical sense, there have already been changes in our data management processes and resources, clinical trial agreements and negotiations with collaborators. Ethically, this policy has impact on the consent process which includes the increasing use of broad consent, the changes in the language of information sheets, study protocols and ethics application documents and the actual consent taking by research staff. Now that that these new data-sharing mechanisms have been put in place there is a need to evaluate their impact on practice. The aim of this study is to identify and analyse ethical challenges related to consent following implementation of a new data sharing policy with the aim of refining the data sharing policy and its related consent processes

NCT ID: NCT03344653 Completed - Clinical trials for Coronary Artery Disease

A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Onyx ONE
Start date: November 2, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

NCT ID: NCT03344627 Completed - Sepsis Clinical Trials

Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock

NCT ID: NCT03342404 Completed - Thalassemia Clinical Trials

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia

BEYOND
Start date: February 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP), Open-label Phase (OLP), and Post-Treatment Follow-up Period (PTFP). It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus placebo.

NCT ID: NCT03342313 Completed - Mastication Clinical Trials

Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults

Start date: March 15, 2015
Phase: N/A
Study type: Interventional

A randomized cross-over design aims to investigate chewing activities between healthy vs. overweight and determine effects chewing times on energy intake and postprandial plasma glucose and insulin. Forty-one participants were allocated into lean and overweight groups according to BMI. Phase I, Bite size (g/bite), bite rate (bites/min), chewing frequency (chews/min), and chews (chews/g food) were recorded after a sandwich breakfast. Phase II, gram of sandwich eaten ad libitum after 15 and 50 chew per bite (number from phase I) were recorded. Postprandial plasma glucose and insulin were examined at 0 (baseline), 30, 60, 90, 120 and 180 min.

NCT ID: NCT03341819 Completed - Clinical trials for Urinary Tract Infections

Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia

Start date: November 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia

NCT ID: NCT03337373 Completed - Critical Illness Clinical Trials

The Study of Pharmacokinetics and Pharmacodynamics of Cisatracurium

Start date: December 15, 2017
Phase: Phase 4
Study type: Interventional

Pathophysiological changes influenced by multiple factors in critically ill patients, has a significant impact on pharmacokinetics (PK) and pharmacodynamics (PD) of cisatracurium. In order to understand better and find an appropriate dosing regimen, the purpose of this study is to investigate the PK and PD of a loading dose cisatracurium in critically ill patients. Cisatracurium, nondepolarizing neuromuscular blocking agents (NMBAs), are commonly used in intensive care units because of a lesser effect on hemodynamic parameters and a reduction in mortality rate in ARDS patients. Loading dose recommended in clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient is 0.1-0.2 mg/kg. Then, maintenance dose of 1-3 mcg/kg/min is followed regarding indications, such as ARDS. However, this recommended loading dose might not be adequate in critically ill patients, the study in this specific population might be needed.

NCT ID: NCT03333109 Completed - Episodic Migraine Clinical Trials

Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

EMPOwER
Start date: February 8, 2018
Phase: Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine