louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000327: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: drug dependence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

Detailed description: Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic

Eligibility criteria: Inclusion Criteria:

Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Compliance
measure: Dosing schedule preferences
measure: Analog rating scale for dosing schedule effects
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amass, L., Kamien, J.H., and Mikulich, S.K. Efficacy of and preference for 3-day vs daily dosing with the buprenorphine-naloxone combination tablet. presented to the 1998 Meeting of the College on Problems of Drug Dependence. Scottsdate, AZ (6/13-18). Presenting at CPDD 1998
Clinical trial NCT04098627: The Effects of Laughter Therapy on Hemodialysis on Depression
Official title: The Effects of Laughter Therapy on Hemodialysis on Depression: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Kidney Disease
Keywords: laughter
depression
hemodialysis
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: End stage kidney disease is associated with increased depression. Laughter is associated with improvement in depression in chronic disease. The study objective was to measure the effect of intradialytic group laughter therapy on anxiety and depression. Pragmatic randomized controlled trial conducted in 10 hemodialysis centers in Northern California. The intervention group received a once weekly 30-minute long group laughter therapy session for 8 weeks. Primary outcome was depression score as measured using the Patient Health Questionnaire.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center
* Ability to understand English

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: Depression
timeFrame: 8 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 8 weeks
measure: Subjective Wellbeing
timeFrame: 8 weeks
measure: Patient reported outcome measures (PROMs)
timeFrame: 8 weeks
measure: Psychological Distress - Patient Health Questionnaire 4 (PHQ4)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Satellite Healthcare
state: California
Study officials:
affiliation: Satellite Healthcare
name: Paul N Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03092427: Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)
Official title: Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

Detailed description: Juvenile Idiopathic Arthritis (JIA) is the most frequent rheumatic disorder in children. Numerous studies suggest that alteration of the intestinal barrier may induce abnormal immune responses implicated in development or persistence of arthritis. This paves the way to new therapeutic options aiming to reestablish intestinal homeostasis to treat arthritis or to prevent disease flares. This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

Eligibility criteria: Inclusion Criteria:

* Age ≥1year and \<7years
* Patients with oligoarthritis and polyarthritis with rheumafactor negative and antinuclear antibodies (ANA) positive JIA with onset before the age of 6 years

Exclusion Criteria:

* Change of JIA forme

Primary outcomes:
measure: To evaluate the impact of a regular intake of probiotic VSL#3 in addition to standard treatment in patients with JIA on the clinical activity
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate the impact of a regular intake of probiotic VSL#3 in addition to standard treatment in patients with JIA on the intestinal microbiota.
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: APHP
name: Ulrich Meinzer, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04959227: Investigation of Anxiety, Depression and Physical Activity Level in Whirling Dervishes
Official title: Investigation of Anxiety, Depression and Physical Activity Level in Whirling Dervishes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Depression, Anxiety
Keywords: Anxiety Depression, physical activity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size of the study was calculated at a 0.90 confidence interval in line with the analyzes made with G-Power, and it was aimed to reach 30 people for each group (Leite, J.R. et al., 2010).

Brief summary: Sema, which means "to listen/hear" in lexical meaning, is a special physical activity performed in the form of rotating in different positions rhythmically with music.During the sema activity, although it is similar to dance therapy due to the cyclical movements it contains, it can also be evaluated as a physical activity. With Sema music therapy accompanied by musical melodies, it is similar to meditation, as the ties with the world are cut off and the attempt is made to reach divine love. Various studies have shown that physical activity, music therapy, dance therapy, and meditation have positive effects on depression and anxiety in the literature. However, there is no scientific study in the literature investigating the effects of Sema activity, which includes all these approaches, on depression, anxiety and physical activity. In order to support the literature in this sense, this study was planned to examine the effects of Sema activity on physical activity level, depression and anxiety. Individuals between the ages of 18-60 who are registered in Konya Mevlana Cultural Center who have been doing Sema for at least 1 year will be included in the study. Participants who agree to participate in the study will be asked to fill in the online Informed Volunteer Form, Demographic Information Form, Beck Anxiete Scale, Beck Depression Scale and International Physical Activity Scale - Short Form. The data will be analyzed statistically with SPSS version 23.0.


Eligibility criteria: Inclusion Criteria:

* Being literate
* Between the ages of 18-60
* Performing Sema for at least 1 year
* Doing sema regularly (at least 3 times a week)

Exclusion Criteria:

* Being diagnosed with depression
* Having any psychiatric illness
* Presence of chronic disease (hypertension, diabetes, neurological diseases, cancer etc.)

Primary outcomes:
measure: Depression
timeFrame: including last seven days- instant
measure: Anxiety
timeFrame: including last seven days- instant
measure: Physical Activity Level
timeFrame: including last seven days- instant
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesi̇r
country: Turkey
facility: Bandirma Onyedi Eylül Üniversitesi
Study officials:
References:
Clinical trial NCT02723227: The Impact of Family Financial Support on Parental Stress
Official title: The Impact of Family Financial Support on Parental Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Parenting Stress
Stress
Social Determinants
Socioeconomic status
Financial Coaching
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on family economic strain and parental stress.

Detailed description: Financial coaching is a new tool in the field of community development, but it has already demonstrated significant financial impact in a number of studies, including one randomized trial conducted by the Urban Institute. Financial coaching improves participant financial literacy, budgeting, saving for financial emergencies, and debt level. The investigators' project will help clinicians and the field of community economic development understand health and well-being through a new economic lens and assess the health-related impacts of the emerging field of financial coaching. The investigators have partnered with financial coaching organizations to establish what they have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on parental strain and stress.

Community-based participants will be recruited from South Los Angeles and randomized to receive either monthly financial coaching plus access to referral for social services (intervention) or access to referral for social services alone (control). Inclusion criteria include having dependents under age 18, having some form of income, and having a tax identification number (social security number or Individual Tax Identification Number). Participants will be surveyed quarterly regarding their economic strain using the Family Economic Strain Scale and their individual stress using the Parenting Stress Index.

Eligibility criteria: Inclusion Criteria:

* Participants will include caregivers and parents with one or more dependents, some form of income, and a tax identification number.

Exclusion Criteria:

* Inability to partake in the financial coaching or primary language other than English or Spanish.

Primary outcomes:
measure: Family Economic Strain
timeFrame: Up to one year (if possible)
measure: Parenting Stress
timeFrame: Up to one year (if possible)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LIFT-LA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Adam Schickedanz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256527: REWARDS Premier Taxus-Liberte vs Xience V
Official title: REWARDS-Premier TLX (Registry Experience at the WAshington Hospital CenteR, DeS - Premier Taxus-Liberte vs Xience V)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients male or female, 18 years or older who have undergone percutaneous coronary intervention with Promus Premier (alone) drug eluting stent

Brief summary: Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in which patients received either the Taxus Liberte or XIENCE V drug eluting stent.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Underwent PCI with Promus Premier (alone) DES

Exclusion Criteria:

* Underwent PCI with a non-Promus Premier DES during the same index procedure
* Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor)

Primary outcomes:
measure: Major adverse cardiac event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT06672627: Trueness of Digital Occlusal Analysis
Official title: Trueness of Digital Occlusal Analysis Using Handheld Device Versus Intraoral Scanner (A Diagnostic Evaluative Clinical Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dental Occlusion
Occlusal Analysis
Keywords: Occlusal analysis
Occlusense
Intraoral scanners
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The aims of this observational study are to evaluate the trueness of two different digital occlusal analyzers; handheld occlusal analyzer versus intraoral scanner in comparison to conventional methods in identifying true occlusal contacts and to evaluate inter-examiner reliability of two examiners independently analyzing occlusal contacts.

Detailed description: Evaluate the trueness of two different digital occlusal analyzers; handheld occlusal analyzer (occlusense) versus intraoral scanner (Medit i700-medit occlusal analyzer) in comparison to conventional methods (8 um articulating paper) in identifying true occlusal contacts and to evaluate inter-examiner reliability of two examiners independently analyzing occlusal contacts.

Eligibility criteria: Inclusion Criteria:

* Normal occlusion (Angle Class 1)
* No missing teeth
* No tempromandibular disorders

Exclusion Criteria:

Patients having:

* Dental prostheses
* Extensive restorations
* Severe malocclusion
* Periodontal disease
* Excessive tooth wear
* Orofacial pain
* Temporomandibular joint disorders
* Anterior or posterior open bite
* Active orthodontic treatment.

Primary outcomes:
measure: Evaluation of trueness
timeFrame: 4 months
Secondary outcomes:
measure: Inter-examiner reliability
timeFrame: 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University, Egypt
Study officials:
affiliation: Alexandria University
name: Rania Elsayed Ramadan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06870227: Scenario-Based Simulation
Official title: Effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Simulation
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor

Detailed description: Hypotheses 01; there was no difference between the clinical learning score of the experimental group and the pain score of the control group.

H02; there was no difference between the confidence score of the experimental group and the confidence score of the control group.

H03; there was no difference between the satisfaction score of the of the experimental group and the satisfaction score of the control group.

The study will be carried out in two different groups. The practice will start with meeting the students. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the students who accept. The random distribution of students to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Eclampsia Crisis in Labor training will be given by the responsible investigator, and then one of the groups separated by randomization will perform Eclampsia Crisis in Labor first care on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* Take the Obstetric Emergencies course

Exclusion Criteria:

* Not volunteering to participate in the study
* Not taking the obstetric emergencies course

Primary outcomes:
measure: Self-Confidence/Competence in Patient Intervention Scale
timeFrame: immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
References:
Clinical trial NCT04579627: Facial Hair, PPE and COVID-19
Official title: How Has the Increased Use of FFP3 Style Respirators During the COVID-19 Pandemic Affected Hospital Doctor's Facial Hair? Implications for Staff Safety and Welfare.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Safety Issues
Keywords: Facial Hair
Beard
Personal Protective Equipment
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 358
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospital doctors working at Royal Cornwall Hospital between January 2020 and April 2020.

Brief summary: An observational cross sectional questionnaire study looking into facial hair of hospital doctors during the COVID-19 pandemic, and how personal protective equipment guidance has affected this.

Detailed description: COVID-19 is a highly contagious virus which has caused a global pandemic. There have been significant health consequences for healthcare workers, which may be related to the provision of personal protective equipment (PPE). Following PPE guidance is a significant health and safety concern, under which facial hair guidance for tight fitting masks falls.

This has implications as FFP3 masks are not the only form of PPE for the face, and this study may highlight a need for employers to diversify which PPE they supply to their employees, such as full hoods if staff need to maintain facial hair for cultural or religious reasons.

As such, facial hair has potential implications for patient safety, but also these have to be balanced with personal or religious reasons for maintaining facial hair. Our study aimed to determine the facial hair styles of hospital doctors, and reasons for maintaining them during the COVID-19 pandemic. We also looked at whether these styles adhered to the PPE guidance set about by Public Health England (PHE)

Eligibility criteria: Inclusion Criteria:

All hospital doctors working at the main site at Royal Cornwall Hospital between January and April 2020 were included in the study population. This includes all genders and ethnicities.

Exclusion Criteria:

The principle exclusion criteria were those who did not work at the Royal Cornwall Hospital main site. Also, while not forming part of the exclusion criteria, those who are unable to grow facial hair were excluded from the statistical analyses.

Primary outcomes:
measure: Change in facial hair between January 2020 and during April 2020.
timeFrame: January 2020 and during April 2020.
Secondary outcomes:
measure: Does facial hair change adhere to the PPE guidance from PHE
timeFrame: January 2020 and during April 2020.
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
References: