louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01625676: Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke
Official title: Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: Aphasia
Rehabilitation of Speech and Language Disorders
Lead sponsor: NRZ Magdeburg Median Kliniken GmbH & Co
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 34
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of first-ever stroke
* aphasia in sub-acute stage
* german speakers

Exclusion Criteria:

* presence of residual aphasia
* dysarthria and apraxia of speech

Primary outcomes:
measure: Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)
timeFrame: pretreatment and 4 weeks
measure: change from pretreatment in Aachen Aphasia Test at 8 weeks
timeFrame: pretreatment and 8 weeks
measure: change from pretreatment in Aachen Aphasia Test at 1 year
timeFrame: pretreatment and 1 year
Secondary outcomes:
measure: Change of Communicative Activity (CAL)
timeFrame: pretreatment and 4 weeks
measure: change from pretreatment in communication activity (CAL)at 8 weeks
timeFrame: pretreatment and 8 weeks
measure: Change from pretreatment in communication activity (CAL)at 1 year
timeFrame: pretreatment and 1 year
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: NRZ Median Klinik
Study officials:
affiliation: NRZ Median Klinik Magdeburg
name: Almut A Sickert, PhD
role: STUDY_CHAIR
References:
citation: Sickert A, Anders LC, Munte TF, Sailer M. Constraint-induced aphasia therapy following sub-acute stroke: a single-blind, randomised clinical trial of a modified therapy schedule. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):51-5. doi: 10.1136/jnnp-2012-304297. Epub 2013 Jul 4.
Clinical trial NCT01001676: Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis
Official title: Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Failure
Keywords: renal failure
Restenosis
Dialysis access
Paclitaxel
Angioplasty
Intimal hyperplasia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Narrowing of the draining vein occurs in \>50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access..

Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall.

Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up.

Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis access located in the forearm or upper arm
* Patient with clinical or hemodynamic evidence of graft dysfunction
* Hemodialysis access is \> 3 months old

Exclusion Criteria:

* Intervention of the vascular access circuit within the past 30 days
* Thrombosed/clotted access
* Evidence of systemic infection or a local infection associated with the graft
* Positive pregnancy test within 7 days before enrolment
* Patient is scheduled for a kidney transplant

Primary outcomes:
measure: Primary patency
timeFrame: at 6 months
Secondary outcomes:
measure: Transonic blood flows
timeFrame: monthly for up to 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kong Teng Tan, BCh MB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01331876: Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy
Official title: Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Keywords: Cognitive and Behavioral Therapy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2011-04-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and compulsions are the two manifestations of this disease. Obsessions are recurrent anxious ideas, and compulsions repetitive behavior aiming to decrease this anxiety.

OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more precisely an hyperactivity of prefrontal cortex / basal ganglia loops.

Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex, anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference treatments : medication and Cognitive and Behavioral Therapy (CBT).

Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They are randomised in two groups : one proposing a "reference CBT", the other associate CBT to a new psychopedagogic task developed by the investigators team.

Clinical investigations and neuro-imagery data are collected at the main steps of therapies : before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity, patients and relatives quality of life are also assessed.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65;
* Following Obsessive Compulsive Disorder criteria according to DSM IV(300.3 ;MINI 5.0.0);
* OCD severity range from 20 to 30 on the Y-Brown obsessive compulsive scale;
* Having checking symptoms;
* Understanding and accepting the study;
* Giving his written informed consent to the study.

Exclusion Criteria:

* Claustrophobia;
* Cerebral abnormality;
* Chronic absenteism to CBT (more than 5 missed sessions during the whole therapy).

In case of exclusion of the study either decided by the patient himself or by the investigator, a debriefing is proposed by a psychologist.

Primary outcomes:
measure: Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder
timeFrame: before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière hospital
Study officials:
References:
Clinical trial NCT00713076: Wettability of Contact Lenses With a Multi-Purpose Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision
Keywords: multi-purpose solution
contact lens wearers
Contact lense wearers
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution.


Eligibility criteria: Inclusion Criteria:

* Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study.
* Must be wearing lenses a minimum of eight hours a day
* Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses
* Use no topical ocular OTC or prescribed ocular medication

Exclusion Criteria:

* Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery.
* Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects

Primary outcomes:
measure: Lens Wettability - ex-vivo wetting angle
timeFrame: From baseline
Secondary outcomes:
measure: Slit-lamp findings Corrected visual acuity (snellen) Adverse events
timeFrame: From baseline
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Study Locations
state: Texas
Study officials:
References:
Clinical trial NCT03179176: Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor
Official title: Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Tumor
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision, cognition, etc.). The reference method currently used to improve the quality of resection of brain tumors while minimizing neurological risk for patients is so called "wakeful" surgery with direct electrical stimulation (DES) of the brain. The investigators routinely use ultrasound to localize the tumor within the brain, but to date there is no pre- or intra-operative imaging tool to reliably identify tumors and functional brain regions. There is therefore a need for innovative imaging in this field.

For this reason, the investigators propose to evaluate the interest of a new High Frequence Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management of patients operated in an awake condition for a brain tumor. The ultra high frequency allows to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than 1 mm / second. The safety of this device is demonstrated and validated by CE marking (December 2015).


Eligibility criteria: Inclusion Criteria:

* operated patient of a cerebral tumor in an awake condition
* age\> 18 years
* neurological condition allowing the realization of the tests in the operating room

Exclusion Criteria:

* not indicated for "awake" surgery
* refusal of participation of the patient
* pregnant or nursing women

Primary outcomes:
measure: Diameter of the sulcus blood vessels
timeFrame: before resection of the tumor
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Fabien ALMAIRAC, MD
role: STUDY_DIRECTOR
References:
citation: Almairac F, Fontaine D, Demarcy T, Delingette H, Beuil S, Raffaelli C. Motor cortex neurovascular coupling: inputs from ultra-high-frequency ultrasound imaging in humans. J Neurosurg. 2018 Nov 9;131(5):1632-1638. doi: 10.3171/2018.5.JNS18754. Print 2019 Nov 1.
Clinical trial NCT03776760: Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Official title: Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Hepatitis
Liver Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Digestive System Diseases
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: South Australian Health and Medical Research Institute
name: Flinders University
First posted: 2018-12-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)

Brief summary: A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.

Detailed description: SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* voluntarily signed the informed consent form.

Exclusion Criteria:

* Pregnant women.

Primary outcomes:
measure: Change in Hepatitis C prevalence
timeFrame: Week 0 to week 144
Secondary outcomes:
measure: Change in Hepatitis C incidence
timeFrame: Week 0 to week 144
measure: DAA uptake
timeFrame: To week 144
measure: Treatment response rate (SVR12 rate)
timeFrame: From week 0 to Week 144
measure: HCV reinfection incidence post treatment
timeFrame: 6 monthly from end of treatment until week 144
Other outcomes:
measure: HCV Transmission networks within the Aboriginal community
timeFrame: At screening for all participants
Locations:
city: Lismore
country: Australia
facility: Jullums Lismore Aboriginal Medical Service
state: New South Wales
city: Quirindi
country: Australia
facility: Walhallow Aboriginal Corporation
state: New South Wales
city: Mount Gambier
country: Australia
facility: Pangula Mannamurna Aboriginal Corporation
state: South Australia
city: Port Lincoln
country: Australia
facility: Port Lincoln Aboriginal Health Service
state: South Australia
Study officials:
References:
Clinical trial NCT01986660: Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetic Study
Lead sponsor: Strategic Science & Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.


Eligibility criteria: Inclusion Criteria:

* Signed consent form
* Men, women, 18 to 55 years
* Females must not be pregnant or plan to become pregnant
* BMI 18 to 30 kg/m2
* Past or non-smoker
* High probability of compliance with completion of study
* Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs

Exclusion Criteria:

* Presence or history of disorder that could interfere with completion of study
* Unstable medical condition
* Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
* Positive Hep B, Hep C and/or HIV test
* Positive urine drug screen
* Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows
* Significant disease
* Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test
* History of drug abuse with 1 year
* History of alcoholism with 1 year
* Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1.
* Use of investigational drug within 30 day of Day 1
* Acute disease state within 7 days of Day 1
* Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1
* Tobacco use/caffeine use within 48 hours of Day 1

Primary outcomes:
measure: Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2
timeFrame: 9 days
Secondary outcomes:
measure: Clinical laboratory change from baseline
timeFrame: 14 days
measure: Modified Berger Bowman Skin Assessment
timeFrame: 14 days
measure: Vital Signs
timeFrame: 14 days
measure: Adverse Events
timeFrame: 14 days
Other outcomes:
Locations:
city: New York
country: United States
facility: SST Investigational Site
state: New York
Study officials:
References:
Clinical trial NCT03694860: Rapid Sequence Induction EU: Electronic Survey (RSIEU)
Official title: Rapid Sequence Induction in EU: Electronic Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rapid Sequence Induction
Keywords: crush induction, RSI
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology (ESA)
First posted: 2018-10-03
Enrollment: 1921
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of Europen Society of Anaesthesiology

Brief summary: Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.

Detailed description: Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.

The 11 will be consulted with the research committee of ESA.

Eligibility criteria: Inclusion Criteria:

- Members of European Society of Anaesthesiology

Exclusion Criteria:

- not members of ESA

Primary outcomes:
measure: RSI practice in European countries - questionnaire (electronic survey)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: University Hospital Brno
name: Petr Štourač, doc.MD.Ph.D
role: STUDY_CHAIR
References:
citation: Klucka J, Kosinova M, Zacharowski K, De Hert S, Kratochvil M, Toukalkova M, Stoudek R, Zelinkova H, Stourac P. Rapid sequence induction: An international survey. Eur J Anaesthesiol. 2020 Jun;37(6):435-442. doi: 10.1097/EJA.0000000000001194.
Clinical trial NCT05000060: Restart TICrH AP Pilot Trial
Official title: A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Traumatic Intracranial Hemorrhage
Keywords: restart
antiplatelet
traumatic intracranial hemorrhage
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
Primary purpose: PREVENTION

Brief summary: A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.


Eligibility criteria: Inclusion Criteria:

1. Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy
2. History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet \*Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).

Exclusion Criteria:

1. SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH
2. Physician plan to start/restart anticoagulant therapy during trial period
3. Abbreviated Injury Scale other than head \>3
4. Pregnancy
5. Inability to understand need for adherence to study protocol
6. Any active pathological bleeding (no acute blood on most recent CT)
7. Hypersensitivity to drug or other label contraindication
8. Any bleeding that the investigator deems unsafe to restart at 1 week post injury
9. Inability to swallow

Primary outcomes:
measure: major bleeding
timeFrame: 60 days
measure: Major Vascular Occlusive events
timeFrame: Baseline (gambles performed pre-randomization)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: