louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05137353: A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)
Official title: RitMoZ Training: A Randomized Control Trial Study to Assess a Multisensory Music Intervention for Children With Reading Disorders in Hungary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reading Disorder
Keywords: reading disorders
music intervention
rhythmic stimulations
phonological processing
Event-Related Brain Potentials
Lead sponsor: Research Centre for Natural Sciences
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2021-11-30
Enrollment: 51
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia.

Detailed description: Studies have shown that music in the form of training (i.e., intervention) is able to facilitate linguistic processes (e.g., phonological encoding/decoding, categorical perception) and cognitive functions (e.g., working memory) in children that have dyslexia or reading difficulties. In addition to this, music trainings with a focus on entrainment can improve phonological as well as reading skills.

In line with the above, we have designed and developed a music training programme. This programme, which is called RitMoZ Training (i.e., from Ritmus és Mozgás és Zene: meaning Rhythm and Movement and Music in Hungarian language), is designed for (Hungarian) children who have dyslexia or reading difficulties.

In order to assess the efficacy of the music training, we are going to conduct a randomized controlled trial which consists of a pre-training phase, a training phase and a post-training phase.

Eligibility criteria: Inclusion Criteria:

* diagnosis of reading disorder
* Hungarian as native language

Exclusion Criteria:

* comorbidities (e.g., Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD))
* sensory impairment (e.g., hearing loss, low vision)
* cognitive impairment (e.g., panic disorder, low IQ)

Primary outcomes:
measure: Reading test
timeFrame: 4 minutes
measure: Spelling test
timeFrame: 4-7 minutes
measure: Phoneme deletion test
timeFrame: 3-7 minutes
measure: Letter-sound identification test
timeFrame: 2-3 minutes
measure: Letter-sound discrimination test
timeFrame: 2 - 4 minutes
measure: Rapid Automatized Naming (RAN) test
timeFrame: 3-5 minutes
measure: Choice reaction time test
timeFrame: 1 - 2 minutes
measure: Lexical decision task
timeFrame: 12- 15 minutes
measure: Auditory discrimination of acoustic and phonetic alteration of pseudowords
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Research Centre for Natural Sciences
Study officials:
affiliation: Research Centre for Natural Sciences
name: Ferenc Honbolygó, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03412253: Could Single-anastomosis Gastric Bypass Be a Curative Treatment for Type II Diabetes?
Official title: From Diabetes Care to Diabetes Cure; Could Single-anastomosis Gastric Bypass Be a Safe Bridge to Reach This Target in Non-Obese Patients?
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Metabolic Surgery
Keywords: metabolic surgery, BMI 25-30 kg/m2, SAGB, T2DM remission.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm

Detailed description: Background: T2DM has been considered as a chronic progressive incurable metabolic disease. Single-anastomosis gastric bypass (SAGB) was shown to be effective in obese patients in terms of weight reduction and T2DM remission, yet its effect on non-obese diabetics is not extensively studied. In this study, we tried to determine the anthropometric and glycemic outcomes of SAGB as a proposed line of treatment for type II diabetes mellitus (T2DM) patients with body mass index (BMI) 25-30 kg/m2.

Methods: From November 2013 to March 2016, a prospective study has been conducted at Ain-Shams University hospitals on 17 consecutive patients undergone SAGB. The demographic and anthropometric data of the patients, as well as their relevant laboratory results, were reported, other data including anti-diabetic medications, co-morbid metabolic diseases were also assessed. All patients were scheduled for laparoscopic SAGB and were advised to come in regular follow up at 1, 3, 6, 12 and 18 months postoperatively. T2DM Remission is considered if glycosylated hemoglobin (HbA1c) \<6.5 % and fasting plasma glucose (FPG) \< 126 mg/dl for at least 1 year without medication.

Eligibility criteria: Inclusion Criteria:

.Type II diabetic patients.

* Age: 20-60 years.
* either gender.

Exclusion Criteria:

* Previous bariatric surgery.
* Controlled T2DM.
* Duration of T2DM \>10 years.
* Patients with endocrinal diseases,
* Pregnancy.
* Those unfit for general anesthesia.

Primary outcomes:
measure: Cure of type II DM.
timeFrame: 1Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06503653: Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)
Official title: Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Syncope
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The main aim of this study is to assess the value of creating a "syncope pathway" to optimize diagnostic performance in patients admitted to the emergency department for syncope and not hospitalized, compared with the previous pre-syncope pathway situation.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over;
* Consultant at the emergency department of the Centre Hospitalier de V ersailles
* For a confirmed diagnosis:
* of recurrent syncope with low-risk criteria according to ESC 2018 (1,2) Or
* of syncope recurrent or not, not fulfilling low-risk or high-risk criteria according to the ESC 2018 definition (1,2). These patients are those with minor high-risk criteria without aggravating circumstances:

  * With no personal history of loss of consciousness whose clinical features strongly suggest syncope of rhythmic origin;
  * No structural heart disease or abnormal ECG.
* Outpatient (returning home after emergency);
* Beneficiary or beneficiary of a social security scheme (excluding AME).

Exclusion Criteria:

* Etiology of syncope identified as early as the emergency department visit;
* High-risk syncope according to ESC 2018 criteria (1,3);
* First and only episode of low-risk syncope according to ESC 2018 criteria (1,3);
* Syncope of any risk category requiring hospitalization at the discretion of the emergency physician and cardiologist;
* Legal protection by guardianship ;
* Language barrier or condition incompatible with the patient's understanding or informed adherence to the protocol;
* Opposition to the use of their pseudonymized data (for retrospective inclusions);
* Patient's refusal to give consent to participate in the study (for prospective inclusions);

Primary outcomes:
measure: etiological diagnosis of synchope
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: centre hospitalier de Versailles
state: Yvelines
Study officials:
References:
Clinical trial NCT00669253: Treatment of Periodontitis Using Er:YAG Laser vs. Conventional Treatment Modalities
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.


Eligibility criteria: Inclusion Criteria:

* at least 35 years of age
* at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded)
* presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (\>= 30% of root length)

Exclusion Criteria:

* pregnancy
* removable prosthesis

Primary outcomes:
measure: Probing pocket depth, Clinical attachment level and microbiological analysis
timeFrame: At baseline, 3, 6, 12, 24, 36, 48 and 60 months
Secondary outcomes:
measure: Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions
timeFrame: After 5 years
measure: Consumed time per treatment/ Patient satisfaction/comfort ( Oral Health impact Profile : OHIP )/ The estimated financial costs based on average data delivered for instance by the Belgian Society of Periodontology
timeFrame: After 5 years
measure: Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)
timeFrame: After 5 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353053: Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection
Official title: Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorder of Transplanted Kidney
Cytomegalovirus Infections
Keywords: Immunosuppression
Cytomegalovirus
Renal Transplant
Atrophy/interstitial
Conversion of tacrolimus everolimus
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A randomized study of 82 patients transplanted in first transplant recipients of deceased donor and in line for kidney transplantation.

Brief summary: The aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. The investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.


Eligibility criteria: Inclusion Criteria:

* Patients with BMI below 30,
* first transplants with PRA \< 30,
* no contraindication for induction Thymoglobuline,
* age 18 years or younger than 70 years.

Exclusion Criteria:

* patients with a BMI above 30
* retransplantation
* patients hypersensitized with PRA \> 30
* compared with Thymoglobulina indication for induction
* age under 18 or over 70 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
References:
Clinical trial NCT01308853: Macrolane for Enhancement of the Shape and Fullness of the Female Breast
Official title: An Open, Multi-center Study Evaluating Treatment Procedure, Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Enhancement
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 24
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.

Detailed description: This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.

Eligibility criteria: Inclusion Criteria:

* Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria:

* Unreasonable expectations
* Any medical condition that may interfere with the treatment

Primary outcomes:
measure: Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of Breasts With Improvement as Assessed by the Investigator
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Akademikliniken, Stockholm, Sweden
name: Per Heden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heden P, Olenius M, Tengvar M. Macrolane for breast enhancement: 12-month follow-up. Plast Reconstr Surg. 2011 Feb;127(2):850-860. doi: 10.1097/PRS.0b013e318200ae57.
Clinical trial NCT05475353: The Effects of Ergonomics Awareness Education and Exercise
Official title: The Effects of Ergonomics Awareness Education and Exercise on Physical Activity, Quality of Life, and Musculoskeletal Discomfort in Remote Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ergonomics
Telerehabilitation
Musculoskeletal System Disorder
Quality of Life
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effects of asynchronous and synchronous exercises, which are added to ergonomics awareness education, on musculoskeletal disorders, physical activity and quality of life.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-45
* Working at home at least 5 hours a day
* Not having one or more diagnosed musculoskeletal disorders

Exclusion Criteria:

* Limited access to technology or not being able to actively use the technology
* Had musculoskeletal trauma or surgery
* Pregnancy

Primary outcomes:
measure: Physical activty status
timeFrame: Baseline
measure: Physical activty status
timeFrame: 6 weeks
measure: Quality of life status
timeFrame: Baseline
measure: Quality of life status
timeFrame: 6 weeks
measure: Musculoskeletal Discomfort level
timeFrame: Baseline
measure: Musculoskeletal Discomfort level
timeFrame: 6 weeks
measure: Ergonomic risk level
timeFrame: Baseline
measure: Ergonomic risk level
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Kültür Üniversitesi
Study officials:
affiliation: İstanbul Kültür University
name: Halenur Evrendilek, Res. Asst.
role: STUDY_DIRECTOR
affiliation: İstanbul Kültür University
name: Burcu Semin Akel, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00038753: Vision In Preschoolers Study (VIP Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Amblyopia
Strabismus
Refractive Error
Keywords: vision screening
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
First posted: 2002-06-05
Sex: ALL
Minimum age (years): 36
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: To identify vision-screening tests that can accurately predict those three- and four-year old preschoolers who would benefit from a comprehensive vision examination because of signs of amblyopia, strabismus, and/or significant refractive error.

Detailed description: The Vision In Preschoolers (VIP) Study is a multi-center, multidisciplinary, prospective clinical study to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations. The primary goal of the VIP Study is to identify an effective and efficient battery of screening tests that has high sensitivity and specificity in identifying preschoolers in need of further evaluation for amblyopia, strabismus and/or significant refractive error.

The VIP Study is designed in three-phases.

Phase I activities will establish which screening tests perform well when administered by licensed eye care professionals (pediatric optometrists and pediatric ophthalmologists) in a population of 1000 Head Start preschoolers at high risk for the targeted vision disorders.

Phase II activities will provide evaluation of the tests' performance when administered by pediatric nurses and lay people on a high risk population of 1000 Head Start preschoolers. Each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener. Tests selected for Phase II will be determined by the outcome of Phase I.

Phase III activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of (6400) Head Start preschoolers. The category of screening personnel and the specific screening tests used in Phase III will be determined by the outcome of Phases I and II.

Eligibility criteria: Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley School of Optometry
state: California
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
city: Tahlequah
country: United States
facility: Oklahoma Northeastern State University College of Optometry
state: Oklahoma
city: Philadelphia
country: United States
facility: Pennsylvania College of Optometry
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01232153: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon
Official title: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preoxygenation
Keywords: chest tube
preoxygenation
NIV
out-of-hospital
patients needing tracheal chest tube managed by Medical Mobile Emergency rescue services
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
Collaborators: name: Service d'Aide Médicale Urgente de Seine et Marne
First posted: 2010-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

Detailed description: This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.

Eligibility criteria: Inclusion Criteria:

* Patients needing chest tube intubation

Exclusion Criteria:

* Cardiac arrest
* Children
* Pregnancy
* Incompetents

Primary outcomes:
measure: length of hypoxemia
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Melun
country: France
facility: SAMU 77
Study officials:
References:
Clinical trial NCT00294853: Multi Detector-Row Computed Tomography (MDCT) Calcium Score of Heart Transplanted Patients
Official title: MDCT Calcium Score of Heart Transplanted Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary calcium score
Coronary artery disease
Cardiac transplantation
Coronary calcium score in heart transplanted patients
Coronary artery disease in heart transplanted patients
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine if calcium score can be used as a predictor of coronary artery disease in heart transplanted patients, as it is used in non-transplanted persons.

Detailed description: Several studies have shown that a negative calcium score is a strong independent negative predictor of coronary artery disease (CAD). CAD in heart transplants (HTx) differs from CAD lesions in native hearts. The aim of this study is to see if there is a similar relation between coronary artery calcium and CAD in transplanted hearts as in native hearts.

Eligibility criteria: Inclusion Criteria:

* Heart transplanted patient
* Aged 18 or above.

Exclusion Criteria:

* Pregnancy
* Atrial fibrillation
* Severe heart failure New York Heart Association (NYHA) class IV
* Severe pulmonary disease making the patient unable to hold his/her breath for more than 10 seconds.

Primary outcomes:
measure: Calcium score
timeFrame: at the date of examination
Secondary outcomes:
measure: Coronary stenoses found on coronary angiography
timeFrame: at the date of examination
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Oslo University Hospital
name: Anne Günther, MD
role: PRINCIPAL_INVESTIGATOR
References: