louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06589362: Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
Official title: Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a single-blind sham-controlled randomized crossover pilot study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).

Detailed description: Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.

Eligibility criteria: Inclusion Criteria:

In inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years.

Ability to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.

Exclusion criteria:

Acute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. Significant gross or fine motor weakness. Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments.

Acute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments.

Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay.

Diagnosis of depression. Active substance abuse.

Primary outcomes:
measure: N-Back Computerized Task
timeFrame: 15 minutes
measure: Trail Making Test - Parts A & B
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Shira Cohen-Zimerman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01351662: Balancing Lupus Experiences With Stress Strategies
Official title: An Intervention to Reduce Psychosocial and Biological Indicators of Stress in African American Lupus Patients: The Balancing Lupus Experiences With Stress Strategies (BLESS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
stress
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Linking a psychosocial stress intervention with clinical measures of stress in African American lupus patients will assess the utility of this method in reducing perceived stress, and provide the necessary preliminary steps toward future investigations of potential mechanisms.

Detailed description: To begin to fill this research void, a stress intervention will be piloted and both biological specimens and questionnaire responses collected to assess changes in stress state following the intervention in patients who participated in the intervention compared to those who did not participate in the intervention.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* African American
* Diagnosis of Lupus

Exclusion Criteria:

* Previous participation in a disease self management program

Primary outcomes:
measure: Perceived stress
timeFrame: Four months
measure: Biological Indicators of stress
timeFrame: Four months
Secondary outcomes:
measure: Quality of Life
timeFrame: Four months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Edith M Williams, PhD
role: STUDY_DIRECTOR
affiliation: Medical University of South Carolina
name: James C Oates, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316562: Predictive Value of Cognitive Tests Performed for the Diagnosis of Alzheimer's Disease and Related Disorders
Official title: Valeur prédictive d'Une évaluation Cognitive standardisée en Centre d'Examens de Santé Pour le Diagnostic de la Maladie d'Alzheimer ou Des Maladies apparentées en Population générale Chez Les Plus de 65 Ans Avec Plainte mnésique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer's Disease
Impaired Cognition
Memory Disorders
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects with memory complaint recruited during a free medical examination in Health examination centres of Lyon, Saint-Etienne and Angers, France

Brief summary: The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Detailed description: The main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Community-dwellers
* Volunteers receiving a free medical examination in Health examination centre
* Subjective memory complaint

Exclusion Criteria:

* Known dementia
* Sensory deficit compromising the cognitive evaluation
* Poor workmanship of the written or oral French language

Primary outcomes:
measure: Score of episodic memory and executive psychometric tests
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: CES Baraban
Study officials:
affiliation: CES de Baraban, Lyon
name: Bruno Fantino, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Bathsavanis A, Rouch I, Deville N, Beauchet O, Krolak-Salmon P, Fantino B. Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community-dwelling elderly people with memory complaints: the EVATEM study. Eur J Neurol. 2016 Mar;23(3):554-61. doi: 10.1111/ene.12888. Epub 2015 Oct 30.
citation: Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Rouch I, Beauchet O, Krolak-Salmon P, Fantino B. Early detection of memory impairment in people over 65 years old consulting at Health Examination Centers for the French health insurance: the EVATEM protocol. BMC Geriatr. 2013 Jun 6;13:55. doi: 10.1186/1471-2318-13-55.
Clinical trial NCT01393262: Orthopaedic Hand Service Data Repository
Official title: Orthopaedic Hand Service Data Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-traumatic and Traumatic Health Issues
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 9620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals will be over the age of 18 and English speaking, excluding vulnerable populations (mental disabilities, prisoners etc.). Patients may be traumatic or non-traumatic.

Brief summary: The purpose of the research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against standard of care objective measurements (grip strength and range of motion).

The data repository also serves to streamline our studies and amalgamate many studies that are no more than minimal risk and do not involve randomization in any way.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Patients presenting to Hand Service for traumatic or non-traumatic issues.
* English Speaking

Exclusion Criteria:

* under 18 years
* vulnerable population

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02697162: Antiseptic-coated Intermittent Urinary Catheter
Official title: Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Neurogenic Bladder
Catheter-Related Infections
Keywords: Intermittent catheterisation
Antiseptic
Octenidine chloride
Children
Lead sponsor: Children's Hospital Zagreb
Sponsor class: OTHER
Collaborators: name: GuardianMed j.d.o.o. Research and development in medicine
First posted: 2016-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study design is a prospective, randomised, double-blind, and interventional. Primary aim of the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary catheters in prevention and reduction of catheter-associated urinary tract infections in children with neurogenic bladder. Secondary aim is to assess feasibility of antiseptic-coated intermittent hydrophilic urinary catheters in neurogenic bladder management. Octenidine chloride will be used as antiseptic.


Eligibility criteria: Inclusion Criteria:

* neurogenic bladder
* use of intermittent catheterisation for neurogenic bladder management
* informed oral and written consent from the child and both parents/legal guardian

Exclusion Criteria:

* Congenital anomalies of urinary tract or genitals
* Immunodeficiency
* Urinary tract fistula

Primary outcomes:
measure: Number of urinary tract infections
timeFrame: 6 months after start of intervention
Secondary outcomes:
measure: Safety during catheterisation
timeFrame: 6 months after start of intervention
measure: Adverse reactions
timeFrame: 6 months after start of intervention
measure: Expenses of infection-associated treatment
timeFrame: 6 months after start of intervention
measure: Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
timeFrame: 6 months after start of intervention
Other outcomes:
measure: Gut flora and catheter-associated infections
timeFrame: 2 years after start of intervention
Locations:
city: Zagreb
country: Croatia
facility: Children's Hospital Zagreb
Study officials:
affiliation: Children's Hospital Zagreb
name: Slaven Abdovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519662: Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors
Official title: Phase 1 Open-Label Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of SNS-314, a Novel Aurora Kinase Inhibitor, Administered to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Solid
Tumors
Advanced
Lead sponsor: Sunesis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.

Detailed description: Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).

Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor and that is measurable by a scan

Exclusion Criteria:

* Uncontrolled or untreated central nervous system metastases
* Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
* Any of the following cardiac conditions:
* History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
* Class III or IV heart failure up to 6 months before Cycle 1 Day 1
* Baseline heart rate corrected QT interval (QTc)\> 450 msec
* History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1
* Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP)
* Previous cancer treatment up to 21 days before first dose
* Any investigational therapy up to 28 days before Cycle 1 Day 1
* Known allergy to cyclodextrins

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.

Primary outcomes:
measure: To assess the safety and tolerability of SNS-314
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Sunesis Pharmaceuticals
name: Glenn Michelson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02777762: Strategies to Promote Physical Activity
Official title: Strategies to Promote Physical Activity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Getting regular physical activity has many health benefits. Current physical activity programs often encourage people to track their physical activity as a way to motivate them to continue being physically active over time. However, not everyone enjoys physical activity, so tracking physical activity may not be very motivating. This research study will evaluate whether a new program-specifically designed to enhance people's enjoyment of physical activity-improves people's attitudes toward physical activity compared to a program that encourages people to track their physical activity with a mobile app.


Eligibility criteria: Inclusion Criteria:

1. 25 ≤ BMI ≤ 39 kg/m2
2. Systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg
3. Not currently taking medications for blood pressure

Exclusion Criteria:

1. Not free of diagnosed heart disease, diabetes, and cancer
2. Medical contraindications to regular, unsupervised physical activity
3. Not stable on all medications over the past 3 months
4. Not free of binge eating disorder or bulimic compensatory symptoms
5. No regular access to a mobile phone and Internet
6. Not able to speak and understand English
7. Currently pregnant or planning to be within the next year
8. Planning to move in the next year
9. Not willing to be randomized

Primary outcomes:
measure: Change in self-reported enjoyment of physical activity assessed with the Behavioral Regulation in Exercise Questionnaire Version 2 (BREQ-2) Intrinsic Regulation subscale
timeFrame: Change from baseline to 2 months
Secondary outcomes:
measure: Change in self-reported physical activity assessed with the Stanford Leisure-Time Categorical Item (L-Cat)
timeFrame: Change from baseline to 2 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Michaela Kiernan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468962: The Effct of Chitooligosaccharide on Immune Function in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunity
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
First posted: 2007-05-03
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Functional properties of chitooligosaccharides have been studied for antitumor activity, immunostimulating effects, antimicrobial activity, free radical scavening activity, adn angiotensin I converting enzyme inhibitory activity. Recent in vitro, and in vivo toxicity and absorbability studies have demonstrated that chitooligosaccharides have high absorbability and are essentially non-toxic. In the present study, we prepared a chitooligosaccharide with high absorbability and evaluated its effects on activation of immune function and cardiovascular funciton(lipid, atrial stiffness, etc) in healthy adults.

This study was a 8-week, randomized, double-blind clinical trial. The 30 volunteers were divided into a control group(n=10), half dose chitooligosaccaride(FACOSTM) intake group(n=10), and full dose FACOS intake group(n=10). Peripheral blood mononuclear cells(PBMCs) were isolated and cultured in 12 well plate for 48 hours. Cytokine production by PBMCs pre- and postintervention were measured simultaneously after stimulation with lipopolysaccaride.


Eligibility criteria: Inclusion Criteria:

* healthy adults(the ages between 20\~50 year)

Exclusion Criteria:

* food allergy and allergy skin disease
* severe liver and kidney disease
* pregnant, lactating women
* cancer, stroke, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eulji University Hospital
name: Hee-Jeong Choi, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743262: Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis
Official title: Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Total Laryngectomy
Keywords: laryngectomy
larynx cancer
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: The Netherlands Cancer Institute
First posted: 2008-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.


Eligibility criteria: Inclusion Criteria:

* Total laryngectomy
* Use Provox ActiValve

Exclusion Criteria:

* Current problems with TE puncture

Primary outcomes:
measure: Short-term Feasibility Provox Vega 22.5 French
timeFrame: 3 weeks
Secondary outcomes:
measure: Subjective Voice and Speech Quality
timeFrame: 3 weeks
measure: Device Life Time
timeFrame: one year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord Holland
Study officials:
affiliation: The Netherlands Cancer Institute
name: Frans JM Hilgers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Netherlands Cancer Institute
name: Michiel WM van den Brekel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01193491: Dose Escalation of IPI-493 in Hematologic Malignancies
Official title: A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of IPI-493 in Patients Experiencing Advanced Hematologic Malignancies With Client Proteins of Hsp90
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hematologic Malignancies
Keywords: Phase 1
AML
CML
MPD
Client Proteins
Hsp90
Lead sponsor: Infinity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and schedule of IPI-493 in patients with hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* \>/=18 years old
* ECOG 0-1
* confirmed hematological malignancy
* refractory to available therapy or for which no therapy is available
* adequate hepatic, renal function

Exclusion Criteria:

* active CNS malignancy
* prolonged QT interval
* significant GI/liver disease
* other serious concurrent illness or medical condition

Primary outcomes:
measure: Evaluation of Safety Endpoints
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of Efficacy Endpoints
timeFrame: 1 year
measure: Evaluation of Efficacy Endpoints
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Cancer Center
state: Maryland
city: New York
country: United States
facility: Weill Cornell Cancer Center
state: New York
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: Infinity Pharmaceuticals, Inc.
name: Robert Ross, M.D.
role: STUDY_DIRECTOR
References: