louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00051883: Chemical Dependency and Smoking Cessation: Patient's Views - 1
Official title: Chemical Dependency and Smoking Cessation: Patient's Views
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-01-20
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Substance abuse treatment patients

Brief summary: The purpose of this study is to asses patient views on smoking cessation and tobacco harm reduction during drug treatment.

Detailed description: Participants included 34 patients who had never voluntarily quit smoking for longer than 24 hours (continuous smokers), 34 smokers who had quit smoking for at least 24 hours before but had relapsed (relapsers), and 10 former smokers who had been abstinent for at least the past 6 months (successful quitters). We held 7 focus groups, 3 with continuous smokers and 4 with relapsers. Focus groups lasted 2 hours and were held at participants' clinics to preserve confidentiality. We conducted hour-long individual interviews with successful quitters. All participants completed a brief written survey immediately before their session. Survey items included questions on demographics, smoking behaviors, and motivation for cessation, reduction, and nicotine maintenance. We reimbursed all participants $40 and provided a meal to focus group attendees.

Eligibility criteria: Inclusion Criteria:

Selection criteria included being 18 years or older, smoking 5 or more cigarettes per day for at least 2 years, and being enrolled continuously in methadone maintenance treatment (MMT) for at least the past 2 years.

Exclusion Criteria:

Being less than 18 years of age, smoking 4 or fewer cigarettes per day, smoking less than daily for less than 2 years, and not being enrolled continuously in methadone treatment for at least the 2 past years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kimber Richter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483261: An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC
Official title: Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-traumatic Stress Symptoms
Psychosocial Distress
Keywords: Trauma-Focused Cognitive Behavior Therapy
Sexually Exploited Girls
Post-traumatic Stress Symptoms
Psychosocial Distress
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: World Vision
First posted: 2011-12-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Eligibility criteria: Inclusion Criteria:

-Suicidal ideation (irrespective of score on any other measure)

Exclusion Criteria:

* psychosis
* mental retardation
* inability to understand Swahili
* one standard deviation below the mean on every measure

Primary outcomes:
measure: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
timeFrame: baseline, post-intervention and 3-months
Secondary outcomes:
measure: Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument
timeFrame: baseline post-intervention and 3-months
Other outcomes:
Locations:
city: Beni
country: Congo
facility: World Vision Rebound Centre
state: South Kivu
Study officials:
affiliation: Chartered Clinical Psychologist (British Psychological Society)
name: Dr Ciaran Shannon, BA, MA, DClin
role: STUDY_DIRECTOR
References:
citation: O'Callaghan P, McMullen J, Shannon C, Rafferty H, Black A. A randomized controlled trial of trauma-focused cognitive behavioral therapy for sexually exploited, war-affected Congolese girls. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):359-69. doi: 10.1016/j.jaac.2013.01.013. Epub 2013 Mar 6.
Clinical trial NCT05840861: Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
Official title: Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Bipolar Disorder
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 healthy controls, 22 MDD patients, 22 BD patients

Brief summary: Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. The investigators hypothesized that patients with MDD and BP have abnormal mGluR5 availability in certain brain regions, and baseline mGLUR5 availability can predict prognosis the prognosis of MDD and BD. fMRI and NODDI are also used to evaluate the function or neurite condition at baseline and 8 week


Eligibility criteria: Inclusion Criteria:

* Meet DSM-V criteria for a current depressive episode.
* Being first-episode patients who were medication-naïve;
* Score \>17 on 17-item Hamilton Depression Rating Scale (HDRS), score \>22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score \<6 on Young Mania Rating Scale (YMRS).
* Age 18 to 35.
* Able to give written informed consent.

Exclusion Criteria:

* Have a current or past significant medical, neurological or metabolic disorder or head injury
* Have active, significant suicidal ideation or past suicide attempts
* Have implanted metallic devices or any MR contraindications
* Are women who are pregnant or breastfeeding
* Met DSM-5 criteria for substance use disorder
* Met DSM-5 criteria for any current Axis I diagnosis (except Generalized Anxiety Disorder)
* Are MDD patients present with delusions and/or hallucinations

Primary outcomes:
measure: Baseline concentration of mGLUR5 availability
timeFrame: Day 0
measure: Change in concentration of mGLUR5 availability from baseline to 8 weeks
timeFrame: Week 8
measure: Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks
timeFrame: Week 8
measure: Clinical outcome: Number of Participants with remitters and non-remitters
timeFrame: Week 8
measure: functional-connectivity
timeFrame: baseline and week8
measure: neurite density
timeFrame: baseline and week8
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT01688661: The Effects of Age and Gender on the Advantage of Sniffing Position for Laryngoscopic View
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal View
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients who are scheduled for elective surgery under general anesthesia

Brief summary: The sniffing position has been regarded as a standard position for direct laryngoscopic view. This study evaluated the effects of the age and gender on the advantage of the sniffing position compared with simple head extension for laryngeal view during direct laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* • Patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* • Patients with anatomical defects of the face, neck, or upper airway

Primary outcomes:
measure: the percentage of glottic opening
timeFrame: during laryngoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
Study officials:
References:
Clinical trial NCT03912961: The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study
Official title: Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Retina Global
Sponsor class: OTHER
Collaborators: name: VisionQuest Biomedical LLC
First posted: 2019-04-11
Enrollment: 1034
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 who are known diabetics in the hospital, or seeking help from the eye clinics or from associated specialties, e.g. endocrinology, will be included in the study as subjects. The Investigators will also recruit subjects who are evaluated in organized outreach visits in the community.

Brief summary: In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;
3. Subjects who have been diagnosed with Type I or Type II diabetes mellitus.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
3. Subject blind in one eye due to any cause
4. Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Primary outcomes:
measure: Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
timeFrame: 3 months
Secondary outcomes:
measure: Number of subjects with gradable images taken by the hand held camera
timeFrame: 3 months
measure: Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists
timeFrame: 3 months
Other outcomes:
Locations:
city: Santa Cruz de la Sierra
country: Bolivia
facility: Centro Medico Kolping
city: Santa Cruz de la Sierra
country: Bolivia
facility: Clinica Incor
city: Santa Cruz de la Sierra
country: Bolivia
facility: Hospital Universitario Japones
Study officials:
affiliation: Retina Global
name: Rajat Agrawal, MD MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06132061: Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community
Official title: Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression in Old Age
Lead sponsor: Affiliated Hospital of Yunnan University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the effect of three level interventions(universal prevention, selective prevention and targeted prevention) in elderly depression and find out the most efficient intervention path. The main questions it aims to answer are:

* Whether the pre-disease three-level prevention model (universal prevention, selective prevention and targeted prevention) is applicable for elderly depression in urban communities;
* Which level of intervention has the best effect on elderly depression.

Participants will be given the following treatments:

* Level 1 intervention(universal prevention): Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors.
* Level 2 intervention(selective prevention): Psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms.
* Level 3 intervention(targeted prevention): Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms.

Researchers will compare control group to see if the three levels of intervention have a significant effect.


Eligibility criteria: Inclusion Criteria:

1. Aged 60 and above;
2. Permanent residents of urban communities in China;
3. Geriatric Depression Scale (GDS-15) \< 9 points;
4. There are susceptibility factors such as living alone, poverty, and suffering from serious diseases.

Exclusion Criteria:

1. There is suicidal behavior or risk;
2. A history of any other mental illness, including drug or alcohol dependence;
3. Those who have speech and hearing disorder and cannot communicate normally;
4. Geriatric Depression Scale (GDS-15) ≥10 points;
5. Do not agree to participate in the research.

Primary outcomes:
measure: Level of depression
timeFrame: Measurements were taken at baseline, after intervention(3 months after baseline) and 6 months after intervention.The data will be reported through study completion, an average of 1 year.
Secondary outcomes:
measure: Psychological flexibility
timeFrame: Measurements were taken at baseline, after intervention(3 months after baseline) and 6 months after intervention.The data will be reported through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04848961: A Study to Develop a Strategy to Increase Lung Cancer Screening in Women Who May Be at Risk for Lung Cancer
Official title: Leveraging Mammography to Identify and Engage Women at Risk for Lung Cancer in Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Smoking
Keywords: mammogram
LDCT screening
BiRADS 1
BiRADS 2
21-103
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop a digital strategy to increase awareness about lung cancer screening among women who are eligible to receive it. The digital strategy involves email communications and LungTalk, a web-based (accessed through the Internet) health communication tool that uses text, audio, video, and animation to increase awareness and knowledge about lung cancer screening. This study will focus on women who have recently received a screening mammogram.


Eligibility criteria: Inclusion Criteria:

* LDCT screening-eligible women who received a BiRADS 1 (negative) or 2 (benign/non-cancerous finding) result from a screening mammogram in the last 7 days
* Age 50-80 years
* ≥ 20-pack-year smoking history of combustible cigarettes as per self report
* Women who currently smoke or quit within past 15 years as per self report
* Lung screening naïve as per self-report

Exclusion Criteria:

* Lung cancer diagnosis
* Chest CT within the last 12 months

Primary outcomes:
measure: Number of participants accrued through digital outreach to identify breast screening participants eligible for lung screening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Cancer Institute @ Hartford Hospital
state: Connecticut
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tali Amir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384461: An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)
Official title: An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe rheumatoid arthritis initiated on treatment with RoActemra/Actemra in combination with methotrexate

Brief summary: This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
* Active, severe infection or history of recurrent clinically significant infection
* Pregnancy
* Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
* Methotrexate intolerance

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy: Disease Activity Score (DAS 28)
timeFrame: 12 months
measure: Pain: Visual Analogue Scale (VAS) pain scale
timeFrame: 12 months
measure: Physical Function: Health Assessments Questionnaire (HAQ)
timeFrame: 12 months
measure: Incidence of patients with all-cause discontinuation of tocilizumab
timeFrame: 12 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Esztergom
country: Hungary
city: Gyula
country: Hungary
city: Győr
country: Hungary
city: Heviz
country: Hungary
city: Kecskemet
country: Hungary
city: Kistarcsa
country: Hungary
city: Miskolc
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pécs
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: