louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02533479: Erythrocytes and Skeletal-muscle Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
Official title: Erythrocytes and Skeletal-muscle Unsaturated and Omega-6 Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Centre d'Alt Rendiment
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles in adult healthy human after caloric restriction and acute exercise in order to validate erythrocyte FAs profile as marker of changes in muscle fatty acid composition.

Detailed description: The study was performed with 11 healthy sportsmen participating in a caloric restriction trial for 1 month. The participants follow a caloric restriction, 30-40% respect to the usual diet of each participant, three alternate days weekly along 4 weeks. After the caloric restriction period the participants realized an exercise stress test. For each participant one blood sample and muscular biopsy were obtained after acute exercise and caloric restriction intervention. All the participants were informed of the purpose and demands of the study before giving their written consent to participate. The study protocol was in accordance with the Declaration of Helsinki for research on human participants and was approved by the local Ethics Committee of the Consell Català de l'Esport.

Eligibility criteria: Inclusion Criteria:

* age (18-50 years old),
* sex (male),
* equilibrate diet and physical activity of 3 days weekly.

Exclusion Criteria:

* sex (female),
* smokers.

Primary outcomes:
measure: Changes in skeletal muscle FAs profiles in adult healthy human after caloric restriction and acute exercise
timeFrame: 8 weeks
measure: Changes in erythrocytes FAs profiles in adult healthy human after caloric restriction and acute exercise
timeFrame: 8 weeks
Secondary outcomes:
measure: Densitometry
timeFrame: 8 weeks
measure: Exercise stress test energy efficiency
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centre D'Alt Rendinemt, Sant Cugat
Study officials:
affiliation: Centre d'Alt Rendiment, Sant Cugat
name: Franchek Drobnic, Ph D
role: STUDY_CHAIR
References:
citation: Capo X, Martorell M, Sureda A, Tur JA, Pons A. Effects of docosahexaenoic supplementation and in vitro vitamin C on the oxidative and inflammatory neutrophil response to activation. Oxid Med Cell Longev. 2015;2015:187849. doi: 10.1155/2015/187849. Epub 2015 Apr 19.
citation: Pons V, Riera J, Capo X, Martorell M, Sureda A, Tur JA, Drobnic F, Pons A. Calorie restriction regime enhances physical performance of trained athletes. J Int Soc Sports Nutr. 2018 Mar 9;15:12. doi: 10.1186/s12970-018-0214-2. eCollection 2018.
Clinical trial NCT05887479: The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
Official title: The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cerebrovascular Disorders
Spasticity, Muscle
Botulinum Toxin
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).


Eligibility criteria: Inclusion Criteria:

* hemiplegia due to a cerebrovascular accident at least 1 month ago
* cognitively competent
* have spasticity of 1 and above according to the Modified Ashworth Scale
* receive at least 3 cubes in the Box Block Test

Exclusion Criteria:

* Patients with upper extremity brachial plexus lesions,
* shoulder subluxation,
* arthritis and joint contracture,
* neglect syndrome,
* cerebellar and brain stem lesions
* those who did not accept the study

Primary outcomes:
measure: Pain - Visual Analog Scale
timeFrame: 2 weeks after treatment
measure: Range of Motion
timeFrame: 2 weeks after treatment
measure: Modified Ashworth Scale
timeFrame: 2 weeks after treatment
measure: The Fugl-Meyer assessment scale
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Pain - Visual Analog Scale
timeFrame: 3 months after treatment
measure: Range of Motion
timeFrame: 3 months after treatment
measure: Modified Ashworth Scale
timeFrame: 3 months after treatment
measure: The Fugl-Meyer assessment scale
timeFrame: 3 months after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05814679: Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
Official title: The Effect of Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Based on the task of providing the comfort of the patient, which is an indispensable part of the nursing profession, which many nurse theorists emphasize, there has been no study in the literature on the determination of the effect of virtual relaxation, which can be effective on the fatigue and comfort levels of patients receiving hemodialysis treatment. Therefore, the aim of this study is to examine the effect of virtual reality and relaxation on fatigue and comfort in hemodialysis patients.

Detailed description: The patient will be prepared for relaxation with virtual reality and will be given a comfortable sitting position.

The patient will watch the relaxation practice with virtual reality once during the hemodialysis treatment.

The application will be terminated with the expiration of the virtual reality relaxation video.

Fatigue and comfort score will be measured after the application.

Eligibility criteria: Inclusion Criteria:

* Receiving hemodialysis treatment for the last 6 months
* Receiving four-hour hemodialysis treatment three times a week
* 18 years or older
* Deaf and visually impaired
* Without cognitive and psychiatric diagnosis
* Open to communication and cooperation
* Patients who agreed to participate in the study

Exclusion Criteria:

* Kidney transplant
* Discomfort due to virtual reality glasses
* Suspected/diagnosed COVID-19
* Patients who want to leave the study voluntarily
* Death

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: Assessing change of fatigue severity scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and fatigue severity scale score will measure fifth week.
measure: Hemodialysis Comfort Scale
timeFrame: Assessing change of fatigue comfort scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and comfort scale score will measure fifth week.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Cit Hospital
Study officials:
References:
Clinical trial NCT04902079: Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy
Official title: Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure, Systolic
Keywords: Heart Failure
Quality of Life
Cardiac Contractility Modulation
Lead sponsor: Monaldi Hospital
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard indication to CardiaC Contractility Modulation (CCM) therapy device system implantation

Brief summary: Observational and perspective study with acute and chronic endpoint.

Detailed description: This registry includes patients who have undergone implantation of the cardiac contractility modulation device due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, as indicated in the guidelines of the ESC of 2016 and the Expert Consensus Document of the ESC Heart Failure group published in May 2019 for to assess the benefits after the CCM device.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female, aged 18 or older;
* chronic heart failure with symptomatic left ventricular systolic function; (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
* Appropriate and optimized medical therapy
* Patient signed and dated informed consent form at enrollment;
* life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis

Exclusion Criteria:

* absence of venous access available for implant;
* contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
* pregnant patients

Primary outcomes:
measure: Improvement Quality of Life
timeFrame: 12 months
measure: Functional Capacity
timeFrame: 12 months
measure: Reduction of HF Hospitalizations and Emergency Ward accesses
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Monaldi Hospital
Study officials:
affiliation: Ao dei Colli - Monaldi Hospital
name: Antonio D'Onofrio, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04625179: Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
Official title: Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties.

the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated

Detailed description: 16 participants with missing maxillary posterior teeth and residual alveolar ridge of at least 5 mm will be equally and randomly divided into two groups.

The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and simultaneous implant placement while the control group will not receive any materials after sinus membrane elevation and simultaneous implant placement.

Eligibility criteria: Inclusion Criteria:

* Age range will be between (30 - 50) years old.
* Patients with missed one or more of posterior teeth with minimum residual bone height 5 mm
* Adequate inter-occlusal space of at least 8 mm

Exclusion Criteria:

* Maxillary sinus diseases.
* Previous sinus surgery like the Caldwell-Luc operation.
* History of chemotherapy or radiotherapy to maxilla.
* Presence of Underwood's septa/severe sinus floor convolutions.
* Systemic disease affecting bone metabolism.
* Uncontrolled diabetes mellitus.
* Heavy smokers.
* Para functional habits.

Primary outcomes:
measure: change Implant stability
timeFrame: at baseline and 6 months
measure: change in bone density
timeFrame: at baseline, 1 month and 6 months
measure: change in vertical bone height
timeFrame: at baseline, 1 month and 6 months
measure: change in marginal bone level
timeFrame: at baseline, 1 month and 6 months
Secondary outcomes:
measure: Postoperative pain
timeFrame: after 1 week
measure: Postoperative swelling
timeFrame: after 1 week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT04923984: Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)
Official title: Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subdural Hematoma
Keywords: Embolization
Middle Meningeal Artery
Chronic Subdural Hematoma
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH.

Hypothesis- EMMA reduces the recurrence rate of SDH with or without concomitant surgical evacuation.

Detailed description: The purpose of our study is to conduct a prospective cohort study to assess the safety and effectiveness of MMA embolization for the treatment of CSDH. All patients with CSDH presenting to the emergency room or to neurosurgical outpatient clinic will be screened for potential enrollment. If the subject is willing to participate an informed consent will be obtained.

All patients presenting to the emergency room or in neurosurgery clinic with CSDH diagnosed on CT scan will be considered for the study. If the patient needs emergent evacuation for clinical reasons, patient will be taken for surgical evacuation before consideration of EMMA. Patients that are more likely to have recurrence after surgical evacuation are those with recurrent CSDH, on antiplatelet or antithrombotic treatment. The EMMA could be used as primary treatment or in conjunction with surgery in these patients or in patients who may not be good surgical candidate.

Follow up - All patients will be followed after discharge from the hospital at 1, 3 and 6 months interval. The follow up at 1 and 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 months will be only clinical follow up.

Patients will be assessed for recurrence of CSDH on CT scan of head. The size of the CSDH will be measured and compared to previous scans and peri-procedural morbidity and mortality related to EMMA will be sought. This will be done at 1 and 3 months post EMMA.

Eligibility criteria: Inclusion Criteria:

* All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic

Exclusion Criteria:

* When informed consent is not possible
* Known allergy to liquid embolic agent

Primary outcomes:
measure: Subdural Hematoma recurrence at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Size
timeFrame: 1 month and 3 months
measure: Mortality
timeFrame: 1month, 3months, 6months
Other outcomes:
Locations:
city: Winnipeg MB
country: Canada
facility: Health Sciences centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jai Shankar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03821584: Brain Perfusion Assessment in the Acute Phase of Migraine Aura
Official title: Brain Perfusion Assessment in the Acute Phase of Migraine Aura.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Emergencies
Keywords: migraine
perfusion arterial
aura brain
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital with neurological deficit and final clinical diagnosis of migraine with aura (certain probable as defined by The International Classification of Headache Disorders)

Brief summary: The aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.

Detailed description: Migraine is a benign and frequent disorder. Migraine aura consists in reversible focal neurological symptoms developing gradually during attack. Its diagnosis relies mainly on patient's history, clinical examination and exclusion of other possible secondary causes to explain transient neurological signs. Thus it can be difficult particularly during first attack or during attack without headache to differentiate migraine aura from transient ischemic stroke. Considering the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest. MRI with diffusion, SWI, Flair 2D, ARM 3D TOF, ASL sequences' are routinely performed for the management of acute neurological deficit. Arterial spin labeling (ASL), as a MR perfusion method, will be used to describe brain perfusion during migraine aura. The study hypothesis is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms during migraine aura.

Eligibility criteria: Inclusion Criteria:

* Age between greater than or equal to 18
* Able to undergo MRI during migraine aura

Exclusion Criteria:

* Pregnant females
* Contraindications towards MRI scanning
* History of epilepsy, psychiatric disease, or any other neurologic disease (brain tumors, stroke..).
* Presence of abnormalities on the MRI that could explain the neurological deficit.
* Adults under guardianship or trusteeship

Primary outcomes:
measure: Perfusion pattern of concerned brain areas
timeFrame: 1 hour
Secondary outcomes:
measure: Pattern of perfusion and aura duration
timeFrame: 12 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Solene de Gaalon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06599684: Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
Official title: Phase 2a Pilot, Open Label, Multicenter, Study of INV-102 Ophthalmic Solution in Subjects With Diabetic Macular Edema (DME) Associated With Non-proliferative Diabetic Retinopathy (NPDR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-center Involved Diabetic Macular Edema
Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
Diabetic Retinopathy
Center-involved Diabetic Macular Edema
Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
Lead sponsor: Invirsa, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR \[Part 1\] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR \[Part 2\].


Eligibility criteria: Key Inclusion Criteria:

* Male or female subjects ≥ 18 years of age and \< 76 years of age
* Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
* Study eye must have NCIDME (Part 1) or CIDME (Part 2)
* Study eye must be moderate to severe NPDR

Key Exclusion Criteria:

* Prior laser treatment for DR in the study eye within 12 months from Screening Visit

Primary outcomes:
measure: Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
timeFrame: Day 84 (Part 1) and Day 56 (Part 2)
measure: Change from baseline in central subfield thickness (Part 2 only)
timeFrame: Day 56
Secondary outcomes:
measure: Change from baseline in macular volume
timeFrame: Day 84 (Part 1) and Day 56 (Part 2)
measure: Change from baseline in subfield thickness
timeFrame: Day 84 (Part 1) and Day 56 (Part 2)
measure: Change from baseline in the retinal thickness at the thickest point of the subfield thickness
timeFrame: Day 84 (Part 1) and Day 56 (Part 2)
measure: Change in best corrected visual acuity (BCVA) (Part 2 only)
timeFrame: Day 56
Other outcomes:
Locations:
city: Dallas
country: United States
facility: MedTrials, Inc.
state: Texas
Study officials:
affiliation: Invirsa, Inc.
name: Robert Shalwitz
role: STUDY_CHAIR
References: