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NCT ID: NCT01702766 Completed - Clinical trials for Respiratory Tract Infections

Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children

PROBIC II
Start date: December 2012
Phase: N/A
Study type: Interventional

Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb. The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections. The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving. The placebo product is an identical product except for the absence of probiotics. The study includes an intervention period lasting the length of the hospital stay. The study product will be consumed daily in the morning together with breakfast. The consumption of the study products will be taken under the surveillance of the physician. Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.

NCT ID: NCT01702753 Completed - Clinical trials for Respiratory Tract Infections

Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers

PROBBIC
Start date: January 2013
Phase: N/A
Study type: Interventional

Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers. The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections. The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics. The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal. The consumption of the study products will be taken under the surveillance of the parents. During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel. Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log). All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's & physician's).

NCT ID: NCT01700803 Completed - Wound Infections Clinical Trials

Povidone Iodine and Cesarean Section Wound Infections

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections & compare side effects of both agents.

NCT ID: NCT01697826 Completed - Vaginal Infections Clinical Trials

Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

Start date: April 2011
Phase: Phase 4
Study type: Interventional

Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.

NCT ID: NCT01697748 Completed - Post Operative Pain Clinical Trials

Prospective Study on Cesarean Wound Outcomes

Start date: September 2013
Phase: N/A
Study type: Interventional

This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads. The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

NCT ID: NCT01691820 Completed - Clinical trials for Infections, Cytomegalovirus

A Study in Adolescent Females to Explore Cytomegalovirus Infection

Start date: October 5, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary infections (re-infections/re-activations) and the incidence of CMV primary infections in adolescent females.

NCT ID: NCT01691599 Completed - Tibia Fracture Clinical Trials

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India

Start date: August 2012
Phase:
Study type: Observational

The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions: 1. What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation? 2. What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation? Secondary objectives 1. How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation? 2. What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation? 3. What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation? 1. Hospital standard hygienic and antibiotic protocol for infection prevention 2. Subject demographics 3. Time between injury and surgery and between admission and surgery 4. Fracture type (AO Müller classification) 5. Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures) 6. Fracture management and implant type 7. Surgical details such as duration of surgery 4. Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections? 5. Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?

NCT ID: NCT01690559 Completed - Infection Clinical Trials

Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution

Start date: April 2010
Phase: N/A
Study type: Observational

This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

NCT ID: NCT01690533 Completed - Clinical trials for Anti-Infective Agents

Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease

Start date: May 13, 2008
Phase:
Study type: Observational

The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg (hereinafter as "Avelox") in treating secondary infection of chronic respiratory disease.It is a local prospective and observational study of patients who have received Avelox tablets for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and assessed during the period of treatment with Avelox.

NCT ID: NCT01689285 Completed - Clinical trials for Varicella Zoster Virus Infection

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

VALID-I
Start date: December 2013
Phase: Phase 1
Study type: Interventional

A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.