louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01301300: Evaluating Central Line Hub Contamination Using a Novel Capping Device
Official title: Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Catheter-related Bloodstream Infection Due to Central Venous Catheter
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use.

If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.


Eligibility criteria: Inclusion Criteria:

* Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.

Exclusion Criteria:

* Minors and adult inpatients without PICCs or with PICCs for \< 5 days

Primary outcomes:
measure: Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
timeFrame: Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.)
Secondary outcomes:
measure: Central line associated bloodstream infections
timeFrame: Throughout the study and from historical data
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore: Evanston Hospital
state: Illinois
city: Glenview
country: United States
facility: NorthShore: Glenbrook Hospital
state: Illinois
city: Highland Park
country: United States
facility: NorthShore: Highland Park Hospital
state: Illinois
city: Skokie
country: United States
facility: NorthShore: Skokie Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT00189800: A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Solifenacin
tolterodine
randomized controlled trial
double-blind method
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Symptoms of overactive bladder
* Must be able to complete the micturition diary

Exclusion Criteria:

* Pregnant or lactating
* Clinically significant outflow obstruction
* Significant post void residual urine
* Significant stress incontinence
* Urinary tract infection
* Chronic inflammation
* Bladder stones
* Previous pelvic radiation therapy
* Previous or current malignant disease of the pelvic organs
* Uncontrolled narrow angle glaucoma
* Urinary or gastric retention
* Electrostimulation therapy
* Bladder training
* Diabetic neuropathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
city: Bucheon
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Cheonan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: Department of Urology, Korea University Anam Hospital
name: Prof. Jeong Gu Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: EU Shi-liang, et al. Efficacy and safety of solifenacin in the treatment of patients with urgency and urge incontinence. Chin J Urol (2009) 30(9); 1-5
citation: Choo MS, Lee JZ, Lee JB, Kim YH, Jung HC, Lee KS, Kim JC, Seo JT, Paick JS, Kim HJ, Na YG, Lee JG. Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study. Int J Clin Pract. 2008 Nov;62(11):1675-83. doi: 10.1111/j.1742-1241.2008.01898.x.
Clinical trial NCT02905500: Estimation of Disability Adjusted Life Years in Reunion Island and Comparison to Metropolitan France and Other Countries in the Indian Ocean Zone
Official title: Estimation Des années de Vie ajustées Sur l'incapacité à La réunion et Comparaison à la France métropolitaine et Aux Pays de la Zone Océan Indien
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality-Adjusted Life Years
Epidemiology
Public Health
Keywords: Disability-Adjusted Life Years
Epidemiology
Public Health
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 800000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resident of Reunion Island

Brief summary: AVIRON study aims at estimating the burden of various causes of death and morbidity in the Reunion Island population.

Detailed description: The identification of health priorities on a given territory is a major field of the research in Public health. The World Health Organization leads since the 1990s the "Global Burden of Disease" study. This study has for objective to estimate the burden of various causes of death and morbidity in a given population. It defines a standardized measure allowing the comparisons between the various countries. The measure developed internationally is the Disability-adjusted life year (DALY).

For the Indian Ocean zone, the international study provides values of DALYs for Madagascar, Seychelles and Mauritius. The estimation of DALYs for Reunion Island are based on data of mainland France and does not take into account specificities from Reunion Island. To better define Public health priorities, it seems essential to decline this measure at the regional level.

Eligibility criteria: Inclusion Criteria:

* The whole population of Reunion Island

Exclusion Criteria:

* People not living in Reunion Island

Primary outcomes:
measure: Incidence of years of life lost or lived with disabilities
timeFrame: 3 years
measure: Prevalence of years of life lost or lived with disabilities
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Universitaire de La Réunion
Study officials:
References:
Clinical trial NCT01792700: Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Infections
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 648
Sex: ALL
Minimum age (years): 23
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion Criteria:

* Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.

Primary outcomes:
measure: Helicobacter pylori reinfection rate
timeFrame: From date of randomization until the date of first documented reinfection of Helicobacter pylori, whichever came first, assessed up to 90 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Kim MS, Kim N, Kim SE, Jo HJ, Shin CM, Park YS, Lee DH. Long-term follow up Helicobacter Pylori reinfection rate after second-line treatment: bismuth-containing quadruple therapy versus moxifloxacin-based triple therapy. BMC Gastroenterol. 2013 Sep 19;13:138. doi: 10.1186/1471-230X-13-138.
Clinical trial NCT06189352: Positive Feeding of the Preterm Infant
Official title: Positive Feeding of the Preterm Infant - a Feasibility Study of a Developmental Supportive Feeding Strategy in the NICU
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm Infant
Breast Feeding
Bottle Feeding
Enteral Feeding
Cue Based Feeding
Develomentally Supportive Care
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants.

The main questions it aims to answer are:

* Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit?
* Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit?

Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.

Detailed description: The parents will be recruited before or as soon as possible after birth. The intervention will start as soon as the parents have given written consent for themselves and behalf of their infant.

The intervention is developed in line with the MRC framework of developing and evaluating complex interventions in an iterative and dynamic way. The intervention will be based on parents counseling and an infant feeding protocol.

Eligibility criteria: Inclusion Criteria:

* gestational age of 28 weeks
* post menstrual age of 28 weeks after transition from regional hospital

Exclusion Criteria:

* diagnoses or malformations that makes eating difficult
* triplets or more
* parents not speaking/understanding Norwegian or English
* parents with challenges or special needs for follow up

Primary outcomes:
measure: Recruitment rates and sample criteria
timeFrame: Prospective over a period of 1 year
measure: Data collection and outcome variables
timeFrame: Prospective over a period of 1 year
measure: Acceptability
timeFrame: Prospective over a period of 1 year
measure: Resources and organisation
timeFrame: Prospective over a period of 1 year
Secondary outcomes:
measure: Infant outcome variables
timeFrame: Prospective over a period of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Oslo Metropolitan University
name: Nina M Kyno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05179252: Shenfu Injection for Postoperative Delirium (SFI for POD)
Official title: POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Delirium
Lead sponsor: Shandong University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shandong Institute of Science and Technology Information
First posted: 2022-01-05
Enrollment: 350
Sex: ALL
Minimum age (years): 75
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.

Detailed description: SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.

Eligibility criteria: Inclusion Criteria:

* hip fracture surgery under epidural anesthesia

Exclusion Criteria:

* Severe dementia, hearing/vision impairment, coma, etc., unable to communicate;
* patients with end-stage diseases such as tumor;
* 3 months after myocardial infarction, cerebral infarction;
* severe heart, liver and renal dysfunction.

Primary outcomes:
measure: incidence of postoperative delirium within 7 days
timeFrame: day 1-7 after surgery, more scores means higher incidence of POD
Secondary outcomes:
measure: non-delirium complications
timeFrame: day 1-7 after surgery
measure: length of stay
timeFrame: approximately day 1 in hospital to day 7
measure: pain assessment within 3 days
timeFrame: day 1-3 after surgery, higher scores mean more pain.
measure: all-caused mortality within 30 days
timeFrame: 30 days after surgery
measure: survival in 1 year
timeFrame: 1 year discharge from hospital
measure: adverse events to shenfu injection
timeFrame: approximately day1-7 after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Shandong University of Traditional Chinese Medicine
name: zhang xin
role: STUDY_DIRECTOR
References:
Clinical trial NCT01201252: Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates
Official title: An Observational, Hospital-based Surveillance to Estimate the Disease Burden of Acute Rotavirus (RV) Gastroenteritis (GE) in Children < 5 Years of Age in United Arab Emirates (UAE).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotaviral Gastroenteritis
Keywords: children
gastroenteritis
Rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-14
Enrollment: 717
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children \< 5 years of age hospitalised with acute gastroenteritis

Brief summary: The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.


Eligibility criteria: Inclusion Criteria:

* A male or female \< 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* The diagnosis for treatment at the study site does not include acute gastroenteritis.
* The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.

Primary outcomes:
measure: Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.
timeFrame: Twelve months from study initiation
Secondary outcomes:
measure: Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.
timeFrame: Twelve months from study initiation
measure: Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.
timeFrame: Twelve months from study initiation
measure: Distribution of different strains of rotavirus in children < 5 years of age.
timeFrame: Twelve months from study initiation
measure: Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.
timeFrame: Twelve months from study initiation
measure: Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.
timeFrame: Twelve months from study initiation
Other outcomes:
Locations:
city: Abu-Dhabi
country: United Arab Emirates
facility: GSK Investigational Site
city: Al-Ain
country: United Arab Emirates
facility: GSK Investigational Site
city: Sharjah
country: United Arab Emirates
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02715752: A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin
Official title: A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Simplex Infections
Human Papillomavirus
Epstein-Barr Virus Infections
Varicella-zoster Virus Infection
Cytomegalovirus Infections
Lead sponsor: The Center for the Biology of Chronic Disease
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women ages greater than 18 years old

Brief summary: This study measured the changes in health-related complaints by analyzing charts of individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.

Detailed description: The medical community calls the movement from severe to mild disease and from mild to normal health, 'relieving symptoms', and the interventions that cause such movement, drugs, medications, or therapies. The alternative community calls the movement from normal health to superior health, 'boosting health' (or boosting the immune system, or improving your sex drive, or boosting any another well functioning physiological system), and the interventions that cause such movement, natural remedies, dietary supplements, complementary treatments, etc. In general, these interventions aim to achieve superior performance of a normal human body. Of course, boosting the body's normal performance improves many of its capabilities, such as higher resistance to diseases, faster recovery from fatigue, better mental concentration, etc. Each movement presents different objectives. Relieving symptoms represents the ability of an intervention to reduce the frequency, duration, and severity of a disease. In contrast, boosting health represents the ability of an intervention to increase the frequency, duration, and quality of a person's health. In the current study, the investigators would like to measure the changes in health-related complaints by analyzing charts of individuals, who are infected with latent virus, and who have used Gene-Eden-VIR/Novirin.

Eligibility criteria: Inclusion Criteria:

* Latent viral infection with either HSV, HPV, VZV, EBV, or CMV
* Taking Gene-Eden-VIR/Novirin

Exclusion Criteria:

* Use of other antiviral treatments

Primary outcomes:
measure: frequency of symptoms
timeFrame: one year
measure: duration of symptoms
timeFrame: one year
Secondary outcomes:
measure: time to first recurrence
timeFrame: one year
Other outcomes:
Locations:
city: Valley Cottage
country: United States
facility: The Center for the Biology of Chronic Disease
state: New York
Study officials:
References:
citation: Polansky H, Itzkovitz E, Javaherian A. Clinical study of Gene-Eden-VIR/Novirin in genital herpes: suppressive treatment safely decreases the duration of outbreaks in both severe and mild cases. Clin Transl Med. 2016 Dec;5(1):40. doi: 10.1186/s40169-016-0121-6. Epub 2016 Oct 20.
Clinical trial NCT05200052: Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking
Official title: Effect of Colchicine Use On Left Ventricle Systolic Function Using Speckle Tracking Echocardiography in Patients With Anterior S-T Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior MI
Colchicine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of colchicine use on Left ventricles systolic function in patients with anterior S-T elevation myocardial infarction undergoing primary Percutaneous coronary intervention by using speckle tracking Echocardiography longitudinal strain pattern

Detailed description: The study participants are patients presented with anterior myocardial infarction.

They will be divided into 2 groups. The first group will receive colchicine loading dose of 1mg then 0.5 mg maintenance dose in addition to the standard anti ischemic treatment for 6 months.

The other group will only receive the standard anti ischmic treatment. Speckle tracking echocardiography will be done to all patients to assess left ventricular longitudinal strain pattern.

Eligibility criteria: Inclusion Criteria:

▪︎Anterior S-T segment elevation myocardial infarction with time of presentation less than 12 hours.

Exclusion Criteria:

* Severe renal impairment.
* Cardiac arrest.
* Cardiogenic shock.

Primary outcomes:
measure: Average of global longitudinal strain pattern
timeFrame: 6 months
Secondary outcomes:
measure: Number of mortality during study
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
affiliation: Ain Shams University
name: Mohamed Radwan, Master
role: PRINCIPAL_INVESTIGATOR
References: