louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03486808: Dual Site-Dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Healthy Subjects
Official title: Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Language and Cognitive Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: transcranial direct current stimulation
motor function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of language and cognitive function in healthy. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on left inferior frontal cortex, ii) anodal stimulation on left dorsolateral prefrontal cortex. 2) IFG stimulation: anodal stimulation on left inferior frontal cortex; 3) DLPFC stimulation: anodal stimulation on left dorsolateral prefrontal cortex area. 4) sham stimulation


Eligibility criteria: Inclusion Criteria:

* healthy subjects with age over 19 years old

Exclusion Criteria:

* history of disorders involving central nervous system
* patients with severe medical or psychiatric disease

Primary outcomes:
measure: Korean Boston naming test
timeFrame: Baseline and after intervention (approximately 30 minutes)
measure: Verbal 3 back test
timeFrame: Baseline and after intervention (approximately 30 minutes)
Secondary outcomes:
measure: Korean Color Word Stroop test
timeFrame: Baseline and after intervention (approximately 30 minutes)
measure: Controlled Oral Word Association Test
timeFrame: Baseline and after intervention (approximately 30 minutes)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05384808: Canine-assisted Psychotherapy Motivation Alliance
Official title: Effects of the Inclusion of a Dog in Psychotherapy on Children's Alliance and Treatment Motivation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motivation
Alliance, Therapeutic
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the needed extent and the way a dog is integrated into psychotherapeutic interventions for them to be motivating and alliance building for children and adolescents with psychiatric disorders aged 9 to 17 years old. Specifically, we want to elaborate if the dog needs to be integrated into the therapy in a form that it is part of the therapeutic context or if the presence of the dog without being part of the therapeutic context per se is beneficial.


Eligibility criteria: Inclusion Criteria for children and adolescents: :

* Age between 9 and 17 years
* Children are seeing the therapist for the first time
* Basic knowledge of child and parents in either German or English to be able to fill in questionnaires
* Informed consent given by legal guardian
* Positive or neutral attitude towards dogs

Exclusion Criteria for children and adolescents: :

* acute psychosis; early childhood autism
* diagnosed developmental disorder or intellectual delay; if not diagnosed, exclusion when questionnaires cannot be completed due to development level
* fear of dogs
* allergic reactions to dogs
* reported aggressive behavior towards animals in the past

Inclusion criteria for therapists:

* working with an own therapy dog
* completed therapy training or if not completed far advanced therapy training under supervision
* working with children and adolescents aged 9 to 17 years

Exclusion criteria for therapists:

* not working with an own therapy dog
* no completed or far advanced therapy training
* not working with children and adolescents aged 9 to 17 years

Primary outcomes:
measure: Therapeutic alliance of patients
timeFrame: 9 weeks
measure: Motivation of patients
timeFrame: 9 weeks
Secondary outcomes:
measure: Treatment satisfaction of patients
timeFrame: 4 weeks
measure: Number of missed sessions
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
References:
Clinical trial NCT00006308: Observational Cohort Study of Sodium, Weight and Cardiovascular Disease
Official title: Observational Cohort Study of Sodium, Weight and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-09-29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate cardiovascular events among individuals with low sodium intake or large weight changes in a prospective observational follow-up of subjects from the Trials of Hypertension Prevention (TOHP) study.

Detailed description: BACKGROUND:

Sodium reduction and weight loss lead to decreased blood pressure (BP). Among hypertensives, BP lowering leads to decreased risk of MI, stroke, and cardiovascular death. Nonetheless, concerns have been raised about increased numbers of cardiovascular events among individuals with low sodium intake or large weight changes.

DESIGN NARRATIVE:

The prospective observational follow-up of the Trials of Hypertension Prevention (TOHP) includes cardiovascular events among the 4, 507 surviving participants from the ten clinical centers involved in Phases I and II of TOHP. Phase I was a randomized trial of the effects of non- pharmacologic interventions, including sodium reduction and weight loss, on BP over 18 months of follow-up with 2,182 participants. Phase II examined the effects of sodium reduction and weight loss on BP over a longer 36-month period in a randomized 2X2 factorial design with 2,382 participants. During follow-up in Phases I and II of TOHP, several measures of both weight and sodium excretion were carefully obtained on all participants. The prospective observational follow-up specifically examines whether these values, with an emphasis on average level of sodium excretion and weight changes are predictive of later cardiovascular disease. The follow-up is conducted centrally by mail from the Division of Preventive Medicine, which served as the Coordinating Center for Phases I and II, and which has been very successful in conducting such large-scale studies by mail. Information on cardiovascular events subsequent to the trial periods is collected through June, 2003, representing an average follow-up of approximately fourteen years from the end of Phase I and eight years from the end of Phase II. This cohort provides a unique resource to address the impact in a normotensive population of salt restriction and weight change on subsequent cardiovascular events.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Nancy R Cook, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242008: A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease
Official title: A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: IDIOPATHIC PARKINSON'S DISEASE
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.

Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial.

The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease

Exclusion Criteria:

* Not taking a dopamine agonist

Primary outcomes:
measure: Tolerability of rotigotine as determined by the total number of subjects completing the trial.
measure: Effect on symptoms and other variables.
measure: Safety.
Secondary outcomes:
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: LeWitt PA, Boroojerdi B, MacMahon D, Patton J, Jankovic J. Overnight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease. Clin Neuropharmacol. 2007 Sep-Oct;30(5):256-65. doi: 10.1097/wnf.0b013e318154c7c4.
Clinical trial NCT03872323: Open and Endovascular Surgical Treatment for Artery Injuries
Official title: Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Artery Injury
Keywords: Artery Injury
Surgery
Endovascular Repair
Peripheral Arteries
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.


Eligibility criteria: Inclusion Criteria:

Injuries in the peripheral arteries; Loss of blood supply to the remote area; High-risk emergency artery reconstruction; Participate in the study voluntarily, accept follow up study. -

Exclusion Criteria:

Bleeding can be easily control; There is contraindications for surgical operation. -

Primary outcomes:
measure: 5-year treatment success rate
timeFrame: 60 months
Secondary outcomes:
measure: Technically success rate of surgery
timeFrame: immediately after surgery
measure: Surgery-related complications or death
timeFrame: 60 months
measure: Currence of stenosis of target lesion
timeFrame: 60 months
measure: Device-related serious adverse events
timeFrame: 60 months
measure: Target lesion was treated by interventional or surgical therapy once again
timeFrame: 60 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: 960 Hospital of PLA
state: Shandong
Study officials:
References:
Clinical trial NCT01044823: Use of Thermal and 3D Imaging to Quantify Arthritis
Official title: Use of Thermal and 3D Imaging to Quantify Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Juvenile Rheumatoid Arthritis
Keywords: RA
JRA
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2010-01-08
Enrollment: 157
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with JRA adults with RA

Brief summary: One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. We have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. The goal of our studies is to test the hypothesis that this Imager can improve the clinical assessment of arthritis.


Eligibility criteria: Inclusion Criteria:

* at least 4 years of age

Exclusion Criteria:

* less than 4 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04998123: Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures
Official title: A Randomized, Sham-controlled Study of the Efficacy of Intersectional Short Pulse (ISP) Stimulation for Seizure Termination
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Seizures
Focal Epilepsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study which seeks to develop a novel therapeutic approach, Intersectional Short Pulse (ISP) stimulation for seizure termination. The device embodiment of ISP is a scalp EEG recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. The study team has already collected safety and tolerability data in human subjects, demonstrated ISP efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. Now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.


Eligibility criteria: Experiment 3: Epilepsy patients

Inclusion criteria:

* Adult patients (age 18-65).
* Fluent in English.
* Epilepsy patients with poorly controlled (\>=2 seizures per week).
* Focal onset seizures.
* Seizure onset zone in the mesial temporal or neocortical onset as determined by \>2 concordant criteria, without discordant criteria (semiology, MRI Brain, and EEG).
* Able to give informed consent.

Exclusion criteria:

* Patients with skull defects.
* Patients with implanted neurostimulator or other implanted cerebral hardware.
* Patients with multifocal onset epilepsy.
* Patients who are non-verbal or incapable of providing informed consent.
* Current substance abuse.
* Pregnancy.
* Patients with non-MRI compatible implants (for Experiments 2 and 3).

Primary outcomes:
measure: Mean duration of seizures detected
timeFrame: up to Day 10
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Anli Liu, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630123: Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.
Official title: Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) on Serum Levels of Brain Derived Neurotrophic Factor in Depressed Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients with current major depressive disorder or bipolar depression who are to receive either ECT or TMS.

Brief summary: To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post treatment for patients with depression with either ECT or TMS.


Eligibility criteria: Inclusion Criteria:

* MDD or bipolar disorder;
* current depressive episode, ham-d17\>17 and ymrs\<8;
* recommended to receive ECT or TMS as part of clinical care;
* male/female;
* age 18-65;
* inpatient or outpatient;
* comorbid dysthymic disorder, gad, or social anxiety will be included;
* able to give written consent and agree.

Exclusion Criteria:

* current manic, hypomanic, or mixed episode, ymrs\>7;
* current schizophrenia, anorexia, bulimia, substance dependence (current within past 6 months excluding caffeine and nicotine);
* TMS or ECT in the last 3 months;
* any other primary diagnosis;
* uncontrolled medical illness;
* epilepsy or severe personality disorder at the discretion of the investigators;
* 3 weeks prior to first blood test, antidepressants, mood stabilizers, antipsychotics can not be added or increased;
* pregnant women or women of childbearing potential not willing to use appropriate contraception, nursing women;
* known intolerance or lack of response to treatment receiving as judged by the investigator;
* medical conditions that would affect serum levels of BDNF;
* involvement in planning and conduct of the study.

Primary outcomes:
measure: Serum levels of BDNF.
timeFrame: pre and post treatment
Secondary outcomes:
measure: Correlation between the change in BDNF levels and illness severity after treatment.
timeFrame: pre and post treatment
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Care Mental Health Services
state: Ontario
Study officials:
affiliation: Queen's University
name: Roumen Milev, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842723: Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
Official title: Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Craniopharyngioma
Keywords: craniopharyngioma
protontherapy
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 33
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.

Detailed description: This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).

Eligibility criteria: Inclusion Criteria:

* Histologically documented craniopharyngioma
* Age range between 3 and 16 years
* Landsky performance status \> 60
* Incomplete surgical resection or simple biopsy
* Solid and/or cystic aspect on imaging
* Irradiation performed at the time of presentation or of local progression
* Signed informed consent by parents or by legal representative (with copy to each participating center)

Exclusion Criteria:

* Previous history of radiotherapy (including stereotactic) administered to the head and neck region
* Severe vasculopathy
* Participation to a concurrent study
* Contra-indication to general anesthesia in children below 5 years
* Patient non-compliant to a minimum 30 mn immobilisation
* Patient deprived of freedom or under guardianship
* Patient not expected to be followed in a long run

Primary outcomes:
measure: local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
timeFrame: at 3 years
Secondary outcomes:
measure: visual pathway tolerance according to NCI-CTC v3.0 scale
timeFrame: through study completion, up to 9 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Groupe Hospitalier Necker Enfants Malades
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References:
Clinical trial NCT00463723: Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Penetrating Keratoplasty
Keywords: penetrating keratoplasty
graft rejection
immunosuppression
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Sucampo Pharmaceuticals, Inc.
First posted: 2007-04-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.


Eligibility criteria: Inclusion Criteria:

* Penetrating keratoplasty for Keratoconus
* Penetrating keratoplasty for Fuchs endothelial dystrophie
* Penetrating keratoplasty for Bullous keratopathy

Exclusion Criteria:

* Glaucoma
* Limbal stem cell deficiency
* Herpetic eye disease
* Repeat Keratoplasty

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University eye hospital Freiburg, Germany
name: Thomas Reinhard, MD
role: STUDY_CHAIR
References:
citation: Reinhard T, Mayweg S, Reis A, Sundmacher R. Topical FK506 as immunoprophylaxis after allogeneic penetrating normal-risk keratoplasty: a randomized clinical pilot study. Transpl Int. 2005 Feb;18(2):193-7. doi: 10.1111/j.1432-2277.2004.00006.x.