louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04921098: CPC in Adult Refractory Glaucoma
Official title: Evaluation of Diode Laser Cyclophotocoagulation in Adult Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Glaucoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma.

Detailed description: A hospital -based, prospective interventional non comparative case series study.This study will be conducted on patients with refractory glaucoma whose ages are 18 years and older.They will be subjected to Transscleral Diode Laser Cyclophotocoagulation.

Postoperative evaluation will be scheduled for the first day postoperative, then 1 week later and then at 1st, 3rd, month postoperative.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  1. Patients with refractory glaucoma aging 18 years and older.
  2. Both sexes are included.
  3. Patients Capable of giving informed consent.
  4. Pseudophkic glaucoma.
  5. Aphakic glaucoma.
  6. Silicon oil induced glaucoma.
  7. Neovascular glaucoma.
  8. Inflammatory glaucoma.

Exclusion Criteria:

1. Patients \<18 years of age.
2. Patients controlled on regular antiglaucomatous therapy.
3. Patients who cannot do regular follow up visits.
4. Diffuse scleral staphyloma at the site of CPC.

Primary outcomes:
measure: change in intraocular pressure
timeFrame: First day postoperative and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
citation: Ansari E, Gandhewar J. Long-term efficacy and visual acuity following transscleral diode laser photocoagulation in cases of refractory and non-refractory glaucoma. Eye (Lond). 2007 Jul;21(7):936-40. doi: 10.1038/sj.eye.6702345. Epub 2006 Apr 21.
citation: Lai JS, Tham CC, Chan JC, Lam DS. Diode laser transscleral cyclophotocoagulation in the treatment of chronic angle-closure glaucoma: a preliminary study. J Glaucoma. 2003 Aug;12(4):360-4. doi: 10.1097/00061198-200308000-00011.
citation: Nassiri N, Kamali G, Rahnavardi M, Mohammadi B, Nassiri S, Rahmani L, Nassiri N. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J Ophthalmol. 2010 Jun;149(6):893-902. doi: 10.1016/j.ajo.2010.01.025. Epub 2010 May 8.
Clinical trial NCT00835198: Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 163
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Facial acne vulgaris characterized by the following:

  * 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
  * Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
* Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

* Non-compliance with washout period;
* History of clinically significant anemia or hemolysis;
* Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
* Allergy or sensitivity to any component of the test medications

Primary outcomes:
measure: Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Investigator Global Assessment at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Overall Disease Severity at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Strongsville
country: United States
state: Ohio
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05511298: Empowering Students Project
Official title: Empowering Students Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relationship, Social
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 1332
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students who are enrolled in schools (or other programs) that opt to offer the intervention.

Brief summary: The Empowering Students Project is an evaluation of the effectiveness of a psychoeducational program for adolescents, intended to help youth build healthy relationship skills while supporting positive socioemotional development and promoting successful transition to young adulthood.

Detailed description: Participants complete measures of the primary outcomes immediately prior to beginning the intervention and again immediately after completion of the program. Analyses will examine within-person change from pre-test to post-test.

Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Relationship Quality
timeFrame: Baseline: Immediately prior to the first workshop session; Follow-up: Immediately following the last workshop session (ranging from ~4-8 weeks in between time points, depending on how the workshop is delivered)
measure: Change in Communication Skills
timeFrame: Baseline: Immediately prior to the first workshop session; Follow-up: Immediately following the last workshop session (ranging from ~4-8 weeks in between time points, depending on how the workshop is delivered)
measure: Change in Knowledge About Healthy Relationships
timeFrame: Baseline: Immediately prior to the first workshop session; Follow-up: Immediately following the last workshop session (ranging from ~4-8 weeks in between time points, depending on how the workshop is delivered)
measure: Knowledge about Intimate Partner Violence
timeFrame: Baseline: Immediately prior to the first workshop session; Follow-up: Immediately following the last workshop session (ranging from ~4-8 weeks in between time points, depending on how the workshop is delivered)
measure: Change in Increased Knowledge, Skills, and Confidence
timeFrame: Baseline: Immediately prior to the first workshop session; Follow-up: Immediately following the last workshop session (ranging from ~4-8 weeks in between time points, depending on how the workshop is delivered)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: The Parenting Center
state: Texas
Study officials:
References:
Clinical trial NCT05728398: Music in Interventional Radiology Procedures
Official title: Music in Interventional Radiology Procedures: Effect on Patient and Staff Experience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Keywords: Interventional radiology
Music
procedure sedation
patient experience
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The use of music as medical therapy for the treatment of mental health conditions like depression and anxiety is well established. Furthermore, music is sometimes played in operating rooms and several small single center studies done during cardiology and interventional radiology procedures have demonstrated that the use of music can decrease in the use of sedation medications, pain, and anxiety during the procedures.

These past studies have only looked at the impact on the participants, as the music was delivered to the participants only through headphones. This means that the impact of music on the healthcare team was not studied. However, separate systematic literature reviews on the impact of playing music in operating rooms during surgical procedures have highlighted some positive effects music has on the surgeon and the surgical team.

The purpose of this study is to evaluate the effects of playing music during interventional radiology procedures on the participants and the healthcare team. One way of studying this is to compare the responses and experience of participants and healthcare team that hear ambient music during the procedure with those who did not.


Eligibility criteria: Inclusion Criteria:

* Undergoing an out-patient or non-emergent in-patient interventional radiology procedure

Exclusion Criteria:

* Participants unable to consent or complete survey information
* Participants receiving procedures under general anesthesia
* Participants unable to receive IV conscious sedation
* Emergent cases or those performed outside of routine hospital hours

Primary outcomes:
measure: Procedural Sedation required
timeFrame: Intra-procedure
Secondary outcomes:
measure: Participant intra-procedural anxiety
timeFrame: Intra-procedure
measure: Participant procedural pain
timeFrame: Immediately post-procedure
measure: Participant Procedural Experience
timeFrame: Immediately post-procedure
measure: Interventional radiology procedure length
timeFrame: Intra-procedure
measure: Healthcare team experience
timeFrame: Immediately post-procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02529098: Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
Official title: Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vision Disorders
Keywords: functional magnetic resonance imaging
Lens implantation
pseudophakia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.


Eligibility criteria: Inclusion Criteria:

* Cataract surgery with an bilateral multifocal lens implant Restor

Symptomatic patients :

* Symptomatic bilateral visual difficulties for 3 months or more after the intervention which impact the daily activity

Asymptomatic patients :

* No visual complaint for 3 months or more after the intervention

Exclusion Criteria:

* Patients with ophthalmology disorders
* Contra indication for fMRI

Primary outcomes:
measure: Extent of neural activation in visual cortex measured by the number of voxels
timeFrame: 1 day
Secondary outcomes:
measure: extent of neural activation in visual cortex measured by the number of voxels
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Francois Malecaze, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260098: StressLess Yoga Study
Official title: StressLess Yoga Study: A Scientific Exploration of Yoga for Stress Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Self-identification as "stressed"
* Scoring 8 or higher on the Perceived Stress Scale (PSS) indicating moderate-to-high stress
* Willingness to complete the 8-week yoga intervention
* Willingness to attend baseline and follow-up visits
* Ability to read and write in English
* Having practiced yoga ≤ 2x in the last 6 months

Exclusion Criteria:

* Serious or unstable psychiatric illness (e.g., psychosis, mania)
* Major coexisting medical illness (e.g., cancer, COPD, obesity)

Primary outcomes:
measure: The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits)
timeFrame: 8 weeks
measure: The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Bousfield Psychology Building, 406 Babbidge Road
state: Connecticut
Study officials:
References:
Clinical trial NCT04723498: Problematic Use of the Internet in Child and Adolescent Psychiatry
Official title: Problematic Use of the Internet in Child and Adolescent Psychiatry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pathological internet use is a blanket term for problematic behavior types (e.g. uncontrolled gaming, cyber pornography, cyber mobbing and excessive use of social media): all perpetrated through the internet. There is little documentation or research on interdependencies/interplay between problematic internet and/or media use and child-adolescent disturbances. Very few clinical examples of syndromes like attention deficiency/hyperactivity (ADHS), anxiety disorder or affective disturbances associated with pathological media/internet use, or gaming, are found in literature.


Eligibility criteria: Inclusion Criteria:

* male and female patients ages from 8 - 18 years
* All study participants or their legal representative have given written permission for their experiences to be documented in the study.

Exclusion Criteria:

* Inability to understand explanations and the questionnaire, whether linguistic or cognitative

Primary outcomes:
measure: Symptoms severity of problematic internet and media use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
state: ZH
Study officials:
affiliation: Sponsor GmbH
name: Susanne Walitza, Prof. Dr. med. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06104098: A User Study With Vernivia® for Bacterial Vaginosis.
Official title: A User Study With Vernivia® for Bacterial Vaginosis (USV01) Evaluation of User-friendliness, Measure Time From the Start of Treatment to Symptom Relief and the Clarity of Instructional Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginoses
Lead sponsor: PepTonic Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Key2Compliance
name: Replior AB
First posted: 2023-10-27
Enrollment: 76
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material.

The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.


Eligibility criteria: Inclusion Criteria:

* Age 16 - 49 years Informed consent to take part in the study Bacterial vaginosis (based on self-assessment or diagnosed by a doctor or midwife) Access to a smartphone

Exclusion Criteria:

* Symptoms of vaginal candida infection and/or Pregnancy

Primary outcomes:
measure: Evaluate symptom relief during treatment with Vernivia®.
timeFrame: 1-7 days
Secondary outcomes:
measure: Self-reported grading of malodorous discharge (0-3)
timeFrame: 1-7 days
measure: Net Promotor Score regarding user-friendliness
timeFrame: 1-7 days
measure: Clarity of the IFU (Instructions For Use)
timeFrame: 1-7 days
measure: Clarity of instructional video
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Väla
country: Sweden
facility: Mama Mia Väla
state: Helsingborg
city: Linköping
country: Sweden
facility: Mednika AB
city: Lomma
country: Sweden
facility: Hälsomedicinskt Center
city: Malmö
country: Sweden
facility: Mama Mia Barnmorskemottagning
city: Nyköping
country: Sweden
facility: Kvinnohälsan Stadsfjärden
city: Stockholm
country: Sweden
facility: 2Heal Medical
city: Sundsvall
country: Sweden
facility: Ondrasek Läkarmottagning
Study officials:
References:
Clinical trial NCT00950898: The Acute Effects of Coffee on Glucose Metabolism
Official title: Human Trial of the Acute Effects of Coffee on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: coffee
caffeine
glucose metabolism
insulin sensitivity
diabetes
Lead sponsor: Brooklyn College of the City University of New York
Sponsor class: OTHER
First posted: 2009-08-03
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans


Eligibility criteria: Inclusion Criteria:

* healthy young males
* nonsmokers
* moderate alcohol users

Exclusion Criteria:

* not on any medications that could alter glucose metabolism
* no history of blood disorders

Primary outcomes:
measure: plasma glucose levels
timeFrame: 0, 10, 30, 60, 90, and 120 minutes.
Secondary outcomes:
measure: plasma insulin
timeFrame: 0, 10, 30, 60, 90, and 120 minutes
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn College of the City University of New York
state: New York
Study officials:
affiliation: Brooklyn College of the City University of New York
name: James Greenberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04282798: Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
Official title: Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project will study the efficacy of a personalized receptive music intervention on neuropsychiatric symptoms and general cognitive function in patients with mild and moderate Alzheimer's disease (AD) by race.

Detailed description: Music interventions have become a popular treatment option to be used alongside medicinal treatment for many chronic conditions including Alzheimer's disease. Healthcare providers and researchers have found that when patients who have chronic conditions engage with music that is patients' preference or most familiar to patients, the patients display positive changes in mood regulation and thinking overall. The investigators are trying to understand to what extent these music interventions could be useful for patients with Alzheimer's disease and for which populations the intervention is more effective for. To do this, the investigators are looking to recruit participants with a diagnosis of Alzheimer's disease to complete a four (4) week personalized music intervention where patients listen to a one-hour playlist created from patients' described preferences and songs.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's disease
* English speaking

Exclusion Criteria:

* Deaf or hard of hearing

Primary outcomes:
measure: Change in severity of neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) severity score
timeFrame: Initial and final visit, four weeks apart
measure: Change in Montreal Cognitive Assessment (MoCA) score
timeFrame: Initial and final visit, four weeks apart
Secondary outcomes:
measure: Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score
timeFrame: At the end of the study, up to 9 months
measure: Correlation between the BMRQ score and MoCA score
timeFrame: At the end of the study, up to 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Paul Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University Kreiger School of Arts & Sciences
name: Melissa K Eustache, BS
role: STUDY_DIRECTOR
References: