louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05745532: Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients
Official title: Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: β-thalassemia
Lead sponsor: Shenzhen Hemogen
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label study to evaluate the safety and efficacy of β-globin Restored Autologous Hematopoietic Stem Cells in ß-Thalassemia Major Patients

Detailed description: We will recruit ß-thalassaemia major patients and collect their autologous hematopoietic stem cells, which will be modified with the LentiHBBT87Q system to restore β-globin expression. After conditioning, the autologous hematopoietic stem cells with restored β-globin will be reinfused to the patients and followed up for two years to collect data.

Eligibility criteria: Inclusion Criteria:

* 8-16 years old. Subject and/or subject's legal guardian fully understand and voluntarily sign informed consent;
* Clinically diagnosed as transfusion-dependent β-thalassemia major;
* With sufficient RBC infusion, subjects must maintain hemoglobin ≥9g/dL, serum ferritin threshold ≤ 3000 ng/mL and the liver iron overload mild or absent for at least 3 months before mobilization of hematopoietic stem cell;
* Follow the arrangements for treatment and regular medical checks within two years post-transplantation

Exclusion Criteria:

* The physical condition does not meet the requirements for hematopoietic stem cell mobilization and transplantation myeloablation;
* Received gene therapy and allogeneic HSCT in the past.
* Have an available HLA matched donor.
* Enrolling in another clinical trial.
* Other unsuitable conditions identified by doctors.

Primary outcomes:
measure: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 0-100 days
measure: Overall survival
timeFrame: 0-24 months
measure: Proportion of engraftment
timeFrame: 0-24 months
measure: Replication competent lentivirus (RCL)
timeFrame: 0-24 months
measure: Dynamics of viral integration sites (VIS)
timeFrame: 0-24 months
Secondary outcomes:
measure: The average Insertion copy number (VCN) in peripheral blood mononuclear cells
timeFrame: 18-24 Months
measure: The expression level of exogenous adult hemoglobin
timeFrame: 18-24 Months
measure: Change from baseline in annualized frequency of packed RBC transfusions
timeFrame: 18-24 Months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Hemogen
name: Chao Liu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Children's Hospital
name: Sixi Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03444532: Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
Official title: Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Prostate
Insomnia
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.

Detailed description: This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.

In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer
* Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
* Insomnia
* Over 18-yers old
* Understand oral and written Danish
* Written informed consent

Exclusion Criteria:

* Medical assessment that does not allow aerobic exercise
* Severe cognitive problems
* Night work during the interventions period
* Exercise training more than three times a week

Primary outcomes:
measure: Sleep
timeFrame: Change from baseline sleep at 12 weeks
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline, 12-weeks
measure: Fatigue
timeFrame: Baseline, 12 weeks, 6 month
measure: Physical activity
timeFrame: Baseline, 12 weeks, 6 month
measure: Depression
timeFrame: Baseline, 12 weeks, 6 month
measure: Anxiety
timeFrame: Baseline, 12 weeks, 6 month
measure: Stress
timeFrame: Baseline, 12 weeks, 6 month
measure: Quality of life
timeFrame: Baseline, 12 weeks, 6 month
measure: Sleep quality
timeFrame: Baseline, 12 weeks, 6 month
measure: Sleep pattern
timeFrame: Baseline, 12 weeks, 6 month
measure: Insomnia
timeFrame: Baseline, 12 weeks, 6 month
measure: Physical activity
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Oncology Department
Study officials:
affiliation: Danish Cancer Society Research Center
name: Christoffer Johansen, PhD, Dr.Med
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Cancer Society Research Center
name: Katrine Løppenthin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06942832: Integrating SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia
Official title: The Integration of SPOZ Technology to Support and Enhance the Vitality Acupunch Exercise Program for Improving the Disease Dysfunction and Functional Fitness Deterioration of Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disease and Dysfunction
Functional Fitness Deterioration
Activities of Daily Living
Instrumental Activities of Daily Living
Sleep Quality
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the disease dysfunction and functional fitness deterioration of older adults with dementia in adult daycare centers.

Detailed description: A cluster-randomized controlled trial will be conducted to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the disease dysfunction, functional fitness deterioration (balance, lower muscle endurance, gait speed, handgrip strength, cardiorespiratory endurance, muscle endurance, agility, body flexibility), activities of daily living, instrumental activities of daily living, and sleep quality of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. The two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Eligibility criteria: Inclusion Criteria:

* diagnosed as dementia by a physician, or
* screened by the SPMSQ as dementia
* age 65 and older

Exclusion Criteria:

* have severe cardiopulmonary disease
* have physical mobility impairment
* have spinal cord injury

Primary outcomes:
measure: Balance
timeFrame: 6 months
measure: Lower muscle endurance
timeFrame: 6 months
measure: Gait speed
timeFrame: 6 months
measure: Handgrip strength
timeFrame: 6 months
measure: Cardiorespiratory endurance
timeFrame: 6 months
measure: Muscle endurance
timeFrame: 6 months
measure: Agility
timeFrame: 6 months
measure: Body flexibility
timeFrame: 6 months
Secondary outcomes:
measure: Activities of daily living (ADL)
timeFrame: 6 months
measure: Instrumental activities of daily living (IADL)
timeFrame: 6 months
measure: Sleep quality
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Kuei-Min Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02864732: Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain
Official title: A Comparison Between Stabilization Exercises and Stabilization Exercises Supplemented With Neuromuscular Electrical Stimulation: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
stabilization exercises
neuromuscular electrical stimulation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Saudi Arabian Cultural Mission
name: King Fahad Specialist Hospital Dammam
First posted: 2016-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.


Eligibility criteria: Inclusion Criteria:

* Between 18 years of age and 60.
* Body Mass Index (BMI) of less than 34.
* Low Back Pain duration of 3 months or greater (chronic).
* Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
* Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
* Understands English

Exclusion Criteria:

* Positive nerve root tension signs
* Progressive neurological deficit
* Positive Babinski sign.
* Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
* History of spinal surgery
* History of inflammatory joint disease
* Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise.
* Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives
* History of metastatic cancer in previous 5 years or present treatment for cancer
* Women who indicate that they are pregnant or plan to become pregnant

Primary outcomes:
measure: Tolerability of Electrical Stimulation (NMES)
timeFrame: Participants were followed from baseline to 6 weeks
measure: Modified Oswestry Disability Questionnaire (MODQ)
timeFrame: Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)
measure: Fear-avoidance Behavior Questionnaire
timeFrame: Baseline to 6 weeks (post-treatment)
measure: Paraspinal Muscle Strength
timeFrame: Baseline - 6 weeks (post-treatment)
measure: Patient Satisfaction Survey
timeFrame: only post-treatment at 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Muhammad Z Alrwaily, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Anthony Delitto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06591637: Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care
Official title: The Effects Of Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care On Healthy Lifestyle Behaviors And İn Vitro Fertilization (IVF) Success İn Women With Primary Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
IVF
Keywords: Fertility
Watson's Human Caring Theory
Lifestyle
Nursing Care
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (IVF) in women with primary infertility


Eligibility criteria: Inclusion Criteria:

* Women have a diagnosis of primary infertility.
* Women over the age of 18 and under the age of 32.
* Women able to read and write in Arabic.
* The cause of infertility must be a male factor.
* Women who are undergoing assisted reproductive techniques, specifically İn Vitro Fertilization-Intracytoplasmatic Sperm Injection.
* Women using the same drugs and protocols for IVF treatment.
* Only women who receive a fresh embryo transfer during their IVF treatment included in the study.

Exclusion Criteria:

* Women who have problems with understanding or perception
* The presence of tubal, uterine or other infertility factors in women
* Women undergoing a frozen embryo transfer as part of their IVF treatment
* Women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.

Primary outcomes:
measure: The Health-Promoting Lifestyle Profile II instrument
timeFrame: Both groups completed a Health-Promoting Lifestyle Profile instrument and pre-test measures, at the onset of the study. At the end of treatment after embryo transfer they were administered test measures.After 3 months were administered posttest measure
Secondary outcomes:
measure: A quantitative human chorionic gonadotropin (HCG or hCG) blood test
timeFrame: 14 days after embryo transfer
Other outcomes:
Locations:
city: Gaza
country: Palestinian Territory, occupied
facility: Albasma a private IVF center
Study officials:
References:
Clinical trial NCT00043537: Treatment of Childhood Social Phobia
Official title: Treatment of Childhood Social Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Phobia
Keywords: Phobic Disorders
Mutism
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-08-12
Enrollment: 139
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.

Detailed description: Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. Recent findings indicate a new psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. Treatment effects have been maintained for up to 6 months. This study will examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of treatment will be monitored over a 1-year follow-up period.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of social phobia

Exclusion Criteria:

* Pervasive developmental disorders (PDD)
* Schizophrenia
* Major Depression
* IQ of less than 80
* Medical conditions contraindicating use of fluoxetine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: University of Maryland, College Park
country: United States
facility: Maryland Center for Anxiety Disorders
state: Maryland
Study officials:
References:
citation: Beidel DC, Turner SM, Sallee FR, Ammerman RT, Crosby LA, Pathak S. SET-C versus fluoxetine in the treatment of childhood social phobia. J Am Acad Child Adolesc Psychiatry. 2007 Dec;46(12):1622-32. doi: 10.1097/chi.0b013e318154bb57.
citation: De Los Reyes A, Alfano CA, Beidel DC. Are clinicians' assessments of improvements in children's functioning "global"? J Clin Child Adolesc Psychol. 2011;40(2):281-94. doi: 10.1080/15374416.2011.546043.
citation: De Los Reyes A, Alfano CA, Beidel DC. The relations among measurements of informant discrepancies within a multisite trial of treatments for childhood social phobia. J Abnorm Child Psychol. 2010 Apr;38(3):395-404. doi: 10.1007/s10802-009-9373-6.
Clinical trial NCT05493137: Physical Activity Levels of Parents of Children With Cystic Fibrosis- (PHACTS-CF)
Official title: Investigating Physical Activity Levels of Parents of Children With Cystic Fibrosis and Its Influence on Their Children's Physical Activity Levels and Nebuliser Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis in Children
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children with cystic fibrosis.

Brief summary: This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. Parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.


Eligibility criteria: Inclusion Criteria:

1. Parents of Children aged 5-16 years.
2. Under the care of Cambridge University Hospitals CF team
3. Confirmed Cystic Fibrosis diagnosis
4. Uses an ineb as main nebulizer delivery device.
5. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID).
2. If not yet doing lung function.
3. If has any other self-identified physical disability which may limit physical activity.

Primary outcomes:
measure: GPAQ
timeFrame: Reviews the past 7 days activities.
Secondary outcomes:
measure: CPAQ
timeFrame: Reviews the past 7 days activities.
measure: YPAQ
timeFrame: Reviews the past 7 days activities.
measure: Ineb adherence
timeFrame: 1 year
measure: Lung function
timeFrame: Best score in the last 1 year.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04988737: Usability of a Perioperative Medication-Related Clinical Decision Support Application
Official title: Usability of a Perioperative Medication-Related Clinical Decision Support Application: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Medication Errors
Perioperative Adverse Medication Events
Keywords: Usability
Clinical Decision Support
Anesthesiology
Medication Safety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: OTHER

Brief summary: The goal of this study is to compare the usability of a novel, medication-related clinical decision support (CDS) application to the current standard medication administration and documentation workflow. The study will occur in a simulation setting, using a manikin and test patient data - no actual patients will participate. Forty clinician participants will be randomly assigned to either the CDS group (who will complete simulation tasks using the CDS prototype) or the Control group (who will complete simulation tasks using the standard medication administration workflow).


Eligibility criteria: Inclusion Criteria:

* Anesthesia Clinicians including attending anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs), and house staff (residents and fellows)

Exclusion Criteria:

* Study Staff
* Medical Students

Primary outcomes:
measure: Total time to complete 7 simulations tasks.
timeFrame: Measured from task start time to task end time, a cumulative average of 15 minutes
Secondary outcomes:
measure: Total number of mouse clicks in 7 simulations tasks.
timeFrame: Measured from task start time to task end time, a cumulative average of 15 minutes
measure: Total distance traveled on the screen in pixels for 7 simulation tasks.
timeFrame: Measured from task start time to task end time, a cumulative average of 15 minutes
Other outcomes:
measure: System Usability Scale (SUS) score.
timeFrame: Measured at the conclusion of study participation, an average of 15 minutes after the participant's start time
measure: Number of usability issues.
timeFrame: Identified continuously over the duration of study participation, a cumulative average of 15 mins
measure: Single Ease Question score for each simulation task.
timeFrame: Measured at the end of each of the 7 tasks (each task requires an average of 3 minutes to complete)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen C Nanji, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: