louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05541731: Implementation Study of the ICOPE Program for the Detection of Frailty in the Elderly Within the Territorial Health Professional Communities (CPTS) of Brest Region
Official title: Implementation Study of the ICOPE Program for the Detection of Frailty in the Elderly Within the Territorial Health Professional Communities (CPTS) of Brest Region
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Frailty
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All primary care staff in the two CPTS caring for non-dependent patients aged 70 and over

Brief summary: Frailty is a geriatric syndrome resulting from a decrease in physiological reserve capacities altering the mechanisms of adaptation to stress with, in the absence of diagnosis and management, a short-term risk of falls, hospitalization, loss of autonomy and death.

In 2019, the World Health Organization has taken up this subject with the objective of reducing the number of dependent people in the world by 15 million, i.e. 150,000 in France. For this purpose, recommendations for integrated care for seniors (Integrated Care for Older People = ICOPE) have been published.

6 functions are essential to maintain autonomy: mobility, memory, sight, hearing, mental health and nutrition. The first step of the ICOPE program consists of screening for a decline in one of these functions using a tool made up of questions or tests that can be carried out in 8 to 10 minutes in primary care by trained non-professionals. The second step is a thorough evaluation of the person screened, leading to the creation of a personalized care plan. In the current state of affairs, despite its recommendations, this identification is not carried out in Brittany.

The objective of this study is to demonstrate the feasibility of implementing the first stage of the ICOPE program by seizing the opportunity of the creation in the Brest region of two Territorial Health Professional Communities (CPTS) : Brest Santé Océane and Iroise santé.


Eligibility criteria: Inclusion Criteria:

* Primary care staff belonging to one of the 2 CPTS (CPTS Brest Santé Océane and CPTS Iroise santé) and having accepted to participate in the study

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Feasibility of identifying frail elderly people aged 70 and over
timeFrame: Month 12
Secondary outcomes:
measure: Rate of individuals who had one or more of the 6 essential functions for maintaining independence
timeFrame: Month 12
measure: Feeling about the ICOPE MONITOR tool
timeFrame: Month 12
Other outcomes:
Locations:
city: Guipavas
country: France
facility: Cpts Brest Sante Oceane
city: Saint-Renan
country: France
facility: Cpts Pays D'Iroise
Study officials:
References:
Clinical trial NCT01804231: Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer
Official title: A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
PET
MRI
Hybrid
Recurrence
Fluorocholine
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-03-05
Enrollment: 22
Sex: MALE
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy.

We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.

Detailed description: The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy or radiation with negative bone and CT scans. Hybrid PET/MRI using 18F-FCH will be obtained and a consensus staging report generated for the attending clinician. Clinical management questionnaires completed by the study investigator will be obtained pre and post imaging in order to gauge the impact of the hybrid imaging on clinical decision making.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer with rising prostate specific antigen (PSA) post prostatectomy or radiotherapy
* Suspected recurrence based on PSA rise measured on 3 occasions at least 3 months apart and an absolute PSA \> 0.2 ng/mL
* Bone scan and CT scan of the abdomen and pelvis negative for metastatic disease

Exclusion Criteria:

* Evidence of metastatic disease
* Contradiction to 18F-FCH PET scan
* Contraindication to MRI

Primary outcomes:
measure: Frequency in change of clinical management based on results of 18F-FCH PET/MRI
timeFrame: Within 2 weeks of study scan
Secondary outcomes:
measure: Number of lesions identified with 18F-FCH based on consensus reporting
timeFrame: Within 2 weeks of study scan
Other outcomes:
measure: Concordance between MRI and 18F-FCH PET for lesion identification
timeFrame: Within 2 weeks of study scan
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Dr. Glenn S Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06459531: Effect of VR VS Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
Official title: Effect of Virtual Reality Versus Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises. Studies have indicated that VR can lead to significant improvements in motor function, coordination, and strength of the affected upper limb.

Detailed description: These advancements are often attributed to the ability of VR to provide real-time feedback, varied and repetitive tasks, and the stimulation of neuroplasticity. In contrast, conservative treatments, such as traditional physical and occupational therapy, though beneficial, may not offer the same level of stimulation and engagement. Overall, VR therapy can be a valuable adjunct to traditional rehabilitation, potentially accelerating recovery and improving functional outcomes for chronic stroke patients by providing a more dynamic and engaging approach to therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
* Adults aged 18 years and older.
* Demonstrable sensorimotor impairment of the upper extremity due to stroke, as assessed by clinical evaluation.
* Sufficient cognitive ability to follow instructions and participate in VR therapy, as determined by a Mini-Mental State Examination (MMSE) score of 24 or higher.
* Medically stable and able to participate in physical rehabilitation sessions, as cleared by a healthcare professional.

Exclusion Criteria:

* Severe communication difficulties that would impede the ability to follow instructions during therapy.
* Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher)

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA) for Upper Extremity
timeFrame: 12 Months
measure: Stroke Impact Scale (SIS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: General hospital Jinnah hospital Mayo hospital Chaudhry Muhammad Akram Teaching and research hospital Services hospital Lahore (SHL)
Study officials:
References:
Clinical trial NCT04217031: Decision Variability Between Different Heart Teams for Complex Coronary Artery Diseases
Official title: Decision Variability Between Different Heart Teams for Complex Coronary Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Heart team
Decision making
Complex coronary artery disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-01-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients will be randomly selected and enrolled from a coronary angiography registry database at Fuwai hospital to make sure the representativity of enrolled patients.

Brief summary: The purposes of this study are 1) to explore the variability of decisions between different heart teams in complex coronary artery disease; 2) to evaluate the reasons of the discrepancy in decision making.

Detailed description: Heart team has been recommended by guideline for optimizing the decision making for patients with complex coronary artery diseases (CAD). However, prior studies have demonstrated that heart team decision might have poor reproducibility, and the variability of heart team decision remains unknown.

Thus, the investigators designed a single-center, retrospective, cross-sectional study to explore the decision variability of heart team in CAD patients. The investigators will retrospectively recruit patients with angiographically confirmed 3-vessel or left main disease from a coronary angiography database at Fuwai hospital. Patients' baseline information will be collected. And different heart teams will be established and made decisions for the enrolled patients. First, the investigators will assess the decision variability between different heart teams. Secondary, the investigators will evaluate the reason of discrepancy by qualitative and quantitative analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with angiographically confirmed 3-vessel disease or left main disease

Exclusion Criteria:

* Prior percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
* Myocardial infarction with acute phase judged by Electrocardiograph or biomarkers
* Combined with severe valvular disease, great vessel disease or huge ventricular aneurysm which need surgery
* Combined with atrial fibrillation or severe arrhythmia

Primary outcomes:
measure: Kappa value of decisions
timeFrame: at the end of enrollment (6 months)
Secondary outcomes:
measure: Concordance rate of decisions
timeFrame: at the end of enrollment (6 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04640831: Safety of GH001 in Healthy Volunteers
Official title: A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: healthy volunteers
5-MeO-DMT
5-methoxy-dimethyltryptamine
Lead sponsor: GH Research Ireland Limited
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.

The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.


Eligibility criteria: Inclusion Criteria:

* Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive);
* Subject is in good general health in the opinion of the medical supervisor;
* Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview;

Exclusion Criteria:

* Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
* Has received any investigational medication within the last 1 month.
* Has a medically significant condition, which renders the subject unsuitable for the study.

Primary outcomes:
measure: The safety and tolerability of GH001
timeFrame: up to 7 days
measure: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale
timeFrame: Retrospectively assessed at 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Clinical Trial Site
Study officials:
affiliation: GH Research Ireland Limited
name: GH Research Clinical Team
role: STUDY_DIRECTOR
References:
citation: Reckweg J, Mason NL, van Leeuwen C, Toennes SW, Terwey TH, Ramaekers JG. A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Front Pharmacol. 2021 Nov 25;12:760671. doi: 10.3389/fphar.2021.760671. eCollection 2021.
Clinical trial NCT00497731: AZD1152 in Patients With Advanced Solid Malignancies-Study 1
Official title: A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Advanced solid tumors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 70
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 primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of a solid, malignant tumour
* At least measurable or non measurable site of disease as defined by modified RECIST criteria.

Exclusion Criteria:

* Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug
* Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
* Recent major surgery within 4 weeks prior to entry to the study

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Assessed at each visit
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Assessed at predetermined timepoints after dose administration
measure: Effect on biomarkers
timeFrame: Assessed after treatment
measure: Anti-tumor activity
timeFrame: Assessed after treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
affiliation: NKI
name: Jan Schellens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06016231: Clinical Outcomes of Patients with a Light Adjustable Lens (LAL) in At Least One Eye
Official title: Clinial Outcomes of Bilateral Pseudophakic Patients with a Light Adjustable Lens (LAL) Implanted in At Least One Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IOL
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bilateral pseudophakia in adults implanted with the LAL in at least one eye and who have completed Light Delivery Device (LDD) light treatments

Brief summary: To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye


Eligibility criteria: Inclusion Criteria:

* Adults with bilateral pseudophakia who have been implanted with the LAL in at least one eye and who have completed LDD light treatments

Exclusion Criteria:

* Visually significant eye disease

Primary outcomes:
measure: Patient Satisfaction - subjective questionnaire
timeFrame: 3-18 months after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision Institute
name: Frank A Bucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05116631: Evaluation of Emergency Department Visits and Activity : Study
Official title: Analysis of Emergency Department Visits and Activity in Montpellier Dental University Hospital : Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental
Keywords: Dental emergencies
Emergency department
Patients coming to the CHU ADV Montpellier for consultation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults (\>18years) consulting in the emergency department (Montpellier University Hospital)

Brief summary: The main objective will be to evaluate the type of care performed and the main reasons for consulting patients for an odontological emergency in order to better adapt to the flow and expectations of patients.


Eligibility criteria: Inclusion criteria:

- All adults (\>18years) consulting in the emergency department (Montpellier University Hospital)

Exclusion criteria:

* person under 18 years old
* patients who does not speak French

Primary outcomes:
measure: Rate of The result for each item of the questionnaire according to the reason for the emergency
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants with Know the type of population received
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Camille INQUIMBERT, PhD
role: STUDY_DIRECTOR
affiliation: UH MONTPELLIER
name: samuel MORAND-MANAS, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297231: Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI
Official title: Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: fibroglandular tissue
tamoxifen
MRI
Background Parenchymal Enhancement
10-217
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible premenopausal patients with stage 0-3 breast cancer for whom MRI staging is planned will be enrolled.

Brief summary: Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.

This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.


Eligibility criteria: Inclusion Criteria:

* Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI within 1 year prior to starting tamoxifen
* Premenopausal status is defined as intact ovaries and still menstruating
* Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility
* Willing and able to undergo all study procedures

Exclusion Criteria:

* Contraindication to breast MRI (such as non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium)
* Bilateral breast cancer or treatment such as:
* History of or planned bilateral breast irradiation
* History of or planned bilateral mastectomy
* Bilateral breast cancer
* History of unilateral mastectomy or radiation treatment with contralateral breast cancer
* Taking chemo- or hormonal therapy at the time of the baseline breast MRI
* Estrogen and progesterone receptor negative breast cancer
* GFR less than GFR \< 30 mL/min/1.73m2
* Postmenopausal women
* Pregnant and/or nursing women
* Less than 21 years of age

Primary outcomes:
measure: To compare the level of BPE on breast MRI
timeFrame: 3 years
Secondary outcomes:
measure: To compare the amount of fibroglandular tissue on breast MRI
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Valencia King, MD
role: PRINCIPAL_INVESTIGATOR
References: