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NCT ID: NCT03875274 Completed - Postoperative Pain Clinical Trials

Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

Start date: April 1, 2017
Phase: Phase 4
Study type: Interventional

prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB

NCT ID: NCT03809702 Recruiting - Herpes Zoster Clinical Trials

Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

Start date: October 4, 2018
Phase: Phase 4
Study type: Interventional

All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead control group will receive Placebo.

NCT ID: NCT03807427 Completed - Mental Disorders Clinical Trials

Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)

READY-Nepal
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

Published research on the development of mental health symptomatology among adolescents has expanded in recent years and indicates the presence of a growing public health concern. The 2015 earthquakes in Nepal are a risk factor for increased psychological distress across all age groups. Prior studies have also demonstrated high chronic risk of suicidal thoughts and behaviors (STBs) among adolescents in Nepal and throughout South Asia. Despite the need for mental health promotion interventions in Nepal, there is a lack of psychological treatments for suicide prevention that have been rigorously evaluated in Nepal. To address this gap, a trans diagnostic, emotion -focused mental health promotion intervention (Regulating Emotions through Adapted Dialectical behavior skills for Youth in NepalÍž READY-Nepal) was developed for delivery in school-based settings. A pilot quasi-experimental trial utilizing a wait-list control group will be used to evaluate the feasibility and acceptability of the intervention in a cohort of school -going adolescents in the Kathmandu Valley. Qualitative methodology will be used to augment quantitative findings via exploration of gender differences in perception and uptake of the program, program feasibility and acceptability, as well as changes in coping skills and explanatory models of stress between baseline and follow- up. This pilot study will aid in modifying the intervention to inform the development of a larger, adequately powered cluster randomized trial (CRT) of READY-Nepal.

NCT ID: NCT03807362 Recruiting - Leprosy Clinical Trials

CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

Start date: January 7, 2018
Phase: Phase 2
Study type: Interventional

This study will be a single center, Phase 2, open-label trial to evaluate the safety and efficacy of 200mg CC-11050 administered twice daily taken with food for patients with moderate to severe ENL. The study will be performed in two steps: 1) to evaluate immediate effect in safety and efficacy of drug in 10 males with new or new recurrent episode ENL and, if found to be safe and effective by the DSMB and 2) if allowed by the DSMB, and approved by relevant study stakeholders, an additional 40 ENL patients will be enrolled for up to 52 weeks of treatment. A safety analysis will be conducted on all patients who have received at least one dose of study drug, and will include the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation.

NCT ID: NCT03775460 Not yet recruiting - Clinical trials for Erythema Nodosum Leprosum

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

MaPs
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

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: May 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 disease 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 screening program employing OCT and intraocular pressure testing to screen for glaucoma, DR, and AMD followed by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving only visual acuity assessment. An initial door-to-door census will assess baseline visual acuity in both study arms. The investigators will compare visual acuity between the two arms through a second door-to-door census 4 years later (primary outcome). The investigators maximize their 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.