louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04535661: Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children
Official title: A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carbapenem-Resistant Enterobacteriaceae Infection
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 536
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019

Brief summary: Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. The objectives of this study are to characterize the risk factors for colonization or infection with CRE and describe the microbiologic characteristics of pediatric CRE isolates. The investigators will perform a single retrospective study from January 2018 to December 2019 at PICU of Children's Hospital of Fudan University .

Detailed description: The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Children who had positive cultures for any Enterobacteriaceae species before their admission will be excluded. Children with a PICU length of day less than 48h will also be excluded. According to their clinical cultures results, they will be divided into non-CRE、CRE colonization and CRE infection. CRE was defined according to the 2015 Centers for Disease Control and Prevention (CDC) definition as an isolate resistant to imipenem, meropenem, or ertapenem. Clinical and demographic data will be collected from the electronic health record.

Eligibility criteria: Inclusion Criteria:

* All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.

Exclusion Criteria:

* discharge within 48 hours
* patients had a positive culture for CRE before admission
* incomplete clinical and demographic data

Primary outcomes:
measure: mortality
timeFrame: within 28 days after they discharged from PICU
Secondary outcomes:
measure: length of stay in PICU
timeFrame: within 28 days after they discharged from PICU
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fundan University
name: Gangfeng Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03910361: Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
Official title: A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2 Diabetes
Non-Alcoholic Fatty Liver Disease
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases

Detailed description: 1. Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
2. Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks

Eligibility criteria: Inclusion Criteria:

* Type II diabetes mellitus
* Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
* Subjects with 6.5%≤HbA1c≤9.0% at screening
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* AST \> upper normal range\*3
* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
* Pregnant women

Primary outcomes:
measure: Changes from baseline intrahepatic fat (%)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Changwon
country: Korea, Republic of
facility: Samsung Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung Dongsan University Medical Center
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University of Seoul ST.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Byung Wan Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06125561: Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients
Official title: A Study of Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Periodontal Diseases
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2023-11-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient presented at dental department of hospital

Brief summary: Periodontal diseases, encompassing a range of inflammatory conditions affecting the supporting structures of the teeth, have long been recognized as a prevalent comorbidity in individuals with diabetes. The severity of periodontal disease is usually documented by research clinicians using clinical parameters such as bleeding on probing (BOP), probing pocket depth (PPD), and clinical.

Detailed description: Oral health plays a pivotal role in the overall well-being and quality of life of individuals. Any condition affecting oral health can have far-reaching consequences for an individual's daily life.Both periodontitis and diabetes have been reported to have negative impacts on aspects of daily living and health-related quality of life. Evidence suggests that oral health problems can adversely affect an individual's physical functioning, social standing and wellbeing, and that it can be difficult to dissociate oral health from general health with regards to impacts on quality of life. Oral health-related quality of life (OHRQoL) can be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with Diabetes Mellitus for case group, non diabetic patients for control group, Age range between 18 to 60 years, informed consent, Participants with varying degrees of periodontal health

Exclusion Criteria:

* Participants with severe systemic illnesses and habits that may significantly affect oral health or quality of life, Individuals with severe cognitive impairment or psychiatric conditions that hinder their ability to participate and provide informed consent.

Primary outcomes:
measure: oral health-related quality of life
timeFrame: 1 day
Secondary outcomes:
measure: Clinical attachment loss
timeFrame: 1 day
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: PIMS
Study officials:
References:
Clinical trial NCT04087161: Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
Official title: Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Assessment of AKI After TAAA Repair
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Münster, University Hospital, Department of Vascular Surgery
name: Berlin, University medicine Charité, Department of Vascular Surgery
First posted: 2019-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective, open TAAA repair

Brief summary: Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system.

Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe


Eligibility criteria: Inclusion Criteria:

elective open TAAA repai

18-80 years

no pregnancy

Exclusion Criteria:

emergency treatment participation in another Trial renal replacement therapy

Primary outcomes:
measure: Acute kidney injury after open TAAA repair
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Mortality, major adverse events such as any complication
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
Study officials:
References:
Clinical trial NCT02511561: OTO-201 for the Treatment of Otitis Externa
Official title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otitis Externa
Keywords: Otitis externa
Swimmer's ear
Ear infection
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 80 years, inclusive
* Subject has a clinical diagnosis of unilateral otitis externa
* Subject or subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has tympanic membrane perforation
* Subject has a history of known immunodeficiency disease
* Subject has fungal otitis externa, based on clinical signs

Primary outcomes:
measure: Otoscopic Examination: Tympanic Membrane
timeFrame: Up to 1 month
measure: Otoscopic Examination: Middle Ear
timeFrame: Up to 1 month
measure: Feasibility of Administration
timeFrame: Day1
measure: Overall Adverse Events
timeFrame: up to 1 month
Secondary outcomes:
measure: Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
timeFrame: Day 15 (two weeks from dosing)
measure: Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
timeFrame: Day 15 (2 weeks from dosing)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Email Otonomy Central Contact for Trial Locations
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05396261: a Flexible Wound Dressing for the Management of Genital Skin Conditions
Official title: Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginitis
Atrophic Vaginitis
Lichen Planus
Lichen Sclerosus
Menopause Related Conditions
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 54
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Diagnosed genital skin condition

Exclusion Criteria:

* Unable to give informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products

Primary outcomes:
measure: gynaecological skin condition
timeFrame: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
Secondary outcomes:
measure: patient symptoms
timeFrame: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
Other outcomes:
Locations:
city: Spring Hill
country: Australia
facility: St. Andrews War Memorial Hospital
state: Queensland
Study officials:
affiliation: St. Andrews War Memorial Hospital - Australia
name: Philip Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04845061: Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd
Official title: Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Copd
Keywords: beta blockers -nebivolol
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To Evaluate the Outcome of cardio selective beta1 (β1-) blockers use in patients with chronic obstructive pulmonary disease.

Patient education about the COPD and their medications.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a common preventable and Treatable airway disorder characterized by symptoms such as dyspnea, chronic Cough, and sputum production along with persistent airflow limitation that is not fully Reversible.

Evidence provided by post hoc analysis of clinical trials and large observational studies suggests a beneficial effect of beta-blockers on mortality and exacerbation in mild to moderate COPD patients.

Evidence concerning cardio selective B blockers. Over the past 20 years' non selective B blockers have largely been replaced with cardio selective blockers. Cardio selective beta blockers such as atenolol and metoprolol are at least 20 times more potent at blocking B-1 receptors than B-2 receptors. At therapeutic doses the B-1 blocking effect, and therefore the risk of bronco constriction, is negligible. In addition there is strong evidence that B-blocked cause up-regulation and sensitization of B-receptors.

Eligibility criteria: Inclusion Criteria:

1. Male or female.
2. informed consent.
3. Age \>40years.
4. FEVl/FVC\<70%.
5. diagnosed 3 month before enrollment (mild-moderate)
6. Reversability test pre-post bronchodilators FEVl predicted\<200ml/hr and less than 12%.

Exclusion Criteria:

1. Asthmatic patient.
2. patient already use B blockers.
3. Acute exacerbation.
4. Pregnency -lactation.
5. Advanced cardiac, renal or liver disease according to investigator opinion.

Primary outcomes:
measure: forced vital capacity
timeFrame: 3 months
measure: forced expiratory volume in one second
timeFrame: 3 month
measure: blood pressure
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Chest Department, Ain Shams University Hospitals, Cairo, Egypt.
city: Cairo
country: Egypt
facility: Chest Department, Ain Shams University Hospitals
city: Cairo
country: Egypt
facility: Chest Department, Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT02931461: Interest of Procore Needle® for Diagnosis of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore
Keywords: endobronchial transbronchial needle aspiration lung cancer procore
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.


Eligibility criteria: Inclusion Criteria:

* mediastinal lymphadenopathy \>10 millimeters
* lung cancer suspected

Exclusion Criteria:

* coagulopathy contraindication for midazolam contraindication for bronchoscopy

Primary outcomes:
measure: Proportion of histological diagnoses for each needle
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02200861: Tooth Extraction With Deep Sedation in Children: A Retrospective Study
Official title: Tooth Extraction With Deep Sedation in Children: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Extraction Status Nos
Keywords: sedation,
tooth extraction,
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 885
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children

Brief summary: In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.

Detailed description: Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperated patients with severe anxiety. In these patients, unpleasant dental experiences may lead to development of dental phobia when they become adults . Therefore, it is important to eradicate anxiety, and to prevent a possible psychological trauma in pediatric patients. For this purpose, psychological and medical methods have been applied to increase patient compliance. It has been proven that general anesthesia especially prevents dental phobia in elderly, and increases the quality of life related to oral health. In this study we aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.

Eligibility criteria: Inclusion Criteria:

* the patients who dental treatment was performed with deep sedation

Exclusion Criteria:

* the patients who dental treatment was performed local anesthesia or general anesthesia

Primary outcomes:
measure: anesthetic technics used for deep sedation
timeFrame: 2 month
Secondary outcomes:
measure: side effects observed in patients
timeFrame: 2 months
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References:
Clinical trial NCT00447161: Preventing Antibiotic-Associated DiarRhea Using Erceflora
Official title: Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea, Infantile
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 323
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.


Eligibility criteria: Inclusion Criteria:

* Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.

Exclusion Criteria:

* Children with unstable medical condition
* In any form of immunocompromized state
* With contraindication to take medication
* Has taken antibiotics for 3 weeks before start of trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
timeFrame: From baseline to end of treatment
measure: All adverse event regardless of seriousness or relationship to the study drug
timeFrame: From baseline to end of treatment
Secondary outcomes:
measure: Reduction in the number of antibiotic-associated diarrhea events per day
timeFrame: From baseline to end of treatment
measure: Reduction in the severity of diarrhea events
timeFrame: From baseline to end of treatment
measure: Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
timeFrame: From baseline to end of treatment
measure: Reduction in C. dificille -associated diarrhea.
timeFrame: From baseline to end of treatment
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Paz Figueroa
role: STUDY_DIRECTOR
References: