louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05850169: The Effects of Creative Dance Therapy on Motor and Executive Functions in Children With Dyslexia
Official title: The Effects of Creative Dance Therapy on Motor and Executive Functions in Children With Dyslexia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia
Dance Therapy
Motor Skills
Executive Function
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although some benefits of dance have been described for motor and cognitive skills, the effects on individuals with dyslexia are unclear. The purpose of this study was to investigate the effects of creative dance training on the motor and executive skills of children with dyslexia.

Detailed description: Although some benefits of dance have been described for motor and cognitive skills, the effects on individuals with dyslexia are unclear. The purpose of this study was to investigate the effects of creative dance training on the motor and executive skills of children with dyslexia.

The randomized controlled trial was conducted between August 2019 and December 2020 in the Occupational Therapy Department of Hacettepe University. The sample consisted of 51 children with dyslexia aged 8-10 years. While 26 of the participants received routine literacy training, the other 25 also received creative dance training three times a week for 4 weeks. Motor functions were assessed using the "Bruininks-Oseretsky Motor Competence 2 Test- Short Form", and executive functions were assessedusing the "Executive Function and Occupational Routines Scale".

Eligibility criteria: Inclusion Criteria:

* an age between 6 and 10 years
* a diagnosis of dyslexia according to DSM-V criteria
* continued formal education in elementary school
* participation in routine literacy training in a special education and rehabilitation center
* voluntary participation in the study.

Exclusion Criteria:

* having additional physical or psychological problem accompanying the dyslexia
* using of psychotic drugs
* participating in sports regularly.

Primary outcomes:
measure: Bruininks-Oseretsky Test of Motor Proficiency Second Edition Brief Form, (BOT-2 SF)
timeFrame: 20 minutes
measure: Executive Function and Occupational Routines Scale (EFORTS)
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Cemre Bafralı
state: Altındağ
Study officials:
affiliation: Ankara Medipol University
name: Cemre Bafralı, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02303769: Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
Official title: A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Lower Urinary Track Syndrome
Harnal
Tamsulosin HCL 0.4mg
Lead sponsor: GL Pharm Tech Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-01
Enrollment: 309
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic

Detailed description: GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech

Eligibility criteria: Inclusion Criteria:

* Over 50 years old, BPH diagnosted, Adult Male Subject
* IPSS ≥ 13 point
* PSA \< 4ng/mL
* 5ml/sec \< Qmax ≤ 15ml/sec

Exclusion Criteria:

* Prostatic cancer
* 250ml \< PVR
* ALT or AST \> 2 times (Upper Normal Range)
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* Treated with α-adrenalin receptor blocker within 2weeks before screening
* Treated with 5Alpha-Reductase Inhibitor within 6 months before screening
* Treated with phytotherapy within 2weeks before screening
* Treated with Anabolic Steroid within 6 months before screening

Primary outcomes:
measure: Change from baseline to endpoint in total International Prostate Symptom Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline to endpoint in total International Prostate Symptom Score
timeFrame: 4 weeks
measure: Change from baseline to endpoint in voiding score
timeFrame: 4 weeks, 8 weeks
measure: Change from baseline to endpoint in IPSS QoL
timeFrame: 4 weeks, 8 weeks
measure: Change from baseline to endpoint in Qmax
timeFrame: 4 weeks, 8 weeks
measure: Change from baseline to endpoint in PVR
timeFrame: 4 weeks, 8 weeks
measure: Time to event/proportion of subjects with AUR
timeFrame: 8 weeks
measure: Time to event/proportion of subjects undergoing BPH related prostatic surgery
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji general hospital
Study officials:
affiliation: Eulji General Hospital
name: You T Gun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05687669: Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU
Official title: Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pre-Eclampsia; Complicating Pregnancy
Pre-eclampsia Aggravated
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 170
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective study will be done in Assiut university hospital obstetric ICU, 2 groups will be examined and randomly assigned: group A using glyceryl trinitrate (GTN) to emergency control of blood pressure and group B using phentolamine infusion to control blood pressure. Each group consists of 85patients:
Primary purpose: PREVENTION

Brief summary: Severe pre-eclamptic toxemia has a high incidence of renal complications. Rapid diagnosis and termination of pregnancy are still the gold standard main treatment for pre-eclampsia. Rapid control of blood pressure showed to provide protection against many adverse effects of preeclampsia as intracranial hemorrhage, subcapsular hepatic hematoma and acute kidney injury (AKI).

In Assiut university hospital ICU regimen, glyceryl trinitrate (GTN) was used primarily for this purpose. But it was accused in many cases as a cause for AKI without any other organ damage along with the severe preeclampsia disease. Some previous studies supported this assumption as , Ying-Hsuan .T. et.,al during their study of GTN on renal outcome during cardiopulmonary bypass in cardiac surgery. Phentolamine infusion is a new rising alternative for an old drug with a high safety profile.

In this research protocol the researchers will study comparative effect of glyceryl trinitrate (GTN) versus phentolamine on renal outcome in severe pre-eclampsia patients during their stay in obstetric ICU.


Eligibility criteria: Inclusion Criteria:

* Severe preeclampsia defined by presentation of 2 or more of the following criteria:

  1. Blood pressure more than 160/100
  2. Proteinuria
  3. Pitting edema
  4. With or without organ dysfunctions

Exclusion Criteria:

1. Patient relatives' refusal
2. Recent active internal hemorrhage
3. Chronic renal impairment or failure on dialysis for any other etiology

Primary outcomes:
measure: kidney function tests
timeFrame: 96 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04825769: Red Light Intervention for Myopia Prevention
Official title: A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Children and adolescents
Myopia
Prevention and control
Red light
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 278
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.


Eligibility criteria: Inclusion Criteria:

* Students of grade 1-4 in the participating schools;
* Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） \>-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D \<cycloplegic SE≤0.50D;
* Students whose mother and/or father are in myopia status (SE \< -3.0D for either of eyes);
* Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.

Exclusion Criteria:

* Students whose parents do not sign informed consent;
* Students who have strabismus and/or other binocular vision abnormality;
* Students who have other eye diseases and/or systematic diseases;
* Students who have DC \<=-1.5D;
* Students whose difference of SE between the two eyes \>=1.5D;
* Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.

Primary outcomes:
measure: One-year cumulative incidence of myopia (%) in the intervention group and the control group.
timeFrame: 1 year
Secondary outcomes:
measure: The progress of spherical equivalent(SE,D) of children in intervention group and control group.
timeFrame: 1 year
measure: The progress of axial length of children in intervention group and control group.
timeFrame: 1 year
measure: The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.
timeFrame: 1 year
measure: The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiangui He
state: Shanghai
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: Xiangui He
role: STUDY_DIRECTOR
References:
Clinical trial NCT06510569: 3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding
Official title: Three-Dimensional Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Resorption of External Root
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2024-07-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.

Detailed description: Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.

Group (B): Patients will be treated with clear aligner therapy in lower anterior crowding.

Eligibility criteria: Inclusion Criteria:

Adult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .

Exclusion Criteria:

Previous orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.

Primary outcomes:
measure: Correction of lower anterior crowding
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Root resorption
timeFrame: 6 month
Locations:
city: Cairo
country: Egypt
facility: Al Azhar Universty
city: Zagazig
country: Egypt
facility: Haidy Fekry
Study officials:
affiliation: Al azhar universty
name: samir A ibrahim, proffesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiori A, Minervini G, Nucci L, d'Apuzzo F, Perillo L, Grassia V. Predictability of crowding resolution in clear aligner treatment. Prog Orthod. 2022 Nov 28;23(1):43. doi: 10.1186/s40510-022-00438-z.
Clinical trial NCT06136169: Reminder-cue Scanning Training for Homonymous Visual Field Loss
Official title: Reminder-cue Scanning Training for People With Homonymous Visual Field Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Homonymous Hemianopia
Homonymous Quadrantanopia
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate a new approach to training people with visual field loss to scan when driving

Detailed description: Homonymous visual field loss is the loss of vision on the same side in both eyes. The most common types are hemianopia (the loss of one half of the field of vision) and quadrantanopia (the loss of one quarter of the field of vision). Hemianopia and quadrantanopia may cause difficulties in seeing objects on the side of the field loss. People with these types of field loss can compensate by scanning (looking) toward the side of the field loss. However, sometimes they might not scan sufficiently well resulting in delayed responses to hazards when driving. The purpose of this research study is to evaluate a new approach, "reminder-cue scanning training", to training people with homonymous visual field loss to scan when driving.

Participants will receive reminder-cue scanning training in the driving simulator.Typically there will be three training sessions within about a 2-week period. In addition, participants will complete an evaluation in the driving simulator before and after the training.

Eligibility criteria: Inclusion Criteria:

* Homonymous hemianopia or homonymous quadrantanopia for at least 3 months
* Binocular visual acuity of at least 20/40
* Prior or current driving experience
* Able to attend multiple study visits
* Able to communicate in English sufficiently to understand the study procedures

Exclusion Criteria:

* Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training

Primary outcomes:
measure: Change in rate of adequate scanning to the side of the field loss
timeFrame: Pre-training, post-training (up to 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schepens Eye Research Institute of Mass Eye and Ear
state: Massachusetts
Study officials:
affiliation: Schepens Eye Research Institute of Mass Eye and Ear
name: Alex Bowers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03203369: Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN
Official title: Phase 1, Open-label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of a Single Dose of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Keywords: Blastic plasmacytoid dendritic cell neoplasm
Natural Killer (NK) cell blastic lymphoma
Hematologic malignancies
Cluster of differentiation (CD) CD4+CD56+ hematodermic tumor
Acute leukemia and myeloid neoplasms
Chimeric Antigen Receptor T-cell (CAR-T) therapy
Allogeneic
Cluster of differentiation 4 (CD4)
Cluster of differentiation 56 (CD56)
Lead sponsor: Cellectis S.A.
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.


Eligibility criteria: Main Inclusion Criteria:

* Patients with a diagnosis BPDCN according to World Health Organization (WHO) classification confirmed by hematopathology;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

Primary outcomes:
measure: Incidence, nature, and severity of adverse events and serious adverse events
timeFrame: Through day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cellectis S.A.
name: Ioana Kloos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03189069: A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage
Official title: Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 36000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from the MORE Registry according to the inclusion/exclusion criteria. Four different cohorts will be evaluated: patients who were prescribed warfarin, apixaban, dabigatran or rivaroxaban. Only users of oral anticoagulant treatment from January 1, 2013 to January 1, 2016 will be included in this study.

Brief summary: The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.


Eligibility criteria: Inclusion Criteria:

* Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015)
* Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period)
* Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date
* Had at least 1 medical claim for atrial fibrillation any time before or on index date

Exclusion Criteria:

* Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period
* Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period
* Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period
* Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date
* Had claims for a diagnosis or procedure code for reversible atrial fibrillation
* Had medical claims indicating pregnancy during the study period
* Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period
* Had \> 1 oral anticoagulant prescription claim on the index date

Primary outcomes:
measure: Major bleeding
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02700269: Vanderbilt-Zambia Innovations in Global Health Technologies
Official title: Vanderbilt-Zambia Innovations in Global Health Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria Diagnosis
Lead sponsor: Macha Research Trust, Zambia
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2016-03-07
Enrollment: 278
Sex: ALL
Minimum age (years): 6
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those seeking care for suspected malaria in Zambia

Brief summary: Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.


Eligibility criteria: Inclusion Criteria:

* Individuals giving written informed consent for themselves
* Children under the age of 18 for whom a parent or guardian can give consent
* Individuals seeking care or treatment of suspected or possible malaria
* Individuals being screened as a contact of someone with recent malaria
* Other individuals willing to have their blood tested for malaria

Exclusion Criteria:

* Anyone over 18 unwilling or unable to provide informed consent
* Anyone under 18 who does not have a parent or guardian to give consent
* Anyone between the age of 12 and 18 who does not give assent

Primary outcomes:
measure: Enhancement of malaria RDT to detect low levels of P falciparum parasites
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Choma
country: Zambia
facility: Macha Research Trust
Study officials:
References: