louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02354248: Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
Official title: Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patients
Keywords: TST
TMS
Stroke patients
EMG
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: TST (Triple stimulation technique) helps to better quantify the proportion of motor units activated by transcranial magnetic stimulation. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise with this technique than with the slowing of the central conduction time (CCT).

The investigators propose to use this technique in CNS pathologies where this disorder is significant and essential, like multiple sclerosis and stroke.


Eligibility criteria: Inclusion Criteria:

* stroke patients with hemiparesia

Exclusion Criteria:

* pace maker
* epilepsia
* metallic neurosurgical implants

Primary outcomes:
measure: Amplitude of the motor evoked potentials
timeFrame: during the TST (30 min)
measure: Surface of the motor evoked potentials
timeFrame: during the TST (30 min)
measure: Amplitude ratio of the TST
timeFrame: during the TST (30 min)
measure: Surface ratio of the TST
timeFrame: during the TST (30 min)
measure: TMS threshold
timeFrame: during TST (30 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Bernard Dachy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Andrey Bragin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Pedro Calderon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magistris MR, Rosler KM, Truffert A, Myers JP. Transcranial stimulation excites virtually all motor neurons supplying the target muscle. A demonstration and a method improving the study of motor evoked potentials. Brain. 1998 Mar;121 ( Pt 3):437-50. doi: 10.1093/brain/121.3.437.
citation: Magistris MR, Rosler KM, Truffert A, Landis T, Hess CW. A clinical study of motor evoked potentials using a triple stimulation technique. Brain. 1999 Feb;122 ( Pt 2):265-79. doi: 10.1093/brain/122.2.265.
Clinical trial NCT04800848: Effects of the Face Mask on Physical Fitness in Children
Official title: Effects of the N95/FFP2 Face Mask on Physical Fitness in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Fitness
Health
Childhood ALL
Emotional Stress
Sedentary Behavior
Cardiorespiratory Fitness
Keywords: Exercise
Alpha fitness battery
Kids
N95/FFP2
Physical Activity
CDI
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 165
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 6 an 12 years that attend classes in state or private schools.

Brief summary: The aim of this multicenter randomized crossover design study is to evaluate a sample of 500 boys and girls from public and private schools in the Principality of Asturias, aged between 6 and 12 years, with the objective of determining the level of physical condition, as well as to evaluate the effect of the use of FFP2/N95 face masks during the execution of the ALPHA Fitness battery, and the emotional effects caused by the use of these masks. This is a sample obtained by accessibility, in which the sampling will be stratified by age and academic year.


Eligibility criteria: Inclusion Criteria:

1. Age between 6 and 12 years old.
2. Be able to perform all the tests and procedures that comprise the study.
3. Have signed informed parental consent.

Exclusion Criteria:

1. To take drugs that can affect the measurements
2. Contraindications or pathologies associated with exercise

Primary outcomes:
measure: Physical Activity
timeFrame: at the beginning of the study (Day 1)
measure: Sedentarism
timeFrame: at the beginning of the study (Day 1)
measure: Emotional states
timeFrame: at the beginning of the study (Day 1)
measure: Handgrip strength
timeFrame: at the beginning of the study (Day 1)
measure: Horizontal Jump
timeFrame: at the beginning of the study (Day 1)
measure: Horizontal Jump
timeFrame: Day 2 (two weeks later)
measure: Speed and agility
timeFrame: at the beginning of the study (Day 1)
measure: Speed and agility
timeFrame: Day 2 (two weeks later)
measure: Aerobic capacity
timeFrame: at the beginning of the study (Day 1)
measure: Aerobic capacity
timeFrame: Day 2 (two weeks later)
measure: Comfort with the use of masks
timeFrame: at the beginning of the study (Day 1)
measure: Comfort with the use of masks
timeFrame: Day 2 (two weeks later)
measure: Height
timeFrame: at the beginning of the study (Day 1)
measure: Weight
timeFrame: at the beginning of the study (Day 1)
measure: waist circumference
timeFrame: at the beginning of the study (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hugo Olmedillas
state: Asturias
Study officials:
References:
Clinical trial NCT06000748: NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
Official title: NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Cirrhosis
Portal Hypertension
Hepatorenal Syndrome
Acute Tubule Necrosis
Prerenal Failure
Keywords: PRAGMATIC
FEASIBILITY
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind, randomized control, parallel-group, pragmatic trial.
Primary purpose: TREATMENT

Brief summary: The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (\<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (\<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7
* Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7 to 365 days prior to admission

Exclusion Criteria:

1. Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement;
2. Patients who are already on kidney replacement therapy (KRT) at the time of enrollment;
3. Patients with an oxygen requirement greater than 6L via nasal cannula;
4. Patients with a serum creatinine level exceeding 5 mg/dL.

Primary outcomes:
measure: Differences in mean arterial pressure.
timeFrame: 14 days.
Secondary outcomes:
measure: Acute kidney injury reversal.
timeFrame: 14 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Giuseppe Cullaro, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982548: The Use of a Virtual Reality Intervention on Stigma, Empathy and Attitudes Towards People With Psychotic Disorders
Official title: The Use of a Virtual Reality Intervention on Stigma, Empathy and Attitudes Towards People With Psychotic Disorders Among Mental Healthcare Professionals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of a VR intervention on (1) stigma, (2) empathy and (3) attitudes towards those experiencing mental disorders.

Participants will review a VR intervention, and complete questionnaires at pre-test, post-test and one month follow-up.

Researchers will compare the VR intervention with a control VR intervention to evaluate the varying effects on stigma, empathy and attitudes towards those experiencing mental disorders.


Eligibility criteria: Inclusion Criteria:

* Participants who are aged at least 21 years old
* Employed by the Institute of Mental Health as a physician, allied health professional or nurse.
* understands English
* work directly with patients.

Exclusion Criteria:

* unable to use virtual reality interventions due to reasons including motion sickness, disorientation, nausea and vomiting.
* history of epilepsy

Primary outcomes:
measure: Desire for Social Distance
timeFrame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
measure: Personal Stigma
timeFrame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
measure: Empathy
timeFrame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
measure: Attitudes towards those experiencing mental disorders
timeFrame: pre-intervention, immediately after the intervention, follow-up at 1 month after intervention
Secondary outcomes:
measure: Demographic data
timeFrame: pre-intervention
measure: Acceptability of the intervention
timeFrame: immediately after the intervention
measure: Safety of VR intervention
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health
Study officials:
References:
Clinical trial NCT01423448: Effectiveness of an Online Bulletin Board for Depression: a Longitudinal Randomized Controlled Trial
Official title: A Randomized Controlled Trial of an Online Bulletin Board for Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Depression
Keywords: Depression
mental health
wellbeing
online bulletin board
online support group
Lead sponsor: Australian National University
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is a randomised controlled trial that aims to examine the efficacy of an established online bulletin board for depression. It has been estimated that millions of people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs) for health conditions. However, little is known about the effectiveness of these groups in terms of symptom reduction or improvement in quality of life. The current project investigates the effectiveness of an established online bulletin board for depression available to the public. To our knowledge, this is the first randomised controlled trial of the effectiveness of a pre-existing, well-established online bulletin board for depression in the community. The aims of the project are to determine whether the bulletin board improves mental health, quality of life, and related outcomes among members of the community with high levels of self-reported psychological distress and previous history or current experience of depression.


Eligibility criteria: Inclusion Criteria:

1. Over 18 years of age
2. Internet access with email
3. Self-report of current or previous experience of depression

Exclusion Criteria:

1. Current participation in an online support group for depression
2. Diagnosis of bipolar disorder, schizophrenia, or psychosis

Primary outcomes:
measure: Depressive symptoms: Centre for Epidemiological Studies - Depression Scale (CES-D)
timeFrame: Baseline
measure: Depressive symptoms: Centre for Epidemiological Studies - Depression Scale (CES-D)
timeFrame: 6 months post-baseline
measure: Depressive symptoms: Centre for Epidemiological Studies - Depression Scale (CES-D)
timeFrame: 12 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Centre for Mental Health Research, The Australian National University
state: Australian Capital Territory
Study officials:
References:
Clinical trial NCT01374048: Intracranial Pressure Waves Via Lumbar Puncture
Official title: Are Intracranial Pressure Waves Measurable Through Lumbar Puncture?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Normal Pressure Hydrocephalus
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic normal pressure hydrocephalus

Brief summary: Patients are subjected to simultaneous intracranial and lumbar puncture pressure measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial pressure amplitude is reflected by lumbar puncture pressure amplitude.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Idiopathic Normal Pressure Hydrocephalus

Exclusion Criteria:

* Known cause of hydrocephalus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04676048: ASC618 Gene Therapy in Hemophilia A Patients
Official title: Assessment of Safety and Preliminary Efficacy of ASC618 in Subjects With Severe and Moderately Severe Hemophilia A
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hemophilia A
Lead sponsor: ASC Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, hemophilia A patients are managed with prophylactic or on-demand replacement therapy with recombinant FVIII or alternative therapeutics. The major challenges of current treatment regimens, such as the short half-life of hemophilia therapeutics with the need for frequent IV injections, encourage the current efforts for gene transfer therapy.

This study will evaluate the safety and preliminary efficacy of ASC618, an AAV vector encoding B-domain deleted codon-optimized human factor VIII under a synthetic liver-directed promoter


Eligibility criteria: Inclusion Criteria:

* Male ≥18 years of age
* Severe or moderately severe hemophilia A (FVIII activity ≤ 2 IU/dL) as evidenced by
* medical history
* Received FVIII prophylactic or on-demand replacement therapy for ≥ 150 accumulated
* days (exposure days)
* ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
* BMI ≤ 30
* Agree to use double-barrier contraceptive until at least 3 consecutive semen samples are negative after ASC-618 infusion

Exclusion Criteria:

* Pre-existing immunity to AAV8 vector as defined by AAV8 total antibodies and neutralizing antibodies qualified tests.
* Current inhibitors, or history of high titer FVIII inhibitors
* Presence of \> Grade 2 liver fibrosis on elastography/Fibroscan or comparable imaging methodology
* History of chronic renal disease
* Active infection or any immunosuppressive disorder
* History of cardiac surgery and need anticoagulant therapy
* Any cardiovascular / genetic risk factors for thromboembolic disorders
* Evidence of active Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)-1/2 or syphilis infection.
* Receipt of any vector or gene transfer agent
* Current antiviral therapy for hepatitis B or C

Primary outcomes:
measure: Number of adverse events, and serious AEs
timeFrame: 12 months post-infusion
Secondary outcomes:
measure: Changes in FVIII activity levels from baseline
timeFrame: 12 months post-infusion
measure: Annualized FVIII consumption
timeFrame: 12 months post-infusion
measure: Annualized bleeding rate (ABR)
timeFrame: 12 months post-infusion
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
References:
Clinical trial NCT05747248: Tracheal, Lung, and Diaphragmatic Ultrasonography Applications for Rapid Confirmation of Endotracheal Tube Position
Official title: Tracheal, Lung, and Diaphragmatic Ultrasonography Applications for Rapid Confirmation of Endotracheal Tube Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Intubation
Keywords: ETT
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intubated with a cuff ETT

Brief summary: Nowadays endotracheal intubation is considered a fundamental management procedure during emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity and mortality in emergency intubations. The aim of this study is to determine the diagnostic accuracy of the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old with endotracheal intubation
* Having normal airway anatomy

Exclusion Criteria:

* Age below 18 years old
* Neck deformities,
* Presence in history of neck radiation,
* Cervical spine immobility/instability
* Unstable vital signs
* Unwilling to participate or denial of informed consent

Primary outcomes:
measure: The verification of endotracheal tube position using the ultrasonography in the respiratory intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Islam Galal Sayed
Study officials:
References:
citation: Sethi AK, Salhotra R, Chandra M, Mohta M, Bhatt S, Kayina CA. Confirmation of placement of endotracheal tube - A comparative observational pilot study of three ultrasound methods. J Anaesthesiol Clin Pharmacol. 2019 Jul-Sep;35(3):353-358. doi: 10.4103/joacp.JOACP_317_18.
Clinical trial NCT06131957: Root Caries Prevention Using Fluoride Varnish Fortified With SBGC
Official title: Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries of Root Surface
Root Caries
Keywords: Strontium-doped Bioactive Glass Ceramic
Fluoride varnish
Older adults
Root caries
Dentine
Prevention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 540
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized assigned to either experimental group or controlled group.
Primary purpose: PREVENTION

Brief summary: The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

Detailed description: This 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

Participants will be divided in to two groups, The main question it aims to answer is: Is fluoride varnish with SBGC more effective than that without SBGC on prevention root caries in community-dwelling older adults? Participants will be divided into two groups, experimental group and controlled group after randomization. Subjects in the experimental group will receive fluoride varnish with SBGC quarterly, and subjects in the controlled group will receive fluoride varnish without SBGC quarterly.

It is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing SBGC will develop fewer root caries.

Eligibility criteria: Inclusion Criteria:

* Adult \> 60 years old
* good collaborative relationships

Exclusion Criteria:

* less than 8 natural teeth
* have severe medical conditions
* are in use of high fluoride toothpaste

Primary outcomes:
measure: New root caries lesions and restorations
timeFrame: Baseline, 12, 24, 36 months
Secondary outcomes:
measure: Arrested root caries
timeFrame: Baseline, 12, 24, 36 months
measure: Satisfaction of the use of varnish
timeFrame: 12, 24, 36 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Clinical Research Center, the Prince Philips Dental Hospital
Study officials:
affiliation: Faculty of Dentistry, The University of Hong Kong
name: Katherine CM Leung, BDS,MDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04817657: Pre-approval Access for Janssen's COVID Vaccine VAC31518 for Treating Physician Use
Official title: COVID Vaccine VAC31518 Pre-approval Access Study
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-03-26
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this Pre-approval access (PAA) program is to provide VAC31518 (Ad26.CoV2.S) vaccine for the prevention of coronavirus disease-2019 (COVID-19) infection. This PAA program may be considered to protect participants against a serious/life-threatening diseases or conditions, where there are no alternative treatments available.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: