louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06930339: Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis
Official title: Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Gait deficit, PoNS
Lead sponsor: Helius Medical Inc
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry is designed to collect retrospective clinical/medical outcome data on the therapeutic response of MS patients with gait deficit who underwent at least an initial 14-week PoNS Therapy course.

Brief summary: The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include:

disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects.

By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.


Eligibility criteria: Inclusion Criteria: none

* Diagnosis of gait deficit due to MS

Exclusion Criteria: none

* unable to ambulate with or without an assisting device

Primary outcomes:
measure: Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Newtown
country: United States
facility: Helius Medical
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03075839: Impact of Switching to Non-Menthol Cigarettes Among Smokers
Official title: Impact of Switching to Non-Menthol Cigarettes Among Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
First posted: 2017-03-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes
Primary purpose: OTHER

Brief summary: This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.

Detailed description: The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).

Eligibility criteria: Inclusion Criteria:

* 18 or older
* Able to read English
* Cigarette smoker

Exclusion Criteria:

* Seeking smoking cessation treatment
* Serious psychiatric or medical condition
* Use of other drugs
* Unable or unwilling to complete study protocol

Primary outcomes:
measure: Total Number of Cigarettes Smoked
timeFrame: Menthol smoking (Week 2), Non-menthol smoking (Week 4)
Secondary outcomes:
measure: Nicotine Dependence
timeFrame: Week 4 (non-menthol)
measure: Quitting Interest
timeFrame: Week 4 (non-menthol)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Krysten Bold, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bold KW, Jatlow P, Fucito LM, Eid T, Krishnan-Sarin S, O'Malley S. Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Tob Control. 2020 Nov;29(6):624-630. doi: 10.1136/tobaccocontrol-2019-055154. Epub 2019 Nov 4.
Clinical trial NCT02376439: Discordance of Obesity in Adolescent Sibilngs
Official title: Non-shared Environments and Discordance of Obesity in Adolescent Sibilngs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: siblings
overweight
adolescent
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 176
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty-eight sibling pairs (24 pairs of boys and 24 pairs of girls, 96 total adolescents) age 13 to 17 years who are discordant for overweight/obesity will be studied to assess potentially modifiable non-shared experiences within and outside the family environment that alter energy balance behaviors and contribute to adolescent overweight. We will also measure the height and weight of up to 3 of their best friends.

Brief summary: This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight).

Detailed description: This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight). To accomplish this, siblings attend four laboratory sessions where they consume one of two types of kool-aid, smell the pizza, or rest quietly. Siblings then eat a dinner meal. Siblings also wear an activity monitor for one week and record their physical activity and sedentary activities in a habit book.

Eligibility criteria: Inclusion Criteria:

* between 13-17 years old
* Have discordant same gender sibling (one is below 70th percentile, one is above 85th percentile
* Speak/read English
* Moderate or greater liking of study foods

Exclusion Criteria:

* No current diagnosis of a psychiatric or eating disorder.
* No dieting, dietary restrictions, or allergies that would interfere with study participation.
* No medications or conditions that could influence taste or appetite.
* No health concern or physical disability that would limit participation in physical activity.
* No endocrine or central nervous system disorder that could produce overweight.
* No current use of tobacco or nicotine products by the adolescent siblings.

Primary outcomes:
measure: Internal and external satiety calories consumed
timeFrame: Calories consumed are measured at week 1, week 2, week 3 and week 4.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Leonard Epstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876939: Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
Official title: Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atunomic Neuropathy
Keywords: Hereditary Sensory Neuropathy
Autonomic Neuropathy
Familial Dysautonomia
proprioception
motor control
sensory nervous system.
HSAN III
IKBKAP gene mutation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project comprises three sets of physiological studies - testing eight specific hypotheses - that will contribute new knowledge on proprioception and motor control in a genetic disorder that affects specific components of the sensory nervous system.

I: To investigate the neurophysiological basis for disturbed motor control in Hereditary sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing cutaneous feedback on motor control in HSAN III III: To investigate the cortical representation of proprioceptive inputs in HSAN III

Detailed description: HSAN III patients (n=15) and healthy control subjects (n=15) will lay supine on an MRI bed and a tungsten microelectrode inserted percutaneously into a muscle or cutaneous fascicle of the right common peroneal nerve at the fibular head, according to standard techniques employed by Prof Macefield. Neural activity will be acquired, RMS-processed (200 ms) and analysed on computer. The subject's head will be tightly enclosed in a standard clinical 32-channel SENSE head coil and headphones will be provided to minimize noise and to allow communication with the subject. The subject will be placed in the bore of a 3T whole-body scanner for 60-90 minutes.

Eligibility criteria: Inclusion Criteria:

* Confirmed genetic diagnosis of HSAN III will be recruited from the Dysautonomia Center at NYU

Exclusion Criteria:

* homeless
* active drug or alcohol dependence
* evidence of neurological disorder or diabetes
* exposure to neurotoxic drugs that in the investigator's opinion may compromise results
* Pregnant women

Primary outcomes:
measure: Measurement of gait in HSAN III
timeFrame: 120 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Horacio Kaufmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02009839: Web-Based CBT Protocol for Treatment of Selective Mutism
Official title: Effectiveness of a Web-Based CBT Protocol for Treatment of Selective Mutism in Singapore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Selective Mutism
Keywords: anxiety
frequency of speech
selective mutism
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
First posted: 2013-12-12
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to examine the effectiveness of a web-based CBT protocol (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The researchers hypothesized that the Meeky Mouse program would be associated with higher frequency of speaking behaviors, lower levels of anxiety, greater improvements in clinician-rated severity of mental illness, and higher clinician-rated improvement scores at post-treatment.


Eligibility criteria: Inclusion Criteria:

* 6-12 years old
* primary clinical diagnosis of Selective Mutism
* confirmed diagnosis of Selective Mutism by structured clinical parent interview
* fluent in English

Exclusion Criteria:

* below average intellectual functioning
* the presence of autism and schizophrenia

Primary outcomes:
measure: Selective Mutism Questionnaire
timeFrame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores
Secondary outcomes:
measure: Asian Children's Anxiety Scale-Caretaker Version (ACAS)
timeFrame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS total scores
measure: Asian Children's Anxiety Scale-Child (ACAS-C)
timeFrame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS-C total scores
measure: Clinical Global Impression (CGI)
timeFrame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Child Guidance Clinic
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Daniel Fung, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04004286: Defense and Veterans Center for Integrative Pain Management (DVCIPM) Pain Registry Biobank
Official title: Defense and Veterans Center for Integrative Pain Management (DVCIPM)Pain Registry Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Keywords: Pain PASTOR Biobank
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female military health care beneficiaries age 18 years and older presenting for an appointment care at WRNMMC

Brief summary: This Pain Registry Biobank is a prospective cohort design study whereby data (PASTOR survey, blood and saliva specimens, clinical data) is collected from participants in a longitudinal fashion with continual enrollment.

Detailed description: The Defense and Veterans Center for Integrative Pain Management (DVCIPM) established a clinical data registry and tissue biobank (pain registry/biobank) for the advancement of pain-related research. This Pain Registry Biobank will address the complexity of pain by utilizing the Pain Assessment Screening Tool \& Outcomes Registry (PASTOR), a thorough biopsychosocial assessment that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments. As a uniform assessment system, PASTOR also mitigates a significant challenge in pain-related research, the lack of standardized, cross-study outcomes. Additionally, the richness of PASTOR data matched with biological samples allows future researchers to address significant research gaps and enhance health care for service members, veterans, and civilians.

Eligibility criteria: Inclusion Criteria:

* Eligibile for care within the Military Healthcare System
* Able and willing to provide written consent

Exclusion Criteria:

* Cannot understand English

Primary outcomes:
measure: Pain Registry: PASTOR survey
timeFrame: Up to 30 years
measure: Pain Registry: Blood specimens
timeFrame: Up to 30 years
measure: Pain Registry: Saliva
timeFrame: Up to 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Defense and Veterans Center for Integrative Pain Management
name: Harold J Gelfand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00187239: Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
Official title: Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Keywords: ICDs
Ventricular pacing
Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
At the time of enrollment, patient is paced in the RV ≤25% of the time as determined by the device diagnostics.
Patient is medically stable.
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 157
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: The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.


Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
* At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
* Patient is medically stable.

Exclusion Criteria:

* Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
* Patient is younger than 18 years of age.
* Patient is pregnant.

Primary outcomes:
measure: The primary endpoint is the percentage of intrinsic ventricular events.
timeFrame: 3 months
Secondary outcomes:
measure: Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes
timeFrame: 3 months
measure: Frequency of inappropriate ICD therapy during AT/AF
timeFrame: 3 months
measure: Frequency of appropriate ICD therapy for VT/VF
timeFrame: 3 months
measure: Study related adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
Study officials:
affiliation: Abbott Medical Devices
name: Zaffer Syed, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03040739: Treatment of Acetabulum Fracture With O'ARM Surgical Imaging
Official title: Treatment of Acetabulum Fracture With O'ARM Surgical Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabulum Fracture
Keywords: O'ARM
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patients admitted in the service of orthopaedic surgery for fracture of the cotyle

Brief summary: Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. So surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .

The aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* acetabulum fracture dating less than a month

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Height of incongruity
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT00939939: Effect of Sitagliptin on Postprandial Lipoprotein Metabolism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* dietary therapy

Exclusion Criteria:

* lipid-lowering therapy
* anti-hyperglycemic drug therapy

Primary outcomes:
measure: incremental area under the triglyceride curve (iAUC-TG)
timeFrame: 10 weeks
Secondary outcomes:
measure: LDL-cholesterol
timeFrame: 10 weeks
measure: HDL-cholesterol
timeFrame: 10 weeks
measure: VLDL-cholesterol
timeFrame: 10 weeks
measure: triglycerides
timeFrame: 10 weeks
measure: area under the triglyceride curve (AUC-TG)
timeFrame: 10 weeks
measure: area under the VLDL-triglyceride curve (AUC-VLDL-TG)
timeFrame: 10 weeks
measure: incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG)
timeFrame: 10 weeks
measure: glucose
timeFrame: 10 weeks
measure: insulin
timeFrame: 10 weeks
measure: HOMA
timeFrame: 10 weeks
measure: HbA1c
timeFrame: 10 weeks
measure: interleukin-6
timeFrame: 10 weeks
measure: hs-CRP
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Medical Dept. 2, Grosshadern, University Munich
Study officials:
References:
Clinical trial NCT01306539: Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Official title: Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: deep brain stimulation
subthalamic nucleus
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2011-03-02
Enrollment: 20
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: Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.


Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with idiopathic Parkinson's disease that meet criteria for treatment of their disease with STN-DBS. Participants will be selected for this study without regard for age (provided they are older than 18), gender or ethnic background.
* Participants must have undergone subthalamic nucleus DBS surgery and be receiving treatment at the Scripps Clinic in La Jolla, CA

Exclusion Criteria:

* Patients under 18 years old.
* Patients with mini-mental status scores below 26/30.
* Patients with known psychiatric disease.
* Patients who are too infirm, demented or dysarthric to clearly understand the consenting process, task instructions, or to communicate verbally regarding participation or non-participation.

Primary outcomes:
measure: behavioral task performance
timeFrame: 1 to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
Study officials:
affiliation: University of California, San Diego
name: Adam Aron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenhouse I, Gould S, Houser M, Hicks G, Gross J, Aron AR. Stimulation at dorsal and ventral electrode contacts targeted at the subthalamic nucleus has different effects on motor and emotion functions in Parkinson's disease. Neuropsychologia. 2011 Feb;49(3):528-34. doi: 10.1016/j.neuropsychologia.2010.12.030. Epub 2010 Dec 22.