louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01571882: Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
Official title: Effects of the Consumption of a no Added Sugar Fermented Milk Product Enriched With Plant Sterols and Policosanols on Hypercholesterolaemia Management in Moderately Hypercholesterolaemic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mildly Hypercholesterolemic Subjects
Keywords: Plant sterol - Policosanols - Hypercholesterolemia - Dairy
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.


Eligibility criteria: Inclusion Criteria:

* male and female aged 20-75 years;
* BMI between 19 and 30 kg/m2 ,
* LDL-cholesterol plasma level between 130 mg/dL and 190 mg/dL (bounds included) stabilized for more than 3 months,
* without statin monotherapy or other hypocholesterolaemic drug treatment,
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)

Exclusion Criteria:

* serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Guildford Clinical Pharmacology Unit Ltd. (Gcpl)
state: Surrey
Study officials:
References:
Clinical trial NCT03049982: A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
Official title: A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Oral appliance therapy
Lead sponsor: Zephyr Sleep Technologies
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

Detailed description: One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner.

The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Eligibility criteria: Inclusion Criteria:

1. Minimum 18 years of age
2. Participant has been deemed suitable for oral appliance therapy
3. Prescription for oral appliance
4. Adequate range of motion
5. Adequate dentition
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule

Exclusion Criteria:

1. Loose teeth or advanced periodontal disease
2. Full dentures

Primary outcomes:
measure: Integration of the device into the existing workflow of a dental sleep medicine practice
timeFrame: 6 months
measure: Convenience/feasibility of carrying out a multi-night AMP study in the home
timeFrame: 6 months
measure: Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
timeFrame: 6 months
Secondary outcomes:
measure: Time to therapy
timeFrame: 6 months
measure: Number of study visits
timeFrame: 6 months
measure: Length of study visits
timeFrame: 6 months
measure: Ease of scheduling study visits
timeFrame: 6 months
Other outcomes:
Locations:
city: Encino
country: United States
facility: Encino Center for Sleep and TMJ Disorders
state: California
Study officials:
References:
Clinical trial NCT04677582: VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities
Official title: Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 140
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested:

Detailed description: Specific Aim 1: To test the acceptability of a multidisciplinary group intervention targeted towards low-income Latino families with a child who is obese.

Specific Aim 2: To test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (BMI-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.

Eligibility criteria: Inclusion Criteria:

* Pre-pubertal (girls must not have started menses)
* Of Latino/Hispanic descent (parent self-identified)
* BMI for age \>85th percentile (based on CDC growth reference)
* Child between 5-11 years old
* Healthy (no known chronic diseases or regular medication)
* Parent/adult caregivers willing to participate in all study visits

Exclusion Criteria:

* Not of Latino/Hispanic descent
* \<5 years old or \>11 years old
* BMI for age \<85th percentile
* Not pre-pubertal (girls have experienced their first menses)
* Child has learning deficits or acute/chronic medical condition
* Parent/guardian has no transportation or unable to participate in sessions

Primary outcomes:
measure: Change from Baseline BMI at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
measure: Change from Baseline Body Fat Percentage at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
measure: Change from Baseline Blood Pressure at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
measure: Change from Baseline Waist Circumference at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
measure: Change from Baseline HbA1c at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
measure: Change from Baseline Glucose at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
measure: Change from Baseline Blood Lipids at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woodbridge
country: United States
facility: Featherstone Elementary School
state: Virginia
city: Woodbridge
country: United States
facility: Kilby Elementary School
state: Virginia
Study officials:
affiliation: George Mason University
name: Margaret Jones, PhD, CSCS*D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873582: Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
Official title: Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia Repair
Lead sponsor: Distalmotion SA
Sponsor class: INDUSTRY
Collaborators: name: confinis AG
First posted: 2023-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair

Brief summary: This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.


Eligibility criteria: Inclusion Criteria:

* Aged \> 18 years
* Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
* Able to provide Informed Consent according to local regulation

Exclusion Criteria:

* Morbidly obese patients (BMI \> 40)
* Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
* Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
* Bleeding diathesis
* Pregnancy
* Patients with pacemakers or internal defibrillators
* Any planned concomitant procedures
* Patient deprived of liberty by administrative or judicial decision or under legal guardianship
* Participation in another interventional clinical trial

Primary outcomes:
measure: Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events
timeFrame: perioperatively up to 30 days
measure: Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Saintes
country: France
facility: Centre Hospitalier de Saintes
city: Kiel
country: Germany
facility: UKSH Kiel
city: Winterthur
country: Switzerland
facility: Kantonspital Winterthur
Study officials:
References:
Clinical trial NCT03021382: Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
Collaborators: name: HeartFlow, Inc.
First posted: 2017-01-13
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 72 vessels in 57 patients

Brief summary: The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.

Detailed description: Analysis of cCTA and OCT was conducted under blind in independent organizations.

After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data.

After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry.

Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.

Eligibility criteria: Inclusion Criteria:

- Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.

Exclusion Criteria:

1. Prior coronary artery bypass graft (CABG) surgery
2. Contraindication to beta blocker agents or nitrates
3. Tachycardia or significant arrhythmia
4. Impaired chronic renal function (eGFR \<30)
5. Subjects with known anaphylactic allergy to iodinated contrast material
6. Pregnancy or unknown pregnancy status in subject of childbearing potential
7. Cases with poor OCT or CCTA image for analyzing

Primary outcomes:
measure: Correlation between cCTA and OCT for MLA measurements
timeFrame: Immediately after OCT scan
Secondary outcomes:
measure: Correlation between FFRCT and FFROCT
timeFrame: Immediately after OCT scan
measure: Impact of calcification on the agreement of MLA between OCT and cCTA measurement
timeFrame: Immediately after OCT scan
measure: Impact of calcification on the agreement of FFR between OCT and cCTA
timeFrame: Immediately after OCT scan
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine, Department of Cardiology
state: Hyogo
Study officials:
References:
Clinical trial NCT04080882: Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands
Official title: A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Platysmal Bands
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe platysmal bands at maximum contraction as assessed by the Investigator using a photographic scale
* Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the subject using a photographic scale

Exclusion Criteria:

* Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment

Primary outcomes:
measure: Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo
timeFrame: Month 1 after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Galderma Research Site
state: California
city: Encino
country: United States
facility: Galderma Research Site
state: California
city: Boynton Beach
country: United States
facility: Galderma Research Site
state: Florida
city: Miami
country: United States
facility: Galderma Research Site
state: Florida
city: New Orleans
country: United States
facility: Galderma Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Galderma Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Galderma Research Site
state: Maryland
city: New York
country: United States
facility: Galderma Research Site
state: New York
Study officials:
References:
Clinical trial NCT03974282: Brain Function and Decision-Making
Official title: Brain Function and Decision-Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Social
Psychology, Social
Social Interaction
Interpersonal Relations
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-06-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is about how brain function and structure is different between two universities. Participant in this project will contribute to a better understanding of how universities affect the brain.

Detailed description: Some study details are purposely omitted at this time to preserve scientific integrity. Now that the study is completed, full details are included below.

The true purpose of this study was to investigate the psychometric properties of the two computer tasks that participants completed. Specifically, researchers wanted to know if they would be able to accurately measure motivated empathy. To better understand this, participants were asked to rate images of people expressing pain and were told that these were either students from their university or students from a different university. This was not the case. The faces shown were random images produced for a research study.

Researchers also wanted to know if they could accurately measure moral decision making and how those judgments relate to aggression. To examine this, participants were asked whether various scenarios were immoral and then asked about aggressive tendencies.

Eligibility criteria: Inclusion Criteria:

* Undergraduate students aged 18 - 35 years of age
* No current or regular use of prescribed or illicit psychoactive drugs
* Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
* Free of a neurological or psychiatric disorders
* No current drug abuse (e.g., recreational drug use, average alcohol intake in excess of 4 drinks per day).
* Right hand dominant
* Free of claustrophobia
* Free of pregnancy or suspected pregnancy
* Absent MRI risk factors (e.g., implanted medical device, body mass index \> 35, braces)
* Free of medical conditions that render individuals with overly sensitive hearing
* No colorblindness

Exclusion Criteria:

• Not meeting the inclusion criteria listed above.

Primary outcomes:
measure: Change in Prefrontal Cortex Brain Activity Assessed by fMRI
timeFrame: Baseline to 3 hours
measure: Change in Accuracy of Empathic Pain Judgments
timeFrame: Baseline to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: David Chester, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044382: Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Official title: A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: Revimid
CC5013
CC-5013
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2002-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .


Eligibility criteria: * Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
* Baseline mean hemoglobin \< 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
* More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
* Women must not be pregnant or lactating
* No use of another experimental study drug within 30 dy\\ays of baseline
* Understand and sign written informed consent
* Able to adhere to study visit schedule, understand and comply with other protocol requirements.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
Study officials:
References:
citation: List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.
Clinical trial NCT05175482: Health Belief Model Based Education on Human Papilloma Virus Infection and Vaccination
Official title: The Impact of Health Belief Model Based Education on Human Papilloma Virus Infection and Vaccination Among University Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Health Behavior
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate impact of Health Belief Model Based Education on Human Papilloma Virus Infection and Vaccination among University Students

Detailed description: In this randomized controlled study, it aims to evaluate impact of Health Belief Model based virtual education on Human Papilloma Virus Infection and Vaccination among University Students.

Eligibility criteria: Inclusion Criteria:

* University students aged 18 years or over

Exclusion Criteria:

* University students have been received HPV vaccine

Primary outcomes:
measure: Change from baseline assessment of knowledge level on Human Papilloma Virus (HPV) Infection and Vaccination at first day
timeFrame: baseline and next day after the education (at first day)
measure: Change from baseline score of Human Papilloma Virus (HPV) Infection and Vaccination Health Belief Model Scale at first day
timeFrame: baseline and next day after the education (at first day)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Betul Okuyan
role: PRINCIPAL_INVESTIGATOR
References: