louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00234598: Strategies to Prevent Pneumonia (SToP Pneumonia)
Official title: Oral Care Intervention in Mechanically Ventilated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventilator Associated Pneumonia
Keywords: Pneumonia
Dental Health
Critical Care
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-10-07
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study tests whether special oral care provided by nurses to critically ill patients who are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental plaque on the teeth and reduce the risk of pneumonia.

Detailed description: Pneumonia is the leading cause of death from hospital-acquired infections. Intubation and mechanical ventilation greatly increase the risk of bacterial ventilator associated pneumonia. Growth of potentially pathogenic bacteria in dental plaque of critically ill patients provides a nidus of infection for microorganisms that have been shown to be responsible for the development of Ventilator Associated Pneumonia. Since these organisms are concentrated in dental plaque, removal of organisms from the oral cavity by oral care interventions is a theoretically attractive method to reduce the risk of development of Ventilator Associated Pneumonia. However, evidence-based protocols for oral care of mechanically ventilated patients are not available. Results of the study have the potential to improve nursing care, and to positively affect patient well-being, morbidity, mortality, and health care costs.

Eligibility criteria: Inclusion Criteria:

* 18 years or older, admitted to one of four intensive care units at the study hospital, breathing tube in place, and on a breathing machine (mechanical ventilator)

Exclusion Criteria:

* Breathing tube in place for more than 24 hours prior to entry into the study, absence of teeth, or a medical diagnosis of pneumonia when the breathing tube is put in.

Primary outcomes:
measure: Reduction of build-up of dental plaque on the teeth and reduced risk of pneumonia in critical care patients, as a result of special oral care provided by nurses.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Cindy Munro, RN, ANP,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04645498: COVID-19 and Hereditary Metabolic Diseases
Official title: Prospective Study on the Impact of COVID-19 on the Equilibrium of Hereditary Metabolic Disease (MHM) in Patients With or Who Have Contracted COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Metabolism, Inborn Errors
Keywords: COVID-19
Inherited metabolic diseases
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IMD patients followed in reference centers for IMD in France. children and adult patients with MHM who have been infected with COVID-19 (tested positive or considered positive for COVID-19). Asymptomatic MHM patients tested positive for COVID 19 (contact case, for example) will also be studied.

Brief summary: No additional risk factors have been identified in patients with Inherited Metabolic Diseases (IMD) for contracting or presenting complications of COVID-19 compared to the general population. Yet, IMD patients have cell/tissue alterations that could constitute a potential direct or indirect target for the virus. We do not know the impact of this infection on patients suffering from MHM, nor the possible effect of specific treatment of MHM on the evolution of COVID-19.

This study will collect French IMD patients having or having had COVID-19 infection. The main objective is to estimate among IMD patients contracting COVID-19 the frequency of disease aggravation or metabolic decompensation.

The secondary objectives will be : a. to evaluate the incidence of COVID-19 diagnosed in a given group of IMD when the number of patients with this IMD is known (Urea Cycle Deficiency, Gaucher Disease). b. to evaluate the impact of IMD on the and severity of COVID-19 infection


Eligibility criteria: Inclusion Criteria:

* Child or adult patient with a diagnosis of IMD
* Symptomatic or asymptomatic patient tested positive for COVID-19 (PCR and/or serology)
* Symptomatic patient non tested but with strong clinical suspicion for COVID-19
* Patient affiliated with the health insurance

Exclusion Criteria:

* inability to receive informed information
* Persons deprived of liberty

Primary outcomes:
measure: Frequency of MHM imbalance triggered by COVID-19
timeFrame: at 8 weeks
Secondary outcomes:
measure: Number of COVID-19 patients in Gaucher's disease
timeFrame: at 24 months
measure: Number of COVID-19 patients in Urea Cycle Disorder
timeFrame: at 24 months
measure: Severity of COVID-19 infection
timeFrame: at 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Claire Douillard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01681498: Fetal Electrocardiogram Extraction-Pilot Study
Official title: Fetal Electrocardiogram Extraction-Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Keywords: pregnant
fetal ecg
ecg
Lead sponsor: Huntleigh Healthcare Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prenatal care clinic

Brief summary: This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.


Eligibility criteria: Inclusion Criteria:

* Subjects must be pregnant women at least 18 years of age.
* Subject's fetus must be between the gestational ages of 16 weeks and term.
* Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position.
* Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study.

Exclusion Criteria:

* Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.

Primary outcomes:
measure: Beat-to-beat fetal heart rate will be compared to the Doppler result.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the presence of other fECG intervals.
timeFrame: 2 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Wheaton Franciscan, Inc. - St. Joseph
state: Wisconsin
Study officials:
affiliation: Wheaton Franciscan Healthcare
name: Menachem H. Graupe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710905: Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
Official title: Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract IOL ReSTOR Aspheric
Bilateral cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.


Eligibility criteria: Inclusion Criteria:

* Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

* Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
* All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Primary outcomes:
measure: Binocular Visual Acuity at Near, Intermediate and Distance
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Dr John Blaylock
state: British Columbia
city: Quebec City
country: Canada
facility: Dr Dominique Meyer
state: Quebec
Study officials:
name: John Blaylock
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02112305: Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children
Official title: Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Severe Asthma
Keywords: Magnesium sulphate nebulized
Lead sponsor: Queen Sirikit National Institute of Child Health
Sponsor class: OTHER_GOV
First posted: 2014-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate

Detailed description: Intervention: At randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/L) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. The asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. Adverse event were assessed at each assessment point. Patients were followed up until discharge from hospital to collect secondary outcome data.

Eligibility criteria: Inclusion Criteria:

* Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy

Exclusion Criteria:

* chronic lung disease
* history of adverse reaction form magnesium sulphate
* life threatening condition

Primary outcomes:
measure: Asthma severity score
timeFrame: 60 minute
Secondary outcomes:
measure: Length of stay in the hospital
timeFrame: within 2 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
Study officials:
affiliation: Queen Sirikit National Institute of Child Health
name: Tassalapa Daengsuwan, Pediatrician
role: STUDY_DIRECTOR
References:
citation: Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.
Clinical trial NCT01789905: Tygacil Drug Use Investigation
Official title: Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-Abdominal Infections
Skin Disease, Infectious
Keywords: Tygacil
Tigecycline
Post marketing surveillance
Japanese
Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).

Brief summary: Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice


Eligibility criteria: Inclusion Criteria:

* All patients who are prescribed tigecycline (Tygacil).

Exclusion Criteria:

* Subject who have not been prescribed tigecycline (Tygacil).

Primary outcomes:
measure: Number of Participants With Adverse Drug Reaction (ADR)
timeFrame: Up until 14 days from the start date and 28 days from the end of the observation period
Secondary outcomes:
measure: Clinical Response Rate
timeFrame: Within 14 days from the start date
measure: Clinical Response Rate of Cure
timeFrame: Within 28 days post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05273905: Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries
Official title: Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries: In Relation to Arterial Stiffness and Cardiovascular Risk Factors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Stiffness
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Apparently healthy volunteers

Brief summary: Background:

Augmented Velocity Index (Avi) is a new Doppler index which can potentially be used to assess arterial stiffness. The Avi of common carotid artery is found to be associated with arterial stiffness and have initial correlation with cardiovascular risk factors. Avi can be used in any vessels (superficial or deep vessels) where arterial Doppler waveforms can be obtained.

Aims:

The aims of this study are to investigate the associations of Avi of hepatic artery, renal artery, central retinal artery and internal carotid artery with arterial stiffness and cardiovascular risk factors in a group of apparently normal subjects.

Methods:

Recruit 350 subjects with no known medical illness or drug treatment for ultrasound examinations and blood tests. In ultrasound examination, the Avi of carotid arteries, hepatic arteries, renal arteries and retinal arteries are recorded. The carotid-femoral pulse wave velocity is also calculated for the assessment of central aortic stiffness.

Other important correlates of arterial stiffness including carotid intima-media thickness, fatty liver status, liver stiffness and abdominal fat thickness are assessed in the ultrasound examination.

The clinical and laboratory examinations include anthropometric indexes, plasma glucose level, lipid profile, renal function tests, liver function test, urinary albumin creatinine ratio, blood pressure measurement.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy volunteers

Exclusion Criteria:

* Subjects with known medical illnesses including cancer, stroke, cardiovascular disease, diabetes, hypertension, dyslipidaemia, peripheral vascular disease, gout, systemic lupus erythematosus, psoriasis, rheumatoid arthritis and thyrotoxicosis.
* Subjects with long term drug use

Primary outcomes:
measure: Augmented Velocity Index (Avi)
timeFrame: Aug 2022 - May 2024
Secondary outcomes:
measure: Arterial wall thickness, liver stiffness and fatty liver status
timeFrame: Aug 2022 - May 2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05038605: Topical vs Oral Metronidazole After Benign Anorectal Surgery
Official title: Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Anal Fissure
Anal Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.

No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex aged below 70 years
* Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.

Exclusion Criteria:

* Grade I-II hemorrhoids.
* acute anal fissure.
* complex anal fistula
* perianal abscess
* perianal Crohn's disease
* malignancy.

Primary outcomes:
measure: Postoperative pain score
timeFrame: at one day after surgery
measure: Postoperative pain score
timeFrame: at two days after surgery
measure: Postoperative pain score
timeFrame: at seven days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
References:
Clinical trial NCT03325205: MR Guided tDCS in Alzheimer's Disease
Official title: MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Transcranial direct current stimulation
Neuromodulation
Individualizing brain stimulation
Neuropsychology
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Helse Nord
First posted: 2017-10-30
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp. Electrode placement is individualized for each participant. Participants will undergo 15 stimulations, with a duration of 20 minutes each. All patients will undergo neuropsychological assessment and MRI evaluation.

Detailed description: The project will be run as a Randomized Controlled Trial (RCT), where patients will be randomized to receive either active anodal tDCS or sham tDCS. The performance on neuropsychological tests will be the primary outcome variables in the present project. In addition, whole brain MRI volume measures will be used to measure specific effects of tDCS treatment. Electrode placement is individualized for each participant with brain modeling techniques.

Eligibility criteria: Inclusion Criteria:

* Alzheimer's Disease, mild and moderate stage

Exclusion Criteria:

* Other neurological diseases or injuries
* Stroke
* Cancer
* Psychiatric disorders (moderate/ severe depression, psychosis)

Primary outcomes:
measure: Performance on Neuropsychological tests
timeFrame: 4 months
Secondary outcomes:
measure: Hippocampal volume
timeFrame: 4 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Department of Psychology, University of Northern Norway
Study officials:
affiliation: University of Tromso
name: Per M Aslaksen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen ID, Boayue NM, Mittner M, Bystad M, Gronli OK, Vangberg TR, Csifcsak G, Aslaksen PM. High-Definition Transcranial Direct Current Stimulation Improves Delayed Memory in Alzheimer's Disease Patients: A Pilot Study Using Computational Modeling to Optimize Electrode Position. J Alzheimers Dis. 2021;83(2):753-769. doi: 10.3233/JAD-210378.
Clinical trial NCT01734005: Efficacy and Safety of Red Ginseng on Decrement of Body Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-65 years old
* BMI(body mass index) ≥ 25 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Body Fat Mass
timeFrame: 12 weeks
measure: Changes in Percent Body Fat
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in weight
timeFrame: 12 weeks
measure: Changes in BMI(body mass index)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: