louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06447766: Pediatric Parental Feeding Video Education Program
Official title: A Clinical-Community Partnership to Promote Food Access and Parental Feeding Practices: A Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2024-06-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn about the acceptability and feasibility of nutrition education videos among food-insecure parents and caregivers of young children (under 8 years old).

Participants will:

* Watch short nutrition education videos weekly for 8 weeks.
* Complete demographic and nutrition behavior questionnaires at week 1 and week 8.
* Participate in three motivational interview phone calls with a nutrition educator lasting 20 minutes over the course of 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Screen positive for food insecurity at Hasbro Children's Hospital Primary Care Clinic.
* Parent or caregiver of at least one child between 3-8 years old.
* Speak English or Spanish fluently.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Food Security Status
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05718466: Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Official title: Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent or Progressive Glioblastoma
Keywords: glioblastoma
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.


Eligibility criteria: Inclusion Criteria:

* Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
* Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
* History and physical exam, including neurologic examination, within 4 weeks prior to registration

Exclusion Criteria:

• Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding

Primary outcomes:
measure: Local Tumor Control
timeFrame: 2 months
measure: Overall Survival
timeFrame: 12 months
measure: Progression Free Survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Farzan Siddiqui, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00138866: Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury
Official title: Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Spinal cord injury
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: St. Joseph's Health Care London
First posted: 2005-08-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Traumatic spinal cord injury of greater than 18 months
* Osteopenia or osteoporosis of the hip
* Must be able to swallow tablets and sit upright

Exclusion Criteria:

* Bilateral heterotopic ossification
* Bilateral lower extremity metal implants
* Pregnant or lactating females
* Paget's disease
* Osteomalacia
* Steroid induced bone loss
* Untreated parathyroid or thyroid disease
* Symptomatic hypocalcemia or hypophosphatemia
* Treatment in the last year with calcitonin, fluoride or anabolic steroids
* Current treatment with prednisone

Primary outcomes:
measure: Change in bone mineral density of the distal femur between baseline and 18-months
timeFrame: 18 months
Secondary outcomes:
measure: Change in bone mineral density of the hips and proximal tibia between baseline and 18-months
timeFrame: 18 months
measure: The change in biochemical bone markers of bone turnover between baseline and 18-months
timeFrame: 18 months
measure: The frequency and severity of adverse events
timeFrame: 18 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehab, Lyndhurst Centre
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: B. Cathy Craven, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02510066: Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain
Official title: Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain: : a Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Pain
Keywords: Pancreatic Cancer
Pain
Acupuncture
Lead sponsor: Shanghai Cancer Hospital, China
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.

Detailed description: Acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. Pain scores on numeric rating scale (NRS) and blood levels of β-endorphin and nerve growth factor are compared.

Eligibility criteria: Inclusion Criteria:

* Advanced pancreatic cancer at Ⅲ-Ⅳ stage diagnosed by histological/cytological examination.
* Pain score of abdominal or back pain ≥3 on a numeric rating scale (NRS) graduated from 0 to 10.
* Stable dose of analgesics at least 72 hours before randomization.
* Expected survival time more than 1 month.

Exclusion Criteria:

* Another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder).
* Acupuncture treatment in the past.
* Contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points).
* Unable to give informed consent.

Primary outcomes:
measure: Pain scores, assessed with numeric rating scale (NRS)
timeFrame: 1 week
Secondary outcomes:
measure: Karnofsky performance status (KPS) score
timeFrame: 1 week
measure: Blood levels of β-endorphin
timeFrame: 1 week
measure: Blood levels of nerve growth factor
timeFrame: 1 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Cancer Hospital
name: Hao Chen
role: STUDY_CHAIR
References:
Clinical trial NCT03235466: A Prospective Trial of Behavioral Therapy for Chronic Cough
Official title: A Prospective Trial of Behavioral Therapy for Chronic Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial of 3 groups: 1) standard voice therapy 2) voice therapy and heart rate variability biofeedback and 3) heart rate variability biofeedback
Primary purpose: TREATMENT

Brief summary: This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However, among a subset of cough patients, no clear cause is found despite extensive workup, and traditional treatment methods do not provide relief. Several studies revealed less common causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal fold motion, and stress. Additional research identified links between the neurological networks that produce the cough reflex and those that maintain normal breathing. HRV biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate and breathing, two key functions of the autonomic nervous system. By using this non-invasive behavioral technique, cough patients can regulate their breathing and autonomic function, potentially leading to improved autonomic balance and a reduction in cough symptoms.


Eligibility criteria: Inclusion Criteria:

* 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device

Exclusion Criteria:

* On neuromodulator therapy, cardiac arrhythmia, dysphagia, prior HRVB or mindfulness, head and neck surgery of the oropharynx, neck or larynx, lung surgery, pulmonary pathology other than asthma, tourette syndrome, ACE inhibitor use, current or recent smoker.

Added exclusion criteria as of March 2020 - history of COVID+.

Primary outcomes:
measure: Percentage of Cough reduction
timeFrame: 3 weeks
Secondary outcomes:
measure: Durability of cough remediation
timeFrame: 8 weeks
measure: Changes in dyspnea
timeFrame: 3 weeks
measure: Change in voice
timeFrame: 3 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Center for Voice and Swallowing
state: California
Study officials:
References:
Clinical trial NCT06621966: Effectiveness of Topical Application of Olive Oil in Preventing Pressure Injuries
Official title: Effectiveness of Topical Application of Olive Oil in Preventing Pressure Injuries Among Hospitalized Patients With Mobility Limitations: A Cluster Randomized Trial in the United Arab Emirates
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Disability Physical
Keywords: Olive oil, Pressure injury, mobility limitations, United Arab Emirates
Lead sponsor: RAK Medical and Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 80
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: Pressure injuries (PIs) pose significant public health concerns, particularly for hospitalized patients with limited mobility. They are one of the five most common causes of harm in healthcare settings, with a global prevalence ranging from 0% to 72.5%. Hospitalized patients face a higher risk of developing PIs compared to those in community settings, with older adults (over 65 years) being particularly vulnerable.

Meta-analysis reveals a global prevalence of PIs at 14.8%, varying significantly across care settings. For instance, in acute care environments, the prevalence ranges from 6% to 18%, highlighting the need for improved preventive measures. A study in the UAE demonstrated that implementing a new intervention protocol reduced the prevalence of PIs from 2% in 2013 to 1.8% in 2018, underscoring that prevention is less costly than treatment.

Furthermore, research indicates that maintaining skin integrity is crucial in preventing PIs, with the Agency for Healthcare Research and Quality emphasizing the use of "Care Bundles" that include comprehensive skin assessments. Topical emollients and products containing hyper-oxygenated fatty acids (HOFAs) are recommended for enhancing skin hydration and reducing PI risk.

Evidence from studies in Gulf countries shows the effectiveness of olive oil in preventing and treating PIs. Despite existing interventions, recent data from the hospital conducting this study revealed a rising incidence of PIs, from 40 cases in 2020 to 55 cases in 2021. This research aims to evaluate the effectiveness of applying extra virgin olive oil topically, alongside standard preventive measures, to reduce the risk of PIs in mobility-compromised patients.


Eligibility criteria: Inclusion Criteria:

- mobility-limited stroke, spinal cord injuries, fractures, multiple sclerosis

Exclusion Criteria:

unwilling to participate,

Primary outcomes:
measure: Change Pressure Ulcer incidence at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ras al-Khaimah
country: United Arab Emirates
facility: RAKMHSU
Study officials:
References:
Clinical trial NCT01260766: Acne Treatment With Active Oplon's Patches - 15-18 Years Old
Official title: Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Oplon-Pure Science Ltd.
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Detailed description: Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

Eligibility criteria: Inclusion Criteria:

* Acne Vulgaris
* Over 15 years
* Signing informed consent

Exclusion Criteria:

* Active treatment of acne
* Change in hormonal therapy
* Antibiotic treatment in a week prior to the experiment
* Sensitive skin
* Pregnancy

Primary outcomes:
measure: Severity Score of lesion
timeFrame: Severity Score of lesion [Time Frame: 24 hours following patch removal]
Secondary outcomes:
measure: Severity Score of lesion
timeFrame: Severity Score of lesion [Time Frame: 12 hours with the patch]
Other outcomes:
Locations:
city: Natanya
country: Israel
facility: Dermatology Clinic
Study officials:
affiliation: Laniado Medical Center
name: Avner Shemer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636466: The Everolimus-Transplant Exit Strategy Trial (E-TEST)
Official title: Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Kidney Failure, Chronic
Keywords: Chronic allograft failure
Kidney Transplantation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2012-07-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.

The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.


Eligibility criteria: Inclusion Criteria:

* recipient of deceased or living donor kidney transplant
* Age 18-75 years (inclusive)
* Male or female
* renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
* Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
* Willing and able to provide informed consent for study participation

Exclusion Criteria:

* Prior solid organ transplant (other than kidney)
* History of donor-specific antibody
* History of biopsy-proven acute rejection within 1 year prior to enrollment
* Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
* Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
* Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
* Subjects receiving belatacept (Nulojix)
* Pregnant or nursing (lactating) women
* Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study

Primary outcomes:
measure: Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)
timeFrame: 36 months
Secondary outcomes:
measure: Incidence of Return to Dialysis Dependence
timeFrame: 36 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Ashtar Chami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04651166: Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Official title: Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abortion
Dilation and Evacuation
Hemorrhage
Blood Loss
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2020-12-03
Enrollment: 48
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D\&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D\&E at 16 to 24 weeks gestation.


Eligibility criteria: Inclusion Criteria:

* Requesting pregnancy termination
* Intrauterine pregnancy at 16 to 24 weeks gestation
* Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English.

Exclusion Criteria:

* History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)

Primary outcomes:
measure: Intervention to control blood loss
timeFrame: At time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Marit Pearlman Shapiro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05788666: Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
Official title: Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: GeriKit
Comprehensive Geriatric Assessment (CGA)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study seeks to expand the use of the NYU GeriKit mobile application ("app") in a diverse range of settings to better phenotype older patients, which will enhance both research and patient care.

Detailed description: This is a single-center proof of concept study of geriatric impairments and feasibility metrics through the use of the GeriKit software application in older adults with ischemic heart disease at the NYU Langone Medical Center. The GeriKit mobile application was developed to make geriatric assessment instruments easily accessible to clinicians who do not have subspecialty training in geriatrics. The GeriKit app has been used clinically but is untested in research settings.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 75
2. Currently hospitalized for acute mycardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG); or hospitalized for AMI, PCI, or CABG within the prior 4 weeks
3. Capable of self-consent
4. Understand and are able to perform study procedures in English

Exclusion Criteria:

1. Non-ambulatory
2. Moderate or severe cognitive impairment (operationalized as known diagnosis of dementia)
3. Unable or unwilling to consent
4. Incarcerated
5. Unable to use complete assessments in English
6. Unable to complete geriatric assessment for other reasons

Primary outcomes:
measure: Incidence of Mortality or Hospital Readmission
timeFrame: Month 6
Secondary outcomes:
measure: 12-Item Short Form Survey (SF-12) Score
timeFrame: Baseline
measure: 12-Item Short Form Survey (SF-12) Score
timeFrame: Month 6
measure: Seattle Angina Questionnaire Short-Form (SAQ-7)
timeFrame: Baseline
measure: Seattle Angina Questionnaire Short-Form (SAQ-7)
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: John A. Dodson, MD, MPH, FACC
role: PRINCIPAL_INVESTIGATOR
References: