louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02444117: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication in ASD
Official title: Autism Spectrum Disorders: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autistic Disorder
Keywords: neurophysiology
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with autism spectrum disorders

Brief summary: This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.

Detailed description: 200 children with autism spectrum disorders (1-12 years old) will be included in a 2 years follow-up study. Both clinical and neurophysiological evaluations (electrophysiological and eye tracking) will be completed at different times of the follow-up. This integrative approach, combining clinical and biological markers, will allow the identification of different developmental trajectories and then a better individuation of treatment in autism spectrum disorders.

Eligibility criteria: Inclusion Criteria:

* re-education of social communication

Exclusion Criteria:

* multi-handicapped associated to ASD

Primary outcomes:
measure: Clinical changes between Baseline and Two years
timeFrame: 2 years
Secondary outcomes:
measure: neurophysiological evaluations at baseline
timeFrame: baseline
measure: neurophysiological evaluations at 1 year
timeFrame: 1 year
measure: neurophysiological évaluations at 2 years
timeFrame: 2 years
measure: Social and cognitive evaluations at baseline
timeFrame: baseline
measure: Social and cognitive évaluations at 1 year
timeFrame: 1 year
measure: Social and cognitive évaluations at 2 years
timeFrame: 1 year
measure: Repetitive behaviors évaluations at baseline
timeFrame: baseline
measure: Repetitive behaviors évaluations at one year
timeFrame: 1 year
measure: Repetitive behaviors at two years
timeFrame: 2 years
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital Tours
Study officials:
affiliation: University Hospital, Tours
name: Joelle Malvy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khanna RK, Kovarski K, Arsene S, Siwiaszczyk M, Pisella PJ, Bonnet-Brilhault F, Batty M, Malvy J. Ophthalmological findings in children with autism spectrum disorder. Graefes Arch Clin Exp Ophthalmol. 2020 Apr;258(4):909-916. doi: 10.1007/s00417-019-04594-7. Epub 2020 Jan 9.
Clinical trial NCT01228617: Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
Official title: Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

Detailed description: This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

Eligibility criteria: Inclusion Criteria:

* Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Concentration
timeFrame: Baseline to 10 hours post-dose
measure: Area under the Curve
timeFrame: 10 hours post-dose
Secondary outcomes:
measure: Time to Maximum Concentration
timeFrame: 10 hours post-dose
measure: Residual Nicotine
timeFrame: 30 minutes
measure: Dissolution Time
timeFrame: 10 hours post-dose
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Trial Unit, Clinical Research and Trial Centre
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02769117: Bone Ultrasound to Access Fracture Healing
Official title: Utilizing Bone Ultrasound to Access Fracture Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forearm Fracture
Clavicle Fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 13
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate sequential fracture healing with radius/ulna fractures or clavicle fractures and compare ultrasound to radiographs.

Detailed description: Investigators will recruit 60 pediatric and adult patients with complete radius, ulna and/or clavicle fractures and obtain ultrasound data from the fractured bones and the contralateral intact bone (as control) at each clinical visit. Ultrasound will be compared to radiographs. Completion of this aim will validate the concept and correlate clinical healing with ultrasound findings. For the ultrasound method, investigators will use ultrasound energy to produce a secondary mechanical vibration in bone that can be used to characterize the integrity of the bone. (This is in contrast with conventional sonography where ultrasound echoes are used to image the tissue.) The proposed method is based on the use of Ultrasound Radiation Force (URF) to excite the bone. URF is a "pushing" force exerted by ultrasound on an object. This force can be static, transient (pulse), or harmonic. Harmonic URF can be generated by modulating the amplitude of the ultrasound beam at a desired frequency. This force initiates bone vibration, where the frequency and amplitude of such vibrations depend on bone geometry and elastic properties. Hence, any fracture (or fracture repair) will alter the vibration pattern, thus enabling us to monitor fracture and fracture healing by analyzing such patterns.

Eligibility criteria: Inclusion Criteria:

* Forearm fractures and no patients with hemiplegia -OR-
* Clavicle fractures

Exclusion Criteria:

* Non-English speakers
* Known pregnancy

Primary outcomes:
measure: Sequential fracture healing
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Todd Milbrandt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385917: Observational Study of Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping
Official title: Study of Clinical and Radiological Changes in Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne Muscular Dystrophy
strength and function tests
MRI
Lead sponsor: Genethon
Sponsor class: OTHER
Collaborators: name: Institute of Myology
First posted: 2011-06-30
Enrollment: 45
Sex: MALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with theoretically exon 53 skipping-treatable DMD

Brief summary: PreU7-53 is a natural history study. The objective is to monitor the clinical and radiological course of upper limb muscle impairment in patients with Duchenne Muscular Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Duchenne muscular dystrophy confirmed by at least genetic testing, theoretically treatable by exon 53 skipping.
* Age between ≥ 12 and \<20 years old.
* Non ambulant patients (i;e; inability to walk more than 10 meters without any of assistance).
* Patients covered by a national health insurance scheme.
* Signed informed consent.

Exclusion Criteria:

* Patient incapable of sitting upright in a wheelchair for at least one hour.
* Patients with severe intellectual impairment preventing them from fully understanding the exercises to be performed.
* Recent (less than 6 months ago) upper limb surgery or trauma This criteria is however no definitive. Patients who have undergone upper limb surgery or trauma may nonetheless be enrolled once the 6 month period is over.
* Known immune deficiency.
* Contraindications to NMR exams

Primary outcomes:
measure: PreU7-53 is a natural history study
timeFrame: Every year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Myology Institute
city: London
country: United Kingdom
facility: Great ormond Street Hospital & University College London Hospital
Study officials:
affiliation: Myology Institute
name: Laurent SERVAIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099917: Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?
Official title: Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: MDS
Maitake
mushroom
09-094
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: YUKIGUNI COMPANY
name: Weill Medical College of Cornell University
First posted: 2010-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e).

Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.


Eligibility criteria: Inclusion Criteria:

* MSKCC patients age 18 or older able to sign informed consent
* Absolute Neutrophil count \>0.5 K/mcL
* Diagnosis of MDS by bone marrow biopsy
* Patient not a candidate for aggressive standard treatment

Exclusion Criteria:

* IPSS (High risk)
* History of AML
* History of Stem Cell transplant
* Known history of HIV+
* Allergy to mushrooms
* Bone Marrow blasts \>10%

HEALTHY CONTROL ELIGIBILTY CRITERIA

Inclusion Criteria

* Age ≥55 years

Exclusion Criteria

* Currently taking corticosteroids or other immunosuppressants
* Known history of HIV+
* Current or previous malignancy or hematology disorder except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 3 years

Primary outcomes:
measure: Changes in Neutrophil Counts
timeFrame: baseline and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kathleen Wesa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05639517: The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients
Official title: The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 30
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: TREATMENT

Brief summary: Core stability, which is affected from the early period in with patients Multiple Sclerosis (PwMS), is due to deterioration in the somatosensory, motor and musculoskeletal systems. Based on the knowledge that core stability is effective on many functions, it is seen that trunk stabilization exercises are included in the physiotherapy and rehabilitation programs of patients. However, the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training in PwMS, has not been adequately investigated in the literature. The aim of the study is to investigate the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training, on neuromuscular and sensorimotor parameters in PwMS.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with relapsing remitting MS by a neurologist,
* Having a disability level between 1 and 5 according to the Expanded Disability Status Scale (EDSS),
* Those who get over 24 points in the Standardized Mini Mental State Test (SMMT),
* Those who have not had an MS attack in the last three months,
* Volunteer individuals

Exclusion Criteria:

* Receiving corticosteroid therapy in the last 4 weeks,
* Having additional neurological disease that may cause balance disorder
* Individuals who have had surgery related to the spine, hip, knee or ankle

Primary outcomes:
measure: Balance
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Muscle Activity
timeFrame: Change from baseline at 8 weeks
measure: Core Muscle Endurance-Trunk Flexor
timeFrame: Change from baseline at 8 weeks
measure: Core Muscle Endurance- Trunk Extansor
timeFrame: Change from baseline at 8 weeks
measure: Core Muscle Endurance- Side Bridge
timeFrame: Change from baseline at 8 weeks
measure: Trunk Position Sense
timeFrame: Change from baseline at 8 weeks
measure: Spinal mobility
timeFrame: Change from baseline at 8 weeks
measure: Fatique-Fatigue Severity Scale
timeFrame: Change from baseline at 8 weeks
measure: Fatigue- Fatigue Impact Scale
timeFrame: Change from baseline at 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03657017: PET/MR in Locally Advanced Nasopharyngeal Carcinoma
Official title: PET/MR in Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
PET/MR
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 150
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PET/MR in Locally Advanced Nasopharyngeal Carcinoma


Eligibility criteria: Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing carcinoma.
* Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
* Performance status: KPS\>70
* With normal liver function test (ALT, AST \<1.5ULN)
* Renal: creatinine clearance \>60ml/min
* Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
* Written informed consent

Exclusion Criteria:

* Adenocarcinoma
* Age \>70
* Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin)
* Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
* Patient is pregnant or lactating
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), or emotional disturbance.

Primary outcomes:
measure: Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma
timeFrame: From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years.
Secondary outcomes:
measure: Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma
timeFrame: about 4 years (all of patients complete treatment)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
References:
Clinical trial NCT02193217: A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy and free from clinically significant illness or disease.
* Male and female subjects of non-childbearing potential aged 18 to 55 years.
* Normal or non-clinically significant 12-lead ECG.
* Holter recording with no clinically significant abnormalities.
* Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg

Exclusion Criteria:

* A History of severe adverse reaction or allergy to any medical product.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder.
* A history of tuberculosis.
* Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test.
* Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators.
* Clinical relevant abnormal medical history, or physical findings or laboratory values.
* Clinically significant 12-lead ECG abnormalities.
* Clinical relevant abnormal findings in echocardiograph.

Primary outcomes:
measure: Mean hourly heart rate
timeFrame: up to day 42
Secondary outcomes:
measure: Plasma concentration of MT-1303 and its metabolite
timeFrame: up to day 28
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Investigational site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Europe Ltd.
name: Peter Sowood, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01103817: Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
Official title: Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
Adolescents and Young Adults
Vitamin D
Cardiovascular Disease
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the role of low vitamin D levels on the health of blood vessels or vascular function in adolescents and young adults with type 1 diabetes.

Detailed description: Vitamin D deficiency is known to be common in patients with type 1 diabetes. Studies in adults have shown that vitamin D deficiency is associated with cardiovascular events such as stroke, myocardial infarction and peripheral arterial disease. However, the impact of this deficiency on vascular health in adolescents with diabetes has not been examined. Furthermore given that endothelial dysfunction is reversible, early detection of this process may have therapeutic and prognostic implications in this population.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 1 diabetes, according to Canadian Diabetes Association guidelines
2. Diagnosed with type 1 diabetes for at least 2 years
3. Between the ages of 12 and 18 years

Exclusion Criteria:

1. Previous organ transplantation
2. Diagnosed with familial hypercholesterolemia
3. Active smoker
4. Receiving lipid lowering medications
5. Receiving anti hypertensive medication
6. Significant chronic medical illness, including granulomatous disease
7. History of hypertension
8. BMI \>95%tile
9. Known renal failure
10. HbA1c greater than 12% on two successive occasions
11. Known peripheral vascular disease
12. Known hypercalcemia

Primary outcomes:
measure: Comparison of Endothelial Function
timeFrame: Baseline
measure: Change in Endothelial Function after Treatment with Vitamin D
timeFrame: Baseline, 3 or 6 months
Secondary outcomes:
measure: Monitoring of Vitamin D Levels in Vitamin D deficient subjects
timeFrame: 2-3 months
measure: Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects
timeFrame: 2-3 months
measure: Comparison of Systemic Blood Pressure
timeFrame: Baseline
measure: Comparison of Urinary Albumin/Creatinine Ratio
timeFrame: Baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Farid Mahmud, MD
role: PRINCIPAL_INVESTIGATOR
References: