louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02997917: Effect of Education on the Responses to Meal Ingestion
Official title: Factors That Determine the Response to Meal Ingested: Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low temperature and 25 g bread) will be studied in a parallel design. The effects of education will be tested in two different groups in random order: real versus sham education. In each group the responses to a probe meal will be tested on 2 different days before and after the intervention. Participants will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility criteria: Inclusion Criteria:

- non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Change in digestive well-being measured after a test meal by the end of the intervention versus before.
timeFrame: 1 day
Secondary outcomes:
measure: Change in satiety measured after a test meal by the end of the intervention versus before
timeFrame: 1 day
measure: Change in fullness sensation measured after a test meal by the end of the intervention versus before.
timeFrame: 1 day
measure: Change in discomfort/pain measured after a test meal by the end of the intervention versus before
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fernando Azpiroz
Study officials:
affiliation: University Hospital Vall d'Hebron
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06892717: Caregiver Burden in Parkinson's Disease
Official title: Caregiver Burden and Associated Factors in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of caregivers of patients diagnosed with Parkinson's disease, aged between 40-80 years, who meet the inclusion criteria.

Brief summary: Primary caregivers of patients diagnosed with idiopathic Parkinson's disease will be included in the study. A total of 43 participants will be recruited. At the beginning of the study, demographic data and clinical characteristics of the patients, including disease stage, history of falls, presence of fractures, presence and severity of pain, comorbidities, and medication use, will be recorded.

Subsequently, caregivers' age, gender, occupation, relationship to the patient, caregiving duration, and their own comorbidities will be assessed. Sleep problems will be evaluated using the Insomnia Severity Index (ISI), while symptoms related to depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be examined using the Zarit Caregiver Burden Scale.


Eligibility criteria: Inclusion Criteria:

* Age between 40-80 years
* Diagnosed with Parkinson's disease, Hoehn and Yahr stage 2-5
* Requires assistance in daily activities
* Informal caregiver providing care (unpaid, typically a family member such as a spouse or child)
* Caregiver has sufficient proficiency in Turkish to understand and respond to the study questions

Exclusion Criteria:

* Presence of any additional neurodegenerative disease other than Parkinson's disease
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Advanced heart failure classified as New York Heart Association (NYHA) Class IV (symptoms at rest)
* Active cancer disease
* History of stroke causing limitations in daily life
* Immobility due to reasons other than Parkinson's disease

Primary outcomes:
measure: Zarit Caregiver Burden Scale
timeFrame: Baseline
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)- Anxiety score
timeFrame: Baseline
measure: Hoehn and Yahr Scale
timeFrame: Baseline
measure: Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)- Depression score
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References:
Clinical trial NCT01172041: The Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging
Official title: Investigating the Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 10
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: Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center

Brief summary: This study will investigate whether audiovisual biofeedback, in which visual and audio cues are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D PET scans.


Eligibility criteria: Inclusion Criteria:

Required for inclusion in this study are:

* Informed consent
* Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center
* Age 18 or greater
* Painfree in supine position
* Karnofsky performance status 50 or greater

The inclusion of educationally disadvantaged, decisionally impaired or homeless people are allowed if informed consent, in the opinion of the consenting investigator (study PI, co-PI or research nurse), is obtained.

Exclusion Criteria:

No

* Pregnant women
* Stanford employees
* Stanford students
* Prisoners will be eligible for the study.

Primary outcomes:
measure: Measure the difference in number of artifacts on 4D CT scans using audiovisual biofeedback in comparison to Free breathing.
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Bill Loo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang J, Yamamoto T, Pollock S, Berger J, Diehn M, Graves EE, Loo BW Jr, Keall PJ. The impact of audiovisual biofeedback on 4D functional and anatomic imaging: Results of a lung cancer pilot study. Radiother Oncol. 2016 Aug;120(2):267-72. doi: 10.1016/j.radonc.2016.05.016. Epub 2016 May 30.
Clinical trial NCT01572441: Parent-Adolescent Interactions and Adolescent Development
Official title: Responses During Parent-child Interactions and Alcohol Use Behavior in Adolescents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Abuse
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-04-06
Enrollment: 245
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 12-14 year olds and their primary caregivers.

Brief summary: The purpose of this study is to observe parent-adolescent interactions and to examine the parenting behaviors and adolescent emotional and physiological responses that are associated with youth's substance use.

Detailed description: The study examines parenting behaviors and adolescent emotional responses during parent-adolescent interactions and whether these predict youth's current and future substance use over a 3 year follow-up.

