louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02029014: Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
Official title: Evaluation of Safety and Efficacy of the New Generation of Left Appendage Closure With the LAmbre Device in AF Patients Not Suitable for Use of Warfarin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: LAmbre
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.


Eligibility criteria: Inclusion Criteria:

* Age\>=18, CHADS2 score\>=1
* Patients cannot be treated long-term with Warfarin
* Eligible for clopidogrel and aspirin
* Provide written informed consent and agree to comply with required follow-ups

Exclusion Criteria:

* Need to take Warfarin
* Presence of rheumatic, degenerative or congenital valvular heart diseases
* Early stage or paroxysmal AF
* Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%)
* Heart failure NYHA grade IV
* Recent 30 days stroke or TIA
* Presence of active sepsis or endocarditis
* Cardiac tumors or other malignancy with estimated life expectancy \<2 years
* Abnormal blood test; renal disfunction
* LAA removed or heart implant patients
* Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
* Patients have history of mechanical prosthesis operation
* Patients who are pregnant, or desire to be pregnant during the during the study
* Participation in other trials
* A known allergy to nitinol
* Patients will not be able to complete the trial

Esophageal ultrasonic exclusion criteria:

* LAA Ostium \<=12mm or \>=30mm
* LVEF \<30%
* Presence of thrombus in the heart
* High risk PFO
* Mitral valve stenosis (valve area \<2 cm2

Primary outcomes:
measure: Ischemic stroke
timeFrame: One year
measure: Successful sealing of the LAA
timeFrame: One year
Secondary outcomes:
measure: Component events
timeFrame: One year
measure: MACCE
timeFrame: One year
measure: Complication at puncture site
timeFrame: One year
measure: Device performance assessed by TEE/TTE
timeFrame: One year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: People's Hospital of Wuhan University
name: Congxin Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03248414: Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Official title: Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.

Detailed description: We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.

Eligibility criteria: Inclusion Criteria:

* age 20-65 years
* BMI equal to higher than 25 kg/m2

Exclusion Criteria:

* under anti-obesity medication
* uncontrolled diabetes
* uncontrolled hypertension
* any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
* thyroid function test abnormality
* malignancy within 5 years
* immune compromised hosts or under immune suppressants
* antibiotics or probiotics withing 2 weeks
* any intervention to reduce body weight within 6 months

Primary outcomes:
measure: Fat mass change in 12-week
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in body weight
timeFrame: 12 weeks
measure: Changes in waist circumference
timeFrame: 12 weeks
measure: Glucose metabolism
timeFrame: 12 weeks
measure: Glucose metabolism
timeFrame: 12 weeks
measure: Glucose metabolism
timeFrame: 12 weeks
measure: Glucose metabolism
timeFrame: 12 weeks
Other outcomes:
measure: GI adverse effect
timeFrame: 12 weeks
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
citation: Lim S, Moon JH, Shin CM, Jeong D, Kim B. Effect of Lactobacillus sakei, a Probiotic Derived from Kimchi, on Body Fat in Koreans with Obesity: A Randomized Controlled Study. Endocrinol Metab (Seoul). 2020 Jun;35(2):425-434. doi: 10.3803/EnM.2020.35.2.425. Epub 2020 Jun 24.
Clinical trial NCT02855814: Body Composition Reference Data for Preterm Infants
Official title: Body Composition Reference Data for Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Medical Center
name: Baystate Medical Center
First posted: 2016-08-04
Enrollment: 223
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AGA, singleton, healthy infants born between 30+0 and 36+6 weeks gestation were eligible. The study was conducted between 2010 and 2015 at three tertiary NICU's in the United States: the University of Minnesota Masonic Children's Hospital in Minneapolis, MN (referred to hereafter as the MN site), Santa Clara Valley Medical Center in San Jose, CA (referred to as the SC site), and Baystate Medical Center in Springfield, MA (referred to as BS).

Brief summary: The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.


Eligibility criteria: Inclusion Criteria:

* Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age

Exclusion Criteria:

* Congenital defects that affect growth
* Inability to tolerate room air for 5 minutes without desaturation or bradycardia
* \<1 kg birth weight
* Parents did not provide consent

Primary outcomes:
measure: Fat mass
timeFrame: Within 72 hours of birth
measure: Fat-free mass
timeFrame: Within 72 hours of birth
measure: Percent body fat
timeFrame: Within 72 hours of birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Demerath EW, Johnson W, Davern BA, Anderson CG, Shenberger JS, Misra S, Ramel SE. New body composition reference charts for preterm infants. Am J Clin Nutr. 2017 Jan;105(1):70-77. doi: 10.3945/ajcn.116.138248. Epub 2016 Nov 2.
Clinical trial NCT01334814: Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Official title: Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.

Detailed description: The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.

Eligibility criteria: Inclusion Criteria:

* individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
* maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
* no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment

Exclusion Criteria:

* patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
* women who are not post-menopausal
* patients with other significant neurological or psychiatric disease other than essential tremor
* patients treated with pallidotomy or thalamotomy
* patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic

Primary outcomes:
measure: sleep quality
timeFrame: 10 weeks
Secondary outcomes:
measure: measures of tremor,voltage threshold for optimal tremor control
timeFrame: 10 weeks
measure: Side effects
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Ryan Uitti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04215614: Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
Official title: The Comparison of Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries and Disorders
Forearm Injuries
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Our aim was to compare the ultrasound-guided infraclavicular and costoclavicular approach in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients
* Patients who will undergo hand or forearm surgery

Exclusion Criteria:

* Infection in the area to be injected
* Coagulopathy,
* Previously known neurological damage

Primary outcomes:
measure: Block performance time
timeFrame: Twenty minutes before surgery
Secondary outcomes:
measure: Visual analog pain score
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Yayik AM, Cesur S, Ozturk F, Celik EC, Ahiskalioglu A. Ultrasound guided costoclavicular approach to brachial plexus: First pediatric report. J Clin Anesth. 2019 Aug;55:136-137. doi: 10.1016/j.jclinane.2019.01.008. Epub 2019 Jan 15. No abstract available.
citation: Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
Clinical trial NCT04408014: Seroepidemiological Study of SARS-CoV-2 (COVID-19) Infection in Population Subgroups in the State of São Paulo
Official title: Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
SARS-CoV 2
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2020-05-29
Enrollment: 18901
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Home contacts of health professionals at the Hospital das Clínicas of the Medical School of USP diagnosed with COVID-19;
* Refugees living in the city of São Paulo - CORAS-BR Project;
* Blood Donors of the Fundação Pró-Sangue Hemocentro de São Paulo
* Butantan Penitentiary Progression Center participants;
* Penitentiary System Hospital Center (CHSP) participants;
* SABE Project - Cohort of the Elderly in the city of São Paulo and their home contacts;
* Residents of the Long Term Care Institution (ILPI) of Botucatu;
* Home contacts of children and adolescents with a positive diagnosis for COVID-19, attended at Instituto da Criança, HCFMUSP.

Brief summary: Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo

Detailed description: This is a cross-sectional study to estimate the prevalence of antibodies against SARS-CoV-2 is different population subgroups in the State of São Paulo

Eligibility criteria: Inclusion Criteria:

* All potential volunteers invited to participate in the study.

Exclusion Criteria:

* All potential eligible participants, but who do not show interest in participating in the study.

Primary outcomes:
measure: Prevalence of antibodies against SARS-CoV-2 through serological testing
timeFrame: 1 month
measure: Frequency of participants with a positive RT-PCR test result for SARS-CoV-2
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Avenida Vital Brasil 1500
Study officials:
affiliation: Instituto butantan
name: Alexander R Precioso, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05214014: Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells
Official title: Treatment of Patients With Systemic Sclerosis With Autologous Regulatory Т-cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Systemic Sclerosis
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2022-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of patients with systemic sclerosis with autologous regulatory Т-cells

Detailed description: Considering the fact that a decrease in the content and functional activity of T-reg plays an important role in the immunopathogenesis of many systemic diseases of the connective tissue, the use of a large amount of T-reg can have a therapeutic effect.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Systemic Sclerosis
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* The presence of any malignant tumor within the last 5 years
* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Primary outcomes:
measure: ACR/EULAR systemic sclerosis criteria
timeFrame: 6 month
measure: ACR/EULAR systemic sclerosis criteria
timeFrame: 1 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Adverse effects associated with the therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: Andrei Hancharou, Dr
role: STUDY_DIRECTOR
affiliation: Belarusian State Medical University
name: Kanstantsin Chyzh, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01497314: Growth and Safety of a Low Lactose Milk-Based Infant Formula
Official title: An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Healthy Term Infants
Keywords: healthy term infants
growth
infant formula
Lead sponsor: Perrigo Nutritionals
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 85
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Detailed description: Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Eligibility criteria: Inclusion Criteria:

* healthy term infants
* birth weight 2500 - 4500 g
* singleton birth
* 37 - 42 weeks gestation

Exclusion Criteria:

* clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
* receiving medications other than vitamins

Primary outcomes:
measure: Weight
timeFrame: 16 weeks
Secondary outcomes:
measure: Length gain
timeFrame: 16 weeks
measure: Occipital Head Circumference
timeFrame: 16 weeks
measure: Acceptability and Tolerability
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Accelovance Melbourne Site
state: Florida
city: Haughton
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Murray
country: United States
facility: Jean Brown Research
state: Utah
city: Burke
country: United States
facility: PI-Coor Research
state: Virginia
Study officials:
affiliation: Perrigo Nutritionals
name: Cynthia M Barber, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03629314: Improving Surgical Patient Knowledge and Safe Use of Opioids
Official title: Improving Surgical Patient Knowledge and Safe Use of Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: Opioid
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Educational-Interventional Pilot study
Primary purpose: OTHER

Brief summary: Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to educate surgical patients about the risks of opioids and how to safely use opioids after surgery. The investigators have developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids. The objective of this pilot study is to determine the usability and readability of an educational pamphlet about the safe use, proper storage and disposal of opioids. The educational pamphlet will be modified based on the feedback from the pilot study and subsequently used for a randomized controlled trial.

Detailed description: Twenty participants presenting to the preoperative clinic will be recruited for the pilot study. After informed consent is obtained, patients will be given an opioid knowledge questionnaire to complete before the education. They will then be given an educational pamphlet to review. After they have reviewed the educational pamphlet, they will complete the same opioid knowledge questionnaire. They will also complete a questionnaire evaluating the patient educational pamphlet. The pamphlet will be modified based on the feedback from the patients in the pilot study.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years adults
2. Proficient in English
3. scheduled for elective surgery

Exclusion Criteria:

1. Patients who are on opioids for chronic pain
2. Patients have taken opioids in the past 30 days
3. Patients who are unable to read and understand English -

Primary outcomes:
measure: Opioid Education Questionnaire
timeFrame: 10 - 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network/Toronto Western Hospital
name: Jean Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: