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NCT ID: NCT02129465 Recruiting - Pregnancy Clinical Trials

Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy

CMV
Start date: June 2014
Phase: N/A
Study type: Observational

Analysis of several characteristics of blood from pregnant women with CMV infection according to maternal-fetal transmission. These include CMV viral load, cytokine profile in response to in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal DNA polymorphism and microarray of gene expression.

NCT ID: NCT02128217 Completed - HIV-1 Infection Clinical Trials

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

SWIFT-C
Start date: May 30, 2014
Phase: Phase 1
Study type: Interventional

Early identification of acute HCV infection is essential to prevent chronic infections and the long-term liver disease complications that may occur. Early identification and treatment of HCV during the acute phase can result in significantly higher response rates with shorter durations of therapy. Pegylated-interferon alfa (PEG-IFN) was the typical treatment for HCV infection. Participants subcutaneously inject PEG-IFN where the average duration of treatment was approximately 20 weeks. With the advancement of direct-acting antivirals (DAAs), it was possible to see if a new DAA might be non-inferior compared to (PEG-IFN). The study was designed to see if a fixed-dose combination tablet can replace the old HCV treatments by being more effective, safer and better tolerated in HIV-infected participants with new HCV infection. The study was a Phase I, open-label, two cohort clinical trial, in which 44 acutely HCV-infected HIV-1 positive participants were enrolled. Participants in each cohort were evaluated in two steps: on treatment (Step 1) and follow-up after discontinuing study treatment (Step 2). The cohorts were enrolled sequentially. Participants in Cohort 1 were enrolled and administered oral Sofosbuvir (SOF) in combination with weight-based ribavirin (RBV). Participants in Cohort 2 were enrolled and administered an oral fixed dose combination of Ledipasvir/Sofosbuvir (LDV/SOF).

NCT ID: NCT02127970 Completed - Clinical trials for Surgical Site Infection

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: April 18, 2014
Phase: Phase 3
Study type: Interventional

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

NCT ID: NCT02126930 Completed - Infection Clinical Trials

Pharmaceutical Consultation at Hospital Discharge and Adherence to Anti-infective Treatment

CPS-INFECTIO
Start date: November 2014
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the impact of a pharmaceutical consultation at the time of hospital discharge on the adherence of patients ; non-adherence is determined by the following criteria: As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria is true: 1. . the patient did not go and get his/her treatment at the pharmacy; 2. . the number of treatment units dispensed by the pharmacy is < the number of treatment units prescribed; 3. . the patient stopped taking a treatment before the recommended time, or continued taking a treatment after the recommended time; 4. . the number of treatment units taken by the patient (self-declaration) is < or > to the number of units prescribed.

NCT ID: NCT02124096 Completed - Influenza Clinical Trials

Zoonotic Influenza Infections of Swine Origin at Ohio Agricultural Fairs

Start date: April 25, 2014
Phase:
Study type: Observational

Background: - The flu is a very infectious and contagious virus that affects both people and pigs. Studies show that pigs can be sources of the flu virus in humans. Researchers want to know more about how the flu is transmitted from animals to people. If they know more about it, they can find better ways to prevent the flu and treat people who get sick from it. Objective: - To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural fairs. Eligibility: - Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs. Design: - Before or on the first day of the fair, participants will fill out a short demographic and medical history form. They will also complete a two-page symptom questionnaire. This is a form that asks them about any flu symptoms they might have. - Participants will have a nasal swab performed. The inside of the participant s nose will be rubbed with a swab to collect nasal fluid. - Researchers will see participants 2 days later and 4 days later. During these visits, participants will again fill out a symptom questionnaire and have a nasal swab.

NCT ID: NCT02123771 Recruiting - Clinical trials for HELICOBACTER PYLORI INFECTIONS

Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections

Start date: May 2013
Phase: Phase 1
Study type: Observational

The investigators hypothesis: Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.

NCT ID: NCT02123433 Completed - HIV Infection Clinical Trials

Serological Response to Antipneumococcal Vaccination and Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Adults

PCV13HIV2011
Start date: December 2011
Phase: Phase 3
Study type: Interventional

S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects are more sensitive to invasive diseases and recurrent infection than the general population. Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain and their nasopharyngeal isolates have features similar to subsequent invasive strains. A 23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+ population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+ are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23 seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins results in an improved T-cell dependent immune response, characterized by increased antibody concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3, 5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that are the main target of conjugate vaccines licensure. Some trials showed a better antibody response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23. However these data were not unequivocally confirmed in further studies on the use of PCV7 alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same or even better response compared to PPV23, with a safety and tolerability similar to PCV7. PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal infections. The purpose of this study is to evaluate serological response and prevalence of nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following vaccination with 2 doses of PCV13.

NCT ID: NCT02121938 Completed - Infection Clinical Trials

Dynamics of the Microbiome in the Premature Infant

Start date: April 2014
Phase:
Study type: Observational

The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.

NCT ID: NCT02120274 Terminated - Hepatitis C Clinical Trials

Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

Start date: March 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.

NCT ID: NCT02119754 Completed - Infection Clinical Trials

Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.