Eligibility criteria: Inclusion Criteria:

* Adolescent between ages 12-14 years

Exclusion Criteria:

* For adolescent, Intelligence Quotient (IQ) \< 70 on standardized test, for parent, evidence of inability to read or write.
* Evidence of a psychotic disorder for parent or adolescent
* Diagnosis of autism or pervasive developmental disorder for adolescent, as determined by parent report in the screening.
* For adolescent, current need for acute treatment of a psychiatric disorder, as determined by parent report in the study screening.
* For adolescent and parent, inadequate English proficiency to comprehend task instructions

Primary outcomes:
measure: Substance Use
timeFrame: Baseline
measure: Substance Use
timeFrame: 6 month follow-up
measure: Substance Use
timeFrame: 1 year follow-up
measure: Substance Use
timeFrame: 2 year follow-up
measure: Substance Use
timeFrame: 3 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
city: Fairfax
country: United States
facility: George Mason University
state: Virginia
Study officials:
affiliation: Yale University
name: Tara Chaplin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaplin TM, Sinha R, Simmons JA, Healy SM, Mayes LC, Hommer RE, Crowley MJ. Parent-adolescent conflict interactions and adolescent alcohol use. Addict Behav. 2012 May;37(5):605-12. doi: 10.1016/j.addbeh.2012.01.004. Epub 2012 Jan 13.
citation: Turpyn CC, Chaplin TM, Cook EC, Martelli AM. A person-centered approach to adolescent emotion regulation: Associations with psychopathology and parenting. J Exp Child Psychol. 2015 Aug;136:1-16. doi: 10.1016/j.jecp.2015.02.009. Epub 2015 Apr 4.
Clinical trial NCT03891641: Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
Official title: A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Treadwell Therapeutics, Inc
First posted: 2019-03-27
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.
Primary purpose: TREATMENT

Brief summary: This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.


Eligibility criteria: Inclusion Criteria:

* Be able to walk without an assistive aid (i.e., walker, cane)
* Have the capacity the provide written informed consent
* Have previously diagnosed peripheral arterial disease (by self-report)

Exclusion Criteria:

* Lower extremity injury or fracture within the last 6 months
* Have a leg prosthesis
* Prisoners
* Individuals clearly lacking the capacity to provide informed consent
* Vestibular impairment

Primary outcomes:
measure: Change in Overground Walking Speed After Intervention
timeFrame: Baseline, 6 weeks
measure: Change in 6-min Walk Distance
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change in Stride Length
timeFrame: Baseline, 6 weeks
measure: Change in Peak Ankle Power
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Biomechanics Laboratory
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jason Franz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758041: A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Official title: A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Acne Vulgaris
Keywords: Acne
Lead sponsor: Sebacia, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 16-45 years of age.
2. Moderate to moderately-severe facial inflammatory acne vulgaris
3. Fitzpatrick skin phototype I-III

Exclusion Criteria:

1. Pregnant, lactating, nursing or planning to become pregnant
2. Tattoo in the treatment area
3. Active skin disease, excessive scarring or excess facial hair in the treatment area
4. Certain current or recent acne treatments
5. Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
6. Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
7. Known allergy to gold

Primary outcomes:
measure: Percent reduction in lesion count from baseline
timeFrame: Baseline, Week 12, Week 24, Week 36
Secondary outcomes:
measure: Improvement in Investigator Global Acne Score
timeFrame: Baseline, Week 12, Week 24, Week 36
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Lasercenter North
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
city: Geneva
country: Switzerland
facility: SKINPULSE Dermatology Laser & Beauty Center
Study officials:
affiliation: Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
name: Merete Haedersdal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391741: The Effect of High-Volume Walking With Visual Cues (VC) in Parkinson´s Disease (PD)
Official title: The Effect of High-Volume Walking With Visual Cues on Gait in People With Parkinson´s Disease. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson´s Disease
Keywords: Parkinson´s Disease
Walking
Exercise
Automaticity
Dual Task
Visual Cues
Cueing
Neuroplasticity
Gait analysis
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: The Icelandic Parkinson´s Association.
name: Icelandic Physiotherapy Association
First posted: 2011-07-12
Enrollment: 26
Sex: ALL
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with disease (PD) tend to walk with short steps, decreased velocity, and increased stride time variability. Short steps and increased variability are related to greater fall risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked effects on gait in people with PD which is considered to reflect an impaired automaticity of gait.

Objective: To investigate short and long term effects of high-volume walking with visual spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with Parkinson´s Disease (PD), compared with walking without VSC.


Eligibility criteria: Inclusion Criteria:

* a confirmed diagnosis of PD according to the UK Parkinson´s Disease Society Brain Bank Clinical Diagnostic Criteria (18)
* \<80 years of age
* community residing
* Hoehn and Yahr (HY) stage 2-3
* Mini Mental State Examination (MMSE) score of \>23
* ability to walk without walking aids for a total of 20 minutes over a 30-minute period

Exclusion Criteria:

* major modifications of Parkinson´s medication (Madopar \>200 mg/d or \>20% increase in Dopamine agonists) 3 weeks prior to baseline assessment
* comorbidities or disabilities, which might influence walking
* a history of brain surgery

Primary outcomes:
measure: Change in Step Length
timeFrame: Before, after and 3 months after a 4 week training period
measure: Change in Gait Velocity
timeFrame: Before, after and 3 months after a 4 week training period
measure: Change in Stride Time Variability
timeFrame: Before, after and 3 months after a 4 week training period
Secondary outcomes:
measure: Change in Timed Up & Go (seconds)
timeFrame: Before, after and 3 months after a 4 week training period
Other outcomes:
Locations:
city: Mosfellsbaer
country: Iceland
facility: Reykjalundur Rehabilitation Center
Study officials:
affiliation: University of Iceland / Reykjalundur Rehabilitation Center
name: Andri T Sigurgeirsson, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06860841: Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM
Official title: Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and Type 2 Diabetes Mellitus: a Placebo-controlled Randomized Double-Blind Crossover Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Overweight and Obese Adults
Keywords: D-Chiro-Inositol
Type 2 Diabetes Mellitus
Insulin Resistance
Metformin
Glycemic Variability
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of D-Chiro-Inositol (DCI) as an add-on therapy to metformin in improving insulin resistance, measured by the HOMA index, in people with overweight or obesity and type 2 diabetes mellitus (T2DM). Secondary outcomes include glycemic variability, indirect calorimetry, respiratory quotient, and other metabolic parameters.

Detailed description: The DIACHIRO trial is a randomized, double-blind, crossover clinical trial assessing the impact of DCI combined with metformin versus metformin plus placebo on insulin resistance in people with overweight or obesity and T2DM. The primary outcome is the change in the HOMA index. Secondary outcomes include glycemic variability parameters (e.g., time in range), oxidative stress markers, indirect calorimetry, respiratory quotient, and HbA1c levels. Participants are monitored using Flash Glucose Monitoring (FGM) systems.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of type 2 diabetes mellitus.
2. Age between 18-75 years.
3. BMI ≥25 kg/m².
4. HbA1c \< 9%.
5. Stable dose of metformin for at least three months prior to enrollment.

Exclusion Criteria:

1. Use of antidiabetic drugs other than metformin within three months prior to enrollment.
2. History of ketoacidosis or severe hypoglycemia within six months prior to enrollment.
3. Significant renal or hepatic impairment (eGFR \<60 mL/min/1.73 m²; ALT/AST \>2× ULN).
4. Pregnancy or lactation.

Primary outcomes:
measure: Change in the HOMA index
timeFrame: at the end of treatment phase (two weeks)
Secondary outcomes:
measure: Time in Range in %
timeFrame: at the end of treatment (two weeks)
measure: Changes in oxidative stress markers
timeFrame: at the end of treatment (two weeks)
measure: Indirect calorimetry measurements
timeFrame: at the end of treatment (two weeks)
measure: Respiratory quotient measurements.
timeFrame: at the end of treatment (two weeks)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
state: RM
Study officials:
References:
Clinical trial NCT03837041: Evaluation of Proprioception
Official title: Evaluate the Proprioception in Patients with Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proprioceptive Disorders
Keywords: total knee arthroplasty
Proprioception
osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2019-02-11
Enrollment: 71
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty.

Several studies demonstrated the correlation between OA, proprioception reduction and increased risk of falling. The aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.


Eligibility criteria: Inclusion Criteria are patients with ASA: 1, 2 or 3; patients who have given their informed written consent to participate in the study; patients live in Bologna and neighboring areas.

Exclusion Criteria are patients with previous osteotomy of the lower limbs; patients with post-traumatic arthrosis; patients with severe preoperative valgus deformity (Hip Knee Ankle angle\> 10 °); patients with BMI\> 40 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with walking diseases (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with Severe arthrosis of the ankle (Kellgren-Lawrence\> 3); patients with Severe coxarthrosis (Kellgren-Lawrence\> 3); patients with severe postural instability; patients with cognitive impairments, patients with concomitant neurological diseases

Primary outcomes:
measure: Improvement of a proprioception
timeFrame: 24 months
Secondary outcomes:
measure: Evaluation of performance in lower limb questionnaire
timeFrame: 24 months
measure: KSS Score
timeFrame: 24 months
measure: Clinical score
timeFrame: 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References: