louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02729649: ArmAssist Robotic Device for Arm Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.


Eligibility criteria: Inclusion Criteria:

* unilateral paresis;
* ability to understand and follow simple instructions;
* minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints.

Exclusion Criteria:

* bilateral impairment;
* severe sensory deficits in the paretic upper limb;
* cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment;
* inability to provide informed consent;
* other current severe medical problems.

Primary outcomes:
measure: Fugl Mayer motor score for upper extremity
timeFrame: 4 weeks
Secondary outcomes:
measure: Ashworth score
timeFrame: 4 weeks
measure: Action research arm score
timeFrame: 4 weeks
measure: Wolf motor function test
timeFrame: 4 weeks
measure: Barthel index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Study officials:
References:
citation: Tomic TJ, Savic AM, Vidakovic AS, Rodic SZ, Isakovic MS, Rodriguez-de-Pablo C, Keller T, Konstantinovic LM. ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial. Biomed Res Int. 2017;2017:7659893. doi: 10.1155/2017/7659893. Epub 2017 Jan 31.
Clinical trial NCT06348849: The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation
Official title: The Desensitising Effect of Nanosilver Fluoride Compared to Low-Level Laser Therapy in Molar-Incisor Hypomineralisation: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Molar Incisor Hypomineralization
Hypersensitivity
Keywords: Nanosilver fluoride
Low-level laser therapy
Desensitising
Molar-incisor hypomineralisation
First permanent molars
Pediatric
Clinical trial
Nanosilver
LLLT
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy.


Eligibility criteria: Inclusion Criteria:

* The presence of at least one hypersensitive first permanent molar in MIH patient (using the Schiff Cold Air Sensitivity Scale (SCASS)).
* Completion of an informed consent to participate in the study.

Exclusion Criteria:

* Hypomineralised molars resulting from other medical conditions, such as enamel malformations associated with syndromes, dental fluorosis, enamel hypoplasia, amelogenesis imperfecta, and dental caries.
* The presence of active tooth decay or defective restorations in the tooth under examination which can confound the aetiology of hypersensitivity with pulpitis.
* The presence of pulpal symptoms.
* Having undergone any professional desensitising treatment in the previous 6 months.
* Having used a desensitising paste other than habitual toothpaste in the previous 3 months.
* Use of anti-inflammatory drugs or analgesics at the time of recruitment.
* Allergy or sensitivity to silver or any of the materials included in the study.

Primary outcomes:
measure: Desensitising effect in hypersensitive MIH molars
timeFrame: 1 month
Secondary outcomes:
measure: Change in the plaque index scores
timeFrame: 1 month
measure: Change in children's frequency of toothbrushing
timeFrame: 1 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT03841149: Volume 3D_US Kidney
Official title: Measurement of Kidney Volume and Renal Tumor Volume Using 3D-Ultrasound Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Renal Tumor
Keywords: 3D Ultrasound volume measurements
Renal volume
Tumour Volume
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (n=80) referred for renal tumour management (including imaging, biopsy or percutaneous ablation)

Brief summary: The purpose of this study is to measure the volume of the kidney and tumors using 3D-US acquisition and to correlate these measurements to contrast-enhanced CT or MRI.

Detailed description: Additional objectives are comparison between true volume measurements and volume estimation using measurements of the three perpendicular diameters, comparison of inter and intra variability of 3D US measurements with inter and intra variability of 3D CT or MRI measurements, calculation of 3D and 2D volume measurements during contrast-enhanced US examination when the injection is performed for clinical routine purposes such as vascular and extension staging, during interventional procedures such as US guided biopsy targeting the non-necrotic tumour parenchyma. Concordance between 2D and 3D US acquisitions will be compared to CT and MRI measurements. Comparison of volume measurements between non-contrast and contrast-enhanced methods (US, CT and MRI) will be performed. The results will be compared to renal function before and after tumour treatment.

Eligibility criteria: Inclusion Criteria:

* Adult patient (age 18)
* Absence of participant's opposition
* No contra-indication to contrast-enhanced CT AND MRI (a single contrast-enhanced imaging modality is sufficient)
* Affiliated to Social Security

Exclusion Criteria:

- Contra-indication to both contrast-enhanced CT AND MRI

Primary outcomes:
measure: 3D-US volume measurements
timeFrame: 1 month
Secondary outcomes:
measure: 2D-US volume measurements
timeFrame: 1 month
measure: Inter and intra variability measurements
timeFrame: 1 month
measure: 2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management)
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Michel Correas, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464849: Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension
Official title: Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arterial Hypertension
Resistant Hypertension
Microvascular Rarefaction
Endothelial Dysfunction
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2022-07-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Resistant hypertension: Blood pressure levels outside the treatment goals in patients using three or more classes of antihypertensive drugs, one of which is preferably a thiazide diuretic.

Brief summary: Systemic arterial hypertension is a serious health problem worldwide. In some cases, it can phenotypically present as resistant arterial hypertension, which consists of blood pressure levels outside the treatment goals in patients using three or more classes of antihypertensive drugs, one of which is preferably a thiazide diuretic. Resistant hypertension contributes to a 47% higher risk of developing cardiovascular events when compared to patients with non-resistant hypertension. It is known that the microcirculation plays a relevant role in the pathophysiology of arterial hypertension. Furthermore, it is known that the cutaneous microvascular network is an adequate model and that it reflects the systemic microcirculation. In this sense, the present research proposes the study of cutaneous capillary density - through high resolution intravital microscopy - and of the endothelium-dependent and independent microvascular vasodilator response - by the speckle laser flowmetry method coupled to a pharmacological system of micro- iontophoresis - in patients diagnosed with resistant hypertension, with the aim of identifying changes in comparison with patients with non-resistant hypertension and normotensive individuals. Additionally, the evaluation of the association between systemic microvascular function and the presence of target organ lesions in this population may indicate that this is a new non-invasive way of stratifying cardiovascular risk in these individuals.


Eligibility criteria: Inclusion Criteria:

* Resistant hypertension

Exclusion Criteria:

* Pregnancy or lactation for all groups.
* For the control group: endocrine and metabolic diseases, including diabetes mellitus, cardiovascular diseases, including hypertension, autoimmune diseases and cancer.
* For the resistant arterial hypertension and non-resistant arterial hypertension groups: endocrine diseases, except diabetes mellitus, autoimmune diseases and cancer .

Primary outcomes:
measure: Systemic microvascular reactivity
timeFrame: two years - during one visit to the microcirculation laboratory
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Eduardo Tibiriçá
Study officials:
References:
Clinical trial NCT06203249: Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease
Official title: Microecology and Host Immunity in Patients With Anti-melanoma Differentiation Associated Gene 5 Antibody Positive Dermatomyositis and Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microbiome
Immune Function
Anti-MDA5 Antibody Positive Dermatomyositis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anti-MDA5 antibody positive dermatomyositis patients with or without interstitial lung disease

Brief summary: The purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-MDA5 antibody positive dermatomyositis.

Detailed description: Methods: Bronchoalveolar lavage specimens of patients with anti-MDA5 antibody positive dermatomyositis and interstitial lung disease were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Eligibility criteria: Inclusion Criteria:

* Patients who meet the diagnostic criteria of dermatomyositis and anti-MDA 5 antibody positive.
* Anti-MDA5 antibody positive DM patients with RPILD meet the diagnostic criteria for RPILD.
* Must have undergone bronchoalveolar lavage.
* Age≥18 years old.
* Patients who signed informed consent forms

Exclusion Criteria:

* Patients who had other connective tissue diseases.
* Patients with ILD or RPILD caused by infection, tumors, drugs, biochemistry and other factors.
* Pregnant or lactating patients.
* The patient also participated in any other clinical trial.
* Disagreement for inclusion in this study

Primary outcomes:
measure: The relationship between the microbial community and the presence or absence of interstitial lung disease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA
state: Beijing
Study officials:
References:
Clinical trial NCT04944849: Reaction Time in Digital Game Players
Official title: Reaction Time is Better in Digital Game Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Computer Games
Keywords: digital game players
reaction time
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male individuals aged between 18-25 years who have been playing digital games for more than 2 years

Brief summary: With the increasing use of computers in recent years, the effects of games have started to be discussed. Young people who play computers are exposed to many stimuli during the game and they react to these stimuli with reactions at various rates. In our study, we wanted to find out whether there is a significant difference in reaction time between young people who play computers more than 14 hours a week and those who do not.

Detailed description: While doing our research, the reaction time test in the Human Benchmark application, where the reaction time to many different stimuli on the computer can be evaluated, the Aim Trainer test and the auditory reaction time tests at https://playback.fm/audio-reaction-time will be applied. The way the tests are applied; the first test will be separated as a trial and will not be included in the average. The next three tests will be averaged. Height, weight, smoking, use of antidepressants or stimulants, any ear or hearing problems, any eye disease, how many days a week and how much sports they do, the dominant side, whether they play digital and video games, for how long, what type of device (computer, tablet, phone), which games (League of legends, Player unknown's battlegrounds, World of Warcraft, Valorant, FIFA, PES, Call of duty, NBA, Counter strike:Global offensive CS:GO, other), how many hours a day and how many hours a week they play digital video games will be questioned whether they participate in the tournament with at least one of these games.

Eligibility criteria: Inclusion Criteria:

* male
* playing digital games for more than 2 years

Exclusion Criteria:

* female
* not having played any digital games for 2 years

Primary outcomes:
measure: Visual reaction time
timeFrame: 15 minutes
measure: Auditory reaction time
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT05282849: Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .
Official title: Ultrasound Guided Quadratus Lumborum Block Versus Fascia Iliaca Block in Pediatric Patients Undergoing Developmental Dysplasia of Hip Surgical Repair. A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Keywords: ultrasound
quadratus lumborum
fascia iliaca
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between ultrasound guided transmuscular QL block and Fascia iliaca block in pediatric patients undergoing DDH surgery regarding the quality of pain control in the perioperative period..


Eligibility criteria: Inclusion Criteria:

* Children aged 2-12 years
* Of both sexes
* American society of anesthesiologist (ASA) physical status classification class I
* Undergoing general anaesthesia for DDH surgery

Exclusion Criteria:

* Parents' refusal of regional block
* Duration of surgery over 120 min.
* History of allergy to local anesthetics
* Bleeding disorders (INR \>1.4, Platelet count\< 75000)

Primary outcomes:
measure: Total 12 hours postoperative opioid consumption
timeFrame: from the time of transfer of the patient to the pacu at one hour intervals for 12 hours
Secondary outcomes:
measure: Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale
timeFrame: from the time of transfer to the PACU, every hour for the first 24 hours postoperative]
measure: Side effects
timeFrame: from the time of transfer to the PACU, for the first 24 hours postoperative
measure: Total 24 hours postoperative opioid consumption
timeFrame: from the time of transfer of the patient to the pacu at one hour intervals for 24hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Cairo university
Study officials:
References:
Clinical trial NCT06277349: Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery
Official title: Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea
Astigmatism
Cataract
Keywords: multifocal
IOL
astigmatism
incision
cataract surgery
implant
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions.
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.

Detailed description: This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.

Eligibility criteria: Inclusion Criteria:

* Bilateral cataract and be planning to have both eyes operated on.
* Age 21 and older
* Have cataracts that allow IOL master biometry
* Regular corneal astigmatism 1.00 up to 2.50 D
* Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D
* written informed consent to surgery and participation in the study
* Speak English

Exclusion Criteria:

* Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* Irregular corneal astigmatism on Pentacam topography

Primary outcomes:
measure: Composite scoring of unaided distance and near vision (monocularly)
timeFrame: 3 months
measure: Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01411449: Primovist Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of EOB-Primovist Inj. Syringe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Imaging
Keywords: Primovist
MRI agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 2030
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who received Primovist for liver MRI. The study is expected to collect data of 2,000 patients in about 150 hospitals in Japan.

Brief summary: This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.


Eligibility criteria: Inclusion Criteria:

* Patients who received Primovist for liver MRI

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
timeFrame: After Primovist injection, up to 7 days
measure: Incidence of adverse drug reactions in patients with renal impairment
timeFrame: After Primovist injection, up to 7 days
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]
timeFrame: After Primovist injection, up to 7 days
measure: MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired
timeFrame: After Primovist injection, up to 7 days
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: