louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05640414: Weekly Family Food Packages: Food is Medicine
Official title: Healthy Families Clinic and Teaching Kitchen Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Overweight
Obesity
Cardiometabolic Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Ardmore Foundation
name: Vitamix Foundation
First posted: 2022-12-07
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aims and objectives of this proposal are to:

1. Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families.
2. In a subset of families with a child aged 6-17 years, test a pilot intervention offering the following components, with a goal of improving family behavioral, social and health outcomes:

   1. Weekly family food packages from the Revere Food Pantry
   2. 6-Monthly group sessions that include information on healthy behaviors, chronic disease management and teaching families how to prepare simple recipes based on the food they receive that week from the food pantry.


Eligibility criteria: Inclusion Criteria:

* Referral to the food pantry

Additional inclusion criteria for Group Sessions:

- Family has a child aged 6-17 years

Exclusion Criteria:

- Not able to speak English or Spanish

Primary outcomes:
measure: Change in BMI at 6 months
timeFrame: 0-6 months
measure: Change in Food Insecurity Status at 3 months
timeFrame: 0-3 months
measure: Change in Diet Quality at 3 months
timeFrame: 0-3 months
Secondary outcomes:
measure: Change in Binge Eating Symptoms at 3 months
timeFrame: 0-3 months
measure: Change in Blood Pressure at 6 months
timeFrame: 0-6 months
measure: Change in Sleep at 3 months
timeFrame: 0-3 months
measure: Change in Physical Activity at 3 months
timeFrame: 0-3 months
measure: Change in Screen Time at 3 months
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Revere
country: United States
facility: MGH Revere HealthCare Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02893514: Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings
Official title: Leveraging Technology to Address Unhealthy Drug Use in Primary Care: Effectiveness of the Substance Use Screening and Intervention Tool (SUSIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Keywords: Drug Use
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-09-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will develop a clinical decision support tool that assists primary care providers in carrying out substance use interventions, and then compare (in Phase 2) two clinical scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention received) and changes in drug use at 3 and 6 months, among primary care patients. Investigators will develop the Clinical Decision Support (CDS) component and then test the full SUSIT approach, using mixed methods to assess its acceptability and adoption, and gathering preliminary data on its efficacy for reducing unhealthy drug use. CDS development is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a secondary study site to avoid contaminating the SO condition.

Detailed description: This study has 3 specific aims:

Aim 1 is to develop clinical decision support that assists primary care providers in carrying out a brief intervention.

Aim 2 is to assess the impact of the SUSIT on dose of substance use brief intervention received by patients.

Aim 3 is to gather preliminary evidence on the efficacy of the SUSIT approach for reducing moderate-risk drug use.

Eligibility criteria: Inclusion Criteria:

* Substance use screening results (collected using the tablet-based screening tool) indicating current moderate risk drug use, based on a substance specific involvement score (SSIS) indicating current (past 3 months) use of at least one drug with a moderate risk level (SSIS 4-26), in the absence of any high-risk drug or alcohol use (SSIS 27+);
* Presenting for visit with a participating PCP

Exclusion Criteria:

* Prior participation in the study (i.e. participation in the SO study phase would preclude participation in the SUSIT phase);
* Attending a formal addiction treatment program (not including informal treatment such as Alcoholics Anonymous, Narcotics Anonymous), in the past 3 months;
* Pregnant (based on self-report).

Primary outcomes:
measure: Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennifer McNeely, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032314: Lower Extremity Outcome Measures in SCI
Official title: Lower Extremity Outcome Measures: A Cross-sectional and Longitudinal Observation of Kinematic, Kinetic and Electromyographic Parameters Focussing on Lower Extremity Function in Spinal Cord Injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an acute or chronic spinal cord injury

Brief summary: Lower extremity (LE) function of patients with a spinal cord injury (SCI) will be assessed in an observational project with a cross-sectional and a longitudinal study design. The main goal is to identify kinematic and kinetic parameters to precisely characterize LE function and in parallel the impairment and limitation in SCI patients throughout rehabilitation in acute patients and in chronic patients to define LE function and LE recovery.


Eligibility criteria: Inclusion Criteria - Patients:

* Age 18-80
* Written informed consent
* General consent
* Spinal cord injury (SCI)
* ASIA A-D injury with lowest extent of lesion between C1 and Th12
* Mini-Mental stat examintation score \> 26

Exclusion Criteria - Patients:

* Inability to undertake any component of the trial protocol
* Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease
* Pure cauda equina i.e. peripheral nerve injury

Inclusion Criteria - Healthy controls:

* Age 18-80
* Written informed consent
* General consent

Exclusion Criteria - Healthy controls:

* Reliance on walking aids / prostheses for mobilisation
* Orthopaedic diagnosis with potential impact on gait
* Previous operations on the lower limbs or spine with potential impact on gait
* Inabilitay to undertake any component of the trial protocol
* Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease

Primary outcomes:
measure: Kinematic movement analysis recorded with a motion capture system
timeFrame: Cross-sectional part: one measurement timepoint for patients with chronic SCI within 2 weeks after inclusion (chronic is defined as > 6 months after injury)
measure: Kinematic movement analysis recorded with a motion capture system
timeFrame: Longitudinal part: approx. one measurement timepoint per month where outcome measures will be assessed. Starting < 6 weeks after SCI and continued up to 6 months (or end of rehabilitation).
measure: Kinematic movement analysis recorded with a motion capture system
timeFrame: Longitudinal part: approx. one measurement timepoint per month where outcome measures will be assessed. Starting < 6 weeks after SCI and continued up to 6 months (or end of rehabilitation)
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Balgrist
state: Zurich
Study officials:
References:
Clinical trial NCT06712914: Rapid Non-Invasive Brain Stimulation for Hoarding Disorder
Official title: Rapid Non-Invasive Brain Stimulation for Hoarding Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hoarding Disorder
Hoarding
Clutter
Keywords: TMS
hoarding disorder
hoarding
clutter
iTBS
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study explores whether rapid non-invasive brain stimulation can help reduce hoarding disorder symptoms.

Detailed description: Hoarding disorder (HD) is characterized by difficulty letting go of possessions, leading to clutter that congests living spaces and impairs daily functioning. The majority of HD patients treated with cognitive behavioral therapy for HD usually experience considerable residual symptoms. New treatments are greatly needed. This study explores whether rapid non-invasive brain stimulation can help reduce hoarding disorder symptoms.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years
2. Primary diagnosis of hoarding disorder
3. Sufficient severity of hoarding symptoms
4. Willing and able to understand and complete consent and study procedures

Exclusion Criteria:

1. Psychiatric or medical conditions or medications that make participation unsafe
2. Pregnant or nursing females
3. Previous exposure to TMS or ECT
4. History of any implanted device or psychosurgery

Primary outcomes:
measure: Change in Compulsive Acquisition Scale (CAS)
timeFrame: Change from baseline to 3 weeks after treatment starts
Secondary outcomes:
Other outcomes:
measure: Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)
timeFrame: Change from baseline to 3 weeks after treatment starts
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Carolyn I Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02473614: Efficacy Study of the Music Glove Patients With Spinal Cord Injuries
Official title: To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to patients with spinal cord injuries. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with minimum of 3 hours of exercise time per week. Participants will receive the other intervention at their 3 week post-therapy follow-up visits. Clinical evaluations will be performed at baseline 1 and 2 (3 to 10 days apart), post-therapy after the first intervention, 3-week post-therapy follow up, post-therapy after the second intervention, and 3-week post-second intervention follow up visits.


Eligibility criteria: Inclusion Criteria:

* History of spinal cord injury affecting the arm and hand functions, at least 6 months prior to enrollment
* Upper extremity weakness as measured on a standard clinical scale
* No active major psychiatric problems, or neurological/orthopedic problems affecting the training upper extremity
* No active major neurological disease other than the spinal cord injury
* Absence of pain in the affected upper extremity

Exclusion Criteria:

* Severe tone at the affected upper extremity as measured on a standard clinical scale
* Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
* Difficulty in understanding or complying with instructions given by the experimenter
* Inability to perform the experimental task that will be studied
* Increased pain with movement of the training upper extremity

Primary outcomes:
measure: Box and Blocks Test
timeFrame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
Secondary outcomes:
measure: Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Kelli Sharp, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanders Q, Chan V, Augsburger R, Cramer SC, Reinkensmeyer DJ, Sharp K. Feasibility of home hand rehabilitation using musicglove after chronic spinal cord injury. Spinal Cord Ser Cases. 2022 Nov 9;8(1):86. doi: 10.1038/s41394-022-00552-4.
Clinical trial NCT06056414: Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation
Official title: Study of the Reduction of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation in the Management of Patients Requiring Breast Macrobiopsy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Keywords: macrobiopsy
anxiety
Energy Resonance by Cutaneous Stimulation
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Performing a breast macrobiopsy can be extremely delicate and anxiety-provoking. It can have an impact on the course of future examinations.

Patients' emotional feelings also have a definite impact on the nursing staff. The purpose of the MBRESC study is to evaluate Energy Resonance by Cutaneous Stimulation , a manual acupressure technique, in the management of anxiety prior to breast macrobiopsy.


Eligibility criteria: Inclusion Criteria:

* Patient has received full information on the organization and purpose of the research, and has signed an informed consent form.
* Patient over 18 years of age
* Patient undergoing a diagnostic breast macrobiopsy for suspected breast cancer
* Patient undergoing a macro breast biopsy for the first time
* Patient affiliated to or benefiting from a social security schem

Exclusion Criteria:

* Patient with a history of breast cancer or other pathologies requiring invasive procedures
* Patient with several lesions to be biopsied
* Patient with psychiatric pathology
* Patient under anxiolytic or psychotropic treatment initiated in the month before the breast macrobiopsy

Primary outcomes:
measure: Evaluation of the reduction in ANXIETY STATE
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of the reduction in ANXIETY STATE
timeFrame: 3 days
measure: Evaluation of the reduction in ANXIETY STATE
timeFrame: 7 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Celine Lemaire
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03642314: HIV Self-testing in Implementation PrEP Study
Official title: ImPrEP Sub-study - HIV Self-Testing to Increase Combination Prevention Demand in the ImPrEP Project: an Adaptative Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Prevention
Keywords: pre exposure prophylaxis
men who have sex with men
Lead sponsor: Oswaldo Cruz Foundation
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a sub-study of an ongoing PrEP study ( HIV PrEP for men who have sex with men - MSM - and transgender women - TGW: a demonstrative project in Brazil, Peru and Mexico - ImPrEP). MSM/TGW enrolled to ImPrEP Study at the selected sites, who agree to participate in this HIV Self Test (HIVST) sub-study, will be 1:1 randomized at the third study visit either to receive 5 HIVST+voucher (intervention arm) or 5 vouchers alone (control arm) to secondarily distribute into their MSM/TGW network. All vouchers are numbered invitations for priority access to individualized HIV risk assessment and combination prevention services, including PrEP, at the ImPrEP sites. Study population comprises ImPrEP participants and their referred peers. Sample size is going to be determined at an interim analysis performed when each city has enrolled 70 participants. Trial participants will be at maximum 876 (438 intervention and 438 in the control arm) MSM and TGW included in the ImPrEP Study who received PrEP for at least 6 months in the sites from Rio de Janeiro and Lima. The study is designed as a multicenter, open, adaptative, randomized trial. The main study outcome is the voucher redemption proportion by arm.


Eligibility criteria: Inclusion Criteria:

* individuals who were included in the ImPrEP Study
* performed at least 3 study visits,
* accepted to participate in this sub study,
* provide informed consent form

Exclusion Criteria:

* Individuals included into ImPrEP as a result of HIVST secondary distribution

Primary outcomes:
measure: voucher redemption proportion by arm
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oswaldo Cruz Foundation
name: Valdilea Veloso, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT07023614: A Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Official title: A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy - FORTITUDE-HCM
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-obstructive Hypertrophic Cardiomyopathy
Keywords: nHCM
non-obstructive HCM
non-obstructive hypertrophic cardiomyopathy
HCM
hypertrophic cardiomyopathy
Lead sponsor: Imbria Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 165
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: FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM


Eligibility criteria: Select Inclusion Criteria:

* Has a clinical diagnosis of HCM consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definitions
* Has had confirmation of nHCM by the echocardiography core laboratory based on screening rest and exercise stress echocardiography
* New York Heart Association (NYHA) functional Class II or III at screening
* Functional limitation as defined by a screening CPET

Select Exclusion Criteria:

* Has a known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nHCM
* Has any other condition judged by the investigator to be the primary cause of dyspnea, exercise intolerance, and/or angina
* Has an inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
* Has any medical condition that precludes upright exercise stress testing

Other protocol-defined inclusion and exclusion criteria apply.

Primary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in ventilatory efficiency (VE/VCO2 slope) during cardiopulmonary exercise testing (CPET)
timeFrame: Baseline to Week 12
measure: Change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
timeFrame: Baseline to Week 12
measure: Change in the Kansas City Cardiomyopathy Questionnaire Physical Limitations Score (KCCQ-PLS)
timeFrame: Baseline to Week 12
measure: Change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02071914: A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza A
Keywords: efficacy
safety
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

Detailed description: This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.

Eligibility criteria: Inclusion Criteria:

* Healthy Male \& Female volunteers

Exclusion Criteria:

* Current clinically significant disease
* Pregnant or nursing mother
* Abnormal pulmonary function, nose or nasopharynx

Primary outcomes:
measure: Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
timeFrame: Three times a day from Day 1(the day after virus inoculation) to Day 9
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Retroscreen Virology Ltd.
Study officials:
affiliation: Celltrion Inc.
name: SuEun Song
role: STUDY_DIRECTOR
References: