louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03794700: Pilot Evaluation of Hospice Decision Support Tools
Official title: Pilot Evaluation of Hospice Decision Support Tools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospice
End-of-life Decision Making
Hospice Decision Making
Keywords: Hospice
End-of-life
Patient decision aid
Shared decision making
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-01-07
Enrollment: 131
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to determine the feasibility and acceptability of a hospice decision aid among a diverse population of older adults at multiple stages of illness (Aim 1) and to determine the preliminary efficacy of the hospice decision aid on decision quality, hospice knowledge, and values-concordance (Aim 2). By testing the feasibility, acceptability, and preliminary efficacy of a novel hospice Patient Decision Aid (PTDa) in a diverse population of older adults, additionally the study will simultaneously explore barriers to PtDA implementation in both an outpatient primary care and inpatient palliative care setting. The study will also gather sufficient pilot data to support a subsequent effectiveness/implementation trial and thus address the absence of quality of SDM interventions for end-of-life care decision-making.


Eligibility criteria: Inclusion Criteria:

* 65 or older.
* At least one life-limiting illness or syndrome.

Exclusion Criteria:

* Non-English speakers.
* Patients with cognitive Impairments preventing ability to provide informed consent.
* Patients on isolation precautions due to resistant bacteria or impaired immune function.

Primary outcomes:
measure: Hospice Knowledge Scale
timeFrame: 1 month follow-up
measure: Hospice Beliefs and Attitudes Scale
timeFrame: 1-Month follow up
measure: Decision Self Efficacy Scale
timeFrame: 1 month Follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Daniel Matlock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brereton E, Harger G, Matlock DD, Dorsey Holliman B, Tate CE. How Do Patients Describe Hospice Care? A Qualitative Analysis of the Language Used by Older Adults to Describe Hospice Care. J Palliat Med. 2022 Nov;25(11):1692-1696. doi: 10.1089/jpm.2022.0011. Epub 2022 Aug 9.
citation: Tate CE, Venechuk G, Pierce K, Khazanie P, Ingle MP, Morris MA, Allen LA, Matlock DD. Development of a Decision Aid for Patients and Families Considering Hospice. J Palliat Med. 2021 Apr;24(4):505-513. doi: 10.1089/jpm.2020.0250. Epub 2021 Jan 13.
Clinical trial NCT01820000: Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE
Official title: Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Attack
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Use of MRI and DWI to diagnose cardiac scarring after heart attack.

Detailed description: To discover new information about MRI (magnetic resonance imaging) called DWI (diffusion weighted imaging) and its ability to diagnose cardiac scarring.

CMR-DE (cardiac MR with delayed contrast enhancement) evaluates if there has been scarring in the heart muscle following a heart attack.

Subjects are injected with a contrast medication that makes the scarring visible if present. To prove the efficacy of DWI (diffusion weighted imaging) to provide the same images that CMR-DE (cardiac magnetic resonance with delayed contrast enhancement) provides.

Eligibility criteria: Inclusion Criteria:

* Males and females 21 years of age and older
* Healthy volunteers
* subjects with a prior history of heart attack and prior CMR-DE imaging.

Exclusion Criteria:

* Women who are pregnant
* Subjects with GFR \< 60 ml/min/1.73m2
* Subjects with ICD
* Subjects with coronary stents incompatible with 3T

Primary outcomes:
measure: presence and apparent diffusion coefficient (ADC) quantification of scar on (DWI) diffusion weighted image
timeFrame: single occurance
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jadranka Stojanovska, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488800: Safety and Local Tolerability of Prevenar in Indian Children
Official title: A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Infections/PC (Prevention & Control)
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.

Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.

Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.

This is an observational study and the protocol for the study has been approved by the Board of Health.


Eligibility criteria: INCLUSION CRITERIA

Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:

For Primary Immunization Schedule:

* Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
* For Catch-up Immunization Schedule:
* Healthy male or female subjects 12-23 months of age

EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.

* A known or suspected history of Streptococcus pneumoniae disease.
* A previous anaphylactic or other severe vaccine-associated adverse event.
* A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents.
* A major congenital, developmental or serious chronic disorder.
* A confirmed or suspected underlying evolving neurological disorder or history of seizures.
* A history of thrombocytopenia or any coagulation disorder.
* Any acute illness at the time of vaccine administration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06519500: Generation of Organoids of Neuroendocrine Neoplasms of the Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery
Official title: Generation of Organoids of Neuroendocrine Neoplasms of the Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro-entero-pancreatic Neoplasms
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients affected by GEP-NEN undergoing treatment will be enrolled in this study surgery to remove the tumor

Brief summary: Observational, prospective, feasibility pilot study of the preparation of organoids starting from tumor tissue and surrounding healthy tissue, collected during surgery, performed according to standard clinical practice.

Detailed description: Given the need for the use of experimental models that mimic the tumor of origin

Eligibility criteria: Inclusion Criteria:

* over 18 years of age;
* diagnosis of GEP-NEN carried out via histological investigation or via positivity to the uptake PET-CT with 68Ga-peptides;
* availability of adequate material for the preparation of organoid cultures, derived from surgery;
* written informed consent.

Exclusion Criteria:

* previous chemotherapy treatments

Primary outcomes:
measure: Set up of at least 10 organoid cultures
timeFrame: 42 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Laura Monteonofrio, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03235700: Hyperemic Efficacy of IV Adenosine in HFrEF
Official title: Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Coronary Artery Disease
Keywords: heart failure with reduced ejection fraction
intermediate coronary stenosis
adenosine
hyperemia
Lead sponsor: Sejong General Hospital
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire.

Detailed description: Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire. Patients with an angiographically intermediate lesion (40-70% diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection fraction ≤40% will be prospectively enrolled. FFR under the various hyperemic stimulation using IV adenosine 140 \& 180, IC adenosine, and IC nicorandil will be measured sequentially.

Eligibility criteria: Inclusion Criteria:

* angiographically proven epicardial intermediate stenosis (40-70%)
* echocardiographically proven LV dysfunction (LVEF ≤40%)

Exclusion Criteria:

* infarct-related artery, less than 2 weeks
* Killip class 3 and 4
* bronchial asthma
* second degree or third degree AV block
* any contraindications to adenosine

Primary outcomes:
measure: Failure to induce maximal hyperemia
timeFrame: less than 1 day
Secondary outcomes:
measure: Fractional flow reserve
timeFrame: less than 1 day
measure: time to maximal hyperemia
timeFrame: less than 1 day
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
state: Gyeonggi
Study officials:
References:
Clinical trial NCT04087200: Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome
Official title: The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Keywords: STEMI
NSTEMI
Acute kidney injury
Renal function
Statin therapy
Lead sponsor: Centro Cardiopatici Toscani
Sponsor class: OTHER
Collaborators: name: Azienda USL 4 Prato
First posted: 2019-09-12
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Statin-naive patients and those on statin therapy with ACS (both STEMI and NSTEMI)

Brief summary: Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.

Detailed description: Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.

Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome (ST elevation and non ST elevation)
* Early invasive strategy

Exclusion Criteria:

* contraindication to statin therapy
* refusal of consent

Primary outcomes:
measure: Acute renal function changes
timeFrame: Within 72 hours after hospital admission
measure: Inflammatory profile changes
timeFrame: up to 1 month
measure: Lipid profile changes
timeFrame: up to 1 month
measure: Platelet count
timeFrame: up to 1 month
measure: Platelet volume
timeFrame: up to 1 month
measure: Platelet aggregation profile
timeFrame: up to 1 month
Secondary outcomes:
measure: Major cardiovascular adverse events
timeFrame: up to 12 months
measure: Renal function changes
timeFrame: Changes from baseline at 1 month
measure: Major adverse cardiovascular and renal adverse events
timeFrame: up to 1 month
Other outcomes:
measure: Impact of age and frailty profile on primary and secondary outcomes
timeFrame: Up to 1 month
Locations:
city: Prato
country: Italy
facility: Cardiology Division, Prato Hospital
Study officials:
References:
Clinical trial NCT02901600: Expression of DMBT1 in Colorectal Cancer Patients
Official title: Modification of the Expression and the Localization of DMBT1 (Deleted in Malignant Brain Tumor 1) in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DMBT1 Protein, Human
Colorectal Cancer
Keywords: DMBT1 expression
Colorectal cancer
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 145
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: Individuals with colorectal carcinoma, with polyps or without colonic pathology

Brief summary: Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease.

Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.


Eligibility criteria: Inclusion Criteria:

* for colon cancer: patients surgically treated for colorectal cancer at the Group of hospitals of the Catholic Institute of Lille.
* for adenomatous polyps : patients treated for adenomatous polyps at the Group of hospitals of the Catholic Institute of Lille.
* for controls: patients surgically treated for diverticular disease at the Group of hospitals of the Catholic Institute of Lille.

Exclusion Criteria:

* none

Primary outcomes:
measure: Semi-quantitative determination of the histological expression of DMBT1
timeFrame: at baseline
measure: Determination of the histological localisation of DMBT1
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GHICL
name: Adriana Mihalache, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05118100: Effectiveness of Adhesive Containing MDPB
Official title: Effectiveness of Adhesive Containing MDPB: a Practice-based Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Caries
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 5102
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited one of the participating general dental practices during the study period needing at least one dental restoration

Brief summary: 9 general practices in the Netherlands were provided with two composite resin adhesives, each for a period of 9 months. One contained MDPB (Adhesive P), and the other one was used as a control (Adhesive S). Patient's age, SES, and caries risk, as well as tooth type/number, reason for restoration placement, used restorative material and bonding agent, and affected surfaces were recorded. All interventions carried out on these teeth in the next 6 years were extracted from the electronic patient records, along with their date, type, reason, and surfaces. Two dependent variables were defined: general failure, and failure due to secondary caries. All data handling and statistical analyses were carried out in R 4.0.5.


Eligibility criteria: Inclusion Criteria:

* Needing at least one dental restoration

Exclusion Criteria:

* Opted out of data collection

Primary outcomes:
measure: Restoration survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Failure through caries
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03898700: Coaching for Caregivers of Children With Spinal Cord Injury
Official title: Coaching in Context for Caregivers of Children With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 9
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post coaching intervention
Primary purpose: OTHER

Brief summary: This pilot study has two aims. The first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.

Detailed description: This study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. A one-group pre-post treatment design will be used. Consented caregivers will receive coaching via face-to-face or via the phone. Each caregiver will participate in up to 10 coaching sessions. Each coaching session will last up to 90 minutes. Coaching sessions will be audiorecorded and transcribed verbatim. Outcomes of coaching on caregivers' self-identified goals will be assessed using the Canadian Occupational Performance Measure.

Eligibility criteria: Inclusion Criteria:

* female primary caregiver of youth between 6-13 years of age with traumatic spinal cord injury
* female primary caregivers have legal guardianship of their child with spinal cord injury
* speak, read and comprehend English
* be available for face-to-face coaching
* have a cell phone with text messaging capabilities, and willing to utilize cell or land line for coaching and data collection
* able to verbalize changes in their own participation or their child's participation during initial screen
* written consent

Exclusion Criteria:

* severe mental health condition of female caregiver, as documented in child's medical record or reported to research staff by child's treating MD or medical team member
* abuses illicit or prescribed substances or alcohol at time of initial screen as documented in child's medical record or reported to research staff by child's treating MD or medical team member

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shriners Hospitals for Children
state: Illinois
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children
state: Pennsylvania
city: Houston
country: United States
facility: TIRR Memorial Hermann Rehabilitation Hospital
state: Texas
Study officials:
affiliation: Thomas Jefferson University
name: MJ Mulcahey, PhD
role: PRINCIPAL_INVESTIGATOR
References: