louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06346496: Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study
Official title: Effect of an AI Agent Trained on a Large Language Model (LLM) as an Intervention for Depression and Anxiety Symptoms in Young Adults: a 28-day Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LLM-based AI Dialogue Bot
Depression
Anxiety
Lead sponsor: Institute of Psychology, Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively.


Eligibility criteria: Inclusion Criteria:

* 18-25 years old
* Proficient in Chinese
* Not dyslexic
* Scoring at least 5 on the PHQ-9 or GAD-7
* Not having a serious physical or diagnosed mental illness

Exclusion Criteria:

* Unwilling to continue to participate in the study
* Insufficient clocking in

Primary outcomes:
measure: Depression
timeFrame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
measure: Anxiety
timeFrame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
measure: Positive and negative moods
timeFrame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Psychology, Chinese Academy of Sciences
state: Beijing
Study officials:
affiliation: Institute of Psychology, Chinese Academy of Sciences
name: Zhengkui Liu, PhD
role: STUDY_CHAIR
affiliation: Institute of Psychology, Chinese Academy of Sciences
name: Kankan Wu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02816996: Patient Comfort During Dermatologic Procedures
Official title: Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Undergoing a dermatologic procedure
* Willing and able to understand and provide informed consent and communicate with the investigator

Exclusion Criteria:

* Subjects who have wound healing problems
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with self-reported mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders

Primary outcomes:
measure: Anxiety
timeFrame: immediately after dermatologic procedure
measure: Pain
timeFrame: immediately after dermatologic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.
Clinical trial NCT05336396: Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
Official title: Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Plaque Score
Bleeding on Probing
Gingival Index
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is a 3-year follow-up clinical trial to evaluate longitudinal indicators of periodontal disease (plaque score, bleeding on probing (BOP), and gingival index (GI)) in 58 participants who completed NCT03571958. These participants were randomized to a brief motivational (BMI) test group or a traditional oral hygiene instruction (OHI) group for a 1-year clinical trial from 2018-2020.

In addition, analysis of retrospective data to determine health topics that emerge from the behavior change strategy of BMI compared to traditional OHI by transcription of audio recordings from 2018-2020.


Eligibility criteria: Inclusion Criteria:

° Completed all study visits of STUDY00003697 (NCT03571958)

Exclusion Criteria:

* Current smoker or quit smoking within the last year
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
* Uncontrolled diabetes (HbA1C \> 7)
* Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
* Current use of oral bisphosphonates
* History of IV bisphosphonates
* Require pre-medication or on long-term antibiotics
* Current orthodontic treatment or planning to begin orthodontic treatment during the study
* Unable to comply with the study protocol

Primary outcomes:
measure: Plaque score
timeFrame: Recorded one time 2 years +/- 8 months
measure: Bleeding on probing
timeFrame: Recorded one time 2 years +/- 8 months
measure: Gingival index
timeFrame: Recorded one time 2 years +/- 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: School of Dentistry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michelle Arnett
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770496: Age-Specific Strategies for Immunization Reminders and Recalls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Vaccination
Keywords: immunization
vaccination
immunization information system
immunization registry
reminder / recall
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-01-17
Enrollment: 10175
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study was to assess the relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones.


Eligibility criteria: Inclusion Criteria:

* 7 and 19 month recall groups: children not up to date for at least one vaccination at the time of notification
* 12 month reminder group: 12 months of age at time of notification
* Hib vaccination series was not assessed due to a vaccine shortage

Exclusion Criteria:

* Children were ineligible for notifications if they were designated in the Michigan Care Improvement Registry (MCIR)as having died, documented previously as having moved out of the jurisdiction ("Moved or Gone Elsewhere" (MOGE)), opted out of MCIR by their parent, or if they had been previously mailed for MCIR reminder/recall activity in the prior 60 days.

Primary outcomes:
measure: new immunization doses
timeFrame: within 60 days of reminder notification
Secondary outcomes:
measure: Cost of vaccination reminder
timeFrame: During the time of reminder notification preparation and mailing and approximately 1 month following mailing
measure: historical immunization doses
timeFrame: within 60 days of reminder notification
measure: waived doses
timeFrame: within 60 days of reminder notification
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, Child Health Evaluation and Research (CHEAR) Unit
state: Michigan
Study officials:
affiliation: University of Michigan, Child Health Evaluation and Research (CHEAR) Unit
name: Kevin J Dombkowski, DrPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dombkowski KJ, Costello LE, Harrington LB, Dong S, Kolasa M, Clark SJ. Age-specific strategies for immunization reminders and recalls: a registry-based randomized trial. Am J Prev Med. 2014 Jul;47(1):1-8. doi: 10.1016/j.amepre.2014.02.009. Epub 2014 Apr 18.
Clinical trial NCT01862458: Empyema Treated With tPA & DNAse
Official title: Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Empyema
Keywords: empyema
tPA
dornase
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.

The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.

The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.


Eligibility criteria: Inclusion Criteria:

Patients less than 18 years of age requiring an intervention for empyema by one of the following:

* Septation or loculation seen on ultrasound or computed tomography or
* Greater than 10,000 white blood cells identified on pleural tap

Exclusion Criteria:

* Immunodeficiency process
* Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
* Existing contraindications to chest tube
* Documented allergy to one of the study medications

Primary outcomes:
measure: Length of stay
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital and Clinics
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604758: Tidal Model's Effect on Coping and Self-Esteem
Official title: The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People With Alcohol Dependency: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Alcoholics [M01.066]
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to determine the effect of the psychiatric nursing approach based on the Tidal Model on coping and self-esteem in people with alcohol dependency.


Eligibility criteria: Inclusion Criteria:

* People with alcohol dependency were included in the study who were between 30 and 50 years of age who were admitted for treatment to the Alcohol and Substance Addiction Treatment clinic.

Exclusion Criteria:

* People with alcohol dependency who were severely depressed with a Beck Depression score of 41 or more and those with severe anxiety(a Beck Anxiety score of 26 or more) were not included in the study.

Primary outcomes:
measure: The Coping Inventory
timeFrame: after three months
measure: The Coopersmith Self-Esteem Inventory
timeFrame: after three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03838458: Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces
Official title: Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypospadias
Keywords: hypospadias
prepuce
HOXA13
FGFR2
TGF beta
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 52
Sex: MALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 0-18 years old pediatric male population, patients with isolated hypospadias are study group, patients with planned circumcision are control group.

Brief summary: The aim of this study is to compare prepuce tissue samples from healthy male children who applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1), androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene expression in the prepuce is planned to investigate via polymerase chain reaction (PCR) method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and collagen protein is planned to investigate via immunohistochemical examination.


Eligibility criteria: Inclusion Criteria:

* To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group.
* To have isolated hypospadias for study group.

Exclusion Criteria:

* To have genitourinary surgery before.

Primary outcomes:
measure: Genetic analysis 1
timeFrame: 1 year
measure: Genetic analysis 2
timeFrame: 1 year
measure: Genetic analysis 3
timeFrame: 1 year
measure: Genetic analysis 4
timeFrame: 1 year
measure: Genetic analysis 5
timeFrame: 1 year
measure: Immunohistochemical study 1
timeFrame: 1 year
measure: Immunohistochemical study 2
timeFrame: 1 year
measure: Histological study 1
timeFrame: 1 year
measure: Histological study 2
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine
Study officials:
affiliation: Trakya University Faculty of Medicine, Pediatric Surgery Department
name: Dincer Avlan, Profesor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256358: Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
Official title: Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychomotor Agitation
Keywords: child, ketamine, midazolam
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Detailed description: Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (\<2hr)

Exclusion Criteria:

* children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

Primary outcomes:
measure: Emergence Agitation
timeFrame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Haeundae paik hospital, inje university
name: Kihwa Lee, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03925558: Tolerance of a Probiotic Formula
Official title: Tolerance of a Probiotic Formula Containing Lactobacilli
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 95
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluate the tolerance of a probiotic formula in infants


Eligibility criteria: Inclusion Criteria:

- Full term healthy infant aged 3-95 days

Exclusion Criteria:

* Prematurity
* Low birth weight
* Congenital anomalies
* Chronic disease
* Failure to thrive
* Allergy or atopic disease
* Recent exposure to antibiotics

Primary outcomes:
measure: Body weight (g)
timeFrame: 8 weeks
measure: Body length (cm)
timeFrame: 8 weeks
measure: Head circumference (cm)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06519058: Effectiveness of Self-Myofascial Stretching on Carpal Tunnel Syndrome
Official title: Effectiveness of Carpal Ligament Self-Myofascial Stretching Over Conventional Physical Therapy on Reducing Pain and Improving Function in Patients With Stage I and II Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Stage I and II Carpal Tunnel Syndrome
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and aim: Carpal tunnel syndrome (CTS) also known as median mononeuropathy occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS.

Methodology: Thirty-six subjects with stage I and II CTS who fulfilled the inclusion criteria were randomly assigned to experimental group and control group with 18 patients in each group. Experimental Group received carpal ligament self-myofascial stretching along with conventional physical therapy while the Control Group received conventional physical therapy alone. The duration of the treatment was 6 weeks. The outcome measures used were Boston Carpal Tunnel Questionnaire and Visual Analogue Scale.


Eligibility criteria: Inclusion criteria:

* Patients diagnosed with carpal tunnel syndrome.
* Age range between 30 - 60 years
* Both genders.
* Patients with stage I and II (mild) carpal tunnel syndrome, confirmed by nerve conduction study (EMG diagnosed by a medical professional)
* Unilateral and bilateral dominant hand.
* Patients who are able to read and understand English.

Exclusion criteria: Participants with:

* Presence of polyneuropathy
* Consistent use of adaptive equipment, such as wheelchair or cane.
* Patients presenting with shoulder pathologies
* Patients with other neurological or musculoskeletal conditions as Cervical radiculopathy, history of wrist and hand fractures, upper extremity joint dislocations, brachial plexus injuries, cubital tunnel syndrome, rheumatoid arthritis, De quervain's tenosynovitis, or cut injuries of hand.
* Patients who have underwent recent carpal tunnel release (within 1 year)

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 6 weeks
measure: Visual Analogue Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Calicut
country: India
facility: Awh special college
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Shibili Nuhmani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113658: Clinical Evaluation of the SNaP Wound Care System
Official title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute and Chronic Wounds
Pressure Ulcers
Trauma Wounds
Diabetic Foot Ulcers
Venous Stasis Ulcers
Keywords: negative pressure wound therapy
NPWT
Spiracur
SNaP Wound Care System
Lead sponsor: 3M
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.


Eligibility criteria: Inclusion Criteria:

* Wound \< 10 cm in greatest diameter
* Patient \>18 years of age
* Willing and able to sign informed consent

Exclusion Criteria:

* Patients with wound-related cellulitis
* Patients with thick eschar at wound base post debridement
* Patients with wounds located in an area not amenable to forming an air- tight seal
* Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome
* Patient has untreated osteomyelitis
* Patient is allergic to wound care products
* Patient wounds with exposed blood vessels not suitable for negative pressure therapy
* Pregnant or pregnancy-suspected patients
* Subject actively participating in other clinical trials that conflict with the current study

Primary outcomes:
measure: Frequency of complaints about device use and operation
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daly City
country: United States
facility: San Francisco Center for Advanced Wound Care
state: California
city: Daly City
country: United States
facility: The SF Center For Advanced Wound Care At
state: California
Study officials:
affiliation: Seton Hospital
name: Kristine K Nemes, DPM
role: PRINCIPAL_INVESTIGATOR
References: