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NCT ID: NCT05471466 Completed - Surgical Incision Clinical Trials

Scar Outcomes for Scalpel Versus Diathermy Neck Incisions in an Afro-Caribbean Population

Start date: August 21, 2019
Phase: N/A
Study type: Interventional

This is randomized controlled double-blinded trial comparing the scar outcomes of diathermy versus scalpel surgical incisions in the neck. It was conducted in humans in an Afro-Caribbean (black) population.

NCT ID: NCT04479618 Completed - Clinical trials for Sickle Cell Leg Ulcer

Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics

SCLUJamaica
Start date: July 6, 2021
Phase: N/A
Study type: Interventional

One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months). SCLUs heal very slowly, and sometimes they never close. SCLU patients would benefit from an economical, less painful, dressing option. In addition, because SCLUs often compromise education and employment opportunities, improving wound care for this population benefits their entire community. This three-armed evaluator-blinded randomized controlled trial will determine if a cut-to-fit food-grade plastic-based improvised dressing decreases pain, improves quality of life, and is safe, effective, and acceptable for managing SCLUs in Jamaica. The negative control will be usual practice, and the positive control will be the advanced wound dressing with the strongest evidence supporting its use in a tropical climate (polymeric membrane dressing). Patients with SCLUs will be actively recruited from three adjacent parishes. The first 120 SCLU patients meeting study criteria presenting to UHWI, Mona, will be randomized immediately after initial cleansing/debriding into group (1) current usual practice, group (2) improvised dressings, or group (3) advanced dressings. Data will be added to each participant's data collection tool weekly. Results will be reported using descriptive statistics and ANCOVA. The expected outcome is both improvised and advanced dressing superiority to usual practice. Because proposed improvised dressing materials are easily obtainable, their use would increase the capacity of wound patients to safely and effectively care for themselves. Signed informed consent will be obtained from patients/parents. Only principal research investigators will have access to participant confidential information. The literature review demonstrates that risks are not higher than usual practice.

NCT ID: NCT04388540 Completed - Iodine Deficiency Clinical Trials

Caribbean Island Urinary Iodine Survey 2018

CRUISE
Start date: January 1, 2018
Phase:
Study type: Observational

Many of the Caribbean island nations have no data on iodine status in their populations. Iodine deficiency in children can reduce IQ but can be easily corrected through a program of salt iodization. The study will be located at 11 islands of the Caribbean region. At each of the 11 study sites, we will measure the iodine status in school-age children by collecting morning spot urine samples for measurement of urinary iodine concentration (UIC). We will also measure height and weight in all children. We will collect a repeat, next-day spot urine sample in 1/3rd of children to adjust for intra-individual variation in spot UIC and calculate the distribution of population intake.

NCT ID: NCT04118517 Completed - Clinical trials for Nutrition Deficiency Due to A Particular Kind of Food

Quality of Protein From the Common Bean

Start date: May 29, 2019
Phase: N/A
Study type: Interventional

Dietary Protein quality is based on digestion of proteins to amino acids and the bioavailability of the amino acids to maintain good health and body function. Currently, digestibility of proteins, which is measured as the difference between protein intake and faecal loss, is underestimated. This is because, in addition to loss from dietary proteins, faecal loss includes additional protein from gut secretions and bacteria residing in the large intestine. The expert committee on protein quality suggested that a minimally invasive accurate method based on Dual Stable Isotope Tracer approach (non-radioactive) could be developed. This method is based on the concept that if amino acids in proteins become labelled with an isotopic tracer within the food matrix, their appearance in the blood gives a measure of bioavailability. The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) are promoting peas and beans to combat poverty, hunger and malnutrition because they are relatively less expensive sources of protein. We hypothesized that digestibility of protein in the common bean and absorption of amino acids is higher than current estimates. The aim of this proposal is to conduct a study in 12 healthy adults, aged 20 to 45 years, to test a novel method to assess protein quality of the common bean using the isotopic approach. The Scientific Research Council will grow the labelled beans by adding a tracer dose of deuterium to the irrigation water. The beans are prepared a typical Jamaican meal for consumption. The meal is mixed with a labelled reference protein (U-13C-spirulina) which is universally (U) labelled with stable isotope 13-Carbon (13C) to estimate digestibility; and the amino acid, phenylalanine, in which the 6 ring carbon atoms are labelled with 13C (ring-13C6- phenylalanine) to provide an index of amino acids absorption. Before and after consumption of the meal, samples of blood, breath and urine will be taken. These samples and a sample of the diet will be analysed for amino acids composition and deuterium enrichment using mass-spectrometry. The appearance of each labelled essential amino acid in blood from the bean protein will be calculated. The data will provide accurate date on amino acids bioavailability from the common bean that will be useful for dietary guideline for good health.

NCT ID: NCT04015401 Completed - Sickle Cell Disease Clinical Trials

Neuropathic Pain in Jamaicans With Sickle Cell Disease

Start date: July 15, 2019
Phase:
Study type: Observational

Pain is the most common component of the morbidity seen in sickle cell disease (SCD), and may be acute or chronic. It is most commonly acute and a result of the hallmark vaso-occlusive episodes of the disease. Many patients however suffer from chronic pain - defined as pain lasting over three months- with neuropathic pain being a component of chronic pain. Neuropathic pain significantly contributes to the chronicity and morbidity of pain in SCD patients, and is an inadequately managed complication. There is a paucity of literature covering this area, and it has never been examined in the Jamaican population. The main objective of this study is to determine the epidemiology of pain among Jamaicans with SCD, and determine the prevalence of chronic and neuropathic pain among these patients. A second objective is to validate, using gold-standard measures, screening tools to determine neuropathic pain among the study population. This cross-sectional study will investigate the prevalence of neuropathic pain and complications in a sample of persons with SCD in Jamaica aged 14 years and older, with a validation sub-study to be conducted on a random 20 percent of the sample. With improved diagnosis of neuropathic pain, clinicians may potentially improve the management of pain in SCD, as clinicians should be able to direct our treatment toward medications and non-pharmacological methods of pain relief that are more specific for neuropathic pain. All data will be de-identified and maintained in a secure database, with access limited to key personnel. There is very minimal risk to participants.

NCT ID: NCT03775642 Completed - Clinical trials for Contraception Behavior

Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

Start date: November 21, 2018
Phase: N/A
Study type: Interventional

The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.

NCT ID: NCT03763656 Completed - Sickle Cell Disease Clinical Trials

Pharmacokinetics of Oral Hydroxyurea Solution

HUPK
Start date: November 20, 2018
Phase: Phase 2
Study type: Interventional

An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatment period for each participant. The study treatment duration will be for 6 months at the maximum tolerated dose [MTD], which is usually reached by 6 months after initiation of treatment. For patients in whom time to MTD is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.

NCT ID: NCT03626441 Completed - Clinical trials for Postoperative Nausea and Vomiting

The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting

Start date: December 2, 2017
Phase: Phase 2
Study type: Interventional

This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.

NCT ID: NCT03488264 Completed - Quality of Life Clinical Trials

Stigma, Self-management, & Quality of Life in SCD

SSQ
Start date: February 13, 2018
Phase:
Study type: Observational

Many individuals with sickle cell disease experience both a poor quality of life and stigma. Individuals with SCD often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. The purpose of this research is to improve understanding of the relationships between stigma, self-management, and quality of life in SCD in the United States and Jamaica. The findings from this project will contribute to the development of a tool to measure self-management strategies and will also guide the development of interventions to improve SCD self-management.

NCT ID: NCT03478982 Completed - Epilepsy Clinical Trials

Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern

StATES
Start date: March 16, 2018
Phase: Phase 2
Study type: Interventional

This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).