louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06422871: PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
Official title: PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Renal Disease
Hemodialysis Access Failure
Keywords: HeRO
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-21
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: NON_PROBABILITY_SAMPLE
Study population: End-stage renal disease patients on hemodialysis who have exhausted all other access options.

Brief summary: The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.


Eligibility criteria: Key Inclusion Criteria:

* Subject provides written informed consent
* Subject is ≥ 18 years
* Subject is end-stage renal disease patient on hemodialysis.
* Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)

Key Exclusion Criteria:

* Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
* Subject has a topical or subcutaneous infection associated with the implantation site
* Subject has known or suspected systemic infection, bacteremia or septicemia

Primary outcomes:
measure: Composite Endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Success
timeFrame: 12 and 24 months
measure: Proportion of subjects with primary patency
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects with cumulative patency
timeFrame: 6, 12, and 24 months
measure: Device-related safety events
timeFrame: 24 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Heart and Vascular Hospital - Dallas
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Stephen Hohmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04275271: The Effect of Skill Centered Intervention Based on IMB Model on Promoting Teachers' Professional Competence in Teaching Sexuality Health.
Official title: The Effect of Skill Centered Intervention Based on IMB Model on Promoting School Teachers' Professional Competence in Teaching Sexuality Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Performance
Keywords: skill based intervention,
IMB model,
Professional Competence,
Sexual Health.
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Biotechnology and Biological Sciences Research Council
name: Mazandaran University of Medical Sciences
First posted: 2020-02-19
Enrollment: 56
Sex: MALE
Minimum age (years): 27
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study aim is determining the impact of a skill based intervention based on IMB model on Promoting School Teachers' Professional Competence in Teaching Sexual Health.

Detailed description: This research is a randomized control field trial with two groups; intervention and control. Sampling will be conducted by block design (with block size of 4) random allocation.

Intervention group: Intervention group will be received sexuality teaching skills for promotion of professional competence based on information, motivation and behavioral skills model for adolescent sexuality after signing informed consent form and being informed about the goals and details of intervention for 6 sessions (one two hour session per week).

The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness can use the content of program.

Eligibility criteria: Inclusion Criteria:

* Having instructors' consent to enter the study, instructor approval for teaching in terms of education system
* Having at least 5 years of teaching experience.

Exclusion Criteria:

* Not participating in at least a third of the sessions
* Not willing to continue cooperation.

Primary outcomes:
measure: Changes of mean difference score of professional competence.
timeFrame: Before intervention
measure: Mean difference score
timeFrame: immediately after the intervention
measure: Mean difference score
timeFrame: 6 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tehran University of Medical Sciences
name: Raziyeh Maasoumi, Assistant
role: STUDY_CHAIR
References:
citation: Griewatz J, Simon M, Lammerding-Koeppel M. Competency-based teacher training: A systematic revision of a proven programme in medical didactics. GMS J Med Educ. 2017 Oct 16;34(4):Doc44. doi: 10.3205/zma001121. eCollection 2017.
citation: Defebvre MM, Pavageau M, Chretien A, Carron F, Vanlacken V. [Evaluation of health education training in a French region]. Sante Publique. 2007 Jan-Feb;19(1):39-51. doi: 10.3917/spub.071.0039. French.
Clinical trial NCT05476471: The Effectiveness of Health Promotion Programs on the Pre-frail Individuals
Official title: The Short Effectiveness of Self-Management Skills and Health Promotion Programs on the Health Status of the Pre-frail Individuals in the Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: multicomponent exercise training
older adults
physical activity
physical performance
Pre-frailty
Coronavirus Disease 2019 pandemic
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2022-07-27
Enrollment: 169
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet.
Primary purpose: PREVENTION

Brief summary: This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

Detailed description: This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven eligible subjects consented to participate in the study. Community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet. Assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.

Eligibility criteria: Inclusion Criteria:

* older adult with age ≥ 60 years
* community-dwelling
* no hearing and visual acuity difficulties

Exclusion Criteria:

* Unconscious
* Cognitive impairment or dementia

Primary outcomes:
measure: Physical activity
timeFrame: 4 month follow up
measure: short physical performance battery
timeFrame: 4 month follow up
measure: Frailty
timeFrame: 4 month follow up
Secondary outcomes:
measure: upper limb muscle strength
timeFrame: 4 month follow up
measure: static balance ability
timeFrame: 4 month follow up
measure: physical agility and dynamic balance ability
timeFrame: 4 month follow up
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Shu-Hung Chang, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00055471: A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Metastases, Neoplasm
Keywords: prostate cancer
Metastatic prostate cancer
bone metastases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-03-04
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer


Eligibility criteria: Inclusion Criteria:

* Men 18 years \& older
* Confirmed diagnosis of prostate cancer with bone metastases

Exclusion Criteria:

* No more than 2 prior chemotherapy regimens
* No radiation, chemotherapy or bisphosphonates in the past 4 weeks

Primary outcomes:
measure: Dose Limiting Toxicities (DLTs)
timeFrame: Baseline to Day 29.
Secondary outcomes:
measure: Total Prostate Specific Antigen (PSA) Concentration
timeFrame: Baseline to Day 15.
measure: Change in Total Prostate Specific Antigen (PSA)
timeFrame: Baseline to Day 15.
measure: Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
timeFrame: Baseline to Day 15.
measure: Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
timeFrame: Baseline to Day 15.
measure: Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
timeFrame: Baseline to Day 15.
measure: Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
timeFrame: Baseline to Day 15.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References:
Clinical trial NCT04579471: Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study
Official title: Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
SARS-CoV Infection
Transplantation Infection
Keywords: covid19
SARS-CoV Infection
transplantation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Hasselt University
name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
First posted: 2020-10-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who underwent solid organ or hematopoietic transplantation at UZ Leuven and who give informed consent

Brief summary: This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.


Eligibility criteria: Inclusion Criteria:

* all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent

Exclusion Criteria:

* age under 18 years

Primary outcomes:
measure: Prevalence and risk-factors for SARS-CoV-2 infection
timeFrame: inclusion during 4 months
measure: Prevalence and risk-factors for COVID-19
timeFrame: inclusion during 4 months
Secondary outcomes:
measure: Durability of IgG positivity
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Jef Verbeek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372671: Evaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation Participation
Official title: Evaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation Participation, the CR$P-2 Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Unstable Angina
Coronary Angioplasty
Coronary Artery Bypass Surgery
Keywords: Cardiac Rehabilitation
Improving Cardiac Rehabilitation Participation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether a pre-discharge videotape introducing the concept and benefit of a Cardiac Rehabiliation \& Secondary Prevention (CRSP) program will increase intent to participate in a CRSP program in post myocardial infarction, unstable angina, coronary artery bypass surgery, or coronary angioplasty patients.

Detailed description: There is compelling evidence that a comprehensive CR program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, unstable angina, angioplasty or coronary artery bypass. However less than 20% of eligible patients participate in CRSP programs. This study will look at a method of potentially improving enrollment and adherence to a CRSP program. Patients will be randomized into two groups. One group will complete a survey and view a videotape introducing the concept of a CRSP program. The second group will be requested to complete a survey only, but will not be exposed to the videotape. It is expected that the patients who view the videotape will be more likely to express intent to participate in CRSP versus those patients who do not view the videotape.

Eligibility criteria: Inclusion Criteria:

* Admission to hospital for MI, UA, PTCA or CABS

Exclusion Criteria:

* Inability to provide written informed consent or complete the survey for any reason
* Previous CRSP participation
* Patients who are scheduled to undergo coronary artery bypass surgery within 3 months following the index hospital discharge
* Patients with an inability to exercise due to musculoskeletal problems or previous stroke

Primary outcomes:
measure: Expressed intent to participate in a CRSP program.
Secondary outcomes:
measure: Number of patients who continue to adhere to the 6-month CRSP program beyond the initial expressed intent to participate.
measure: Impact of other patient variables and how they influence participation in a CRSP program.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Western Ontario and London Health Sciences Centre
name: Neville Suskin, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04570371: Non-pharmacological Pain Management After Surgery
Official title: Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-09-30
Enrollment: 81938
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a stepped wedge cluster randomized pragmatic clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the impact of a bundled NOHARM Conversation Guide with clinical decision support intervention embedded within an Electronic Health Record (EHR) on pain and function 3 months following surgery.


Eligibility criteria: Inclusion Criteria:

* All patients 18 years of age and older.
* Must be undergoing qualifying surgeries at participating sites.
* Patients under 18 years of age.

Exclusion Criteria:

- Patients under 18 years of age.

Primary outcomes:
measure: PROMIS-CAT Pain
timeFrame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
measure: PROMIS-CAT Physical Function
timeFrame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
measure: PROMIS-CAT Physical Anxiety
timeFrame: Baseline (before hospital discharge), 3-Months Post-Surgery
measure: Use of Non-Pharmacological Pain Control Modalities
timeFrame: 3 Months Post-Surgery
measure: Opioid Use
timeFrame: 3-Months Post-Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrea L Cheville
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redmond S; Mayo Clinic NOHARM Research Team; Tilburt J, Cheville A. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial. Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3.
Clinical trial NCT04509271: Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease
Official title: Shanghai Mental Health Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 1300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: NC, AD, DLB, FTD and MCI due to AD

Brief summary: The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.


Eligibility criteria: Inclusion Criteria:

* 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)

Exclusion Criteria:

* Dementia caused by infection or substance
* Thyroid disease

Primary outcomes:
measure: The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.
timeFrame: 1 and half years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02624271: Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk
Official title: Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Gastric Precancerous Lesions
Keywords: gastric cancer
gastric precancerous lesions
blood test
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis.

Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care
* Patients with increased risk of gastric cancer (at least one of the following criteria):

  * age \> 50 years,
  * family cases of gastric cancer,
  * known precancerous lesions,
  * Biermer disease,
  * H. Pylori infection,
  * genetic predisposition (ex: Lynch syndrome),
  * MALT lymphoma,
  * dyspepsia.
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Subjects with known active cancer
* Pregnancy
* Patients receiving proton-pump inhibitors
* Conditions that may interfere with the study objectives according to the investigator

Primary outcomes:
measure: Sensitivity of GastroPanel blood test
timeFrame: One assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: MATYSIAK BUDNIK Tamara, Pr
role: PRINCIPAL_INVESTIGATOR
References: