louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06374550: Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children
Official title: Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children in Childcare Centers Using a Mobile Application
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings.


Eligibility criteria: Centers Inclusion Criteria:

1. Centers must have \>30 children ages 2-to-5
2. Center must serve low income families
3. Centers must reflect the ethnic diversity of the Miami Dade County Public School System (60% Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White).

Participants Inclusion Criteria:

1. Participants must speak English or Spanish or Creole
2. Parents must have a child enrolled in the childcare center that is participating in the study.
3. Children ages 2-5: Parent reported data (name, Date of Birth, behaviors)

Exclusion Criteria:

1. any participants who do not speak English or Spanish or Creole.

Primary outcomes:
measure: Change in classroom practices as measured by Health Environment Rating Scale
timeFrame: Baseline, 2 months after baseline, and up to 1 year
Secondary outcomes:
measure: Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA)
timeFrame: Baseline, 2 months after baseline, and up to 1 year
measure: Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline and up to 1 year
measure: Change in resiliency as measured by Brief Resiliency Coping Scale
timeFrame: Baseline and up to 1 year
measure: Change in stress as measured by Childcare Worker Job Stress Index
timeFrame: Baseline and up to 1 year
measure: Change in stress as measured by Everyday Stressors Index
timeFrame: Baseline and up to 1 year
measure: Change in satisfaction as measured by Teacher Opinion and Satisfaction survey
timeFrame: Baseline and up to 1 year
measure: Mobile Application satisfaction as measured by the Mobile Application Rating Scale
timeFrame: 2 months after baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ruby Natale, PhD, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05116150: Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males
Official title: Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplementation
Lead sponsor: California Baptist University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study.

Detailed description: The investigators aimed the additive effects of combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and oxygen consumption (O2) were examined at rest and during cycling exercise.

Eligibility criteria: Inclusion Criteria:

* healthy males

Exclusion Criteria:

* cardiovascular and/or pulmonary disease, musculoskeletal disorders, or medications that prevent the safe completion of the exercise protocol

Primary outcomes:
measure: Systolic blood pressure (mmHg)
timeFrame: 7 days
measure: Diastolic blood pressure (mmHg)
timeFrame: 7 days
measure: Mean arterial pressure (mmHg)
timeFrame: 7 days
measure: Heart rate (bpm)
timeFrame: 7 days
measure: Stroke volume (ml)
timeFrame: 7 days
measure: Cardiac output (l/min)
timeFrame: 7 days
measure: Total vascular conductance (ml/min/mmHg)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: California Baptist University
state: California
Study officials:
affiliation: California Baptist University
name: Jong-Kyung Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04581850: Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
Official title: Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-traumatic Stress Disorder
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of patients suffering from an active PTSD and healthy individuals.

Brief summary: Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.

Sleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.

According to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.

In the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.


Eligibility criteria: Inclusion Criteria:

* Military or former military
* Age between 18 and 65 years old
* PTSD group : with a PTSD diagnosis
* Control group : without any sleep, psychiatric or neurologic pathology

Exclusion Criteria:

* Diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for PTSD
* Sleep pathology prior to the traumatic event responsible for PTSD
* Neurological pathology or severe head injury within the last 3 years

Primary outcomes:
measure: Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.
timeFrame: 1 month after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpoital d'Instruction des Armées Percy
city: Mailly-le-Camp
country: France
facility: 52e Antenne Médicale
city: Marseille
country: France
facility: Hôpital d'Instruction des Armées Laveran
city: Mourmelon-le-Grand
country: France
facility: 29e Antenne Médicale
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References:
Clinical trial NCT05909150: Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
Official title: Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Heart Transplantation
Acute Kidney Injury
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.

Detailed description: Acute kidney injury (AKI) is a frequent complication immediately after heart transplantation (HT), with incidence rates between 40-70%. Several factors contribute to this complication, such as hypervolemia, hyperactivation of renin-angiotensin-aldosterone system (RASS) and low cardiac output. Hypertonic saline solution (HSS) can reduce diuretic resistance, increase urinary output and improve renal function in hypervolemic status such as acute heart failure. Therefore, the investigators hypothesized that the use of HSS could prevent or attenuate AKI after heart transplantation in the early postoperative phase. The investigators aim to randomize 74 patients to receive 150 mL of HSS 3,5% or placebo (saline solution 0,9%) twice daily for 3 days after HT. Renal function, right ventricular echocardiographic parameters and pulmonary artery catheter parameters will be assessed. Patients will be followed-up until 30 days, or death.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients submitted to orthotopic heart transplantation (HT)

Exclusion Criteria:

* Requirement of renal replacement therapy at the time of HT
* Requirement of extracorporeal membrane oxygenation (ECMO) before or immediately after HT
* Severe peri-operative mechanical complications
* Double transplant (e.g. heart-kidney or heart-lung)
* Hypernatremia (Na ≥ 145)
* Severe hyponatremia (Na ≤ 120)

Primary outcomes:
measure: Prevention of acute kidney injury
timeFrame: Days 3 -7 post-transplantation
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Incidence of acute kidney injury requiring hemodialysis
timeFrame: 30 days
measure: Intensive care unit (ICU) length of stay
timeFrame: During ICU stay, an average of 5 days
measure: Time to wean inotropes and vasopressors
timeFrame: During ICU stay, an average of 5 days
measure: Incidence of right ventricular dysfunction
timeFrame: Until day 5 post-transplantation
measure: Hypertonic saline solution (HSS) hemodynamic effect
timeFrame: Until day 3 post-transplantation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute, University of São Paulo.
Study officials:
affiliation: University of Sao Paulo
name: Fernando Bacal, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01057550: Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
Official title: A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary Incontinence
autologous slings
slings
tvt
grafts
surgery
Lead sponsor: Abertawe Bro Morgannwg University NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: C. R. Bard
First posted: 2010-01-27
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.


Eligibility criteria: Inclusion Criteria:

* Women requiring surgery for SUI following failed conservative treatment

Exclusion Criteria:

* Under 18 years of age
* Previous surgery for SUI
* Evidence of neurological disease
* Pelvic Organ Prolapse (POP) greater than Grade 2
* Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment

Primary outcomes:
measure: success rate at improving symptom of stress urinary incontinence
timeFrame: 1 year
Secondary outcomes:
measure: completely dry rates
timeFrame: 1 year
measure: quality of life scores
timeFrame: 1 year
measure: intra & post-operative complications
timeFrame: 1 year
measure: re-operation rates
timeFrame: 1 year
measure: hospital stay
timeFrame: 5 days
measure: operative time
timeFrame: hours
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: ABM University Hospital NHS trust
state: Wales
Study officials:
affiliation: ABM University Hospital NHS trust
name: Malcolm G Lucas
role: STUDY_CHAIR
References:
citation: Guerrero KL, Emery SJ, Wareham K, Ismail S, Watkins A, Lucas MG. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG. 2010 Nov;117(12):1493-502. doi: 10.1111/j.1471-0528.2010.02696.x. Epub 2010 Sep 24.
Clinical trial NCT04970550: Vaccination Against SARS-Cov2 (COVID-19) in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.
Official title: Vaccination Against SARS-Cov2 in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Keywords: SARS COV 2 vaccination
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A questionnaire is completed by the patient with the investigator during the medical consultation.

Brief summary: Rheumatoid arthritis and spondyloarthritis (ankylosing spondylitis and psoriatic arthritis mainly) are chronic inflammatory rheumatism (RIC), frequently onset in young adults. The prevalence is respectively 0.3 to 0.8% and 0.4%. or about 600,000 people. The "basic" treatments (DMARDs), essential to control the progression of the disease, are classified into csDMARDs (chemical), the first of which is methotrexate, or bDMARDs (biological). These treatments are immunomodulators and there is an increased risk of severe infection under these therapies. Several vaccinations are therefore recommended by learned societies in patients receiving these treatments, in order to prevent certain infectious risks.In the current pandemic context, the vaccination of these patients against SARS-Cov2 is a major issue in their management and is recommended by the French society of rheumatology. However, many patients express doubts about this vaccination or refuse it. The factors associated with the vaccination will are not known. Better identifying them would make it possible to adapt the information to be given to our patients to promote their adherence.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients
* Men or women of any age
* Follow-ups for chronic inflammatory rheumatism such as rheumatoid arthritis or spondyloarthritis
* Treated with methotrexate or biotherapy.

Exclusion Criteria:

* Patients not treated with biotherapy or methotrexate.
* Patients in whom the assessment could not be performed reliably

Primary outcomes:
measure: Determine the desire to be vaccinated against SARS-CoV2
timeFrame: At inclusion
Secondary outcomes:
measure: Factors associated with the desire for vaccination against SARS-CoV2
timeFrame: At inclusion
Other outcomes:
Locations:
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT05246150: NIRS Levels of Infants in Neonatal Intensive Care
Official title: The Effect Of Nursıng Practıces On The Near Infrared Spectroscopy Levels Of Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 premature newborns

Brief summary: Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU).

Materials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart." The data were evaluated with the IBM SPSS 24 package program.


Eligibility criteria: Inclusion Criteria:

* Neonates younger than a gestational age of 37 weeks
* Those monitored in an open or closed incubator

Exclusion Criteria:

* Intubated neonates connected to a mechanical ventilator
* Infants of a gestational age of 37 weeks or more
* Infants under sedation
* Infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)

Primary outcomes:
measure: nursing practices
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir
Study officials:
References:
Clinical trial NCT01162850: Oral Polypodium Leucotomos for Melasma
Official title: A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Keywords: Melasma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.

To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.

Detailed description: Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.

Oral Polypodium Leucotomos is safe and effective in patients with melasma.

Eligibility criteria: Inclusion Criteria:

* Healthy female subjects 18-50 years of age.
* Female subjects with epidermal melasma.
* Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
* Subjects with Fitzpatrick skin types II, III, \& IV
* Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.

Exclusion Criteria:

* Pregnant or lactating
* Dermal Melasma
* Hormonal therapies less than or equal too 4 weeks prior to study
* Use of photosensitizing medications
* Simultaneous use of any form of treatment for melasma
* Subjects who were concurrently receiving light therapies
* Subjects who were unwilling to limit the amount of sun exposure
* Simultaneous ( or past 30 day) participation in a clinical research study.

Primary outcomes:
measure: Melasma Area and Severity Index (MASI)
timeFrame: Day 0, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Patient Assessment
timeFrame: Week 4, Week 8, Week 12
measure: Evaluation of Photographs
timeFrame: Post-Week 12
measure: Adverse Events
timeFrame: Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Cosmetic Center
state: Florida
Study officials:
affiliation: University of Miami
name: Heather Woolery-Lloyd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06270550: Role of Dynamic Movement Intervention in Children with Spastic Diplegia
Official title: Efficacy of Dynamic Movement Intervention on Children with Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spastic Diplegia
Keywords: Dynamic Movement Intervention
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.


Eligibility criteria: Inclusion criteria:

* Age ranged from 4-7 years.
* They can walk alone short distance and climb stairs holding on rail (Grade I \& II according to GMFCS).
* They can understand and execute instructions.
* They will be medically stable.
* Degree of spasticity will be ranged from 1 to 1+ degree according to the Modified Ashworth Scale.

Exclusion criteria:

* Visual impairment (visual loss- cataract- myopia- hyperopia).
* Hearing impairment (deafness)
* Cognitive problem.
* Uncontrolled Convulsions.
* Orthopedic surgery for the affected lower limbs within one year.
* Botulinum toxin injection within the last 6 months or within the study period.

Primary outcomes:
measure: Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: