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NCT ID: NCT03374800 Not yet recruiting - Clinical trials for Gastrointestinal Hemorrhage (Clinically Important, Upper)

Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial

REVISE
Start date: January 15, 2018
Phase: Phase 3
Study type: Interventional

Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, today, compared to decades ago, critically ill patients rarely develop gastrointestinal bleeding. This decrease is likely due to modern medicine, better resuscitation and earlier feeding. There may also be harms associated with pantoprazole and other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and bowel infections (clostridium difficile). Studies in this area are old and of modest quality. Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these days, or whether the possible harms of lung and bowel infections are actually more common and more serious problems. The goal of this international study is to determine if, in critically ill patients using breathing machines, the use of pantoprazole is effective in preventing bleeding from stomach ulcers or whether it causes more problems such as lung infection (pneumonia) and bowel infection (Clostridium difficile), or whether pantoprazole has no effect at all. Whether the harms are worth the benefits, and whether the benefits are worth the costs, will be determined by an economic analysis to inform patients, families, clinicians, and healthcare systems globally.

NCT ID: NCT03374761 Enrolling by invitation - Child Abuse Clinical Trials

Families First Program Evaluation in Indonesia

Start date: March 22, 2017
Phase: N/A
Study type: Interventional

Families First Home Visiting Program (Families First) is a parenting support program anchored on children's rights that gives parents clear guidance on child development, parenting, and positive discipline practices. Families First is an adaptation of the Positive Discipline in Everyday Parenting (PDEP) Program for the West Java context. This trial aims to evaluate the effectiveness of Families First. This is a pragmatic, delayed-entry, parallel-group, stratified, cluster-randomized controlled trial in a real-world setting. Twenty rural and urban villages in the Cianjur district of Indonesia, involving 720 caregivers of children up to 7 years of age, are randomized to two parallel arms. Villages receive either a parenting program consisting of 10 group sessions and 4 home visits or the standard community health and social services. After completion of the trial period, the delayed group is offered the program. The primary outcome is self-reported frequency of corporal/physical and emotional punishment. The secondary outcomes are indicators of involved and positive parenting. Concurrent process evaluation and qualitative research are conducted to identify program satisfaction and facilitators and barriers to the implementation. Outcome data are collected immediately after the intervention and six months later. The results will be used to inform a violence prevention strategy in West Java and possible scale up in of the intervention in Indonesia.

NCT ID: NCT03374683 Recruiting - Parenting Clinical Trials

Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

Children's risky play is associated with a variety of positive developmental, physical and mental health outcomes, including greater physical activity, self-confidence and risk management skills. Children's opportunities for risky play have eroded over time, limited by parents' fears and beliefs about risk, particularly among mothers. We have developed a digital and in-person workshop version of a tool to reframe parents' perceptions of risk. We will examine whether the tool increases mothers' tolerance for risky play and influences parenting behaviour change, in the short and long term, and whether these changes are greater than those in the control group. We will conduct a single-blind (researchers and outcome assessors) randomized controlled trial and will recruit at total of 501 mothers of children aged 6-12 years. The risk reframing (RR) digital tool is designed for a one-time visit and includes three chapters of self-reflection and experiential learning tasks. The RR in-person tool is a 2-hour facilitated workshop in which participants are guided through discussion of the same tasks contained within the digital tool. The control condition consists of reading the Position Statement on Active Outdoor Play. Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale. Secondary outcome is self-reported attainment of a behaviour change goal that participants set for themselves. We will test the hypothesis that there will be differences between the experimental and control groups with respect to tolerance of risk in play and goal attainment.

NCT ID: NCT03374436 Recruiting - Physical Activity Clinical Trials

Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function

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

Prolonged sitting has been shown to impair metabolism and vascular function. The overall purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with brief (~20 second) stair climbing exercise "snacks" can improve markers of metabolic control and vascular health in healthy young male participants. An additional purpose is to determine if saliva insulin can be used as a valid indicator of blood insulin when measured throughout the day in sedentary and active conditions and when diets with different amounts of carbohydrates are consumed.

NCT ID: NCT03372278 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

Start date: January 2013
Phase: N/A
Study type: Observational

This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

NCT ID: NCT03372239 Recruiting - Healthy Clinical Trials

Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers

Start date: November 21, 2017
Phase: Phase 1
Study type: Interventional

This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers.

NCT ID: NCT03370237 Completed - Clinical trials for Foot Ulcer, Diabetic

Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm

Start date: July 1, 2017
Phase: N/A
Study type: Observational

The main objective of this research study is to validate the St Joseph's Health Care Harmonized Foot Ulcer Assessment and Stratification tool using inter-rater reliability technique to determine if the score would consistently be reproducible by examiners of different role (Nurse Practitioner, Family physician, Registered Nurse and Resident). A validated assessment tool allows collecting better quality data with high comparability which enhances quality of foot care and increases the credibility of the tool.

NCT ID: NCT03369678 Recruiting - Clinical trials for Interventions to Enhance Emergency Health Care

EQUIP Emergency: Promoting Health Equity for Indigenous and Non-Indigenous People in Emergency Departments

Start date: November 28, 2017
Phase: N/A
Study type: Observational

Emergency Departments (EDs) in Canada often operate over-capacity and are under significant pressures. In this environment, particular groups of people experience inadequate and inequitable treatment in EDs, including Indigenous people, racialized newcomers, people with mental illnesses, those living in unstable housing or facing homelessness, experiencing interpersonal violence or using substances, and people involved in sex work. Stigma and discrimination in health care deter people from accessing care, interfering with effective care delivery, increasing reliance on EDs, and increasing human and financial costs. This project will develop and test a framework for health equity interventions to promote the provision of equity-oriented care in EDs.

NCT ID: NCT03367741 Not yet recruiting - Clinical trials for Recurrent Uterine Corpus Carcinoma

Cabozantinib and Nivolumab in Treating Patients With Advanced, Recurrent or Metastatic Endometrial Cancer

Start date: January 26, 2018
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well cabozantinib and nivolumab work in treating patients with endometrial that has come back or spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may work better in treating endometrial cancer.

NCT ID: NCT03367728 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP)

LapTAP
Start date: March 2018
Phase: Phase 4
Study type: Interventional

Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block and rectus sheath block in reducing post-operative opioid consumption and improving outcomes in patients undergoing laparoscopic gastric bypass surgery. The results of this study will provide further evidence on the optimal means to obtain analgesia in patients undergoing gastric bypass surgery