louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01985308: A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
Official title: A Randomized Double-Blind Sham-Controlled Trial To Evaluate The Treatment Efficacy of Magnetic Resonant Therapy in Autistic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show that a magnetic field applied to the front part of the brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and ameliorate symptoms.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Autism Spectrum Disorder by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) rendered by the examination and sufficient Childhood Autism Rating Scale 2nd Edition (CARS-2) score to qualify as autism.
* CARS-2 score between 36 and 47 inclusively
* Age between 4 and 12 years (at day of informed consent)
* Child must suffer disrupted sleep patterns defined as a minimum of 3 nights per week of delayed onset of sleep or night-time awakenings. If these are medicated with mild sedatives or melatonin and corrected, the requirement for medication or melatonin will qualify as evidence of a sleep disorder.

Exclusion Criteria:

* Diagnosis of Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise specified
* History of clinically significant traumatic brain injury
* Any condition associated with increased intracranial pressure
* Cerebral Aneurysm
* Down's Syndrome or other chromosomal abnormality
* EEG abnormalities that indicate seizure risk
* Intracranial implant
* Unstable medical condition not otherwise specified
* Clinically significant organic disease unrelated to autism

Primary outcomes:
measure: Childhood Autism Rating Scale 2nd Edition (CARS2)
timeFrame: 5 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Brain Treatment Center
state: California
city: Buford
country: United States
facility: Brain Treatment Center of Atlanta
state: Georgia
Study officials:
name: Keun-Young Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02407808: Cannabinoids, Learning, and Memory
Official title: Cannabinoids, Learning, and Memory
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cannabis
Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

Detailed description: This study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis and a cannabinoid-1 receptor (CB1R) agonist, on a wide range of memory tasks in healthy human subjects.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 and 55 years (extremes included) on day of first dosing
* Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

* Cannabis naive
* Positive pregnancy screen during screening
* Hearing deficits

Primary outcomes:
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: +35 minutes after infusion
measure: N-Back Task
timeFrame: +65 minutes after infusion
Secondary outcomes:
measure: Clinician Administered Dissociative Symptoms Scale (Total Score)
timeFrame: Baseline, +10, +85, and +240 minutes after the first infusion
measure: Visual Analog Scale (Total Score)
timeFrame: Baseline, +10, +85, +240 minutes after the first infusion
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Assistant Professor
name: Mohini Ranganathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130308: Predictive Factors for a Successful Return to Run After ACL-R
Official title: Predictive Factors for a Successful Return to Run After Anterior Cruciate Ligament Reconstruction and Underlying Bio-mechanical Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Ordre Professionnel de la Physiothérapie du Québec (OPPQ)
First posted: 2019-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After anterior cruciate ligament (LCA) rupture, the recommended treatment for athletes is the surgical reconstruction of the ligament (ACL-R), followed by a long rehabilitation period. The results of this treatment are sub-optimal with a low rate of return to pre-injury level of sport, a high risk of reinjury and early knee osteoarthritis. To improve treatment outcomes, researchers and clinicians recommend optimizing rehabilitation protocols. They recommend individualizing rehabilitation progression based on objective criteria. However, current defined criteria relied on experts' opinions and not scientific validation.

Return to run after ACL reconstruction is an important rehabilitation milestone. It often means the beginning of the return to sport continuum. A successful return to run is therefore crucial for both the patient and clinician. In this study, the investigators aim to determine the predictive outcomes for a successful return to run after ACL-R.


Eligibility criteria: Experimental group

Inclusion Criteria:

* ACL-R 3 to 4 months ago

Exclusion Criteria:

* already returned to run
* multiple ligament lesions

Control group

Inclusion Criteria:

- healthy person

Exclusion Criteria:

* history of ACL lesion or reconstruction
* history of knee injury
* injured in the last year

Primary outcomes:
measure: Muscular strength assessment
timeFrame: Day 0
measure: Modified Y-balance test
timeFrame: Day 0
measure: step-down test
timeFrame: Day 0
measure: Self-reported outcomes: ACL-RSI
timeFrame: Day 0
measure: Self-reported outcomes: IKDC
timeFrame: Day 0
Secondary outcomes:
measure: Running kinematic
timeFrame: Day 0 and Day 14
measure: Running kinetic
timeFrame: Day 0 and Day 14
measure: Knee joint contact force
timeFrame: Day 0 and Day 14
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
state: Quebec
Study officials:
affiliation: Laval University
name: Jean-Sébastien Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421108: The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents
Official title: The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Health Behavior
Keywords: oral health
dental brushing
dental flossing
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 372
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study explores the effectiveness of message framing, loss-framed vs. gain-framed messages on oral health in Iran.

Detailed description: This is a study to explore the impact of two pamphlets with gain-framed and loss-framed messages on brushing and flossing attitudes, intentions , behaviors and clinical characteristics among a sample of adolescent students.

Eligibility criteria: Inclusion Criteria:

* They are not involved in the oral health education
* Ability to understand Persian language Adolescents attending high schools in Qazvin

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: changes in frequencies of dental brushing and flossing
timeFrame: changes from baseline, two weeks after the intervention and six months follow-up
Secondary outcomes:
measure: Changes in psychological predictors of dental brushing (attitude, intention).
timeFrame: changes from baseline, two weeks after the intervention and six months follow-up
measure: Changes in Community Periodontal Index (CPI)
timeFrame: changes from baseline, two weeks after the intervention and six months follow-up
measure: Changes in Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: changes from baseline, two weeks after the intervention and six months follow-up
measure: Oral health related quality of life
timeFrame: changes from baseline and six months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: The Organization for Education
Study officials:
affiliation: Qazvin university medical of sciences
name: Amir H Pakpour, PhD
role: STUDY_CHAIR
References:
citation: Pakpour AH, Yekaninejad MS, Sniehotta FF, Updegraff JA, Dombrowski SU. The effectiveness of gain-versus loss-framed health messages in improving oral health in Iranian secondary schools: a cluster-randomized controlled trial. Ann Behav Med. 2014 Jun;47(3):376-87. doi: 10.1007/s12160-013-9543-1.
Clinical trial NCT00452608: Statin for Immunomudulation in Sepsis
Official title: Use of Statins in Modulation of Inflammatory Answer in Septic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sepsis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2007-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of several sepsis or shock septic
* no more than twenty four hours than diagnosis

Exclusion Criteria:

* use of statins in the last thirty days
* unequivocal indication for statin treatment
* active treatment with imunosuppressors drugs
* High risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase \> three times upper limit of normal
* diagnosis of AIDS
* unable to receive enteral medications
* pregnancy
* expected survival of less than 48 hours

Primary outcomes:
measure: action in inflammmatory biologic makers
timeFrame: 24h; 72h; 10 days
measure: valuation of flow-mediated vasodilation of the brachial artery
timeFrame: 24h; 72; 10 days
Secondary outcomes:
measure: mortality
timeFrame: at end
measure: time of permanence in intensive care unity
timeFrame: at end
measure: time of permanence in mechanical ventilation
timeFrame: at end
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA - Clinical Hospital fo Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul - Brazil
name: Nadine Clausell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06575608: Estimation of VO2Max Using Smartphone Application
Official title: Estimation of VO2Max Using Smartphone Application in Elderly: Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Assessmet of VO2max in Elderly
Keywords: VO2MAX
Smartphone application
Elderly
cardiorespiratory fitness (CRF)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (52) Male and female participants will be recruited from the out clinic customers, and workers at the faculty of physical therapy Delta University at ELmansoura governorate.

Brief summary: The aim of this observational study Is to examine the validity of the Smartphone application (VO2max calculator) in calculating VO2max in elderly population.

Research hypotheses:

this study will test the following null hypothesis: (Vo2max calculator) application will not have criterion validity in estimating VO2max values in the elderly population.

Research question:

Is the Smartphone application (VO2max calculator) considered a valid tool for estimating accurate values of VO2max in the elderly population in comparison to the golden standard method?

Detailed description: Although maximal oxygen consumption (VO2max) is growing in evidence as a powerful indicator of several health conditions it's rarely used in clinical practice due to the high expense, requirement of specialized equipment, and related risks of maximal exertion. So, we aim to develop a simpler method for estimating VO2max using modern smartphone technologies.

Method: participants of this study will be divided into 2 equal groups. The first group will perform a gold standard treadmill-based VO2max measurement and the other group will perform a smartphone based 1-mile walk test for VO2max estimation.

Eligibility criteria: Inclusion Criteria:

* Elderly subjects aged from (65 to 75) years.
* BMI 18.5-29.9 kg/m2
* Answer (NO) to all of the questions in the Physical activity readiness questionnaire (PAR-Q)
* Do not have any absolute or relative contraindications for exercise testing according to the American Heart Association (AHA) statement.

Exclusion Criteria:

* Recent surgical conditions.
* Skeletal deformities.
* Blood pressure regulating medication intake.
* Any respiratory disorders.
* Back, hip, knee or ankle pain within last month.
* Any neurological or psychiatric conditions.
* Implanted pacemaker.
* Anemic patients.

Primary outcomes:
measure: maximum oxygen consumption (VO2MAX)
timeFrame: at the peak of exercise (peak VO2) over the final 30 seconds of exercise
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: at baseline one shot
measure: The Borg rating of perceived exertion (RPE) scale
timeFrame: at baseline one shot
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00139308: High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
Official title: Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tourette's Syndrome
Keywords: Tourette's syndrome
High frequency stimulation
Globus pallidus
Thalamus
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.


Eligibility criteria: Inclusion Criteria:

* Tourette's syndrome (DSM IV)
* inducing a disability in the social and personal life
* No improvement with medical treatment
* Severe self suffering

Exclusion Criteria:

* Cognitive impairment (MMS \< 24)
* Depression

Primary outcomes:
measure: Severity of tics
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Study officials:
affiliation: CIC-Pitié-Salpêtrière
name: Yves Agid, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Welter ML, Mallet L, Houeto JL, Karachi C, Czernecki V, Cornu P, Navarro S, Pidoux B, Dormont D, Bardinet E, Yelnik J, Damier P, Agid Y. Internal pallidal and thalamic stimulation in patients with Tourette syndrome. Arch Neurol. 2008 Jul;65(7):952-7. doi: 10.1001/archneur.65.7.952.
Clinical trial NCT02341508: A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
Official title: A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lpathomab Administered Intravenously to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Lpath, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female subject ≥ 18 years old between 50 and 145 kg
* Laboratory values and ECG during Screening period within normal range or evaluated as not clinically significant (NCS)
* Female subjects must be not of child-bearing potential or using double-barrier method of contraception
* Male subjects must use double-barrier contraception during the study period
* Subject is able to read, understand, and sign the informed consent form (ICF) and HIPAA release

Key Exclusion Criteria:

* Subjects with diabetes mellitus (glycated hemoglobin \[HbA1c\]≥6.5%) or pre-diabetes mellitus (HbA1c between 5.7 and 6.4%).
* Male subjects with corrected Q-T interval (QTc)\> 450 msec or a QRS interval\>120 msec and female subjects with QTc\> 470 or a QRS interval\>120 msec.
* Subject's blood pressure (BP) during screening period exceeds 140/90 mm Hg
* Subject is positive for HIV, hep B and/or hep C at screening
* Subject has significant psychiatric co-morbidity including but not limited to major depression-severe, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or active suicidal ideation in 6 months prior to screen.
* Subject has any significant or advanced systemic illness, unstable or severe medical condition(s) or end stage disease that could put them at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures and requirements.
* Subject has history of cancer stability/remission for less than 5 years, with the exception of non-metastatic basal and/or squamous cell carcinomas of the skin and cervical cancer in situ.

Primary outcomes:
measure: Proportion of patients with local or systemic Adverse Events
timeFrame: 85 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Lpath, Inc.
name: Dario A Paggiarino, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01614808: Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor
Official title: Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Stage III Wilms Tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-08
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed.

Brief summary: This research study is looking at biomarkers in urine samples from patients with Wilms tumor. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment

Detailed description: PRIMARY OBJECTIVES:

I. To characterize the urinary metabolite signature of 10 stage III, favorable-histology, Wilms tumor patients from the Cooperative Human Tissue Network (CHTN) Databank, as distinct from 10 normal controls.

II. To characterize and compare the urinary metabolite profile in 50 randomly selected, stage III, favorable-histology, Wilms tumor patients enriched with an additional 30 stage III Wilms tumor patients who have relapsed.

III. To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature.

IV. To characterize the urinary metabolite signature of Wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology.

OUTLINE:

Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed

  * Tumor samples available from both groups
* Urine samples from the CHTN bank
* Control urine samples
* Urine samples from patients with unfavorable histology
* Not specified
* Not specified

Primary outcomes:
measure: Identification of metabolomic markers in urine that would assist in identifying higher risk of relapse of Wilms tumor in otherwise lower-risk stratified patients as assessed by NMR spectroscopy and PCA
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Dawn Maclellan, MD
role: PRINCIPAL_INVESTIGATOR
References: