louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06100848: Hydrogen Peroxide Fumigation in Dental Office Environment
Official title: The Impact of Hydrogen Peroxide (H₂O₂) Fumigation on Bacterial Level in Dental Office Environment: A Clinical Trial Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Dental Caries
Aerosol Disease
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's null hypothesis posits no significant difference in bacterial levels in the dental office environment before and after implementing hydrogen peroxide (H₂O₂) fumigation. The study comprised 30 participants, 18 females and 12 males, all diagnosed with moderate caries decay (ICDAS 3 and 4) in their mandibular molars, averaging 42.2 ± 8.3 years in age. Sample size calculations for 30 microbiological plates in each group utilized G\*Power software (Kiel University, Germany), factoring in prior research, with a significance level of 0.05, effect size (d) of 0.72, 95% confidence interval, and 85% power. Aerobic bacterial content in the dental office air was assessed using the Koch sedimentation method. The study employed 60 Petri dishes with Columbia Agar and 5% Sheep Blood. During caries treatment, thirty plates were opened and sealed 40 minutes later, while another set of thirty plates was opened and closed 60 minutes post-fumigation. Measurements were taken 1 meter above the ground and 2 meters from the patient's mouth. After 48 hours of incubation at 37°C, microbiological contamination was calculated as CFUs (colony-forming units) in one cubic meter using the formula: L = a × 1000 / (πr² × k). Fumigation involved a 20-minute treatment with 6% hydrogen peroxide biosanitizer (Saniswiss, Switzerland) via a compressed air device (Fumi-Jet, Kormed, Poland). The process included 3 minutes of fumigation and a 17-minute waiting period for the chemotoxic effect, with 45 ml of 6% hydrogen peroxide sprayed in a 20 m² room.


Eligibility criteria: Inclusion Criteria:

* diagnosed with moderate caries decay based on the International Caries Detection and Assessment System (ICDAS 3 and 4) in their mandibular molar teeth
* received hygienist treatment two weeks before the study initiation

Exclusion Criteria:

* use anti-inflammatory medications
* non-smokers
* had systemic illnesses
* with uncompensated diabetes
* with halitosis symptoms
* with gastric diseases

Primary outcomes:
measure: Number of bacteria after caries treatment
timeFrame: After 48 hours of incubation
measure: Number of bacteria after caries treatment and fumigation
timeFrame: After 48 hours of incubation
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Oral Surgery Department
Study officials:
References:
Clinical trial NCT04400448: Acceptance of Telemedicine During the COVID-19 Pandemic
Official title: Acceptance of Telemedicine in Outpatient Clinic Consultations During COVID-19 Pandemic. An International, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: telemedicine
patient acceptance
covid-19
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the described inclusion criteria will be included in the registry. Participants will be asked to answer an anonymous and voluntary questionnaire by telephone, that will be completed online by the researcher and collaborators through a Google form, aimed to assess the acceptance of the use of telemedicine in consultations during the pandemic.

Brief summary: Currently, due to the effects of COVID-19 pandemic, there is an imperative need to change the healthcare model. In this regard, telemedicine has proved very useful in health crises, in which there is a possibility of infection between people, offering remote access to medical care. Telemedicine has been used in many chronic diseases such as asthma and chronic obstructive pulmonary disease, diabetes mellitus, and appears to be well accepted by patients. However, few studies have been conducted in surgical services and in other diseases. Therefore, the aim of this study is to assess the level of acceptance of the patients, in this pandemic situation, to a telemedicine follow-up in different departments.

This is an observational, cross-sectional, multicenter and international study with prospective and retrospective data collection. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ). In addition, all patients will provide an overall satisfaction score for telemedicine on a scale from 1 to 5 (1=lowest; 5=highest satisfaction).


Eligibility criteria: Inclusion Criteria:

* Patients contacted by telemedicine (phone and/or video call) during the COVID-19 pandemic in outpatient clinics
* Follow-up of patients with any chronic disease and postoperative patients, preoperative and urgent consultation
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patients with cognitive or sensory difficulties or with insufficient comprehension of the language in which the survey is conducted
* Patients who decline to take part in the telephone survey

Primary outcomes:
measure: Acceptance of telemedicine
timeFrame: 1 month
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00759148: Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Keywords: pink eye
conjunctivitis
moxifloxacin
fluoroquinolone
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 1179
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with bacterial conjunctivitis in 1 or both eyes;
* Able to understand and sign an informed consent form. If subject is \<18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
* Agrees to comply with the visit schedule and other requirements of the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
* Presence of concomitant viral infection;
* Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
* Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
* Infants undergoing treatment for retinopathy of prematurity;
* Contact lens wear during the course of the study;
* Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
* Use of medications, as specified in the protocol;
* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
* Known or suspected allergy or hypersensitivity to fluoroquinolones;
* Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Clinical Cure at the Day 4 (EOT)/Exit Visit
timeFrame: Day 4
Secondary outcomes:
measure: Microbiological Success at the Day 4 (EOT)/Exit Visit
timeFrame: Day 4
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Alcon Research, Ltd.
role: STUDY_DIRECTOR
References:
citation: Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.
Clinical trial NCT03788148: Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion
Official title: Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythrocyte Transfusion
Percutaneous Coronary Intervention
Revascularization
Keywords: transfusion, PCI, DES, BMS
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 28322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Korean patients undergoing BMS or DES implantation from January 1, 2005 to December 31, 2016 who received periprocedural red blood cell transfusion

Brief summary: Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

Detailed description: A Korean nationwide, multi-center, retrospective observational cohort study.

The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion.

Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate.

Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.

Eligibility criteria: Inclusion Criteria:

* Patients with percutaneous coronary intervention from 2006 to 2015
* Patients with the implantation of BMS or DES
* Patients with the receipt of periprocedural red blood cell transfusion

Exclusion Criteria:

* Patients without any of stent implantation

Primary outcomes:
measure: Incidence density of MACE (Major adverse clinical events)
timeFrame: 3 years
measure: Incidence density of MACE (Major adverse clinical events)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gang nam-Gu, Ilwon-Dong
Study officials:
affiliation: Samsung Medical Center
name: Jin-Ho Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968448: Inspiratory Muscle Training (IMT) in Athletes
Official title: Inspiratory Muscle Training (IMT) in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Running Endurance
Keywords: respiratory muscle
breathing pattern
exercise performance
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2009-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine weather well trained athletes benefit from inspiratory (respiratory) muscle training.

Detailed description: * Subject: The investigators intend to include 40 well trained runners, 18 years or older.
* Design: Following lung function and exercise testing (incremental treadmill test to exhaustion, 5000m run time trial) participants will be randomly assigned to a verum or a control group. The verum group will train with a hand-held, commercially available pressure threshold loading device (POWERbreathe,UK). The control group will perform a sham-training with the same device. After six to eight weeks the the initial tests will be repeated.
* Hypothesis: Inspiratory muscle training enhances performance on submaximal work loads and in the 5000m run time trial by changes in breathing pattern. Maximum oxygen uptake remains unchanged.

Eligibility criteria: Inclusion Criteria:

* well trained runners

Exclusion Criteria:

* previous respiratory muscle training
* cardiovascular diseases
* impaired lung function

Primary outcomes:
measure: performance in the 500m run time trial
timeFrame: 6-8 weeks
Secondary outcomes:
measure: maximum inspiratory pressure
timeFrame: 6-8- weeks
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Universität des Saarlands
state: Saarland
Study officials:
affiliation: Institute for Sports Medicine and Prevention / Saarland Universitiy
name: Ulf Such, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509248: Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants
Official title: Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apea of Prematurity
Keywords: Theophylline
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
name: Korea University Anam Hospital
First posted: 2012-01-12
Enrollment: 110
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted to Neonatal Intensive Care Unit

Brief summary: 1. Population pharmacokinetics : The purpose of this study is

   - to investigate the population pharmacokinetics of theophylline in premature Korean infants and to assess the influence of demographic and clinical covariates.
2. Metabolomics : The purpose of this study are

   * to predict serum theophylline levels and to assess CYP1A2 activities in premature infants by analyzing urinary metabolites of theophylline
   * to examine which factors affect clearance of theophylline and CYP1A2 activity in premature infants


Eligibility criteria: Inclusion Criteria:

* Inborn preterm infants (GA \< 37 weeks)
* Dx : Apnea of prematurity
* Tx : Aminophylline / Theophylline
* Informed consent of parents

Exclusion Criteria:

* Major congenital anomaly
* Expired within 72 hours
* Proven secondary apnea

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kim SE, Kim BH, Lee S, Sohn JA, Kim HS, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. Population pharmacokinetics of theophylline in premature Korean infants. Ther Drug Monit. 2013 Jun;35(3):338-44. doi: 10.1097/FTD.0b013e3182866695.
Clinical trial NCT02303548: Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
Official title: Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Arrest
Metabolic Acidosis
Keywords: Sodium Bicarbonate
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-12-01
Enrollment: 50
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: A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.


Eligibility criteria: Inclusion Criteria:

* adult cardiac arrest patient with arterial pH \<7.1 or bicarbonate \<10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation

Exclusion Criteria:

* age \<18 trauma patient Do Not Resuscitate state

Primary outcomes:
measure: Return of Spontaneous Circulation (ROSC)
timeFrame: checked during CPR, duration of ROSC >20 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ahn S, Kim YJ, Sohn CH, Seo DW, Lim KS, Donnino MW, Kim WY. Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study. J Thorac Dis. 2018 Apr;10(4):2295-2302. doi: 10.21037/jtd.2018.03.124.
Clinical trial NCT02676648: Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
Official title: Randomized Trial of Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.

Detailed description: The research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.

Eligibility criteria: Inclusion Criteria:

* overweight or obese
* English-speaking
* diagnosis of type 2 diabetes (HbA1c \> 6.5%)
* regular access to the internet and text messages

Exclusion Criteria:

* taking diabetes medications other than metformin
* being pregnant or breastfeeding
* currently undergoing cancer treatments
* untreated serious mental illness

Primary outcomes:
measure: HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: Body Weight Percent Lost
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Laura Saslow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saslow LR, Moskowitz JT, Mason AE, Daubenmier J, Liestenfeltz B, Missel AL, Bayandorian H, Aikens JE, Kim S, Hecht FM. Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial. JMIR Diabetes. 2020 Sep 9;5(3):e15835. doi: 10.2196/15835.
Clinical trial NCT04656548: A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line
Official title: A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral ICC
PICC
Lead sponsor: Access Vascular Inc
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients at the study site that received a 4 Fr single lumen PICC line from Aug 2020 through Oct 2020.

Brief summary: This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.

Detailed description: Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020.

The two groups will be HydroPICCs and the standard of care for the facility.

A comparison of multiple endpoints will be evaluated between the two groups.

Eligibility criteria: Inclusion Criteria:

* Subjects who have been inserted with the HydroPICC during a specific time range.
* During the same time period, any competitor 4 Fr single lumen placed.

Exclusion Criteria:

* None

Primary outcomes:
measure: Intended dwell time based on a comparison of the actual dwell time to the intended time
timeFrame: August 2020 through October 2020
Secondary outcomes:
measure: Comparison of failure rates
timeFrame: August 2020 through October 2020
Other outcomes:
Locations:
city: Romeoville
country: United States
facility: Joseph Bunch
state: Illinois
Study officials:
affiliation: ProVasc
name: Joseph Bunch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189748: A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
Official title: An Extension Study of the Patients Enrolled in Acute Graft Versus Host Disease (GVHD) Prophylaxis Study (Protocol No. FJ-506E-BT01) to Assess Safety and Efficacy of GVHD Prophylaxis of a Tacrolimus New Oral Formulation (MR4).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Marrow Transplantation
Graft Versus Host Disease
Graft-Versus-Host Disease
Graft-Vs-Host Disease
Keywords: Tacrolimus
Immunosuppression
Bone Marrow Transplantation
Graft versus Host Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)


Eligibility criteria: Inclusion Criteria:

* Patient had enrolled in GVHD prophylaxis study.
* Patient had been fully informed.

Exclusion Criteria:

* The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Hokkaido region
country: Japan
city: Kanto region
country: Japan
city: Kyusyu region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc., Japan
name: Clinical development
role: STUDY_CHAIR
References: