louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04460833: Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy
Official title: Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Gait Disorders, Neurologic
Feedback, Psychological
Keywords: Serious Game
Rehabilitation
Lead sponsor: Fondation Ellen Poidatz
Sponsor class: OTHER
Collaborators: name: Université Paris-Sud
First posted: 2020-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.

Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.


Eligibility criteria: Inclusion Criteria:

* Children with Cerebral palsy (medical file)
* Age 12-18
* Global Motor Function Classification System (GMFCS) I-III
* Functional Mobility Scale (FMS) minimum 2 for "50 meters"
* Ability to cooperate, to understand and to follow instructions
* Patient affiliated to the French social security system
* Patient volunteers whose the parents given their authorization to participate

Exclusion Criteria:

* Medical decision for any reason
* Child or parent decision for any reason
* Inability to cooperate, to understand and to follow instructions

Primary outcomes:
measure: walking speed
timeFrame: 1 year
measure: step length
timeFrame: 1 year
Secondary outcomes:
measure: Moizer Questionary
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint-Fargeau-Ponthierry
country: France
facility: Fondation Ellen Poidatz
state: ILE DE France
Study officials:
affiliation: Fondation Ellen Poidatz
name: Eric DESAILLY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guinet AL, Bouyer G, Otmane S, Desailly E. Visual Feedback in Augmented Reality to Walk at Predefined Speed Cross-Sectional Study Including Children With Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2322-2331. doi: 10.1109/TNSRE.2022.3198243. Epub 2022 Aug 22.
Clinical trial NCT00192933: Evaluation of the Quality of the NovoSeven (rFVIIa) Tratment Practice at Rigshospitalet, Copenhagen University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhage
Shock
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose is to evaluate and improve NovoSeven treatment practice done according to our guidelines


Eligibility criteria: Inclusion Criteria:

* Indication for NovoSeven treatment according to our guideline

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Blood Bank, Rigshospitalet, Copenhagen University Hospital
name: Pär Johansson, MD, MPA
role: STUDY_CHAIR
References:
Clinical trial NCT00959933: Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions
Official title: A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Non-Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under non-fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allied Clinical Research
name: Piyush Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070433: A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
Official title: A Phase II, Randomized, Controlled, Multi-Center Study of the Safety and Efficacy of Topically Applied MEBO Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: Diabetic Foot Ulcers (DFUs)
Lead sponsor: Skingenix, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

Detailed description: This is a phase II, randomized, controlled, multi-center study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years of age
* Able and willing to provide informed consent
* Able and willing to comply with protocol visits and procedures
* Target ulcer duration of ≥4 weeks

Exclusion Criteria:

* Ulcer of a non-diabetic pathophysiology
* Known or suspected allergies to any of the components of MEBO
* Malignancy on target ulcer foot
* Non-compliance in the screening or run-in period

Primary outcomes:
measure: The incidence of complete healing of the target ulcer.
timeFrame: 8 week treatment period
Secondary outcomes:
measure: Time required to achieve complete healing (days).
timeFrame: 8 week treatment period
measure: Absolute and percentage change in ulcer surface area from baseline to endpoint.
timeFrame: 8 week treatment period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Encinitas
country: United States
facility: ILD Consulting, Inc.
state: California
city: Fair Oaks
country: United States
facility: Sacramento Foot and Ankle Center
state: California
city: Fresno
country: United States
facility: Valley Vascular Surgery Associates
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Las Vegas
country: United States
facility: Advanced Foot and Ankle Center
state: Nevada
city: McAllen
country: United States
facility: Complete Family Foot Care
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, San Antonio Podiatry Associates
state: Texas
Study officials:
affiliation: University of Miami
name: Robert S Kirsner, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03227133: Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode
Official title: An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unipolar Depression
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Depressive episode according to DSM-5 criteria
* Unipolar depression
* MADRS ≥ 20
* Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors)

Exclusion Criteria:

* Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction \< 3 months except for tobacco)
* Depression with psychotic features
* Serious unstabilized somatic illness
* Protected persons
* Dementia suspected at the time of enrollment

Primary outcomes:
measure: Ability of the verbal fluency test score to predict the response to antidepressive treatment
timeFrame: week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Caroline Masse-Sibille, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05541133: Effect of Acute Exercise on Exosome Associated Biomarkers
Official title: Effect of Acute Exercise on Exosome Associated Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally healthy individuals around the Rochester MN area.

Brief summary: This research study is being done to understand the underlying mechanism by which exercise affects the body on the cellular level, in an acute aerobic endurance setting. This may help to better understand the overall benefits of endurance exercise.


Eligibility criteria: Inclusion Criteria:

* Ages: 18 to 45 years

Exclusion Criteria:

* BMI \>32 kg/m2. Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease.
* Orthopedic problems that would keep them from being able to perform an exercise. - --
* Medications that are known to affect mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta-blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist).
* Smoking.
* Pregnancy.

Primary outcomes:
measure: List of biomarkers
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: K. Sreekumaran Nair, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05555433: Calprotectine in Spondyloarthritis
Official title: Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spondylarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 190
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: Primary clinic care, rheumatology patients at the CHU de NICE

Brief summary: To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology


Eligibility criteria: Inclusion Criteria:

Patients in the active line of the rheumatology department with one of the following criteria:

active spondyloarthritis (BASDAI \>4), or spondyloarthritis in low activity (BASDAI\<4), or fibromyalgia without associated inflammatory rheumatism, or healthy subjects (without inflammatory rheumatism and without fibromyalgia. Patients who have not objected to the use of their samples

Exclusion Criteria:

Minor patient Subject not affiliated to the social security system Subject deprived of liberty Patient under guardianship or curatorship

Primary outcomes:
measure: calprotectine rate
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT02915133: The Relationship Between Structure and Visual Function in Myopia Foveoschisis
Official title: Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: High Myopia
Keywords: high myopia
myopia foveoschisis
macular buckling
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive participants with high myopia associated macular foveoschsis, who scheduled for surgery at Zhongshan Ophthalmic Center, Sun Yat-sen University.

Brief summary: Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.


Eligibility criteria: Inclusion Criteria:

1. axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
2. macular foveoschisis that requires surgical intervention.

Exclusion Criteria:

1. ocular trauma or surgery history;
2. glaucoma, diabetic retinopathy;
3. intraocular active hemorrhage or inflammation;
4. unable to coordinate the OCT, mfERG, or other ophthalmological examinations.

Primary outcomes:
measure: change from baseline OCT at 6 months
timeFrame: 6 month postoperatively
measure: change from multifocal ERG at 6 months
timeFrame: 6 month postoperatively
Secondary outcomes:
measure: change from Best-corrected visual acuity (BCVA) at 6 months
timeFrame: 6 month postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03622333: Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
Official title: Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Intestinal Carcinoid Tumors
Keywords: Neuroendocrine tumors
carcinoid tumors
midgut
small intestine
genetic predisposition
hereditary
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.

The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.


Eligibility criteria: inclusion criteria :

* Small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
* At least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
* Agreement to participate to the study exclusion criteria :
* Subjects unable to provide consent

Primary outcomes:
measure: Deletion
timeFrame: day 0
measure: duplication
timeFrame: Day 0
measure: amplification
timeFrame: Day 0
measure: mutation
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT05123833: The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Official title: The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Disorder
Hypospadias
Congenital Hypospadia
Urologic Diseases
Keywords: Hypospadias repair
Tunica Vaginalis Flap
Dartos Fascia
Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 88
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 6 months.
* Distal, mid-shaft penile hypospadias.

Exclusion Criteria:

* Glanular hypospadias.
* Penoscrotal, Scrotal \& Perineal hypospadias.
* Recurrent cases.

Primary outcomes:
measure: Fistula
timeFrame: Within the first three months after surgery.
Secondary outcomes:
measure: Cosmetic outcome
timeFrame: Within the first three months after surgery.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center, Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT03626233: Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection
Official title: Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 500
Sex: FEMALE
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: pregnant women with or without vascular pathology

Brief summary: Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. The consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. Pre-eclampsia associates maternal hypertension with dysfunction kidney. There is no cure for pre-eclampsia or IUGR vascular during pregnancy. These pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. Primary prevention and secondary education and screening for these pathologies are still insufficient. A better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal


Eligibility criteria: Inclusion Criteria:

* pregnant women
* With or without vascular pathology

Exclusion Criteria:

* refusal to participate
* multiple pregnancy
* major fetal malformation diagnosed during pregnancy follow-up

Primary outcomes:
measure: genomic analysis on placenta
timeFrame: day of delivery
Secondary outcomes:
measure: genomic analysis on blood
timeFrame: day of delivery
measure: genomic analysis on placenta
timeFrame: day of delivery
measure: VEGF blood level
timeFrame: day of delivery
measure: PLGF blood level
timeFrame: day of delivery
measure: sFlt1 blood level
timeFrame: day of delivery
measure: sKDR blood level
timeFrame: day of delivery
Other outcomes:
Locations:
city: Creteil
country: France
facility: CHi Creteil
Study officials:
affiliation: CHI CRETEIL
name: Edouard Lecarpentier, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: