louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04546061: Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Official title: Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Mental Health
Keywords: Sexual and Gender Minorities
Substance Use and Mental Health Treatment
Mental Health
Substance Use
Minority Stress
Young Adults
Intensive Case Management
Peer Support
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study provides substance use and mental health treatment for young sexual and gender minority adults in Durham and Charlotte, NC and seeks to provide intensive wraparound services that address factors that influence substance use and mental health among this population such as minority stressors and lack of social support, housing instability, lack of access to affirmative health care, and limited job opportunities.

Detailed description: Project Uplift provides evidenced-based substance use and mental health treatment, intensive case management, and peer support services for sexual and gender minorities, ages 18-35. The program is based in two metropolitan areas in North Carolina, Durham and Charlotte, and will offer services for approximately 80 sexual and gender minority young adults. Survey data collected from participants at baseline and at the end of the 6-month program will be used to evaluate the effectiveness the comprehensive care program.

Eligibility criteria: Inclusion Criteria: 1) age 18-35; 2) substance use in the last 90 days; 3) self-identify as a sexual and/or gender minority; 4) reside in the Durham or Charlotte geographic areas including neighboring counties

Exclusion Criteria: 1) inability to speak and read English

Primary outcomes:
measure: Change in substance use from baseline to 6-month follow-up
timeFrame: Baseline and 6-months
measure: Change in mental health status from baseline to 6-month follow-up
timeFrame: Baseline and 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Mecklenburg County Community Support Services
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Sara H LeGrand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Susan Reif, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04037761: Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study)
Official title: Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P) Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Development
Keywords: early child development
cohort study
education
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 20899
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A stratified random sample of children aged 3-4 from 9 levels kindergartens in 16 districts of Shanghai.

Brief summary: Shanghai is one of pilot areas for the early education of 3-6 years old infants in China. Shanghai Municipal Education Commission has been actively exploring more effective early education guidance methods. This survey, in the form of online questionnaire and site test, aims to dynamically evaluate the changes in the early development level of children in Shanghai and provide scientific basis for providing better early education services in the future.


Eligibility criteria: Inclusion Criteria:

* All 3-year-old children entered into public kindergartens or private kindergartens in Shanghai since 2016.

Exclusion Criteria:

* Children entered into international kindergartens

Primary outcomes:
measure: Demographics and Socioeconomic statue information
timeFrame: 2 weeks
measure: Child Care Environment
timeFrame: 2 weeks
measure: Parent-child interaction
timeFrame: 2 weeks
measure: Child behavior assessment, Sleep Habits
timeFrame: 2 weeks
measure: Child behavior assessment, Screening Exposure
timeFrame: 2 weeks
measure: Early Child Development
timeFrame: 2 weeks
measure: Social-emotion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01455961: An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder
Official title: An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder Treated With Quetiapine XR and/or Quetiapine IR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Real life setting
Bipolar Disorder
Registry based Data Base Audit
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have been hospitalised in Sweden at least once since 1987 with a diagnosis during hospitalisation of Bipolar Disorder.

Brief summary: The aim of this study is to describe the treatment pattern and patient characteristics in real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel IR in Sweden.

Detailed description: An epidemiological registry study to evaluate clinical practice treatment in patients with Bipolar Disorder treated with quetiapine XR and/or quetiapine IR

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of BD.

Exclusion Criteria:

* Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of bipolar disorder.

Primary outcomes:
measure: Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before, at and after the index date.
timeFrame: 1st of January 2009 to 31st of December 2010.
Secondary outcomes:
measure: Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before and at the index date.
timeFrame: 1st of January 2009 to 31st of December 2010.
measure: Description of the detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD, including all drug treatment after the index date
timeFrame: 1st of January 2009 to 31st of December 2010.
measure: Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD, including all drug treatment before and at the index date
timeFrame: 1st of January 2009 to 31st of December 2010.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Neuroscience, Karolinska Institutet 171 76 Stockholm
name: Andreas Carlborg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlborg A, Thuresson M, Ferntoft L, Bodegard J. Characteristics of bipolar disorder patients treated with immediate- and extended-release quetiapine in a real clinical setting: a longitudinal, cohort study of 1761 patients. Ther Adv Psychopharmacol. 2015 Feb;5(1):13-21. doi: 10.1177/2045125314560740.
Clinical trial NCT04638361: Laryngeal Disorders After Childhood Cardiac Surgery
Official title: Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Injury
Swallowing Disorder
Voice Disorders in Children
Surgery--Complications
Keywords: Laryngeal dysfunction
Cardiac surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 5 and 10 years old, having undergone a nasofibroscopy following cardiac surgery performed before their first year of life (between 01/01/2010 and 12/31/2015).

Brief summary: Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).


Eligibility criteria: Inclusion Criteria:

* No opposition from children and parents
* Patient or parents able to understand the ins and outs of the study

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of a laryngeal mobility disorder after childhood cardiac surgery
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,
name: Sonia AYARI-KHALFALLAH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263561: Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Official title: Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
filtration surgery
trabeculectomy
ExPRESS shunt
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

Detailed description: Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Eligibility criteria: Inclusion Criteria:

* age 18 to 85
* open-angle glaucoma uncontrolled medically
* intraocular pressure ≥ 18 mmHg
* trabeculectomy as the planned surgical procedure

Exclusion Criteria:

* any previous ocular incisional surgery with the exception of previous clear
* cornea cataract surgery
* uveitis
* vitreous present in anterior chamber
* patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 1 year post surgery
measure: Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
timeFrame: 1 year post surgery
Secondary outcomes:
measure: Complications
timeFrame: 1 year post surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Graham E Trope, Professor
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Yvonne M Buys, Professor
role: STUDY_DIRECTOR
References:
citation: Gonzalez-Rodriguez JM, Trope GE, Drori-Wagschal L, Jinapriya D, Buys YM. Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up. Br J Ophthalmol. 2016 Sep;100(9):1269-73. doi: 10.1136/bjophthalmol-2015-307161. Epub 2015 Dec 16.
Clinical trial NCT05873361: Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival
Official title: Interest of Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Papillary Carcinoma
Keywords: Papillary Carcinoma
Postoperative
Follow-up
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with papillary microcarcinoma asymptomatic

Brief summary: This is a study assessing the interest of post-operative follow-up of asymptomatic papillary microcarcinomas. Today, this post-operative follow-up represents an economic cost and is a source of anxiety for patients.

The aim of this study is to determine the global survival of patients with asymptomatic papillary microcarcinoma to assess the interest of a post-operative ultrasound and/or biological follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients with uni or multifocal papillary microcarcinoma (cumulative size of foci \<10mm) asymptomatic or not and who underwent partial or total thyroidectomy from 2012 to 2017.
* Non opposition patient
* Affiliation to a social security scheme

Exclusion Criteria:

* Lesion crossing the thyroid capsule, or cervical lymph node involvement clinical or histological cervical lymph node involvement.
* Patient under guardianship, curators or safeguard of justice

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Disease control rate
timeFrame: 10 years
measure: Surgical complications rate
timeFrame: 10 years
measure: Detection of recurrence rate
timeFrame: 10 years
measure: Recovery surgical or iratherapie recovery rate
timeFrame: 10 years
measure: Anxiety evaluation
timeFrame: 1 month
measure: Prognostics survival criteria
timeFrame: 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Agnès DUPRET-BORIES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04967261: The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors
Official title: The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiology
Keywords: Cardiac arrest
post-cardiac arrest syndrome
neurological outcome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 529
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-traumatic cardiac arrest who have been successfully resuscitated by first aid and admitted to the intensive care unit

Brief summary: To explore whether the patient's neurological function recovery period is sufficient after successful emergency resuscitation recommended by the current guidelines

Detailed description: The research team will collect patient data after successful emergency resuscitation after cardiac arrest in the emergency room of National Taiwan University Hospital, and will collect and analyze the relationship between the time for patients to regain consciousness and drug use, hemodynamic changes, and neurological examination results after resuscitation. To explore whether the patient population needs to extend the observation time of neurological function after a certain CPR emergency treatment, and allow the patient to have a longer observation period to regain consciousness.

Eligibility criteria: Inclusion Criteria:

* Patients with non-traumatic cardiac arrest in the emergency room of National Taiwan University Hospital (including pre-hospital cardiac arrest and in-hospital cardiac arrest) after successful emergency resuscitation

Exclusion Criteria:

* Under 20 years old
* Pregnant women
* Those who have not been admitted to the intensive care unit
* Unconsciousness before the heartbeat stops
* A clear consciousness after successful first aid resuscitation

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongshan South Road
Study officials:
affiliation: National Taiwan University Hospital
name: Min-Shan Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03109561: Apolipoprotein E (ApoE) and Metabolism
Official title: APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Function
Healthy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cognitively normal and are in good overall health.

Brief summary: Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.

Detailed description: The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.

To more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).

To determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood.

Eligibility criteria: Inclusion Criteria:

* all races/ethnicities
* ages 18-65
* cognitively normal
* good health

Exclusion Criteria:

* pregnant or breastfeeding.
* have a bleeding disorder,
* have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.
* have a history of alcoholism or drug abuse
* have a history of schizophrenia or currently suffer from bipolar disorder or major depression.
* have vision or hearing loss severe enough to interfere with cognitive testing

Primary outcomes:
measure: Indirect Calorimetry
timeFrame: 4 hours
Secondary outcomes:
measure: Respiratory Quotient (RQ)
timeFrame: 4 hours
Other outcomes:
measure: Urea Nitrogen Output
timeFrame: 4 hours
measure: Genotype
timeFrame: 4 hours
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Lance Johnson1, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05634161: Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
Official title: Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mild Cognitive Impairment
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Boramae Hospital
First posted: 2022-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cognitively Impaired patients aged 55 to 85, based in South Korea.

Brief summary: Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.


Eligibility criteria: Inclusion Criteria:

* Male and Female patients, 55\~85 years
* Adequate vision, hearing and speaking for neuropsychological testing
* No difficulty in using mobile application using smartphone
* Patients with subjective memory complaints, confirmed by informants
* Cognitive impairment of SD 1 or greater from the age-adjusted normal range in Memory domain in CERAD-NP battery
* Global CDR 0.5 \~ 1
* Korean speaker
* Have an identified trial partner
* All subjects signed written consent

Exclusion Criteria:

* Those unable to provide consent
* History of transient ischemic attack, stroke, brain tumor
* History of diagnosis of major depression
* Symptoms that may interfere with the subject's testing procedure
* Cerebral hemorrhage
* Central nervous system infections
* Prohibited concomitant medication
* Known or suspected history of drug or alcohol abuse

Primary outcomes:
measure: Usability: Based on scenarios
timeFrame: Single-point evaluation (baseline)
Secondary outcomes:
measure: Usability: Based on user survey
timeFrame: Single-point evaluation (baseline)
measure: Usability: Based on hemodynamic responses
timeFrame: Single-point evaluation (baseline)
measure: Changes in Adas-cog
timeFrame: After 12 weeks of system usage
measure: Changes in ADCS-ADL
timeFrame: After 12 weeks of system usage
measure: Changes in self-reported quality of life
timeFrame: After 12 weeks of system usage
measure: Changes in blood biomarker
timeFrame: After 12 weeks of system usage
Other outcomes:
measure: MMSE
timeFrame: Single-point evaluation (baseline)
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center
name: Jun-Young Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: