louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06411314: Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis
Official title: Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Candidiasis, Genital
Keywords: vulvovaginal candidiasis
itching
Natamycin
Lactulose
Lead sponsor: Avva Rus, JSC
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.


Eligibility criteria: Inclusion Criteria:

* two or more of the following signs and symptoms of vulvovaginal candidiasis: white or yellowish-white curd-like, thick or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination (dysuria);
* yeast cells in the vaginal swab specimen;
* vaginal pH ≤ 4.5.

Exclusion Criteria:

* a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused by specific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the female genital tract; previous surgery on external or internal genitalia within 6 months; childbirth and abortion within 6 months.

Primary outcomes:
measure: Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2
timeFrame: 7 days
Secondary outcomes:
measure: Proportion (%) of patients with the clinical response at Visit 3
timeFrame: 24 days
measure: Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3
timeFrame: 24 days
measure: Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3
timeFrame: 24 days
measure: Patient's efficacy assessment by the 5-point scale at Visits 2, 3
timeFrame: 24 days
measure: Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)
timeFrame: 24 days
measure: Incidence of adverse events
timeFrame: 24 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University
Study officials:
References:
Clinical trial NCT02032914: Prevalence of Colon Cancer in Pyogenic Liver Abscess
Official title: The Prevalence of Colonic Neoplasm in Cryptogenic Pyogenic Liver Abscess
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryptogenic Pyogenic Liver Abscess
Keywords: pyogenic liver abscess
colon cancer
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Pusan National University Yangsan Hospital
First posted: 2014-01-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients diagnosed as pyogenic liver abscess, the cause of which is not found at initial evaluation

Brief summary: Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions, the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of cryptogenic pyogenic liver abscess by colonoscopic examination.


Eligibility criteria: Inclusion Criteria:

* Pyogenic liver abscess radiologically and bacteriologically diagnosed

Exclusion Criteria:

* Amebic liver abscess
* Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma
* Refusal to colonoscopic examination
* Inadequate general patient status to perform the colonoscopic examination
* Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam

Primary outcomes:
measure: The prevalence of colonic neoplasm
timeFrame: within 6 weeks after diagnosis of pyogenic liver abscess
Secondary outcomes:
measure: Prevalence of colon polyp
timeFrame: Within 6 weeks at diagnosis of pyogenic liver abscess
measure: Prevalence of colonic diverticulitis
timeFrame: Within 6 weeks at diagnosis of pyogenic liver abscess
measure: Prevalence of inflammatory bowel disease
timeFrame: Within 6 weeks at diagnosis of pyogenic liver abscess
measure: Prevalence of intestinal tuberculosis
timeFrame: Within 6 weeks at diagnosis of pyogenic liver abscess
Other outcomes:
Locations:
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National Unversity Yangsan Hospital
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
Study officials:
affiliation: Inje University Haeundae Paik Hosptial
name: Tae Oh Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791214: Evalution of Nurse's Abilities in ICU Setting
Official title: Evalution of Nurse's Specific Abilities in ICU Setting: Creation and Validation of a New Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assessment Tool of Nurses' Skills
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The coordinator nurses of the ICU, considered collaborators of the PI, will use the Scale for the evaluation of 10 nurses belonging to their staff, as in the case of the usual annual performance evaluation, therefore only once per person

Brief summary: The assessment of nurses' skills is of fundamental importance in order to predict their performance, this is true in all areas of care but especially in the critical area. The aim of the single center prospective observational study is to provide the organization and specifically the nursing coordinator with an evaluation form that is as specific and complete as possible for evaluating the performance of nurses in ICU.

The nursing coordinators of 4 UOCs of intensive care for adults in the IRCCS Gemelli Polyclinic Foundation in Rome will be involved in the use of an evaluation scale for nurses. In each UOC, 10 nurses will be randomly selected for which to carry out the evaluation, subject to informed consent and compliance with the inclusion criteria in the study.

Results Certify the reliability of the Scale for evaluating the performance and attitudes of nurses working in intensive care.

It is hypothesized that an objective assessment tool of nurses' skills allows for an adequate allocation of resources not only in quantitative terms but also and above all in qualitative terms.


Eligibility criteria: Inclusion Criteria:

* Intensive care nurses present for at least 12 months in the relevant unit,

Exclusion Criteria:

* Newly hired or newly transferred nurses (\<12 months of presence in the relevant ICU).

Primary outcomes:
measure: evaluation the performance of nurse in ICU
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli
Study officials:
References:
Clinical trial NCT01528514: Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
Official title: The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Keywords: Myocardial infarction
Coronary artery bypass grafting
Anti-oxidant
Curcuminoids
Lead sponsor: Thailand Research Fund
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is well-established that myocardial infarction (MI) associated with coronary artery bypass graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies to limit myocardial injury after CABG are lacking. Previous studies have shown that curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after CABG, compared to placebo.


Eligibility criteria: Inclusion Criteria:

Patients undergoing CABG without valve surgery

Exclusion Criteria:

* emergency cardiac surgery
* any increase in CK-MB above upper limit of normal range (ULN) at the time of randomization
* patients with cholestatic jaundice (total bilirubin \> 2-fold ULN)
* severe liver disease (AST or ALT \> 3-fold ULN)

Primary outcomes:
measure: Incidence of postoperative myocardial infarction
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai hospital
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Wanwarang Wongcharoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03745014: Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia
Official title: Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gram-negative Bacteremia
Lead sponsor: Accelerate Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
* Blood culture drawn in the Emergency Department (ED)

Exclusion Criteria:

* Patients not admitted to hospital
* Patients discharged from hospital prior to blood culture positivity
* Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
* Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
* Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
* GNR plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture Gram stain
* Deceased or palliative care at the time of randomization
* Patient who is moribund (does not survive the initial 72 hours after enrollment)

Primary outcomes:
measure: Desirability of Outcome Ranking (DOOR) - composite outcome
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05331014: To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Hypertension
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 155
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

Detailed description: Multicenter, randomized, double-blind, parallel-design, phase III clinical study

Eligibility criteria: Inclusion Criteria:

* Patients with hypertension and dyslipidemia

Exclusion Criteria:

* The subject not meet the specified msBP and LDL-C level

Primary outcomes:
measure: msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
timeFrame: week 8
Secondary outcomes:
measure: efficacy and safety
timeFrame: week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangdong Sacred Heart Hospital
state: Korea
Study officials:
affiliation: Gangdong Sacred Heart Hospital
name: Gyurok Han, CI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05643014: Observational Study of Exposure to Environmental Toxicants Among Firefighters
Official title: Evaluate the Exposure to Toxicants Emitted During a Structural Fire Assessed by Urinary and Buccal Cell Biomarkers Found in Firefighters.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: PAH
1-HOP
PheT
SPMA
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Firefighters who are exposed to fires containing carcinogens will join this study. Three sample collections will be taken to measure the biomarkers; pre-exposure, 24h post-exposure and 1 week post-exposure.

Brief summary: Observational, within subject study design with 1 pre and 2 post-fire exposure biomarker samples collected to assess exposure to toxicants from combustion emissions related to fighting a structural fire.


Eligibility criteria: Inclusion Criteria:

* Firefighter (career or volunteer)
* Over 18 years of age
* Able to provide written voluntary consent

Exclusion Criteria:

* Unwilling to provide a pre and post-exposure urine sample
* Current cancer diagnosis
* Tobacco use within the last 1 year (verified by urinary TNEs)

Primary outcomes:
measure: Studying biomarker levels in firefighters pre and post fire call.
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center
state: Minnesota
Study officials:
References:
Clinical trial NCT05181514: Impact of Plasma Lipids on β Cell Function and Insulin Sensitivity
Official title: Impact of Plasma Lipids on β Cell Function and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Glucose Intolerance
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim to evaluate whether and to what extent glucose tolerance, beta cell function, insulin clearance, and glucose metabolic fluxes change in response to an acute increase in plasma triglycerides during lipid infusion, independently of free fatty acid (FFA) levels, in nondiabetic subjects.

Detailed description: Mild hypertriglyceridemia is associated with reduced glucose tolerance and increased risk of type 2 diabetes, independent of obesity, in both cross-sectional and prospective studies. It is unclear whether this association is direct or mediated by circulating lipid substrates of triglycerides (free fatty acids, or FFA) and which are the mechanisms involved.

To comprehensively examine the effects of mild acute hypertriglyceridemia on major glucose homeostatic mechanisms involved in diabetes progression, two dual-labeled oral glucose tolerance tests (OGTT) during 5-hour intravenous infusions of either 20% Intralipid or normal saline will be performed in healthy lean volunteers. Lipid-induced changes in glucose tolerance and insulin metabolism will be evaluated.

Eligibility criteria: Inclusion Criteria:

* age 18-65 years
* Body mass index (BMI) 18-35 kg/m2
* both women and men

Exclusion Criteria:

* chronic or acute diseases
* any medications
* pregnancy

Primary outcomes:
measure: Glucose control
timeFrame: At the end of the 5-hour lipid infusion
measure: Insulin secretion
timeFrame: At the end of the 5-hour lipid infusion
measure: Beta cell glucose sensitivity
timeFrame: At the end of the 5-hour lipid infusion
measure: Insulin sensitivity
timeFrame: At the end of the 5-hour lipid infusion
measure: Insulin clearance
timeFrame: At the end of the 5-hour lipid infusion
measure: Rate of oral glucose appearance (RaO)
timeFrame: At the end of the 5-hour lipid infusion
measure: Endogenous glucose production (EGP)
timeFrame: At the end of the 5-hour lipid infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: University of Pisa
name: Andrea Natali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00476814: NPD Measurements in PSC Patients
Official title: Cystic Fibrosis Transmembrane Conductance Regulator Function as Measured by Nasal Potential Difference Measurements in Patients With Primary Sclerosing Cholangitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Sclerosing Cholangitis
Keywords: cystic fibrosis,
nasal potential difference,
primary sclerosing cholangitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-05-22
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: Primary Sclerosing Cholangitis (PSC) is a chronic disorder of the liver causing jaundice and liver damage. When Cystic Fibrosis affects the liver, the damaged liver looks like the liver in PSC. This study is designed to answer the question whether isolated PSC may be a form of CF only in the liver

Detailed description: Cystic Fibrosis (CF) is a progressive autosomal recessive disorder caused by defects in the cystic fibrosis transmembrane conductance regulator gene (CFTR). CFTR mutations cause loss or impairment of CFTR-mediated ion transport across epithelial cell membranes. CF affects many organs including the respiratory tract, pancreas, intestine, liver and the male reproductive tract. Liver disease occurs less frequently than pulmonary disease. CFTR is expressed in the bile duct epithelial cells and is responsible for the hydration of biliary secretions.

CF was until recently, thought to be a multi-organ disease. However, there are now recognized non-classical presentations of CF involving a few organs only and now there is well established data on single -organ involvement including Congenital Absence of the Vas Deferens and recurrent pancreatitis.

CF and PSC have several features in common. They both affect intrahepatic bile ducts by inspisated biliary secretions, chronic inflammation and fibrosis. Is PSC the "single-organ presentation" of CF? Patients with PSC will undergo testing of the CF protein channel by nasal potential testing. This test is performed by insering a thin plastic tube 2 to 3 cms into the nostril and chloride transport can be measured. This test may shows that the patient has an abnormality in the CF protein channel.

Eligibility criteria: Inclusion Criteria:

* Age \> 10 years
* Patients diagnosed as Non-IBD PSC
* Patients diagnosed as IBD PSC

Exclusion Criteria:

* Age \< 10 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Wilschanski, Dr
role: PRINCIPAL_INVESTIGATOR
References: