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NCT ID: NCT01115010 Terminated - Colonoscopy Clinical Trials

Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes

Start date: December 2009
Phase: N/A
Study type: Interventional

The study aims to determine whether a proprietary, FDA approved stiffening wire improves the efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables complete visualization of the colon in a greater proportion of cases (than when the procedure is performed without it) with old, used colonoscopes. Colonoscopes are designed with a delicate balance between stiffness and flexibility. Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the colon that are not fixed to the wall of the abdominal cavity and flexibility enables successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose stiffness and this makes it very challenging to advance the colonoscope all the way to the cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take an inordinately long time. In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned colonoscopes imported from the USA, because the average patient and local health insurance companies cannot bear the level of fees that would enable cost recovery for new equipment. The stiffening wires (in two grades of stiffness) used in this study are passed through the biopsy channel of the colonoscope only after its tip has passed the upper end of the descending colon and entered the transverse colon. The device is safe when used as recommended by the manufacturers (and approved by the FDA), and does not appear to increase risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the device clearly improves the stiffness of the colonoscope, there is no research evidence that it actually works in practice, either to improve cecal intubation rate or to decrease procedure time. It is therefore also unclear whether the possible benefit of using the device is achieved if introduced at the first opportunity allowed by the manufacturers or only after difficulty is encountered with the unassisted colonoscope. In this study, patients are randomly assigned to one of 3 "interventions". One group has colonoscopy performed with the colonoscope alone and the wires are only introduced if there is difficulty advancing the colonoscope after it has passed into the transverse colon ("difficulty" defined as failure to advance the tip of the colonoscope after 5 minutes). In the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope enters the transverse colon and is removed if "difficulty" is encountered, as defined above. The different phases of colonoscopy will be timed with a stop watch and when a sufficient number of patients has been accrued, the investigator will be able to compare the time it takes to complete the procedure with and without the wires as well as the proportion of cases in which the cecum was reached with and without the assistance of the wires.

NCT ID: NCT00842088 Completed - Sickle Cell Disease Clinical Trials

Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of HQK-1001 administered for a total of 12 weeks (with one dosing break) in subjects with sickle cell disease.

NCT ID: NCT00818935 Completed - Type 2 Diabetes Clinical Trials

Low-Intermediate-Glycemic Index Caribbean Foods Versus High Glycemic Index Foods in Type 2 Diabetes

Start date: June 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether low and intermediate GI Caribbean foods are effective in the management of type 2 diabetes.

NCT ID: NCT00429351 Completed - Kwashiorkor Clinical Trials

Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

Start date: September 2006
Phase:
Study type: Observational

This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.

NCT ID: NCT00409890 Completed - Labor Stage, First Clinical Trials

The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies

Start date: June 2005
Phase: Phase 2
Study type: Interventional

To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.

NCT ID: NCT00340821 Completed - HTLV-I Clinical Trials

A Study of Familial and Genetic Aspects of Adult T-Cell: Leukemia/Lymphoma , Tropical Spastic Paraparesis, and Infective Dermatitis

Start date: May 17, 1993
Phase: N/A
Study type: Observational

Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.

NCT ID: NCT00339807 Completed - HTLV-I Clinical Trials

Natural History of HTLV-I Infection: Prospective Follow-up of a Cohort of Blood Donors in Jamaica

Start date: January 17, 2002
Phase: N/A
Study type: Observational

Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean, but disease manifestations differ across geographic regions. Though age, gender, and route of infection may determine the natural history of this infection, the observed geographic differences also may, in part, reflect the distinct genetic background of the host as evidenced by the distribution of human leukocyte antigens (HLA) and the presence of other environmental factors. Studies already completed or ongoing have shown notable differences in incidence and prevalence of HTLV-I associated diseases and underscore the need for comparative studies and analyses in these areas. This prospective new study of blood donors in Jamaica provides us with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan. This study will - identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis. - directly calculate the incidence of HTLV-I associated diseases in this population. - examine the role of HTLV-I in the pathogenesis of other common infectious agents. Approximately 5,000+ blood donors who came to the National Blood Transfusion each year will be screened for HTLV-I serology. Of those who agreed to participate, all HTLV-I carriers and age-, and sex-matched HTLV-I-negatives will be invited to the University of the West Indies clinic for a full study enrollment. Study participants will be given a standardized questionnaire, a full physical examination, and a phlebotomy (25-30 mL), and will be followed every other year for interim health status and additional phlebotomy. All subjects will receive an ophthalmologic examination for detection of uveitis and other ocular diseases. Some subjects will be further referred to a neurologist, hematologist or dermatologist, according to their signs and symptoms. Approximately 1200 HTLV-I carriers and 600 HTLV-I negatives will be recruited for a longitudinal follow-up over the next 5-year period. Two types of analyses will be conducted: comparison of HTLV-I-positive and HTLV-I-negative subjects, and comparison among HTLV carriers between those with a high level of viral load and those with a low level.

NCT ID: NCT00339638 Completed - Clinical trials for Human T-Lymphoma Virus Type I

Study of Adult T-Cell Leukemia/Lymphoma Among Carriers of HTLV-1

Start date: December 21, 2004
Phase: N/A
Study type: Observational

This study will identify chemical and protein markers in the blood of people who carry the human T-lymphotropic virus type I (HTLV-I), a virus associated with various pathologies, including an increased risk in adults of a rare and aggressive cancer called adult T cell leukemia/lymphoma (ATL). The study will also examine differences in these markers before and after the onset of ATL. ATL has been reported in every area where HTLV-1 is common, including the Caribbean and parts of Japan, West Africa, the Middle East, South America, and Pacific Melanesia. Risk factors for the disease are largely unknown and seem to vary among those affected in different endemic regions. People who acquire the infection early in life are thought to be at higher risk than those who are infected later. In Japan, men seem to be at greater risk than women, but the same is not evident among the black population in the Caribbean and Brazil. Findings from this study will increase understanding of the cause of ATL and identify differences in tumor characteristics and the course of disease across geographical areas. Study subjects are drawn from among participants in eight studies of HTLV-1 carriers, including the 1) Jamaica Mother-Infant Cohort Study, 2) Jamaica Family Study, 3) Jamaica Food Handlers Study, 4) Miyazaki Cohort Study in Japan, 5) Nagasaki Cohort Study in Japan, 6) Japan Public Health Center-based Prospective Study on Cancer and Cardiovascular Disease, 7) HTLV Outcome Studies in the United States, and 8) GIPH Cohort Study in Brazil. Stored blood samples previously collected from patients in the above studies who did and did not develop ATL will be analyzed for immunologic and genetic factors.

NCT ID: NCT00125970 Completed - HIV Infections Clinical Trials

HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

Start date: September 2005
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

NCT ID: NCT00102791 Terminated - Sickle Cell Disease Clinical Trials

A Stratified Sickle Event Randomized Trial (ASSERT)

ASSERT
Start date: February 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.