louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06574490: Myofunctional Therapy in Open Bite - RCT
Official title: Effectiveness of Myofunctional Therapy in Children With Open Bite - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Open Bite
Keywords: open bite
child
myofunctional
myotherapy
exercises
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.

Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.

Participants will exercise according to a pre-established regimen and schedule


Eligibility criteria: Inclusion Criteria:

* generally healthy children aged 6-10 years,
* infant swallowing type,
* open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
* mixed dentition

Exclusion Criteria:

* finger sucking habit (or similar) occurring within the last 6 months,
* previous myofunctional therapy,
* upper airway obstruction,
* congenital craniofacial developmental disorder,
* connective tissue or muscle disease,
* macroglossia,
* ankyloglossia,
* mental retardation

Primary outcomes:
measure: Overbite
timeFrame: 12months
Secondary outcomes:
measure: Swallowing pattern
timeFrame: 12 months
measure: Articulation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03332290: Diving for Post Traumatic Stress Disorder (PTSD)
Official title: Post Traumatic Stress Disorder (PTSD): Benefits of Diving Practice on Patient Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ptsd
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2017-11-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized opened clinical trial
Primary purpose: TREATMENT

Brief summary: within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training using a clinical trial protocol


Eligibility criteria: Inclusion Criteria:

* ptsd

Exclusion Criteria:

* mindfulness practice

Primary outcomes:
measure: quality of life (Mental Health Continuum-Short Form (MHC-SF))
timeFrame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline)
Secondary outcomes:
measure: post-traumatic checklist scale; a 20-item self-report scale assessing the 20 DSM-5 symptoms of PTSD with a symptom severity from 0 to 80 and a cut-point score of 33.
timeFrame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
measure: heart rate variability on morning
timeFrame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Marion Trousselard
state: Not In US/Canada
Study officials:
References:
Clinical trial NCT04127890: ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control
Official title: ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control (EDEN Study) - A Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: oxygen-enriched water
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: ELO Water Pte. Ltd.
First posted: 2019-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blinded, randomised and controlled trial evaluates the efficacy of oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks. The primary outcome is improvement in glycaemic control.

Detailed description: Global diabetes mellitus prevalence is rapidly increasing. In 2015, IDF reported that Singapore has 12.8% of its population diagnosed with diabetes mellitus, of which more than 90 percent are type 2 diabetes with underlying insulin resistance. With the aging population and increasing prevalence of obesity and sedentary lifestyles, the prevalence is expected to continue to rise.

In vitro studies demonstrated that hypoxia creates a state of insulin resistance through HIF (Hypoxia Inducible Factor) transcription factor expression in adipocytes. Insulin sensitivity was shown to improve in type 2 diabetes patients and overweight non diabetic patients placed in a hyperbaric oxygen chamber.Increased water intake has been associated with lower HbA1c in the general population , and also with lower post-prandial glucose in type 2 diabetic individuals.

This study aims to evaluate the effects of 1.5 L daily of ELO water, a drinking water enriched with molecular oxygen in a stable form, with a similar volume of bottled drinking water, on glycaemic control in adults with type 2 diabetes in Singapore.

Eligibility criteria: Inclusion Criteria:

Type 2 diabetes mellitus with HbA1c 8.0% to 11%, within the last 6 months

Exclusion Criteria:

1. Type 1 diabetes patients
2. Pregnant or lactating women
3. Comorbid conditions requiring fluid restriction to below 1.5 L daily
4. Terminal illness with life expectancy less than 1 year

Primary outcomes:
measure: Improvement of glycaemic control
timeFrame: 12 weeks
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Joan Khoo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764890: Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica
Official title: Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sciatica
Electroacupuncture
Manual Therapy
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Electroacupuncture and manual therapy
Primary purpose: TREATMENT

Brief summary: The aims of the study are:

To study the pain efficacy of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.

To study the efficacy on function of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.


Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 50 years old.
* Diagnosis of sciatica

Exclusion Criteria:

* Pregnancy.
* Fear of needles.
* Coagulation disorders.

Primary outcomes:
measure: Visual analog scale for pain
timeFrame: up to 5 weeks
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEU-San Pablo Universtiy
Study officials:
References:
Clinical trial NCT03506490: Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People
Official title: Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Lead sponsor: Instituto Politécnico de Castelo Branco
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Scientific evidence suggests that an aerobic exercise session promotes improvements in the consolidation of motor memory in adults. In this sense, the main purpose of this study was to investigate if an aerobic training session could improve motor memory consolidation in older people.

Detailed description: The participants of this study were 33 subjects of both genders (M = 68 years old; SD = 4.2 years old) and were divided in two groups: a control group (N = 15; M = 67, 6 years old; SD = 4.1 years old) and an experimental group (N = 18; M = 67, 4 years old; SD = 4.4 years old). The participants performed a Soda Pop test before the aerobic training session (Baseline). The training session lasted 45 minutes and was composed of running exercises. After the training session, the motor memory consolidation was held in three different stages: Training; 1 hour after training; 24 hours after training.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* sensory abnormalities;
* mental abnormalities;
* motor abnormalities;
* other atypical health problems.

Primary outcomes:
measure: The participants performed a Soda Pop test before the aerobic training session (Baseline).
timeFrame: The participants performed a Soda Pop test before the aerobic training session (Baseline).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01711190: Astigmatism Post-trabeculectomy
Official title: The Effect of Trabeculectomy on Astigmatism.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: glaucoma
trabeculectomy
astigmatism
intraocular pressure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 52
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: All patients having a primary trabeculectomy between January and April 2012 for glaucoma that was not adequately controlled with maximal tolerated medical therapy and/or laser therapy.

Brief summary: The aim of this project:

1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab.
2. Medium-term follow up (6 months) of the induced corneal astigmatism.
3. Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma
* Normal tension glaucoma
* Pseudoexfoliation glaucoma
* Pigment dispersion glaucoma

Exclusion Criteria:

* Patients who refuse to sign the informed consent.
* Patients with primary angle closure glaucoma (PACG).
* Patients younger than 18 years old.
* Other ocular diseases besides glaucoma.
* Significant corneal opacities.
* Refractive error more than + or -6.00 diopters.
* Visual acuity less than 0.05
* Previous intra-ocular surgery (except cataract surgery more than six months preceding the trabeculectomy).
* Laser treatment for glaucoma within 6 months of the surgery.

Primary outcomes:
measure: Change in ocular cylinder and axis untill 6 months after trabeculectomy.
timeFrame: pre-operative until 6 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Sint-Raphaël hospital
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Heleen Delbeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03367390: A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
Official title: An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to.

This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year
* Have a body mass index of 18.5 to 35 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

Primary outcomes:
measure: Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges
timeFrame: Up to 4 hours post challenge
measure: Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge
timeFrame: Up to 4 hours post challenge
measure: Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity
timeFrame: Up to 4 hours post challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Renton
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00162890: Evaluation and Physical Therapy for Patients With Degenerated Cervical Spine
Official title: Evaluation and Physical Therapy for Patients With Degenerated Cervical Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerated Cervical Spine
Spinal Diseases
Keywords: degenerated cervical spine
assessment
physical therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged 20-75 year-old will be recruited. One hundred participants are anticipated to be recruited in this study.

Brief summary: The specific aims are as follows:

1. To investigate the degree of impairment, such as range, proprioception, sensation, and electromyography (EMG) pattern of healthy, older subjects.
2. To investigate the relationship of these impairment measurements, the functional outcome and disability in patients with cervical spondylosis.
3. To develop an exercise program with an emphasis on proprioception, stability and coordination for patients with neck-shoulder complaints to decrease the impairment and increase the functions of patients.


Eligibility criteria: Inclusion Criteria:

* Group one: participants without degenerated disease in the cervical spine
* Group two: participants with degenerated disease in the cervical spine

Exclusion Criteria:

* Grade III, IV of degenerated cervical spine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Shwu-Fen Wang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01101490: Changes of Right and Left Cerebral Oxygen Saturation and Blood Flow During Nephrectomy in Lateral Decubitus Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrectomy
Keywords: To compare the change of cerebral oxygen saturation and blood flow between right and left side in lateral decubitus position during nephrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients who visit Severance hospital for nephrectomy

Brief summary: The purpose of this study is to determine changes of right and left cerebral oxygen saturation and blood flow during nephrectomy in lateral decubitus position.


Eligibility criteria: Inclusion Criteria:

* Adult patients (ASA physical status I and II) aged between 20-65 yrs

Exclusion Criteria:

* Cardiovascular, renal, hepatic disease, or communication failure

Primary outcomes:
measure: brain oximeter saturation(%)
timeFrame: 1 hour after operation
measure: blood flow
timeFrame: 1 hour after operation
measure: velocity of superficial temporal artery in right and left side
timeFrame: 1 hour after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Department of Anesthesiology & Pain Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
name: Jeong-Yeon Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04528303: Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty
Official title: A Randomized, Controlled Trial of the Effectiveness of Whole Genome Sequencing Versus Whole Exome Sequencing for Screening Patients With Congenital Diarrhea and Enteropathy (CODESeq)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diarrhea, Infantile
Enteropathy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 180
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will seek to determine if whole genome sequencing (WGS) improves diagnostic rates, and outcomes for congenital diarrhea and enteropathy (CODE) patients. The investigator will enroll 180 patients in a randomized controlled study to either WGS or whole exome sequencing (WES). This study is designed to evaluate whether CODE patients would benefit from WGS guided precision medicine.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic diarrhea lasting greater than 2 months
* Patients with consent from parents or legal guardians
* Biological relative of a patient enrolled in this study.

Exclusion Criteria:

* Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
* Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
* Functional diarrhea
* Patients with previously confirmed monogenic diarrhea
* Patients with poor compliance

Primary outcomes:
measure: Diagnostic rates between WGS and WES
timeFrame: Within approximately 60 days of enrollment
Secondary outcomes:
measure: Number of patients receiving precision medicine guided by sequencing results
timeFrame: Within approximately 60 days of enrollment
measure: Mortality of patients
timeFrame: Within approximately 1 year of enrollment
measure: Rate of parental satisfaction with sequencing
timeFrame: Within one week of patient enrollment
measure: Number of parents who are available for trio sequencing
timeFrame: Within one week of patient enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ying Huang
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Huang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02714803: Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
Official title: Assistant Professor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.


Eligibility criteria: Inclusion Criteria:

* Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
* Willing to participate

Exclusion Criteria:

* Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
* neurological disease;
* psychiatric disease;
* serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
* pregnant during the study

Primary outcomes:
measure: Change in low back pain intensity as measured by Visual Analog Scale
timeFrame: Change from baseline low back pain intensity at 2 weeks
Secondary outcomes:
measure: Change in quality of life as assessed by Short Form-36
timeFrame: Change from baseline quality of life at 2 weeks
measure: Change in functional statue as assessed by Oswestry Disability Index
timeFrame: Change from baseline functional statue at 2 weeks
measure: Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale
timeFrame: Change from baseline psychologic statue at 2 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ataturk Training and Research Hospital
state: Cankaya
Study officials:
References: