louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05107648: Gardner Packard Healthy Lifestyles Program
Official title: Gardner GOALS for Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gardner GOALS is a 6 month program for treatment of childhood obesity that consists of twice monthly telehealth meetings with a health educator. Potential participants enter the study using a randomly ordered list of eligible patients based on BMI, age and number of clinic visits in 2020.

Detailed description: The Gardner GOALS curriculum focuses on healthy eating and activity. The study participants are kids 6 to 14 years old with BMI ≥95th percentile who are patients at the Gardner Packard Children's Health Center, a federally qualified health center. Lessons contain educational materials and behavioral change strategies to promote healthy eating and physical activity and reduce screen time. Patients are encouraged to continue routine clinic visits with their primary care physicians during the course of the study.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 95th percentile
* Two clinic visits in 2020

Exclusion Criteria:

* Signs of an eating disorder
* Moved out of town and not planning to return to Gardner Packard Children's Health Center

Primary outcomes:
measure: Body mass index
timeFrame: Baseline, year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Atherton
country: United States
facility: Gardner Packard Children's Health Center
state: California
Study officials:
affiliation: Stanford University
name: Elizabeth Shepard, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00809848: Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Hypertension
Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 172
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 study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma
* Females of non-childbearing potential
* Subject requires IOP-lowering therapy in both eyes
* IOP ≥ 22 mm Hg and ≤ 34 mm Hg
* Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Active ocular disease
* Alteration of existing chronic systemic medications
* Known allergy or sensitivity to the study medications
* Ophthalmic corticosteroids
* Visual field loss which in the opinion of the investigator is functionally significant
* History of ocular laser, intraocular surgery, or refractive surgery

Primary outcomes:
measure: Change From Baseline in Average Eye Intraocular Pressure (IOP)
timeFrame: Baseline, Day 14 Hour 0
Secondary outcomes:
measure: Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
timeFrame: Baseline, Day 14
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00188448: MRI Superficial Temporal Artery
Official title: MRI of the Superficial Temporal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Temporal Arteritis
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Repeat MRI of the Superficial temporal Artery in 5 volunteers

Detailed description: Repeat MRI of the Superficial temporal Artery in 5 volunteers

Eligibility criteria: Inclusion Criteria:

* controls with normal temporal arteries

Exclusion Criteria:

* contraindication to MR

Primary outcomes:
measure: Accuracy in displaying the superfifical temporal artery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02232048: The Influence of Corticosteroid Treatment on Heart Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Function
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being treated with corticosteroids for various clinical indications who have been hospitalized in the internal medicine department of the Hillel Yaffe Medical Center.

Brief summary: Patients hospitalized in internal medicine departments are given corticosteroid treatment according clinical indications. Patients receive treatment at different dosage levels and in different preparations according to clinical indications. This study will investigate how corticosteroids effect the heart and specifically, longitudinal strain.


Eligibility criteria: Inclusion Criteria:

* Stable patients able to undergo Transthoracic Echocardiogram
* Patients beginning treatment with corticosteroids

Exclusion Criteria:

* Pregnant
* Patients recently or chronically treated with corticosteroids

Primary outcomes:
measure: Change in Heart Function
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00540748: Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful?
Official title: Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Keywords: first trimester abortion
oxytocin
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2007-10-08
Enrollment: 400
Sex: FEMALE
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 is a randomized, single-blind study using oxytocin 5U i.v. during surgical abortion in one arm of the study, and no medication in the other arm of the study. Comparison is done between the two groups measuring the following outcomes: pain, nausea and blood loss. The investigators' hypothesis is that there will be no significant differences between the two groups.

Detailed description: All women seeking surgical abortion before 12 weeks of pregnancy will be invited to participate in the study. We will include 400 patients. Written consent is given. Pain is measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively. Nausea is categorized in 4 groups, from 1 (no nausea) to 4 (pronounced nausea with vomiting)and is registered together with bloodloss also during the hospital stay (2 hours) and 2 days postoperatively. The two groups will be compared.

Eligibility criteria: Inclusion Criteria:

* seeking legal abortion
* first trimester
* surgical intervention
* no current medication
* fluent in norwegian language

Exclusion Criteria:

* current medication
* medical condition with coagulopathy

Primary outcomes:
measure: blood loss, pain, nausea
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baerum
country: Norway
facility: Kvinneklinikken SABHF
state: Rud
Study officials:
affiliation: Kvinneklinikken SABHF
name: Annelill Valbo, consultant, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06204848: Imaging of Vitreous Opacities in a Canadian Population
Official title: Acquisition of Imaging Data of Vitreous Opacities in Human Eyes Using a Non-Invasive Imaging Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Floaters
Vitreous Opacities
Lead sponsor: PulseMedica
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to capture imaging data of eye floaters in the population to build an imaging database to learn more about them in. Participants will imaged with an investigational ophthalmic imaging device to capture images of their floaters.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Symptomatic vitreous opacities (floaters) in vision
* Clear ocular media, to allow a clear view of the vitreous for the SVO-ID

Exclusion Criteria:

* Younger than 18 years of age
* Presence of vitreous hemorrhage
* Cataract Grade 3 and above
* Opacification of lens, cornea, or vitreous
* Diagnosis of narrow angle glaucoma
* Refractive error is outside the range of -6D to+3D
* Astigmatism is outside the range of +/-2D of cylinder

Primary outcomes:
measure: Successful capture of SLO and OCT imaging data of SVOs for algorithm development
timeFrame: Through study completion, an average of 6-8 months
Secondary outcomes:
measure: Collection of patient-reported symptoms
timeFrame: Through study completion, an average of 6-8 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Retina Consultants
state: Alberta
Study officials:
References:
Clinical trial NCT02113748: Downhill Walking Training in COPD
Official title: Downhill Walking to Enhance Training Effects in Patients With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary disease, chronic obstructive
Downhill walking
exercise
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-04-15
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD.

Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.


Eligibility criteria: Inclusion Criteria:

* Patients with a primary diagnosis of COPD according to internationally accepted guidelines
* Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium)

Exclusion Criteria:

* Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities
* Absence of exacerbations in the previous month before entering the present study
* Patients included on the waiting list for lung transplantation

Primary outcomes:
measure: changes in 6-minute walking distance
timeFrame: changes from baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vl-Brabant
Study officials:
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camillo CA, Osadnik CR, Burtin C, Everaerts S, Hornikx M, Demeyer H, Loeckx M, Rodrigues FM, Maes K, Gayan-Ramirez G, Janssens W, Troosters T. Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. Eur Respir J. 2020 Sep 17;56(3):2000639. doi: 10.1183/13993003.00639-2020. Print 2020 Sep.
Clinical trial NCT00808548: Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prader-Willi Syndrome
Keywords: stress
carer's experiences
Prader-willi syndrome
personal experiences
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a person who care and live with childre with Prader-Willi syndrome

Brief summary: Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention


Eligibility criteria: Inclusion Criteria:

* a person who care and live with children with Prader-Willi syndrome

Exclusion Criteria:

* siblings or less-contact family
* teachers

Primary outcomes:
measure: experience
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT01112748: Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury
Official title: Evaluation of Predictors of Response for the Efficacy of Topical Lidocaine Patch (Versatis) on Chronic Neuropathic Pain After Peripheral Nerve Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Keywords: Focal neuropathic pain
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Grünenthal Denmark ApS
First posted: 2010-04-28
Enrollment: 24
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 primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The primary outcome measure is the predictive role for these three measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point pain reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric rating scale) of pain from the baseline week to the last week of lidocaine treatment). Secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week versus last week of each treatment) and pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.


Eligibility criteria: Inclusion Criteria:

* patients aged 18 or more with neuropathic pain after a peripheral nerve injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale.

Exclusion Criteria:

* pregnancy or lactation,
* allergy to lidocaine,
* alcohol abuse,
* psychiatric disorders,
* skin diseases in the area where the patches are to be applied,
* treatment with class I antiarrhythmic agents,
* any treatment within the past one month or concomitantly with Na2+-channel blockers (e.g., mexiletine, phenytoine, propafenone),
* any topical treatment with capsaicin within the last three months before entering the study, or any other topical treatment in the area of neuropathic pain,
* concomitant therapy with TENS or acupuncture.

Primary outcomes:
measure: Change in pain intensity (measured daily on a 10 point NRS)of spontaneous pain from baseline week to last week of treatment
timeFrame: 4 or 12 weeks
Secondary outcomes:
measure: Pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain
timeFrame: 4 or 12 weeks
measure: Effect on ongoing pain, brush-evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia
timeFrame: 4 or 12 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Danish Pain Research Center
Study officials:
affiliation: Danish Pain Research Center
name: Nanna B. Finnerup, MD, DMSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00787748: COPD and Cardiovascular Risk in the Population
Official title: COPD and Cardiovascular Risk in the Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Cardiovascular Disease
Keywords: Cardiovascular
COPD
Population
Prevalence
Underdiagnosis
Lead sponsor: Cimera
Sponsor class: NETWORK
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2008-11-07
Enrollment: 623
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Random population sample, and a sample of hospital cardiovascular patients

Brief summary: The prevalence of chronic obstructive pulmonary disease (COPD) in patients with cardiovascular disease (CVD) is unknown, and whether or not COPD is adequately diagnosed and treated in these patients has not been investigated before.

We hypothesized that the prevalence of COPD would be significantly higher (30%) in patients with CVD than in the general population. Besides, we anticipated that COPD, a potentially treatable CV risk factor, would be undiagnosed in more than 80% of CVD patients.

Detailed description: We aim to compare clinical and spirometric data in three groups of individuals. Two of them are participants in an ongoing population-based study (CORSAIB) aimed at investigating the distribution of CVD risk factors in the general population of the Balearic Islands, Spain. The design and full methodological details of the CORSAIB study have been published elsewhere (Rigo F, et al. Rev Clin Espa 2005). A third group will include patients with stable CVD regularly visited at the referral hospital of our community.

Inclusion criteria for the study are male and female individuals, aged 40 to 81 years, residents of the Balearic Islands, and who are willing to participate in this research.

Eligibility criteria: Inclusion Criteria:

* residents of the Balearic Islands
* willing to participate in this research
* able to sign the written consent form

Exclusion Criteria:

* none

Primary outcomes:
measure: Prevalence of COPD defined according to the current GOLD guidelines as a post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) <0.7.
timeFrame: Current
Secondary outcomes:
measure: Underdiagnosis of COPD
timeFrame: Current
measure: Undertreatment of COPD
timeFrame: Current
Other outcomes:
Locations:
city: Bunola
country: Spain
facility: CIMERA
state: Illes Balears
Study officials:
affiliation: Atención Primaria de Mallorca
name: Fernando Rigo, MD
role: STUDY_DIRECTOR
affiliation: Cimera
name: Alvar Agusti, MD
role: STUDY_DIRECTOR
References:
citation: Soriano JB, Rigo F, Guerrero D, Yanez A, Forteza JF, Frontera G, Togores B, Agusti A. High prevalence of undiagnosed airflow limitation in patients with cardiovascular disease. Chest. 2010 Feb;137(2):333-40. doi: 10.1378/chest.09-1264. Epub 2009 Sep 25.
Clinical trial NCT01156948: Misoprostol For Nulliparous Women Before Hysteroscopy
Official title: Comparison of Vaginal Versus Oral Misoprostol for Nulliparous Women Prior to Operative Hysteroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Ripening
Keywords: misoprostol
nulliparous
hysteroscopy
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2010-07-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Detailed description: There is no consensus on the effect of misoprostol on cervical ripening for nulliparous women. The aim of the study is to compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.

Exclusion Criteria:

* women with a known allergy to misoprostol.

Primary outcomes:
measure: cervical width
timeFrame: one day
Secondary outcomes:
measure: side effects
timeFrame: one day
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: the 1st Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: the 1st affiliated hospital of Wenzhou Medical College
name: Feng Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781948: Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT
Official title: Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cornea
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2016-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine or follow-up care

Brief summary: Evaluate the repeatability and reproducibility of iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.


Eligibility criteria: Inclusion Criteria:

Normal

* Able and willing to provide consent.
* Able and willing to complete required exams. Corneal conditions
* Able and willing to provide consent.
* Able and willing to complete required exams.
* History of refractive surgery, contact lens, dry eye or keratoconus.

Exclusion Criteria:

Normal

* History of refractive surgery, contact lens, dry eye or pathology.
* Blepharitis or meibomitis
* Unable to complete required exams. Corneal conditions
* Unable to complete required exams.

Primary outcomes:
measure: Epithelial thickness
timeFrame: Day 1
Secondary outcomes:
measure: Corneal thickness
timeFrame: Day 1
Other outcomes:
measure: Stromal thickness
timeFrame: Day 1
Locations:
Study officials:
References: