louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02810951: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Official title: A Phase I/II Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Epidermolysis Bullosa Dystrophica, Recessive
Keywords: RDEB
Lead sponsor: Castle Creek Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
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 evaluate the safety of FCX-007, evaluate Type VII collagen (COL7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of FCX-007 administration in subjects with recessive dystrophic epidermolysis bullosa (RDEB). Funding Source- FDA OOPD

Detailed description: RDEB is a rare skin and connective tissue disease characterized clinically by skin fragility with easy blistering, erosion and scarring of skin and mucous membranes, and caused by the deficiency of the protein type VII collagen (COL7). The objective of this study is evaluate the safety of FCX-007 intradermal injections in RDEB subjects. Additionally, the trial will evaluate COL7 expression, the presence of anchoring fibrils, as well evidence of wound healing.

Approximately twelve subjects are expected to enroll in the Phase I/II trial. Phase I will enroll approximately six adult subjects. Phase II will enroll approximately six subjects both adults and pediatric (aged seven (7) years or older). All subjects will receive FCX-007 to one or more paired target RDEB wounds. Proof of mechanism will be monitored through digital photography of target wounds and assays conducted on biopsies taken from intact skin sites where FCX-007 is administered.

Eligibility criteria: Key Inclusion Criteria:

1. Age

   1. Phase I: Eighteen (18) years or older.
   2. Phase II: Seven (7) years or older.
2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)

Key Exclusion Criteria:

1. Medical instability limiting ability to travel to the investigative center.
2. Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic infection
3. Current evidence of metastatic squamous cell carcinoma at the site to be injected
4. Clinically significant abnormal laboratory result or other significant clinical abnormalities
5. Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months

Primary outcomes:
measure: Adverse Events
timeFrame: 52 weeks post treatment
Secondary outcomes:
measure: Complete Wound Closure
timeFrame: Through Week 52
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT01542151: Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas
Official title: Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, Prolonged
Keywords: Labor, induced
Sleep
Fatigue
Patient satisfaction
Circadian rhythm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 72
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This randomized clinical trial will examine if there are any differences between post-dates inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the evening for first-time mothers. Sleep and fatigue measures will be measured to see if they differ by time of induction. Other measures will include the rate of births within 24 hours of admission, length of labor, use of labor analgesics, and method of delivery.

Detailed description: Randomized clinical trial of first-time pregnant women requiring post-dates induction (induction after 40 weeks gestation). Women will be randomized to a labor induction time in the morning or the evening. On hospital admission once women have signed the study consent, they will complete sleep questionnaires and a fatigue assessment. Fatigue and sleep time assessments will subsequently done by the study subject every 4 hours until women enter active labor. At the onset of active labor, assessments will stop. Labor outcomes and patient satisfaction will be obtained once women deliver.

Eligibility criteria: Inclusion Criteria:

* Pregnant at 40 weeks gestation or more
* Nulliparous
* 14 years old or older
* English or Spanish speaking
* Healthy maternal status
* Labor induction able to be scheduled

Exclusion Criteria:

* Less than 40 weeks gestation
* Multiparous
* Younger than 14 years old
* Not able to speak or write in English or Spanish
* Fetal or maternal status requires immediate induction

Primary outcomes:
measure: Birth within 24 hours of induction
timeFrame: Day 1
Secondary outcomes:
measure: Cesarean rate
timeFrame: Day 1
measure: Change in fatigue scores
timeFrame: Day 1
measure: Change in hand grip strength
timeFrame: Day 1
measure: St. Mary's Sleep scale
timeFrame: Prebaseline: Baseline - 12-24 hours
measure: Labor and birth satisfaction
timeFrame: Day 2
measure: Morning-evening chronotype
timeFrame: Day 1
measure: Sleep Quality
timeFrame: Prebaseline: Baseline - 30 days
measure: Length of time to labor intervention
timeFrame: Day 1
measure: Neonatal outcomes
timeFrame: Day 1
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Medicall Center
state: California
Study officials:
affiliation: University of Clifornia, San Francisco
name: Mary K Barger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725551: The Effect of Shotblocker, Finger Puppet And Balloon Method During Intramuscular Injection
Official title: Three Applıed Durıng Intramuscular Injectıon In Chıldren Effect Of Dıfferent Method On Paın And Fear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 148
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level.

Detailed description: The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12 age group children on pain and fear level.

The purpose of the research and all the working processes were explained to the children and parents by the researcher.

Children who met all eligibility criteria were invited to participate in the study with their parents.

The children and their parents were informed about the study, they were included in the study by announcing that they would be in one of the four groups, and this group was randomly determined.

Before starting the application, verbal and written consent was obtained from the parents of the children by reading/reading the Informed Voluntary Consent Form.

The child and parent were informed by the researcher about the pain and fear level assessment tools and application before and after the procedure.

Eligibility criteria: Inclusion Criteria:

* Children who volunteered to participate in the study and who met the inclusion criteria

Exclusion Criteria:

* Children who did not volunteer to participate in the study

Primary outcomes:
measure: Child Fear Scale
timeFrame: 1 day
measure: Facial Pain Scale
timeFrame: 1 day
measure: Visual Analog Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Mersin University
name: Diğdem Lafcı pHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102151: Reducing the Duration of Untreated Psychosis
Official title: Reducing the Duration of Untreated Psychosis Through Community Education
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: First Episode Psychosis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2017-04-05
Enrollment: 137
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Living in the catchment area of San Fernando Mental Health Outpatient clinic, a clinic with the Los Angeles County Department of Mental Health

Brief summary: The study examines the possible effect of a community campaign to decrease the duration of untreated psychosis in persons with their first episode of a psychotic disorder.

Detailed description: The study examines whether a community campaign can reduce over time the duration of untreated psychosis (DUP) among persons with first episode psychosis (FEP). The DUP of mental health patients with FEP who sought services at a public outpatient or an inpatient facility was assessed for a 15 month period prior to the campaign launch. This serves as the baseline or historical control. The DUP will continue to be assessed for another 3 years. The hypothesis being tested is that there will be a significant decrease in DUP between baseline, one-year, two-year and three-year follow-ups. This study is being carried out with Latinos in Los Angeles County because as a group, particularly among Spanish-speaking immigrants, Latinos are at high risk for prolonged DUP.

Eligibility criteria: Inclusion Criteria:

* Meet Diagnostic and Statistical Manual-4 criteria for a psychotic disorder
* of Latino origin

Exclusion Criteria:

* has a neurological disorder or suffers from brain trauma

Primary outcomes:
measure: Latency to Treatment (LTT) a novel interview based assessment tool to measure the Duration of Untreated Psychosis
timeFrame: At the time of recruitment into the study
Secondary outcomes:
measure: Psychosis literacy, a questionnaire based inquiry for which the respondents answer either open-ended questions (e.g., What is serious mental Illness?) or "Yes-no" questions ("e.g., Can you recognize a serious mental illness in others?)
timeFrame: At the time of recruitment in to study
Other outcomes:
Locations:
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
Study officials:
affiliation: University of Southern California
name: Steven Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05954351: PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.
Official title: PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-07-20
Enrollment: 2465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.

Brief summary: PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.


Eligibility criteria: Inclusion Criteria:

* receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2
* admitted to one of the ICUs of the participating hospitals

Exclusion Criteria:

* none

Primary outcomes:
measure: ICU mortality
timeFrame: 90 days from inclusion
Secondary outcomes:
measure: Duration of ventilation
timeFrame: 90 days from inclusion
measure: 28-day ventilator free days
timeFrame: 90 days from inclusion
measure: 28-day, 90-day mortality
timeFrame: 90 days from inclusion
measure: ICU and hospital length of stay
timeFrame: 90 days from inclusion
Other outcomes:
measure: Acute kidney injury
timeFrame: 90 days from inclusion
measure: duration of ventilation in survivors
timeFrame: 90 days from inclusion
measure: use of muscle paralysis
timeFrame: 90 days from inclusion
measure: vasopressor or inotrope administration
timeFrame: 90 days from inclusion
measure: occurrence of tracheostomy
timeFrame: 90 days from inclusion
measure: pneumothorax and thromboembolic complications
timeFrame: 90 days from inclusion
measure: use of immunomodulating drugs
timeFrame: 90 days from inclusion
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
References:
Clinical trial NCT01260051: Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes
Official title: Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Epidural
Breast Feeding
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients who delivered at UHCMC between August 2009 and January 2010

Brief summary: Currently, no clear consensus exists regarding the effect of epidural anesthesia upon breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies have failed to separate these potential mechanisms. The present study examines whether epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and 2) neonatal neurobehavioral deficits in feeding, as measured by the L\&A components of the standardized, validated LATCH scoring system.


Eligibility criteria: Inclusion Criteria:

* Vaginal delivery
* Delivery of a single live neonate

Exclusion Criteria:

* NICU admission following delivery
* Pitocin augmentation

Primary outcomes:
measure: Breast-Feeding at Hospital Discharge
timeFrame: Baseline
Secondary outcomes:
measure: L&A Components of LATCH Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Ashley L Szabo, MD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.
citation: Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I. Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study. Anesthesiology. 2005 Dec;103(6):1211-7. doi: 10.1097/00000542-200512000-00016.
citation: Wiklund I, Norman M, Uvnas-Moberg K, Ransjo-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. doi: 10.1016/j.midw.2007.07.005. Epub 2007 Nov 5.
Clinical trial NCT00437151: Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
Official title: An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 61
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

Detailed description: Same as above.

Eligibility criteria: Inclusion Criteria:

* Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris

Exclusion Criteria:

* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)

Primary outcomes:
measure: Efficacy - Percent adherence calculated from MEMS Caps readings
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire
timeFrame: 12 weeks
measure: Safety - tolerability and adverse event reporting
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Galderma Laboratories, LP
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03896451: Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Official title: Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.

Primary outcome measures KOOS, Forgotten Knee Score and range of motion.

Single-center, randomized trial

Detailed description: The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).

Secondary outcome measures: number of reoperations and revisions, survival of the prosthesis

The patient population would consist patients with knee osteoarthritis eligible for total knee replacement

The aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome

Eligibility criteria: Inclusion Criteria:

* patient is eligible for a total knee replacement
* patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis
* patient signed the informed consent

Exclusion Criteria:

* patient is pregnant

Primary outcomes:
measure: Change in Knee injury and Osteoarthritis Outcome Score
timeFrame: preoperative, 1 year, 5 year and 10 year after surgery
measure: Change in Forgotten Joint Score
timeFrame: 1 year, 5 year and 10 year after surgery
Secondary outcomes:
measure: Change in revison
timeFrame: 1 year, 5 year and 10 year after surgery
measure: Change in range of motion
timeFrame: preoperative, 1 year, 5 year and 10 year after surgery
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
Study officials:
affiliation: Principal Investigator
name: Peter Koch, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02181751: A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse
Official title: A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sexual Abuse of Child (If Focus of Attention is on Victim)
Keywords: Child Sexual Abuse
CSA
Treatment
Prevention
PTSD
Post Traumatic Stress Disorder
Depression
Anxiety
Quality of Life
Attachment
Cognitive Behavioural Therapy
Group Therapy
Lead sponsor: Little Warriors
Sponsor class: OTHER
First posted: 2014-07-04
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: Our goal in this study is examine if a program designed to decrease the severity of Post-Traumatic Stress Disorder symptoms in sexually abused children between the ages of 8-12 was effective.


Eligibility criteria: Inclusion Criteria:

* History of sexual abuse
* Aged 8 - 12 years
* Developmentally able to be on-site in a "camp-like" treatment facility for 3 weeks with their parent/guardian (or without if family is not available to join the child at the Be Brave Ranch)
* Able to perform skills of daily living for self care
* Good physical health

Exclusion Criteria:

* Severe mental health issues including (but not limited to):
* Recent suicide attempt
* History of psychosis
* History of significant self-harm
* History of homicidal thoughts or actions
* History of violent behaviours sufficient to be considered a threat to others
* Acute eating disorder.
* Significant risk of absconding, or history of absconding
* Serious behavioural problems
* Significant use of drugs or alcohol
* History of sexual violence or sexual behaviour towards others
* Any significant interaction with the justice system or police
* Cognitive impairment that would interfere with treatment benefits
* Medical conditions that are not stable
* Severe medical conditions

Primary outcomes:
measure: Post Traumatic Stress Disorder Symptom Severity
timeFrame: 4 Months
Secondary outcomes:
measure: Quality of Life
timeFrame: 4 Months
measure: Depression and Anxiety
timeFrame: 4 Months
measure: Level of Attachment
timeFrame: 4 Months
Other outcomes:
Locations:
city: Ardrossan
country: Canada
facility: Be Brave Ranch
state: Alberta
Study officials:
affiliation: University of Alberta
name: Farrel Greenspan, MC
role: PRINCIPAL_INVESTIGATOR
References: