louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03312582: Locally Delivered 1% Metformin Gel in Peri-implantitis
Official title: Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peri-Implantitis
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.

Detailed description: Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus patients.
* Patients with peri-implantitis

Exclusion Criteria:

* History of any other systemic diseases
* Cigarette smokers
* Smokeless tobacco users
* Patients who underwent scaling in the last 1 year
* Patients who took antibiotics in tje past 6 months

Primary outcomes:
measure: Marginal bone loss
timeFrame: 6 months
measure: Peri-implant prpbing depth
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04804982: Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army
Official title: Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acoustic Trauma
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of male and female Army soldiers practicing shooting on a regular basis.

Brief summary: Each year, military epidemiological surveillance counts approximately 1,000 acute acoustic injuries. Most are caused by exposure to weapon noise during training sessions while military personnel are provided with hearing protection. Several hypotheses could explain the occurrence of acute acoustic trauma despite wearing protections:

* A lack of practices or knowledge about the use of hearing protection equipment that could facilitate the occurrence of acute acoustic trauma (improper fitting, use of an inappropriate type of protection, dropping of protectors, inappropriate removal)
* A failure to seal the external ear canal due to an inappropriate plug size. These hypotheses will be explored using a questionnaire distributed to a population of Army soldiers training to shoot.

The main objective is to determine the predictive factors corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma in a population of Army soldiers.


Eligibility criteria: Inclusion Criteria:

* Be a member of the Army
* Having performed at least one shooting session in the last 12 months

Exclusion Criteria:

* Inability to read and/or write in French language

Primary outcomes:
measure: Measurement of the importance of variables corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma.
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: 119e Antenne Médicale, 14e Centre Médical des Armées
city: Angoulême
country: France
facility: 101e Antenne Médicale, 13e Centre Médical des Armées
city: Brive-la-Gaillarde
country: France
facility: 93e Antenne Médicale, 8e Centre Médical des Armées
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
city: Montauban
country: France
facility: 176e Antenne Médicale, 11e Centre Médical des Armées
city: Suippes
country: France
facility: 31e Antenne Médicale
city: Varces-Allières-et-Risset
country: France
facility: 76e Antenne Médicale, 7e Centre Médical des Armées
Study officials:
References:
Clinical trial NCT03516682: Reducing Delay in Vaccination of Children: Logistic Barriers
Official title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communicable Disease
Keywords: Logistic Barriers to Vaccination
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2018-05-04
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.

Detailed description: Parents of children less than 11 months of age will be identified as delayed or missing vaccinations due to logistic barriers in the Kaiser Permanente Colorado population. Parents identified will be randomized to the intervention arm or the usual care arm. Those in the intervention arm will receive automated reminders for the 6 month and 12 month vaccine visits. Reminders will include scheduling information as well as access to a website with vaccine and scheduling information. They will also have an opportunity to provide preferences in how they receive the automated reminders (text, phone or email). There will be 2 reminders before the 6 and 12 month visits and 2 after the 6 and 12 month visits. Parents will be excluded from receiving reminders if they have received vaccines within the time frame when they are eligible to receive another vaccine or have a well child visit scheduled.

Eligibility criteria: Inclusion Criteria:

* Parents of children less than 11 months of age
* Currently enrolled at Kaiser Permanente Colorado at the time of identification
* The child is missing recommended vaccinations

Exclusion Criteria:

* Non-english speaking
* diagnosis code indicating parent vaccine refusal

Primary outcomes:
measure: Vaccines received (Electronic Health Record)
timeFrame: up to a year of follow up
Secondary outcomes:
measure: Vaccine dose (Electronic Health Record)
timeFrame: up to a year of follow up
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado Institute for Health Research
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Jason Glanz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
Clinical trial NCT00573482: A Cafeteria Based Study of Weight Gain Prevention
Official title: A Cafeteria Based Study of Weight Gain Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: weight gain prevention
obesity
overweight
food environment
The intervention group received the education in REDE techniques
The control group received no intervention at all.
Both groups were exposed to the food labels and the new lower ED foods.
Only the intervention group received the education sessions and only they were eligible for the price reductions.
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-12-14
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The dramatic rise in overweight and obesity during the past several decades can be explained by environmental changes that foster increased energy intake and decreased energy expenditure. There are several reasons to suggest that the most effective approach to weight gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering the energy density of the diet. Our energy density manipulations will be designed to reduce both the fat content and the caloric density of foods served at a cafeteria, which serves as the "food environment" for hospital employees.


Eligibility criteria: Inclusion Criteria:

* works at one of the two hospitals and eats lunch in the cafeteria 2x per week
* BMI between 23 and 25

Exclusion Criteria:

* current diagnosis of a chronic disease or condition known to affect appetite or body weight
* currently taking medication known to affect appetite or body weight
* current pregnancy or plans to become pregnant within the next 24 months
* current enrollment or plans to enroll within the next 24 months in an organized weight management program
* plans to terminate employment at the hospital within the next 12 months

Primary outcomes:
measure: Weight
timeFrame: 36 months
Secondary outcomes:
measure: Caloric and macro-nutrient intake
timeFrame: 36 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Local Hospitals
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Michael R Lowe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872182: Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
Official title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Abdominal Obesity Metabolic Syndrome
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 64 years(Both genders)
* more than 2 among components of the metabolic syndrome

  * Triglyceride \>= 150mg/dL
  * HDL-D: Women \< 50mg/dL or Men \< 40mg/dL
  * Hypertension: Systolic blood pressure \>= 130mmHg or Diastolic blood pressure \>= 85mmHg
  * Hyperglycemia: fasting plasma glucose \>= 100 mg/dL
* Informed consent awarding

Exclusion Criteria:

* Alcohol or any drug abuse
* Any investigational medication during the preceding 3 months

Primary outcomes:
measure: Percent change from baseline to 12 week in visceral fat area measured by CT
timeFrame: baseline and 12 week
Secondary outcomes:
measure: improvement of metabolic profile
timeFrame: baseline and 12 week
measure: change of insulin resistance
timeFrame: baseline and 12 week
measure: change of BMI
timeFrame: baseline and 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 5 Institutions
Study officials:
affiliation: Asan Medical Center
name: Hye Soon Park, M.D., Ph.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04448782: Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation
Official title: Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ICU under invasive mechanical ventilation with ARDS secondary to COVID-19

Brief summary: Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients under invasive mechanical ventilation more than 24 hours and with a minimum of 48 hours of respiratory signals registered from the ventilator
* Diagnosis of COVID-19

Exclusion Criteria:

* less than 48 hours of data,
* age \< 18 years
* admitted from other centers under invasive mechanical ventilation.

Primary outcomes:
measure: Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation
timeFrame: during the 5 first days of invasive mechanical ventilation
Secondary outcomes:
measure: Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation
timeFrame: From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation
measure: Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation
timeFrame: From the day of mechanical ventilation initiation up to 5 days
measure: Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation
timeFrame: Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days
measure: Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation
timeFrame: Each day from the day of mechanical ventilation initiation until the end of invasive mechanical ventilation, ICU discharge and hospital discharge or up to 28 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Candelaria de Haro
state: Barcelona
Study officials:
References:
Clinical trial NCT01791582: Pulse Oximetry- Evaluating Resp Rate- PCBA-1
Official title: Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Subjects

Brief summary: To assess performance of resp rate parameter in a monitoring system PCBA-1


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects ages 18 or older.
2. Subject is willing and able to provide written consent.

Exclusion Criteria:

1. Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
2. Subjects with abnormalities that may prevent proper application of the device.
3. Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds).
4. Women who are pregnant or lactating.

Primary outcomes:
measure: ME (mean error) of Respiration Rate values for each subject
timeFrame: 1-2 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Covidien
state: Colorado
Study officials:
References:
Clinical trial NCT03151382: A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
Official title: A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer Disease
Cognitive Function
Keywords: Alzheimer Disease
Cognitive Function
tandospirone
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with AD comorbid anxiety.

Number of Patients: 30

Methodology: Randomized, open-label, parallel-group

Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control group: Donepezil, 10 mg/d.

Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12; NPI scale total score at week 12;


Eligibility criteria: Inclusion Criteria:

* 55-80 years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment;
* Patients who were diagnosed with AD according to the DSM-IV;
* MMSE score \> 10 and ≤ 24;
* HAMA score \> 8;
* HAMD score ≤ 7;
* Brain CT or MRI supports the diagnosis of AD;
* Provide written informed consent by the patient himself and his family member or guardian.

Exclusion Criteria:

* Dementia from any other cause;
* Brain MRI showed that the diameter of hyperintense lesions in T2-FLAIR sequences were larger than 5mm;
* Patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease;
* Any primary neurologic or psychiatric disease other than AD;
* Mental disorders due to substance abuse;
* Participation in other clinical studies within the last 30 days;
* History of alcohol or substance abuse or dependence within the past year;
* Pregnant or breastfeeding, or of child-bearing potential during the study.

Primary outcomes:
measure: Change of ADAS-cog total score
timeFrame: week 12
measure: NPI scale total score
timeFrame: week 12
Secondary outcomes:
measure: HAMA total score
timeFrame: week 12
measure: FAB score
timeFrame: week 12
measure: relative power
timeFrame: week 12
measure: the image of PET
timeFrame: week 12
measure: MMSE score
timeFrame: week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01395082: ACAM2000® Myopericarditis Registry
Official title: ACAM2000® Myopericarditis Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Pericarditis
Keywords: Myocarditis
Pericarditis
Vaccinia virus
ACAM2000®
Smallpox vaccine
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will have received previous vaccination with ACAM2000® but will not receive any vaccination as part of the registry.

Brief summary: The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.

Primary Objective:

- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.

Other Pre-defined Objective:

- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.

Detailed description: All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).

Eligibility criteria: Inclusion Criteria:

* Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
* Documented vaccination with ACAM2000® vaccine
* Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.

Exclusion Criteria:

* Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.

Primary outcomes:
measure: The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination
timeFrame: 2 years after enrollment or after the last symptoms or positive findings
Secondary outcomes:
Other outcomes:
measure: The natural history of myopericarditis in terms of time to resolution or change in status of myopericarditis and the pattern of changes in status of myopericarditis
timeFrame: 2 years after enrollment or after the last symptoms or positive findings
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Emergent BioSolutions
name: Medical Director
role: STUDY_DIRECTOR
References: