louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05070117: The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
Official title: The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: San Jose State University
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cerebral palsy (CP) is a neurodevelopmental disorder and is the most common childhood disability. CP is characterized by abnormal development, impaired motor function, and muscular and skeletal abnormalities. Due to their diminished musculoskeletal function, individuals with CP suffer a high rate of moderate to severe bone fractures, which can lead to further immobility. Optimizing muscle and bone health with exercise may be important in minimizing fractures from limited mobility, and fundamental for maximizing health-related quality of life. The main purpose of this research is to investigate the effect of exercise training on musculoskeletal system in individuals with CP, with the goal of reducing the incidence of falls and fractures. To accomplish these aims, musculoskeletal health will be assessed using various physiological techniques (e.g., Dual energy X-ray Absorptiometry, Humac Norm Isokinematic System, Biodex Balance System) before, during, and after one year of exercise training in individuals with CP. In addition, various functional mobility tests to quantify fitness levels will be performed. Findings may lead to the development of novel therapeutic interventions targeted at improving musculoskeletal health in individuals with CP.


Eligibility criteria: Inclusion Criteria:

* those who can follow simple commands and walk independently with or without the use of an assistance apparatus (within Classification level I-III, based on Gross Motor Functioning Classification System, GMFCS) and have cerebral palsy will be included in the study. The rationale for such inclusion criteria (level I-III) is to make sure they can perform some leg exercise and tests.

Exclusion Criteria:

* If subjects have a history or symptoms of cardiovascular, renal, hepatic, or respiratory diseases, they will be excluded in the study.

Primary outcomes:
measure: Height measurement
timeFrame: 1 minute
measure: Body composition
timeFrame: 8 minutes
measure: Muscular strength
timeFrame: 15 minutes
measure: Balance and related fall risks
timeFrame: 20 minutes
measure: Bone mineral density
timeFrame: 8 minutes
measure: Weight measurement
timeFrame: 1 minute
measure: Waist and hip circumferences
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: San Jose State University
state: California
Study officials:
affiliation: SJSU
name: Mohamed Abousalem, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05699317: Clinical Use of Cold and Contact Heat-evoked Potentials: Normative Values
Official title: Establishing Normative Values for the Clinical Use of Cold and Contact Heat-evoked Potentials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Establishing Normative Values of Cold and Contact Heat-evoked Potentials
Keywords: Healthy participants
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 26
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This prospective interventional study aims at recording contact heat evoked potentials (CHEPs) and cold evoked potentials (CEPs) in a healthy population sample in an aim to derive normative values which could be used to evaluate evoked potentials (EPs) of patients.

Detailed description: Population sample of 80 healthy volunteers between 26 and 75 years old will be recruited and will be categorized into 5 age subgroups (26-35, 36-45, 46-55, 56-65, 66-75 years old).

Upon arrival, participants will be reminded of the aims and of the content of the experiment. After informed consent (recorded in writing), healthy subjects will be screened with a baseline examination:

1. brief neurological examination
2. sensory nerve conduction study-related
3. quantitative sensory testing

If the baseline examination screening is considered normal, CEPs and CHEPs will be performed. To avoid bias, the side and order of the tests will be randomized.

All thermal stimuli for CEPs and CHEPs will be delivered delivered using a contact thermal stimulator (TCS model II.1, QST.Lab, Strasbourg, France).

Only stimuli that are safe and acceptable for the subject will be used in the study, and all experimental procedures can be interrupted at any time by the participant, with no detrimental effect.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 26 and 75 years old having a normal baseline testing.

Exclusion Criteria:

* Age\<26 and \>75 years old
* Known neurological condition.
* Acute or chronic pain condition.
* Currently taking drugs that may influence the recording of evoked potentials (analgesics, psychotropic substances, antiepileptics...).
* History of neurological, or metabolic disorder.
* Inability to complete study task.
* History of chemotherapy.
* Habitual substance abuse(alcoholic beverages intake \>21 units/week for males, \>14 units/week for females.)
* Being a volley ball player (due to risk of modified sensibility of the volar forearm skin)
* Abnormal baseline neurological, SNC or QST testing

Primary outcomes:
measure: Evoked potentials variables
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience
state: Woluwe Saint Lambert
Study officials:
affiliation: UCLouvain, IONS
name: André Mouraux, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886417: Auditory Verbal Hallucinations in Schizophrenia
Official title: Electromyography Study of Lip Muscles During Auditory Verbal Hallucinations Without Subvocalization in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: GIPSA-LAB
First posted: 2013-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in- and out-patients

Brief summary: Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring would cause the verbal thoughts of the patient to be perceived as external voices resulting in AVHs.

In order to examine whether AVHs correspond to self-generated inner speech, the present study aims at collecting speech muscle activity during covert AVHs (without articulation), overt speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and control subjects to detect any speech muscle activity during AVH.


Eligibility criteria: Inclusion Criteria:

Healthy controls:

* must be more than 18 years and less than 60 years old
* pre-inclusion medical examination
* must have signed consent form
* must be able to read stimuli on a screen

Schizophrenia patients:

* must be more than 18 years and less than 60 years old
* pre-inclusion medical examination
* must have signed consent form
* must be able to read stimuli on a screen
* diagnosed with a schizophrenia disorder according to DSM-IV TR (diagnostic and statistical of mental disorders) (PANSS item P3 greater than 4)
* prior evaluation of the secondary effects of any medication via Barnes and AIMS scales
* affiliated with the French social security
* if under guardianship, must have additional consent form signed by guardian

Exclusion Criteria:

Healthy controls:

* if aged less than 18 years or more than 60 years
* diagnosed with any psychiatric disorder
* with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.)
* with auditory impairment
* pregnant, parturient, breast-feeding

Schizophrenia patients:

* if aged less than 18 years or more than 60 years
* significant secondary effects of antipsychotic medication, measured with the Barnes and AIMS scales
* with a neurodegenerative disease
* with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.)
* with auditory impairment
* pregnant, parturient, breast-feeding

Primary outcomes:
measure: Labial EMG activity during auditory verbal hallucination
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital of Grenoble, France
name: Thierry BOUGEROL, MD, PHD, HDR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053217: Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain
Official title: Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herniated Disk Lumbar
Fibromyalgia
Keywords: fibromyalgia
lumbar disc herniation
tfese
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar radicular pain is defined as low back and leg pain caused by inflammation in the affected nerve root due to various etiological factors. In its treatment, there are various options such as anti-inflammatory drugs, physical therapy modalities, exercises, epidural steroid injections, and surgery. Epidural steroid injections have also become a frequently applied method in the treatment of lumbar radicular pain unresponsive to conservative treatments. The steroid applied here acts by suppressing the inflammation around the affected nerve root. Epidural steroid injections can be applied in lumbar radicular pain with 3 different approaches: caudal, interlaminar and transforaminal. In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term. As far as we know, there is no previous study investigating the effect of fibromyalgia on TFESE treatment outcomes. For this reason, the aim of our study is to examine the effect of fibromyalgia on treatment outcomes in patients who underwent TFESE for lumbar radicular pain.


Eligibility criteria: Inclusion Criteria:

* Findings of root compression on MRI, lumbar radicular pain for at least 3 months, no previous history of lumbar spinal surgery, pain score of 4 and above according to the numerical rating scale (NRS), and ACR 2016 diagnostic criteria for the fibromyalgia group were met. patients

Exclusion Criteria:

* Patients who received lumbar epidural steroid injection in the last 3 months, who have pregnancy-breastfeeding, bleeding diathesis, contrast hypersensitivity, and patients who did not give consent for participation in the study

Primary outcomes:
measure: Rate of Successful Response
timeFrame: 3 months
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: 3 months
measure: Istanbul Low Back Pain Disability Index (ILBPDI)
timeFrame: 3 months
measure: Short Form 12 (SF-12)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT00382317: A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
Official title: A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diagnostic Imaging
Keywords: MSCT indications
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2006-09-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.


Eligibility criteria: Inclusion Criteria:

* Male or female having reached legal majority age and up to 85 years included.
* Scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pre-therapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material).
* Female of childbearing potential must have effective contraception (contraceptive pill or intra-uterine device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.

Exclusion Criteria:

* Patients with overt non-compensated heart failure.
* Patients with hemodynamic instability.
* Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP \[systolic blood pressure) over or equal to 180 mm Hg or DBP \[diastolic blood pressure\] over or equal to 110 mm Hg)
* Patients with known severe renal failure (defined as creatinine clearance \< 30 ml/min as calculated by the Cockroft and Gault formula).
* Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
* Patients with known thyreotoxicosis.
* Patients with history of immediate or delayed major hypersensitivity reaction to iodinated contrast media.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
affiliation: Guerbet
name: Corinne Dubourdieu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00002217: A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs
Official title: Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Patient Compliance
Anti-HIV Agents
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.

Detailed description: In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.

Eligibility criteria: Inclusion Criteria

Patients must have:

* CD4 count greater than 50 cells/mm3.
* HIV RNA less than 50,000 copies/ml.
* No active AIDS (excluding CD4 count less than 200 cells/mm3).
* Ability to comply with dosing schedule and protocol evaluations.

Prior Medication:

Allowed:

AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Active AIDS (not excluding CD4 count less than 200).
* Malabsorption syndrome affecting drug absorption.
* Serious medical condition that would compromise safety of the patient.

Concurrent Medication:

Excluded:

* AZT or NNRTIs.
* More than 1 week treatment with any protease inhibitor.
* Enrollment in any other investigational drug protocol.

Patients with the following prior conditions are excluded:

History of clinically relevant pancreatitis or hepatitis within the past 6 months.

Required:

Antiretroviral therapy with either single or double reverse transcriptase inhibitors.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
Study officials:
References:
citation: Henry K, Shaeffer M, Ross L, Johnson M, Fisher R, Liao Q, Graham N. Response to Combivir and abacavir given bid to nucleoside experienced patients is not affected by the presence of the M184V mutation. 6th Conf Retro and Opportun Infect. 1999 Jan 31 - Feb 4 (abstract no 132)
citation: Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS; TARGET Study Team. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001 Feb 15;183(4):571-8. doi: 10.1086/318527. Epub 2001 Jan 11.
Clinical trial NCT02640417: Nucleotides and B Vitamins in the Treatment of Low Back Pain
Official title: Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Nucleotides (uridine, cytidine)
Vitamin B1
Vitamin B6
Vitamin B12
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.

Detailed description: This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be monitored throughout the treatment period. Subjects will be randomized in a double-blind fashion to either treatment group.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders, at least 18 years of age
* Clinical presentation of acute lumbago (\<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
* Female subjects should be post-menopausal or using birth control
* Subjects must sign informed consent document

Exclusion Criteria:

* Intolerance to any component of the study treatments
* Pregnancy or breastfeeding
* Need for surgical treatment
* Use of other analgesic drugs
* dyshematopoiesis or coagulation disorder
* Gastric or intestinal ulcer
* Gastrointestinal, cerebrovascular, or other bleeding
* Creatinine \>3x% reference range
* Urea, ALT, AST, or GGT \>2x% reference range
* Any other disease or condition that in the investigator's opinion should exclude the subject from the study

Primary outcomes:
measure: Adverse Event Occurrence
timeFrame: Throughout 60 day treatment period
Secondary outcomes:
measure: Low back pain Questionnaire
timeFrame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
measure: Visual Analog Pain Scores
timeFrame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
measure: Finger-to-Floor Distance
timeFrame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Other outcomes:
Locations:
Study officials:
affiliation: UNIFESO - Fundação Educacional Serra dos Órgãos
name: Marco AN Mibielli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034241: Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning
Official title: Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin
Glucose Metabolism
Keywords: milk protein
overweight
insulin metabolism
substrate partitioning
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Nederlandse Zuivel Organisatie
First posted: 2009-12-17
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.


Eligibility criteria: Inclusion Criteria:

* BMI: 18.5-25 kg/m2 (lean)
* Gender: Male
* Age: \<35 years
* Caucasian

Exclusion Criteria:

* Elevated fasting blood glucose level
* Lactose intolerant
* Diabetes Mellitus
* Hypertension (systolic/diastolic blood pressure)
* Hypotension (systolic/diastolic blood pressure)
* Cardiovascular diseases
* Asthma and other obstructive pulmonary diseases

Primary outcomes:
measure: Glucose and insulin metabolism (24 h)
timeFrame: 24 h
Secondary outcomes:
measure: Substrate partitioning and metabolic markers
timeFrame: 24 h
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University
name: Wim Saris, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munsters MJ, Geraedts MC, Saris WH. Effects of different protein and glycemic index diets on metabolic profiles and substrate partitioning in lean healthy males. Appl Physiol Nutr Metab. 2013 Nov;38(11):1107-14. doi: 10.1139/apnm-2012-0409. Epub 2013 Apr 25.
Clinical trial NCT03366441: Reactivation of Inactive Blood Donors
Official title: Effective Methods for Reactivating Inactive Blood Donors: a Stratified Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Donor
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2017-12-08
Enrollment: 11880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Blood donor retention is a critical strategy to ensure the safety and sufficiency of clinical blood supply. An effective strategy can prevent donors from lapsing and eventually becoming inactive.


Eligibility criteria: Inclusion Criteria:

* Donated blood at least once between Januanry 1 to September 30 2016, and the blood test result is qualified.

Exclusion Criteria:

* Having donated again before intervened.

Primary outcomes:
measure: Blood donation rate
timeFrame: 1 year
Secondary outcomes:
measure: Self-deferral reasons of not donating
timeFrame: 1 day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References: