louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05276557: PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Official title: PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Helicobacter Pylori
Safety
Efficacy
Lead sponsor: ARJ Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.

Centers will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.

Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.

Total duration of study is anticipated to be approximately 6 months.


Eligibility criteria: Inclusion Criteria:

* Male or female age 3-17 at the time of visit
* Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
* Naive to H. pylori treatment in the past 4 weeks

Exclusion Criteria:

* Pregnant and/or lactating women
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
* Participation in other interventional trials
* Allergy to test substrates
* Antibiotics taken within 4 weeks of the testing
* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food
* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group

Primary outcomes:
measure: Number of participants with recorded adverse events
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of Agreement
timeFrame: 7 days
Other outcomes:
Locations:
city: Doral
country: United States
facility: Dolphin Medical Research
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: El Paso
country: United States
facility: Harmony United Research
state: Texas
Study officials:
References:
Clinical trial NCT00291057: Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Official title: Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lice Infestations
Keywords: Pediculosis
Head Lice
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Eligibility criteria: Inclusion Criteria:

* Confirmed active head lice infestation
* Parent or guardian must be able to apply treatment

Exclusion Criteria:

* Allergy to pediculicides or hair care products
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment

Primary outcomes:
measure: Change in cholinesterase level
timeFrame: 1 day
Secondary outcomes:
measure: Clinical evidence of cholinesterase inhibition
timeFrame: 1 day
measure: Local tolerability
timeFrame: 1 day
measure: Cure of head lice 14 days after last treatment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigator Site
state: Arizona
city: St. Petersburg
country: United States
facility: Investigator Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigator Site
state: Florida
city: New York
country: United States
facility: Investigator Site
state: New York
city: Miamiville
country: United States
facility: Investigator Site
state: Ohio
Study officials:
References:
Clinical trial NCT03424057: Asymmetric Primary Closure and Additional Skin Excision Technique.
Official title: A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Pilonidal Disease of Natal Cleft
Surgical Technique
Keywords: Karydakis modification
pilonidal sinus
seroma
Lead sponsor: Siverek Devlet Hastanesi
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

Detailed description: All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.

In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.

In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.

In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Eligibility criteria: Inclusion Criteria:

* All patients between age of 18-65 who had chronic pilonidal disease

Exclusion Criteria:

* Patients who did not accept the procedure
* Patients had undergone previous pilonidal sinus surgery
* Patientshad active infection
* Patients who were not minimum of 18 years of age

Primary outcomes:
measure: Early postoperative complications.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00216957: Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
Official title: Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Disease
Lead sponsor: Maritime Heart Centre
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Coronary artery bypass grafting (CABG) is a well established treatment modality for patients with coronary artery disease. For 30 years now CABG operations have been performed with the help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is believed to be responsible for many of the side effects and complications seen in patients following CABG surgery. The organs most commonly affected are the brain, blood constituents, lungs and kidneys.

In the last few years, stabilising devices have been developed that allow CABG operations to be performed safely without the use of the heart lung machine. Our hypothesis was that CABG done without the heart lung machine may be better tolerated by patients resulting in lower morbidity, increased functional outcome and shorter hospital length of stay.

Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient was enrolled in June of 2003. The initial results from the study suggest that excellent results can be obtained with both techniques and contrary to others no advantages could be demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass (Legare et al. Circulation 2005).

Detailed description: We are now in follow-up to evaluate the medium term and long term outcomes of all 300 patients originally enrolled in above mentioned randomized clinical trial. The follow-up of patients is approved by the Capital Health Research Ethics Board (CDHA-RS/2004-295).

Eligibility criteria: Inclusion Criteria:

* Any patient suitable for CABG surgery

Exclusion Criteria:

* Emergency, concomitant procedure, low ejection fraction (\<20%)

Primary outcomes:
measure: Length of hospitalization
measure: Blood product utilization
measure: Post operative atrial fibrillation
Secondary outcomes:
measure: Myocardial infarction
measure: Mortality
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Jean-Francois Legare, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06840457: COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
Official title: COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mental Health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-02-21
Enrollment: 4400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.


Eligibility criteria: Inclusion Criteria:

* Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services.
* Must have daily access to a smartphone version that is compatible with study activity trackers.
* Understands English to enable consent and use of the MyDataHelps app and app-based interventions

Exclusion Criteria:

* Self-reported or medical record indication of a current eating disorder
* Unable to provide informed consent (e.g., cognitive or guardianship restrictions)
* Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)

Primary outcomes:
measure: Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
timeFrame: From enrollment to the 6-week assessment.
measure: Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
timeFrame: From enrollment to the 6-week assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04499157: Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
Official title: Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open-angle Glaucoma
Visual Field
Keywords: Citicoline
Gingko biloba
magnesium
Open-angle Glaucoma
visual field
MEMOPTIC
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients.

The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* diagnosis of GCAO defined by OCT RNFL alterations and visual fields defects
* age between 20 and 80 years old
* Well controled intra-ocular pressure under treatment (PIO\<21mmHg or decreased by 20% compared to initial the PIO)

Exclusion Criteria:

* retinal or macular disease
* diagnosis of cataract or surgery of cataract during the follow-up
* allergy to citicolin
* ocular hypertonia due to a secondary cause (like corticosteroids)
* history of anterior, intermediate or posterior uveitis
* general treatment affecting PIO (beta blockers, corticosteroids)
* pregnancy or breastfeeding

Primary outcomes:
measure: Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment
timeFrame: from day 0 to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Claire Iscar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02599857: The Effects of a CONCOR Smartphone Application
Official title: The Effects of a CONCOR Smartphone Application on Arrhythmia, Heart Failure Events and Quality of Life in Patients With Congenital Heart Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congenital Heart Disease
Smartphone Application
Arrhythmia
Heart Failure
mHealth
Mobile Health
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 0
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: Life expectancy of children with congenital heart disease (CHD) has increased dramatically during the past years, due to the successes of cardiac surgery. Nearly all of these children with CHD can be operated at young age and more than 90% reach adulthood. However, many adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. These events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult CHD. Especially for adults with CHD patient care with a smartphone is suited because of their young age and chronic condition. So far, data are lacking on smartphone interventions in patients with CHD.

Detailed description: The investigators aim to determine feasibility of CONCOR smartphone application management in adults with CHD. Moreover, during a twelve months follow up period the investigators aim to evaluate whether management with a CONCOR smartphone application results in a lower rate of heart failure events and arrhythmia as well as a better quality of life than usual care, because of increased patient awareness, behavioral stimuli, healthy life style reminders and more precise medical treatment.

Eligibility criteria: Inclusion Criteria:

* Adults with CHD being an Academic Medical Center (AMC) patient and/ or patients registered in the Dutch CONCOR registry
* Owning a smartphone

Exclusion Criteria:

* Mental retardation and/ or Down syndrome

Primary outcomes:
measure: Composite of arrhythmia and heart failure events
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: Medication adherence questionnaire
timeFrame: 1 year
measure: Usability and learnability questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References:
Clinical trial NCT02044757: The Potentially Addictive Properties of Soda: A Feasibility Study
Official title: The Potentially Addictive Properties of Soda: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Withdrawal Symptoms
Keywords: Caffeine
Addiction
Withdrawal symptoms
Pediatric
Adolescent
Overweight
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2014-01-24
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.


Eligibility criteria: Inclusion Criteria:

* Drinks more than 36 ounces of sugar-sweetened beverages per day
* Speaks fluent English
* Parent speaks English or Spanish
* Lives in San Francisco Bay Area

Exclusion Criteria:

* Pregnant or nursing
* Taking medication to address mental health issues

Primary outcomes:
measure: Symptoms of withdrawal
timeFrame: Days 1-3 and days 6-8
Secondary outcomes:
measure: Change in diet
timeFrame: Days 1-2, 6-8
measure: Change in impulsivity
timeFrame: Days 1 and 8
measure: Change in stress
timeFrame: Days 1 and 8
measure: Change in preference for soda
timeFrame: Days 1-3, 6-8
Other outcomes:
measure: Compliance with intervention to only drink water and unflavored milk during the SSB withdrawal phase
timeFrame: Days 6-8
Locations:
city: Oakland
country: United States
facility: Children's Hospital and Reasearch Center Oakland
state: California
Study officials:
affiliation: University of California, Berkeley School of Public Health
name: Kristine A Madsen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00202657: Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide
Official title: Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Pergolide
Keywords: parkinson's disease
pergolide
heart valve disease
Lead sponsor: Société Française de Cardiologie
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2005-09-20
Enrollment: 149
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: Patients treated with Pergolide for Parkinson disease or Patients with parkinson disease not treated with Pergolide

Brief summary: The purpose of this study is to determine whether patients with Parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinson's disease not treated with pergolide.

Detailed description: Pergolide is an ergot dopamine receptor agonist with demonstrated efficacy in Parkinson's disease. Last year, two studies showed that pergolide can induce unexpected heart valve disease potentially severe and frequent. The late discovery of this unknown side effect had dramatic consequences in Parkinson's disease management and the French drug agency (AFFSAPS) has recently published guidelines for its prescription. Little is known about the prevalence and the molecular mechanisms leading to this adverse event. To determine the prevalence, evolution, and potential risk factors of pergolide-induced heart valve disease, we propose an echocardiographic observational study in parkinsonian patients taking pergolide compared to matched controls. This clinical study will be performed in the Clinical Investigation Centre in collaboration with the Institute of Cardiology of the Salpétrière Hospital

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease
* Hoehn and Yahr score inferior or equal to 4
* treated with pergolide since more than 3 months (pergolide group)
* never treated by pergolide (control group)

Exclusion Criteria:

* Parkinson + syndrome, multiple system atrophy, supranuclear palsy
* hoehn and yahr score equal to 5

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Investigation Centre, Pitie-Salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Christophe CORVOL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corvol JC, Anzouan-Kacou JB, Fauveau E, Bonnet AM, Lebrun-Vignes B, Girault C, Agid Y, Lechat P, Isnard R, Lacomblez L. Heart valve regurgitation, pergolide use, and parkinson disease: an observational study and meta-analysis. Arch Neurol. 2007 Dec;64(12):1721-6. doi: 10.1001/archneur.64.12.1721.