louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05467774: Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
Official title: Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Training
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators performed a feasibility trial of operant conditioning of spinal reflex excitability on five healthy individuals and two post-stroke individuals. The investigators found that operant conditioning of rectus femoris reflex excitability was feasible in all participants.

Detailed description: The investigators performed a cohort study on 7 individuals (5 healthy, 2 post-stroke) to examine the feasibility of operant down-conditioning of rectus femoris reflex excitability (i.e. H-reflex). Each individual performed 30 sessions, 6 baseline sessions with no operant conditioning (225 trials of surface electrical stimulation of the femoral nerve), followed by 24 training sessions (20 baseline trials followed by 225 trials with feedback of H-reflex magnitude). The investigators' main outcome measure was rectus femoris H-reflex magnitude. We also examined H-reflex magnitude of other quadriceps muscles.

Eligibility criteria: Inclusion Criteria:

* Premorbidly independent
* Mild to moderate impairment determined by standard practices per the physical therapist
* Ability to stand for 10-minute intervals unassisted
* Ability to walk for 10-minutes on a treadmill
* Reduced knee flexion during phase and SKG as determined by a clinician
* Hemiparesis
* Ability to provide informed consent

Exclusion Criteria:

* History of cerebellar stroke, multiple stroke
* History of serious lower limb musculoskeletal injury
* Functionally relevant osteoarthritis and weight-bearing restrictions
* Have condition related to claustrophobia or other MRI contraindications
* Functionally relevant cognitive impairment
* Functionally relevant vision impairment
* Took antispasmodic medication one day prior to the session
* Had Botox injection one week prior to the session
* Pregnant women

Primary outcomes:
measure: Percentage Change From Baseline in RF H-reflex Magnitude
timeFrame: 3 months
Secondary outcomes:
measure: Percentage Change From Baseline in VM H-reflex Magnitude
timeFrame: 3 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT02219074: Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Official title: A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Sebacia, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of moderate to severe acne vulgaris

Exclusion Criteria:

* use of oral retinoid therapy in the past 12 months
* pregnancy, lactating, or planning to become pregnant
* excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne

Primary outcomes:
measure: Change in inflammatory lesion count
timeFrame: Week 12
measure: Number of adverse events
timeFrame: Screening to 26 weeks
Secondary outcomes:
measure: Investigator Global Assessment
timeFrame: Week 12
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny
city: Warsaw
country: Poland
facility: Military Institute of Health Services
Study officials:
References:
Clinical trial NCT05015374: Effect of Astaxanthin on the Patients With Alzheimer Disease
Official title: Effect of Astaxanthin on the Patients With Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease
Keywords: Alzheimer disease
Astaxanthin
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, China
First posted: 2021-08-20
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study adapts a randomized, double-blind, placebo-controlled trial, to exam the possible benefit of Astaxanthin on Alzheimer disease. The enrolled Alzheimer patients will take Astaxanthin or placebo for 1 year. We will follow up Mini-Mental State Examination, Cognitive Ability Screening Instrument, Clinical Dementia Rating, and Neuropsychiatric Inventory at the end of the study.

Detailed description: This study aims to examine the benefit of Astaxanthin as adjuvant therapy for Alzheimer's disease.

Eligibility criteria: Inclusion Criteria:

1. 60 ≦ age ≦ 90
2. Clinical Dementia Rating Scale = 0.5 or 1
3. Under treatment with donepezil、rivastigmine or galantamine with good medical adherence
4. Get a signed informed consent from the patient or his/her family

Exclusion Criteria:

1. Not using or poor medical adherence to donepezil、rivastigmine or galantamine
2. Combined using memantine or other cerebral perfusion enhancing agent, such as Piracetam, Dihydroergotoxine, Nicergoline etc.
3. New cerebrovascular disease happens during 3-year follow up
4. Mixed type dementia
5. Major psychiatric disease (such as depression, bipolar disorder, schizophrenia) or substance abuser (such as alcohol, illegal drug, hypnotics)
6. Heart failure, end stage renal disease, liver cirrhosis, or other major organ failure
7. Severe hearing impairment results in incomplete survey of neuropsychatric evaluation
8. No informed consent or no regular follow up

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: 3 years
measure: Cognitive Ability Screening Instrument (CASI)
timeFrame: 3 years
measure: Clinical Dementia Rating (CDR)
timeFrame: 3 years
measure: Neuropsychiatric Inventory (NPI)
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events [safety and tolerability]
timeFrame: 3 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT01948674: Cognitive Stimulation in Adolescents
Official title: Cognitive Training in Adolescents During Treatment for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Use Disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-09-23
Enrollment: 87
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks.


Eligibility criteria: Inclusion Criteria:

* age 14-21
* Diagnosis of substance use disorder (SUD) by DSM-IV criteria with marijuana as primary substance of abuse
* eligible for intensive outpatient treatment

Exclusion Criteria:

* Untreated psychiatric disorder that might make participation hazardous
* Any condition associated with severe cognitive impairment

Primary outcomes:
measure: working memory (change from baseline)
timeFrame: expected within 2 weeks after intervention
Secondary outcomes:
measure: timeline follow back (change from baseline)
timeFrame: expected within 2 weeks after intervention
measure: delay discounting (change from baseline)
timeFrame: expected within 2 weeks after intervention
measure: Stroop (change from baseline)
timeFrame: expected within 2 weeks after intervention
measure: reading comprehension (change from baseline)
timeFrame: expected within 2 weeks after intervention
measure: emotion regulation (change from baseline)
timeFrame: expected within 2 weeks after intervention
measure: Go-No Go (change from baseline)
timeFrame: expected within 2 weeks after intervention
measure: Global Appraisal of Individual Needs (change from baseline)
timeFrame: expected within 2 weeks after intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mountain Manor Treatment Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Matthew W Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03747874: OSA and Sudden Sensorineural Hearing Loss
Official title: Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Sudden Hearing Loss
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2018-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study studies the prevalence between obstructive sleep apnea syndrome and sensorineural hearing loss. We recruit patients who have been treated for sudden sensorineural hearing loss in Poitiers' University Hospital between 2010 et 2017, and we detect if they have OSA with a ventilatory polygraphy.


Eligibility criteria: Inclusion Criteria:

* past medical history of sudden hearing loss between 2010 and 2017
* no contraindication to a non supervised sleeping monitoring

Exclusion Criteria:

* past medical history of fluctuant hearing loss or pre-existant significative hearing loss

Primary outcomes:
measure: Study of the prevalence of OSA on patient with a history of sudden hearing loss
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Dufour Xavier
Study officials:
References:
Clinical trial NCT02520674: Glaucoma Screening With Smartphone Ophthalmology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the accuracy and reliability of smartphone ophthalmoscopy compared to slit-lamp biomicroscopy in glaucoma screening for potential community screening programs.


Eligibility criteria: Inclusion Criteria:

* ocular hypertension
* glaucoma

Exclusion Criteria:

* substantial media opacity
* refractive error outside the range from -10.00 to +5.00 diopters

Primary outcomes:
measure: Vertical cup-to-disc ratio
timeFrame: Up to 25 weeks from date of study initiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01246674: Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty
Official title: Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty Monitored Pre-operatively, on the Day of Discharge, and One Week Post-surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthrosis Patients With Total Hip Arthroplasty
Keywords: function, hip muscle strength, hip replacement, hip pain,
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2010-11-23
Enrollment: 30
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: from a department of orthopedic surgery

Brief summary: By this study the investigators wish to (1) quantify hip strength and functional-performance deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if changes in thigh circumferences, or hip pain are correlated to changes in hip strength and functional-performance after fast-track THA.

Detailed description: The investigators intend to use the results to optimize the rehabilitation programs for THA patients shortly after surgery

Eligibility criteria: Inclusion Criteria:

* Total hip arthroplasty patients

Exclusion Criteria:

* inability to speak and understand Danish
* inability to perform the functional measurements due to other conditions

Primary outcomes:
measure: hip muscles strength
timeFrame: 6 months
Secondary outcomes:
measure: Functional performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dep. of Physical Therapy, Copenhagen University Hospital at Hvidovre
Study officials:
affiliation: The Lundbeckcenter for hip and knee surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre Denmark
name: Bente Holm, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
citation: Holm B, Thorborg K, Husted H, Kehlet H, Bandholm T. Surgery-induced changes and early recovery of hip-muscle strength, leg-press power, and functional performance after fast-track total hip arthroplasty: a prospective cohort study. PLoS One. 2013 Apr 16;8(4):e62109. doi: 10.1371/journal.pone.0062109. Print 2013.
Clinical trial NCT01470274: Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients
Official title: Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Chronic Obstructive Pulmonary Disease
Keywords: Blood volume
CO-rebreathing
COPD
CVD
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable, optimally medicated coronary artery disease and COPD patients with LVEF ≥ 0.40 will be recruited

Brief summary: The primary objective is to establish the safety of the CO-rebreathing method for measuring total blood and plasma volume in CAD patients. The working hypothesis is that the CO-rebreathing method is safe in use with coronary artery disease patients and that it does not cause myocardial ischemia or cardiovascular damage.


Eligibility criteria: Inclusion Criteria:

* Stable coronary artery disease
* Stable COPD
* Optimal medication

Exclusion Criteria:

* Unstable disease
* co-morbidities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Karlsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karlsen T, Leinan IM, Aamot IL, Dalen H, Stoylen A. Safety of the CO-Rebreathing Method in Patients with Coronary Artery Disease. Med Sci Sports Exerc. 2016 Jan;48(1):33-8. doi: 10.1249/MSS.0000000000000729.
Clinical trial NCT03742674: Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke
Official title: Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CVA
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2018-11-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post stroke Age 18-69 years Hospitalized in brain injury rehabilitation at Sheba Tel-Hashomer medical center

Brief summary: Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke


Eligibility criteria: Inclusion Criteria:

* First cerebro vascular accident (CVA) diagnosis
* Basic cognitive and communicative abilities

Exclusion Criteria:

* Traumatic brain injury (TBI)
* Confusion state and lack of cooperation due to brain lesion
* Unstable cardiovascular status
* Independently climbing stairs ability at entrance

Primary outcomes:
measure: Independently climbing stairs ability
timeFrame: Through study completion, an average of 1-2 years
Secondary outcomes:
measure: Time post stroke
timeFrame: Through study completion, an average of 1-2 years
measure: Time for ascending and descending staircase
timeFrame: Through study completion, an average of 1-2 years
measure: Stairs climbing tipe
timeFrame: Through study completion, an average of 1-2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02050074: The Role of Metformin and Colesevelam in Human GLP-1 Secretion
Official title: The Role of Metformin and Colesevelam in Human GLP-1 Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).


Eligibility criteria: Inclusion Criteria:

* Normal hemoglobin
* BMI \> 23kg/m2
* HbA1c \<9 %
* Informed concent

Exclusion Criteria:

* Liver disease ( aspartate aminotransferase/alanine aminotransferase \>2 × reference value)
* Chronic intestinal disease
* History of liver and / or gallbladder disease
* Nephropathy (se-creatinine \>110 µM and / or albuminuria)
* Insulin or GLP-1-based antidiabetic treatment
* History of cholecystectomy or surgical resection of bowel segment
* BMI \<23kg/m2 or BMI \>35 kg/m2
* Pregnancy

Primary outcomes:
measure: Change in the gut hormone glucagon-like peptide 1 (GLP-1)
timeFrame: 0-240 min
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Diabetes Research Division, Department of Medicine, Gentofte Hospital
state: Copenhagen
Study officials:
References:
citation: Bahne E, Sun EWL, Young RL, Hansen M, Sonne DP, Hansen JS, Rohde U, Liou AP, Jackson ML, de Fontgalland D, Rabbitt P, Hollington P, Sposato L, Due S, Wattchow DA, Rehfeld JF, Holst JJ, Keating DJ, Vilsboll T, Knop FK. Metformin-induced glucagon-like peptide-1 secretion contributes to the actions of metformin in type 2 diabetes. JCI Insight. 2018 Dec 6;3(23):e93936. doi: 10.1172/jci.insight.93936.
Clinical trial NCT05790174: Weight-loss Treatment Program in Children and Adolescents
Official title: Healthy Weight Development Among Children and Adolescents in the Central Denmark Region
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Childhood Obesity
Health Behavior
Weight Loss
Motivation
Keywords: Childhood obesity treatment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with overweight and obesity were referred from their general practitioners, school- and community-based doctor/nurse to childhood obesity treatment at Hospital in the Central Denmark Region

Brief summary: The study will evaluate the effect of an existing hospital-based obesity treatment in children and adolescents in relation to weight loss and motivation. This is to ensure that children who have developed obesity have the possibility to obtain a healthier lifestyle, including a healthier body weight during their school years. This study will test whether an obesity treatment program designed for school children can reduce the degree of overweight in children and adolescents with overweight and obesity.


Eligibility criteria: Inclusion Criteria:

* 2-18 years old
* BMI SDS above the 90th percentile

Exclusion Criteria:

* Reached a BMI SDS below the 75th percentile
* Attained 19 years of age

Primary outcomes:
measure: Changes in BMI during weight-loss program of childhood overweight and obesity
timeFrame: December 2022 - December 2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: