louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01751464: A WrapAround Case Management Program for Youth Injured by Violence
Official title: A WrapAround Case Management Program for Youth Injured by Violence: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intentional Injury
Keywords: youth
violence
injury
emergency department
intervention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a feasibility study of a WrapAround Case Management Program for Youth Injured by Violence. Youth (aged 10-24) who have been injured by violence and visit the emergency department will be offered a support worker who will provide WrapAround Case Management. This study is designed to assess the feasibility of recruitment, enrollment and follow-up.


Eligibility criteria: Inclusion Criteria:

1. Age 10 - 24 and
2. Presentation to an ED or trauma floor with an injury caused by violence (defined as an injury inflicted by someone else and one of a gunshot wound, stab wound, injury due to blunt object, or injury due to bodily force).

Exclusion Criteria:

1. Unable to consent due to language or brain injury,
2. Sexual assault,
3. Child Abuse
4. Self-Inflicted Injury,
5. Subject is under arrest or
6. Non-resident of Winnipeg.

Primary outcomes:
measure: To estimate the recruitment rate of an ED referral program for injured youth
timeFrame: 6 months
Secondary outcomes:
measure: To identify barriers to participation in a hospital-based case management program
timeFrame: 6 months
measure: To determine the average number of contacts and amount of time required per participant
timeFrame: 6 months
measure: To estimate the rates of follow-up among those successfully recruited
timeFrame: 6 months
measure: To determine the most appropriate way to notify the case manager of an eligible participant
timeFrame: 6 months
measure: To determine the most successful enrollment strategy for retention of participants
timeFrame: 6 months
measure: To determine level of engagement between the case manager and youth
timeFrame: 6 months
measure: To determine the most appropriate method of follow-up
timeFrame: 6 months
measure: To determine the impact in violence-related attitudes and behaviours among participants
timeFrame: 6 months
measure: To determine the impact on recurrent intentional injury amongst participants
timeFrame: 6 months
measure: To determine the impact on modifiable risk factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Carolyn E Snider, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512564: Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia
Official title: Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia - An Observational and Laboratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Anemia
Sickle Cell Thalassemia
Keywords: Sickle Cell Anemia
Sickle Cell Thalassemia
Iron overload
Non transferrin binding iron
Hepcidin
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All tha patinets suffering from Sickle cell disease trreated at the Pediatric Hematology Unit

Brief summary: Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't developed significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpose of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order to determine the cardiac and liver iron.


Eligibility criteria: Inclusion Criteria:

* All the patients with Sickle Cell Anemia and Sickle Cell Thalassemia that are treated and followed up at the Pediatric Hematology Unit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01234064: Graduated Compression Stockings (GCS) Pilot Substudy
Official title: Graduated Compression Stockings (GCS) for Prevention of Venous Thromboembolism in Patients Who Have Major Surgery: Pilot Study Assessing Feasibility of Adding This Evaluation to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Symptomatic Venous Thromboembolism
Graduated Compression Stockings
Randomized Controlled Trial
Noncardiac Surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: BSN Medical Inc
name: McMaster University
First posted: 2010-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an intervention.

Detailed description: Objective: To determine if thigh-level graduated compression stockings (below-knee graduated compression stockings may be used if thigh level graduated compression stockings are not feasible, such as after knee surgery), started before surgery and worn until discharge and for a minimum of 10 days (whichever is longer), reduce symptomatic venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) in the 30 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Randomized to PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)

Exclusion Criteria:

* Unable to wear a graduated compression stockings on a leg that has been operated on (e.g., below knee skin grafting)
* Leg has not been operated on and graduated compression stockings cannot be worn on either leg (e.g. bilateral leg amputations or skin ulceration, allergy to material in the graduated compression stockings)
* Graduated compression stockings cannot be fitted because the patient's legs are too big, or too small (not compatible with manufacturer's recommendations)
* The responsible physician/nurse judges that graduated compression stockings are contraindicated because of: i) decreased circulation in the legs as evidenced by very pale, cyanotic, or gangrenous conditions; or ii) risk of stocking-induced skin necrosis due to an established sensory neuropathy with numbness to touch.

Primary outcomes:
measure: Objectively confirmed symptomatic major venous thromboembolism
timeFrame: 30 days
Secondary outcomes:
measure: Any symptomatic venous thromboembolism or pulmonary embolism
timeFrame: 30 days
measure: Major venous thromboembolism and death
timeFrame: 30 Days
measure: Safety Outcomes
timeFrame: 30 Days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Henderson Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Clive Kearon, MB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06688864: Under-Resourced Adults With Chronic Pain eHealth Study
Official title: Delivery of an eHealth Intervention for Under-resourced Adults With Chronic Pain (Flourish Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the feasibility of the dissemination of a cognitive-behavioral eHealth application (app) for pain self-management with Black and LGBTQ+ adults with high-impact chronic pain lasting at least 3 months and disrupting daily functioning (Implementation aim).


Eligibility criteria: Inclusion Criteria:

* Identify as Black or LGBTQ+.
* Reside in MN, WI, or IA.
* Chronic pain diagnosis for at least 3 months.
* Experience chronic pain that makes it harder to do their day-to-day activities
* Have daily access to a smart mobile device (smartphone or table) and are willing to use the EPIO app.

Exclusion Criteria:

* Unable or unwilling to use the digital app for the study
* Do not have daily access to a smart mobile device (smartphone or tablet)
* Self-report cancer related pain, or severe untreated psychological illness (e.g., psychosis); and/or do not fit into one of the demographic categories listed in #1-3 for inclusion criteria.

Primary outcomes:
measure: Change in West Haven Yale Multiphasic Pain Inventory (WHYMPI) score
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Pain Catastrophizing Scale (PCS) score
timeFrame: Baseline, 3 months
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ) score
timeFrame: Baseline, 3 months
measure: Change in Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) score
timeFrame: Baseline, 3 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Baseline, 3 months
measure: Change in Short Form-36 score
timeFrame: Baseline, 3 months
measure: Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score
timeFrame: Baseline, 3 months
measure: Change in Perceived Stress Scale (PSS) score
timeFrame: Baseline, 3 months
measure: System Usability Scale score (SUS)
timeFrame: 3 months
measure: Everyday Discrimination Scale-Expanded (EDS-E) score
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eleshia J. Morrison, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940664: CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
Official title: CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Retinal
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with surgical retinal

Brief summary: The aims of this study were

* to analyze CD160 expression in both normal and pathological eyes from human adults
* to evaluate association between CD160 presence on endothelial cells from blood vessels and retinal vascular disease

Detailed description: Anti-angiogenic agents stand first in the treatment of neovascular diseases of the retina. Intravitreal injections of anti-Vascular Endothelial Growth Factor (VEGF) agents have emerged over the past decade as the first line of treatment in some neovascular diseases of the retina. Nevertheless, anti-VEGF therapies suffer some limitations, among which a short time to recurrence (1 week to 3 months) of retinal neovascularization and an eroding biological effect after prolonged use and.

CD160 appeared in several experimental studies as a marker of activated endothelial cells, suggesting it could represent a promising target for novel anti-angiogenic.

Eligibility criteria: inclusion criteria :

* Patients with retinal surgery
* Patients who agree to participate to the study
* Major patient

exclusion criteria :

* Patient under law protection
* Minor patient

Primary outcomes:
measure: CD160 staining intensity score
timeFrame: Day0
Secondary outcomes:
measure: CD105 staining intensity score
timeFrame: Day0
Other outcomes:
Locations:
city: France
country: France
facility: Chu Reims
state: Reims
Study officials:
References:
citation: Henry A, Boulagnon-Rombi C, Menguy T, Giustiniani J, Garbar C, Mascaux C, Labrousse M, Milas C, Barbe C, Bensussan A, Durlach V, Arndt C. CD160 Expression in Retinal Vessels Is Associated With Retinal Neovascular Diseases. Invest Ophthalmol Vis Sci. 2018 Jun 1;59(7):2679-2686. doi: 10.1167/iovs.18-24021.
Clinical trial NCT05368064: Cleidocranial Dysplasia (CCD): From Genotype to Phenotype and Considerations for Care
Official title: Cleidocranial Dysplasia (CCD): From Genotype to Phenotype and Considerations for Care
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cleidocranial Dysostosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Greenberg Center
First posted: 2022-05-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with clinical or molecular diagnosis of CCD

Brief summary: Cleidocranial Dysplasia (CCD) is a rare, autosomal dominant disorder characterized by dysplasia of bones and teeth. Given the rarity of this condition (prevalence of 1 in 1,000,000), the variable phenotype and lack of correlation to specific genotypes, coordinated clinical research is needed to better understand CCD. The purpose of this project is to: investigate the genetic makeup and phenotypic expression of CCD, understand the quality of life for patients with this diagnosis, and further identify the multidimensional healthcare needs of these patients. Participation involves completion of a survey to ascertain medical history and quality of life, a physical exam and research whole exome sequencing from a blood or saliva sample. The goal of this research is to elucidate critical pathways in skeletal and dental development and improve quality of life for CCD patients through the standardization and optimization of timely diagnosis and multidisciplinary care.


Eligibility criteria: Inclusion Criteria:

* Patient has molecular or clinical diagnosis of CCD
* Caregiver or parent of patient with CCD.

Exclusion Criteria:

* Patient does not have CCD
* Patient over 18 but cannot consent for themselves
* Not fluent in English.

Primary outcomes:
measure: Presence of RUNX2 mutation
timeFrame: 3 years
measure: Phenotypic description of each patient with CCD
timeFrame: 3 years
Secondary outcomes:
measure: Patient financial stress quality of life score as assessed by the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)
timeFrame: 3 years
measure: Patient-reported health-related quality of life as assessed by the FANLTC (Functional Assessment of Non-life-threatening conditions)
timeFrame: 3 years
measure: Patient-reported health-related quality of life
timeFrame: 3 years
measure: Caregiver-reported quality of life of caregivers for patients with CCD
timeFrame: 3 years
measure: Whole exome sequencing if RUNX2 molecular analysis negative for pathogenic variant
timeFrame: 3 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ilana Ickow, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00359164: Phase II Pilot Study of Visudyne® Photodynamic Therapy (PDT) (Low and Very Low Fluence) Combined With Bevacizumab.
Official title: A Randomized, Controlled, Double-Masked, Phase II Pilot Study of Visudyne® Photodynamic Therapy (PDT) (Low and Very Low Fluence) Combined With Bevacizumab (Avastin), in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: AMD
Avastin
Visudyne
Medical condition being studied AMD
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2006-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if Visudyne photodynamic therapy (low or very low fluence rate) combined with intravitreal injections of bevacizumab (Avastin) compared with bevacizumab alone will, with similar safety and efficacy, delay time to retreatment with bevacizumab after the initial treatment, in subjects with new wet AMD Hypothesis: PDT in combination with Avastin at either the low or very low fluence rate will delay time to retreatment and reduce the average number of treatments required, compared to Avastin alone, but will have a similar safety and efficacy profile.


Eligibility criteria: Inclusion Criteria:

new wet AMD

Exclusion Criteria:

-

Primary outcomes:
measure: To determine if Visudyne therapy (low or very low fluence rate) combined with bevacizumab compared with bevacizumab alone will, with similar safety and efficacy, delay time to retreatment with bevacizumab
Secondary outcomes:
measure: To determine if Visudyne therapy (low or very low fluence rate) combined with bevacizumab compared with bevacizumab alone will, with similar safety and efficacy, reduce the average number of bevacizumab treatments
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital Eye Care Centre (UBC)
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Michael Potter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784064: Multicenter Survey About Acute Uncomplicated Diverticulitis Management
Official title: Multicenter Survey About Acute Uncomplicated Diverticulitis Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Uncomplicated Diverticulitis
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every surgeon with emergency surgery activity or colorectal surgeons that work at any Spanish hospital.

Brief summary: Acute uncomplicated diverticulitis is a quite prevalent situation and consultation in the emergency department.

Its management has progresively changed towards a more conservative one and it is currently recommended in several guidelines the option of avoiding antibiotics in certain highly selected cases.

Nevertheless, the implantation of such recommendations in current clinical pratice is unknown and, hypothesizing it was still low, the reasons for such reluctancy are also unknown.

Both aspects can be considered quite interesting in order to design a specific plan in order to overcome such difficulties.

In order to do so, an online survery was designed and colorectal surgeons along Spain, based in the census of the Young Group from the Spanish Association of Colorectal Surgery were invited to participate. Invitations were distributed along usual communication channels of this group, such as email or chat mobile phone applications. All the responses to the survey will be analyzed in order to find out how many hospitals are using current managemente without antibiotics, its characteristics and, opposite, what are the main reasons for those hospitals that are not using it yet.


Eligibility criteria: Inclusion Criteria:

* Colorectal surgeons.
* Surgeons with emergency surgery activity.

Exclusion Criteria:

* Any other medical speciality.

Primary outcomes:
measure: Acute uncomplicated diverticulitis management without antibiotics
timeFrame: 3rd january 2023-30th may 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
References:
Clinical trial NCT04269564: Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound
Official title: the Use of Intraoperative Bedside Lung Ultrasound in Optimizing "Positive End Expiratory Pressure"PEEP in Patients Undergoing Laparoscopic Bariatric Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis, Postoperative Pulmonary
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 40
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: PREVENTION

Brief summary: Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.

in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric patients to prevent postoperative collapse and atlectasis with simple non-invasive procedure.


Eligibility criteria: Inclusion Criteria:

* they are between 18 and 65 years of age
* BMI more than 35
* patients with normal respiratory functions
* ASA 1 or 2

Exclusion Criteria:

* Previous lung surgery
* Bronchial asthma
* Contralateral lung bullae 4. Uncompensated cardiac disease (NYHA class 3 or 4) 5. Obstructive or restrictive lung disease 6. Patients on home oxygen therapy 7. Hemodynamic instability and increased intracranial pressure 8. In adittion , any patient who developes hemodynamic instability (MAP \<60mmHg) or hypoxia (Po2 less than 60) during the study will excluded from the study

Primary outcomes:
measure: efficacy of lung ultrasound in optimizing peep
timeFrame: intraoperative and early postoperative first 24 hours after recovery from anaesthesia
Secondary outcomes:
measure: effect on early postoperative oxygenation
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
citation: Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
citation: Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.