Clinical Trials Logo

Filter by:
NCT ID: NCT03758560 Recruiting - Pain, Postoperative Clinical Trials

Preoperative Pain Catastrophizing and Its Association With Postoperative Pain After Lower Limb Trauma Surgery

Start date: December 16, 2018
Phase:
Study type: Observational

The Pain Catastrophizing Scale (PCS) is a psychometric tool to identify PC. A positive correlation between PCS scores and various pain outcomes has been reported in acute and chronic pain settings. Preoperative catastrophizing is associated with an increased intensity of postoperative pain and more analgesic consumption. Likewise, a recent meta-analysis revealed that PC is a strong predictor of persistent postsurgical pain. The Nepali version of PCS has been validated recently in patients with chronic pain. However, it has not been used in patients with acute pain. Therefore, our aim is to assess the relationship between preoperative Nepali PCS (N-PCS) scores and postoperative pain intensity and total opioid consumption in patients with musculoskeletal trauma planned for surgery.

NCT ID: NCT03752840 Not yet recruiting - Glaucoma Clinical Trials

Village-Integrated Eye Worker Trial II

VIEW II
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates that 80% of cases of visual impairment could be prevented or reversed with early diagnosis and treatment. The leading causes of visual impairment are cataract and refractive error, followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR). Loss of vision from these conditions is not inevitable; however, identifying at-risk cases and linking cases with appropriate care remain significant challenges. To address the global burden of avoidable blindness, eye care systems must determine optimal strategies for identifying people with or at risk for visual impairment beyond opportunistic screening. Outreach programs can prevent blindness both by screening for asymptomatic disease like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case detection of symptomatic dis-ease like cataract and refractive error. Eye care systems have developed numerous community-based approaches to these identification methods, including screening using telemedicine and case detection via cataract camps or community health worker models, but no studies have been conducted on the comparative effectiveness or cost effectiveness of these various approaches. Technology promises to greatly improve access to sophisticated eye care. AMD, DR, and glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment can prevent progression.Thus, community screening programs may prevent progression and improve the vision of a population.However, mass screening for eye disease is currently not recommended. Although self-evident that early detection can prevent blindness for an individual, no randomized controlled trial has been able to demonstrate that screening improves visual acuity at the community level. However, recent technological advances promise to dramatically change the equation by allowing non-medical personnel to use mobile,easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD, DR, and glaucoma. Mobile technology could also transform the way clinics communicate with their patients, improving linkage to and retention in care. Optical coherence tomography (OCT) is an ideal test for community-based screening. OCT can be performed through an undilated pupil and is less subject to optical aberrations due to cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for glaucoma, and major anatomical abnormalities can easily be detected even by novice technicians. The infrared image allows detection of referable diabetic retinopathy, and newer OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT machines are ever more portable, and could be feasibly used in community-based screening programs. The investigators propose a large cluster-randomized trial in Nepal to compare two community-based blindness prevention programs: (1) a state-of-the-art telemedicine program employing OCT to screen for glaucoma, DR, and AMD followed by enhanced linkage-to-care to the local eye hospital, and (2) a community health worker (CHW) program in which CHWs perform visual acuity screening only. The investigators will assess the number of cases of AMD, DR, and glaucoma diagnosed as a result of screening, and ultimately assess visual acuity through a door-to-door census 4 years later. The investigators maximize our chances of finding an effect by conducting the study in Nepal, where the burden of undiagnosed eye diseases is high. If successful in Nepal, future studies could assess the generalizability of such a program to other settings, such as rural communities in the industrialized world.

NCT ID: NCT03747055 Recruiting - Depression Clinical Trials

Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises

GroupPM+
Start date: November 25, 2018
Phase: N/A
Study type: Interventional

This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).

NCT ID: NCT03723837 Not yet recruiting - Poliomyelitis Clinical Trials

Persistence of IPV Immunity

Start date: November 15, 2018
Phase: Phase 4
Study type: Interventional

In 2015, Strategic Advisory Group of Experts in Immunization (SAGE) recommended the global switch from trivalent to bivalent oral poliovirus vaccine (OPV) that does not contain type 2 poliovirus and introduction of a single dose of inactivated poliovirus vaccine (IPV) to maintain population immunity to type 2 polio to reduce the risk of vaccine derived polio. Following SAGE recommendations, Nepal introduced one dose of IPV in routine immunization in 2015 followed by withdrawal trivalent OPV in April 2016. However, Nepal, like many other countries had to stop vaccination by the end of 2016 because of a global shortage of IPV. Single dose of IPV induces detectable antibodies in 34% to 80% of infants, compared to >90% after three doses and most of seronegative children (84-98%) are "immunologically primed" by the first dose. Primed individuals produce protective antibody levels in serum within one week of exposure to a new dose of IPV or OPV. However, it is unknown whether seroconversion or priming responses persist, and for how long they persist after the single dose of IPV. IPV immunogenicity for vaccine delivered low-resource countries may also be inferior to that observed in clinical trials because of program factors that decrease vaccine efficacy. This cross sectional study aims to determine whether the immune response provided by a single dose of IPV delivered through routine immunization services persists for more than a year. The study will be implemented in three study sites in Kathmandu, Nepal during November 2018- July 2019. Information generated from this study is expected to allow better estimation of children partially protected (primed) or fully protected against type 2 poliovirus depending on coverage and time since last IPV vaccination. These estimates will help inform the Global Polio Eradication Initiative on vaccine choices for responding to type 2 vaccine derived poliovirus (VDPV) outbreaks and will help guide decisions on polio immunization schedules for Nepal and for other countries in future.

NCT ID: NCT03723525 Recruiting - HIV Clinical Trials

Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals

PRAN
Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

This is a cluster randomized trial to determine whether a package of care including rapid antiretroviral therapy (ART) initiation, as compared to standard ART initiation, improves mortality, retention in care and viral suppression among treatment naive people living with HIV (PLHIV) in Nepal. Package of care includes immediate screening and treatment of opportunistic infections (OIs), rapid ART initiation and enhanced retention in care using mobile health (mHealth) and weekly/biweekly home-based adherence/ retention support linked to community care centre. Standard of care includes screening and management of common OIs, baseline assessment (CD4, viral load and other tests), antiretroviral drugs and ART follow up.

NCT ID: NCT03700034 Not yet recruiting - Clinical trials for Gestational Diabetes

mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal

Start date: November 2019
Phase: N/A
Study type: Interventional

The trial aims to enhance antenatal care (ANC) to address the changing disease burden affecting pregnant women in India and Nepal. The enhancement includes using a tablet-based electronic decision support system that prompts front line health workers to provide evidence-based routine ANC, enhances detection and management of pregnancy-induced hypertension and gestational diabetes, facilitates record-keeping and reporting, and links across levels of care providers.

NCT ID: NCT03668977 Recruiting - Clinical trials for Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition

Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Birth Outcomes and Growth in Southern Nepal

Start date: July 16, 2018
Phase: N/A
Study type: Interventional

This project will test the acceptability and efficacy of a balanced protein energy supplement for daily use during pregnancy and the first 6 months after delivery on the outcomes of pregnancy and growth of infants during the first 6 months of life. Approximately 1600 pregnant women from a district in southern Nepal will be recruited and randomly assigned to one of 4 groups, control in pregnancy & post-partum, supplementation in pregnancy & control post-partum, control in pregnancy & supplementation post-partum, or supplementation in pregnancy & post-partum. Pregnancies will be followed until delivery and the infants through 6 months of age. Outcomes of interest include birth size (weight and length), gestational age at delivery, maternal weight gain in pregnancy, maternal weight at 6 months post-partum, infant growth, and breast milk composition.

NCT ID: NCT03630380 Recruiting - Pneumonia Clinical Trials

Accuracy of Clinical and Diagnostic Studies for Pneumonia in Children

Start date: June 1, 2018
Phase:
Study type: Observational

Pneumonia continues to be a leading cause of death in children under five years of age worldwide. Many studies have evaluated clinical signs and symptoms that may predict pneumonia. A recent meta-analysis found that no singular physical exam finding predicted pneumonia. The World Health Organization (WHO) Criteria diagnose pneumonia based on fast breathing; however, tachypnea has not been shown to strongly predict pneumonia. This study will evaluate accuracy of clinical history, physical exam and WHO criteria, laboratory findings, and lung ultrasound compared with chest radiograph for the diagnosis of pneumonia in children under five years of age in a resource limited setting. Determining diagnostic accuracy of these findings may help derive a clinical decision rule that may more accurately predict which children have pneumonia than current WHO guidelines.

NCT ID: NCT03625206 Recruiting - Child Abuse Clinical Trials

Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

Start date: April 17, 2018
Phase: N/A
Study type: Interventional

Adolescents who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition. Outcome measures include measures of cognitive biases and symptoms of psychopathology; in addition, in a subset of adolescents, brain activity data will be acquired. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.

NCT ID: NCT03620513 Recruiting - Throat Disorder Clinical Trials

Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy

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

Fiberoptic laryngoscopy (FOL) is one of the most common procedure done in an Ear Nose Throat (ENT) clinic. Topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. Recently, role of these agents has been questioned. The investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing FOL.