louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02861820: Functional Connectivity Changes During Early Recovery as a Marker for Relapse
Official title: Functional Connectivity Changes During Early Recovery as a Marker for Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use Disorder
Keywords: fMRI
brain networks
biomarker
relapse
stimulants
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-08-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult individuals with Substance Use Disorder

Brief summary: The study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. More specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery. This study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.


Eligibility criteria: Inclusion Criteria:

* At least 18 but no more than 45 years old at the time of consent.
* Able to provide written consent and comply with study procedures.

Exclusion Criteria:

* Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, HIV).
* Any contraindications to MRI scanning (i.e. metal implants, pacemakers, etc.).
* Intellectual developmental disorder as defined in the DSM-V. Participant may have a diagnosis of an Axis I disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable.
* Actively suicidal.
* Positive screen for alcohol and/or drugs. Participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again.
* Evidence for Wernicke-Korsakoff syndrome.
* Healthy Controls may never have had any form of substance use disorder other than caffeine or nicotine. Nicotine use will be recorded but will not be an exclusion criterion.

Primary outcomes:
measure: Brain connectivity
timeFrame: Change from Baseline, to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kelvin O Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542074: Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
Official title: Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Keywords: Bacterial vaginosis
recurrence
male factor
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2007-10-10
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.


Eligibility criteria: Inclusion criteria:

* Vaginal symptoms
* Nugent score \> 6 for vaginal fluid gram stain
* Woman and her male partner both interested in study participation
* Woman able to return for follow-up visits
* Woman able to provide detailed contact information for tracing

Exclusion Criteria:

* Either male or female partner not recruited within 24 hours of the other

Primary outcomes:
measure: bacterial vaginosis by Nugent's score
timeFrame: up to 2 months following treatment
Secondary outcomes:
measure: presence of lactobacillus by culture
timeFrame: 2 months following treatment
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Nairobi City Council STI referral clinic (Special Treatment Clinic)
Study officials:
affiliation: University of Washington
name: King K. Holmes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740974: Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Asthma
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-08-25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Study population: children previously randomized in a clinical study consuming LCP-supplemented infant formula

Brief summary: Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy.


Eligibility criteria: Inclusion Criteria:

* children previously randomized in a clinical study consuming LCP-supplemented infant formula

Exclusion Criteria:

* children who did not previously participate in a randomized clinical study consuming LCP-supplemented infant formula

Primary outcomes:
measure: Prevalence of asthma and allergy related diagnosis in medical records during first 3 years of life.
timeFrame: after first 3 years of life
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
References:
Clinical trial NCT01735474: Results of Manual Therapy on Pulmonary Parameters
Official title: Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Respiratory Disease
Keywords: manual therapy
respiratory disease
thoracic movement
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the effectiveness of different manual techniques included traditionally on respiratory physical therapy

Detailed description: Randomized controlled trial. Participants are classified in two groups and they are assessed using pulmonary functions parameters and thoracic and spinal movements.

There are two interventions: placebo and a manual technique. Participants will be assessed again at the end of the study.

Eligibility criteria: Inclusion Criteria:

* subjects with respiratory conditions
* Must be able to do spirometry

Exclusion Criteria:

* subjects with acute processes in their pathologies

Primary outcomes:
measure: spirometry parameters
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: thoracic movement
timeFrame: at baseline, 6 months
measure: Changes on Functionality scores
timeFrame: baseline, 6 months
measure: Changes on cardiorespiratory capacity
timeFrame: baseline, 6 months
measure: spinal movement
timeFrame: at baseline, 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of health Sciences. University of Granada
Study officials:
affiliation: Universidad de Granada
name: Carmen M Valenza, PH MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564174: Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
Official title: A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Recurrent Pregnancy Loss
Antiphospholipid Antibody Syndrome
Keywords: recurrent pregnancy loss
lupus anticoagulant
anti cardiolipin antibodies
thrombophilia
low molecular weight heparin
aspirin
randomized clinical trial
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Pfizer
First posted: 2007-11-27
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.

Detailed description: Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.

Eligibility criteria: Inclusion Criteria:

* history of two or more unexplained consecutive pregnancy losses prior to 32 weeks
* presence of one of the panel of autoantibodies/thrombophilia markers
* confirmed pregnancy

Exclusion Criteria:

* SLE
* known peptic ulcer disease
* sensitivity to ASA or heparin
* previous thrombotic event
* geographic distance from clinic
* failure to consent

Primary outcomes:
measure: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
timeFrame: Duration of pregnancy
Secondary outcomes:
measure: Secondary outcomes included adverse events and incidence of bone loss in the two groups.
timeFrame: pre-pregnancy through postpartum period
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hosptial
state: Ontario
Study officials:
affiliation: Associate Professor, Department of Medicine, University of Toronto
name: Carl A Laskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
Clinical trial NCT06789874: To Compare the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars
Official title: Comparing the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrophic Acne Scar
Atrophic Acne Scarring
Keywords: Acne scars
TCA peel
Intralesional saline
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2025-01-23
Enrollment: 126
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.

Detailed description: Acne vulgaris is a common skin problem affecting adolescents and adults. It is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.A randomized controlled trial was conducted at the Dermatology Department, Sheikh Zayed Hospital, Rahim Yar Khan, from 1st April 2023 to 31st October 2023. 126 patients were enrolled. Scar grading was based on Goodman and Baron's Qualitative Scar Classification. The Observer Scar Assessment Scale (OSAS) was used by dermatologists. Patients rated their acne scars using the Visual Disease Severity Scale. Photographs were taken for comparison. Efficacy was defined as ≥50% improvement in the OSAS.

Eligibility criteria: Inclusion Criteria:

* Age: 13-50 years
* Clinically diagnosed patients of atrophic acne scars on face
* duration of more than 6 months
* no history of any procedural intervention in past 3 months

Exclusion Criteria:

* history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities
* history of use of oral isotretinoin, OCPs, steroids or immunosuppressants
* pregnant or lactating females

Primary outcomes:
measure: Observer Scar Assessment Scale
timeFrame: clinical assessment will be done monthly for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rahimyarkhan
country: Pakistan
facility: Sheikh Zayed Medical College/Hospital
state: Punjab
city: Rahimyarkhan
country: Pakistan
facility: Sheikh Zayed Medical College/Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT02087774: Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children
Official title: The Effects of a Brief Physical Activity Program on Elementary School Students' Physical Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise.

Detailed description: Intervention group played music for 6 minutes each morning in addition to recess and physical activity classes. Baseline fitness data and after-intervention data were compared.

Eligibility criteria: Inclusion Criteria:

* All students were invited to participate.

Exclusion Criteria:

* Lack of parental consent

Primary outcomes:
measure: Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes
timeFrame: Baseline to 12 weeks later
measure: Change From Baseline to After Intervention for After-Exercise Heart Rate
timeFrame: Baseline to 12 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall University
state: West Virginia
Study officials:
affiliation: Marshall University
name: Rebecca H Hayes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299374: Effectiveness of the Pilates Method to Prevent and Reduce Falls in Older People
Official title: Estudio Comparativo de Los Beneficios Del Método Pilates Frente a un Programa específico de prevención de caídas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging Problems
Keywords: Pilates
Balance
Falls
Older people
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present research aims at evidencing the effect of one of the training methodologies increasingly demanded by the older adult, and used to promote, maintain and enhance physical and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates as an effective method in the following specific aspects: balance, prevention and reduction of falls, and improvement of the quality of life in the older adult


Eligibility criteria: Inclusion Criteria:

* Subjects +60 years.
* Subjects without cognitive impairment that prevent from performing interventions. A score in the Mini-Cognitive Examination of Lobo has to be equal or greater than 20 points.
* Subjects without physical impairment that prevent from performing interventions, or can directly influence the evaluation of the balance abilities (i.e., vestibular pathologies, amputated limbs, etc.)
* Subjects willing to participate, and have read, understood and signed an informed consent.

Primary outcomes:
measure: Falls calendar
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Falls Efficacy Scale International
timeFrame: change from baseline to end of intervention (4 month) and follow-up (1 year)
measure: Timed UP and Go Test
timeFrame: change from baseline to end of intervention (4 month) and follow-up (1 year)
measure: Functional Reach Test
timeFrame: change from baseline to end of intervention (4 month) and follow-up (1 year)
measure: One Leg stance
timeFrame: change from baseline to end of intervention (4 month) and follow-up (1 year)
measure: Euro Quality of Life 5 Dimension
timeFrame: change from baseline to end of intervention (4 month) and follow-up (1 year)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Jose M Blasco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875574: Improving the Management of Drug Resistant Tuberculosis in the UK
Official title: Improving the Management of Drug Resistant Tuberculosis in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Isoniazid
Drug Resistance
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2016-08-23
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with isoniazid resistant tuberculosis disease notified in England to Public Health England's Enhanced Tuberculosis Surveillance System 2009-13 who were not treated at private hospitals.

Brief summary: The 'rising tide' of antimicrobial resistance is a source of concern across most infectious diseases. In the UK, for example, 6.8% of the \~8,500 tuberculosis patients seen in 2012 were resistant to the cheap and effective first-line drug isoniazid. It is of great importance to prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance by treating such patients as well as possible.

Currently, guidance on the best treatments for isoniazid resistant tuberculosis is inconsistent globally. Data from randomised controlled trials, the peak quality of evidence, is sparse. It is thus important that studies using pre-existing observational data are undertaken.

The investigators aim to use data and samples collected from Public Health England and National Health Service hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug resistance in the infecting bacteria influence a) (nested case-control study). Eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in England between 2009 and 2013 and will have been notified to Public Health England. The study will be conducted at University College London, National Health Service hospitals and Public Health England and will last until December 2017. Patient hospital records and disease surveillance records will be accessed and cultured bacteria from previously stored samples sequenced.


Eligibility criteria: Inclusion Criteria:

* Isoniazid resistant non-multidrug resistant tuberculosis patients.
* Notified to Public Health England's Enhanced Tuberculosis Surveillance System between 2009-2013.
* Adults aged 18 years and over.
* Patients not treated at private hospitals.

Exclusion Criteria:

* Non-notified patients.
* Individuals where the site of disease required more than 12 months of treatment.
* Individuals diagnosed post-mortem.

Primary outcomes:
measure: Treatment outcome
timeFrame: Up to 12 months after the start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
state: Greater London
Study officials:
References:
Clinical trial NCT05801874: Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
Official title: Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke Sequelae
Hemiparesis
Gait Disorders, Neurologic
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single laboratory movement analysis with different tools and tecniques

Brief summary: The purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. Device as single Microsoft sensor Kinect v2, wearable sensorized clothing and/or smartphone-type devices will be used; it is also planned to analyze and compare such parameters with those obtained through a technique of manual palpatory analysis. Finally the obtained measures will be compared with the corresponding ones obtained with Three-dimensional instrumented gait analysis (3D-GA).


Eligibility criteria: Inclusion Criteria:

* patient with post-stroke chronic hemiparesis (at least 6 month post-acute event)
* ability to stand erect for 30 seconds
* ability to walk with or without aids for 10 meters

Exclusion Criteria:

* Moderate/severe cognitive impairment (MMSE \< 22)
* Moderate/severe depression (Hamilton Depression Scale \> 20)
* Severe spasticity

Primary outcomes:
measure: GPS (Gait Profile Score index) - differences between techniques
timeFrame: During movement analysis
Secondary outcomes:
measure: Gait cycle values (stance and swing duration) - differences between techniques
timeFrame: During movement analysis
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
affiliation: Istituto Auxologico Italiano
name: Matteo Bigoni, MD
role: PRINCIPAL_INVESTIGATOR
References: