louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04927091: Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine
Official title: Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Opioid-use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Ukrainian Institute on Public Health Policy
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-15
Enrollment: 1458
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: A randomized controlled trial to:

1. To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
2. Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.

Detailed description: Original outcomes were edited and Implementation outcomes were added November 2023.

Eligibility criteria: Inclusion Criteria:

* PWID
* Interested in MMT
* Meets DSM-V criteria for Opioid Dependence

Exclusion Criteria:

* Not willing to consent

Primary outcomes:
measure: Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy
timeFrame: every 6 months up to 24 months
Secondary outcomes:
measure: Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy
timeFrame: every 6 months up to 24 months
measure: Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy
timeFrame: every 6 months up to 24 months
measure: Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy
timeFrame: every 6 months up to 24 months
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: European Institute for Public Health Policy
Study officials:
affiliation: Yale University
name: Frederick Altice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02055391: A Weight Loss Trial for Emotional Eating
Official title: A Randomized Controlled Trial of a Novel Weight Loss Intervention for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions.


Eligibility criteria: Inclusion Criteria:

* Non-smoker, free of diabetes, overweight and interested in losing weight, eat in response to emotions

Exclusion Criteria:

* Diabetes, any major medical or psychiatric condition that would compromise ability to participate, hypertension, current mental health treatment

Primary outcomes:
measure: weight change
timeFrame: 12 weeks and 20 weeks
Secondary outcomes:
measure: changes in emotional eating
timeFrame: 12 weeks and 20 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: CORE
state: Pennsylvania
Study officials:
affiliation: Universidad La Salle, Mexico
name: Edie M Goldbacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldbacher E, La Grotte C, Komaroff E, Vander Veur S, Foster GD. An initial evaluation of a weight loss intervention for individuals who engage in emotional eating. J Behav Med. 2016 Feb;39(1):139-50. doi: 10.1007/s10865-015-9678-6. Epub 2015 Sep 4.
Clinical trial NCT01706991: Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
Official title: MEPEDS New Device Pediatric Vision Scanner
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Strabismus
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2012-10-15
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presenting for ophthalmic exam at eye clinic.

Brief summary: The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus. All tests and observations will be done at a single visit over the course of approximately 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Children aged 6 months to 6 years
* Signed Informed consent by parent or guardian
* Meet all inclusion criteria.

Exclusion Criteria:

* Children with a history of developmental delay or cognitive deficit
* Children unable to complete the GSE (including visual acuity testing)

Primary outcomes:
measure: Binocularity score
timeFrame: Day 1
Secondary outcomes:
measure: Presence of amblyopia risk factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Doheny Eye Institute
state: California
Study officials:
affiliation: University of Southern California
name: Rohit Varma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
Clinical trial NCT01019291: Role of Indoor Pollutants on House Dust Mite Allergic Asthma
Official title: Aldehyde and Nitrogen Dioxide at Homes: Measurement of the Exposure and Their Role on Allergic Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Allergic Asthma
Allergy to House Dust Mite
Keywords: Indoor pollutants
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: It seems that the aldehydes and NO2, at the levels found indoor, could be the aggravating factors for an allergic response. However this effect has not been demonstrated. The investigators plan to study the effect of exposure to standard doses of these pollutants on the bronchial reactivity as measured by bronchial challenge tests with dust mite extract in volunteers asthmatic, allergic to house dust mite.


Eligibility criteria: Inclusion criteria:

* M/F 18-50 years of age
* History of intermittent HDM allergic asthma-FEV1 \> 80%
* Non smokers or smokers with smoking \< 10 PY

Exclusion criteria:

* Persistent asthma and FEV1\<80%
* Allergic to pets and pets at home

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Unité de Pneumologie, d'Allergologie et de Pathologie Respiratoire de l'Environnement, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Pneumologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
name: Frederic DE BLAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03186391: Exercise Testing in Peripheral Artery Disease Patients
Official title: Sensitivity and Specificity of the AHA Post-exercise ABI Criteria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to our vascular unit with exercise limitation

Brief summary: The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).

Detailed description: This is a non interventional prospective cross sectional, monocentric study. All patients addressed in our vascular unit for exercise testing were included. All patients' data performed in clinical routine can be analyzed.

Eligibility criteria: Inclusion Criteria:

* All patients addressed in our vascular unit for exercise limitation

Exclusion Criteria:

* Incapacity to walk on the treadmill.
* A severe cardiopathy contraindicating a stress test

Primary outcomes:
measure: 1-min Post-exercise Ankle-Brachial Index (ABI)
timeFrame: at 1 minute after the stop of walking
Secondary outcomes:
measure: 3-min Post-exercise Ankle-Brachial Index (ABI)
timeFrame: at 3 minutes after the stop of walking
measure: 5-min Post-exercise Ankle-Brachial Index (ABI)
timeFrame: at 5 minutes after the stop of walking
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre hospitalier Universitaire
Study officials:
affiliation: Rennes University Hospital
name: Mahé Guillaume, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Metairie A, Tollenaere Q, Laneelle D, Le Faucheur A, Le Pabic E, Omarjee L, Mahe G. Simplification of ankle-brachial-index measurement using Doppler-waveform classification in symptomatic patients suspected of lower extremity artery disease. Front Cardiovasc Med. 2022 Sep 9;9:941600. doi: 10.3389/fcvm.2022.941600. eCollection 2022.
Clinical trial NCT00319891: Computer-Based Training for Mild Alzheimer's Disease
Official title: Computer-Based Training for Mild Cognitive Impairment and Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's
AD
Mild Cognitive Impairment
Dementia
Cognitive remediation
computer-based training
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2006-04-27
Enrollment: 6
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effects of computer-based training program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild Alzheimer's Disease (AD).

Detailed description: The purpose of this study is to determine the extent to which computer-based cognitive remediation improves cognitive functions using standardized neuropsychological assessments relevant to AD; 2) the acceptability and feasibility of using computer-based cognitive remediation in an AD population.

Eligibility criteria: Inclusion Criteria:

* Fluent in English.
* Mini-Mental Status Examination (MMSE) score of 22 or higher.
* Adequate visual capacity.
* Adequate hearing capacity.
* Has a caregiver with some computer experience.
* Willing and able to commit to the time requirement of the entire study.

Exclusion Criteria:

* Clinically significant cerebrovascular disease.
* Participant is planning to begin acetylcholinesterase inhibitor (AChEI) therapy.
* Participants with severe tremor.
* Axis 1 or 2 psychiatric disorders.
* History of substance abuse.
* History of head trauma.

Primary outcomes:
measure: The primary objective of this trial will be to assess the feasibility of using computer-based
measure: cognitive training in an a population with early Alzheimer's Disease.
Secondary outcomes:
measure: A standardized set of neuropsychological assessments will be conducted pre- and post-
measure: compuer-based training.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joel Kramer, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kristine Yaffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141791: Study Evaluating Etanercept in Moderate to Severe Asthma
Official title: A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Anti-Asthmatic Agents
Receptors
Tumor Necrosis Factor
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe persistent asthma for at least 1 year
* Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
* Subjects must be on a high-dose inhaled corticosteroid (ICS)

Exclusion Criteria:

* Previous treatment with etanercept
* Current use of cigarettes
* Significant concurrent medical conditions at the time of screening

Primary outcomes:
measure: Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Secondary outcomes:
measure: Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Denver
country: United States
state: Colorado
city: Sarasota
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Valrico
country: United States
state: Florida
city: Covington
country: United States
state: Louisiana
city: Wheaton
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rockville Center
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Holgate ST, Noonan M, Chanez P, Busse W, Dupont L, Pavord I, Hakulinen A, Paolozzi L, Wajdula J, Zang C, Nelson H, Raible D. Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. Eur Respir J. 2011 Jun;37(6):1352-9. doi: 10.1183/09031936.00063510. Epub 2010 Nov 25.
Clinical trial NCT05385094: Consistency Between Measures of Renal Function in ICU Patients
Official title: Consistency Between Measures of Renal Function in ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 5000
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: General ICU patients

Brief summary: This study aim to compare different measures of renal function (glomerular filtration rate) in ICU patients.

Detailed description: The study uses a large dataset of prospectively collected data according to clinical routines.

Eligibility criteria: Inclusion Criteria:

* ICU patients with at least one measurement of urinary creatinine clearance

Exclusion Criteria:

* Renal replacement therapy initiated before the measurement of creatinine clerance

Primary outcomes:
measure: Correlations between estimates of renal function
timeFrame: 7 days
measure: Correlations between changes in estimates of renal function
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
References:
Clinical trial NCT03076294: Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: knee ostearthritis
transcranial magnetic stimulation
repetitive transcranial magnetic stimulation
chronic pain
musculoskeletal manipulations
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach). For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of knee OA;
* Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
* Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.

Exclusion Criteria:

* Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
* Had an opioid or corticosteroid injection in the last 30 days;
* Modified chronic pain medication in the last month before participating in the study;
* History of knee surgery in the last six months;
* Obese;
* Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.

Primary outcomes:
measure: Pain
timeFrame: Until one day (before and after the interventions)
measure: Pain Rating Scale (NPRS)
timeFrame: Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
Secondary outcomes:
measure: Cortical excitability
timeFrame: One day (before and after the interventions)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
state: PE
city: Recife
country: Brazil
facility: Kinesiotherapy and manual therapeutic resources laboratory
state: PE
Study officials:
affiliation: Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
name: Kátia Monte-Silva, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06140394: The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy in Different Age Groups
Official title: The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Inflammation
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2023-11-20
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: the summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients

Detailed description: 2 ml of unstimulated saliva will be collected using spitting method, the collected samples will then be analyzed using Elisa technique for salivary Inducible nitrous oxide synthase levels.

Eligibility criteria: Inclusion Criteria:

* males and females
* aged below 40 or above 60
* periodontitis stage 2
* no tooth loss due to periodontitis

Exclusion Criteria:

* smoking habits
* history of antibiotics
* history of systemic diseases

Primary outcomes:
measure: clinical parameters (gingival index)
timeFrame: 6 months
measure: clinical parameters (clinical attachment loss)
timeFrame: 6 months
Secondary outcomes:
measure: assessment of inducible nitrous oxide synthase levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
state: Nasrcity Nasr Street
city: Cairo
country: Egypt
facility: Hamdy Nassar
Study officials:
affiliation: Faculty of Dental Medicine for Girls
name: Alaa H hesham mosa, bachelor's
role: STUDY_CHAIR
affiliation: Faculty of Dental Medicine for Girls
name: hamdy H nassar
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dental Medicine for Girls
name: amal AA ali
role: STUDY_DIRECTOR
References: