louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06295601: Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis
Official title: Effect of Telerehabilitation-Based Motor Imagery and Action Observation Training on Balance and Functional Mobility in Multiple Sclerosis: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: motor imagery
telerehabilitation
action observation therapy
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

Detailed description: The study population was participants with relapsing remitting multiple sclerosis. The traditional rehabilitation program consists of a joint treatment in which lower extremity strengthening and balance exercises are carried out synchronously for the experimental and control groups. Motor imagery and action observation therapy based on telerehabilitation of certain movements will be applied to the experimental group. All treatments will be carried out online via the zoom program. The treatment program will be applied 3 times a week for 6 weeks. Evaluations will be made before and after the treatment program. Assessments include balance, lower extremity muscle strength and functional mobility, fatigue, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with mulltiple sclerosis according to the McDonald criteria
* Expanded Disability Status Scale\<5.5,
* Being between the ages of 18-65,
* Mini mental test score\>24,
* Have a phone that can adapt to participating in a video call

Exclusion Criteria:

* Having another additional neurological disease that may cause balance and coordination disorders,
* Receiving physical therapy in the last 6 months,
* Having an attack in the last 3 months
* Refusal to participate in the study.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: 6 weeks after baseline
measure: Muscle strength and functional mobility
timeFrame: Baseline
measure: Muscle strength and functional mobility
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: Baseline
measure: Fatigue Severity Scale
timeFrame: 6 weeks after baseline
measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire
timeFrame: Baseline
measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire
timeFrame: 6 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University
name: Burcu talu
role: STUDY_DIRECTOR
References:
Clinical trial NCT05597501: Covid-Intervention-Study
Official title: Manual-based Psychosocial Group Interventions for Coping With the Covid-19 Pandemic and Other Crises
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosocial Intervention
Keywords: manual-based group intervention
short-term intervention
covid-19
crisis
Lead sponsor: Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this invention study is test and compare short-term manual-based psychosocial group interventions in die Austrian population suffering from stresses and strains due to the Covid-19 Pandemic and other crises.

The main question it aims to answer: Does short-term manual-based psychosocial group interventions improve the mental well-being of the participants?

Participants will attend weekly a manual-based group (8 weeks) and answer online-questionnaires and surveys (pseudonymized).


Eligibility criteria: Inclusion Criteria:

* above 18 years with psychosocial stresses and strains due to covid-19 pandemic and other crises

Exclusion Criteria:

* suicidal tendency
* insufficient knowledge of the German language
* psychotic episode
* no internet-access

Primary outcomes:
measure: Positive Mental Health Scale (PMH)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Secondary outcomes:
measure: WHO-Five Well-Being Index (WHO-5)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
measure: Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
measure: Somatic Symptome Scale-8 (SSS-8)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
measure: Stress Coping Inventars (SCI)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
measure: Pereived Stress Scale (PSS)
timeFrame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Other outcomes:
Locations:
city: Krems an der Donau
country: Austria
facility: University of Continuing Education Krems
Study officials:
affiliation: University of Continuing Education Krems
name: Thomas Probst, Univ.Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Continuing Education Krems
name: Carina Dinhof, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Continuing Education Krems
name: Rafael Rabenstein, MBA, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06985667: Cognitive-Based Behavior Change Training Program
Official title: The Effect of the 'Cognitive-Based Behavior Change Training Program' Applied to Parents of Preschool Children With Behavior Problems on Parents' Attitudes and Stress Levels Towards the Child and on the Problematic Behaviors of the Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavioral Symptom
Preschool Child
Parent
Parent-Child Relations
Cognitive Ability, General
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to determine the effects of the Parent Education Program Based on the Cognitive Development of the Child, which is applied to the parents of preschool children with behavioral problems, on the attitudes and stress levels of the parents and the problematic behaviors of the children.

The purpose of this study has two dimensions;

Dimension 1: The 'Parent Education Program Based on the Cognitive Development of the Child', which is planned to be developed for the purpose of measuring the attitudes, stress levels of the parents and the effects on the problematic behaviors of the children.

The development of the program was based on Jean Piaget's theory of cognitive development.

Dimension: It is experimental. The aim is to reveal the effectiveness of the Parent Education Program, which will be applied to the parents of children with behavioral problems. There are parent training programs developed for children with behavioral problems in the preschool period. However, the lack of parent studies based on the child's cognitive development reveals the rationale and importance of this study.


Eligibility criteria: Inclusion Criteria:

* Children must be between the ages of 3-6
* Participating in the study as a mother and father together
* Not having attended any parent training

Exclusion Criteria:

* Participating in the study as a single parent
* The child must have been diagnosed in the special needs category

Primary outcomes:
measure: Preschool Behavior Problems Screening Scale
timeFrame: One month prior to the intervention / One month following the intervention
measure: Parent Stress Scale
timeFrame: One month prior to the intervention / One month following the intervention
measure: Parent Attitude Scale
timeFrame: One month prior to the intervention / One month following the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gazi̇antep
country: Turkey
facility: Gaziantep Municipality Kindergartens
Study officials:
References:
Clinical trial NCT00949767: Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
Official title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male 18-55
* Women not of child bearing potential, 18-55

Exclusion Criteria:

* History of or current treatment for psychiatric illnesses, substance abuse or dependence
* History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)

Primary outcomes:
measure: Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
timeFrame: up to Day 14 +/- 2 days post-dose
Secondary outcomes:
measure: Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples
timeFrame: Blood samples will be taken up to 144 hour post-dose
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Local Institution
Study officials:
References:
Clinical trial NCT04446767: Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
Official title: Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing Disorder
Keywords: diabetes
foot ulcer
polarized light
;wound healing
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2020-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer

Detailed description: Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.

Eligibility criteria: Inclusion Criteria:

1. The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
2. Cooperative and mentally stable patients .

Exclusion Criteria:

1. Hepatic patients .
2. Uncontrolled hypertension .
3. Uncontrolled diabetic patients with HbA1c\>8.5% .
4. Neurological disorders .
5. Musculoskeletal disorders that interfere with program .
6. Previous history or any sign of DVT .

Primary outcomes:
measure: Histologic evaluation:
timeFrame: two months
measure: Wound assessment
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini
Study officials:
References:
citation: Taha MM, El-Nagar MM, Elrefaey BH, Elkholy RM, Ali OI, Alkhamees N, Felaya EEE. Effect of Polarized Light Therapy (Bioptron) on Wound Healing and Microbiota in Diabetic Foot Ulcer: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Dec;40(12):792-799. doi: 10.1089/photob.2021.0175. Epub 2022 Oct 28.
Clinical trial NCT03185767: Long Non Coding RNA in Complications of Systemic Lupus
Official title: Long Non Coding RNA IN Systemic Lupus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication in Systemic Lupus Erythematosus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: the precise role of RNA in setting of this complication in systemic lupus erythematosus (SLE) is largely unknown


Eligibility criteria: Inclusion Criteria:

* with systemic lupus

Exclusion Criteria:

vasculitis

Primary outcomes:
measure: non coding RNA expression by real time PCR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02477267: Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Official title: A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opiate Dependence
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: within 21 days
measure: Time to Cmax (Tmax)
timeFrame: within 21 days
measure: Elimination rate constant
timeFrame: within 21 days
measure: Elimination half-life (T½)
timeFrame: within 21 days
measure: Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])
timeFrame: within 21 days
measure: Area under the curve extrapolated to infinity (AUCinf)
timeFrame: within 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services, LLC
state: Texas
Study officials:
affiliation: INSYS Therapeutics Inc
name: Giovanni DeCastro
role: STUDY_DIRECTOR
References:
Clinical trial NCT02981667: Higher Enjoyment in Response to High Intensity Interval Training Versus Moderate Intensity Continuous Exercise
Official title: Enjoyment Responses to High Intensity Interval Training and Moderate Intensity Continuous Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Training
Lead sponsor: California State University, San Marcos
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Habitually active young men and women ages 18-45 yr

Brief summary: Previous research is equivocal concerning if high intensity interval training is viewed as more aversive versus moderate exercise. Our data in active men and women showed that interval training is viewed as more enjoyable than higher volume moderate exercise.

Detailed description: Twelve men and women who were habitually active initially performed ramp exercise on a cycle ergometer to assess maximal oxygen uptake (VO2max) and peak power output (PPO), which was used to determine workload for the subsequent 2 bouts. They returned at least 48 h later at the same time of day to complete high intensity interval training (HIIT consisting of repeated 1 min bouts at 85 %PPO) or moderate intensity continuous training (MICT consisting of 25 min at 40 %PPO). During exercise, heart rate, oxygen uptake, perceived exertion, pleasure:displeasure, and blood lactate concentration were continuously assessed. Ten minutes post-exercise, physical activity enjoyment was measured. Data showed that despite higher oxygen uptake, heart rate, blood lactate concentration, and perceived exertion in HIIT, enjoyment was higher in HIIT versus MICT.

Eligibility criteria: Inclusion Criteria:

* Habitually active, healthy, non-obese

Exclusion Criteria:

* Sedentary, unhealthy, joint pain precluding tolerance to exercise

Primary outcomes:
measure: Physical activity enjoyment score (PACES)
timeFrame: This was measured 10 min post-exercise in all participants during the 3 mo of data collection.
measure: Oxygen uptake
timeFrame: Measured continuously during exercise during the 3 mo of data collection.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Thum JS, Parsons G, Whittle T, Astorino TA. High-Intensity Interval Training Elicits Higher Enjoyment than Moderate Intensity Continuous Exercise. PLoS One. 2017 Jan 11;12(1):e0166299. doi: 10.1371/journal.pone.0166299. eCollection 2017.
Clinical trial NCT03697967: Supine vs Prone Position During Delayed Cord Clamping
Official title: Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn; Anemia
Umbilical Cord Problem
Keywords: Delayed cord clamping
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 210
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised two arms study
Primary purpose: PREVENTION

Brief summary: This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position.

Detailed description: At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic screening sample. There is no added heelstick to routine care, as current standard in our institution requires the bilirubin to be drawn at 30 hours of life.

During universal screening for congenital cardiac defects (30 hours of life), a value of cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy, INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead and the newborn is in supine position.

Eligibility criteria: Inclusion Criteria:

Newborn ≥ 36 weeks gestational age and Born vaginally and Well appearing

Exclusion Criteria:

Out born infant, Infant born by caesarian section, Preterm born less than 36 weeks GA, Infant with intra uterine growth restriction (IUGR: less than 10th percentile) Asphyxiated infant Infant needing immediate resuscitation, Newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease Newborn with mother with preeclampsia or gestational hypertension or diabetes on insuline or hemolytic disease or on chemotherapy or on cortisone.

Primary outcomes:
measure: Hemoglobin and hematocrit
timeFrame: 24-48 hours
Secondary outcomes:
measure: Cerebral saturation by near infrared spectroscopy (NIRS)
timeFrame: 24-48 H of life
measure: Bilirubin
timeFrame: 24-48 hours
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Brahim Bensouda
state: Quebec
Study officials:
References:
Clinical trial NCT00116467: Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
Official title: Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Keywords: AML
Acute Myelogenous Leukemia
GVAX
Vaccine
Stem Cell Transplant
Autologous
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-06-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).


Eligibility criteria: Inclusion Criteria:

* Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.
* No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

Exclusion Criteria:

* Prior myelodysplastic disorder, or treatment-related leukemia.
* Prior myeloproliferative disease.
* Acute promyelocytic leukemia (APL).
* Prior chemotherapy for a malignant or nonmalignant disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
References:
citation: Borrello IM, Levitsky HI, Stock W, Sher D, Qin L, DeAngelo DJ, Alyea EP, Stone RM, Damon LE, Linker CA, Maslyar DJ, Hege KM. Granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting cellular immunotherapy in combination with autologous stem cell transplantation (ASCT) as postremission therapy for acute myeloid leukemia (AML). Blood. 2009 Aug 27;114(9):1736-45. doi: 10.1182/blood-2009-02-205278. Epub 2009 Jun 25.