louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03049501: Caring for the Caregiver Network
Official title: A Tailored Technology Intervention for Diverse Caregivers of AD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers of Alzheimer's Disease or Memory Problem Patients
Keywords: Alzheimer's caregivers
Technology-based intervention
Culturally-tailored intervention
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-02-10
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.


Eligibility criteria: Inclusion Criteria:

1. Speak and understand English or Spanish
2. Provide care to a loved one with memory decline
3. Not having terminal illness/condition
4. 18+ yrs old

Exclusion Criteria:

1. Not providing care to a loved one with Alzheimer disease or dementia
2. Not speak English or Spanish
3. Have cognitive deficit
4. Have terminal illness
5. Plan to place their loved one in a facility
6. Plan to move away in the next 12 months

Primary outcomes:
measure: Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Caregiving Burden as Measured by Burden Inventory
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Caregiver's Self Report of Self-care
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Caregiver's Self-report of Physical Health
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Caregiver's Self-efficacy
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Positive Aspects of Caregiving
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: David Loewenstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385501: Educational Intervention to Improve Vaccine Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Hesitancy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This research project will develop an educational intervention to improve immunization acceptance by vaccine hesitant parents. This is prospective interventional case-control trial, where the investigators will provide the intervention in the clinical setting. Enrollees will be screened and selected if they meet criteria for "vaccine hesitancy". The investigators will conduct follow up surveys following the intervention to assess change in attitude and follow immunization rates through 18 month well visit.

Detailed description: The intervention is a 8 minute video addressing common concerns that have been reported by vaccine hesitant parents. The video includes an expert in pediatric infectious diseases answering these common questions as well as 3 parental accounts of children who contracted vaccine preventable diseases. Also, the interventional group will be provided with two handouts: one listed information on how parents can find accurate vaccine information on the internet, and another that addresses more common concerns of vaccine hesitant parents and available for our use from the Children's Hospital of Philadelphia Vaccine Center website.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old for parent
* \< 30 days old for infant
* full term (\>37 weeks gestational age) infant

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in parental attitude regarding vaccines
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Vaccination rates of control and interventional groups
timeFrame: 6-8 weeks, 19 months
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Pediatric Associates
state: Tennessee
city: Nashville
country: United States
facility: University Pediatrics
state: Tennessee
Study officials:
References:
Clinical trial NCT06013501: The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia
Official title: The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Fear
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2023-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.

Detailed description: Before and during subcutaneous injection administration to the children in the study group There will be a puppet show. No distraction method will be applied to the children in the control group and the clinical A subcutaneous injection will be administered in accordance with the routine. Pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.

Eligibility criteria: Inclusion Criteria:

* Child \<3 and \>7 years old
* Medically unstable (dehydration, septic shock, sedation)
* Children who are being treated for leukemia in the Pediatric Hematology Service will be included in the study.

Exclusion Criteria:

* Not exposed to any other interventional procedure before (same day) subcutaneous intervention
* Not expressing any pain before subcutaneous intervention
* Heart rate to be within age-appropriate limits
* Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago)
* Having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment)
* The child and family do not know Turkish

Primary outcomes:
measure: procedure-related pain with Wong Baker Pain Rating Scale
timeFrame: change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
measure: procedure-related fear with Child Fear Scale
timeFrame: change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
measure: procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
timeFrame: change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Secondary outcomes:
measure: Heart rate
timeFrame: change from the heart rate at 10 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, pHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554901: The Effect of Cocoa on Platelet Function Profiles in Patients
Official title: The Effect of Cocoa on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago: The ECLAIR Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Dysfunction
Keywords: Platelet Dysfunction
Cocoa
Polyphenol
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Blood samples will be collected from participants in 2 separate instances. Initially, a baseline VerifyNow P2Y12 PRU test assay, followed by a subsequent repeat test 2-week after a 2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars).
Primary purpose: TREATMENT

Brief summary: The effects of chocolate on cardiovascular health are still a matter of debate. It can potentially favor cardiovascular health through the antioxidative effects of cocoa ingredients, such as polyphenols (present in dark but not white chocolate).

Detailed description: Epidemiologic studies have shown inverse associations between dietary polyphenols (present in dark chocolate and cocoa) and mortality from coronary heart disease. However, the basis for this protective association is uncertain. Food polyphenols such as in cocoa reportedly have antioxidant properties and decrease platelet function in vitro. The goal of the present study was to investigate whether the beneficial antioxidant effect of polyphenol-rich cocoa can induce an improvement of endothelial and platelet function in patients with stable coronary artery disease with known platelet hyperreactivity.

Eligibility criteria: Inclusion Criteria:

1. Patients with stable coronary artery disease.
2. Patients \> 18y of age.

Exclusion Criteria:

1. Patients with T2DM.
2. Patients who already ingest any cocoa-based products.

Primary outcomes:
measure: P2Y12 Reaction Units
timeFrame: 2-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Augustine
country: Trinidad and Tobago
facility: The University of the West Indies
state: North
Study officials:
References:
citation: Seecheran NA, Sukha D, Grimaldos K, Grimaldos G, Richard S, Ishmael A, Gomes C, Kampradi L, Seecheran R, Seecheran V, Peram L, Dookeeram D, Giddings S, Sandy S, Ramlackhansingh A, Raza S, Umaharan P, Tello-Montoliu A, Schneider D. Effect of cocoa (Theobroma cacao L.) on platelet function testing profiles in patients with coronary artery disease: ECLAIR pilot study. Open Heart. 2022 Sep;9(2):e002066. doi: 10.1136/openhrt-2022-002066.
Clinical trial NCT00285701: Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study
Official title: Early Detection of Pre-malignant and Malignant Conditions in the Colon by Means of Fluorescence Endoscopy Using Local and Oral Sensitisation With Hexaminolevulinate (HAL) - a Dose Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Photocure
Sponsor class: INDUSTRY
Collaborators: name: KARL STORZ Endoscopy-America, Inc.
First posted: 2006-02-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue light illumination will induce red fluorescence of polyps and tumours, improving detection of the polyps and tumors. Different HAL doses will be tested to find the optimal image conditions. Tolerability measurements will be performed to ensure patient safety.

Detailed description: Colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. The sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily missed, are often not recognised. Fluorescence imaging may increase the sensitivity of standard white light colonoscopy by identifying more polyps and flat adenomas which will make the resection of adenomas more complete.

In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient safety assessments.

Both standard white light and blue light (fluorescence) inspection will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients with suspicion of colorectal cancer
* Written informed consent
* Data protection consent
* 18-85 years

Exclusion Criteria:

* Liver cirrhosis
* Hepatitis
* Abnormal liver function
* Porphyria
* Patient non-compliance
* Coagulation disorder
* Contraindication to colonoscopy
* Pregnancy and lactation
* Participation in another study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munic
country: Germany
facility: Dept of Medicine, Munic-Hospital Pasing
state: Bayern
Study officials:
affiliation: Endlicher E, et al. Hexaminolevulinate-induced fluorescence endoscopy in patients with rectal adenoma and cancer: a pilot study. Gastrointestinal Endoscopy 2004;60:449-454
name: Brigitte Mayinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981901: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
Official title: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Epithelial Cancer
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Cancer Côte d'or registry
name: Cancer Calvados registry
First posted: 2016-12-05
Enrollment: 376
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with ovarian epithelial cancer diagnosed in 2012

Brief summary: No structured organization for ovarian first line management emerges in France. Management across France seems to depend on regional contexts.

Regions display no specific organization or delineate regional network for the ovarian cancer management or report centralized management revolving around referent centers. These different templates present a major problem in identifying differences, costs and benefit.

To deal with this issue the Investigators propose a health economic evaluation based on cost-effectiveness analyses, completed with a budget impact analysis. This study will investigate the cost-effective management of patients with initial ovarian cancer using databases representative of different parts of French territories.


Eligibility criteria: Inclusion Criteria:

* Ovarian epithelial cancer initially diagnosed in 2012
* Age \> 18 years old
* Residency in France (Rhône-Alpes region, District of Calvados and Cotes d'Or)
* First-line ovarian epithelial cancer

Exclusion Criteria:

* Relapsed ovarian epithelial cancer
* Non epithelial ovarian cancer

Primary outcomes:
measure: Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained
timeFrame: 2 years after diagnosis
Secondary outcomes:
measure: Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.
timeFrame: 2 years after diagnosis
measure: Budget impact analysis
timeFrame: 2 years after diagnosis
measure: Relapse-free survival (RFS)
timeFrame: RFS will be assessed 2 years after diagnosis
Other outcomes:
Locations:
city: Caen
country: France
facility: Calvados registry
city: Dijon
country: France
facility: Côte d'or registry
city: Lyon
country: France
facility: Oveval
Study officials:
affiliation: Centre Leon Berard
name: Isabelle RAY-COQUARD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192801: Kidney Function in Patients With Bladder Exstrophy
Official title: Evaluation of Long-term Renal Function in Patients After Surgical Repair of Classical Bladder Exstrophy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Classic Bladder Exstrophy
Renal Function
GFR
Proteinuria
Keywords: Classic Bladder Exstrophy
Renal function
GFR
Proteinuria
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with calssic bladder exstrophy

Brief summary: Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.


Eligibility criteria: Inclusion Criteria:

* All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic

Exclusion Criteria:

* No

Primary outcomes:
measure: Renal function
timeFrame: 1 day (last visit )
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center
Study officials:
References:
Clinical trial NCT01944501: Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
Official title: Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Hearing Loss
Keywords: tinnitus
hearing loss
Transcranial magnetic stimulation
Transcranial direct current stimulation
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss.

Detailed description: Tinnitus is a very common condition and affects approximately 15% of the population, disrupting sleep, emotional balance and social life of the patients. Acoustic deprivation causes hearing loss and is responsible for a cascade of processes that result in the reorganization of the cortex through a synchronization of neuronal activity related to a cortical re-mapping. Consistent with the hypothesis that tinnitus is caused by abnormal activation of the auditory cortex, repetitive transcranial magnetic stimulation (rTMS) can temporarily reduce cortical hyperactivity through direct neuromodulation of the temporal cortex. Furthermore, studies have shown that transcranial direct current stimulation (tDCS) can also suppress tinnitus. Objective: To determine the effectiveness of rTMS and TDCS in the treatment of patients with chronic tinnitus and auditory loss. Methods: We performed an analytical experimental double-blind study using rTMS and tDCS in patients with chronic tinnitus and hearing loss.

Eligibility criteria: Inclusion Criteria:

* chronic tinnitus
* hearing loss

Exclusion Criteria:

* neurological diseases
* use of drugs affecting the central nervous system
* evidence of dementia
* clinical diagnosis of depression

Primary outcomes:
measure: Change in Tinnitus Handicap Inventory (THI) scores
timeFrame: THI was measured before intervention (baseline) and after 5 daily sessions (day 5)
Secondary outcomes:
measure: Change in Visual Analog Scale scores
timeFrame: Visual analog scale of tinnitus was recorded at baseline and after daily 5 TMS or TDCS sessions ( day 5)
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Universidade de Brasília
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Joaquim P Brasil-Neto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01150604: Depression Management Project
Official title: Depression Management Project (DMP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Depression
Keywords: Cognitive Behavioral Therapy
Mood Management
Self-help
Internet
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Robert Wood Johnson Foundation
First posted: 2010-06-25
Enrollment: 547
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 determine whether an eight-lesson self-help intervention delivered online will result in a reduction of depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Participants will be 18 years of age or older,
* Participants will have regular (\>1 time/week) access to internet and email, with a valid email address,
* Participants will be fluent or almost fluent in English, and
* Participants will be looking for information to help themselves, rather than another person.
* Only those invited to participate will be eligible.

Exclusion Criteria:

* Participants under 18 years of age,
* Participants will with sporadic (\< 1 time/week) access to internet and email,
* Participants who fail to provide an email address,
* Participants with English difficulties,
* Participants looking for information to help someone else, and
* Participants not invited will be ineligible.

Primary outcomes:
measure: Quick Inventory of Depressive Symptoms - Self-report
timeFrame: Baseline, 1, 2, and 5 months post consent
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yan Leykin, PhD
role: PRINCIPAL_INVESTIGATOR
References: