louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06139549: The Effects of Playful Pathways
Official title: The Effects of Playful Pathways, a Play-Based Developmentally Focused Group Program, and How it Affects Caregivers' Health Literacy and Self-Efficacy and Influences Outcomes for Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gross Motor Development Delay
Keywords: INFANT
GROSS MOTOR DEVELOPMENT
GROUP SESSION
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants ages 0-6 months Caregivers age 18 and older

Brief summary: The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. The researchers aim to screen and identify developmental delays and the effects of the 8 week program on gross motor development as well as explore parent perceptions of the program.

The aim of this study is to assess the physical, social, and emotional outcomes of an interactive group program for infants 0-6 months and their families/caregiver.


Eligibility criteria: All babies typically developing or any diagnosis ages 0 - 6 months; parents/caregivers of babies typically developing or any diagnosis ages 0 - 6 months participating in the intervention. Sample size will be 12 babies ages 0-6 months and their caregivers (1-2 caregivers per baby). Total population 12 infants with up to 30 caregivers.

Inclusion criteria:

1. All babies typically developing or any diagnosis ages 0 - 6 months

Inclusion criteria for parents/caregivers:

1. At least 18 years of age
2. Able to communicate in and read English
3. Parent/caregiver of baby ages 0 - 6 months who is participating in the program
4. Ability to provide transportation to/from research site(s)

Primary outcomes:
measure: DAYC-2
timeFrame: 9/20/23 - 2/20/24
measure: PHLAT-8
timeFrame: 9/20/23 - 2/20/24
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Arkansas Colleges of Health Education
state: Arkansas
Study officials:
affiliation: Arkansas Colleges of Health Education
name: Allison N Young, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alkhazrajy, L. A., & Aldeen, E. R. S. (2017). Assessment of mothers knowledge regarding the developmental milestone among children under two years in Iraq. American Journal of Applied Sciences, 14(9), 869-877.
citation: Aoyama T, Hikihara Y, Watanabe M, Wakabayashi H, Hanawa S, Omi N, Takimoto H, Tanaka S. Association Between Age of Achieving Gross Motor Development Milestones During Infancy and Body Fat Percentage at 6 to 7 Years of Age. Matern Child Health J. 2022 Feb;26(2):415-423. doi: 10.1007/s10995-021-03238-9. Epub 2021 Oct 16.
Clinical trial NCT03534349: Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance
Official title: Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Performance
Flexibility
Keywords: Duchenne Muscular Dystrophy
lower limb flexibility
performance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 30
Sex: MALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children with ambule Duchenne Muscular Dystrophy

Brief summary: The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy.

Detailed description: Thirty children whose functional levels were in 1 or 2 according to the Brooke Lower Extremity Functional Classification Scale were included in the study. Flexibilities of hamstrings, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. Popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. Functional performance was assessed with 6 Minute Walk Test (6 MWT) and Timed Performance Tests. The correlation between the flexibility of lower limb muscles' and performance tests were examined.

Eligibility criteria: Inclusion Criteria:

* Having a Duchenne Muscular Dystrophy diagnosis,
* Being in the ambulatory period and climbing four steps independently,
* To be able to cooperate the physiotherapist's directions,
* Not having any severe contracture in the lower limbs which may prevent assessments,
* Not having any injury or surgery involving the lower limbs during the last 6 months.

Exclusion Criteria:

Children who did not provide these criteria and did not will to participate the study were excluded.

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: 6 Minute
Secondary outcomes:
measure: Timed Performance Test
timeFrame: 3 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Öznur Tunca Yılmaz, Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: İpek Alemdaroğlu Gürbüz, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ayşe Karaduman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368249: Does Terlipressin Improve Renal Outcome After Liver Surgery
Official title: Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kidney Failure
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.


Eligibility criteria: Inclusion Criteria:

* \>=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial

Exclusion Criteria:

* \< 18 years
* liver cirrhosis
* coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
* pregnancy and breast feed

Primary outcomes:
measure: serum creatinine peak level within 48 hours post-operative
timeFrame: within 48 hours post-operative
Secondary outcomes:
measure: the urinary output/24h
timeFrame: Post Operative Day 0 to 3
measure: Need for hemofiltration and/or hemodialysis
timeFrame: Post Operative Day 0 - 14
measure: Morbidity & mortality
timeFrame: Post Operative Day 0 - 14
measure: Liver function
timeFrame: Post Operative Day 0 - 5
measure: length of hospital stay
timeFrame: Post Operative Day 0 - 14
measure: length of ICU stay
timeFrame: Post Operative Day 0 - 7
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Study officials:
affiliation: Departement of Visceral and Transplantation Surgery Zurich
name: Pierre-Alain Clavien, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06545149: SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.
Official title: SUPPLEMENTATION WITH FERMENTED AND BALANCED FOOD WITH BETA GLUCAN FAVORS THE INNATE AND ADAPTATIVE RESPONSE OF PATIENTS ADMITTED TO A MEDICAL CLINIC WARD? A RANDOMIZED TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical Course
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Kaiser Clinic and Hospital
First posted: 2024-08-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abstract: Studies demonstrate that the use of nutritional supplements containing beta-glucans stimulates the immune system, modulates inflammatory activity, and promotes so-called immune training. Beta-glucans are prebiotics that stimulate the growth and activity of gastrointestinal microbiota and inhibit pathogen growth. Nutritional intervention is crucial for patients\&#39; positive evolution, and providing a supplement with highly bioavailable nutrients can make a difference in their nutritional, metabolic, and immune status. Therefore, the study aims to verify the effectiveness of the innate and adaptive immune response to a nutritionally balanced fermented food, containing oral or enteral beta-glucans, in patients treated at 3 Emergency Care Units in São José do Rio Preto, São Paulo, Brazil. This is a prospective randomized study with a characteristic design involving patients treated in the medical wards of 3 Emergency Care Unit. The following assessments will be conducted: Global Subjective Assessment for adults and Mini Nutritional Assessment for the elderly, Sociodemographic, and Laboratory Evaluation.


Eligibility criteria: Inclusion Criteria:

Patients admitted to the medical clinic ward

Exclusion Criteria:

Patients unable to swallow

Primary outcomes:
measure: length of hospital stay
timeFrame: during hospitalization
Secondary outcomes:
measure: need for readmission
timeFrame: up to 24 weeks
measure: need for ICU
timeFrame: up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06619249: Effect of Endurance Training-Induced Coenzyme Q10 (CoQ10) Supplementation on Myokine, Exerkine Secretion and Cognitive Functions in Long-Distance Runners
Official title: Effect of Endurance Training-Induced Coenzyme Q10 (CoQ10) Supplementation on Myokine, Exerkine Secretion and Cognitive Functions in Long-Distance Runners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Health Knowledge, Attitudes, Practice
Keywords: Coenzyme Q10
Supplementation
Myokine
Exerkine
Cognition
Long-distance runners
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 24
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, double-blind, placebo-controlled, cross-over study
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if CoQ10 amplifies endurance training-induced myokine and exerkine secretion and if those changes influences cognition in long-distance runners.

Does 4-week high-dosage CoQ10 supplementation increase the secretion of myokine, exerkine sercetion? Does the above-mentioned intervention improve the cognitive function in long distance runners?

Participants will:

Take CoQ10 or a placebo every day for 4 weeks. Visit the laboratory once every 4 weeks for checkups and tests. Keep their food and training diary.


Eligibility criteria: Inclusion Criteria:

* training experienced for minimum 2 years
* running training at least 2 times per week
* Personal Best on 10k (\<50 minutes)

Exclusion Criteria:

* taking supplements which can interrupt primary outcomes (vitamin D, omega-3 fatty acids)
* injured in last 6 months to avoid n number reduction

Primary outcomes:
measure: Change in cognitive funtions as a result of CoQ10 supplementation measured via cogntitive function test.
timeFrame: We are going to check this hypothesis after 4 weeks of high-dose supplementation with CoQ10
measure: Change in myokine and exerkine concentration in the blood plasma as a result of CoQ10 supplementation.
timeFrame: We are going to check this hypothesis after 4 weeks of high-dose supplementation with CoQ10
Secondary outcomes:
measure: Change in aerobic capacity measured via direct test to volitional exhaustion on a motorized treadmill
timeFrame: We are going to check this hypothesis after 4 weeks of high-dose supplementation with CoQ10
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Gdansk University of Physical Education and Sport
Study officials:
References:
Clinical trial NCT02789449: Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension
Official title: Non-invasive Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension Pulmonary
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with PH

Brief summary: The aim of the study is to investigate the role of the non-invasive assessment of nitric oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease may more specifically identify the limiting factors between the alveolar space and the lung capillaries including left heart failure (cardiac edema).

As there are no available published data yet to answer this question investigators aim to perform a small pilot study. The results of this study may allow the planning of a prospective study.


Eligibility criteria: Inclusion Criteria:

* patients undergoing right heart catheterization
* patients with clear precapillary PH (PAWP\<12mmHg) or clear postcapillary PH (PAWP\>18mmHg)
* signed informed consent

Exclusion Criteria:

* patients unable to perform the DLCO test

Primary outcomes:
measure: Difference in DLNO (in mmol/min/kPa) between the two predefined groups (patients with clear precapillary PH (PAWP<12mmHg) vs. clear postcapillary PH (PAWP>18mmHg))
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Division of Pulmonology
state: Steiermark
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700349: Evaluation of Impacts of Access to Credit and Loan Size for Microcredit Clients in South Africa
Official title: Evaluation of Impacts of Access to Credit and Loan Size for Microcredit Clients in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Depression
Stress
Keywords: depression
stress
microcredit
poverty
South Africa
Lead sponsor: Innovations for Poverty Action
Sponsor class: OTHER
Collaborators: name: Broadening Access and Strengthening Input Market Systems/USAID
name: U.S. National Science Foundation
name: Bill and Melinda Gates Foundation
name: Princeton University
name: Social Science Research Council Program in Applied Economics
name: Federal Reserve Bank of New York
First posted: 2008-06-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study involves randomization of individuals who were initially rejected from a micro-lending organization in South Africa. Subjects were placed into two arms: (1) not receiving a loan; (2) being reconsidered for a "second look." Of those in the second arm, 53% were then selected by the organization's loan officers to receive a standard loan for first-time borrowers. Mental health and financial data were collected at one timepoint: approximately 6-12 months after the subjects first applied for the loan.


Eligibility criteria: Inclusion Criteria:

* Subjects were recruited from those who had been rejected from a lending organization for non-fraudulent or non-overindebtness reasons.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item questionnaire (0 = no risk, 60 = highest risk)
timeFrame: At follow-up (6-12 months after subject enrollment)
measure: Perceived stress, measured using the Cohen's Perceived Stress Scale (PSS), a 10-item questionnaire (0 = no stress, 40 = high stress)
timeFrame: At follow-up (6-12 months after subject enrollment)
Secondary outcomes:
measure: Household income, measured by a variety of questions that asked about all sources of income obtained by all members of the applicant's household.
timeFrame: At follow-up (6-12 months after subject enrollment)
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Innovations for Poverty Action
city: Durban
country: South Africa
facility: Innovations for Poverty Action
city: Port Elizabeth
country: South Africa
facility: Innovations for Poverty Action
Study officials:
affiliation: Innovations for Poverty Action
name: Dean Karlan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth University
name: Jonathan Zinman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Lia Fernald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02360449: Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
Official title: Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Pivotal Response Treatment
Applied Behavior Analysis
Peer Initiation
Social Skills Group
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether a social initiation motivation intervention (SIMI) focused on training children with ASD to initiate to peers during structured play activities will result in more frequent initiations to typically developing peers during free play. The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or a waiting list. Treatment will be provided for 8 weeks in the context of a weekly social skills group.


Eligibility criteria: Inclusion Criteria:

1. age 4.0 to 6.11 years;
2. diagnosis of Autism Spectrum Disorder
3. without intellectual disability
4. stable community treatments four weeks before and throughout the trial.

Exclusion criteria:

1. diagnosed severe psychiatric or genetic disorder or medical problem;
2. severe disruptive behavior that would interfere with peer interactions

Primary outcomes:
measure: Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Grace Gengoux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gengoux GW, Schwartzman JM, Millan ME, Schuck RK, Ruiz AA, Weng Y, Long J, Hardan AY. Enhancing Social Initiations Using Naturalistic Behavioral Intervention: Outcomes from a Randomized Controlled Trial for Children with Autism. J Autism Dev Disord. 2021 Oct;51(10):3547-3563. doi: 10.1007/s10803-020-04787-8. Epub 2021 Jan 2.
Clinical trial NCT00008749: Role of Altered CD40-Ligand Gene Transcription in Systemic Lupus Erythematosus
Official title: Role of Altered CD40-Ligand Gene Transcription in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Arthritis Foundation
First posted: 2001-01-18
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL

Brief summary: Systemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in 2,000 women in the United States. Recently, several research laboratories have reported that a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells, called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the immune system has been shown to decrease disease activity in animal models of lupus. We propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its abnormal and deleterious expression.


Eligibility criteria: Inclusion:

A diagnosis of systemic lupus erythematosus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References: