louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03874143: Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care
Official title: Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care Provided by Community Health Workers in Southwest Niger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Diarrhea
Acute Respiratory Infection
Lead sponsor: World Vision Canada
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Ministry of Public Health Niger
name: Toronto Metropolitan University
name: Global Affairs Canada
First posted: 2019-03-14
Enrollment: 520
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Under the World Health Organization's (WHO) integrated community case management (iCCM) Rapid Access Expansion Program (RAcE), World Vision Niger and Canada supported the Niger Ministry of Public Health to implement iCCM in four health districts in Niger in 2013. Community health workers (CHWs), known as Relais Communautaire (RCom), were deployed in their communities to diagnose and treat children under five years of age presenting with diarrhea, malaria and pneumonia and refer children with severe illness to the higher-level facilities. Two of the districts piloted RCom using smartphones equipped with an application to support quality case management and provide good timely clinical data. A two-arm cluster randomized trial assessed the impact of use of the mHealth application mainly on quality of care (QoC), but also on motivation, retention and supervision


Eligibility criteria: Inclusion Criteria:

* children presenting symptoms of illness

Exclusion Criteria:

-

Primary outcomes:
measure: Quality of Care (QoC) provided by RCom
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04356443: Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection
Official title: Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Ventilatory Failure
COVID-19
Pneumonia
ARDS, Human
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 500
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: This is a pilot study that aims to recruit 500 patients with respiratory failure due to COVID-19 infection at Massachusetts General Hospital.

Brief summary: This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.


Eligibility criteria: Inclusion Criteria:

* Admitted to the hospital
* ≥ 18 years of age
* Clinically suspected or confirmed COVID-19 infection
* Spontaneously breathing
* For patients not on supplemental oxygen at their location of residence prior to hospital admission, need for supplemental O2 to maintain SpO2 \>=92%
* For patients on supplemental O2 at their location of residence prior to hospital admission, an increase in requirement of supplemental oxygen from baseline

Exclusion Criteria:

* Intubated patients
* Pregnant women
* Moribund patients
* Patients who are on comfort measures (CMO)

Primary outcomes:
measure: Endotracheal intubation during present hospitalization, recorded through chart review
timeFrame: Up to three weeks
Secondary outcomes:
measure: Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review
timeFrame: Up to three weeks
measure: Premature need for removal of the band, recorded through investigator report
timeFrame: Up to three weeks
measure: In-hospital mortality, recorded through chart review
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01957943: Omega 3 Lipid Emulsions and Liver Transplantation
Official title: Impact of Pre-treatment of Living-donor Liver Transplant Recipients With Omega 3 Enriched Lipid Emulsions on Graft and Patient Outcome. A Prospective, Randomized, Multi-central Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia Re-perfusion Injury
Keywords: Omega 3 lipid emulsions
Liver transplantation
Ischemia reperfusion injury
graft function
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.

Detailed description: Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .

A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration

Eligibility criteria: Inclusion Criteria:

* All liver transplant recipients

Exclusion Criteria:

* Budd chiari
* Previous upper abdominal surgery
* Re-transplantation
* Known allergy to the study emulsion

Primary outcomes:
measure: Ischemia reperfusion injury
timeFrame: 5 days
Secondary outcomes:
measure: Liver functions
timeFrame: 5 days
measure: Early graft regeneration
timeFrame: one month
measure: Late graft regeneration
timeFrame: 3 month
Other outcomes:
measure: mortality
timeFrame: 28 days
measure: Renal functions
timeFrame: 28 days
measure: Infection
timeFrame: 28 days
measure: length of hospital stay
timeFrame: 30 days
Locations:
city: Mansoura
country: Egypt
facility: Liver transplantation program - Gastroenterology surgical center - Mansoura university
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Amr M Yassen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00647543: Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand
Official title: A Multicenter, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.


Eligibility criteria: Inclusion Criteria:

* Dyslipidemic patients who were eligible for lipid lowering therapy
* Willingness to follow study diet for 1 month prior to screening and for the duration of the study

Exclusion Criteria:

* Use of other lipid lowering agents (6-week washout period)
* Uncontrolled high blood pressure
* Impaired liver function

Primary outcomes:
measure: Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target
timeFrame: Week 8
Secondary outcomes:
measure: Adverse events and laboratory test changes
timeFrame: Weeks 2, 4, and 8
measure: Percentage of patients who achieved LDL-C target
timeFrame: Weeks 2 and 4, and Week 8 with 1 step titration
measure: Change and percent change from baseline in LDL-C
timeFrame: Weeks 2, 4, and 8
measure: Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
timeFrame: Weeks 2, 4, and 8
measure: Change and percent change from baseline in LDL/HDL ratio
timeFrame: Weeks 2, 4, and 8
measure: Change and percent change from baseline in total cholesterol
timeFrame: Weeks 2, 4, and 8
measure: Change and percent change from baseline in triglycerides
timeFrame: Weeks 2, 4, and 8
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Chiang Mai
country: Thailand
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03371043: Outpatient Use of Analgesics in Children and Adolescents in France
Official title: Outpatient Use of Analgesics in Children and Adolescents in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outpatient Use of Analgesics in Children and Adolescents
Keywords: analgesics
opioids
outpatient drug use
pediatrics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 1
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolesents who are users of analgesic medications, 2012 to 2015

Brief summary: outpatient use of analgesics in children and adolescents in France from 2012 to 2015

Detailed description: To describe the outpatient use of analgesics in children and adolescents in France from 2012 to 2015

Eligibility criteria: Inclusion Criteria:

* all children and adolescents (0-17 years)
* registered in the French Health Insurance Database from 2012-2015

Primary outcomes:
measure: Analgesic and anti-migraine drugs with a specific focus on opioids
timeFrame: 4 years
Secondary outcomes:
measure: Co-analgesic drugs (antidepressants and anticonvulsants) for pain management
timeFrame: 4 years
measure: Description of outpatient use of opioid analgesics over time in children with malignant disease
timeFrame: 4 years
measure: Evaluation of the dispensing without medical prescription of analgesics in children and adolescents.
timeFrame: 4 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré, APHP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florentia Kaguelidou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741843: Impact of Patient Education on Influenza Vaccine Uptake Among Community-dwelling Chinese Elderly
Official title: Impact of Patient Education on Influenza Vaccine Uptake Among Community-dwelling Chinese Elderly: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-04-18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the effectiveness of brief face-to-face patient education in increasing uptake of influenza vaccine among Chinese elderly in the community.


Eligibility criteria: Inclusion Criteria:

* Cantonese speaking
* Chinese

Exclusion Criteria:

* cognitively impaired
* unable to communicate effectively
* having known contraindication of vaccination
* institutionalized

Primary outcomes:
measure: proportion of patients receiving influenza vaccination
timeFrame: three working days
Secondary outcomes:
measure: proportion of patients receiving influenza vaccination
timeFrame: five working days
measure: proportion of patients receiving influenza vaccination
timeFrame: seven working days
measure: proportion of patients receiving influenza vaccination
timeFrame: nine working days
Other outcomes:
Locations:
Study officials:
References:
citation: Leung KC, Mui C, Chiu WY, Ng YY, Chen MHY, Ho PH, Kwok CP, Lam SSM, Wong CY, Wong KY, Pang HH. Impact of patient education on influenza vaccine uptake among community-dwelling elderly: a randomized controlled trial. Health Educ Res. 2017 Oct 1;32(5):455-464. doi: 10.1093/her/cyx053.
Clinical trial NCT01731743: Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2012-11-22
Enrollment: 107
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.

Detailed description: After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm) and near (40 cm) distance as well as the subjective refraction.

A patient questionnaire will be used to assess the patient satisfaction and spectacle independence.

Eligibility criteria: Inclusion Criteria:

* Man or woman, over 50 years of age
* Bilateral implantation of a trifocal intraocular lens
* Capsular bag implantation

Exclusion Criteria:

* Existing ocular pathology
* Surgical complications
* Corneal astigmatism ≥ 1.0D

Primary outcomes:
measure: Intermediate visual acuity
timeFrame: up to 3 months postoperatively
Secondary outcomes:
measure: near and far visual acuity
timeFrame: 1 and 3 month postoperatively
Other outcomes:
measure: Patient satisfaction and spectacle independence
timeFrame: 1 and 3 month postoperatively
Locations:
city: Berlin
country: Germany
facility: Carl Zeiss Meditec AG
Study officials:
References:
Clinical trial NCT02015143: A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Unipolar Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: Shanghai Mental Health Center
name: The First Hospital of Hebei Medical University
name: Central South University
name: West China Hospital
First posted: 2013-12-19
Enrollment: 970
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cases were selected from the Sixth Hospital of Peking University and other eight hospitals, and they must meet the diagnosis inclusion criteria of un-bipolar and bipolar disorders. The control group of non-mood disorders will be selected from heathy population who met the following inclusion criteria of healthy controls. Informed consent must be obtained.

Brief summary: The purpose of this study was to investigate the reliability and validity of the bipolar index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar disorder in natural status.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years old；
2. Be able to understand the content of assessment and cooperate；
3. Currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable；
4. Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of bipolar disorder (Type I, II, rapid cycling, mixed episodes)；
5. Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of depressive disorder；
6. No other mental illness or a history of physical disease，or patients with physical disease;
7. Not received modified ECT at least four weeks or more before entering the group.

Exclusion Criteria:

1. Can not understand the content of assessment and cooperate；
2. Meet the diagnosis criteria of schizophrenia and other psychotic disorders;
3. Meet the diagnosis criteria of Diagnosis of mental retardation or pervasive developmental disorder;
4. Clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；

Primary outcomes:
measure: Test-retest reliability of the scale
timeFrame: one year later
Secondary outcomes:
measure: Cronbach's α coefficient of the scale
timeFrame: one year later
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Mental Health
state: Beijing
Study officials:
References:
citation: Ma Y, Gao H, Yu X, Si T, Wang G, Fang Y, Liu Z, Sun J, Yang H, Wang X, Li J, Zhang Y, Sachs G. Bipolar diagnosis in China: Evaluating diagnostic confidence using the Bipolarity Index. J Affect Disord. 2016 Sep 15;202:247-53. doi: 10.1016/j.jad.2016.05.039. Epub 2016 May 24.
Clinical trial NCT02767843: Pilot Study of cNEP for the Treatment of Snoring
Official title: Pilot Study to Assess the Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Reducing Respiratory Sounds in Individuals With Chronic Snoring
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Snoring
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time
* AHI \< 10/hr

Exclusion Criteria:

* previous neck surgery or radiation
* carotid artery disease
* serious medical or psychiatric illness
* pregnancy
* silicone allergy
* excessive use of alcohol or sedating drugs

Primary outcomes:
measure: Response
timeFrame: one night
measure: Adverse Events
timeFrame: one night
Secondary outcomes:
measure: Complete Response
timeFrame: one night
Other outcomes:
Locations:
city: Alameda
country: United States
facility: California Center for Sleep Disorders
state: California
Study officials:
affiliation: California Center for Sleep Disorders, Alameda, CA
name: Jerrold Kram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05331443: Effects of Ramadan Fasting on Endothelial Function
Official title: Effects of Ramadan Fasting on Endothelial Function
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fasting
Endothelial Dysfunction
Keywords: Ramadan Fasting
Endo-pat
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable patients that intend to fast Ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan.

Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Brief summary: Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

Detailed description: All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits.

1. The week before Ramadan (Pre-R).
2. the last week of Ramadan (R).
3. the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

All patients benifit of an endothelial peripheral arterial tonometry (Endo-PAT) test .

Eligibility criteria: Inclusion Criteria:

* Adult patient intending to fast Ramadan.

Exclusion Criteria:

* Age \< 18 years old
* Hemodynamic instability.
* Myocardial infarction requiring urgent revascularization.
* Parkinsonism: tremor problem.
* Refusal, communication problem.

Primary outcomes:
measure: Change in Reactive Hyperemia Index (RHI)
timeFrame: the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University hospital Fattouma Bourguiba
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References: